Patents whose numbers are in italics have been extended under 35 USC 156. Unless otherwise noted, all expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
Products tagged as [GENERIC] have had a generic equivalent approved for at least one strength of the product.
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10596276 DP* Stable, concentrated radionuclide complex solutions Claim Types: Product-by-proces; Process Pat. Sub. Date(s): 001: Apr 13, 2020 | Jan 25, 2039 *PED | |
| Pat. No. 10596278 DP* Stable, concentrated radionuclide complex solutions Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 13, 2020 | Jan 25, 2039 *PED | |
| Pat. No. 11904027 DP* Stable, concentrated radionuclide complex solutions Claim Types: Process; Product-by-process Pat. Sub. Date(s): 001: Mar 15, 2024 | Jan 25, 2039 *PED | |
| Pat. No. 12144873 Stable, concentrated radionuclide complex solutions Claim Types: Method of use; ; Method of Use claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Nov 19, 2024 | Jan 25, 2039 *PED | U-4036: Treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (gep-nets), including foregut, midgut, and hindgut neuroendocrine tumors |
| Pat. No. 12151003 DP* Stable, Concentrated Radionuclide Complex Solutions Claim Types: Formulation; Drug in a container; Method of use Pat. Sub. Date(s): 001: Nov 26, 2024 | Jan 25, 2039 *PED | U-4036: Treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (gep-nets), including foregut, midgut, and hindgut neuroendocrine tumors |
| Pat. No. 12161732 DP* Stable, Concentrated Radionuclide Complex Solutions Claim Types: Process; Product-by-process; Method of use Pat. Sub. Date(s): 001: Dec 10, 2024 | Jul 25, 2038 | U-4036: Treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (gep-nets), including foregut, midgut, and hindgut neuroendocrine tumors |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Oct 23, 2027 PED | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jul 26, 2025 PED | ODE-166: Treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETS) including foregut, midgut, and hindgut neuroendocrine tumors in adults |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 23, 2031 PED | ODE-479: Treatment of pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETS), including foregut, midgut, and hindgut neuroendocrine tumors |
AAA USA INC
NETSPOT (POWDER) (INTRAVENOUS) GALLIUM DOTATATE GA-68
NDA Applicant: AAA USA INC NDA No.: 208547 Prod. No.: 001 RX (2.1-5.5mCi/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9375498 DP* Process for the preparation of complexes of .sup.68Ga Claim Types: Kit; Product-by-process; Drug in a container; Process Pat. Sub. Date(s): 001: Jul 9, 2018 | Aug 10, 2032 |
AADI
FYARRO (POWDER) (INTRAVENOUS) SIROLIMUS
Drug Classes: kinase inhibitor == mTor inhibitor immunosuppressant
NDA Applicant: AADI NDA No.: 213312 Prod. No.: 001 RX (100MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8911786 DP* Nanoparticle comprising rapamycin and albumin as anticancer agent Claim Types: Method of use; Formulation; Kit Pat. Sub. Date(s): 001: Dec 17, 2021 | Feb 14, 2029 | U-3259: Treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PECOMA) |
| Pat. No. 10206887 DP* Prion free nanoparticle compositions and methods of making thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 17, 2021 | Apr 15, 2030 | |
| Pat. No. 10705070 DP* Methods of assessing suitability of use of pharmaceutical compositions of albumin and poorly water soluble drug Claim Types: Process Pat. Sub. Date(s): 001: Dec 17, 2021 | Mar 5, 2036 | |
| Pat. No. 10973806 Methods of treating epithelioid cell tumors comprising administering a composition comprising nanoparticles comprising an mTOR inhibitor and an albumin Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 17, 2021 | Jun 29, 2036 | U-3258: Treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PECOMA) with a dose between about 56 mg/m2 and about 100 mg/m2 administered on days 1 and 8 of a 21-day cycle |
| Pat. No. 11497737 DP* Pharmaceutical compositions of albumin and rapamycin Claim Types: Drug in a container Pat. Sub. Date(s): 001: Nov 23, 2022 | Oct 28, 2040 | |
| Pat. No. 12061183 DP* Methods of assessing suitability of use of pharmaceutical compositions of albumin and poorly water soluble drug Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Aug 13, 2024 | Mar 5, 2036 | |
| Pat. No. 12133844 Methods of treating epithelioid cell tumors Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 4, 2024 | Jun 29, 2036 | U-4040: Treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PECOMA) with a dose administered on days 1 and 8 of a 21-day cycle U-4041: Treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PECOMA) with a dose of 45 mg/m2 or 56 mg/m2 administered on days 1 and 8 of a 21-day cycle U-4042: Treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PECOMA) with a dose of 45 mg/m2 administered on days 1 and 8 of a 21-day cycle |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Nov 22, 2024 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 22, 2028 | ODE-386: For the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PECOMA) |
ABBVIE
ACULAR LS (SOLUTION/DROPS) (OPHTHALMIC) KETOROLAC TROMETHAMINE [GENERIC AT]
Drug Classes: cyclooxygenase inhibitor == nonsteroidal anti-inflammatory drug
NDA Applicant: ABBVIE NDA No.: 021528 Prod. No.: 001 RX (0.4%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8008338 DS* DP* Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 23, 2011 | Nov 24, 2027 *PED | U-1181: A method of treating or preventing ocular pain in a patient |
| Pat. No. 8207215 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 23, 2012 | Nov 28, 2024 *PED | U-1251: A method of controlling postoperative ocular pain and burning/stinging in a patient |
| Pat. No. 8377982 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of administration Pat. Sub. Date(s): 001: Mar 18, 2013 | Nov 28, 2024 *PED | U-1363: A method of treating or preventing ocular pain and burning/stinging following corneal surgery |
| Pat. No. 8541463 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 22, 2013 | Nov 28, 2024 *PED | U-1441: A method of treating or reducing ocular pain and burning/stinging |
| Pat. No. 8648107 DP* Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 4, 2014 | May 28, 2024 | |
| Pat. No. 8906950 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 8, 2015 | May 28, 2024 | U-1626: A method of treating or preventing ocular pain and burning |
| Pat. No. 8946281 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Mar 4, 2015 | May 28, 2024 | U-1662: A method of treating ocular pain |
| Pat. No. 9216167 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 20, 2016 | May 28, 2024 | U-1800: A method of treating ocular pain and/or enhancing ocular comfort |
ABBVIE
ACUVAIL (SOLUTION/DROPS) (OPHTHALMIC) KETOROLAC TROMETHAMINE
Drug Classes: cyclooxygenase inhibitor == nonsteroidal anti-inflammatory drug
NDA Applicant: ABBVIE NDA No.: 022427 Prod. No.: 001 RX (0.45%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7842714 DS* DP* Ketorolac tromethamine compositions for treating ocular pain Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 30, 2010 | Aug 15, 2029 | |
| Pat. No. 8512717 DP* Compositions for delivery of therapeutics into the eyes and methods for making and using same Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 19, 2013 | Mar 7, 2028 | |
| Pat. No. 8992952 DP* Compositions for delivery of therapeutics into the eyes and methods for making and using same Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 10, 2015 | Aug 5, 2024 | |
| Pat. No. 9192571 DP* Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 21, 2015 | Mar 7, 2028 |
ABBVIE
ALPHAGAN P (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE [GENERIC AB]
Drug Classes: alpha-adrenergic receptor agonist
NDA Applicant: ABBVIE NDA No.: 021770 Prod. No.: 001 RX (0.1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8858961 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 13, 2014 | Mar 2, 2024 *PED |
ABBVIE
AVYCAZ (POWDER) (INTRAVENOUS) AVIBACTAM SODIUM; CEFTAZIDIME
Drug Classes: beta lactamase inhibitor == cephalosporin antibacterial
NDA Applicant: ABBVIE NDA No.: 206494 Prod. No.: 001 RX (EQ 0.5GM BASE;2GM/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7112592 DS* DP* Azabicyclic compounds, preparation thereof and use as medicines, in particular as antibacterial agents Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Mar 17, 2015 | Jan 7, 2026 | U-2244: A method of treating bacterial infections in hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) patients comprising administering a bactericidally effective amount of avibactam sodium U-2508: A method of treating bacterial infections in complicated intra-abdominal infection and complicated urinary tract infection, including pyelonephritis, patients comprising administering a bactericidally effective amount of avibactam sodium U-282: Method of treating bacterial infections U-3818: Treatment of complicated intra-abdominal infections, complicated urinary tract infections, and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia in adult and pediatric patients (at least 31 weeks gestational age) |
| Pat. No. 7612087 DP* Heterocyclic compounds as inhibitors of beta-lactamases Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 17, 2015 | Nov 12, 2026 | |
| Pat. No. 8471025 DS* Crystalline forms of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide sodium salt Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Mar 17, 2015 | Aug 12, 2031 | |
| Pat. No. 8835455 DP* Crystalline forms of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide sodium salt Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 17, 2015 | Oct 8, 2030 | |
| Pat. No. 8969566 DS* Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Mar 17, 2015 | Jun 15, 2032 | |
| Pat. No. 9284314 DS* Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Feb 24, 2017 | Jun 15, 2032 | |
| Pat. No. 9695122 DS* Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof Claim Types: Formulation; Compound; Composition Pat. Sub. Date(s): 001: Aug 8, 2017 | Jun 15, 2032 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Feb 25, 2025 GAIN | |
| Exclusivity Code: NPP - New patient population | Dec 20, 2025 | |
| Exclusivity Code: NPP - New patient population | Jan 26, 2027 |
ABBVIE
BYVALSON (TABLET) (ORAL) NEBIVOLOL HYDROCHLORIDE; VALSARTAN [Has competitive generic]
Drug Classes: beta-adrenergic receptor inhibitor == angiotensin II receptor blocker
NDA Applicant: ABBVIE NDA No.: 206302 Prod. No.: 001 DISC (EQ 5MG BASE;80MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7803838 DP* Compositions comprising nebivolol Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 5, 2016 | Aug 29, 2026 | |
| Pat. No. 7838552 Compositions comprising nebivolol Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 5, 2016 | Oct 4, 2027 | U-185: Method of treating hypertension |
ABBVIE
CANASA (SUPPOSITORY) (RECTAL) MESALAMINE [GENERIC AB]
Drug Classes: aminosalicylate
NDA Applicant: ABBVIE NDA No.: 021252 Prod. No.: 002 RX (1GM)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8217083 DP* Mesalamine suppository Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: May 24, 2013 | Jun 6, 2028 | |
| Pat. No. 8436051 DP* Mesalamine suppository Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: May 24, 2013 | Jun 6, 2028 |
ABBVIE
DALVANCE (POWDER) (INTRAVENOUS) DALBAVANCIN HYDROCHLORIDE
Drug Classes: lipoglycopeptide antibacterial
NDA Applicant: ABBVIE NDA No.: 021883 Prod. No.: 001 RX (EQ 500MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6900175 Methods of administering dalbavancin for treatment of bacterial infections Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jun 13, 2014 | May 23, 2028 | U-3499: Treatment of acute bacterial skin and skin structure infections (ABSSSI) in adult and pediatric patients using a two-dose regimen of dalbavancin |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | May 23, 2024 GAIN | |
| Exclusivity Code: NPP - New patient population | Jul 22, 2024 |
ABBVIE
DURYSTA (IMPLANT) (OPHTHALMIC) BIMATOPROST
Drug Classes: prostaglandin analog
NDA Applicant: ABBVIE NDA No.: 211911 Prod. No.: 001 RX (10MCG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7799336 DP* Hypotensive lipid-containing biodegradable intraocular implants and related methods Claim Types: Device; Product-by-process Pat. Sub. Date(s): 001: Mar 24, 2020 | Apr 24, 2029 | |
| Pat. No. 8206737 Hypotensive lipid-containing biodegradable intraocular implants and related methods Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 24, 2020 | Apr 7, 2027 | U-2759: Reduction of intraocular pressure (IOP) in patients with open angle glaucoma(OAG) or ocular hypertension (OHT) with a biodegradable bimatoprost implant |
| Pat. No. 8629185 DS* DP* 7-[3,5-dihydroxy-2- (3-hydroxy-5-phenyl-pent-1-enyl)-cyclopentyl]-N-ethyl-hept-5-enamide (bimatoprost) in crystalline form II, methods for preparation, and methods for use thereof Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Mar 24, 2020 | Jul 15, 2031 | |
| Pat. No. 8673341 Intraocular pressure reduction with intracameral bimatoprost implants Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 24, 2020 | Feb 19, 2025 | U-2759: Reduction of intraocular pressure (IOP) in patients with open angle glaucoma(OAG) or ocular hypertension (OHT) with a biodegradable bimatoprost implant |
| Pat. No. 9149428 DP* Processes for making cyclic lipid implants for intraocular use Claim Types: Device Pat. Sub. Date(s): 001: Mar 24, 2020 | Dec 19, 2026 | |
| Pat. No. 9492316 DP* Prostamide-containing intraocular implants and methods of use thereof Claim Types: Device; Method of use; Process Pat. Sub. Date(s): 001: Mar 24, 2020 | Oct 31, 2034 | |
| Pat. No. 9980974 Prostamide-containing intraocular implants and methods of use thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 24, 2020 | Oct 31, 2034 | U-2759: Reduction of intraocular pressure (IOP) in patients with open angle glaucoma(OAG) or ocular hypertension (OHT) with a biodegradable bimatoprost implant |
| Pat. No. 10398707 Hypotensive lipid-containing biodegradable intraocular implants and related implants Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 24, 2020 | Apr 30, 2024 | U-2759: Reduction of intraocular pressure (IOP) in patients with open angle glaucoma(OAG) or ocular hypertension (OHT) with a biodegradable bimatoprost implant |
| Pat. No. 10441543 DP* Processes for making cyclic lipid implants for intraocular use Claim Types: Device Pat. Sub. Date(s): 001: Mar 24, 2020 | Dec 19, 2026 |
ABBVIE
FETZIMA (CAPSULE, EXTENDED RELEASE) (ORAL) LEVOMILNACIPRAN HYDROCHLORIDE [Has competitive generic]
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI)
NDA Applicant: ABBVIE NDA No.: 204168 Prod. No.: 001 RX (EQ 20MG BASE); 002 RX (EQ 40MG BASE); 003 RX (EQ 80MG BASE); 004 RX (EQ 120MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE43879 Use of the dextrogyral enantiomer of milnacipran for the preparation of a drug Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 15, 2013 | Jan 11, 2026 | U-839: Treatment of major depressive disorder (MDD) |
| Pat. No. 8481598 Stable dosage forms of levomilnacipran Claim Types: Method of use; Method of administration Pat. Sub. Date(s): All strengths: Aug 15, 2013 | Mar 2, 2031 | U-839: Treatment of major depressive disorder (MDD) |
| Pat. No. 8865937 DS* DP* Crystalline forms of (1S,2R)-2-(amino methyl)-N,N-diethyl-1-phenyl cyclopropane carboxamide Claim Types: New polymorph, salt or hydrate; Process; Composition Pat. Sub. Date(s): All strengths: Nov 20, 2014 | May 23, 2032 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Mar 24, 2026 | M-304: Information added to section 8.4 of the labeling to describe the results from study LVM-MD-11 and LVM-MD-14 |
ABBVIE
GELNIQUE (GEL) (TRANSDERMAL) OXYBUTYNIN CHLORIDE
Drug Classes: muscarinic antagonist
NDA Applicant: ABBVIE NDA No.: 022204 Prod. No.: 001 DISC (10% (100MG/PACKET)**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8920392 Method for treating overactive bladders and a device for storage and administration of topical oxybutynin compositions Claim Types: Drug in a container; Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 27, 2015 | Mar 26, 2031 | U-1644: Treatment of overactive bladder by application of oxybutynin chloride gel to skin |
| Pat. No. 9259388 Method for treating overactive bladders and a device for storage and administration of topical oxybutynin compositions Claim Types: Method of administration Pat. Sub. Date(s): 001: Mar 16, 2016 | Nov 6, 2029 | U-1644: Treatment of overactive bladder by application of oxybutynin chloride gel to skin |
| Pat. No. 10449173 DP* Method for treating overactive bladders and a device for storage and administration of topical oxybutynin compositions Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Oct 30, 2019 | Nov 6, 2029 | U-2637: Treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence with a single unit dose of 10% oxybutynin chloride gel |
ABBVIE
KYBELLA (SOLUTION) (SUBCUTANEOUS) DEOXYCHOLIC ACID [GENERIC AP]
NDA Applicant: ABBVIE NDA No.: 206333 Prod. No.: 001 RX (20MG/2ML (10MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7622130 Methods and compositions for the non-surgical removal of fat Claim Types: Method of use Pat. Sub. Date(s): 001: May 7, 2015 | Dec 10, 2027 | U-1690: Method for reduction of submental fat |
| Pat. No. 7754230 Methods and related compositions for reduction of fat Claim Types: Method of use Pat. Sub. Date(s): 001: May 7, 2015 | Dec 10, 2027 | U-1690: Method for reduction of submental fat |
| Pat. No. 8101593 DP* Formulations of deoxycholic acid and salts thereof Claim Types: Formulation Pat. Sub. Date(s): 001: May 7, 2015 | Mar 2, 2030 | |
| Pat. No. 8242294 DS* Synthetic bile acid compositions and methods Claim Types: Formulation Pat. Sub. Date(s): 001: May 7, 2015 | May 16, 2028 | |
| Pat. No. 8298556 Methods and related compositions for the non-surgical removal of fat Claim Types: Method of use Pat. Sub. Date(s): 001: May 7, 2015 | Aug 3, 2025 | U-1690: Method for reduction of submental fat |
| Pat. No. 8367649 DP* Formulations of deoxycholic acid and salts thereof Claim Types: Formulation Pat. Sub. Date(s): 001: May 7, 2015 | Mar 2, 2030 | |
| Pat. No. 8461140 DP* Synthetic bile acid compositions and methods Claim Types: Formulation Pat. Sub. Date(s): 001: May 7, 2015 | Feb 21, 2028 | |
| Pat. No. 8546367 DP* Synthetic bile acid compositions and methods Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): 001: May 27, 2015 | Feb 21, 2028 | U-1690: Method for reduction of submental fat |
| Pat. No. 8653058 DP* Compositions comprising deoxycholic acid and salts thereof suitable for use in treating fat deposits Claim Types: Formulation Pat. Sub. Date(s): 001: May 7, 2015 | Mar 2, 2030 | |
| Pat. No. 8846066 Methods and related compositions for reduction of fat and skin tightening Claim Types: Method of use Pat. Sub. Date(s): 001: May 7, 2015 | Feb 8, 2025 | U-1690: Method for reduction of submental fat |
| Pat. No. 8883770 DP* Synthetic bile acid compositions and methods Claim Types: Composition Pat. Sub. Date(s): 001: May 27, 2015 | Feb 21, 2028 | |
| Pat. No. 9522155 DP* Synthetic bile acid compositions and methods Claim Types: Composition; Method of use; Drug in a container Pat. Sub. Date(s): 001: Jan 19, 2017 | Feb 21, 2028 | U-1940: Improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults by means of reducing submental fat volume as described in the approved labeling |
| Pat. No. 9636349 Synthetic bile acid compositions and methods Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 29, 2017 | Feb 21, 2028 | U-1940: Improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults by means of reducing submental fat volume as described in the approved labeling |
| Pat. No. 9949986 Synthetic bile acid compositions and methods Claim Types: Method of use Pat. Sub. Date(s): 001: May 24, 2018 | Feb 21, 2028 | U-1940: Improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults by means of reducing submental fat volume as described in the approved labeling |
| Pat. No. 10500214 DP* Formulations of deoxycholic acid and salts thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 22, 2020 | Mar 2, 2030 |
ABBVIE
LASTACAFT (SOLUTION/DROPS) (OPHTHALMIC) ALCAFTADINE [GENERIC OTC]
Drug Classes: histamine-1 (H1) receptor antagonist
NDA Applicant: ABBVIE NDA No.: 022134 Prod. No.: 001 OTC (0.25%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8664215 Ocular allergy treatments with alcaftadine Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 21, 2014 | Dec 23, 2027 | U-3267: Use of LASTACAFT to temporary relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander |
| Pat. No. 10617695 DP* Ophthalmic compositions containing alcaftadine Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: May 12, 2020 | Mar 19, 2027 | U-3267: Use of LASTACAFT to temporary relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander |
ABBVIE
LATISSE (SOLUTION/DROPS) (TOPICAL) BIMATOPROST [GENERIC AT]
Drug Classes: prostaglandin analog
NDA Applicant: ABBVIE NDA No.: 022369 Prod. No.: 001 RX (0.03%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8101161 Method of enhancing hair growth Claim Types: Method of use Pat. Sub. Date(s): 001: May 10, 2012 | May 25, 2024 | U-1217: Method of increasing hair growth U-1218: Method of stimulating hair growth |
ABBVIE
LEXAPRO (TABLET) (ORAL) ESCITALOPRAM OXALATE [GENERIC AB]
Drug Classes: selective serotonin reuptake inhibitor (SSRI)
NDA Applicant: ABBVIE NDA No.: 021323 Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 10MG BASE); 003 RX (EQ 20MG BASE)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NPP - New patient population | May 12, 2026 |
ABBVIE
LEXAPRO (SOLUTION) (ORAL) ESCITALOPRAM OXALATE
Drug Classes: selective serotonin reuptake inhibitor (SSRI)
NDA Applicant: ABBVIE NDA No.: 021365 Prod. No.: 001 DISC (EQ 5MG BASE/5ML**)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NPP - New patient population | May 12, 2026 |
ABBVIE
LINZESS (CAPSULE) (ORAL) LINACLOTIDE
Drug Classes: guanylate cyclase-C agonist
NDA Applicant: ABBVIE NDA No.: 202811 Prod. No.: 001 RX (145MCG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7304036 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): 001: Sep 18, 2012 | Aug 30, 2026 | U-1278: Method of treating irritable bowel syndrome with constipation in adults U-1516: Method of treating chronic idiopathic constipation in adult patients. |
| Pat. No. 7371727 DS* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Sep 18, 2012 | Jan 28, 2024 | |
| Pat. No. 7704947 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Sep 18, 2012 | Jan 28, 2024 | |
| Pat. No. 7745409 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Sep 18, 2012 | Jan 28, 2024 | |
| Pat. No. 8080526 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Sep 18, 2012 | Jan 28, 2024 | |
| Pat. No. 8110553 Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 18, 2012 | Jan 28, 2024 | U-1278: Method of treating irritable bowel syndrome with constipation in adults |
| Pat. No. 8748573 Formulations comprising linaclotide Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 11, 2014 | Oct 30, 2031 | U-1515: Method of treating irritable bowel syndrome with constipation in adult patients. U-1516: Method of treating chronic idiopathic constipation in adult patients. |
| Pat. No. 8802628 DP* Stable solid formulation of a GC-C receptor agonist polypeptide suitable for oral administration Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 19, 2014 | Oct 30, 2031 | |
| Pat. No. 8933030 DP* Treatments for gastrointestinal disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Feb 6, 2015 | Feb 17, 2031 | |
| Pat. No. 9708371 DP* Treatments for gastrointestinal disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Aug 10, 2017 | Aug 16, 2033 | U-1515: Method of treating irritable bowel syndrome with constipation in adult patients. U-1516: Method of treating chronic idiopathic constipation in adult patients. |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jun 12, 2026 | I-921: Treatment of functional constipation in pediatric patients 6 to 17 years of age |
ABBVIE
LINZESS (CAPSULE) (ORAL) LINACLOTIDE
Drug Classes: guanylate cyclase-C agonist
NDA Applicant: ABBVIE NDA No.: 202811 Prod. No.: 002 RX (290MCG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7304036 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): 002: None | Aug 30, 2026 | U-1278: Method of treating irritable bowel syndrome with constipation in adults U-1516: Method of treating chronic idiopathic constipation in adult patients. |
| Pat. No. 7371727 DS* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Product-by-process; Process Pat. Sub. Date(s): 002: None | Jan 28, 2024 | |
| Pat. No. 7704947 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 002: None | Jan 28, 2024 | |
| Pat. No. 7745409 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 002: None | Jan 28, 2024 | |
| Pat. No. 8080526 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 002: None | Jan 28, 2024 | |
| Pat. No. 8110553 Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Method of use Pat. Sub. Date(s): 002: None | Jan 28, 2024 | U-1278: Method of treating irritable bowel syndrome with constipation in adults |
| Pat. No. 8748573 Formulations comprising linaclotide Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 11, 2014 | Oct 30, 2031 | U-1515: Method of treating irritable bowel syndrome with constipation in adult patients. U-1516: Method of treating chronic idiopathic constipation in adult patients. |
| Pat. No. 8802628 DP* Stable solid formulation of a GC-C receptor agonist polypeptide suitable for oral administration Claim Types: Formulation Pat. Sub. Date(s): 002: Aug 19, 2014 | Oct 30, 2031 | |
| Pat. No. 8933030 DP* Treatments for gastrointestinal disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: Feb 6, 2015 | Feb 17, 2031 | |
| Pat. No. 9708371 DP* Treatments for gastrointestinal disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: Aug 10, 2017 | Aug 16, 2033 | U-1515: Method of treating irritable bowel syndrome with constipation in adult patients. |
ABBVIE
LINZESS (CAPSULE) (ORAL) LINACLOTIDE
Drug Classes: guanylate cyclase-C agonist
NDA Applicant: ABBVIE NDA No.: 202811 Prod. No.: 003 RX (72MCG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7304036 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): 003: Feb 24, 2017 | Aug 30, 2026 | U-1516: Method of treating chronic idiopathic constipation in adult patients. U-3644: Treatment of functional constipation in pediatric patients 6 to 17 years of age |
| Pat. No. 7371727 DS* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Product-by-process; Process Pat. Sub. Date(s): 003: Feb 24, 2017 | Jan 28, 2024 | |
| Pat. No. 7704947 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 003: Feb 24, 2017 | Jan 28, 2024 | |
| Pat. No. 7745409 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 003: Feb 24, 2017 | Jan 28, 2024 | |
| Pat. No. 8080526 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 003: Feb 24, 2017 | Jan 28, 2024 | |
| Pat. No. 8110553 Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Method of use Pat. Sub. Date(s): 003: Feb 24, 2017 | Jan 28, 2024 | U-1516: Method of treating chronic idiopathic constipation in adult patients. U-3644: Treatment of functional constipation in pediatric patients 6 to 17 years of age |
| Pat. No. 8933030 DP* Treatments for gastrointestinal disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 003: Feb 24, 2017 | Feb 17, 2031 | U-1516: Method of treating chronic idiopathic constipation in adult patients. U-3644: Treatment of functional constipation in pediatric patients 6 to 17 years of age |
| Pat. No. 9708371 DP* Treatments for gastrointestinal disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 003: Aug 10, 2017 | Aug 16, 2033 | U-1516: Method of treating chronic idiopathic constipation in adult patients. U-3644: Treatment of functional constipation in pediatric patients 6 to 17 years of age |
| Pat. No. 10675325 DP* Stable formulations of linaclotide Claim Types: Composition Pat. Sub. Date(s): 003: Jun 22, 2020 | Aug 11, 2031 | |
| Pat. No. 10702576 Stable formulations of linaclotide Claim Types: Method of use Pat. Sub. Date(s): 003: Aug 4, 2020 | Aug 11, 2031 | U-1516: Method of treating chronic idiopathic constipation in adult patients. U-3644: Treatment of functional constipation in pediatric patients 6 to 17 years of age |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jun 12, 2026 | I-921: Treatment of functional constipation in pediatric patients 6 to 17 years of age |
ABBVIE
LUMIGAN (SOLUTION/DROPS) (OPHTHALMIC) BIMATOPROST
Drug Classes: prostaglandin analog
NDA Applicant: ABBVIE NDA No.: 022184 Prod. No.: 001 RX (0.01%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7851504 DS* DP* Enhanced bimatoprost ophthalmic solution Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jun 13, 2027 | |
| Pat. No. 8278353 DP* Enhanced bimatoprost ophthalmic solution Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 2, 2012 | Mar 16, 2025 | |
| Pat. No. 8299118 Enhanced bimatoprost ophthalmic solution Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 16, 2012 | Mar 16, 2025 | U-1295: A method of treating a patient with glaucoma or ocular hypertension |
| Pat. No. 8309605 Enhanced bimatoprost ophthalmic solution Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 16, 2012 | Mar 16, 2025 | U-1293: A method of lowering intraocular pressure in a patient with open angle glaucoma or ocular hypertension U-1294: Method of treating glaucoma in a patient |
| Pat. No. 8338479 DP* Enhanced bimatoprost ophthalmic solution Claim Types: ;Composition; Method of administration Pat. Sub. Date(s): 001: Dec 26, 2012 | Mar 16, 2025 | U-1295: A method of treating a patient with glaucoma or ocular hypertension |
| Pat. No. 8524777 Enhanced bimatoprost ophthalmic solution Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 2, 2013 | Mar 16, 2025 | U-1235: Reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension |
| Pat. No. 8586630 Enhanced bimatoprost ophthalmic solution Claim Types: Method of use Pat. Sub. Date(s): 001: None | Mar 16, 2025 | U-1458: A method of reducing intraocular pressure in patients with open angle glaucoma or ocular hypertension |
| Pat. No. 8772338 DP* Enhanced bimatoprost ophthalmic solution Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 21, 2014 | Mar 16, 2025 | U-1528: A method of lowering intraocular pressure |
| Pat. No. 8933120 DP* Enhanced bimatoprost ophthalmic solution Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 10, 2015 | Mar 16, 2025 | |
| Pat. No. 8933127 DP* Enhanced bimatoprost ophthalmic solution Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 10, 2015 | Mar 16, 2025 | |
| Pat. No. 9155716 DP* Enhanced bimatoprost ophthalmic solution Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 12, 2015 | Mar 16, 2025 | U-1528: A method of lowering intraocular pressure |
| Pat. No. 9241918 DP* Enhanced bimatoprost ophthalmic solution Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Feb 24, 2016 | Mar 16, 2025 | U-1814: Method of treating glaucoma or elevated intraocular pressure |
ABBVIE
MAVYRET (TABLET) (ORAL) GLECAPREVIR; PIBRENTASVIR
Drug Classes: hepatitis C virus (HCV) NS3/4A protease inhibitor == hepatitis C virus (HCV) NS5A inhibitor
NDA Applicant: ABBVIE NDA No.: 209394 Prod. No.: 001 RX (100MG;40MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE48923 DS* Crystal forms Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Mar 8, 2022 | Nov 8, 2035 *PED | |
| Pat. No. 8648037 DS* DP* Macrocyclic proline derived HCV serine protease inhibitors Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Aug 29, 2017 | Jul 19, 2032 *PED | U-2141: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 U-3237: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg |
| Pat. No. 8937150 DS* DP* Anti-viral compounds Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Aug 29, 2017 | Nov 18, 2032 *PED | |
| Pat. No. 9321807 DS* Crystal forms Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Aug 29, 2017 | Dec 5, 2035 *PED | |
| Pat. No. 9586978 Anti-viral compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 29, 2017 | May 6, 2031 *PED | U-2141: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 U-3237: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg |
| Pat. No. 10028937 Anti-viral compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 24, 2018 | Dec 10, 2030 *PED | U-2141: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 U-3237: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg |
| Pat. No. 10039754 Anti-viral compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 6, 2018 | Dec 10, 2030 *PED | U-2141: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 U-3237: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg |
| Pat. No. 10286029 Method for treating HCV Claim Types: Method of use Pat. Sub. Date(s): 001: May 31, 2019 | Sep 14, 2034 *PED | U-3237: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg |
| Pat. No. 11246866 DP* Solid pharmaceutical compositions for treating HCV Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Mar 8, 2022 | Dec 24, 2036 *PED | |
| Pat. No. 11484534 Methods for treating HCV Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 30, 2022 | Sep 14, 2034 *PED | U-3237: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 30, 2026 PED | ODE-232: Treatment of pediatric patients 12 years and older or weighing at least 45 kg with chronic hepatitis C virus (HCV) genotype 1,2,3,4,5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 30, 2026 PED | ODE-233: Treatment of pediatric patients 12 years and older or weighing at least 45 kg with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 10, 2028 PED | ODE-372: For treatment of pediatric patients 3 years of age to less than 12 years of age weighing less than 45 kg with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A); and treatment of pediatric patients 3 years of age to less than 12 years of age weighing less than 45 kg with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both |
ABBVIE
MAVYRET (PELLETS) (ORAL) GLECAPREVIR; PIBRENTASVIR
Drug Classes: hepatitis C virus (HCV) NS3/4A protease inhibitor == hepatitis C virus (HCV) NS5A inhibitor
NDA Applicant: ABBVIE NDA No.: 215110 Prod. No.: 001 RX (50MG;20MG/PACKET)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE48923 DS* Crystal forms Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Mar 8, 2022 | Nov 8, 2035 *PED | |
| Pat. No. 8648037 DS* DP* Macrocyclic proline derived HCV serine protease inhibitors Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jul 8, 2021 | Jul 19, 2032 *PED | U-3238: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in pediatric patients 3 to less than 12 years of age or weighing less than 45 kg |
| Pat. No. 8937150 DS* DP* Anti-viral compounds Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jul 8, 2021 | Nov 18, 2032 *PED | |
| Pat. No. 9321807 DS* DP* Crystal forms Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Jul 8, 2021 | Dec 5, 2035 *PED | |
| Pat. No. 9586978 Anti-viral compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 8, 2021 | May 6, 2031 *PED | U-3238: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in pediatric patients 3 to less than 12 years of age or weighing less than 45 kg |
| Pat. No. 10028937 Anti-viral compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 8, 2021 | Dec 10, 2030 *PED | U-3238: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in pediatric patients 3 to less than 12 years of age or weighing less than 45 kg |
| Pat. No. 10039754 Anti-viral compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 8, 2021 | Dec 10, 2030 *PED | U-3238: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in pediatric patients 3 to less than 12 years of age or weighing less than 45 kg |
| Pat. No. 10286029 Method for treating HCV Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 8, 2021 | Sep 14, 2034 *PED | U-3238: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in pediatric patients 3 to less than 12 years of age or weighing less than 45 kg |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 10, 2028 PED | ODE-372: For treatment of pediatric patients 3 years of age to less than 12 years of age weighing less than 45 kg with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A); and treatment of pediatric patients 3 years of age to less than 12 years of age weighing less than 45 kg with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both |
ABBVIE
NAMENDA XR (CAPSULE, EXTENDED RELEASE) (ORAL) MEMANTINE HYDROCHLORIDE [Has competitive generic]
Drug Classes: N-methyl-D-aspartate (NMDA) receptor antagonist
NDA Applicant: ABBVIE NDA No.: 022525 Prod. No.: 001 DISC (7MG**); 002 DISC (14MG); 003 DISC (21MG); 004 DISC (28MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8039009 Modified release formulations of memantine oral dosage forms Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 16, 2011; 002: None; 003: None; 004: None | Sep 24, 2029 *PED | U-539: Treatment of moderate to severe dementia of the Alzheimer's type |
ABBVIE
NAMZARIC (CAPSULE, EXTENDED RELEASE) (ORAL) DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Drug Classes: acetylcholinesterase inhibitor == N-methyl-D-aspartate (NMDA) receptor antagonist
NDA Applicant: ABBVIE NDA No.: 206439 Prod. No.: 001 RX (10MG;14MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8039009 Modified release formulations of memantine oral dosage forms Claim Types: Method of use Pat. Sub. Date(s): 001: None | Sep 24, 2029 *PED | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8058291 Methods and compositions for the treatment of CNS-related conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 22, 2015 | Dec 5, 2029 | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8168209 DP* DLR* Method and composition for administering an NMDA receptor antagonist to a subject Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 22, 2015 | May 22, 2026 *PED | |
| Pat. No. 8173708 DLR* Method and composition for administering an NMDA receptor antagonist to a subject Claim Types: Method of administration Pat. Sub. Date(s): 001: Jan 22, 2015 | May 22, 2026 *PED | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8283379 DLR* Methods and compositions for the treatment of CNS-related conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 22, 2015 | May 22, 2026 *PED | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8293794 DP* Methods and compositions for the treatment of CNS-related conditions Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 22, 2015 | Nov 22, 2025 | |
| Pat. No. 8338485 DP* Compositions for the treatment of CNS-related conditions Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 16, 2016 | Nov 22, 2025 | |
| Pat. No. 8338486 Methods for the treatment of CNS-related conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 16, 2016 | Nov 22, 2025 | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8580858 Compositions for the treatment of CNS-related conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 16, 2016 | Nov 22, 2025 | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
ABBVIE
NAMZARIC (CAPSULE, EXTENDED RELEASE) (ORAL) DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Drug Classes: acetylcholinesterase inhibitor == N-methyl-D-aspartate (NMDA) receptor antagonist
NDA Applicant: ABBVIE NDA No.: 206439 Prod. No.: 002 RX (10MG;28MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8039009 Modified release formulations of memantine oral dosage forms Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 22, 2015 | Sep 24, 2029 *PED | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8058291 Methods and compositions for the treatment of CNS-related conditions Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 22, 2015 | Dec 5, 2029 | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8168209 DP* DLR* Method and composition for administering an NMDA receptor antagonist to a subject Claim Types: Formulation Pat. Sub. Date(s): 002: Jan 22, 2015 | May 22, 2026 *PED | |
| Pat. No. 8173708 DLR* Method and composition for administering an NMDA receptor antagonist to a subject Claim Types: Method of administration Pat. Sub. Date(s): 002: Jan 22, 2015 | May 22, 2026 *PED | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8283379 DLR* Methods and compositions for the treatment of CNS-related conditions Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 22, 2015 | May 22, 2026 *PED | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8293794 DP* Methods and compositions for the treatment of CNS-related conditions Claim Types: Formulation Pat. Sub. Date(s): 002: Jan 22, 2015 | Nov 22, 2025 | |
| Pat. No. 8329752 DP* DLR* Composition for administering an NMDA receptor antagonist to a subject Claim Types: Formulation Pat. Sub. Date(s): 002: Jan 22, 2015 | May 22, 2026 *PED | |
| Pat. No. 8338485 DP* Compositions for the treatment of CNS-related conditions Claim Types: Formulation Pat. Sub. Date(s): 002: Jan 22, 2015 | Nov 22, 2025 | |
| Pat. No. 8338486 Methods for the treatment of CNS-related conditions Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 22, 2015 | Nov 22, 2025 | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8362085 DLR* Method for administering an NMDA receptor antagonist to a subject Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 22, 2015 | May 22, 2026 *PED | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8580858 Compositions for the treatment of CNS-related conditions Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 22, 2015 | Nov 22, 2025 | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8598233 DP* DLR* Method for administering an NMDA receptor antagonist to a subject Claim Types: Formulation Pat. Sub. Date(s): 002: Jan 22, 2015 | May 22, 2026 *PED |
ABBVIE
NAMZARIC (CAPSULE, EXTENDED RELEASE) (ORAL) DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Drug Classes: acetylcholinesterase inhibitor == N-methyl-D-aspartate (NMDA) receptor antagonist
NDA Applicant: ABBVIE NDA No.: 206439 Prod. No.: 003 RX (10MG;7MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8039009 Modified release formulations of memantine oral dosage forms Claim Types: Method of use Pat. Sub. Date(s): 003: Aug 16, 2016 | Sep 24, 2029 *PED | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8058291 Methods and compositions for the treatment of CNS-related conditions Claim Types: Method of use Pat. Sub. Date(s): 003: Aug 16, 2016 | Dec 5, 2029 | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8293794 DP* Methods and compositions for the treatment of CNS-related conditions Claim Types: Formulation Pat. Sub. Date(s): 003: Aug 16, 2016 | Nov 22, 2025 | |
| Pat. No. 8338485 DP* Compositions for the treatment of CNS-related conditions Claim Types: Formulation Pat. Sub. Date(s): 003: Aug 16, 2016 | Nov 22, 2025 | |
| Pat. No. 8338486 Methods for the treatment of CNS-related conditions Claim Types: Method of use Pat. Sub. Date(s): 003: Aug 16, 2016 | Nov 22, 2025 | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8580858 Compositions for the treatment of CNS-related conditions Claim Types: Method of use Pat. Sub. Date(s): 003: Aug 16, 2016 | Nov 22, 2025 | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
ABBVIE
NAMZARIC (CAPSULE, EXTENDED RELEASE) (ORAL) DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: acetylcholinesterase inhibitor == N-methyl-D-aspartate (NMDA) receptor antagonist
NDA Applicant: ABBVIE NDA No.: 206439 Prod. No.: 004 RX (10MG;21MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8039009 Modified release formulations of memantine oral dosage forms Claim Types: Method of use Pat. Sub. Date(s): 004: Aug 16, 2016 | Sep 24, 2029 *PED | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8058291 Methods and compositions for the treatment of CNS-related conditions Claim Types: Method of use Pat. Sub. Date(s): 004: Aug 16, 2016 | Dec 5, 2029 | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8168209 DP* DLR* Method and composition for administering an NMDA receptor antagonist to a subject Claim Types: Formulation Pat. Sub. Date(s): 004: Aug 16, 2016 | May 22, 2026 *PED | |
| Pat. No. 8173708 DLR* Method and composition for administering an NMDA receptor antagonist to a subject Claim Types: Method of administration Pat. Sub. Date(s): 004: Aug 16, 2016 | May 22, 2026 *PED | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8283379 DLR* Methods and compositions for the treatment of CNS-related conditions Claim Types: Method of use Pat. Sub. Date(s): 004: Aug 16, 2016 | May 22, 2026 *PED | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8293794 DP* Methods and compositions for the treatment of CNS-related conditions Claim Types: Formulation Pat. Sub. Date(s): 004: Aug 16, 2016 | Nov 22, 2025 | |
| Pat. No. 8329752 DP* DLR* Composition for administering an NMDA receptor antagonist to a subject Claim Types: Formulation Pat. Sub. Date(s): 004: Aug 16, 2016 | May 22, 2026 *PED | |
| Pat. No. 8338485 DP* Compositions for the treatment of CNS-related conditions Claim Types: Formulation Pat. Sub. Date(s): 004: Aug 16, 2016 | Nov 22, 2025 | |
| Pat. No. 8338486 Methods for the treatment of CNS-related conditions Claim Types: Method of use Pat. Sub. Date(s): 004: Aug 16, 2016 | Nov 22, 2025 | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8362085 DLR* Method for administering an NMDA receptor antagonist to a subject Claim Types: Method of use Pat. Sub. Date(s): 004: Aug 16, 2016 | May 22, 2026 *PED | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8580858 Compositions for the treatment of CNS-related conditions Claim Types: Method of use Pat. Sub. Date(s): 004: Aug 16, 2016 | Nov 22, 2025 | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8598233 DP* DLR* Method for administering an NMDA receptor antagonist to a subject Claim Types: Formulation Pat. Sub. Date(s): 004: Aug 16, 2016 | May 22, 2026 *PED |
ABBVIE
ORIAHNN (COPACKAGED) (CAPSULE) (ORAL) ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM
Drug Classes: gonadotropin-releasing hormone (GnRH) receptor antagonist
NDA Applicant: ABBVIE NDA No.: 213388 Prod. No.: 001 RX (EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7056927 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods relating thereto Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jun 29, 2020 | Sep 10, 2024 | |
| Pat. No. 7419983 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods related thereto Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jun 29, 2020 | Jul 6, 2029 | |
| Pat. No. 10881659 Methods of treating heavy menstrual bleeding Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 3, 2021 | Mar 14, 2034 | U-2842: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) |
| Pat. No. 11045470 Methods of treating heavy menstrual bleeding Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 27, 2021 | Mar 14, 2034 | U-2842: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) |
| Pat. No. 11459305 DP* Processes for the preparation of uracil derivatives Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 2, 2022 | Nov 7, 2028 | U-2842: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) |
| Pat. No. 11542239 DS* DP* Elagolix sodium compositions and processes Claim Types: Composition; Product-by-process Pat. Sub. Date(s): 001: Feb 6, 2023 | Jul 23, 2039 | |
| Pat. No. 11690845 Methods of administering elagolix Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 2, 2023 | Aug 27, 2040 | U-3655: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) using 300 mg elagolix while co-administering omeprazole |
| Pat. No. 12083227 DP* Solid pharmaceutical formulations for treating endometriosis, uterine fibroids, polycystic ovary syndrome or adenomyosis Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 8, 2024 | Aug 20, 2038 | U-2842: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jul 23, 2023 |
ABBVIE
ORILISSA (TABLET) (ORAL) ELAGOLIX SODIUM
Drug Classes: gonadotropin-releasing hormone (GnRH) receptor antagonist
NDA Applicant: ABBVIE NDA No.: 210450 Prod. No.: 001 RX (EQ 150MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7056927 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods relating thereto Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Aug 20, 2018 | Sep 10, 2024 | |
| Pat. No. 7176211 Gonadotropin-releasing hormone receptor antagonists and methods relating thereto Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 20, 2018 | Jul 6, 2024 | U-2360: Management of moderate to severe pain associated with endometriosis |
| Pat. No. 7419983 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods related thereto Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Aug 20, 2018 | Jul 6, 2029 | U-2360: Management of moderate to severe pain associated with endometriosis |
| Pat. No. 10537572 Methods of administering elagolix Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 19, 2020 | Sep 1, 2036 | U-2735: Management of moderate to severe pain associated with endometriosis using 150mg elagolix while co-administering rifampin |
| Pat. No. 10682351 Methods of administering elagolix Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 15, 2020 | Sep 1, 2036 | U-2850: Management of moderate to severe pain associated with endometriosis using 150 mg elagolix while co-administering ketoconazole |
| Pat. No. 11542239 DS* DP* Elagolix sodium compositions and processes Claim Types: Composition; Product-by-process Pat. Sub. Date(s): 001: Feb 6, 2023 | Jul 23, 2039 | |
| Pat. No. 11690845 Methods of administering elagolix Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 2, 2023 | Aug 27, 2040 | U-3654: Management of moderate to severe pain associated with endometriosis using 150 mg or 200 mg elagolix while co-administering omeprazole |
| Pat. No. 11690854 Methods of treating heavy menstrual bleeding Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 2, 2023 | Apr 19, 2038 | U-3653: Management of moderate to severe pain associated with endometriosis in a patient with moderate hepatic impairment |
| Pat. No. 11707464 Methods of treating heavy menstrual bleeding Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 23, 2023 | Mar 14, 2034 | U-3672: Management of moderate to severe pain associated with endometriosis using 150 mg elagolix for up to 24 months |
| Pat. No. 12102637 DP* Pharmaceutical formulations for treating endometriosis, uterine fibroids, polycystic ovary syndrome or adenomyosis Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 29, 2024 | Aug 20, 2038 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jul 23, 2023 |
ABBVIE
ORILISSA (TABLET) (ORAL) ELAGOLIX SODIUM
Drug Classes: gonadotropin-releasing hormone (GnRH) receptor antagonist
NDA Applicant: ABBVIE NDA No.: 210450 Prod. No.: 002 RX (EQ 200MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7056927 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods relating thereto Claim Types: Compound; Composition Pat. Sub. Date(s): 002: Aug 20, 2018 | Sep 10, 2024 | |
| Pat. No. 7176211 Gonadotropin-releasing hormone receptor antagonists and methods relating thereto Claim Types: Method of use Pat. Sub. Date(s): 002: Aug 20, 2018 | Jul 6, 2024 | U-2360: Management of moderate to severe pain associated with endometriosis |
| Pat. No. 7419983 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods related thereto Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 002: Aug 20, 2018 | Jul 6, 2029 | U-2360: Management of moderate to severe pain associated with endometriosis |
| Pat. No. 11344551 Methods of treating heavy menstrual bleeding Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 27, 2022 | Mar 14, 2034 | U-3388: Use of elagolix 200 mg bid for 6 months to manage moderate to severe pain associated with endometriosis in premenopausal women to reduce dysmenorrhea and non-menstrual pelvic pain U-3389: Use of elagolix 200 mg bid for 6 months to manage moderate to severe pain associated with endometriosis in premenopausal women having dyspareunia associated with endometriosis |
| Pat. No. 11542239 DS* DP* Elagolix sodium compositions and processes Claim Types: Composition; Product-by-process Pat. Sub. Date(s): 002: Feb 6, 2023 | Jul 23, 2039 | |
| Pat. No. 11690845 Methods of administering elagolix Claim Types: Method of use Pat. Sub. Date(s): 002: Aug 2, 2023 | Aug 27, 2040 | U-3654: Management of moderate to severe pain associated with endometriosis using 150 mg or 200 mg elagolix while co-administering omeprazole |
| Pat. No. 12102637 DP* Pharmaceutical formulations for treating endometriosis, uterine fibroids, polycystic ovary syndrome or adenomyosis Claim Types: Formulation Pat. Sub. Date(s): 002: Oct 29, 2024 | Aug 20, 2038 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jul 23, 2023 |
ABBVIE
QULIPTA (TABLET) (ORAL) ATOGEPANT
Drug Classes: calcitonin gene-related peptide receptor antagonist
NDA Applicant: ABBVIE NDA No.: 215206 Prod. No.: 001 RX (10MG); 002 RX (30MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8754096 DS* DP* Piperidinone carboxamide azaindane CGRP receptor antagonists Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Oct 26, 2021 | Jul 19, 2032 | U-3534: Preventive treatment of migraine in adults |
| Pat. No. 9499545 DS* DP* Piperidinone carboxamide azaindane CGRP receptor antagonists Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Oct 26, 2021 | Nov 10, 2031 | U-3534: Preventive treatment of migraine in adults |
| Pat. No. 9850246 DS* Process for making CGRP receptor antagonists Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: Oct 26, 2021 | Mar 13, 2033 | |
| Pat. No. 10117836 DP* Tablet formulation for CGRP active compounds Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 26, 2021 | Jan 30, 2035 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Apr 17, 2026 | I-909: Preventive treatment of migraine in adults |
| Exclusivity Code: NCE - New chemical entity | Sep 28, 2026 |
ABBVIE
QULIPTA (TABLET) (ORAL) ATOGEPANT
Drug Classes: calcitonin gene-related peptide receptor antagonist
NDA Applicant: ABBVIE NDA No.: 215206 Prod. No.: 003 RX (60MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8754096 DS* DP* Piperidinone carboxamide azaindane CGRP receptor antagonists Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 003: Oct 26, 2021 | Jul 19, 2032 | U-3534: Preventive treatment of migraine in adults |
| Pat. No. 9499545 DS* DP* Piperidinone carboxamide azaindane CGRP receptor antagonists Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 003: Oct 26, 2021 | Nov 10, 2031 | U-3534: Preventive treatment of migraine in adults |
| Pat. No. 9850246 DS* Process for making CGRP receptor antagonists Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 003: Oct 26, 2021 | Mar 13, 2033 | |
| Pat. No. 10117836 DP* Tablet formulation for CGRP active compounds Claim Types: Formulation Pat. Sub. Date(s): 003: Oct 26, 2021 | Jan 30, 2035 | |
| Pat. No. 12090148 Treatment of migraine Claim Types: Method of use Pat. Sub. Date(s): 003: Oct 16, 2024 | Jul 29, 2041 | U-3534: Preventive treatment of migraine in adults |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Apr 17, 2026 | I-909: Preventive treatment of migraine in adults |
| Exclusivity Code: NCE - New chemical entity | Sep 28, 2026 |
ABBVIE
RESTASIS MULTIDOSE (EMULSION) (OPHTHALMIC) CYCLOSPORINE [Has competitive generic]
Drug Classes: calcineurin inhibitor immunosuppressant
NDA Applicant: ABBVIE NDA No.: 050790 Prod. No.: 002 RX (0.05%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8292129 DP* Dispensing device Claim Types: Device Pat. Sub. Date(s): 002: Jun 26, 2017 | Feb 25, 2031 | |
| Pat. No. 8561859 DP* Dispensing device Claim Types: Device Pat. Sub. Date(s): 002: Jun 26, 2017 | Apr 16, 2032 | |
| Pat. No. 8629111 DP* DLR* Methods of providing therapeutic effects using cyclosporin components Claim Types: Formulation Pat. Sub. Date(s): 002: Nov 18, 2016 | Aug 27, 2024 | |
| Pat. No. 8633162 DLR* Methods of providing therapeutic effects using cyclosporin components Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 18, 2016 | Aug 27, 2024 | U-1479: Increase tear production to treat patients with keratoconjunctivitis sicca (dry eye). |
| Pat. No. 8642556 DP* DLR* Methods of providing therapeutic effects using cyclosporin components Claim Types: Formulation Pat. Sub. Date(s): 002: Nov 18, 2016 | Aug 27, 2024 | |
| Pat. No. 8648048 DLR* Methods of providing therapeutic effects using cyclosporin components Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 18, 2016 | Aug 27, 2024 | U-1483: Increase tear production in patients with keratoconjunctivitis sicca (dry eye). |
| Pat. No. 8685930 DP* DLR* Methods of providing therapeutic effects using cyclosporin components Claim Types: Formulation Pat. Sub. Date(s): 002: Nov 18, 2016 | Aug 27, 2024 | |
| Pat. No. 9248191 DLR* Methods of providing therapeutic effects using cyclosporin components Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 18, 2016 | Aug 27, 2024 | U-1479: Increase tear production to treat patients with keratoconjunctivitis sicca (dry eye). |
| Pat. No. 9669974 DP* Protective cap for a dispenser, and discharge device for discharging pharmaceutical and/or cosmetical liquids Claim Types: Device Pat. Sub. Date(s): 002: Jun 26, 2017 | May 11, 2034 | |
| Pat. No. 9676525 DP* Protective cap for a dispenser, and discharge device for discharging pharmaceutical and/or cosmetical liquids Claim Types: Device Pat. Sub. Date(s): 002: Jun 26, 2017 | Feb 7, 2034 |
ABBVIE
RINVOQ (TABLET, EXTENDED RELEASE) (ORAL) UPADACITINIB
Drug Classes: Janus kinase (JAK) inhibitor
NDA Applicant: ABBVIE NDA No.: 211675 Prod. No.: 001 RX (15MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE47221 DS* Tricyclic compounds Claim Types: Compound Pat. Sub. Date(s): 001: Sep 13, 2019 | Aug 16, 2033 | |
| Pat. No. 8962629 DS* Tricyclic compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Sep 13, 2019 | Jan 15, 2031 | U-3255: Treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers U-3275: Treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more tnf blockers U-3341: Treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers U-3371: Treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers U-3624: Treatment of adults with moderately to severely active Crohn's disease who have had an inadequate response or intolerance to one or more TNF blockers U-3945: Treatment of patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis who have had an inadequate response or intolerance to one or more TNF blockers U-3946: Treatment of pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers |
| Pat. No. 9951080 DS* DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-alpha]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2- ,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Process Pat. Sub. Date(s): 001: Sep 13, 2019 | Oct 17, 2036 | |
| Pat. No. 9963459 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-alpla]pyrrolo[2,3-e]-pyrazin-8-YL)-N-(2- ,2,2-Trifluoroethyl)pyrrol and solid state forms thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 13, 2019 | Oct 17, 2036 | |
| Pat. No. 10519164 DP* Processes for the preparation of (3S,4R)-3,ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 29, 2020 | Oct 17, 2036 | |
| Pat. No. 10597400 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2- -trifluoroethyl)pyrrolidine-1-carb oxamide and solid state forms thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 17, 2020 | Oct 17, 2036 | U-3255: Treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers |
| Pat. No. 10981923 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[l,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate; Process; Composition Pat. Sub. Date(s): 001: May 18, 2021 | Oct 17, 2036 | |
| Pat. No. 10981924 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Formulation Pat. Sub. Date(s): 001: May 18, 2021 | Oct 17, 2036 | |
| Pat. No. 10995095 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2- -trifluoroethyl)pyrrolidine-1-carb oxamide and solid state forms thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 10, 2022 | Oct 17, 2036 | U-3298: Treatment of adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, or when use of those therapies are inadvisable |
| Pat. No. 11186584 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Dec 17, 2021 | Oct 17, 2036 | |
| Pat. No. 11198697 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 17, 2021 | Oct 17, 2036 | |
| Pat. No. 11365198 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 20, 2022 | Oct 17, 2036 | U-3275: Treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more tnf blockers U-3946: Treatment of pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers |
| Pat. No. 11512092 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 16, 2022 | Oct 17, 2036 | U-3275: Treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more tnf blockers U-3371: Treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers U-3487: Treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to one or more tnf blockers U-3946: Treatment of pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers |
| Pat. No. 11524964 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 12, 2023 | Oct 17, 2036 | U-3371: Treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers |
| Pat. No. 11535624 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-α]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 26, 2023 | Oct 17, 2036 | U-3255: Treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers |
| Pat. No. 11535625 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 26, 2023 | Oct 17, 2036 | U-3298: Treatment of adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, or when use of those therapies are inadvisable |
| Pat. No. 11564922 Methods of treating Crohn's disease and ulcerative colitis Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 15, 2023 | Mar 9, 2038 | U-3624: Treatment of adults with moderately to severely active Crohn's disease who have had an inadequate response or intolerance to one or more TNF blockers |
| Pat. No. 11607411 Methods of treating Crohn's disease and ulcerative colitis Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 18, 2023 | Mar 9, 2038 | U-3341: Treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers |
| Pat. No. 11661425 DS* DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Jun 29, 2023 | Oct 17, 2036 | |
| Pat. No. 11680069 DS* DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate; Composition; Process; Product-by-process Pat. Sub. Date(s): 001: Jul 20, 2023 | Oct 17, 2036 | |
| Pat. No. 11718627 DS* DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Aug 11, 2023 | Oct 17, 2036 | |
| Pat. No. 11767326 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 23, 2023 | Oct 17, 2036 | U-3298: Treatment of adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, or when use of those therapies are inadvisable |
| Pat. No. 11773105 DS* DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]- pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Nov 2, 2023 | Oct 17, 2036 | |
| Pat. No. 11773106 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 2, 2023 | Oct 17, 2036 | U-3275: Treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more tnf blockers U-3371: Treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers U-3487: Treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to one or more tnf blockers U-3946: Treatment of pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers |
| Pat. No. 11780847 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1- carboxamide and solid state forms thereof Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Nov 8, 2023 | Oct 17, 2036 | |
| Pat. No. 11780848 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1- carboxamide and solid state forms thereof Claim Types: Method of Use claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Nov 8, 2023 | Oct 17, 2036 | U-3371: Treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers |
| Pat. No. 11787815 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 8, 2023 | Oct 17, 2036 | |
| Pat. No. 11795175 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Method of Use claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Nov 22, 2023 | Oct 17, 2036 | U-3255: Treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers |
| Pat. No. 11976077 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-α]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms therof Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 5, 2024 | Oct 17, 2036 | U-3298: Treatment of adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, or when use of those therapies are inadvisable |
| Pat. No. 11993605 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 26, 2024 | Oct 17, 2036 | U-3275: Treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more tnf blockers U-3946: Treatment of pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers |
| Pat. No. 11993606 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 26, 2024 | Oct 17, 2036 | U-3487: Treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to one or more tnf blockers |
| Pat. No. 12077545 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 27, 2024 | Oct 17, 2036 | |
| Pat. No. 12103933 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Oct 31, 2024 | Oct 17, 2036 | |
| Pat. No. 12110297 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Formulation; Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Nov 5, 2024 | Oct 17, 2036 | |
| Pat. No. 12110298 DS* DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Compound; Process; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Nov 5, 2024 | Oct 17, 2036 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Dec 14, 2024 | I-880: Treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers |
| Exclusivity Code: I - New Indication | Jan 14, 2025 | I-883: Treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable |
| Exclusivity Code: I - New Indication | Mar 16, 2025 | I-886: Treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers |
| Exclusivity Code: I - New Indication | Apr 29, 2025 | I-888: Treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more tnf blockers |
| Exclusivity Code: I - New Indication | May 18, 2026 | I-919: Treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response or intolerance to one or more TNF blockers |
| Exclusivity Code: I - New Indication | Apr 26, 2027 | I-946: Treatment of patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis (PJIA) who have had an inadequate response or intolerance to one of more tumor necrosis factor (TNF) blockers |
| Exclusivity Code: NCE - New chemical entity | Aug 16, 2024 | |
| Exclusivity Code: NPP - New patient population | Apr 26, 2027 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 26, 2031 | ODE-481: Treatment of pediatric patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers, and for the treatment of pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers |
ABBVIE
RINVOQ (TABLET, EXTENDED RELEASE) (ORAL) UPADACITINIB
Drug Classes: Janus kinase (JAK) inhibitor
NDA Applicant: ABBVIE NDA No.: 211675 Prod. No.: 002 RX (30MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE47221 DS* Tricyclic compounds Claim Types: Compound Pat. Sub. Date(s): 002: Feb 10, 2022 | Aug 16, 2033 | |
| Pat. No. 8962629 DS* Tricyclic compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 002: Feb 10, 2022 | Jan 15, 2031 | U-3341: Treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers U-3624: Treatment of adults with moderately to severely active Crohn's disease who have had an inadequate response or intolerance to one or more TNF blockers |
| Pat. No. 9951080 DS* DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-alpha]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2- ,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Process Pat. Sub. Date(s): 002: Feb 10, 2022 | Oct 17, 2036 | |
| Pat. No. 10344036 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-#a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,- 2-trifluoroethyl)pyrrolidine-1-#carboxamide and solid state forms thereof Claim Types: Formulation Pat. Sub. Date(s): 002: Feb 10, 2022 | Oct 17, 2036 | |
| Pat. No. 10550126 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-A]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Method of use Pat. Sub. Date(s): 002: Feb 10, 2022 | Oct 17, 2036 | U-3298: Treatment of adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, or when use of those therapies are inadvisable |
| Pat. No. 10730883 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Formulation claimed by its inherent performace characteristics; Formulation Pat. Sub. Date(s): 002: Feb 10, 2022 | Oct 17, 2036 | |
| Pat. No. 10981923 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[l,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate; Process; Composition Pat. Sub. Date(s): 002: Feb 10, 2022 | Oct 17, 2036 | |
| Pat. No. 10981924 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Formulation Pat. Sub. Date(s): 002: Feb 10, 2022 | Oct 17, 2036 | |
| Pat. No. 11186584 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 002: Feb 10, 2022 | Oct 17, 2036 | |
| Pat. No. 11198697 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Formulation Pat. Sub. Date(s): 002: Feb 10, 2022 | Oct 17, 2036 | |
| Pat. No. 11535626 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1 carboxamide and solid state forms thereof Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 26, 2023 | Oct 17, 2036 | U-3298: Treatment of adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, or when use of those therapies are inadvisable |
| Pat. No. 11564922 Methods of treating Crohn's disease and ulcerative colitis Claim Types: Method of use Pat. Sub. Date(s): 002: Aug 11, 2023 | Mar 9, 2038 | U-3624: Treatment of adults with moderately to severely active Crohn's disease who have had an inadequate response or intolerance to one or more TNF blockers |
| Pat. No. 11607411 Methods of treating Crohn's disease and ulcerative colitis Claim Types: Method of use Pat. Sub. Date(s): 002: Aug 11, 2023 | Mar 9, 2038 | U-3341: Treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers |
| Pat. No. 11661425 DS* DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 002: Jun 29, 2023 | Oct 17, 2036 | |
| Pat. No. 11680069 DS* DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate; Composition; Process; Product-by-process Pat. Sub. Date(s): 002: Jul 20, 2023 | Oct 17, 2036 | |
| Pat. No. 11718627 DS* DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 002: Aug 11, 2023 | Oct 17, 2036 | |
| Pat. No. 11767326 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Method of use Pat. Sub. Date(s): 002: Oct 23, 2023 | Oct 17, 2036 | U-3298: Treatment of adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, or when use of those therapies are inadvisable |
| Pat. No. 11773105 DS* DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]- pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 002: Nov 2, 2023 | Oct 17, 2036 | |
| Pat. No. 12077545 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Formulation Pat. Sub. Date(s): 002: Sep 27, 2024 | Oct 17, 2036 | |
| Pat. No. 12091415 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 002: Oct 16, 2024 | Oct 17, 2036 | |
| Pat. No. 12110298 DS* DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Compound; Process; New polymorph, salt or hydrate Pat. Sub. Date(s): 002: Nov 5, 2024 | Oct 17, 2036 | |
| Pat. No. 12116373 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Formulation; Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 002: Nov 5, 2024 | Oct 17, 2036 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jan 14, 2025 | I-883: Treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable |
| Exclusivity Code: I - New Indication | Mar 16, 2025 | I-886: Treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers |
| Exclusivity Code: I - New Indication | May 18, 2026 | I-919: Treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response or intolerance to one or more TNF blockers |
| Exclusivity Code: I - New Indication | Apr 26, 2027 | I-946: Treatment of patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis (PJIA) who have had an inadequate response or intolerance to one of more tumor necrosis factor (TNF) blockers |
| Exclusivity Code: NCE - New chemical entity | Aug 16, 2024 | |
| Exclusivity Code: NPP - New patient population | Apr 26, 2027 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 26, 2031 | ODE-481: Treatment of pediatric patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers, and for the treatment of pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers |
ABBVIE
RINVOQ (TABLET, EXTENDED RELEASE) (ORAL) UPADACITINIB
Drug Classes: Janus kinase (JAK) inhibitor
NDA Applicant: ABBVIE NDA No.: 211675 Prod. No.: 003 RX (45MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE47221 DS* Tricyclic compounds Claim Types: Compound Pat. Sub. Date(s): 003: Apr 14, 2022 | Aug 16, 2033 | |
| Pat. No. 8962629 DS* Tricyclic compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 003: Apr 14, 2022 | Jan 15, 2031 | U-3341: Treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers U-3624: Treatment of adults with moderately to severely active Crohn's disease who have had an inadequate response or intolerance to one or more TNF blockers |
| Pat. No. 9951080 DS* DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-alpha]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2- ,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Process Pat. Sub. Date(s): 003: Apr 14, 2022 | Oct 17, 2036 | |
| Pat. No. 10202393 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-.alpha.]pyrrolo[2,3-e]-pyrazin-8-yl)-N-- (2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Formulation Pat. Sub. Date(s): 003: Apr 14, 2022 | Oct 17, 2036 | |
| Pat. No. 10981923 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[l,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate; Process; Composition Pat. Sub. Date(s): 003: Apr 14, 2022 | Oct 17, 2036 | |
| Pat. No. 11186584 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 003: Apr 14, 2022 | Oct 17, 2036 | |
| Pat. No. 11198697 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Formulation Pat. Sub. Date(s): 003: Apr 14, 2022 | Oct 17, 2036 | |
| Pat. No. 11564922 Methods of treating Crohn's disease and ulcerative colitis Claim Types: Method of use Pat. Sub. Date(s): 003: Jun 15, 2023 | Mar 9, 2038 | U-3624: Treatment of adults with moderately to severely active Crohn's disease who have had an inadequate response or intolerance to one or more TNF blockers |
| Pat. No. 11607411 Methods of treating Crohn's disease and ulcerative colitis Claim Types: Method of use Pat. Sub. Date(s): 003: Apr 18, 2023 | Mar 9, 2038 | U-3341: Treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers |
| Pat. No. 11661425 DS* DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 003: Jun 29, 2023 | Oct 17, 2036 | |
| Pat. No. 11680069 DS* DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate; Composition; Process; Product-by-process Pat. Sub. Date(s): 003: Jul 20, 2023 | Oct 17, 2036 | |
| Pat. No. 11718627 DS* DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 003: Aug 11, 2023 | Oct 17, 2036 | |
| Pat. No. 11773105 DS* DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]- pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 003: Nov 2, 2023 | Oct 17, 2036 | |
| Pat. No. 12077545 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Formulation Pat. Sub. Date(s): 003: Sep 27, 2024 | Oct 17, 2036 | |
| Pat. No. 12110298 DS* DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Compound; Process; New polymorph, salt or hydrate Pat. Sub. Date(s): 003: Nov 5, 2024 | Oct 17, 2036 | |
| Pat. No. 12134621 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Formulation; Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 003: Dec 4, 2024 | Oct 17, 2036 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Mar 16, 2025 | I-886: Treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers |
| Exclusivity Code: I - New Indication | May 18, 2026 | I-919: Treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response or intolerance to one or more TNF blockers |
| Exclusivity Code: I - New Indication | Apr 26, 2027 | I-946: Treatment of patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis (PJIA) who have had an inadequate response or intolerance to one of more tumor necrosis factor (TNF) blockers |
| Exclusivity Code: NCE - New chemical entity | Aug 16, 2024 | |
| Exclusivity Code: NPP - New patient population | Apr 26, 2027 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 26, 2031 | ODE-481: Treatment of pediatric patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers, and for the treatment of pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers |
ABBVIE
RINVOQ LQ (SOLUTION) (ORAL) UPADACITINIB
Drug Classes: Janus kinase (JAK) inhibitor
NDA Applicant: ABBVIE NDA No.: 218347 Prod. No.: 001 RX (1MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE47221 DS* Tricyclic compounds Claim Types: Compound Pat. Sub. Date(s): 001: Jun 12, 2024 | Aug 16, 2033 | |
| Pat. No. 8962629 DS* Tricyclic compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: May 23, 2024 | Jan 15, 2031 | U-3945: Treatment of patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis who have had an inadequate response or intolerance to one or more TNF blockers U-3946: Treatment of pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers |
| Pat. No. 9951080 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-alpha]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2- ,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Process Pat. Sub. Date(s): 001: May 23, 2024 | Oct 17, 2036 | |
| Pat. No. 10981923 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[l,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate; Process; Composition Pat. Sub. Date(s): 001: May 23, 2024 | Oct 17, 2036 | |
| Pat. No. 11186584 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: May 23, 2024 | Oct 17, 2036 | |
| Pat. No. 11661425 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: May 23, 2024 | Oct 17, 2036 | |
| Pat. No. 11680069 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate; Composition; Process; Product-by-process Pat. Sub. Date(s): 001: May 23, 2024 | Oct 17, 2036 | |
| Pat. No. 11718627 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: May 23, 2024 | Oct 17, 2036 | |
| Pat. No. 11773105 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]- pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: May 23, 2024 | Oct 17, 2036 | |
| Pat. No. 12110298 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Compound; Process; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Nov 5, 2024 | Oct 17, 2036 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Aug 16, 2024 | |
| Exclusivity Code: NP - New product | Apr 26, 2027 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 26, 2031 | ODE-481: Treatment of pediatric patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers, and for the treatment of pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers |
ABBVIE
SAVELLA (TABLET) (ORAL) MILNACIPRAN HYDROCHLORIDE [GENERIC AB]
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI)
NDA Applicant: ABBVIE NDA No.: 022256 Prod. No.: 001 RX (12.5MG); 002 RX (25MG); 003 RX (50MG); 004 RX (100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7994220 Milnacipran for the long-term treatment of fibromyalgia syndrome Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 1, 2011; 002: None; 003: None; 004: None | Sep 19, 2029 | U-819: Management of fibromyalgia |
ABBVIE
TECHNIVIE (TABLET) (ORAL) OMBITASVIR; PARITAPREVIR; RITONAVIR
Drug Classes: hepatitis C virus (HCV) NS5A inhibitor == hepatitis C virus (HCV) NS3/4A protease inhibitor == CYP3A inhibitor == HIV-1 protease inhibitor
NDA Applicant: ABBVIE NDA No.: 207931 Prod. No.: 001 DISC (12.5MG;75MG;50MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8268349 DP* Solid pharmaceutical dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 6, 2015 | Feb 25, 2025 *PED | |
| Pat. No. 8399015 DP* Solid pharmaceutical dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 6, 2015 | Feb 25, 2025 *PED | |
| Pat. No. 8420596 DS* DP* Macrocyclic hepatitis C serine protease inhibitors Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Aug 6, 2015 | Oct 10, 2031 *PED | |
| Pat. No. 8642538 DS* DP* Macrocyclic hepatitis C serine protease inhibitors Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Aug 6, 2015 | Sep 10, 2029 | U-1638: Treatment of HCV infection using paritaprevir |
| Pat. No. 8686026 DP* Solid compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 6, 2015 | Jun 9, 2031 | |
| Pat. No. 8691938 DS* DP* Anti-viral compounds Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Aug 6, 2015 | Apr 13, 2032 | |
| Pat. No. 9006387 Anti-viral compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 6, 2015 | Jun 10, 2030 | U-1687: Treatment of HCV infection using ombitasvir |
| Pat. No. 9044480 Compositions and methods for treating HCV Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 6, 2015 | Apr 10, 2031 | U-1638: Treatment of HCV infection using paritaprevir |
ABBVIE
TEFLARO (POWDER) (INTRAVENOUS) CEFTAROLINE FOSAMIL
Drug Classes: cephalosporin antibacterial
NDA Applicant: ABBVIE NDA No.: 200327 Prod. No.: 001 RX (400MG/VIAL); 002 RX (600MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8247400 DP* Cephem compounds useful for the treatment of bacterial infections Claim Types: Compound; Composition; Method of use; New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: None | Feb 10, 2031 | U-282: Method of treating bacterial infections |
| Pat. No. 9629861 DP* Compositions and methods for treating bacterial infections using ceftaroline Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 17, 2017 | Sep 21, 2030 |
ABBVIE
TRILIPIX (CAPSULE, DELAYED RELEASE) (ORAL) CHOLINE FENOFIBRATE [GENERIC AB]
NDA Applicant: ABBVIE NDA No.: 022224 Prod. No.: 001 RX (EQ 45MG FENOFIBRIC ACID); 002 RX (EQ 135MG FENOFIBRIC ACID)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7259186 DS* Salts of fenofibric acid and pharmaceutical formulations thereof Claim Types: Formulation; New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: None | Jan 7, 2025 |
ABBVIE
UBRELVY (TABLET) (ORAL) UBROGEPANT
Drug Classes: calcitonin gene-related peptide receptor antagonist
NDA Applicant: ABBVIE NDA No.: 211765 Prod. No.: 001 RX (50MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8754096 DS* DP* Piperidinone carboxamide azaindane CGRP receptor antagonists Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jan 21, 2020 | Jul 19, 2032 | U-2717: Acute treatment of migraine with headache, with or without aura in adults |
| Pat. No. 8912210 DS* DP* Piperidinone carboxamide azaindane CGRP receptor antagonists Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 21, 2020 | Dec 23, 2033 | |
| Pat. No. 9499545 DS* DP* Piperidinone carboxamide azaindane CGRP receptor antagonists Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jan 21, 2020 | Nov 10, 2031 | U-2718: Acute treatment of migraine with or without aura in adults |
| Pat. No. 9833448 Piperidinone carboxamide azaindane CGRP receptor antagonists Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 21, 2020 | Nov 10, 2031 | U-2718: Acute treatment of migraine with or without aura in adults |
| Pat. No. 10117836 DP* Tablet formulation for CGRP active compounds Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 21, 2020 | Jan 30, 2035 | |
| Pat. No. 11717515 Treatment of migraine Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 7, 2023 | Dec 22, 2041 | U-3677: Acute treatment of migraine with or without aura in a patient with severe hepatic impairment |
| Pat. No. 11857542 Treatment of migraine Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 31, 2024 | Dec 22, 2041 | U-3786: Acute treatment of migraine with or without aura in a patient with severe renal impairment |
| Pat. No. 11925709 DP* Tablet formulation for CGRP active compounds Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 10, 2024 | Jan 30, 2035 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Dec 23, 2024 |
ABBVIE
UBRELVY (TABLET) (ORAL) UBROGEPANT
Drug Classes: calcitonin gene-related peptide receptor antagonist
NDA Applicant: ABBVIE NDA No.: 211765 Prod. No.: 002 RX (100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8754096 DS* DP* Piperidinone carboxamide azaindane CGRP receptor antagonists Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 002: Jan 21, 2020 | Jul 19, 2032 | U-2717: Acute treatment of migraine with headache, with or without aura in adults |
| Pat. No. 8912210 DS* DP* Piperidinone carboxamide azaindane CGRP receptor antagonists Claim Types: Compound; Composition Pat. Sub. Date(s): 002: Jan 21, 2020 | Dec 23, 2033 | |
| Pat. No. 9499545 DS* DP* Piperidinone carboxamide azaindane CGRP receptor antagonists Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 002: Jan 21, 2020 | Nov 10, 2031 | U-2718: Acute treatment of migraine with or without aura in adults |
| Pat. No. 9833448 Piperidinone carboxamide azaindane CGRP receptor antagonists Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 21, 2020 | Nov 10, 2031 | U-2718: Acute treatment of migraine with or without aura in adults |
| Pat. No. 10117836 DP* Tablet formulation for CGRP active compounds Claim Types: Formulation Pat. Sub. Date(s): 002: Jan 21, 2020 | Jan 30, 2035 | |
| Pat. No. 11925709 DP* Tablet formulation for CGRP active compounds Claim Types: Formulation Pat. Sub. Date(s): 002: Apr 10, 2024 | Jan 30, 2035 | |
| Pat. No. 12070450 Treatment of migraine Claim Types: Method of use Pat. Sub. Date(s): 002: Sep 25, 2024 | Dec 22, 2041 | U-3992: Acute treatment of migraine with or without aura in a patient undergoing treatment with a weak or moderate CYP3A4 inducer |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Dec 23, 2024 |
ABBVIE
VENCLEXTA (TABLET) (ORAL) VENETOCLAX
Drug Classes: BCL-2 inhibitor
NDA Applicant: ABBVIE NDA No.: 208573 Prod. No.: 001 RX (10MG); 002 RX (50MG); 003 RX (100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8546399 DS* DP* Apoptosis inducing agents for the treatment of cancer and immune and autoimmune diseases Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: May 4, 2016 | Jun 27, 2031 | |
| Pat. No. 8722657 DS* Salts and crystalline forms of an apoptosis-inducing agent Claim Types: New polymorph, salt or hydrate; Composition; Process Pat. Sub. Date(s): All strengths: Feb 13, 2020 | Jan 29, 2032 | |
| Pat. No. 9174982 Apoptosis-inducing agents for the treatment of cancer and immune and autoimmune diseases Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 4, 2016 | May 26, 2030 | U-2323: Treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy U-2445: Treatment in combination with azacitidine or decitabine or low-dose cytarabine of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy U-2446: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy U-2537: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) |
| Pat. No. 9539251 Combination therapy of a type II anti-CD20 antibody with a selective Bcl-2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 13, 2019 | Sep 6, 2033 | U-2538: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (Sll) in combination with a GA101 antibody such as obinutuzumab for one or more dosing periods, wherein the CLL or SLL is a CD20-expressing cancer |
| Pat. No. 10730873 DS* Salts and crystalline forms of an apoptosis-inducing agent Claim Types: New polymorph, salt or hydrate; Composition; Process Pat. Sub. Date(s): All strengths: Aug 17, 2020 | Nov 21, 2031 | |
| Pat. No. 10993942 Combination therapy of a type II anti-CD20 antibody with a selective BCL-2 inhibitor Claim Types: Method of use; Dosaage regimen Pat. Sub. Date(s): All strengths: May 24, 2021 | Sep 6, 2033 | U-3114: Treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) by orally administering venetoclax to an adult according to a dose ramp-up that includes a dose of 50 mg per day for 1 week followed by 100 mg per day for 1 week |
| Pat. No. 11110087 Combination therapy of a type II anti-CD20 antibody with a selective Bcl-2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 7, 2021 | Sep 6, 2033 | U-3222: Treatment of acute myeloid leukemia (AML) by orally administering venetoclax with azacitidine or decitabine or low-dose cytarabine in adults 75 years or older or having certain comorbidities according to a dose ramp-up including a 100 mg per day dose U-3223: Treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) by orally administering venetoclax to an adult according to a dose ramp-up including a 100 mg per day dose |
| Pat. No. 11369599 DP* Melt-extruded solid dispersions containing an apoptosis-inducing agent Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 20, 2022 | May 23, 2032 | |
| Pat. No. 11413282 Combination therapy of a type II anti-CD20 antibody with a selective BCL-2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 12, 2022 | Sep 6, 2033 | U-3412: Treatment of adults with relapsed, refractory or previously untreated chronic lymphocytic leukemia including a dose ramp-up and in combination with obinutuzumab in multiple 28-day dosing cycles followed by administration in absence of obinutuzumab |
| Pat. No. 11590128 Combination therapy of a type II anti-CD20 antibody with a selective BCL-2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 24, 2023 | Sep 6, 2033 | U-3548: Treatment of aml by orally administering venetoclax with azacitidine or decitabine or low-dose cytarabine to adults 75 years or older or having certain comorbidities per a dose ramp-up including an initial 100 mg or a final 400 mg per day dose |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Oct 16, 2023 | M-265: Revisions to the labeling to include results from clinical study M15-656 (VIALE-A) and M16-043 (VIALE-C) to support PMR 3545-1 and PMR 3545-2 |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 8, 2025 | ODE-185: Indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 21, 2025 | ODE-211: Indicated in combo with azacitidine, or decitabine, or low-dose cytarabine for the tx of newly-diagnosed acute myeloid leukemia in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy |
| Exclusivity Code: ODE - Orphan drug exclusivity | May 15, 2026 | ODE-239: Treatment of previously untreated adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) |
ABBVIE
VIBERZI (TABLET) (ORAL) ELUXADOLINE
Drug Classes: mu-opioid receptor agonist
NDA Applicant: ABBVIE NDA No.: 206940 Prod. No.: 001 RX (75MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7741356 DS* DP* Compounds as opioid receptor modulators Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jun 26, 2015 | May 27, 2029 | |
| Pat. No. 7786158 DS* Compounds as opioid receptor modulators Claim Types: Compound Pat. Sub. Date(s): 001: Jun 26, 2015 | Mar 14, 2025 | |
| Pat. No. 8344011 Compounds as opioid receptor modulators Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 26, 2015 | Mar 14, 2025 | U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline). |
| Pat. No. 8609709 DS* Compounds as opioid receptor modulators Claim Types: Compound; New polymorph, salt, or hydrate Pat. Sub. Date(s): 001: Jun 26, 2015 | Mar 14, 2025 | |
| Pat. No. 8691860 DS* Crystals and process of making 5-({(2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(-4-phenyl Claim Types: New polymorph, salt, or hydrate; Method of use Pat. Sub. Date(s): 001: Jun 26, 2015 | Jul 7, 2028 | U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline). |
| Pat. No. 8772325 Compounds as opioid receptor modulators Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 16, 2017 | Mar 14, 2025 | U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline). |
| Pat. No. 9115091 DS* DP* Crystals and process of making 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-- -1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid Claim Types: New polymorph, salt or hydrate; Method of use; Composition Pat. Sub. Date(s): 001: Sep 23, 2015 | Jul 7, 2028 | U-1738: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline) |
| Pat. No. 9205076 Compounds as opioid receptor modulators Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 30, 2015 | Mar 14, 2025 | U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline). |
| Pat. No. 9364489 Crystals and process of making 5-({[2-amino-3-(4-Carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-- 1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 14, 2016 | Jul 7, 2028 | U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline). |
| Pat. No. 9675587 DP* Opioid receptor modulator dosage formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 7, 2017 | Mar 14, 2033 | |
| Pat. No. 9700542 DP* Compounds as opioid receptor modulators Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Aug 7, 2017 | Mar 14, 2025 | |
| Pat. No. 9789125 DP* Crystals and process of making 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-- 1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid Claim Types: New polymorph, salt or hydrate; Method of use Pat. Sub. Date(s): 001: Nov 1, 2017 | Jul 7, 2028 | U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline). U-2152: Treatment of pain associated with irritable bowel syndrome with diarrhea (IBS-D) with VIBERZI (eluxadoline) |
| Pat. No. 10188632 DP* Opioid receptor modulator dosage formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 28, 2019 | Mar 14, 2033 | |
| Pat. No. 10213415 DS* Compounds as opioid receptor modulators Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 21, 2019 | Mar 14, 2025 | U-2152: Treatment of pain associated with irritable bowel syndrome with diarrhea (IBS-D) with VIBERZI (eluxadoline) |
| Pat. No. 11007179 DP* Opioid receptor modulator dosage formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 3, 2021 | Mar 14, 2033 | |
| Pat. No. 11090291 DP* Opioid receptor modulator dosage formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 7, 2021 | Mar 14, 2033 | |
| Pat. No. 11160792 DP* Opioid receptor modulator dosage formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 24, 2021 | Mar 14, 2033 | |
| Pat. No. 11229627 DP* Opioid receptor modulator dosage formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 15, 2022 | Mar 14, 2033 | |
| Pat. No. 11311516 DP* Opioid receptor modulator dosage formulations Claim Types: Formulation Pat. Sub. Date(s): 001: May 19, 2022 | Mar 14, 2033 | |
| Pat. No. 12097187 Opioid receptor modulator dosage formulations Claim Types: Method of use; Method of Use claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Oct 21, 2024 | Mar 14, 2033 | U-3475: Reduction of the frequency of abdominal pain and diarrhea, in an inflammatory bowel disease with diarrhea (IBS-D) patient, with eluxadoline twice daily with food |
ABBVIE
VIBERZI (TABLET) (ORAL) ELUXADOLINE
Drug Classes: mu-opioid receptor agonist
NDA Applicant: ABBVIE NDA No.: 206940 Prod. No.: 002 RX (100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7741356 DS* DP* Compounds as opioid receptor modulators Claim Types: Compound; Composition Pat. Sub. Date(s): 002: Jun 26, 2015 | May 27, 2029 | |
| Pat. No. 7786158 DS* Compounds as opioid receptor modulators Claim Types: Compound Pat. Sub. Date(s): 002: Jun 26, 2015 | Mar 14, 2025 | |
| Pat. No. 8344011 Compounds as opioid receptor modulators Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 26, 2015 | Mar 14, 2025 | U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline). |
| Pat. No. 8609709 DS* Compounds as opioid receptor modulators Claim Types: Compound; New polymorph, salt, or hydrate Pat. Sub. Date(s): 002: Jun 26, 2015 | Mar 14, 2025 | |
| Pat. No. 8691860 DS* Crystals and process of making 5-({(2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(-4-phenyl Claim Types: New polymorph, salt, or hydrate; Method of use Pat. Sub. Date(s): 002: Jun 26, 2015 | Jul 7, 2028 | U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline). |
| Pat. No. 8772325 Compounds as opioid receptor modulators Claim Types: Method of use Pat. Sub. Date(s): 002: Feb 16, 2017 | Mar 14, 2025 | U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline). |
| Pat. No. 9115091 DS* DP* Crystals and process of making 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-- -1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid Claim Types: New polymorph, salt or hydrate; Method of use; Composition Pat. Sub. Date(s): 002: Sep 23, 2015 | Jul 7, 2028 | U-1738: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline) |
| Pat. No. 9205076 Compounds as opioid receptor modulators Claim Types: Method of use Pat. Sub. Date(s): 002: Dec 30, 2015 | Mar 14, 2025 | U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline). |
| Pat. No. 9364489 Crystals and process of making 5-({[2-amino-3-(4-Carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-- 1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 14, 2016 | Jul 7, 2028 | U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline). |
| Pat. No. 9675587 DP* Opioid receptor modulator dosage formulations Claim Types: Formulation Pat. Sub. Date(s): 002: Aug 7, 2017 | Mar 14, 2033 | |
| Pat. No. 9700542 DP* Compounds as opioid receptor modulators Claim Types: Composition; Formulation Pat. Sub. Date(s): 002: Aug 7, 2017 | Mar 14, 2025 | |
| Pat. No. 9789125 DP* Crystals and process of making 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-- 1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid Claim Types: New polymorph, salt or hydrate; Method of use Pat. Sub. Date(s): 002: Nov 1, 2017 | Jul 7, 2028 | U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline). U-2152: Treatment of pain associated with irritable bowel syndrome with diarrhea (IBS-D) with VIBERZI (eluxadoline) |
| Pat. No. 10188632 DP* Opioid receptor modulator dosage formulations Claim Types: Formulation Pat. Sub. Date(s): 002: Feb 28, 2019 | Mar 14, 2033 | |
| Pat. No. 10213415 DS* Compounds as opioid receptor modulators Claim Types: Method of use Pat. Sub. Date(s): 002: Mar 21, 2019 | Mar 14, 2025 | U-2152: Treatment of pain associated with irritable bowel syndrome with diarrhea (IBS-D) with VIBERZI (eluxadoline) |
| Pat. No. 11007179 DP* Opioid receptor modulator dosage formulations Claim Types: Formulation Pat. Sub. Date(s): 002: Jun 3, 2021 | Mar 14, 2033 | |
| Pat. No. 11090291 DP* Opioid receptor modulator dosage formulations Claim Types: Formulation Pat. Sub. Date(s): 002: Sep 7, 2021 | Mar 14, 2033 | |
| Pat. No. 11160792 DP* Opioid receptor modulator dosage formulations Claim Types: Formulation Pat. Sub. Date(s): 002: Nov 24, 2021 | Mar 14, 2033 | |
| Pat. No. 11229627 DP* Opioid receptor modulator dosage formulations Claim Types: Formulation Pat. Sub. Date(s): 002: Feb 15, 2022 | Mar 14, 2033 | |
| Pat. No. 11311516 DP* Opioid receptor modulator dosage formulations Claim Types: Formulation Pat. Sub. Date(s): 002: May 19, 2022 | Mar 14, 2033 | |
| Pat. No. 11484527 Opioid receptor modulator dosage formulations Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 22, 2022 | Mar 14, 2033 | U-3475: Reduction of the frequency of abdominal pain and diarrhea, in an inflammatory bowel disease with diarrhea (IBS-D) patient, with eluxadoline twice daily with food |
ABBVIE
VIEKIRA PAK (COPACKAGED) (TABLET) (ORAL) DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR
Drug Classes: hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor
NDA Applicant: ABBVIE NDA No.: 206619 Prod. No.: 001 DISC (EQ 250MG BASE;12.5MG, 75MG, 50MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8188104 DS* DP* Anti-infective agents and uses thereof Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jan 15, 2015 | May 17, 2029 | U-1636: Use of dasabuvir to inhibit viral replication for the treatment of HCV infection. |
| Pat. No. 8268349 DP* Solid pharmaceutical dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 15, 2015 | Aug 25, 2024 | |
| Pat. No. 8399015 DP* Solid pharmaceutical dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 15, 2015 | Aug 25, 2024 | |
| Pat. No. 8420596 DS* DP* Macrocyclic hepatitis C serine protease inhibitors Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 15, 2015 | Apr 10, 2031 | |
| Pat. No. 8466159 Methods for treating HCV Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 15, 2015 | Sep 4, 2032 | U-1637: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir with ribavirin. |
| Pat. No. 8492386 Methods for treating HCV Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 15, 2015 | Sep 4, 2032 | U-1840: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir, without ribavirin |
| Pat. No. 8501238 DS* DP* Anti-infective agents and uses thereof Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process Pat. Sub. Date(s): 001: Jan 15, 2015 | Dec 19, 2028 | U-1636: Use of dasabuvir to inhibit viral replication for the treatment of HCV infection. |
| Pat. No. 8642538 DS* DP* Macrocyclic hepatitis C serine protease inhibitors Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jan 15, 2015 | Sep 10, 2029 | U-1638: Treatment of HCV infection using paritaprevir |
| Pat. No. 8680106 Methods for treating HCV Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Jan 15, 2015 | Sep 4, 2032 | U-1637: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir with ribavirin. |
| Pat. No. 8685984 Methods for treating HCV Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Jan 15, 2015 | Sep 4, 2032 | U-1840: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir, without ribavirin |
| Pat. No. 8686026 DP* Solid compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 15, 2015 | Jun 9, 2031 | |
| Pat. No. 8691938 DS* DP* Anti-viral compounds Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 15, 2015 | Apr 13, 2032 | |
| Pat. No. 9006387 Anti-viral compounds Claim Types: Method of use Pat. Sub. Date(s): 001: May 6, 2015 | Jun 10, 2030 | U-1687: Treatment of HCV infection using ombitasvir |
| Pat. No. 9044480 Compositions and methods for treating HCV Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 1, 2015 | Apr 10, 2031 | U-1638: Treatment of HCV infection using paritaprevir |
| Pat. No. 9139536 Anti-infective agents and uses thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 21, 2015 | Nov 9, 2028 | U-1753: Treatment of HCV infection using dasabuvir |
| Pat. No. 9629841 DP* Formulations of pyrimidinedione derivative compounds Claim Types: Composition; Method of use Pat. Sub. Date(s): 001: Jun 16, 2017 | Oct 18, 2033 | U-1753: Treatment of HCV infection using dasabuvir |
| Pat. No. 10201542 DP* Formulations of pyrimidinedione derivative compounds Claim Types: Formulation; Method of use; Process; Method of improving a treatment Pat. Sub. Date(s): 001: Mar 14, 2019 | Oct 18, 2033 | U-1753: Treatment of HCV infection using dasabuvir |
ABBVIE
VIEKIRA XR (TABLET, EXTENDED RELEASE) (ORAL) DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR
Drug Classes: hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor == hepatitis C virus (HCV) NS5A inhibitor == hepatitis C virus (HCV) NS3/4A protease inhibitor == CYP3A inhibitor == HIV-1 protease inhibitor
NDA Applicant: ABBVIE NDA No.: 208624 Prod. No.: 001 DISC (EQ 200MG BASE;8.33MG;50MG;33.33MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8188104 DS* DP* Anti-infective agents and uses thereof Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Aug 17, 2016 | May 17, 2029 | U-1636: Use of dasabuvir to inhibit viral replication for the treatment of HCV infection. |
| Pat. No. 8268349 DP* Solid pharmaceutical dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 17, 2016 | Aug 25, 2024 | |
| Pat. No. 8399015 DP* Solid pharmaceutical dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 17, 2016 | Aug 25, 2024 | |
| Pat. No. 8420596 DS* DP* Macrocyclic hepatitis C serine protease inhibitors Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Aug 17, 2016 | Apr 10, 2031 | |
| Pat. No. 8466159 Methods for treating HCV Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Aug 17, 2016 | Sep 4, 2032 | U-1637: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir with ribavirin. |
| Pat. No. 8492386 Methods for treating HCV Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Aug 17, 2016 | Sep 4, 2032 | U-1840: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir, without ribavirin |
| Pat. No. 8501238 DS* DP* Anti-infective agents and uses thereof Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process Pat. Sub. Date(s): 001: Aug 17, 2016 | Sep 17, 2028 | U-1636: Use of dasabuvir to inhibit viral replication for the treatment of HCV infection. |
| Pat. No. 8642538 DS* DP* Macrocyclic hepatitis C serine protease inhibitors Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Aug 17, 2016 | Sep 10, 2029 | U-1638: Treatment of HCV infection using paritaprevir |
| Pat. No. 8680106 Methods for treating HCV Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Aug 17, 2016 | Sep 4, 2032 | U-1637: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir with ribavirin. |
| Pat. No. 8685984 Methods for treating HCV Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Aug 17, 2016 | Sep 4, 2032 | U-1840: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir, without ribavirin |
| Pat. No. 8686026 DP* Solid compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 17, 2016 | Jun 9, 2031 | |
| Pat. No. 8691938 DS* DP* Anti-viral compounds Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Aug 17, 2016 | Apr 13, 2032 | |
| Pat. No. 9006387 Anti-viral compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 17, 2016 | Jun 10, 2030 | U-1687: Treatment of HCV infection using ombitasvir |
| Pat. No. 9044480 Compositions and methods for treating HCV Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 17, 2016 | Apr 10, 2031 | U-1638: Treatment of HCV infection using paritaprevir |
| Pat. No. 9139536 Anti-infective agents and uses thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 17, 2016 | Nov 9, 2028 | U-1753: Treatment of HCV infection using dasabuvir |
| Pat. No. 9333204 DP* Solid antiviral dosage forms Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 17, 2016 | Jan 2, 2035 | U-1889: Treatment of HCV infection using dasabuvir/ombitasvir/paritaprevir/ritonavir fixed dose combination |
| Pat. No. 9744170 DP* Solid antiviral dosage forms Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 27, 2017 | Jan 2, 2035 | U-1889: Treatment of HCV infection using dasabuvir/ombitasvir/paritaprevir/ritonavir fixed dose combination |
| Pat. No. 10105365 DP* Solid antiviral dosage forms Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 20, 2018 | Jan 2, 2035 | U-1889: Treatment of HCV infection using dasabuvir/ombitasvir/paritaprevir/ritonavir fixed dose combination |
| Pat. No. 10201541 DP* Compositions and methods for treating HCV Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 14, 2019 | May 17, 2032 | |
| Pat. No. 10201584 Compositions and methods for treating HCV Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 14, 2019 | May 17, 2032 | U-1889: Treatment of HCV infection using dasabuvir/ombitasvir/paritaprevir/ritonavir fixed dose combination |
ABBVIE
VRAYLAR (CAPSULE) (ORAL) CARIPRAZINE HYDROCHLORIDE
Drug Classes: atypical antipsychotic
NDA Applicant: ABBVIE NDA No.: 204370 Prod. No.: 001 RX (EQ 1.5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE47350 Pharmaceutical formulations containing dopamine receptor ligands Claim Types: Method of use Pat. Sub. Date(s): 001: May 15, 2019 | Jul 16, 2029 | U-1750: Treatment of schizophrenia and/or acute manic or mixed episodes associated with bipolar I disorder with cariprazine U-2543: Treatment of schizophrenia with cariprazine U-2544: Treatment of acute manic or mixed episodes associated with bipolar I disorder with cariprazine U-2545: Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) with cariprazine U-3503: Adjunctive therapy to antidepressants for the treatment of major depressive disorder |
| Pat. No. RE49110 Pharmaceutical formulations containing dopamine receptor ligands Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 21, 2022 | Jul 16, 2029 | U-2543: Treatment of schizophrenia with cariprazine U-2544: Treatment of acute manic or mixed episodes associated with bipolar I disorder with cariprazine U-2545: Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) with cariprazine U-3503: Adjunctive therapy to antidepressants for the treatment of major depressive disorder |
| Pat. No. RE49302 Pharmaceutical formulations containing dopamine receptor ligands Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 13, 2023 | Jul 16, 2029 | U-2543: Treatment of schizophrenia with cariprazine U-2544: Treatment of acute manic or mixed episodes associated with bipolar I disorder with cariprazine U-2545: Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) with cariprazine U-3503: Adjunctive therapy to antidepressants for the treatment of major depressive disorder |
| Pat. No. 7737142 DS* DP* (Thio) carbamoyl-cyclohexane derivatives as D3/D2 receptor antagonists Claim Types: Compound; Process; Method of use; Composition Pat. Sub. Date(s): 001: Oct 16, 2015 | Sep 17, 2029 | U-1750: Treatment of schizophrenia and/or acute manic or mixed episodes associated with bipolar I disorder with cariprazine U-2543: Treatment of schizophrenia with cariprazine U-2544: Treatment of acute manic or mixed episodes associated with bipolar I disorder with cariprazine U-2545: Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) with cariprazine U-3503: Adjunctive therapy to antidepressants for the treatment of major depressive disorder |
| Pat. No. 7943621 DS* DP* Salts of piperazine compounds as D.sub.3/D.sub.2 antagonists Claim Types: Compound; New polymorph, salt or hydrate; Composition; Process Pat. Sub. Date(s): 001: Oct 16, 2015 | Dec 16, 2028 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Dec 16, 2025 | I-904: Adjunctive therapy to antidepressants for the treatment of major depressive disorder in adults |
ABBVIE
VRAYLAR (CAPSULE) (ORAL) CARIPRAZINE HYDROCHLORIDE
Drug Classes: atypical antipsychotic
NDA Applicant: ABBVIE NDA No.: 204370 Prod. No.: 002 RX (EQ 3MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE49110 Pharmaceutical formulations containing dopamine receptor ligands Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 21, 2022 | Jul 16, 2029 | U-2543: Treatment of schizophrenia with cariprazine U-2544: Treatment of acute manic or mixed episodes associated with bipolar I disorder with cariprazine U-2545: Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) with cariprazine U-3503: Adjunctive therapy to antidepressants for the treatment of major depressive disorder |
| Pat. No. RE49302 Pharmaceutical formulations containing dopamine receptor ligands Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 13, 2023 | Jul 16, 2029 | U-2543: Treatment of schizophrenia with cariprazine U-2544: Treatment of acute manic or mixed episodes associated with bipolar I disorder with cariprazine U-2545: Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) with cariprazine U-3503: Adjunctive therapy to antidepressants for the treatment of major depressive disorder |
| Pat. No. 7737142 DS* DP* (Thio) carbamoyl-cyclohexane derivatives as D3/D2 receptor antagonists Claim Types: Compound; Process; Method of use; Composition Pat. Sub. Date(s): 002: Oct 16, 2015 | Sep 17, 2029 | U-1750: Treatment of schizophrenia and/or acute manic or mixed episodes associated with bipolar I disorder with cariprazine U-2543: Treatment of schizophrenia with cariprazine U-2544: Treatment of acute manic or mixed episodes associated with bipolar I disorder with cariprazine U-2545: Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) with cariprazine U-3503: Adjunctive therapy to antidepressants for the treatment of major depressive disorder |
| Pat. No. 7943621 DS* DP* Salts of piperazine compounds as D.sub.3/D.sub.2 antagonists Claim Types: Compound; New polymorph, salt or hydrate; Composition; Process Pat. Sub. Date(s): 002: Oct 16, 2015 | Dec 16, 2028 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Dec 16, 2025 | I-904: Adjunctive therapy to antidepressants for the treatment of major depressive disorder in adults |
ABBVIE
VRAYLAR (CAPSULE) (ORAL) CARIPRAZINE HYDROCHLORIDE
Drug Classes: atypical antipsychotic
NDA Applicant: ABBVIE NDA No.: 204370 Prod. No.: 003 RX (EQ 4.5MG BASE); 004 RX (EQ 6MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE49110 Pharmaceutical formulations containing dopamine receptor ligands Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 21, 2022 | Jul 16, 2029 | U-2543: Treatment of schizophrenia with cariprazine U-2544: Treatment of acute manic or mixed episodes associated with bipolar I disorder with cariprazine U-2545: Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) with cariprazine |
| Pat. No. RE49302 Pharmaceutical formulations containing dopamine receptor ligands Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 13, 2023 | Jul 16, 2029 | U-2543: Treatment of schizophrenia with cariprazine U-2544: Treatment of acute manic or mixed episodes associated with bipolar I disorder with cariprazine U-2545: Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) with cariprazine U-3503: Adjunctive therapy to antidepressants for the treatment of major depressive disorder |
| Pat. No. 7737142 DS* DP* (Thio) carbamoyl-cyclohexane derivatives as D3/D2 receptor antagonists Claim Types: Compound; Process; Method of use; Composition Pat. Sub. Date(s): All strengths: Oct 16, 2015 | Sep 17, 2029 | U-1750: Treatment of schizophrenia and/or acute manic or mixed episodes associated with bipolar I disorder with cariprazine U-2543: Treatment of schizophrenia with cariprazine U-2544: Treatment of acute manic or mixed episodes associated with bipolar I disorder with cariprazine |
| Pat. No. 7943621 DS* DP* Salts of piperazine compounds as D.sub.3/D.sub.2 antagonists Claim Types: Compound; New polymorph, salt or hydrate; Composition; Process Pat. Sub. Date(s): All strengths: Oct 16, 2015 | Dec 16, 2028 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Dec 16, 2025 | I-904: Adjunctive therapy to antidepressants for the treatment of major depressive disorder in adults |
ABBVIE
VUITY (SOLUTION) (OPHTHALMIC) PILOCARPINE HYDROCHLORIDE
Drug Classes: cholinergic agonist
NDA Applicant: ABBVIE NDA No.: 214028 Prod. No.: 001 RX (1.25%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10610518 Presbyopia treatments Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 24, 2021 | Apr 24, 2039 | U-3252: Use of VUITY for the treatment of presbyopia in adults U-3561: Treatment of presbyopia in adults by administration of pilocarpine HCl formulation once daily U-3562: Treatment of presbyopia in adults by administration of pilocarpine HCl formulation twice daily |
| Pat. No. 11285134 Presbyopia treatments Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 28, 2022 | Apr 24, 2039 | U-3252: Use of VUITY for the treatment of presbyopia in adults U-3561: Treatment of presbyopia in adults by administration of pilocarpine HCl formulation once daily U-3562: Treatment of presbyopia in adults by administration of pilocarpine HCl formulation twice daily |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: D - New Dosing Schedule | Mar 28, 2026 | D-187: Addition of second dose for treatment of presbyopia in adults |
| Exclusivity Code: NP - New product | Oct 28, 2024 |
ABBVIE
VYALEV (SOLUTION) (SUBCUTANEOUS) FOSCARBIDOPA; FOSLEVODOPA
NDA Applicant: ABBVIE NDA No.: 216962 Prod. No.: 001 RX (120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9446059 DS* DP* Carbidopa and L-dopa prodrugs and methods of use Claim Types: Formulation; Method of use; Kit; Compound Pat. Sub. Date(s): 001: Nov 14, 2024 | Oct 21, 2035 | U-4030: Treatment of motor fluctuations in adults with advanced parkinson's disease |
| Pat. No. 10174061 DP* Carbidopa and L-dopa prodrugs and methods of use Claim Types: Formulation; Method of use; Kit Pat. Sub. Date(s): 001: Nov 14, 2024 | Oct 21, 2035 | U-4030: Treatment of motor fluctuations in adults with advanced parkinson's disease |
| Pat. No. 10730895 DS* Carbidopa prodrug Claim Types: Compound Pat. Sub. Date(s): 001: Nov 14, 2024 | Oct 21, 2035 |
ABBVIE
ZEMPLAR (SOLUTION) (INTRAVENOUS) PARICALCITOL [GENERIC AP]
Drug Classes: vitamin D analog == vitamin D2 analog
NDA Applicant: ABBVIE NDA No.: 020819 Prod. No.: 001 RX (0.005MG/ML (0.005MG/ML)); 002 RX (0.002MG/ML (0.002MG/ML)); 003 RX (0.01MG/2ML (0.005MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s) | Oct 18, 2023 |
ABBVIE
ZEMPLAR (CAPSULE) (ORAL) PARICALCITOL [GENERIC AB]
Drug Classes: vitamin D analog == vitamin D2 analog
NDA Applicant: ABBVIE NDA No.: 021606 Prod. No.: 001 RX (1MCG); 002 RX (2MCG) NDA No.: 021606 Prod. No.: 003 DISC (4MCG**)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 18, 2023 | ODE-125: Indicated in pediatric patients 10 years and older for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (CKD) stages 3 and 4 and ckd stage 5 in patients on hemodialysis or peritoneal dialysis |
ABBVIE ENDOCRINE INC
LUPRON DEPOT (INJECTABLE) (INJECTION) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: ABBVIE ENDOCRINE INC NDA No.: 020517 Prod. No.: 003 RX (45MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8921326 DP* Sustained-release composition and method for producing the same Claim Types: Formulation Pat. Sub. Date(s): 003: Mar 13, 2015 | Feb 5, 2031 | U-1666: Palliative treatment of prostate cancer |
| Pat. No. 9617303 Sustained-release composition and method for producing the same Claim Types: Method of use Pat. Sub. Date(s): 003: Oct 4, 2024 | Mar 22, 2028 | U-4001: Treatment of advanced prostatic cancer |
ABBVIE ENDOCRINE INC
LUPRON DEPOT-PED KIT (POWDER) (INTRAMUSCULAR) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: ABBVIE ENDOCRINE INC NDA No.: 020263 Prod. No.: 009 RX (45MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8921326 DP* Sustained-release composition and method for producing the same Claim Types: Formulation Pat. Sub. Date(s): 009: May 12, 2023 | Feb 5, 2031 | |
| Pat. No. 9617303 Sustained-release composition and method for producing the same Claim Types: Method of use Pat. Sub. Date(s): 009: May 12, 2023 | Mar 22, 2028 | U-3611: Treatment of pediatric patients with central precocious puberty |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NS - New strength | Apr 14, 2026 |
ACACIA
BARHEMSYS (SOLUTION) (INTRAVENOUS) AMISULPRIDE
Drug Classes: dopamine-2 (D2) antagonist
NDA Applicant: ACACIA NDA No.: 209510 Prod. No.: 001 RX (5MG/2ML (2.5MG/ML)); 002 RX (10MG/4ML (2.5MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9084765 Use of amisulpride as an anti-emetic Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 16, 2020; 002: Feb 9, 2022 | Feb 26, 2034 | U-1744: Prevention of post-operative nausea and vomiting U-2754: Treatment of post-operative nausea and vomiting U-3467: Prevention and treatment of post-operative nausea and vomiting |
| Pat. No. 9545426 Use of amisulpride as an anti-emetic Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 16, 2020; 002: Feb 9, 2022 | Mar 10, 2031 | U-1744: Prevention of post-operative nausea and vomiting U-2754: Treatment of post-operative nausea and vomiting |
| Pat. No. 9889118 Use of amisulpride as an anti-emetic Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 16, 2020; 002: Feb 9, 2022 | Mar 10, 2031 | U-1744: Prevention of post-operative nausea and vomiting U-2754: Treatment of post-operative nausea and vomiting |
| Pat. No. 10525033 DP* Use of amisulpride as an anti-emetic Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Mar 16, 2020; 002: Feb 9, 2022 | Mar 10, 2031 | |
| Pat. No. 11357753 Rescue treatment of post operative nausea and vomiting Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 8, 2022 | Feb 9, 2038 | U-2754: Treatment of post-operative nausea and vomiting |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Feb 26, 2025 |
ACACIA
BYFAVO (POWDER) (INTRAVENOUS) REMIMAZOLAM BESYLATE
NDA Applicant: ACACIA NDA No.: 212295 Prod. No.: 001 RX (EQ 20MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9561236 Dosing regimen for sedation with CNS 7056 (Remimazolam) Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 23, 2020 | Apr 30, 2033 | U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less |
| Pat. No. 9737547 Dosing regimen for sedation with CNS 7056 (Remimazolam) Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 23, 2020 | Nov 7, 2031 | U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less |
| Pat. No. 9777007 DP* Short-acting benzodiazepine salts and their polymorphic forms Claim Types: Composition Pat. Sub. Date(s): 001: Oct 23, 2020 | Jul 10, 2027 | |
| Pat. No. 9827251 Dosing regimen for sedation with CNS 7056 (remimazolam) Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 23, 2020 | Jan 13, 2034 | U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less |
| Pat. No. 9914738 DP* Short-acting benzodiazepine salts and their polymorphic forms Claim Types: Formulation; Product-by-process Pat. Sub. Date(s): 001: Oct 23, 2020 | Jul 10, 2027 | |
| Pat. No. 10052334 Dosing regimen for sedation with CNS 7056 (remimazolam) Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 23, 2020 | Nov 7, 2031 | U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less |
| Pat. No. 10195210 Dosing regimen for sedation with CNS 7056 (Remimazolam) Claim Types: Diagnostic or surgical method Pat. Sub. Date(s): 001: Oct 23, 2020 | Nov 7, 2031 | U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less |
| Pat. No. 10342800 Dosing regimen for sedation with CNS 7056 (Remimazolam) Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 23, 2020 | Nov 7, 2031 | U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less |
| Pat. No. 10472365 Short-acting benzodiazepine salts and their polymorphic forms Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 23, 2020 | Jul 10, 2027 | U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less |
| Pat. No. 10722522 Dosing regimen for sedation with CNS 7056 (remimazolam) Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 23, 2020 | Nov 7, 2031 | U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less |
| Pat. No. 10961250 DP* Short-acting benzodiazepine salts and their polymorphic forms Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jul 8, 2022 | Jul 10, 2027 | U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Oct 6, 2025 |
ACADIA PHARMS INC
DAYBUE (SOLUTION) (ORAL) TROFINETIDE
NDA Applicant: ACADIA PHARMS INC NDA No.: 217026 Prod. No.: 001 RX (200MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9212204 Treatment of rett syndrome using glycyl-L-2-methylprolyl-L-glutamic acid Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 7, 2023 | Jan 27, 2032 | U-3556: Treatment of Rett syndrome or a symptom thereof |
| Pat. No. 11370755 DS* DP* Compositions of trofinetide Claim Types: Formulation; Product-by-process Pat. Sub. Date(s): 001: Apr 7, 2023 | Aug 3, 2040 | |
| Pat. No. 11827600 DS* DP* Crystalline forms of trofinetide Claim Types: New polymorph, salt or hydrate; Kit; Process Pat. Sub. Date(s): 001: Aug 12, 2024 | Jul 12, 2042 | U-3556: Treatment of Rett syndrome or a symptom thereof |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Mar 10, 2028 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Mar 10, 2030 | ODE-425: Treatment of Rett syndrome in adults and pediatric patients 2 years of age and older |
ACADIA PHARMS INC
NUPLAZID (TABLET) (ORAL) PIMAVANSERIN TARTRATE
Drug Classes: atypical antipsychotic
NDA Applicant: ACADIA PHARMS INC NDA No.: 207318 Prod. No.: 001 DISC (EQ 17MG BASE**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7601740 DS* DP* Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseasesClaim Types: Composition; Formulation Pat. Sub. Date(s): 001: May 25, 2016 | Apr 29, 2030 | |
| Pat. No. 7659285 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseasesClaim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: May 25, 2016 | Aug 24, 2026 | U-1844: Treatment of Parkinson's disease psychosis |
| Pat. No. 7732615 DS* DP* N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)phe- nylmethyl)carbamide and its tartrate salt and crystalline forms Claim Types: New polymorph, salt or hydrate; Composition; Product-by-process Pat. Sub. Date(s): 001: May 25, 2016 | Jun 3, 2028 | |
| Pat. No. 7923564 DS* DP* Synthesis of N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy) phenylmethyl)carbamide and its tartrate salt and crystalline forms Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: May 25, 2016 | Sep 26, 2025 | |
| Pat. No. 8618130 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 001: May 25, 2016 | Jan 15, 2024 | U-1845: Treatment of psychosis or a symptom thereof |
| Pat. No. 8921393 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 001: May 25, 2016 | Jan 15, 2024 | U-1846: Treatment of a neurodegenerative disease or a symptom thereof |
| Pat. No. 9566271 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 14, 2017 | Jan 15, 2024 | U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis |
| Pat. No. 10028944 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 6, 2018 | Jan 15, 2024 | U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis |
ACADIA PHARMS INC
NUPLAZID (TABLET) (ORAL) PIMAVANSERIN TARTRATE
Drug Classes: atypical antipsychotic
NDA Applicant: ACADIA PHARMS INC NDA No.: 207318 Prod. No.: 002 RX (EQ 10MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7601740 DS* DP* Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseasesClaim Types: Composition; Formulation Pat. Sub. Date(s): 002: Jul 25, 2018 | Apr 29, 2030 | |
| Pat. No. 7659285 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseasesClaim Types: Method of use; Method of administration Pat. Sub. Date(s): 002: Jul 25, 2018 | Aug 24, 2026 | U-1844: Treatment of Parkinson's disease psychosis |
| Pat. No. 7732615 DS* DP* N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)phe- nylmethyl)carbamide and its tartrate salt and crystalline forms Claim Types: New polymorph, salt or hydrate; Composition; Product-by-process Pat. Sub. Date(s): 002: Jul 25, 2018 | Jun 3, 2028 | |
| Pat. No. 7923564 DS* DP* Synthesis of N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy) phenylmethyl)carbamide and its tartrate salt and crystalline forms Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 002: Jul 25, 2018 | Sep 26, 2025 | |
| Pat. No. 8618130 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 25, 2018 | Jan 15, 2024 | U-1845: Treatment of psychosis or a symptom thereof |
| Pat. No. 8921393 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 25, 2018 | Jan 15, 2024 | U-1846: Treatment of a neurodegenerative disease or a symptom thereof |
| Pat. No. 9566271 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 25, 2018 | Jan 15, 2024 | U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis |
| Pat. No. 10028944 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 25, 2018 | Jan 15, 2024 | U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis |
| Pat. No. 10517860 Combination of pimavanserin and cytochrome P450 modulators Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 10, 2020 | Mar 23, 2037 | U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis |
| Pat. No. 10953000 Combination of pimavanserin and cytochrome P450 modulators Claim Types: Method of improving a treatment Pat. Sub. Date(s): 002: Mar 30, 2021 | Mar 23, 2037 | U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis |
ACADIA PHARMS INC
NUPLAZID (CAPSULE) (ORAL) PIMAVANSERIN TARTRATE
Drug Classes: atypical antipsychotic
NDA Applicant: ACADIA PHARMS INC NDA No.: 210793 Prod. No.: 001 RX (EQ 34MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7601740 DS* DP* Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseasesClaim Types: Composition; Formulation Pat. Sub. Date(s): 001: Jul 25, 2018 | Apr 29, 2030 | |
| Pat. No. 7659285 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseasesClaim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jul 25, 2018 | Aug 24, 2026 | U-1844: Treatment of Parkinson's disease psychosis |
| Pat. No. 7732615 DS* DP* N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)phe- nylmethyl)carbamide and its tartrate salt and crystalline forms Claim Types: New polymorph, salt or hydrate; Composition; Product-by-process Pat. Sub. Date(s): 001: Jul 25, 2018 | Jun 3, 2028 | |
| Pat. No. 7923564 DS* DP* Synthesis of N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy) phenylmethyl)carbamide and its tartrate salt and crystalline forms Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Jul 25, 2018 | Sep 26, 2025 | |
| Pat. No. 8618130 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2018 | Jan 15, 2024 | U-1845: Treatment of psychosis or a symptom thereof |
| Pat. No. 8921393 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2018 | Jan 15, 2024 | U-1846: Treatment of a neurodegenerative disease or a symptom thereof |
| Pat. No. 9566271 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2018 | Jan 15, 2024 | U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis |
| Pat. No. 10028944 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2018 | Jan 15, 2024 | U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis |
| Pat. No. 10449185 DP* Formulations of pimavanserin Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 1, 2019 | Aug 27, 2038 | |
| Pat. No. 10646480 DP* Formulations of pimavanserin Claim Types: Formulation Pat. Sub. Date(s): 001: May 15, 2020 | Aug 27, 2038 | |
| Pat. No. 10849891 DP* Formulations of pimavanserin Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Dec 11, 2020 | Aug 27, 2038 | U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis |
| Pat. No. 11452721 DP* Formulations of pimavanserin Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 27, 2022 | Aug 27, 2038 |
ACCORD
CAMCEVI KIT (EMULSION) (SUBCUTANEOUS) LEUPROLIDE MESYLATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: ACCORD NDA No.: 211488 Prod. No.: 001 RX (EQ 42MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9572857 DP* Pharmaceutical compositions with enhanced stability Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 15, 2021 | Jan 16, 2027 | |
| Pat. No. 9744207 DP* Pharmaceutical compositions with enhanced stability Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 15, 2021 | Jan 16, 2027 | |
| Pat. No. 10646572 DP* Pharmaceutical compositions with enhanced stability Claim Types: Formulation; Kit; Process Pat. Sub. Date(s): 001: Jul 15, 2021 | Jan 16, 2027 | |
| Pat. No. 11717555 DP* Pharmaceutical compositions having a selected release duration Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 25, 2023 | Jan 1, 2039 | |
| Pat. No. 12133878 DP* Pharmaceutical compositions having a selected release duration Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 12, 2024 | Dec 18, 2037 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | May 25, 2024 |
ACCORD HLTHCARE
TERIFLUNOMIDE (TABLET) (ORAL) TERIFLUNOMIDE [GENERIC AB]
Drug Classes: pyrimidine synthesis inhibitor
NDA Applicant: ACCORD HLTHCARE NDA No.: 209690 Prod. No.: 001 RX (7MG); 002 RX (14MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: PC - Patent challenge | Sep 8, 2023 |
ACER
OLPRUVA (FOR SUSPENSION) (ORAL) SODIUM PHENYLBUTYRATE
NDA Applicant: ACER NDA No.: 214860 Prod. No.: 001 RX (2GM/PACKET); 002 RX (3GM/PACKET); 003 RX (4GM/PACKET); 004 RX (5GM/PACKET); 005 RX (6GM/PACKET); 006 RX (6.67GM/PACKET)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11154521 DP* Palatable compositions including sodium phenylbutyrate and uses thereof Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jan 12, 2023 | Oct 17, 2036 | |
| Pat. No. 11202767 Methods of treating urea cycle disorders and maple syrup urine disease Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 12, 2023 | Oct 17, 2036 | U-3502: Treatment of a urea cycle disorder involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase, or argininosuccinic acid synthetase |
| Pat. No. 11433041 DP* Palatable compositions including sodium phenylbutyrate and uses thereof Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jan 12, 2023 | Oct 17, 2036 |
ACERUS
NATESTO (GEL, METERED) (NASAL) TESTOSTERONE
Drug Classes: androgen
NDA Applicant: ACERUS NDA No.: 205488 Prod. No.: 001 RX (5.5MG/0.122GM ACTUATION)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8574622 DP* Controlled release delivery system for nasal applications Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 26, 2014 | Feb 4, 2024 | |
| Pat. No. 8784869 DP* Controlled release delivery system for nasal applications and methods of treatment Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 20, 2014 | Feb 4, 2024 | |
| Pat. No. 8784882 DP* Controlled release delivery system for nasal applications and method of treatment Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 20, 2014 | Feb 4, 2024 | U-1557: A method of testosterone replacement therapy comprising the step of nasally administering to a patient in need of such treatment an effective amount of testosterone gel formulation. |
| Pat. No. 8877230 Controlled release delivery system for nasal applications Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 3, 2014 | Feb 4, 2024 | U-1616: Nasal administration of a testosterone gel to a patient to treat the patient for a condition associated with a deficiency or absence of endogenous testosterone |
| Pat. No. 11090312 Methods of treating hypogonadism with transnasal testerosterone bio-adhesive gel formulations in male with allergic rhinitis, and methods for preventing an allergic rhinitis event Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Sep 10, 2021 | Mar 17, 2034 | U-1616: Nasal administration of a testosterone gel to a patient to treat the patient for a condition associated with a deficiency or absence of endogenous testosterone |
ACERUS PHARMS
NOCTIVA (SPRAY, METERED) (NASAL) DESMOPRESSIN ACETATE
Drug Classes: factor VIII activator == vasopressin analog
NDA Applicant: ACERUS PHARMS NDA No.: 201656 Prod. No.: 001 DISC (0.00083MG/SPRAY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7799761 DP* Pharmaceutical compositions including low dosages of desmopressin Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 31, 2017 | Sep 26, 2024 | |
| Pat. No. 9539302 DP* Safe desmopressin administration Claim Types: Device Pat. Sub. Date(s): 001: Mar 31, 2017 | Jun 15, 2030 | |
| Pat. No. 11419914 Safe desmopressin administration Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 20, 2022 | Jun 15, 2030 | U-3431: Treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void by inducing an antidiuretic effect by intranasally administering a plume of droplets comprising a dose of about 0.05-5 mcg desmopressin |
| Pat. No. 12090190 DP* Safe desmopressin administration Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Oct 11, 2024 | Jun 15, 2030 | U-4003: Treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void by intranasally administering a plume of droplets comprising a dose of 0.75 mcg or 1.5 mcg desmopressin |
ACERUS PHARMS
NOCTIVA (SPRAY, METERED) (NASAL) DESMOPRESSIN ACETATE
Drug Classes: factor VIII activator == vasopressin analog
NDA Applicant: ACERUS PHARMS NDA No.: 201656 Prod. No.: 002 DISC (0.00166MG/SPRAY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9539302 DP* Safe desmopressin administration Claim Types: Device Pat. Sub. Date(s): 002: Mar 31, 2017 | Jun 15, 2030 | |
| Pat. No. 11419914 Safe desmopressin administration Claim Types: Method of use Pat. Sub. Date(s): 002: Sep 20, 2022 | Jun 15, 2030 | U-3431: Treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void by inducing an antidiuretic effect by intranasally administering a plume of droplets comprising a dose of about 0.05-5 mcg desmopressin |
| Pat. No. 12090190 DP* Safe desmopressin administration Claim Types: Device; Method of use Pat. Sub. Date(s): 002: Oct 11, 2024 | Jun 15, 2030 | U-4003: Treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void by intranasally administering a plume of droplets comprising a dose of 0.75 mcg or 1.5 mcg desmopressin |
ACLARIS
ESKATA (SOLUTION) (TOPICAL) HYDROGEN PEROXIDE
NDA Applicant: ACLARIS NDA No.: 209305 Prod. No.: 001 DISC (40%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9675639 DP* Peroxide formulations and methods and applicators for using the same Claim Types: Formulation; Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 3, 2018 | Jul 4, 2035 | U-2205: Treatment of seborrheic keratoses that are raised |
| Pat. No. 9980983 Peroxide formulations and methods and applicators for using the same Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 18, 2018 | Apr 21, 2035 | U-2205: Treatment of seborrheic keratoses that are raised |
| Pat. No. 10098910 DP* Peroxide formulations and methods and applicators for using the same Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Oct 25, 2018 | Apr 21, 2035 | U-2205: Treatment of seborrheic keratoses that are raised |
| Pat. No. 10493103 DP* Peroxide formulations and methods and applicators for using the same Claim Types: Device Pat. Sub. Date(s): 001: Jan 21, 2020 | Apr 21, 2035 | |
| Pat. No. 10729720 DP* Peroxide formulations and methods and applicators for using the same Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 11, 2020 | Apr 21, 2035 |
ACROTECH BIOPHARMA
BELEODAQ (POWDER) (INTRAVENOUS) BELINOSTAT
Drug Classes: histone deacetylase (HDAC) inhibitor
NDA Applicant: ACROTECH BIOPHARMA NDA No.: 206256 Prod. No.: 001 RX (500MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6888027 DS* DP* Carbamic acid compounds comprising a sulfonamide linkage as HDAC inhibitors Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Aug 1, 2014 | Aug 10, 2026 | U-1544: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). |
| Pat. No. 8835501 DP* Pharmaceutical formulations of HDAC inhibitors Claim Types: Formulation; Drug in a container; Kit Pat. Sub. Date(s): 001: Oct 9, 2014 | Oct 27, 2027 |
ACROTECH BIOPHARMA
EVOMELA (POWDER) (INTRAVENOUS) MELPHALAN HYDROCHLORIDE
Drug Classes: alkylating drug
NDA Applicant: ACROTECH BIOPHARMA NDA No.: 207155 Prod. No.: 001 RX (EQ 50MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8410077 DP* Sulfoalkyl ether cyclodextrin compositions Claim Types: Composition; Compound; Product-by-process; Formulation Pat. Sub. Date(s): 001: Apr 5, 2016 | Mar 13, 2029 | |
| Pat. No. 9200088 DP* Sulfoalkyl ether cyclodextrin compositions Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Apr 5, 2016 | Mar 13, 2029 | |
| Pat. No. 9493582 DP* Alkylated cyclodextrin compositions and processes for preparing and using the same Claim Types: Formulation; Product-by-process; Process Pat. Sub. Date(s): 001: Mar 14, 2017 | Feb 27, 2033 | |
| Pat. No. 10040872 DP* Alkylated cyclodextrin compositions and processes for preparing and using the same Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Sep 6, 2018 | Jan 30, 2034 | |
| Pat. No. 10864183 DP* Injectable nitrogen mustard compositions comprising a cyclodextrin derivative and methods of making and using the same Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 15, 2020 | May 28, 2030 | |
| Pat. No. 10940128 DP* Injectable melphalan compositions comprising a cyclodextrin derivative and methods of making and using the same Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Mar 19, 2021 | Jun 14, 2030 | U-3086: For high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma |
| Pat. No. 11020363 DP* Injectable nitrogen mustard compositions comprising a cyclodextrin derivative and methods of making and using the same Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 10, 2021 | May 28, 2030 |
ACROTECH BIOPHARMA
FOLOTYN (SOLUTION) (INTRAVENOUS) PRALATREXATE
Drug Classes: folate analog metabolic inhibitor
NDA Applicant: ACROTECH BIOPHARMA NDA No.: 022468 Prod. No.: 001 RX (20MG/ML (20MG/ML)); 002 RX (40MG/2ML (20MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7622470 Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | May 31, 2025 | U-1015: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma |
| Pat. No. 8299078 Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 19, 2012; 002: None | May 31, 2025 | U-1004: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma |
ACROTECH BIOPHARMA
KHAPZORY (POWDER) (INTRAVENOUS) LEVOLEUCOVORIN
Drug Classes: folate analog
NDA Applicant: ACROTECH BIOPHARMA NDA No.: 211226 Prod. No.: 001 RX (175MG/VIAL) NDA No.: 211226 Prod. No.: 002 DISC (300MG/VIAL )
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11541012 DP* Compositions comprising disodium levofolinate Claim Types: Product-by-process Pat. Sub. Date(s): All strengths: Jan 9, 2023 | Mar 25, 2039 |
ACTELION
OPSUMIT (TABLET) (ORAL) MACITENTAN
Drug Classes: endothelin receptor antagonist
NDA Applicant: ACTELION NDA No.: 204410 Prod. No.: 001 RX (10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7094781 DS* DP* Sulfamides and their use as endothelin receptor antagonists Claim Types: Compound Pat. Sub. Date(s): 001: Nov 6, 2013 | Dec 5, 2025 | |
| Pat. No. 8268847 Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 6, 2013 | Apr 18, 2029 | U-1446: Method of treating pulmonary hypertension comprising administering macitentan in combination with a compound having phosphodiesterase-5 inhibitory properties |
| Pat. No. 8367685 DP* Stable pharmaceutical compositions comprising a pyrimidine-sulfamide Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 6, 2013 | Oct 4, 2028 | U-1445: Method of treating pulmonary arterial hypertension by administering a pharmaceutical composition comprising macitentan and a polysorbate, wherein the polysorbate represents 0.1 to 1% of the weight of said pharmaceutical composition |
| Pat. No. 9265762 DP* Stable pharmaceutical compositions comprising a pyrimidine-sulfamide Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Mar 16, 2016 | May 29, 2027 | U-1820: Method of treating pulmonary arterial hypertension by administering a pharmaceutical composition comprising macitentan and a polysorbate, wherein the polysorbate represents 0.1 to 3% of the weight of said pharmaceutical composition |
| Pat. No. 10946015 DP* Stable pharmaceutical compositions comprising a pyrimidine-sulfamide Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Apr 8, 2021 | Sep 11, 2026 | U-1445: Method of treating pulmonary arterial hypertension by administering a pharmaceutical composition comprising macitentan and a polysorbate, wherein the polysorbate represents 0.1 to 1% of the weight of said pharmaceutical composition |
ACTELION
OPSYNVI (TABLET) (ORAL) MACITENTAN; TADALAFIL
Drug Classes: endothelin receptor antagonist == phosphodiesterase-5 (PDE-5) inhibitor
NDA Applicant: ACTELION NDA No.: 218490 Prod. No.: 001 RX (10MG;20MG); 002 RX (10MG;40MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7094781 DS* DP* Sulfamides and their use as endothelin receptor antagonists Claim Types: Compound Pat. Sub. Date(s): All strengths: Apr 18, 2024 | Dec 5, 2025 | |
| Pat. No. 8268847 DP* Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Apr 18, 2024 | Apr 18, 2029 | U-3882: Method of treating pulmonary arterial hypertension comprising administering a combination of macitentan and tadalafil |
| Pat. No. 10946015 DP* Stable pharmaceutical compositions comprising a pyrimidine-sulfamide Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Apr 18, 2024 | Sep 11, 2026 | U-3881: Use of the combination of macitentan and tadalafil for the chronic treatment of adults with pulmonary arterial hypertension |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Mar 22, 2027 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Mar 22, 2031 | ODE-475: Chronic treatment of adults with pulmonary arterial hypertension (PAH, WHO Group I and WHO functional class (FC) II-III) |
ACTELION
TRACLEER (TABLET) (ORAL) BOSENTAN [GENERIC AB]
Drug Classes: endothelin receptor antagonist
NDA Applicant: ACTELION NDA No.: 021290 Prod. No.: 001 RX (62.5MG); 002 RX (125MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s) | Sep 5, 2024 |
ACTELION
TRACLEER (TABLET, FOR SUSPENSION) (ORAL) BOSENTAN
Drug Classes: endothelin receptor antagonist
NDA Applicant: ACTELION NDA No.: 209279 Prod. No.: 001 RX (32MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7959945 DP* Dispersible bosentan tablet Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 3, 2017 | Dec 28, 2027 | |
| Pat. No. 8309126 DP* Dispersible bosentan tablet Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: Oct 3, 2017 | May 15, 2026 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Sep 5, 2024 | ODE-161: Treatment of pulmonary arterial hypertension (PAH) (WHO group 1) in pediatric patients aged 3 yrs and older with idiopathic or congenital pah to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability |
ACTELION
UPTRAVI (TABLET) (ORAL) SELEXIPAG [GENERIC AB]
Drug Classes: prostacyclin receptor agonist
NDA Applicant: ACTELION NDA No.: 207947 Prod. No.: 001 RX (0.2MG); 002 RX (0.4MG); 003 RX (0.6MG); 004 RX (0.8MG); 005 RX (1MG); 006 RX (1.2MG); 007 RX (1.4MG); 008 RX (1.6MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7205302 DS* DP* Heterocyclic compound derivatives and medicines Claim Types: Composition; Compound; Method of use Pat. Sub. Date(s): All strengths: Jan 19, 2016 | Oct 31, 2026 | U-1797: Method of treating pulmonary arterial hypertension comprising administering a pharmaceutical composition comprising selexipag |
| Pat. No. 8791122 DS* DP* Form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide and method for producing the same Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): All strengths: Jan 19, 2016 | Aug 1, 2030 | |
| Pat. No. 9173881 Therapeutic compositions containing macitentan Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 19, 2016 | Aug 12, 2029 | U-1798: Method of treating pulmonary arterial hypertension comprising administering selexipag in combination with the endothelin receptor antagonist macitentan |
| Pat. No. 9284280 Use of form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 12, 2016 | Jun 25, 2030 | U-1831: Method of treating pulmonary arterial hypertension comprising administering a crystalline form of selexipag |
| Pat. No. 10821108 DP* Pharmaceutical composition containing 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Dec 2, 2020 | Dec 1, 2036 | U-2992: Method of treating pulmonary arterial hypertension comprising administering a solid preparation containing selexipag |
| Pat. No. 10828298 DP* Pharmaceutical composition containing 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy]-N-(methylsu- lfonyl)acetamide Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Dec 2, 2020 | Dec 1, 2036 | U-2991: Method of treating pulmonary arterial hypertension comprising administering a tablet containing selexipag |
ACTELION
UPTRAVI (POWDER) (INTRAVENOUS) SELEXIPAG
Drug Classes: prostacyclin receptor agonist
NDA Applicant: ACTELION NDA No.: 214275 Prod. No.: 001 RX (1.8MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7205302 DS* DP* Heterocyclic compound derivatives and medicines Claim Types: Composition; Compound; Method of use Pat. Sub. Date(s): 001: Aug 27, 2021 | Oct 31, 2026 | U-1797: Method of treating pulmonary arterial hypertension comprising administering a pharmaceutical composition comprising selexipag |
| Pat. No. 8791122 DS* DP* Form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide and method for producing the same Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Aug 27, 2021 | Aug 1, 2030 | |
| Pat. No. 9173881 Therapeutic compositions containing macitentan Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 27, 2021 | Aug 12, 2029 | U-1798: Method of treating pulmonary arterial hypertension comprising administering selexipag in combination with the endothelin receptor antagonist macitentan |
| Pat. No. 9284280 Use of form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 27, 2021 | Jun 25, 2030 | U-1831: Method of treating pulmonary arterial hypertension comprising administering a crystalline form of selexipag |
ACTELION
VELETRI (INJECTABLE) (INJECTION) EPOPROSTENOL SODIUM [GENERIC AP2]
Drug Classes: prostacycline vasodilator
NDA Applicant: ACTELION NDA No.: 022260 Prod. No.: 001 RX (EQ 1.5MG BASE/VIAL); 002 RX (EQ 0.5MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8318802 DP* Epoprostenol formulation and method of making thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 26, 2012; 002: None | Mar 15, 2027 | |
| Pat. No. 8598227 Epoprostenol formulation and method of making thereof Claim Types: Method of use; Process Pat. Sub. Date(s): All strengths: None | Feb 2, 2027 |
ADALVO
ONSOLIS (FILM) (BUCCAL) FENTANYL CITRATE
Drug Classes: opioid agonist
NDA Applicant: ADALVO NDA No.: 022266 Prod. No.: 001 DISC (EQ 0.2MG BASE); 002 DISC (EQ 0.4MG BASE); 003 DISC (EQ 0.6MG BASE); 004 DISC (EQ 0.8MG BASE); 005 DISC (EQ 1.2MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9597288 DP* Transmucosal delivery devices with enhanced uptake Claim Types: Method of administration; Formulation; Method of use Pat. Sub. Date(s): All strengths: Apr 3, 2017 | Jul 23, 2027 | U-767: Management of breakthrough pain in patients with cancer |
ADAMIS PHARMS CORP
SYMJEPI (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: ADAMIS PHARMS CORP NDA No.: 207534 Prod. No.: 001 RX (0.3MG/0.3ML (0.3MG/0.3ML)) NDA No.: 207534 Prod. No.: 002 DISC (0.15MG/0.3ML (0.15MG/0.3ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11141540 DP* Syringe devices Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Jun 16, 2022 | Oct 20, 2036 | U-3379: A method for administering a therapeutic dose of epinephrine |
ADHERA
PRESTALIA (TABLET) (ORAL) AMLODIPINE BESYLATE; PERINDOPRIL ARGININE
Drug Classes: calcium channel blocker == dihydropyridine calcium channel blocker
NDA Applicant: ADHERA NDA No.: 205003 Prod. No.: 001 DISC (EQ 2.5MG BASE;3.5MG ); 002 DISC (EQ 5MG BASE;7MG); 003 DISC (EQ 10MG BASE;14MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7846961 DS* DP* .alpha. crystalline form of the arginine salt of perindopril, a process for its preparation and pharm Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use Pat. Sub. Date(s): All strengths: Dec 29, 2015 | Oct 5, 2029 | U-3: Treatment of hypertension |
ADIENNE SA
TEPADINA (POWDER) (INTRACAVITARY, INTRAVENOUS, INTRAVESICAL) THIOTEPA [GENERIC AP]
Drug Classes: alkylating drug
NDA Applicant: ADIENNE SA NDA No.: 208264 Prod. No.: 001 RX (15MG/VIAL); 002 RX (100MG/VIAL)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity | Jan 26, 2024 | ODE-129: Indicated for reducing the risk of graft rejection when used in conjunction with high-dose busulfan & cyclophosphamide as a preparative regimen for allogenic hematopoietic progenitor cell transplantation for peds. patients with class 3 beta-thalassemia |
AFT PHARMS US
COMBOGESIC (TABLET) (ORAL) ACETAMINOPHEN; IBUPROFEN
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: AFT PHARMS US NDA No.: 209471 Prod. No.: 001 RX (325MG;97.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10532036 Combination composition Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 29, 2023 | Sep 22, 2025 | U-3553: A method of treating mild to moderate acute pain in adults by administering 975-1000 mg of acetaminophen and 292.5-300 mg of ibuprofen in a single administration |
| Pat. No. 11197830 DP* Pharmaceutical composition containing acetaminophen and ibuprofen Claim Types: Product-by-process Pat. Sub. Date(s): 001: Mar 29, 2023 | Feb 27, 2039 | U-3553: A method of treating mild to moderate acute pain in adults by administering 975-1000 mg of acetaminophen and 292.5-300 mg of ibuprofen in a single administration |
| Pat. No. 11534407 DP* Pharmaceutical compostion containing acetominophen and ibuprofen Claim Types: Product-by-process; Formulation claimed by its inherent performace characteristics; Method of use Pat. Sub. Date(s): 001: Mar 29, 2023 | Feb 27, 2039 | U-3553: A method of treating mild to moderate acute pain in adults by administering 975-1000 mg of acetaminophen and 292.5-300 mg of ibuprofen in a single administration |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Mar 1, 2026 |
AGEPHA PHARMA FZ
LODOCO (TABLET) (ORAL) COLCHICINE
Drug Classes: alkaloid
NDA Applicant: AGEPHA PHARMA FZ NDA No.: 215727 Prod. No.: 001 RX (0.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9744144 Method of treating cardiovascular events using colchicine concurrently with an antiplatelet agent Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 29, 2023 | Nov 1, 2033 | U-3643: Method of treating and/or reducing the risk of a cardiovascular event |
| Pat. No. 10130585 Methods of treating and/or preventing cardiovascular disease Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 29, 2023 | May 9, 2034 | U-3642: A method of treating cardiovascular disease |
| Pat. No. 10206891 Method of treating cardiovascular events using colchicine concurrently with an antiplatelet agent Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 29, 2023 | Nov 1, 2033 | U-3641: A method of treating and/or reducing the risk of a cardiovascular event; acute coronary syndrome, out-of-hospital cardiac arrest, and/or noncardioembolic ischemic stroke |
| Pat. No. 10265281 Treatment or prevention of cardiovascular events via the administration of a colchicine derivative Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 29, 2023 | Nov 1, 2033 | U-3639: A method for treating and/or reducing the risk of a cardiovascular event |
| Pat. No. 10842762 Method of treating cardiovascular events using colchicine concurrently with an antiplatelet agent Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 29, 2023 | Nov 1, 2033 | U-3640: A method of treating and/or reducing the risk of inflammation, atherosclerotic vascular disease, and cholesterol crystal induced inflammation within atherosclerotic plaques |
| Pat. No. 11026899 Treatment or prevention of cardiovascular events via the administration of a colchicine derivative Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 29, 2023 | Nov 1, 2033 | U-3639: A method for treating and/or reducing the risk of a cardiovascular event |
| Pat. No. 11026900 Treatment or prevention of cardiovascular events via the administration of a colchicine derivative Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 29, 2023 | Nov 1, 2033 | U-3639: A method for treating and/or reducing the risk of a cardiovascular event |
| Pat. No. 11026901 Treatment or prevention of cardiovascular events via the administration of a colchicine derivative Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 29, 2023 | Nov 1, 2033 | U-3638: A method for treating and/or reducing the risk of acute myocardial infarction |
| Pat. No. 11944594 Treatment or prevention of cardiovascular events via the administration of a colchicine derivative Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Apr 3, 2024 | Nov 1, 2033 | U-3864: Method for reducing a risk of at least one cardiovascular event |
| Pat. No. 11944595 Treatment or prevention of cardiovascular events via the administration of a colchicine derivative Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Apr 5, 2024 | Nov 1, 2033 | U-3867: Method for reducing a composite endpoint risk of myocardial infarction (MI), stroke, coronary revascularization, unstable angina requiring hospitalization, cardiac arrest, and cardiovascular death U-3868: Method for reducing acute myocardial infarction risk |
AGILE
TWIRLA (SYSTEM) (TRANSDERMAL) ETHINYL ESTRADIOL; LEVONORGESTREL
Drug Classes: progestin == progestin-containing intrauterine system
NDA Applicant: AGILE NDA No.: 204017 Prod. No.: 001 RX (0.03MG/24HR;0.12MG/24HR)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8246978 DP* Dermal delivery device with reduced loss of its volatile components Claim Types: Formulation; Device Pat. Sub. Date(s): 001: Mar 10, 2020 | Aug 26, 2028 | |
| Pat. No. 8747888 DP* Dermal delivery device with in situ seal Claim Types: Device; Formulation Pat. Sub. Date(s): 001: Mar 10, 2020 | Jul 10, 2028 | |
| Pat. No. 9050348 DP* Dermal delivery device Claim Types: Device Pat. Sub. Date(s): 001: Mar 10, 2020 | Jul 10, 2028 |
AGIOS PHARMS INC
PYRUKYND (TABLET) (ORAL) MITAPIVAT SULFATE
Drug Classes: pyruvate kinase activator
NDA Applicant: AGIOS PHARMS INC NDA No.: 216196 Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 20MG BASE); 003 RX (EQ 50MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE49582 DS* DP* Therapeutic compounds and compositions Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Jul 27, 2023 | Feb 24, 2031 | |
| Pat. No. 9193701 Pyruvate kinase activators for use in therapy Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 8, 2022 | Oct 26, 2032 | U-3319: Method of using a pyruvate kinase activator for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency |
| Pat. No. 9682080 Pyruvate kinase activators for use in therapy Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 8, 2022 | May 3, 2032 | U-3319: Method of using a pyruvate kinase activator for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency |
| Pat. No. 9980961 Pyruvate kinase activators for use in therapy Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 8, 2022 | May 3, 2032 | U-3319: Method of using a pyruvate kinase activator for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency |
| Pat. No. 10632114 Pyruvate kinase activators for use in therapy Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 8, 2022 | May 3, 2032 | U-3320: Method for increasing the lifetime of red blood cells (RBCS) for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency |
| Pat. No. 11234976 Methods of using pyruvate kinase activators Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 8, 2022 | Oct 11, 2038 | U-3321: Method of using a pyruvate kinase activator for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency by administering a daily dose of 10mg to 100mg |
| Pat. No. 11254652 DS* DP* Crystalline forms of N-(4-(4-(cyclopropymethyl)piperazine-1-carbonyl)phenyl)quinoline-8-sulfon- amide Claim Types: New polymorph, salt or hydrate; Composition; Process Pat. Sub. Date(s): All strengths: Mar 8, 2022 | Nov 21, 2038 | |
| Pat. No. 11793806 Pyruvate kinase activators for use in therapy Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 31, 2023 | Apr 12, 2033 | U-3320: Method for increasing the lifetime of red blood cells (RBCS) for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency |
| Pat. No. 11878049 Mitapivat therapy and modulators of cytochrome P450 Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 26, 2024 | Jul 31, 2041 | U-3782: Method for administering mitapivat or a salt of mitapivat to mitigate drug interactions in patients with hemolytic anemia that are taking moderate CYP3A inducers |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Feb 17, 2027 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Feb 17, 2029 | ODE-392: Treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency |
AKARX INC
DOPTELET (TABLET) (ORAL) AVATROMBOPAG MALEATE
NDA Applicant: AKARX INC NDA No.: 210238 Prod. No.: 001 RX (EQ 20MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7638536 DS* DP* 2-Acylaminothiazole derivative or salt thereof Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jun 15, 2018 | Jul 28, 2027 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 26, 2026 | ODE-246: Treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment |
AKCEA THERAPS
TEGSEDI (SOLUTION) (SUBCUTANEOUS) INOTERSEN SODIUM
Drug Classes: transthyretin-directed antisense oligonucleotide
NDA Applicant: AKCEA THERAPS NDA No.: 211172 Prod. No.: 001 DISC (EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8101743 DS* DP* Modulation of transthyretin expression Claim Types: Compound Pat. Sub. Date(s): 001: Nov 1, 2018 | Apr 1, 2025 | |
| Pat. No. 8697860 DP* Diagnosis and treatment of disease Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 1, 2018 | Apr 29, 2031 | |
| Pat. No. 9061044 DS* Modulation of transthyretin expression Claim Types: Compound Pat. Sub. Date(s): 001: Nov 1, 2018 | Apr 29, 2031 | |
| Pat. No. 9399774 Modulation of transthyretin expression Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 1, 2018 | Apr 29, 2031 | U-2430: Treatment of polyneuropathy of hereditary transthyretin amyloidosis |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Oct 5, 2023 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 5, 2025 | ODE-212: Indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults |
AKEBIA
VAFSEO (TABLET) (ORAL) VADADUSTAT
NDA Applicant: AKEBIA NDA No.: 215192 Prod. No.: 001 RX (150MG); 002 RX (300MG); 003 RX (450MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE47437 DS* DP* Prolyl hydroxylase inhibitors and methods of use Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Apr 10, 2024 | Jun 26, 2027 | |
| Pat. No. 7811595 DS* DP* Prolyl hydroxylase inhibitors and methods of use Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Apr 10, 2024 | Mar 13, 2028 | |
| Pat. No. 8323671 Prolyl hydroxylase inhibitors and methods of use Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 10, 2024 | Apr 3, 2028 | U-3876: Treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months |
| Pat. No. 8343952 DS* DP* Prolyl hydroxylase inhibitors and methods of use Claim Types: Composition; Compound Pat. Sub. Date(s): All strengths: Apr 10, 2024 | Aug 14, 2027 | |
| Pat. No. 8598210 DS* DP* Prolyl hydroxylase inhibitors and methods of use Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Apr 10, 2024 | Jun 26, 2027 | |
| Pat. No. 8940773 Prolyl hydroxylase inhibitors and methods of use Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 10, 2024 | Jun 26, 2027 | U-3876: Treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months |
| Pat. No. 9701636 DS* DP* Solid forms of {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid, compositions, and uses thereof Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): All strengths: Apr 10, 2024 | Nov 14, 2034 | |
| Pat. No. 9987262 Solid forms of {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid, compositions, and uses thereof Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 10, 2024 | Nov 14, 2034 | U-3876: Treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months |
| Pat. No. 10149842 DS* DP* Solid forms of {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid, compositions, and uses thereof Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): All strengths: Apr 10, 2024 | Nov 14, 2034 | |
| Pat. No. 11065237 DS* DP* Solid forms of {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid, compositions, and uses thereof Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): All strengths: Apr 10, 2024 | Nov 14, 2034 | U-3876: Treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months |
| Pat. No. 11324734 DP* Compositions and methods for treating anemia Claim Types: Formulation Pat. Sub. Date(s): All strengths: Apr 10, 2024 | Mar 31, 2036 | |
| Pat. No. 11844756 Compositions and methods for treating anemia Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 10, 2024 | Mar 31, 2036 | U-3876: Treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months |
| Pat. No. 11857543 Compositions and methods for treating anemia Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 10, 2024 | Jun 9, 2034 | U-3876: Treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Mar 27, 2029 |
ALCON LABS INC
EYSUVIS (SUSPENSION/DROPS) (OPHTHALMIC) LOTEPREDNOL ETABONATE
Drug Classes: corticosteroid
NDA Applicant: ALCON LABS INC NDA No.: 210933 Prod. No.: 001 RX (0.25%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9056057 DP* Nanocrystals, compositions, and methods that aid particle transport in mucus Claim Types: Formulation; Method of administration; Process Pat. Sub. Date(s): 001: Nov 20, 2020 | May 3, 2033 | U-2491: A method for delivering a composition to a mucus membrane |
| Pat. No. 9393213 DP* Nanocrystals, compositions, and methods that aid particle transport in mucus Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 20, 2020 | May 3, 2033 | |
| Pat. No. 9532955 Nanocrystals, compositions, and methods that aid particle transport in mucus Claim Types: Method of administration; Process Pat. Sub. Date(s): 001: Nov 20, 2020 | May 3, 2033 | U-2491: A method for delivering a composition to a mucus membrane |
| Pat. No. 9737491 Nanocrystals, compositions, and methods that aid particle transport in mucus Claim Types: Method of administration Pat. Sub. Date(s): 001: Nov 20, 2020 | May 3, 2033 | U-2492: A method for delivering a pharmaceutical agent across a mucosal barrier |
| Pat. No. 9827191 DP* Compositions and methods for ophthalmic and/or other applications Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: Nov 20, 2020 | May 3, 2033 | U-2985: A method for treating dry eye in a patient |
| Pat. No. 10058511 DP* Nanocrystals, compositions, and methods that aid particle transport in mucus Claim Types: Formulation; Method of administration Pat. Sub. Date(s): 001: Nov 20, 2020 | May 3, 2033 | U-2492: A method for delivering a pharmaceutical agent across a mucosal barrier |
| Pat. No. 10646436 DP* Compositions and methods for ophthalmic and/or other applications Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 20, 2020 | May 3, 2033 | |
| Pat. No. 10688045 DP* Compositions and methods for ophthalmic and/or other applications Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 20, 2020 | May 3, 2033 | |
| Pat. No. 10857096 Compositions and methods for ophthalmic and/or other applications Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 28, 2020 | May 3, 2033 | U-2985: A method for treating dry eye in a patient |
| Pat. No. 10940108 Compositions and methods for ophthalmic and/or other applications Claim Types: Method of use; Process Pat. Sub. Date(s): 001: Mar 30, 2021 | May 3, 2033 | U-2985: A method for treating dry eye in a patient |
| Pat. No. 10945948 Compositions and methods for ophthalmic and/or other applications Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 30, 2021 | May 3, 2033 | U-2985: A method for treating dry eye in a patient |
| Pat. No. 10993908 Compositions and methods for ophthalmic and/or other applications Claim Types: Method of administration Pat. Sub. Date(s): 001: May 26, 2021 | May 3, 2033 | U-3117: Administration to the eye of a patient for treatment of dry eye condition |
| Pat. No. 11219596 Compositions and methods for ophthalmic and/or other applications Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 21, 2022 | May 3, 2033 | U-2985: A method for treating dry eye in a patient |
| Pat. No. 11596599 Compositions and methods for ophthalmic and/or other applications Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 31, 2023 | May 3, 2033 | U-2985: A method for treating dry eye in a patient |
| Pat. No. 11642317 DP* Nanocrystals, compositions, and methods that aid particle transport in mucus Claim Types: Formulation; Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: May 31, 2023 | May 3, 2033 | |
| Pat. No. 11872318 DP* Nanocrystals, compositions, and methods that aid particle transport in mucus Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 1, 2024 | May 3, 2033 | |
| Pat. No. 12115246 DP* Compositions and methods for ophthalmic and/or other applications Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 8, 2024 | May 3, 2033 | U-2985: A method for treating dry eye in a patient |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Oct 26, 2023 |
ALCON LABS INC
INVELTYS (SUSPENSION/DROPS) (OPHTHALMIC) LOTEPREDNOL ETABONATE
Drug Classes: corticosteroid
NDA Applicant: ALCON LABS INC NDA No.: 210565 Prod. No.: 001 RX (1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9056057 DP* Nanocrystals, compositions, and methods that aid particle transport in mucus Claim Types: Formulation; Method of administration; Process Pat. Sub. Date(s): 001: Sep 10, 2018 | May 3, 2033 | U-2491: A method for delivering a composition to a mucus membrane |
| Pat. No. 9393213 DP* Nanocrystals, compositions, and methods that aid particle transport in mucus Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 10, 2018 | May 3, 2033 | |
| Pat. No. 9532955 Nanocrystals, compositions, and methods that aid particle transport in mucus Claim Types: Method of administration; Process Pat. Sub. Date(s): 001: Sep 10, 2018 | May 3, 2033 | U-2491: A method for delivering a composition to a mucus membrane |
| Pat. No. 9737491 Nanocrystals, compositions, and methods that aid particle transport in mucus Claim Types: Method of administration Pat. Sub. Date(s): 001: Sep 10, 2018 | May 3, 2033 | U-2492: A method for delivering a pharmaceutical agent across a mucosal barrier |
| Pat. No. 9827191 DP* Compositions and methods for ophthalmic and/or other applications Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: Sep 10, 2018 | May 3, 2033 | U-2493: A method for treating inflammation and/or other disorders in an eye of a patient |
| Pat. No. 10058511 DP* Nanocrystals, compositions, and methods that aid particle transport in mucus Claim Types: Formulation; Method of administration Pat. Sub. Date(s): 001: Sep 10, 2018 | May 3, 2033 | U-2492: A method for delivering a pharmaceutical agent across a mucosal barrier |
| Pat. No. 10646437 DP* Compositions and methods for ophthalmic and/or other applications Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 11, 2020 | May 3, 2033 | |
| Pat. No. 10688045 DP* Compositions and methods for ophthalmic and/or other applications Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 16, 2020 | May 3, 2033 | |
| Pat. No. 10864219 Compositions and methods for ophthalmic and/or other applications Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 28, 2020 | May 3, 2033 | U-3011: A method for treating ocular inflammation |
| Pat. No. 11219597 Compositions and methods for ophthalmic and/or other applications Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 21, 2022 | May 3, 2033 | U-3278: A method of reducing post-surgical pain following ocular surgery U-3279: A method of treating postoperative inflammation following ocular surgery |
| Pat. No. 11642317 DP* Nanocrystals, compositions, and methods that aid particle transport in mucus Claim Types: Formulation; Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: May 31, 2023 | May 3, 2033 | |
| Pat. No. 11872318 DP* Nanocrystals, compositions, and methods that aid particle transport in mucus Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 1, 2024 | May 3, 2033 | |
| Pat. No. 12115246 DP* Compositions and methods for ophthalmic and/or other applications Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 8, 2024 | May 3, 2033 | U-4025: A method for the treatment of post-operative inflammation following ocular surgery |
ALCON LABS INC
PATADAY ONCE DAILY RELIEF (SOLUTION/DROPS) (OPHTHALMIC) OLOPATADINE HYDROCHLORIDE
Drug Classes: H1 receptor antagonist == histamine-1 (H1) inhibitor == mast cell stabilizer
NDA Applicant: ALCON LABS INC NDA No.: 206276 Prod. No.: 001 OTC (EQ 0.7% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8791154 DP* High concentration olopatadine ophthalmic composition Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Mar 31, 2015 | May 19, 2032 | U-1680: Treatment of ocular itching associated with allergic conjunctivitis |
| Pat. No. 9533053 DP* High concentration olopatadine ophthalmic composition Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 31, 2020 | May 19, 2032 |
ALCON LABS INC
RHOPRESSA (SOLUTION/DROPS) (OPHTHALMIC) NETARSUDIL MESYLATE
Drug Classes: Rho kinase inhibitor
NDA Applicant: ALCON LABS INC NDA No.: 208254 Prod. No.: 001 RX (EQ 0.02% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8394826 DS* DP* Dual mechanism inhibitors for the treatment of disease Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 21, 2017 | Nov 10, 2030 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 8450344 DS* DP* Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 21, 2017 | Jul 11, 2026 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 9096569 DS* DP* Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 21, 2017 | Jul 11, 2026 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 9415043 DS* Combination therapy Claim Types: Compound Pat. Sub. Date(s): 001: Dec 21, 2017 | Mar 14, 2034 | |
| Pat. No. 9931336 DS* DP* Combination therapy Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Apr 11, 2018 | Mar 14, 2034 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 10174017 DS* DP* Dual mechanism inhibitors for the treatment of disease Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Mar 28, 2019 | Jan 27, 2030 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 10532993 Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 30, 2020 | Jul 11, 2026 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 10588901 DS* DP* Combination therapy Claim Types: Formulation; Compound; Method of use Pat. Sub. Date(s): 001: Apr 15, 2020 | Mar 14, 2034 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 10654844 DS* DP* Dual mechanism inhibitors for the treatment of disease Claim Types: New polymorph, salt or hydrate; Method of use; Composition Pat. Sub. Date(s): 001: Jun 10, 2020 | Jan 27, 2030 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 10882840 Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 22, 2021 | Jul 11, 2026 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 11020385 Combination therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 12, 2024 | Mar 14, 2034 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 11021456 Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 28, 2021 | Jul 11, 2026 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 11028081 Dual mechanism inhibitors for the treatment of disease Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 28, 2021 | Jan 27, 2030 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 11185538 DP* Compositions for treating glaucoma or reducing intraocular pressure Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Dec 16, 2021 | Mar 14, 2034 | |
| Pat. No. 11618748 Dual mechanism inhibitors for the treatment of disease Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 21, 2023 | Jan 27, 2030 | U-1524: Reduction of elevated intraocular pressure |
ALCON LABS INC
ROCKLATAN (SOLUTION/DROPS) (OPHTHALMIC) LATANOPROST; NETARSUDIL DIMESYLATE
Drug Classes: prostaglandin analog == Rho kinase inhibitor
NDA Applicant: ALCON LABS INC NDA No.: 208259 Prod. No.: 001 RX (0.005%;EQ 0.02% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8394826 DS* DP* Dual mechanism inhibitors for the treatment of disease Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Mar 28, 2019 | Nov 10, 2030 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 8450344 DS* DP* Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Mar 28, 2019 | Jul 11, 2026 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 9096569 DS* DP* Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Mar 28, 2019 | Jul 11, 2026 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 9415043 DS* Combination therapy Claim Types: Compound Pat. Sub. Date(s): 001: Mar 28, 2019 | Mar 14, 2034 | |
| Pat. No. 9931336 DS* DP* Combination therapy Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Mar 28, 2019 | Mar 14, 2034 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 9993470 DS* DP* Combination therapy Claim Types: Composition; Method of use Pat. Sub. Date(s): 001: Mar 28, 2019 | Mar 14, 2034 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 10174017 DS* DP* Dual mechanism inhibitors for the treatment of disease Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Mar 28, 2019 | Jan 27, 2030 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 10532993 Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 30, 2020 | Jul 11, 2026 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 10588901 DS* DP* Combination therapy Claim Types: Formulation; Compound; Method of use Pat. Sub. Date(s): 001: Apr 15, 2020 | Mar 14, 2034 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 10654844 DS* DP* Dual mechanism inhibitors for the treatment of disease Claim Types: New polymorph, salt or hydrate; Method of use; Composition Pat. Sub. Date(s): 001: Jun 10, 2020 | Jan 27, 2030 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 10882840 Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 22, 2021 | Jul 11, 2026 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 11020385 Combination therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 12, 2024 | Mar 14, 2034 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 11021456 Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 28, 2021 | Jul 11, 2026 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 11028081 Dual mechanism inhibitors for the treatment of disease Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 28, 2021 | Jan 27, 2030 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 11185538 DP* Compositions for treating glaucoma or reducing intraocular pressure Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Dec 16, 2021 | Mar 14, 2034 | |
| Pat. No. 11197853 DP* Combination therapy Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 16, 2021 | Mar 14, 2034 | |
| Pat. No. 11618748 Dual mechanism inhibitors for the treatment of disease Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 21, 2023 | Jan 27, 2030 | U-1524: Reduction of elevated intraocular pressure |
ALCON LABS INC
SIMBRINZA (SUSPENSION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE; BRINZOLAMIDE
Drug Classes: alpha-adrenergic receptor agonist == carbonic anhydrase inhibitor
NDA Applicant: ALCON LABS INC NDA No.: 204251 Prod. No.: 001 RX (0.2%;1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9044484 DP* Aqueous pharmaceutical compositions containing borate-polyol complexes Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 9, 2015 | Oct 30, 2030 | |
| Pat. No. 9421265 DP* Aqueous pharmaceutical compositions containing borate-polyol complexes Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 24, 2016 | Jun 17, 2030 |
ALEMBIC
ACYCLOVIR (CREAM) (TOPICAL) ACYCLOVIR [GENERIC AB]
Drug Classes: nucleoside analog HSV DNA polymerase inhibitor / VZV DNA
NDA Applicant: ALEMBIC NDA No.: 212361 Prod. No.: 001 RX (5%)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Jun 12, 2024 |
ALEXION PHARMS INC
VOYDEYA (TABLET) (ORAL) DANICOPAN
NDA Applicant: ALEXION PHARMS INC NDA No.: 218037 Prod. No.: 001 RX (50MG); 002 RX (100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9796741 DS* Aryl, heteroaryl, and heterocyclic compounds for treatment of complement mediated disorders Claim Types: Compound; Method of use Pat. Sub. Date(s): All strengths: May 23, 2024 | Feb 25, 2035 | U-3933: Treatment of extravascular hemolysis (evh) in adults with paroxysmal nocturnal hemoglobinuria (PNH) as add-on therapy to ravulizumab or eculizumab |
| Pat. No. 12076319 Therapeutic regimens for treatment of paroxysmal nocturnal hemoglobinuria Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 24, 2024 | Aug 2, 2038 | U-3933: Treatment of extravascular hemolysis (evh) in adults with paroxysmal nocturnal hemoglobinuria (PNH) as add-on therapy to ravulizumab or eculizumab |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Mar 29, 2029 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Mar 29, 2031 | ODE-476: Treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH) |
ALEXZA PHARMS
ADASUVE (POWDER) (INHALATION) LOXAPINE
NDA Applicant: ALEXZA PHARMS NDA No.: 022549 Prod. No.: 001 RX (10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7458374 DP* Method and apparatus for vaporizing a compound Claim Types: Device; Process Pat. Sub. Date(s): 001: Mar 29, 2013 | Aug 18, 2024 | |
| Pat. No. 7537009 DP* Method of forming an aerosol for inhalation delivery Claim Types: Process Pat. Sub. Date(s): 001: Mar 29, 2013 | Oct 28, 2024 | |
| Pat. No. 8387612 DP* Self-contained heating unit and drug-supply unit employing same Claim Types: Device Pat. Sub. Date(s): 001: Mar 29, 2013 | Oct 23, 2026 | |
| Pat. No. 8991387 DP* Self-contained heating unit and drug-supply unit employing same Claim Types: Device; Drug in a container Pat. Sub. Date(s): 001: Apr 29, 2015 | May 21, 2024 | |
| Pat. No. 9370629 DP* Self-contained heating unit and drug-supply unit employing same Claim Types: Device Pat. Sub. Date(s): 001: Jul 7, 2016 | May 20, 2024 |
ALIMERA SCIENCES INC
ILUVIEN (IMPLANT) (INTRAVITREAL) FLUOCINOLONE ACETONIDE
NDA Applicant: ALIMERA SCIENCES INC NDA No.: 201923 Prod. No.: 001 RX (0.19MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8871241 DP* Injectable sustained release delivery devices Claim Types: Device Pat. Sub. Date(s): 001: Nov 12, 2014 | Aug 12, 2027 |
ALIMERA SCIENCES INC
YUTIQ (IMPLANT) (INTRAVITREAL) FLUOCINOLONE ACETONIDE
NDA Applicant: ALIMERA SCIENCES INC NDA No.: 210331 Prod. No.: 001 RX (0.18MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7998108 DP* Injector apparatus and method of use Claim Types: Device; Process; Method of administration Pat. Sub. Date(s): 001: Sep 9, 2022 | Jan 12, 2028 | U-3410: A method of injecting an implant |
| Pat. No. 8871241 DP* Injectable sustained release delivery devices Claim Types: Device Pat. Sub. Date(s): 001: Nov 1, 2018 | Aug 12, 2027 |
ALK ABELLO
OTIPRIO (INJECTABLE, SUSPENSION) (OTIC) CIPROFLOXACIN
Drug Classes: fluoroquinolone antibacterial
NDA Applicant: ALK ABELLO NDA No.: 207986 Prod. No.: 001 DISC (6% (60MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8318817 Controlled release antimicrobial compositions and methods for the treatment of otic disordersClaim Types: Method of use Pat. Sub. Date(s): 001: Jan 11, 2016 | Apr 27, 2030 | U-1792: Treatment of otic infection or inflammation |
| Pat. No. 9205048 Controlled release antimicrobial compositions and methods for the treatment of otic disorders Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 11, 2016 | Apr 21, 2029 | U-1793: Treatment of pediatric patients with otitis media with effusion undergoing tympanostomy tube placement |
| Pat. No. 9220796 DP* Sterilization of ciprofloxacin composition Claim Types: Product-by-process; Drug in a container; Process Pat. Sub. Date(s): 001: Jan 11, 2016 | Jul 1, 2035 | |
| Pat. No. 9233068 DP* Controlled release antimicrobial compositions and methods for the treatment of OTIC disorders Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 5, 2016 | Dec 11, 2029 | |
| Pat. No. 9603796 DS* DP* Controlled release antimicrobial compositions and methods for the treatment of otic disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 26, 2018 | Apr 21, 2029 | U-2252: The treatment of acute otitis externa in patients 6 months of age and older due to pseudomonas aeruginosa and staphylococcus aureus |
| Pat. No. 11040004 Otic gel formulations for treating otitis externa Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 21, 2021 | Nov 12, 2037 | U-2252: The treatment of acute otitis externa in patients 6 months of age and older due to pseudomonas aeruginosa and staphylococcus aureus |
| Pat. No. 11246863 DP* Ciprofloxacin otic composition and kits and method for using same Claim Types: Kit Pat. Sub. Date(s): 001: Mar 11, 2022 | Nov 27, 2038 | |
| Pat. No. 11369566 DP* Controlled release antimicrobial compositions and methods for the treatment of otic disorders Claim Types: Formulation; Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Jul 14, 2022 | Apr 21, 2029 |
ALKEM LABS LTD
VANCOMYCIN HYDROCHLORIDE (FOR SOLUTION) (ORAL) VANCOMYCIN HYDROCHLORIDE [GENERIC AB]
Drug Classes: glycopeptide antibacterial
NDA Applicant: ALKEM LABS LTD NDA No.: 214913 Prod. No.: 001 RX (EQ 25MG BASE/ML); 002 RX (EQ 50MG BASE/ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: PC - Patent challenge | Feb 25, 2024 |
ALKERMES
VIVITROL (FOR SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) NALTREXONE
Drug Classes: opioid antagonist
NDA Applicant: ALKERMES NDA No.: 021897 Prod. No.: 001 RX (380MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7919499 Naltrexone long acting formulations and methods of use Claim Types: Method of use Pat. Sub. Date(s): 001: May 16, 2011 | Oct 15, 2029 | U-1123: Treatment of alcohol dependence U-1124: Prevention of relapse to opioid dependence, following opioid detoxification |
ALKERMES INC
ARISTADA (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: atypical antipsychotic
NDA Applicant: ALKERMES INC NDA No.: 207533 Prod. No.: 001 RX (441MG/1.6ML (275.63MG/ML)); 004 RX (1064MG/3.9ML (272.82MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8431576 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Compound Pat. Sub. Date(s): 001: Oct 14, 2015; 004: Jun 27, 2017 | Oct 26, 2030 | |
| Pat. No. 8796276 Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 14, 2015; 004: Jun 27, 2017 | Jun 24, 2030 | U-543: Treatment of schizophrenia |
| Pat. No. 9034867 DP* Pharmaceutical compositions comprising sorbitan esters Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 14, 2015; 004: Jun 27, 2017 | Nov 7, 2032 | U-543: Treatment of schizophrenia |
| Pat. No. 9193685 DP* Pharmaceutical compositions having improved storage stability Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Dec 9, 2015; 004: Jun 27, 2017 | Oct 24, 2033 | U-543: Treatment of schizophrenia |
| Pat. No. 9452131 Aripiprazole formulations having increased injection speeds Claim Types: Method of administration Pat. Sub. Date(s): 001: Oct 5, 2016; 004: Jun 27, 2017 | Mar 19, 2035 | U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection |
| Pat. No. 10112903 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Nov 20, 2018 | Jun 24, 2030 | U-543: Treatment of schizophrenia |
| Pat. No. 10226458 Pharmaceutical compositions comprising sorbitan esters Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 8, 2019 | Mar 19, 2032 | U-543: Treatment of schizophrenia |
| Pat. No. 10238651 Aripiprazole formulations having increased injection speeds Claim Types: Method of use; Kit Pat. Sub. Date(s): All strengths: Apr 8, 2019 | Mar 19, 2035 | U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection |
| Pat. No. 10813928 Aripiprazole formulations having increased injection speeds Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 10, 2020 | Mar 19, 2035 | U-2983: Treatment of schizophrenia by rapid and continuous injection |
| Pat. No. 11097006 DP* Pharmaceutical compositions having improved storage stability Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Oct 21, 2021 | Oct 24, 2033 | U-764: Treatment of schizophrenia |
| Pat. No. 11273158 Aripiprazole dosing strategy Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 13, 2022 | Apr 6, 2039 | U-543: Treatment of schizophrenia |
| Pat. No. 11406632 Aripiprazole formulations having increased injection speeds Claim Types: Method of use; Kit Pat. Sub. Date(s): All strengths: Aug 19, 2022 | Mar 19, 2035 | U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection |
ALKERMES INC
ARISTADA (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: atypical antipsychotic
NDA Applicant: ALKERMES INC NDA No.: 207533 Prod. No.: 002 RX (662MG/2.4ML (275.83MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8431576 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Compound Pat. Sub. Date(s): 002: Oct 14, 2015 | Oct 26, 2030 | |
| Pat. No. 8796276 Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Method of use Pat. Sub. Date(s): 002: Oct 14, 2015 | Jun 24, 2030 | U-543: Treatment of schizophrenia |
| Pat. No. 9034867 DP* Pharmaceutical compositions comprising sorbitan esters Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Oct 14, 2015 | Nov 7, 2032 | U-543: Treatment of schizophrenia |
| Pat. No. 9193685 DP* Pharmaceutical compositions having improved storage stability Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Dec 9, 2015 | Oct 24, 2033 | U-543: Treatment of schizophrenia |
| Pat. No. 9452131 Aripiprazole formulations having increased injection speeds Claim Types: Method of administration Pat. Sub. Date(s): 002: Oct 5, 2016 | Mar 19, 2035 | U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection |
| Pat. No. 9526726 DP* Aripiprazole formulations having increased injection speeds Claim Types: Kit Pat. Sub. Date(s): 002: Jan 19, 2017 | Mar 19, 2035 | |
| Pat. No. 10112903 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 002: Nov 20, 2018 | Jun 24, 2030 | U-543: Treatment of schizophrenia |
| Pat. No. 10226458 Pharmaceutical compositions comprising sorbitan esters Claim Types: Method of use Pat. Sub. Date(s): 002: Apr 8, 2019 | Mar 19, 2032 | U-543: Treatment of schizophrenia |
| Pat. No. 10238651 Aripiprazole formulations having increased injection speeds Claim Types: Method of use; Kit Pat. Sub. Date(s): 002: Apr 8, 2019 | Mar 19, 2035 | U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection |
| Pat. No. 10813928 Aripiprazole formulations having increased injection speeds Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 10, 2020 | Mar 19, 2035 | U-2983: Treatment of schizophrenia by rapid and continuous injection |
| Pat. No. 11097006 DP* Pharmaceutical compositions having improved storage stability Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Oct 21, 2021 | Oct 24, 2033 | U-764: Treatment of schizophrenia |
| Pat. No. 11273158 Aripiprazole dosing strategy Claim Types: Method of use Pat. Sub. Date(s): 002: Apr 13, 2022 | Apr 6, 2039 | U-543: Treatment of schizophrenia |
| Pat. No. 11406632 Aripiprazole formulations having increased injection speeds Claim Types: Method of use; Kit Pat. Sub. Date(s): 002: Aug 19, 2022 | Mar 19, 2035 | U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection |
ALKERMES INC
ARISTADA (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: atypical antipsychotic
NDA Applicant: ALKERMES INC NDA No.: 207533 Prod. No.: 003 RX (882MG/3.2ML (275.63MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8431576 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Compound Pat. Sub. Date(s): 003: Oct 14, 2015 | Oct 26, 2030 | |
| Pat. No. 8796276 Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Method of use Pat. Sub. Date(s): 003: Oct 14, 2015 | Jun 24, 2030 | U-543: Treatment of schizophrenia |
| Pat. No. 9034867 DP* Pharmaceutical compositions comprising sorbitan esters Claim Types: Formulation; Method of use Pat. Sub. Date(s): 003: Oct 14, 2015 | Nov 7, 2032 | U-543: Treatment of schizophrenia |
| Pat. No. 9193685 DP* Pharmaceutical compositions having improved storage stability Claim Types: Formulation; Method of use Pat. Sub. Date(s): 003: Dec 9, 2015 | Oct 24, 2033 | U-543: Treatment of schizophrenia |
| Pat. No. 9452131 Aripiprazole formulations having increased injection speeds Claim Types: Method of administration Pat. Sub. Date(s): 003: Oct 5, 2016 | Mar 19, 2035 | U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection |
| Pat. No. 9526726 DP* Aripiprazole formulations having increased injection speeds Claim Types: Kit Pat. Sub. Date(s): 003: Jan 19, 2017 | Mar 19, 2035 | |
| Pat. No. 10112903 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 003: Nov 20, 2018 | Jun 24, 2030 | U-543: Treatment of schizophrenia |
| Pat. No. 10226458 Pharmaceutical compositions comprising sorbitan esters Claim Types: Method of use Pat. Sub. Date(s): 003: Apr 8, 2019 | Mar 19, 2032 | U-543: Treatment of schizophrenia |
| Pat. No. 10238651 Aripiprazole formulations having increased injection speeds Claim Types: Method of use; Kit Pat. Sub. Date(s): 003: Apr 8, 2019 | Mar 19, 2035 | U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection |
| Pat. No. 10813928 Aripiprazole formulations having increased injection speeds Claim Types: Method of use Pat. Sub. Date(s): 003: Nov 10, 2020 | Mar 19, 2035 | U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection |
| Pat. No. 11097006 DP* Pharmaceutical compositions having improved storage stability Claim Types: Formulation; Method of use Pat. Sub. Date(s): 003: Oct 21, 2021 | Oct 24, 2033 | U-764: Treatment of schizophrenia |
| Pat. No. 11273158 Aripiprazole dosing strategy Claim Types: Method of use Pat. Sub. Date(s): 003: Apr 13, 2022 | Apr 6, 2039 | U-543: Treatment of schizophrenia |
| Pat. No. 11406632 Aripiprazole formulations having increased injection speeds Claim Types: Method of use; Kit Pat. Sub. Date(s): 003: Aug 19, 2022 | Mar 19, 2035 | U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection |
ALKERMES INC
ARISTADA INITIO KIT (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: atypical antipsychotic
NDA Applicant: ALKERMES INC NDA No.: 209830 Prod. No.: 001 RX (675MG/2.4ML (281.25MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8431576 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Compound Pat. Sub. Date(s): 001: Jul 18, 2018 | Oct 26, 2030 | |
| Pat. No. 8796276 Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 18, 2018 | Jun 24, 2030 | U-543: Treatment of schizophrenia |
| Pat. No. 10016415 DP* Aripiprazole prodrug compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 18, 2018 | Sep 8, 2035 | |
| Pat. No. 10112903 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Nov 20, 2018 | Jun 24, 2030 | U-543: Treatment of schizophrenia |
| Pat. No. 10688091 DP* Aripiprazole prodrug composition Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 8, 2020 | Aug 17, 2035 | |
| Pat. No. 10849894 Aripiprazole prodrug composition Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 9, 2020 | Aug 17, 2035 | U-543: Treatment of schizophrenia |
| Pat. No. 11154552 DP* Aripiprazole prodrug composition Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 10, 2021 | Aug 17, 2035 | |
| Pat. No. 11273158 Aripiprazole dosing strategy Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 13, 2022 | Apr 6, 2039 | U-543: Treatment of schizophrenia |
ALKERMES INC
LYBALVI (TABLET) (ORAL) OLANZAPINE; SAMIDORPHAN L-MALATE
Drug Classes: atypical antipsychotic == opioid antagonist
NDA Applicant: ALKERMES INC NDA No.: 213378 Prod. No.: 001 RX (5MG;EQ 10MG BASE); 002 RX (10MG;EQ 10MG BASE); 003 RX (15MG;EQ 10MG BASE); 004 RX (20MG;EQ 10MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7262298 DS* 4-hydroxybenzomorphans Claim Types: Compound Pat. Sub. Date(s): All strengths: Jun 25, 2021 | Nov 23, 2025 | |
| Pat. No. 8778960 Methods for treating antipsychotic-induced weight gain Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 25, 2021 | Feb 13, 2032 | U-3136: Method of treating schizophrenia by administering the atypical antipsychotic olanzapine and samidorphan, with reduced antipsychotic induced weight gain U-3137: Method of treating bipolar disorder by administering the atypical antipsychotic olanzapine and samidorphan, with reduced antipsychotic induced weight gain |
| Pat. No. 9119848 DS* Morphinan derivatives for the treatment of drug overdose Claim Types: Method of use; Compound Pat. Sub. Date(s): All strengths: Jun 25, 2021 | Aug 30, 2031 | |
| Pat. No. 9126977 DP* Methods for treating antipsychotic-induced weight gain Claim Types: Method of use; Formulation Pat. Sub. Date(s): All strengths: Jun 25, 2021 | Aug 23, 2031 | U-3136: Method of treating schizophrenia by administering the atypical antipsychotic olanzapine and samidorphan, with reduced antipsychotic induced weight gain U-3137: Method of treating bipolar disorder by administering the atypical antipsychotic olanzapine and samidorphan, with reduced antipsychotic induced weight gain |
| Pat. No. 9517235 Methods for treating antipsychotic-induced weight gain Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 25, 2021 | Aug 23, 2031 | U-3138: Method of treating schizophrenia by administering the atypical antipsychotic olanzapine and samidorphan, with reduction of the adverse metabolic profile U-3139: Method of treating bipolar disorder by administering the atypical antipsychotic olanzapine and samidorphan, with reduction of the adverse metabolic profile |
| Pat. No. 10300054 DP* Methods for treating antipsychotic-induced weight gain Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 25, 2021 | Aug 23, 2031 | U-3140: Method of treating schizophrenia by administering the atypical antipsychotic olanzapine and samidorphan U-3141: Method of treating bipolar disorder by administering the atypical antipsychotic olanzapine and samidorphan |
| Pat. No. 10716785 Methods for treating antipsychotic-induced weight gain Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 25, 2021 | Aug 23, 2031 | U-3136: Method of treating schizophrenia by administering the atypical antipsychotic olanzapine and samidorphan, with reduced antipsychotic induced weight gain U-3137: Method of treating bipolar disorder by administering the atypical antipsychotic olanzapine and samidorphan, with reduced antipsychotic induced weight gain |
| Pat. No. 11185541 Methods for treating antipsychotic-induced weight gain Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 22, 2021 | Aug 23, 2031 | U-3140: Method of treating schizophrenia by administering the atypical antipsychotic olanzapine and samidorphan |
| Pat. No. 11241425 Composition for treating mental illness Claim Types: Method of improving a treatment Pat. Sub. Date(s): All strengths: Mar 3, 2022 | Aug 23, 2031 | U-3137: Method of treating bipolar disorder by administering the atypical antipsychotic olanzapine and samidorphan, with reduced antipsychotic induced weight gain |
| Pat. No. 11351166 Methods for treating antipsychotic-induced weight gain Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 11, 2022 | Aug 23, 2031 | U-3140: Method of treating schizophrenia by administering the atypical antipsychotic olanzapine and samidorphan U-3141: Method of treating bipolar disorder by administering the atypical antipsychotic olanzapine and samidorphan |
| Pat. No. 11707466 DP* Immediate release multilayer tablet Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 23, 2023 | Nov 12, 2041 | |
| Pat. No. 11793805 Methods for treating antipsychotic-induced weight gain Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 13, 2023 | Aug 23, 2031 | U-3734: Method of treating schizophrenia in a patient who has previously experienced significant weight gain induced by olanzapine alone by administering a composition comprising olanzapine and samidorphan |
| Pat. No. 11951111 Immediate release multilayer tablet Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 24, 2024 | Nov 12, 2041 | U-3886: Method of treating bipolar disorder by administering a bilayer tablet comprising olanzapine and samidorphan U-3887: Method of treating schizophrenia by administering a bilayer tablet comprising olanzapine and samidorphan |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | May 28, 2026 |
ALLECRA THERAPS
EXBLIFEP (POWDER) (INTRAVENOUS) CEFEPIME HYDROCHLORIDE; ENMETAZOBACTAM
Drug Classes: cephalosporin antibacterial
NDA Applicant: ALLECRA THERAPS NDA No.: 216165 Prod. No.: 001 DISC (EQ 2GM BASE/VIAL;0.5GM/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7687488 DS* DP* 2-substituted methyl penam derivatives Claim Types: Compound; Process; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Mar 18, 2024 | Dec 3, 2027 | U-3851: Use of EXBLIFEP (cefepime and enmetazobactam) for treating complicated urinary tract infections (CUTI) including pyelonephritis caused by designated susceptible microorganisms |
| Pat. No. 11124526 Crystalline beta-lactamase inhibitor Claim Types: New polymorph, salt or hydrate; Process; Method of use Pat. Sub. Date(s): 001: Mar 18, 2024 | Nov 7, 2034 | U-3852: Use of specified polymorphs of EXBLIFEP (cefepime and enmetazobactam) for treating complicated urinary tract infections (CUTI) including pyelonephritis caused by designated susceptible microorganisms |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Feb 22, 2034 GAIN |
ALLERGAN
SAPHRIS (TABLET) (SUBLINGUAL) ASENAPINE MALEATE [GENERIC AB]
Drug Classes: atypical antipsychotic
NDA Applicant: ALLERGAN NDA No.: 022117 Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 10MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7741358 DS* DP* Crystal form of asenapine maleate Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): All strengths: Feb 10, 2017 | Oct 6, 2026 *PED | U-1064: Treatment of bipolar disorder and schizophrenia U-1960: Use of the atypical antipsychotic asenapine for treatment of schizophrenia in adults U-1961: Use of the atypical antipsychotic asenapine for treatment of manic or mixed episodes of bipolar i disorder: acute monotherapy of manic or mixed episodes (ages 10 to adult) U-1962: Use of the atypical antipsychotic asenapine for treatment of manic or mixed episodes of bipolar i disorder: maintenance monotherapy in adults U-1963: Use of the atypical antipsychotic asenapine for treatment of manic or mixed episodes of bipolar i disorder: as adjunctive treatment to lithium or valproate in adults |
| Pat. No. 8022228 DS* DP* Crystal form of asenapine maleate Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): All strengths: Jul 29, 2014 | Oct 6, 2026 *PED |
ALLERGAN
SAPHRIS (TABLET) (SUBLINGUAL) ASENAPINE MALEATE [GENERIC AB]
Drug Classes: atypical antipsychotic
NDA Applicant: ALLERGAN NDA No.: 022117 Prod. No.: 003 RX (EQ 2.5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7741358 DS* DP* Crystal form of asenapine maleate Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): 003: Sep 12, 2016 | Oct 6, 2026 *PED | U-1893: Method of treating manic or mixed episodes associated with bipolar disorder in pediatric patients U-1966: Use of the atypical antipsychotic asenapine for treatment of manic or mixed episodes of bipolar i disorder: acute monotherapy of manic or mixed episodes in pediatric patients age 10-17 |
| Pat. No. 8022228 DS* DP* Crystal form of asenapine maleate Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 003: Sep 12, 2016 | Oct 6, 2026 *PED |
ALMATICA
GRALISE (TABLET) (ORAL) GABAPENTIN [GENERIC AB2]
NDA Applicant: ALMATICA NDA No.: 022544 Prod. No.: 001 RX (300MG); 002 RX (600MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7438927 Methods of treatment using a gastric retained gabapentin dosage Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 28, 2011; 002: None | Feb 26, 2024 | U-1114: Treatment with gabapentin, including treatment of neuropathic pain, including neuropathic pain associated with postherpetic neuralgia |
ALMATICA
LOREEV XR (CAPSULE, EXTENDED RELEASE) (ORAL) LORAZEPAM
Drug Classes: benzodiazepine
NDA Applicant: ALMATICA NDA No.: 214826 Prod. No.: 001 RX (1MG); 002 RX (2MG); 003 RX (3MG); 004 RX (1.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8999393 DP* Sustained release formulations of lorazepam Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 22, 2021; 002: Sep 22, 2021; 003: Sep 22, 2021; 004: Apr 21, 2022 | Jan 8, 2034 | U-3210: Once daily treatment of anxiety disorder in adults |
ALMATICA
VENLAFAXINE BESYLATE (TABLET, EXTENDED RELEASE) (ORAL) VENLAFAXINE BESYLATE
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI)
NDA Applicant: ALMATICA NDA No.: 215429 Prod. No.: 001 RX (EQ 112.5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7776358 DP* Extended release venlafaxine besylate tablets Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 20, 2022 | May 16, 2028 |
ALMIRALL
ACZONE (GEL) (TOPICAL) DAPSONE [GENERIC AB]
Drug Classes: sulfone
NDA Applicant: ALMIRALL NDA No.: 207154 Prod. No.: 001 RX (7.5%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11273132 DP* Topical dapsone and dapsone/adapalene compositions and methods for use thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 28, 2022 | Nov 18, 2033 |
ALMIRALL
ALTABAX (OINTMENT) (TOPICAL) RETAPAMULIN
Drug Classes: pleuromutilin antibacterial
NDA Applicant: ALMIRALL NDA No.: 022055 Prod. No.: 001 DISC (1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7875630 DS* Process salts compositions and use Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Process Pat. Sub. Date(s): 001: Feb 10, 2011 | Feb 14, 2027 | |
| Pat. No. 8207191 Process, salts, composition and use Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 13, 2016 | Aug 30, 2024 | U-805: Treatment of impetigo due to staphylococcus aureus or streptococcus pyogenes |
ALMIRALL
KLISYRI (OINTMENT) (TOPICAL) TIRBANIBULIN
Drug Classes: microtubule inhibitor
NDA Applicant: ALMIRALL NDA No.: 213189 Prod. No.: 001 RX (1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7300931 DS* DP* Compositions for treating cell proliferation disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 12, 2021 | Feb 6, 2026 | |
| Pat. No. 7851470 DS* DP* Composition and methods for modulating a kinase cascade Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jan 12, 2021 | Feb 2, 2029 | U-3015: Topical treatment of actinic keratosis of the face or scalp |
| Pat. No. 8236799 DS* DP* Biaryl compositions and methods for modulating a kinase cascade Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 12, 2021 | Dec 28, 2025 | |
| Pat. No. 8980890 DS* DP* Compositions and methods of treating cell proliferation disorders Claim Types: Compound Pat. Sub. Date(s): 001: Jan 12, 2021 | Dec 28, 2025 | |
| Pat. No. 10323001 DP* Compositions for modulating a kinase cascade and methods of use thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 12, 2021 | Dec 28, 2027 | |
| Pat. No. 10617693 Methods of treating and/or preventing actinic keratosis Claim Types: Method of use; Dosaage regimen Pat. Sub. Date(s): 001: Jan 12, 2021 | Mar 12, 2038 | U-3015: Topical treatment of actinic keratosis of the face or scalp |
| Pat. No. 10669236 DS* DP* Solid forms of 2-(5-(4-(2-morpholinoethoxy)phenyl)pyridin-2-yl)-N-benzylacetamide Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Jan 12, 2021 | Sep 7, 2038 | |
| Pat. No. 11497750 Methods of treating and/or preventing actinic keratosis Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 14, 2022 | Mar 12, 2038 | U-3015: Topical treatment of actinic keratosis of the face or scalp |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: D - New Dosing Schedule | Jun 7, 2027 | D-192: Expansion of the treatment field on the face or scalp up to 100 cm^2 |
| Exclusivity Code: NCE - New chemical entity | Dec 14, 2025 |
ALMIRALL
SEYSARA (TABLET) (ORAL) SARECYCLINE HYDROCHLORIDE
Drug Classes: tetracycline-class drug
NDA Applicant: ALMIRALL NDA No.: 209521 Prod. No.: 001 RX (EQ 60MG BASE); 002 RX (EQ 100MG BASE); 003 RX (EQ 150MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8318706 DS* DP* Substituted tetracycline compounds Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): All strengths: Oct 12, 2018 | May 1, 2031 | U-2405: A method for treating a bacterial infection in inflammatory lesions of non-nodular moderate to severe acne vulgaris patients 9 years of age and older comprising administering an effective amount of sarecycline hydrochloride |
| Pat. No. 8513223 Substituted tetracycline compounds for treatment of inflammatory skin disorders Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 12, 2018 | Dec 7, 2029 | U-2406: A method for treating a patient 9 years of age and older suffering from an inflammatory skin disorder of non-nodular moderate to severe acne vulgaris comprising administering an effective amount of sarecycline hydrochloride |
| Pat. No. 9255068 DS* DP* Crystalline salts of (4S,4AS,5AR,12AS)-4-dimethylamino-3,10,12,12A-tetrahydroxy-7-[methoxy(met- hyl)amino)-methyl] acid amide and methods of using the same Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): All strengths: Oct 12, 2018 | Feb 9, 2033 | U-2407: A method for treating acne in inflammatory lesions of non-nodular moderate to severe acne vulgaris patients 9 years of age and older comprising administering an effective amount of sarecycline hydrochloride crystalline salt U-2408: A method for treating a bacterial infection in inflammatory lesions of non-nodular moderate to severe acne vulgaris patients 9 years of age and older comprising administering an effective amount of sarecycline hydrochloride crystalline salt |
| Pat. No. 9481639 Substituted tetracycline compounds for treatment of inflammatory skin disorders Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 12, 2018 | Aug 10, 2028 | U-2409: A method for treating acne in inflammatory lesions of non-nodular moderate to severe acne vulgaris patients 9 years of age and older comprising administering sarecycline hydrochloride in 60 mg, 100 mg or 150 mg equivalent doses |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Oct 1, 2023 |
ALMIRALL
VERDESO (AEROSOL, FOAM) (TOPICAL) DESONIDE
Drug Classes: corticosteroid
NDA Applicant: ALMIRALL NDA No.: 021978 Prod. No.: 001 DISC (0.05%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8460641 DP* Microemulsion process and composition Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jul 5, 2013 | Aug 13, 2027 | U-1412: Treatment of atopic dermatitis |
| Pat. No. 8962000 DP* Microemulsion and sub-micron emulsion process and compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Mar 25, 2015 | Aug 31, 2025 | U-1412: Treatment of atopic dermatitis |
| Pat. No. 9492384 DP* Microemulsion and sub-micron emulsion process and compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Dec 19, 2016 | Aug 31, 2025 | U-1412: Treatment of atopic dermatitis |
ALNYLAM PHARMS INC
AMVUTTRA (SOLUTION) (SUBCUTANEOUS) VUTRISIRAN SODIUM
Drug Classes: transthyretin-directed small interfering RNA
NDA Applicant: ALNYLAM PHARMS INC NDA No.: 215515 Prod. No.: 001 RX (EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8106022 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jul 13, 2022 | Dec 12, 2029 | U-3396: AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults |
| Pat. No. 8828956 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jul 13, 2022 | Dec 4, 2028 | U-3396: AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults |
| Pat. No. 9370581 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jul 13, 2022 | Dec 4, 2028 | U-3396: AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults |
| Pat. No. 9399775 DS* DP* RNAi agents, compositions and methods of use thereof for treating transthyretin (TTR) associated diseases Claim Types: Compound; Composition; Cell; Method of use; Kit Pat. Sub. Date(s): 001: Jul 13, 2022 | Nov 16, 2032 | U-3396: AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults |
| Pat. No. 10131907 DS* DP* Glycoconjugates of RNA interference agents Claim Types: Composition; Process; Method of use Pat. Sub. Date(s): 001: Jul 13, 2022 | Aug 24, 2028 | U-3396: AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults |
| Pat. No. 10208307 DS* DP* Transthyretin (TTR) iRNA compositions and methods of use thereof for treating or preventing TTR-associated diseases Claim Types: Compound; Cell; ; Method of use Pat. Sub. Date(s): 001: Jul 13, 2022 | Jul 28, 2036 | U-3396: AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults |
| Pat. No. 10570391 DS* DP* RNAi agents, compositions and methods of use thereof for treating transthyretin (TTR) associated diseases Claim Types: Compound; Cell; ; Composition; Method of use; Kit Pat. Sub. Date(s): 001: Jul 13, 2022 | Nov 16, 2032 | U-3396: AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults |
| Pat. No. 10612024 DS* DP* Modified double-stranded RNA agents Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jul 13, 2022 | Aug 14, 2035 | U-3396: AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults |
| Pat. No. 10683501 DS* DP* Transthyretin (TTR) iRNA compositions and methods of use thereof for treating or preventing TTR-associated diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 13, 2022 | Jul 28, 2036 | U-3396: AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults |
| Pat. No. 10806791 DS* Carbohydrate conjugates as delivery agents for oligonucleotides Claim Types: Compound Pat. Sub. Date(s): 001: Jul 13, 2022 | Dec 4, 2028 | |
| Pat. No. 11286486 DS* DP* Transthyretin (TTR) iRNA compositions and methods of use thereof for treating or preventing TTR-associated diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 13, 2022 | Jul 28, 2036 | U-3396: AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults |
| Pat. No. 11401517 DS* DP* Modified double-stranded RNA agents Claim Types: Compound; Composition; Method of use; Method of administration Pat. Sub. Date(s): 001: Aug 31, 2022 | Aug 14, 2035 | U-3396: AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults |
| Pat. No. 12049628 DS* DP* Transthyretin (TTR) iRNA compositions and methods of use thereof for treating or preventing TTR-associated diseases Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Aug 28, 2024 | Jul 28, 2036 | U-3396: AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jun 13, 2027 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 13, 2029 | ODE-212: Indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults |
ALNYLAM PHARMS INC
GIVLAARI (SOLUTION) (SUBCUTANEOUS) GIVOSIRAN SODIUM
Drug Classes: aminolevulinate synthase 1-directed small interfering RNA
NDA Applicant: ALNYLAM PHARMS INC NDA No.: 212194 Prod. No.: 001 RX (EQ 189MG BASE/ML (EQ 189MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8106022 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 12, 2019 | Dec 12, 2029 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 8828956 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 12, 2019 | Dec 4, 2028 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 9133461 DS* DP* Compositions and methods for inhibiting expression of the ALAS1 gene Claim Types: Compound; Composition; Isolated cell containing the compound;; Method of use Pat. Sub. Date(s): 001: Dec 12, 2019 | Nov 30, 2033 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 9150605 DS* DP* Compositions comprising alternating 2'-modified nucleosides for use in gene modulation Claim Types: Composition Pat. Sub. Date(s): 001: Dec 12, 2019 | Aug 28, 2025 | |
| Pat. No. 9631193 Compositions and methods for inhibiting expression of the ALAS1 gene Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 12, 2019 | Mar 15, 2033 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 9708615 DS* Therapeutic compositions Claim Types: Compound Pat. Sub. Date(s): 001: Dec 12, 2019 | Mar 8, 2024 | |
| Pat. No. 10119143 DS* DP* Compositions and methods for inhibiting expression of the ALAS1 gene Claim Types: Compound; Isolated cell contaiing the compound; Composition; Method of use; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Dec 12, 2019 | Oct 3, 2034 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 10125364 DS* DP* Compositions and methods for inhibiting expression of the ALAS1 gene Claim Types: Compound; Isolated cell containing the compound; Composition; Method of use; Intermediate Pat. Sub. Date(s): 001: Dec 12, 2019 | Mar 15, 2033 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 10131907 DS* DP* Glycoconjugates of RNA interference agents Claim Types: Composition; Process; Method of use Pat. Sub. Date(s): 001: Dec 12, 2019 | Aug 24, 2028 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 10273477 DS* Therapeutic compositions Claim Types: Compound Pat. Sub. Date(s): 001: Dec 12, 2019 | Mar 8, 2024 | |
| Pat. No. 11028392 DS* DP* Compositions and methods for inhibiting expression of the ALAS1 gene Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Feb 16, 2022 | Oct 3, 2034 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 11530408 DS* DP* Therapeutic compositions Claim Types: Composition Pat. Sub. Date(s): 001: Jan 6, 2023 | May 18, 2024 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Nov 20, 2024 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 20, 2026 | ODE-273: Indicated for the treatment of adults with acute hepatic porphyria (AHP) |
ALNYLAM PHARMS INC
ONPATTRO (SOLUTION) (INTRAVENOUS) PATISIRAN SODIUM
Drug Classes: transthyretin-directed small interfering RNA
NDA Applicant: ALNYLAM PHARMS INC NDA No.: 210922 Prod. No.: 001 RX (EQ 10MG BASE/5ML (EQ 2MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8058069 DP* Lipid formulations for nucleic acid delivery Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 6, 2018 | Apr 15, 2029 | |
| Pat. No. 8158601 DP* Lipid formulation Claim Types: Compound; Composition; Formulation; Method of administration Pat. Sub. Date(s): 001: Sep 6, 2018 | Nov 10, 2030 | U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Pat. No. 8168775 DS* DP* Compositions and methods for inhibiting expression of transthyretin Claim Types: Compound; Composition; Intermediate; Method of use Pat. Sub. Date(s): 001: Sep 6, 2018 | Oct 20, 2029 | U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Pat. No. 8334373 DS* DP* Nuclease resistant double-stranded ribonucleic acid Claim Types: Compound; Composition; Process Pat. Sub. Date(s): 001: Sep 6, 2018 | May 27, 2025 | |
| Pat. No. 8492359 DP* Lipid formulations for nucleic acid delivery Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 6, 2018 | Apr 15, 2029 | |
| Pat. No. 8642076 DP* Lipid containing formulations Claim Types: Compound; Formulation Pat. Sub. Date(s): 001: Sep 6, 2018 | Oct 3, 2027 | |
| Pat. No. 8741866 Compositions and methods for inhibiting expression of transthyretin Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 6, 2018 | Oct 20, 2029 | U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Pat. No. 8802644 DP* Lipid formulation Claim Types: Formulation; Method of administration; Method of use Pat. Sub. Date(s): 001: Sep 6, 2018 | Oct 21, 2030 | U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Pat. No. 8822668 DP* Lipid formulations for nucleic acid delivery Claim Types: Formulation; Method of administration; Method of use Pat. Sub. Date(s): 001: Sep 6, 2018 | Apr 15, 2029 | U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Pat. No. 9234196 DP* Compositions and methods for inhibiting expression of transthyretin Claim Types: Formulation; Intermediate; Method of use Pat. Sub. Date(s): 001: Sep 6, 2018 | Oct 20, 2029 | U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Pat. No. 9364435 DP* Lipid formulations for nucleic acid delivery Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 6, 2018 | Apr 15, 2029 | U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Pat. No. 10240152 DS* DP* Compositions and methods for inhibiting expression of transthyretin Claim Types: Formulation claimed by its inherent performace characteristics; Method of Use claimed by its inherent performace characteristics; Composition Pat. Sub. Date(s): 001: Sep 3, 2021 | Oct 20, 2029 | U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Pat. No. 11079379 DS* DP* Methods of treating transthyretin (TTR) mediated amyloidosis Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 3, 2021 | Aug 27, 2035 | U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Pat. No. 11141378 DP* Lipid formulations for nucleic acid delivery Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 9, 2021 | Apr 15, 2029 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Jan 13, 2026 | M-270: Information added to clinical pharmacology section |
| Exclusivity Code: NCE - New chemical entity | Aug 10, 2023 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Aug 10, 2025 | ODE-197: Indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults |
ALNYLAM PHARMS INC
OXLUMO (SOLUTION) (SUBCUTANEOUS) LUMASIRAN SODIUM
NDA Applicant: ALNYLAM PHARMS INC NDA No.: 214103 Prod. No.: 001 RX (EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8106022 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 10, 2020 | Dec 12, 2029 | U-2995: Treatment of primary hyperoxaluria type 1 (PH1) |
| Pat. No. 8828956 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 10, 2020 | Dec 4, 2028 | U-2995: Treatment of primary hyperoxaluria type 1 (PH1) |
| Pat. No. 9828606 DS* DP* Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA Claim Types: Compound Pat. Sub. Date(s): 001: Dec 10, 2020 | Dec 26, 2034 | |
| Pat. No. 10131907 DS* DP* Glycoconjugates of RNA interference agents Claim Types: Composition; Process; Method of use Pat. Sub. Date(s): 001: Dec 10, 2020 | Aug 24, 2028 | U-2995: Treatment of primary hyperoxaluria type 1 (PH1) |
| Pat. No. 10435692 Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 10, 2020 | Dec 26, 2034 | U-2995: Treatment of primary hyperoxaluria type 1 (PH1) |
| Pat. No. 10465195 DS* DP* Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 10, 2020 | Dec 26, 2034 | U-2995: Treatment of primary hyperoxaluria type 1 (PH1) |
| Pat. No. 10478500 DS* DP* Compositions and methods for inhibition of HAO1 (Hydroxyacid Oxidase 1 (Glycolate Oxidase)) gene expression Claim Types: Compound; Method of use Pat. Sub. Date(s): 001: Dec 10, 2020 | Oct 9, 2035 | U-2995: Treatment of primary hyperoxaluria type 1 (PH1) |
| Pat. No. 10487330 DS* DP* Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 10, 2020 | Dec 26, 2034 | U-2995: Treatment of primary hyperoxaluria type 1 (PH1) |
| Pat. No. 10612024 DS* DP* Modified double-stranded RNA agents Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 10, 2020 | Aug 14, 2035 | U-2995: Treatment of primary hyperoxaluria type 1 (PH1) |
| Pat. No. 10612027 DS* DP* Modified double-stranded RNA agents Claim Types: Compound; Composition; Method of use; Method of administration Pat. Sub. Date(s): 001: Dec 10, 2020 | Aug 14, 2035 | U-2995: Treatment of primary hyperoxaluria type 1 (PH1) |
| Pat. No. 11060093 DS* DP* Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Aug 17, 2021 | Dec 26, 2034 | U-2995: Treatment of primary hyperoxaluria type 1 (PH1) |
| Pat. No. 11261447 DS* DP* Methods for inhibition of HAO1 (hydroxyacid oxidase 1 (glycolate oxidase)) gene expression Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 17, 2022 | Nov 20, 2038 | U-2995: Treatment of primary hyperoxaluria type 1 (PH1) |
| Pat. No. 11401517 DS* DP* Modified double-stranded RNA agents Claim Types: Compound; Composition; Method of use; Method of administration Pat. Sub. Date(s): 001: Sep 19, 2022 | Aug 14, 2035 | U-2995: Treatment of primary hyperoxaluria type 1 (PH1) |
| Pat. No. 11446380 DS* DP* Compositions and methods for inhibition of HAO1 (hydroxyacid oxidase 1 (glycolate oxidase)) gene expression Claim Types: Compound; Composition; Cell Pat. Sub. Date(s): 001: Oct 19, 2022 | Oct 9, 2035 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Oct 6, 2025 | I-901: Expanded indication to include lowering of plasma oxalate levels in adult and pediatric patients with primary hyperoxaluria type 1 (PH1) |
| Exclusivity Code: NCE - New chemical entity | Nov 23, 2025 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 23, 2027 | ODE-339: Treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 6, 2029 | ODE-415: Treatment of primary hyperoxaluria type 1 (PH1) to lower plasma oxalate levels in pediatric and adult patients |
ALPHA COGNITION
ZUNVEYL (TABLET, DELAYED RELEASE) (ORAL) BENZGALANTAMINE GLUCONATE
NDA Applicant: ALPHA COGNITION NDA No.: 218549 Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 10MG BASE); 003 RX (EQ 15MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9763953 Cholinergic enhancers with improved blood-brain barrier permeability for the treatment of diseases accompanied by cognitive impairment Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 22, 2024 | Dec 1, 2026 | U-713: Treatment of mild to moderate dementia of the Alzheimer's type |
| Pat. No. 11795176 DS* Solid forms of Alpha-1062 gluconate Claim Types: New polymorph, salt or hydrate; Method of use Pat. Sub. Date(s): All strengths: Aug 22, 2024 | Jan 13, 2042 | U-713: Treatment of mild to moderate dementia of the Alzheimer's type |
ALPHARMA PHARMS
EMBEDA (CAPSULE, EXTENDED RELEASE) (ORAL) MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE
Drug Classes: dopaminergic agonist == opioid agonist == opioid antagonist
NDA Applicant: ALPHARMA PHARMS NDA No.: 022321 Prod. No.: 001 DISC (20MG;0.8MG**); 002 DISC (30MG;1.2MG**); 003 DISC (50MG;2MG**); 004 DISC (60MG;2.4MG**); 005 DISC (80MG;3.2MG**); 006 DISC (100MG;4MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7682633 Pharmaceutical composition Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Jun 19, 2027 | U-1510: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment by orally administering an intact composition as claimed. |
| Pat. No. 7682634 DP* Pharmaceutical compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jun 19, 2027 | |
| Pat. No. 7815934 DP* Sequestering subunit and related compositions and methods Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 19, 2010; 002: None; 003: None; 004: None; 005: None; 006: None | Dec 12, 2027 | |
| Pat. No. 8158156 Abuse-deterrent multi-layer pharmaceutical composition comprising an opioid antagonist and an opioid agonist Claim Types: Method of use Pat. Sub. Date(s): 001: May 10, 2012; 002: None; 003: None; 004: None; 005: None; 006: None | Jun 19, 2027 | U-1510: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment by orally administering an intact composition as claimed. |
| Pat. No. 8623418 Pharmaceutical composition Claim Types: Method of use; Method of administration Pat. Sub. Date(s): All strengths: Jan 22, 2015 | Nov 7, 2029 | U-1640: Treatment of moderate to severe chronic pain by administering an intact composition as claimed |
| Pat. No. 8685443 Sequestering subunit and related compositions and methods Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Jul 3, 2025 | U-1508: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment by orally administering a plurality of composite subunits as claimed |
| Pat. No. 8685444 DP* Sequestering subunit and related compositions and methods Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jul 3, 2025 | |
| Pat. No. 8846104 DP* Pharmaceutical compositions for the deterrence and/or prevention of abuse Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 28, 2014 | Jun 19, 2027 | |
| Pat. No. 8877247 DP* Abuse-deterrent multi-layer pharmaceutical composition comprising an opioid antagonist and an opioid agonist Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 1, 2014 | Jun 19, 2027 |
ALTATHERA PHARMS LLC
SOTALOL HYDROCHLORIDE (SOLUTION) (INTRAVENOUS) SOTALOL HYDROCHLORIDE
Drug Classes: antiarrhythmic
NDA Applicant: ALTATHERA PHARMS LLC NDA No.: 022306 Prod. No.: 001 RX (150MG/10ML (15MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10512620 Method of initiating and escalating sotalol hydrochloride dosing Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 26, 2020 | Aug 14, 2038 | U-2769: Dosing regimen for intravenous sotalol for administration in a facility that can provide continuous electrocardiographic monitoring and cardiac resuscitation. U-3547: Intravenous sotalol dosing regimen for achieving steady state exposure in a facility that can provide electrocardiographic monitoring |
| Pat. No. 10799138 Method of administering sotalol IV/switch Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 11, 2021 | Apr 5, 2039 | U-3125: Use for loading dose in patients with symptomatic Afib/AFL who are currently in sinus rhythm or for the treatment of life-threatening ventricular tachycardia U-3549: Intravenous sotalol dosing regimen for use in a facility that can provide electrocardiographic monitoring |
| Pat. No. 11583216 Method of administering sotalol IV/switch Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Mar 27, 2023 | Aug 21, 2039 | U-3549: Intravenous sotalol dosing regimen for use in a facility that can provide electrocardiographic monitoring |
| Pat. No. 11696902 Method of initiating and escalating sotalol hydrochloride dosing Claim Types: Method of administration Pat. Sub. Date(s): 001: Jul 31, 2023 | Aug 14, 2038 | U-2769: Dosing regimen for intravenous sotalol for administration in a facility that can provide continuous electrocardiographic monitoring and cardiac resuscitation. |
ALTHERA PHARMS
ROSZET (TABLET) (ORAL) EZETIMIBE; ROSUVASTATIN CALCIUM
Drug Classes: dietary cholesterol absorption inhibitor == HMG-CoA reductase inhibitor (statin)
NDA Applicant: ALTHERA PHARMS NDA No.: 213072 Prod. No.: 001 DISC (10MG;EQ 5MG BASE); 002 DISC (10MG;EQ 10MG BASE); 003 DISC (10MG;EQ 20MG BASE); 004 DISC (10MG;EQ 40MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9763885 DP* Oral tablet formulation consisting of fixed combination of rosuvastatin and ezetimibe for treatment of hyperlipidemia and cardiovascular diseases Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): All strengths: Mar 29, 2021 | May 1, 2033 | U-3095: Treatment of hyperlipidemia |
| Pat. No. 10376470 DP* Oral tablet formulation consisting of fixed combination of rosuvastatin and ezetimibe for treatment of hyperlipidemia and cardiovascular diseases Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): All strengths: Mar 29, 2021 | May 1, 2033 | U-3095: Treatment of hyperlipidemia |
AM REGENT
INJECTAFER (SOLUTION) (INTRAVENOUS) FERRIC CARBOXYMALTOSE
NDA Applicant: AM REGENT NDA No.: 203565 Prod. No.: 001 RX (750MG IRON/15ML (50MG IRON/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7612109 DS* DP* Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Sep 12, 2013 | Feb 5, 2025 | |
| Pat. No. 7754702 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 12, 2013 | Feb 15, 2028 | U-1432: Method of treatment of iron-related conditions with at least 0.6 grams of elemental iron via an iron carbohydrate complex U-3312: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron U-3313: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron U-3314: Method of treating IDA in adults & pediatric patients 1 yr & older having intolerance or unsatisfactory response to oral iron associated with heavy uterine bleeding or gastrointestinal disorder by intravenously administering ferric carboxymaltose U-3636: Method to treat IDA in adults weighing at least 40 kg with heart failure & NY heart association class II/III to improve exercise capacity by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron |
| Pat. No. 8895612 Methods and compositions for administration of iron Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Dec 17, 2014 | Jan 8, 2027 | U-1620: Method of treatment of iron-related conditions with at least 0.6 grams of elemental iron via an iron carbohydrate complex, with a substantially non-immunogenic carbohydrate component, in about 15 minutes or less. U-3115: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less U-3116: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less U-3315: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by administering IV at least about 0.6 g of iron as ferric carboxymaltose in about 15 min or less U-3316: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering at least about 0.6 grams of iron as ferric carboxymaltose in about 15 minutes or less U-3635: Method to treat IDA in adults weighing at least 40 kg with heart failure & NY heart association class II/III to improve exercise capacity by administering IV ferric carboxymaltose to provide at least about 0.6 g of elemental iron in about <=15 min |
| Pat. No. 11364260 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 28, 2023 | Jan 8, 2027 | U-3637: Method to treat iron deficiency in adults weighing at least 40 kg with heart failure & ny heart association class II/III to improve exercise capacity by administering iv ferric carboxymaltose to provide at least about 0.6 g of elemental iron |
| Pat. No. 11433091 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 4, 2022 | Jan 8, 2027 | U-3435: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 46.7 kg by intravenously administering ferric carboxymaltose to provide at least 0.7 g of elemental iron in 15 minutes U-3436: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 46.7 kg by intravenously administering ferric carboxymaltose to provide at least 0.7 g of elemental iron in less than 15 minutes U-3437: Method to treat IDA in adults & pediatric patients 1 year & older with intolerance or unsatisfactory response to oral iron & heavy uterine bleeding or gi disorder by administering IV ferric carboxymaltose to give at least 0.7 g of iron in 15 minutes U-3438: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 46.7 kg by administering IV ferric carboxymaltose to provide at least 0.7 g of elemental iron in < 15 minutes U-3634: Method of treating ida in adult patients weighing at least 46.7 kg with heart failure & ny heart association class II/III to improve exercise capacity by administering iv ferric carboxymaltose to provide at least 0.7 g of elemental iron in 15 minutes |
| Pat. No. 11478502 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 21, 2022 | Jan 8, 2027 | U-3472: Method to treat ida in adults with intolerance or unsatisfactory response to oral iron & heavy uterine bleeding or gi disorder weighing at least 40 kg by administering iv ferric carboxymaltose to give at least 0.6 g of iron in 15 minutes or less U-3473: Method to treat iron deficiency anemia in adults with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least 0.6 g of elemental iron in 15 minutes or less U-3474: Method to treat iron deficiency anemia in adults with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least 0.6 g of elemental iron in 15 minutes or less |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | May 31, 2026 | I-915: Treatment of iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity |
| Exclusivity Code: NPP - New patient population | Nov 19, 2024 |
AM REGENT
INJECTAFER (SOLUTION) (INTRAVENOUS) FERRIC CARBOXYMALTOSE
NDA Applicant: AM REGENT NDA No.: 203565 Prod. No.: 002 RX (500MG IRON/10ML (50MG IRON/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7612109 DS* DP* Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes Claim Types: Formulation; Process Pat. Sub. Date(s): 002: Feb 2, 2021 | Feb 5, 2025 | |
| Pat. No. 7754702 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 002: Feb 2, 2021 | Feb 15, 2028 | U-2555: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron U-2556: Method of treating iron deficiency anemia in adults who have intolerance to or have had unsatisfactory response to oral iron associated with heavy uterine bleeding or a gastrointestinal disorder by intravenously administering ferric carboxymaltose U-2557: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron U-3312: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron U-3313: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron U-3314: Method of treating IDA in adults & pediatric patients 1 yr & older having intolerance or unsatisfactory response to oral iron associated with heavy uterine bleeding or gastrointestinal disorder by intravenously administering ferric carboxymaltose U-3636: Method to treat IDA in adults weighing at least 40 kg with heart failure & NY heart association class II/III to improve exercise capacity by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron |
| Pat. No. 8895612 Methods and compositions for administration of iron Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 002: Feb 2, 2021 | Jan 8, 2027 | U-1620: Method of treatment of iron-related conditions with at least 0.6 grams of elemental iron via an iron carbohydrate complex, with a substantially non-immunogenic carbohydrate component, in about 15 minutes or less. U-3050: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less U-3051: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less U-3115: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less U-3116: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less U-3315: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by administering IV at least about 0.6 g of iron as ferric carboxymaltose in about 15 min or less U-3316: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering at least about 0.6 grams of iron as ferric carboxymaltose in about 15 minutes or less U-3635: Method to treat IDA in adults weighing at least 40 kg with heart failure & NY heart association class II/III to improve exercise capacity by administering IV ferric carboxymaltose to provide at least about 0.6 g of elemental iron in about <=15 min |
| Pat. No. 11364260 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 28, 2023 | Jan 8, 2027 | U-3637: Method to treat iron deficiency in adults weighing at least 40 kg with heart failure & ny heart association class II/III to improve exercise capacity by administering iv ferric carboxymaltose to provide at least about 0.6 g of elemental iron |
| Pat. No. 11433091 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 002: Oct 4, 2022 | Jan 8, 2027 | U-3435: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 46.7 kg by intravenously administering ferric carboxymaltose to provide at least 0.7 g of elemental iron in 15 minutes U-3436: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 46.7 kg by intravenously administering ferric carboxymaltose to provide at least 0.7 g of elemental iron in less than 15 minutes U-3437: Method to treat IDA in adults & pediatric patients 1 year & older with intolerance or unsatisfactory response to oral iron & heavy uterine bleeding or gi disorder by administering IV ferric carboxymaltose to give at least 0.7 g of iron in 15 minutes U-3438: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 46.7 kg by administering IV ferric carboxymaltose to provide at least 0.7 g of elemental iron in < 15 minutes U-3634: Method of treating ida in adult patients weighing at least 46.7 kg with heart failure & ny heart association class II/III to improve exercise capacity by administering iv ferric carboxymaltose to provide at least 0.7 g of elemental iron in 15 minutes |
| Pat. No. 11478502 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 21, 2022 | Jan 8, 2027 | U-3472: Method to treat ida in adults with intolerance or unsatisfactory response to oral iron & heavy uterine bleeding or gi disorder weighing at least 40 kg by administering iv ferric carboxymaltose to give at least 0.6 g of iron in 15 minutes or less U-3473: Method to treat iron deficiency anemia in adults with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least 0.6 g of elemental iron in 15 minutes or less U-3474: Method to treat iron deficiency anemia in adults with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least 0.6 g of elemental iron in 15 minutes or less |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | May 31, 2026 | I-915: Treatment of iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity |
| Exclusivity Code: NPP - New patient population | Nov 19, 2024 |
AM REGENT
INJECTAFER (SOLUTION) (INTRAVENOUS) FERRIC CARBOXYMALTOSE
NDA Applicant: AM REGENT NDA No.: 203565 Prod. No.: 003 RX (1GM IRON/20ML (50MG IRON/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7612109 DS* DP* Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes Claim Types: Formulation; Process Pat. Sub. Date(s): 003: May 21, 2021 | Feb 5, 2025 | |
| Pat. No. 7754702 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 003: May 21, 2021 | Feb 15, 2028 | U-2555: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron U-2556: Method of treating iron deficiency anemia in adults who have intolerance to or have had unsatisfactory response to oral iron associated with heavy uterine bleeding or a gastrointestinal disorder by intravenously administering ferric carboxymaltose U-2557: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron U-3312: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron U-3313: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron U-3314: Method of treating IDA in adults & pediatric patients 1 yr & older having intolerance or unsatisfactory response to oral iron associated with heavy uterine bleeding or gastrointestinal disorder by intravenously administering ferric carboxymaltose U-3636: Method to treat IDA in adults weighing at least 40 kg with heart failure & NY heart association class II/III to improve exercise capacity by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron |
| Pat. No. 8895612 Methods and compositions for administration of iron Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 003: May 21, 2021 | Jan 8, 2027 | U-1620: Method of treatment of iron-related conditions with at least 0.6 grams of elemental iron via an iron carbohydrate complex, with a substantially non-immunogenic carbohydrate component, in about 15 minutes or less. U-3050: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less U-3051: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less U-3115: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less U-3116: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less U-3315: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by administering IV at least about 0.6 g of iron as ferric carboxymaltose in about 15 min or less U-3316: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering at least about 0.6 grams of iron as ferric carboxymaltose in about 15 minutes or less U-3635: Method to treat IDA in adults weighing at least 40 kg with heart failure & NY heart association class II/III to improve exercise capacity by administering IV ferric carboxymaltose to provide at least about 0.6 g of elemental iron in about <=15 min |
| Pat. No. 11364260 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 003: Jun 28, 2023 | Jan 8, 2027 | U-3637: Method to treat iron deficiency in adults weighing at least 40 kg with heart failure & ny heart association class II/III to improve exercise capacity by administering iv ferric carboxymaltose to provide at least about 0.6 g of elemental iron |
| Pat. No. 11433091 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 003: Oct 4, 2022 | Jan 8, 2027 | U-3435: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 46.7 kg by intravenously administering ferric carboxymaltose to provide at least 0.7 g of elemental iron in 15 minutes U-3436: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 46.7 kg by intravenously administering ferric carboxymaltose to provide at least 0.7 g of elemental iron in less than 15 minutes U-3437: Method to treat IDA in adults & pediatric patients 1 year & older with intolerance or unsatisfactory response to oral iron & heavy uterine bleeding or gi disorder by administering IV ferric carboxymaltose to give at least 0.7 g of iron in 15 minutes U-3438: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 46.7 kg by administering IV ferric carboxymaltose to provide at least 0.7 g of elemental iron in < 15 minutes U-3634: Method of treating ida in adult patients weighing at least 46.7 kg with heart failure & ny heart association class II/III to improve exercise capacity by administering iv ferric carboxymaltose to provide at least 0.7 g of elemental iron in 15 minutes |
| Pat. No. 11478502 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 003: Nov 21, 2022 | Jan 8, 2027 | U-3472: Method to treat ida in adults with intolerance or unsatisfactory response to oral iron & heavy uterine bleeding or gi disorder weighing at least 40 kg by administering iv ferric carboxymaltose to give at least 0.6 g of iron in 15 minutes or less U-3473: Method to treat iron deficiency anemia in adults with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least 0.6 g of elemental iron in 15 minutes or less U-3474: Method to treat iron deficiency anemia in adults with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least 0.6 g of elemental iron in 15 minutes or less |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | May 31, 2026 | I-915: Treatment of iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity |
| Exclusivity Code: NPP - New patient population | Nov 19, 2024 | |
| Exclusivity Code: NS - New strength | Apr 28, 2024 |
AM REGENT
INJECTAFER (SOLUTION) (INTRAVENOUS) FERRIC CARBOXYMALTOSE
NDA Applicant: AM REGENT NDA No.: 203565 Prod. No.: 004 RX (100MG IRON/2ML (50MG IRON/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7612109 DS* DP* Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes Claim Types: Formulation; Process Pat. Sub. Date(s): 004: Mar 4, 2022 | Feb 5, 2025 | |
| Pat. No. 7754702 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 004: Mar 4, 2022 | Feb 15, 2028 | U-3312: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron U-3313: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron U-3314: Method of treating IDA in adults & pediatric patients 1 yr & older having intolerance or unsatisfactory response to oral iron associated with heavy uterine bleeding or gastrointestinal disorder by intravenously administering ferric carboxymaltose U-3636: Method to treat IDA in adults weighing at least 40 kg with heart failure & NY heart association class II/III to improve exercise capacity by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron |
| Pat. No. 8895612 Methods and compositions for administration of iron Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 004: Mar 4, 2022 | Jan 8, 2027 | U-3115: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less U-3116: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less U-3315: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by administering IV at least about 0.6 g of iron as ferric carboxymaltose in about 15 min or less U-3316: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering at least about 0.6 grams of iron as ferric carboxymaltose in about 15 minutes or less U-3635: Method to treat IDA in adults weighing at least 40 kg with heart failure & NY heart association class II/III to improve exercise capacity by administering IV ferric carboxymaltose to provide at least about 0.6 g of elemental iron in about <=15 min |
| Pat. No. 11364260 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 004: Jun 28, 2023 | Jan 8, 2027 | U-3637: Method to treat iron deficiency in adults weighing at least 40 kg with heart failure & ny heart association class II/III to improve exercise capacity by administering iv ferric carboxymaltose to provide at least about 0.6 g of elemental iron |
| Pat. No. 11433091 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 004: Oct 4, 2022 | Jan 8, 2027 | U-3435: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 46.7 kg by intravenously administering ferric carboxymaltose to provide at least 0.7 g of elemental iron in 15 minutes U-3436: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 46.7 kg by intravenously administering ferric carboxymaltose to provide at least 0.7 g of elemental iron in less than 15 minutes U-3437: Method to treat IDA in adults & pediatric patients 1 year & older with intolerance or unsatisfactory response to oral iron & heavy uterine bleeding or gi disorder by administering IV ferric carboxymaltose to give at least 0.7 g of iron in 15 minutes U-3438: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 46.7 kg by administering IV ferric carboxymaltose to provide at least 0.7 g of elemental iron in < 15 minutes U-3634: Method of treating ida in adult patients weighing at least 46.7 kg with heart failure & ny heart association class II/III to improve exercise capacity by administering iv ferric carboxymaltose to provide at least 0.7 g of elemental iron in 15 minutes |
| Pat. No. 11478502 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 004: Nov 21, 2022 | Jan 8, 2027 | U-3472: Method to treat ida in adults with intolerance or unsatisfactory response to oral iron & heavy uterine bleeding or gi disorder weighing at least 40 kg by administering iv ferric carboxymaltose to give at least 0.6 g of iron in 15 minutes or less U-3473: Method to treat iron deficiency anemia in adults with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least 0.6 g of elemental iron in 15 minutes or less U-3474: Method to treat iron deficiency anemia in adults with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least 0.6 g of elemental iron in 15 minutes or less |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | May 31, 2026 | I-915: Treatment of iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity |
AM REGENT
MULTRYS (SOLUTION) (INTRAVENOUS) CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE
NDA Applicant: AM REGENT NDA No.: 209376 Prod. No.: 003 RX (EQ 60MCG COPPER/ML;EQ 3MCG BASE/ML;EQ 6MCG SELENIUM/ML;EQ 1000MCG BASE/ML (1ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11786548 DP* Trace element compositions, methods of making and use Claim Types: Formulation Pat. Sub. Date(s): 003: Nov 14, 2023 | Jul 1, 2041 | |
| Pat. No. 11975022 Claim Types: Pat. Sub. Date(s): 003: May 8, 2024 | Jul 1, 2041 | U-3900: Neonatal and pediatric patients weighing less than 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated |
| Pat. No. 11998565 DP* Trace element compositions, methods of making and use Claim Types: Formulation Pat. Sub. Date(s): 003: Jun 7, 2024 | Jul 1, 2041 | |
| Pat. No. 12150956 Trace Element Compositions, Methods Of Making And Use Claim Types: Method of use Pat. Sub. Date(s): 003: Dec 3, 2024 | Jul 1, 2041 | U-3900: Neonatal and pediatric patients weighing less than 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated |
| Pat. No. 12150957 Trace Element Compositions, Methods Of Making And Use Claim Types: Method of administration Pat. Sub. Date(s): 003: Dec 3, 2024 | Jul 1, 2041 | U-3900: Neonatal and pediatric patients weighing less than 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Apr 30, 2024 |
AM REGENT
POTASSIUM PHOSPHATES (SOLUTION) (INTRAVENOUS) POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC [GENERIC AP]
NDA Applicant: AM REGENT NDA No.: 216274 Prod. No.: 001 RX (1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Apr 13, 2024 |
AM REGENT
POTASSIUM PHOSPHATES (SOLUTION) (INTRAVENOUS) POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC [GENERIC AP]
NDA Applicant: AM REGENT NDA No.: 216274 Prod. No.: 002 RX (3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)); 003 RX (11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Apr 10, 2024 |
AM REGENT
SELENIOUS ACID (SOLUTION) (INTRAVENOUS) SELENIOUS ACID
NDA Applicant: AM REGENT NDA No.: 209379 Prod. No.: 001 RX (EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)); 002 RX (EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML)); 003 RX (EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11998565 DP* Trace element compositions, methods of making and use Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 7, 2024 | Jul 1, 2041 | |
| Pat. No. 12150957 Trace Element Compositions, Methods Of Making And Use Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Dec 3, 2024 | Jul 1, 2041 | U-4039: Adult and pediatric patients as a source of selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Apr 30, 2024 |
AM REGENT
TRALEMENT (SOLUTION) (INTRAVENOUS) CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE
NDA Applicant: AM REGENT NDA No.: 209376 Prod. No.: 001 RX (EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (1ML)); 002 RX (EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (5ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11786548 DP* Trace element compositions, methods of making and use Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 14, 2023 | Jul 1, 2041 | |
| Pat. No. 11975022 Claim Types: Pat. Sub. Date(s): All strengths: May 8, 2024 | Jul 1, 2041 | U-3899: Adult and pediatric patients weighing at least 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated |
| Pat. No. 11998565 DP* Trace element compositions, methods of making and use Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 7, 2024 | Jul 1, 2041 | |
| Pat. No. 12150956 Trace Element Compositions, Methods Of Making And Use Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 3, 2024 | Jul 1, 2041 | U-3899: Adult and pediatric patients weighing at least 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated |
| Pat. No. 12150957 Trace Element Compositions, Methods Of Making And Use Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Dec 3, 2024 | Jul 1, 2041 | U-3899: Adult and pediatric patients weighing at least 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Apr 30, 2024 |
AMARIN PHARMS
VASCEPA (CAPSULE) (ORAL) ICOSAPENT ETHYL [GENERIC AB]
NDA Applicant: AMARIN PHARMS NDA No.: 202057 Prod. No.: 001 RX (1GM)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8298554 DP* Stable pharmaceutical composition and methods of using same Claim Types: Formulation Pat. Sub. Date(s): 001: None | Apr 29, 2030 | |
| Pat. No. 8399446 Methods of treating hypertriglyceridemia Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 17, 2013 | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8410086 Compositions and methods for lowering triglycerides Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020 | Jun 15, 2030 | U-2688: Use of VASCEPA to lower triglycerides and ldl-c in an adult patient with elevated triglyceride (TG) levels (about 200 mg/dl to less than about 500 mg/dl) and on statin therapy |
| Pat. No. 8415335 Methods of treating hypertriglyceridemia Claim Types: Method of administration Pat. Sub. Date(s): 001: Apr 17, 2013 | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8426399 Methods of treating hypertriglyceridemia Claim Types: Method of use Pat. Sub. Date(s): 001: None | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8431560 Methods of treating hypertriglyceridemia Claim Types: Method of use Pat. Sub. Date(s): 001: None | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8440650 Methods of treating hypertriglyceridemia Claim Types: Method of use Pat. Sub. Date(s): 001: None | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8445003 Stable pharmaceutical composition and methods of using same Claim Types: Method of administration Pat. Sub. Date(s): 001: None | Apr 29, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8445013 Stable pharmaceutical composition and methods of using same Claim Types: Method of administration Pat. Sub. Date(s): 001: None | Apr 29, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8454994 Stable pharmaceutical composition and methods of using same Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020 | Apr 29, 2030 | U-2689: Use of VASCEPA to treat mixed dyslipidemia in an adult patient with elevated triglyceride (TG) levels (>=150 mg/dl) and on statin therapy |
| Pat. No. 8455472 Compositions and methods for lowering triglycerides without raising LDL-C levels in a subject on concomitant statin therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020 | Jun 15, 2030 | U-2690: Use of VASCEPA to lower triglycerides in an adult patient with elevated triglyceride (TG) levels (about 200 mg/dl to less than about 500 mg/dl) and on statin therapy |
| Pat. No. 8501225 Stable pharmaceutical composition and methods of using same Claim Types: Method of administration Pat. Sub. Date(s): 001: None | Apr 29, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8518929 Methods of treating hypertriglyceridemia Claim Types: Method of use Pat. Sub. Date(s): 001: None | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8524698 Methods of treating hypertriglyceridemia Claim Types: Method of administration Pat. Sub. Date(s): 001: Sep 11, 2013 | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8546372 Methods of treating hypertriglyceridemia Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 1, 2013 | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8551521 Stable pharmaceutical composition and methods of using same Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 9, 2013 | Apr 29, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8563608 Methods for lowering triglycerides without raising LDL-C levels in a subject on concomitant statin therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 22, 2013 | Apr 29, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8617593 Stable pharmaceutical composition and methods of using same Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 14, 2014 | Apr 29, 2030 | U-1478: Method of reducing TG levels in patient on statin therapy suffering from severe hypertriglyceridemia U-2691: Use of VASCEPA to treat hypertriglyceridemia in an adult patient with elevated triglyceride (TG) levels (>= 150 mg/dl) and on statin therapy |
| Pat. No. 8617594 Stable pharmaceutical composition and methods of using same Claim Types: Method of administration Pat. Sub. Date(s): 001: None | Apr 29, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8618166 Methods of treating mixed dyslipidemia Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020 | Apr 29, 2030 | U-2689: Use of VASCEPA to treat mixed dyslipidemia in an adult patient with elevated triglyceride (TG) levels (>=150 mg/dl) and on statin therapy |
| Pat. No. 8623406 Stable pharmaceutical composition and methods of using same Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 14, 2014 | Apr 29, 2030 | U-1478: Method of reducing TG levels in patient on statin therapy suffering from severe hypertriglyceridemia U-2692: Use of VASCEPA to reduce triglycerides in an adult patient with elevated triglyceride (TG) levels (>= 150 mg/dl) and on statin therapy |
| Pat. No. 8642077 Stable pharmaceutical composition and methods of using same Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020 | Apr 29, 2030 | U-2693: Use of VASCEPA to reduce triglycerides in a mixed dyslipidemia adult patient with elevated triglyceride (TG) levels (>= 150 mg/dl) and on statin therapy |
| Pat. No. 8669245 Compositions and methods for lowering triglycerides without raising LDL-C levels in a subject on concomitant statin therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020 | Jun 15, 2030 | U-2694: Use of VASCEPA to lower triglycerides in a mixed dyslipidemia adult patient with elevated triglyceride (TG) levels (about 200 mg/dl to less than about 500 mg/dl) and on statin therapy |
| Pat. No. 8680144 Methods of treating mixed dyslipidemia Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020 | Feb 9, 2030 | U-2695: Use of VASCEPA to treat mixed hypertriglyceridemia in an adult patient with elevated triglyceride (TG) levels (>= 150 mg/dl) and on statin therapy |
| Pat. No. 8691871 Methods of treating mixed dyslipidemia Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020 | Apr 29, 2030 | U-2689: Use of VASCEPA to treat mixed dyslipidemia in an adult patient with elevated triglyceride (TG) levels (>=150 mg/dl) and on statin therapy |
| Pat. No. 8703185 Stable pharmaceutical composition and methods of using same Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020 | Apr 29, 2030 | U-2691: Use of VASCEPA to treat hypertriglyceridemia in an adult patient with elevated triglyceride (TG) levels (>= 150 mg/dl) and on statin therapy |
| Pat. No. 8709475 Stable pharmaceutical composition and methods of using same Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020 | Apr 29, 2030 | U-2689: Use of VASCEPA to treat mixed dyslipidemia in an adult patient with elevated triglyceride (TG) levels (>=150 mg/dl) and on statin therapy |
| Pat. No. 8710041 Compositions and methods for lowering triglycerides in a subject on concomitant statin therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020 | Jun 15, 2030 | U-2690: Use of VASCEPA to lower triglycerides in an adult patient with elevated triglyceride (TG) levels (about 200 mg/dl to less than about 500 mg/dl) and on statin therapy |
| Pat. No. 9198892 Composition and/or method for preventing onset and/or recurrence of cardiovascular events Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Jan 10, 2020 | Sep 25, 2027 | U-2706: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of onset and/or recurrence of cardiovascular events in a patient who has escaped the unstable period after cardiovascular angioplasty |
| Pat. No. 9603826 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020 | Jun 28, 2033 | U-2696: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of cardiovascular death, coronary revascularization, and unstable angina in an adult patient with elevated triglyceride levels (TG >= 150 mg/dl to about 500 mg/dl) |
| Pat. No. 9610272 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020 | Jun 28, 2033 | U-2697: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of cardiovascular death and/or unstable angina in an adult patient with elevated triglyceride levels (TG >= 150 mg/dl to about 500 mg/dl) |
| Pat. No. 9623001 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020 | Jun 28, 2033 | U-2698: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of cardiovascular death and/or coronary revascularization in an adult patient with elevated triglyceride levels (TG >= 150 mg/dl to about 500 mg/dl) |
| Pat. No. 9693984 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020 | Jun 28, 2033 | U-2697: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of cardiovascular death and/or unstable angina in an adult patient with elevated triglyceride levels (TG >= 150 mg/dl to about 500 mg/dl) |
| Pat. No. 9693985 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020 | Jun 28, 2033 | U-2696: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of cardiovascular death, coronary revascularization, and unstable angina in an adult patient with elevated triglyceride levels (TG >= 150 mg/dl to about 500 mg/dl) |
| Pat. No. 9693986 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020 | Jun 28, 2033 | U-2698: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of cardiovascular death and/or coronary revascularization in an adult patient with elevated triglyceride levels (TG >= 150 mg/dl to about 500 mg/dl) |
| Pat. No. 9700537 Composition for preventing the occurrence of cardiovascular event in multiple risk patient Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 10, 2020 | May 31, 2027 | U-2707: Use of VASCEPA as an adjunct to statin therapy to reduce the occurrence of a cardiovascular event in an adult patient with hypercholesterolemia |
| Pat. No. 9918954 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020 | Jun 28, 2033 | U-2699: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a cardiovascular event (coronary revascularization, unstable angina, stroke and/or myocardial infarction) in an adult patient with elevated triglyceride levels |
| Pat. No. 10010517 Stable pharmaceutical composition and methods of using same Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020 | Apr 29, 2030 | U-2690: Use of VASCEPA to lower triglycerides in an adult patient with elevated triglyceride (TG) levels (about 200 mg/dl to less than about 500 mg/dl) and on statin therapy |
| Pat. No. 10265287 Methods of reducing triglycerides and LDL-C Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020 | Apr 29, 2030 | U-2700: Use of VASCEPA to reduce triglycerides in an adult patient with elevated triglyceride (TG) levels (about 200 mg/dl to less than about 500 mg/dl) and on rosuvastatin therapy |
| Pat. No. 10278935 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020 | Jun 28, 2033 | U-2701: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of coronary revascularization and/or unstable angina in an adult patient with elevated triglyceride levels (TG >= 150 mg/dl to about 500 mg/dl) |
| Pat. No. 10278936 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020 | Jun 28, 2033 | U-2702: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a cardiovascular event (cardiovascular death, coronary revascularization and/or unstable angina) in an adult patient with elevated triglyceride levels |
| Pat. No. 10278937 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020 | Jun 28, 2033 | U-2703: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a cv event (cv death, coronary revascularization, unstable angina, stroke and/or myocardial infarction) in an adult patient with elevated triglyceride levels and diabetes mellitus |
| Pat. No. 10383840 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020 | Jun 28, 2033 | U-2704: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a cardiovascular event in an adult patient with elevated triglyceride levels and at least one risk factor for cardiovascular disease |
| Pat. No. 10555924 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 26, 2020 | Jun 28, 2033 | U-2743: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of unstable angina in an adult patient with established cardiovascular disease |
| Pat. No. 10555925 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 26, 2020 | Jun 28, 2033 | U-2744: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of stroke in an adult patient with established cardiovascular disease |
| Pat. No. 10568861 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 20, 2020 | Jun 28, 2033 | U-2756: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of cardiovascular death in an adult patient with established cardiovascular disease |
| Pat. No. 10576054 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 27, 2020 | Jun 28, 2033 | U-2762: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a major cardiovascular event in an adult patient with diabetes mellitus and two or more additional risk factors for cardiovascular disease |
| Pat. No. 10668042 Methods of reducing the risk of cardiovascular events in a subject Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 26, 2020 | Jun 28, 2033 | U-2841: Use of VASCEPA with high intensity statin therapy to reduce the risk of a cv event in an adult patient with elevated triglyceride levels and (1) established CV disease, or (2) diabetes mellitus and two or more additional risk factors for CV disease |
| Pat. No. 10786478 Methods of reducing the risk of cardiovascular events in a subject Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 16, 2020 | Jun 28, 2033 | U-2959: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a third and further cardiovascular event in an adult patient with elevated tg levels (>=150 mg/dl) and established cardiovascular disease U-2960: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a second or further cardiovascular (CV) event in an adult patient with elevated tg levels (>= 150 mg/dl) and diabetes mellitus and 2 or more additional risk factors for CV disease |
| Pat. No. 10792267 Methods of treating mixed dyslipidemia Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 16, 2020 | Apr 29, 2030 | U-2961: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of myocardial infarction, stroke, both in an adult patient with Type 2 diabetes mellitus |
| Pat. No. 10792270 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 16, 2020 | Jun 28, 2033 | U-2962: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of coronary revascularization in an adult patient with established cardiovascular disease |
| Pat. No. 10842766 Stable pharmaceutical composition and methods of using same Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 11, 2020 | Apr 29, 2030 | U-2997: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of stroke in an adult patient with elevated triglycerides and atrial fibrillation |
| Pat. No. 10842768 Compositions and methods for lowering triglycerides Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 11, 2020 | Jun 15, 2030 | U-2688: Use of VASCEPA to lower triglycerides and ldl-c in an adult patient with elevated triglyceride (TG) levels (about 200 mg/dl to less than about 500 mg/dl) and on statin therapy |
| Pat. No. 10881632 Stable pharmaceutical composition and methods of using same Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 4, 2021 | Apr 29, 2030 | U-3052: Use of VASCEPA to reduce triglyceride levels in an adult patient on statin therapy and having atrial fibrillation and triglyceride levels of greater than 500 mg/dl |
| Pat. No. 10894028 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 4, 2021 | Jun 28, 2033 | U-3053: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of myocardial infarction in an adult patient with elevated triglyceride levels and established cv disease or diabetes mellitus and two or more additional risk factors for CV disease |
| Pat. No. 11000499 Methods of reducing the risk of cardiovascular events in a subject Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 10, 2021 | Jun 28, 2033 | U-3126: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a second and further cardiovascular event in an adult patient with established cardiovascular disease |
| Pat. No. 11103477 Stable pharmaceutical composition and methods of using same Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 21, 2021 | Apr 29, 2030 | U-3209: Use of VASCEPA as an adjunct to statin therapy to reduce the risk myocardial infarction in an adult patient having atrial fibrillation or atrial flutter and elevated triglyceride levels |
| Pat. No. 11116742 Methods of reducing the risk of cardiovascular events in a subject Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 8, 2021 | Jun 28, 2033 | U-3221: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a cardiovascular event in a patient with prior percutaneous coronary intervention |
| Pat. No. 11154526 Methods of treating mixed dyslipidemia Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 8, 2021 | Apr 29, 2030 | U-3240: Use of VASCEPA to reduce triglyceride levels in an adult patient having triglyceride levels of at least about 500 mg/dl, on anticoagulant/antiplatelet/thrombolytic therapy, and having atrial fibrillation and/or atrial flutter |
| Pat. No. 11213504 Stable pharmaceutical composition and methods of using same Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 3, 2022 | Apr 29, 2030 | U-3292: Use of VASCEPA to reduce triglyceride levels in an adult patient on statin therapy and having atrial fibrillation or atrial flutter and triglyceride levels of about 500 mg/dl to about 2,000 mg/dl |
| Pat. No. 11298333 Methods of reducing the risk of cardiovascular events in a subject Claim Types: Method of use Pat. Sub. Date(s): 001: May 11, 2022 | Jun 28, 2033 | U-3358: Use of VASCEPA to reduce the incidence of MI in an adult patient on statin therapy and with elevated triglyceride levels (>150 mg/dl), wherein the patient experiences atrial fibrillation and/or flutter instead of an incidence of MI |
| Pat. No. 11369582 Methods of reducing the risk of cardiovascular events in a subject Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 28, 2022 | Jun 28, 2033 | U-2841: Use of VASCEPA with high intensity statin therapy to reduce the risk of a cv event in an adult patient with elevated triglyceride levels and (1) established CV disease, or (2) diabetes mellitus and two or more additional risk factors for CV disease |
| Pat. No. 11717504 Methods of reducing the risk of cardiovascular events in a subject Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 18, 2023 | Apr 29, 2030 | U-3669: Use of VASCEPA to reduce the incidence of stroke in an adult patient on statin therapy and with elevated triglyceride levels (>150 mg/dl), wherein the patient experiences atrial fibrillation and/or flutter instead of an incidence of stroke |
AMARIN PHARMS
VASCEPA (CAPSULE) (ORAL) ICOSAPENT ETHYL [GENERIC AB]
NDA Applicant: AMARIN PHARMS NDA No.: 202057 Prod. No.: 002 RX (500MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8298554 DP* Stable pharmaceutical composition and methods of using same Claim Types: Formulation Pat. Sub. Date(s): 002: Jun 26, 2017 | Apr 29, 2030 | |
| Pat. No. 8399446 Methods of treating hypertriglyceridemia Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 26, 2017 | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8410086 Compositions and methods for lowering triglycerides Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 6, 2020 | Jun 15, 2030 | U-2688: Use of VASCEPA to lower triglycerides and ldl-c in an adult patient with elevated triglyceride (TG) levels (about 200 mg/dl to less than about 500 mg/dl) and on statin therapy |
| Pat. No. 8415335 Methods of treating hypertriglyceridemia Claim Types: Method of administration Pat. Sub. Date(s): 002: Jun 26, 2017 | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8426399 Methods of treating hypertriglyceridemia Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 26, 2017 | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8440650 Methods of treating hypertriglyceridemia Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 26, 2017 | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8445003 Stable pharmaceutical composition and methods of using same Claim Types: Method of administration Pat. Sub. Date(s): 002: Jun 26, 2017 | Apr 29, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8445013 Stable pharmaceutical composition and methods of using same Claim Types: Method of administration Pat. Sub. Date(s): 002: Jun 26, 2017 | Apr 29, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8454994 Stable pharmaceutical composition and methods of using same Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 6, 2020 | Apr 29, 2030 | U-2689: Use of VASCEPA to treat mixed dyslipidemia in an adult patient with elevated triglyceride (TG) levels (>=150 mg/dl) and on statin therapy |
| Pat. No. 8501225 Stable pharmaceutical composition and methods of using same Claim Types: Method of administration Pat. Sub. Date(s): 002: Jun 26, 2017 | Apr 29, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8518929 Methods of treating hypertriglyceridemia Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 26, 2017 | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8524698 Methods of treating hypertriglyceridemia Claim Types: Method of administration Pat. Sub. Date(s): 002: Jun 26, 2017 | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8546372 Methods of treating hypertriglyceridemia Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 26, 2017 | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8551521 Stable pharmaceutical composition and methods of using same Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 26, 2017 | Apr 29, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8563608 Methods for lowering triglycerides without raising LDL-C levels in a subject on concomitant statin therapy Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 26, 2017 | Apr 29, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8617593 Stable pharmaceutical composition and methods of using same Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 26, 2017 | Apr 29, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia U-2691: Use of VASCEPA to treat hypertriglyceridemia in an adult patient with elevated triglyceride (TG) levels (>= 150 mg/dl) and on statin therapy |
| Pat. No. 8617594 Stable pharmaceutical composition and methods of using same Claim Types: Method of administration Pat. Sub. Date(s): 002: Jun 26, 2017 | Apr 29, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8623406 Stable pharmaceutical composition and methods of using same Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 26, 2017 | Apr 29, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia U-2692: Use of VASCEPA to reduce triglycerides in an adult patient with elevated triglyceride (TG) levels (>= 150 mg/dl) and on statin therapy |
| Pat. No. 8642077 Stable pharmaceutical composition and methods of using same Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 6, 2020 | Apr 29, 2030 | U-2693: Use of VASCEPA to reduce triglycerides in a mixed dyslipidemia adult patient with elevated triglyceride (TG) levels (>= 150 mg/dl) and on statin therapy |
| Pat. No. 8669245 Compositions and methods for lowering triglycerides without raising LDL-C levels in a subject on concomitant statin therapy Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 6, 2020 | Jun 15, 2030 | U-2694: Use of VASCEPA to lower triglycerides in a mixed dyslipidemia adult patient with elevated triglyceride (TG) levels (about 200 mg/dl to less than about 500 mg/dl) and on statin therapy |
| Pat. No. 8680144 Methods of treating mixed dyslipidemia Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 6, 2020 | Feb 9, 2030 | U-2695: Use of VASCEPA to treat mixed hypertriglyceridemia in an adult patient with elevated triglyceride (TG) levels (>= 150 mg/dl) and on statin therapy |
| Pat. No. 8691871 Methods of treating mixed dyslipidemia Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 6, 2020 | Apr 29, 2030 | U-2689: Use of VASCEPA to treat mixed dyslipidemia in an adult patient with elevated triglyceride (TG) levels (>=150 mg/dl) and on statin therapy |
| Pat. No. 8703185 Stable pharmaceutical composition and methods of using same Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 6, 2020 | Apr 29, 2030 | U-2691: Use of VASCEPA to treat hypertriglyceridemia in an adult patient with elevated triglyceride (TG) levels (>= 150 mg/dl) and on statin therapy |
| Pat. No. 8709475 Stable pharmaceutical composition and methods of using same Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 6, 2020 | Apr 29, 2030 | U-2689: Use of VASCEPA to treat mixed dyslipidemia in an adult patient with elevated triglyceride (TG) levels (>=150 mg/dl) and on statin therapy |
| Pat. No. 8710041 Compositions and methods for lowering triglycerides in a subject on concomitant statin therapy Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 6, 2020 | Jun 15, 2030 | U-2690: Use of VASCEPA to lower triglycerides in an adult patient with elevated triglyceride (TG) levels (about 200 mg/dl to less than about 500 mg/dl) and on statin therapy |
| Pat. No. 9198892 Composition and/or method for preventing onset and/or recurrence of cardiovascular events Claim Types: Method of improving a treatment Pat. Sub. Date(s): 002: Jan 10, 2020 | Sep 25, 2027 | U-2706: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of onset and/or recurrence of cardiovascular events in a patient who has escaped the unstable period after cardiovascular angioplasty |
| Pat. No. 9603826 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 6, 2020 | Jun 28, 2033 | U-2696: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of cardiovascular death, coronary revascularization, and unstable angina in an adult patient with elevated triglyceride levels (TG >= 150 mg/dl to about 500 mg/dl) |
| Pat. No. 9610272 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 6, 2020 | Jun 28, 2033 | U-2697: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of cardiovascular death and/or unstable angina in an adult patient with elevated triglyceride levels (TG >= 150 mg/dl to about 500 mg/dl) |
| Pat. No. 9623001 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 6, 2020 | Jun 28, 2033 | U-2698: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of cardiovascular death and/or coronary revascularization in an adult patient with elevated triglyceride levels (TG >= 150 mg/dl to about 500 mg/dl) |
| Pat. No. 9693984 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 6, 2020 | Jun 28, 2033 | U-2697: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of cardiovascular death and/or unstable angina in an adult patient with elevated triglyceride levels (TG >= 150 mg/dl to about 500 mg/dl) |
| Pat. No. 9693985 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 6, 2020 | Jun 28, 2033 | U-2696: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of cardiovascular death, coronary revascularization, and unstable angina in an adult patient with elevated triglyceride levels (TG >= 150 mg/dl to about 500 mg/dl) |
| Pat. No. 9693986 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 6, 2020 | Jun 28, 2033 | U-2698: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of cardiovascular death and/or coronary revascularization in an adult patient with elevated triglyceride levels (TG >= 150 mg/dl to about 500 mg/dl) |
| Pat. No. 9700537 Composition for preventing the occurrence of cardiovascular event in multiple risk patient Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 10, 2020 | May 31, 2027 | U-2707: Use of VASCEPA as an adjunct to statin therapy to reduce the occurrence of a cardiovascular event in an adult patient with hypercholesterolemia |
| Pat. No. 9918954 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 6, 2020 | Jun 28, 2033 | U-2699: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a cardiovascular event (coronary revascularization, unstable angina, stroke and/or myocardial infarction) in an adult patient with elevated triglyceride levels |
| Pat. No. 10010517 Stable pharmaceutical composition and methods of using same Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 6, 2020 | Apr 29, 2030 | U-2690: Use of VASCEPA to lower triglycerides in an adult patient with elevated triglyceride (TG) levels (about 200 mg/dl to less than about 500 mg/dl) and on statin therapy |
| Pat. No. 10265287 Methods of reducing triglycerides and LDL-C Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 6, 2020 | Apr 29, 2030 | U-2700: Use of VASCEPA to reduce triglycerides in an adult patient with elevated triglyceride (TG) levels (about 200 mg/dl to less than about 500 mg/dl) and on rosuvastatin therapy |
| Pat. No. 10278935 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 6, 2020 | Jun 28, 2033 | U-2701: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of coronary revascularization and/or unstable angina in an adult patient with elevated triglyceride levels (TG >= 150 mg/dl to about 500 mg/dl) |
| Pat. No. 10278936 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 6, 2020 | Jun 28, 2033 | U-2702: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a cardiovascular event (cardiovascular death, coronary revascularization and/or unstable angina) in an adult patient with elevated triglyceride levels |
| Pat. No. 10278937 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 6, 2020 | Jun 28, 2033 | U-2703: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a cv event (cv death, coronary revascularization, unstable angina, stroke and/or myocardial infarction) in an adult patient with elevated triglyceride levels and diabetes mellitus |
| Pat. No. 10383840 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 6, 2020 | Jun 28, 2033 | U-2704: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a cardiovascular event in an adult patient with elevated triglyceride levels and at least one risk factor for cardiovascular disease |
| Pat. No. 10555924 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease Claim Types: Method of use Pat. Sub. Date(s): 002: Feb 26, 2020 | Jun 28, 2033 | U-2743: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of unstable angina in an adult patient with established cardiovascular disease |
| Pat. No. 10555925 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease Claim Types: Method of use Pat. Sub. Date(s): 002: Feb 26, 2020 | Jun 28, 2033 | U-2744: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of stroke in an adult patient with established cardiovascular disease |
| Pat. No. 10568861 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease Claim Types: Method of use Pat. Sub. Date(s): 002: Mar 20, 2020 | Jun 28, 2033 | U-2756: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of cardiovascular death in an adult patient with established cardiovascular disease |
| Pat. No. 10576054 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease Claim Types: Method of use Pat. Sub. Date(s): 002: Mar 27, 2020 | Jun 28, 2033 | U-2762: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a major cardiovascular event in an adult patient with diabetes mellitus and two or more additional risk factors for cardiovascular disease |
| Pat. No. 10668042 Methods of reducing the risk of cardiovascular events in a subject Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 26, 2020 | Jun 28, 2033 | U-2841: Use of VASCEPA with high intensity statin therapy to reduce the risk of a cv event in an adult patient with elevated triglyceride levels and (1) established CV disease, or (2) diabetes mellitus and two or more additional risk factors for CV disease |
| Pat. No. 10786478 Methods of reducing the risk of cardiovascular events in a subject Claim Types: Method of use Pat. Sub. Date(s): 002: Oct 16, 2020 | Jun 28, 2033 | U-2959: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a third and further cardiovascular event in an adult patient with elevated tg levels (>=150 mg/dl) and established cardiovascular disease U-2960: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a second or further cardiovascular (CV) event in an adult patient with elevated tg levels (>= 150 mg/dl) and diabetes mellitus and 2 or more additional risk factors for CV disease |
| Pat. No. 10792267 Methods of treating mixed dyslipidemia Claim Types: Method of use Pat. Sub. Date(s): 002: Oct 16, 2020 | Apr 29, 2030 | U-2961: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of myocardial infarction, stroke, both in an adult patient with Type 2 diabetes mellitus |
| Pat. No. 10792270 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease Claim Types: Method of use Pat. Sub. Date(s): 002: Oct 16, 2020 | Jun 28, 2033 | U-2962: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of coronary revascularization in an adult patient with established cardiovascular disease |
| Pat. No. 10842766 Stable pharmaceutical composition and methods of using same Claim Types: Method of use Pat. Sub. Date(s): 002: Dec 11, 2020 | Apr 29, 2030 | U-2997: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of stroke in an adult patient with elevated triglycerides and atrial fibrillation |
| Pat. No. 10842768 Compositions and methods for lowering triglycerides Claim Types: Method of use Pat. Sub. Date(s): 002: Dec 11, 2020 | Jun 15, 2030 | U-2688: Use of VASCEPA to lower triglycerides and ldl-c in an adult patient with elevated triglyceride (TG) levels (about 200 mg/dl to less than about 500 mg/dl) and on statin therapy |
| Pat. No. 10881632 Stable pharmaceutical composition and methods of using same Claim Types: Method of use Pat. Sub. Date(s): 002: Feb 4, 2021 | Apr 29, 2030 | U-3052: Use of VASCEPA to reduce triglyceride levels in an adult patient on statin therapy and having atrial fibrillation and triglyceride levels of greater than 500 mg/dl |
| Pat. No. 10894028 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease Claim Types: Method of use Pat. Sub. Date(s): 002: Feb 4, 2021 | Jun 28, 2033 | U-3053: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of myocardial infarction in an adult patient with elevated triglyceride levels and established cv disease or diabetes mellitus and two or more additional risk factors for CV disease |
| Pat. No. 11000499 Methods of reducing the risk of cardiovascular events in a subject Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 10, 2021 | Jun 28, 2033 | U-3126: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a second and further cardiovascular event in an adult patient with established cardiovascular disease |
| Pat. No. 11103477 Stable pharmaceutical composition and methods of using same Claim Types: Method of use Pat. Sub. Date(s): 002: Sep 21, 2021 | Apr 29, 2030 | U-3209: Use of VASCEPA as an adjunct to statin therapy to reduce the risk myocardial infarction in an adult patient having atrial fibrillation or atrial flutter and elevated triglyceride levels |
| Pat. No. 11116742 Methods of reducing the risk of cardiovascular events in a subject Claim Types: Method of use Pat. Sub. Date(s): 002: Oct 8, 2021 | Jun 28, 2033 | U-3221: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a cardiovascular event in a patient with prior percutaneous coronary intervention |
| Pat. No. 11154526 Methods of treating mixed dyslipidemia Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 8, 2021 | Apr 29, 2030 | U-3240: Use of VASCEPA to reduce triglyceride levels in an adult patient having triglyceride levels of at least about 500 mg/dl, on anticoagulant/antiplatelet/thrombolytic therapy, and having atrial fibrillation and/or atrial flutter |
| Pat. No. 11213504 Stable pharmaceutical composition and methods of using same Claim Types: Method of use Pat. Sub. Date(s): 002: Feb 3, 2022 | Apr 29, 2030 | U-3292: Use of VASCEPA to reduce triglyceride levels in an adult patient on statin therapy and having atrial fibrillation or atrial flutter and triglyceride levels of about 500 mg/dl to about 2,000 mg/dl |
| Pat. No. 11298333 Methods of reducing the risk of cardiovascular events in a subject Claim Types: Method of use Pat. Sub. Date(s): 002: May 11, 2022 | Jun 28, 2033 | U-3358: Use of VASCEPA to reduce the incidence of MI in an adult patient on statin therapy and with elevated triglyceride levels (>150 mg/dl), wherein the patient experiences atrial fibrillation and/or flutter instead of an incidence of MI |
| Pat. No. 11369582 Methods of reducing the risk of cardiovascular events in a subject Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 28, 2022 | Jun 28, 2033 | U-2841: Use of VASCEPA with high intensity statin therapy to reduce the risk of a cv event in an adult patient with elevated triglyceride levels and (1) established CV disease, or (2) diabetes mellitus and two or more additional risk factors for CV disease |
| Pat. No. 11717504 Methods of reducing the risk of cardiovascular events in a subject Claim Types: Method of use Pat. Sub. Date(s): 002: Aug 18, 2023 | Apr 29, 2030 | U-3669: Use of VASCEPA to reduce the incidence of stroke in an adult patient on statin therapy and with elevated triglyceride levels (>150 mg/dl), wherein the patient experiences atrial fibrillation and/or flutter instead of an incidence of stroke |
AMGEN
SENSIPAR (TABLET) (ORAL) CINACALCET HYDROCHLORIDE [GENERIC AB]
Drug Classes: calcium-sensing receptor agonist
NDA Applicant: AMGEN NDA No.: 021688 Prod. No.: 001 RX (EQ 30MG BASE); 002 RX (EQ 60MG BASE); 003 RX (EQ 90MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7829595 DP* Rapid dissolution formulation of a calcium receptor-active compound Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Dec 2, 2010; 002: None; 003: None | Sep 22, 2026 | U-1098: Method of treating hyperparathyroidism; method of treating hypercalcemia |
| Pat. No. 9375405 DP* Rapid dissolution formulation of a calcium receptor-active compound Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 22, 2016 | Sep 22, 2026 |
AMGEN INC
CORLANOR (TABLET) (ORAL) IVABRADINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: hyperpolarization-activated cyclic nucleotide-gated channel blocker
NDA Applicant: AMGEN INC NDA No.: 206143 Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 7.5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7361649 DS* DP* .beta.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use Pat. Sub. Date(s): All strengths: May 11, 2015 | Aug 22, 2026 *PED | U-1694: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride |
| Pat. No. 7361650 DS* DP* .gamma.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use Pat. Sub. Date(s): All strengths: May 11, 2015 | Aug 22, 2026 *PED | U-1694: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride |
| Pat. No. 7867996 DS* DP* .gamma.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it Claim Types: New polymorph, salt or hydrate; Method of use; Composition Pat. Sub. Date(s): All strengths: May 11, 2015 | Jun 12, 2027 *PED | U-1694: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride |
| Pat. No. 7879842 DS* DP* Beta-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): All strengths: May 11, 2015 | Aug 22, 2026 *PED | U-1694: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride |
AMGEN INC
CORLANOR (SOLUTION) (ORAL) IVABRADINE
Drug Classes: hyperpolarization-activated cyclic nucleotide-gated channel blocker
NDA Applicant: AMGEN INC NDA No.: 209964 Prod. No.: 001 RX (5MG/5ML (1MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7361649 DS* DP* .beta.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use Pat. Sub. Date(s): 001: May 3, 2019 | Feb 22, 2026 | U-1694: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride |
| Pat. No. 7361650 DS* DP* .gamma.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use Pat. Sub. Date(s): 001: May 3, 2019 | Feb 22, 2026 | U-1694: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride |
| Pat. No. 7867996 DS* DP* .gamma.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it Claim Types: New polymorph, salt or hydrate; Method of use; Composition Pat. Sub. Date(s): 001: May 3, 2019 | Dec 12, 2026 | U-1694: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride |
| Pat. No. 7879842 DS* DP* Beta-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): 001: May 3, 2019 | Feb 22, 2026 | U-1694: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 22, 2026 PED | ODE-234: Indicated for the treatment of stable symptomatic heart failure due to dilated cardiomyopathy (DCM) in pediatric patients aged 6 months and older, who are in sinus rhythm with an elevated heart rate |
AMGEN INC
LUMAKRAS (TABLET) (ORAL) SOTORASIB
NDA Applicant: AMGEN INC NDA No.: 214665 Prod. No.: 001 RX (120MG); 002 RX (320MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10519146 DS* DP* KRAS G12C inhibitors and methods of using the same Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Feb 17, 2022; 002: Feb 14, 2023 | May 21, 2038 | |
| Pat. No. 11236091 DS* DP* Solid state forms Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): 001: Feb 23, 2022; 002: Feb 14, 2023 | May 20, 2040 | U-3306: Treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy |
| Pat. No. 11426404 Dosing of KRAS inhibitor for treatment of cancers Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 27, 2022; 002: Feb 14, 2023 | Sep 15, 2040 | U-3306: Treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy |
| Pat. No. 11827635 DS* DP* Solid state forms Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): All strengths: Dec 18, 2023 | May 20, 2040 | U-3306: Treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | May 28, 2026 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | May 28, 2028 | ODE-352: Treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy |
AMGEN INC
LUMAKRAS (TABLET) (ORAL) SOTORASIB
NDA Applicant: AMGEN INC NDA No.: 214665 Prod. No.: 003 RX (240MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10519146 DS* DP* KRAS G12C inhibitors and methods of using the same Claim Types: Compound; Composition Pat. Sub. Date(s): 003: Jul 18, 2024 | May 21, 2038 | |
| Pat. No. 11236091 DS* DP* Solid state forms Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): 003: Jul 18, 2024 | May 20, 2040 | U-3306: Treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy |
| Pat. No. 11426404 Dosing of KRAS inhibitor for treatment of cancers Claim Types: Method of use Pat. Sub. Date(s): 003: Jul 18, 2024 | Sep 15, 2040 | U-3306: Treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy |
| Pat. No. 11827635 DS* DP* Solid state forms Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): 003: Jul 18, 2024 | May 20, 2040 | U-3306: Treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | May 28, 2026 | |
| Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s) | May 28, 2028 |
AMGEN INC
OTEZLA (TABLET) (ORAL) APREMILAST [GENERIC AB]
Drug Classes: phosphodiesterase 4 inhibitor
NDA Applicant: AMGEN INC NDA No.: 205437 Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (30MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7427638 DS* DP* (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminois- oindoline-1,3-dione:, and methods of synthesis and compositions thereof Claim Types: Composition; Formulation Pat. Sub. Date(s): All strengths: Apr 15, 2014 | Aug 16, 2028 *PED | |
| Pat. No. 9872854 Methods for the treatment of psoriatic arthritis using apremilast Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 21, 2018 | Nov 29, 2034 *PED | U-2232: Treatment of psoriatic arthritis using a dosage titration schedule U-2233: Treatment of psoriatic arthritis with apremilast using a dosage titration schedule and a second active agent |
| Pat. No. 10092541 Methods for the treatment of diseases ameliorated by PDE4 inhibition using dosage titration of apremilast Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 9, 2018 | Nov 29, 2034 *PED | U-2403: Treatment of psoriasis using a dosage titration schedule U-2659: Treatment of adult patients with oral ulcers associated with Behcet's disease using a dosage titration schedule |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Dec 20, 2024 | I-884: Revisions to the labeling to include data for subjects with mild to moderate plaque psoriasis, and to allow for an expansion of the indication |
| Exclusivity Code: M - Miscellaneous | Jan 20, 2027 PED | M-299: Clinical study information added to the label about the treatment of moderate to severe genital psoriasis |
| Exclusivity Code: NPP - New patient population | Oct 25, 2027 PED | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jan 19, 2027 PED | ODE-248: Treatment of adult patients with oral ulcers associated with Behcets disease |
AMICUS THERAP US
GALAFOLD (CAPSULE) (ORAL) MIGALASTAT HYDROCHLORIDE
NDA Applicant: AMICUS THERAP US NDA No.: 208623 Prod. No.: 001 RX (EQ 123MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE48608 Method to predict response to pharmacological chaperone treatment of diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 22, 2021 | Oct 20, 2031 | U-2371: The treatment of Fabry patients |
| Pat. No. 8592362 DLR* Method to predict response to pharmacological chaperone treatment of diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 5, 2018 | Feb 12, 2029 | U-2371: The treatment of Fabry patients |
| Pat. No. 9000011 Methods for treatment of Fabry disease Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 5, 2018 | May 16, 2027 | U-2371: The treatment of Fabry patients |
| Pat. No. 9095584 Method to predict response to pharmacological chaperone treatment of diseases Claim Types: Method of use; Diagnostic or surgical method Pat. Sub. Date(s): 001: Sep 5, 2018 | Feb 12, 2029 | U-2371: The treatment of Fabry patients |
| Pat. No. 9480682 Methods for treatment of Fabry disease Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 5, 2018 | May 16, 2027 | U-2371: The treatment of Fabry patients |
| Pat. No. 9987263 Methods for treatment of Fabry disease Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 5, 2018 | May 16, 2027 | U-2371: The treatment of Fabry patients |
| Pat. No. 9999618 Dosing regimens for the treatment of lysosomal storage diseases using pharmacological chaperones Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 5, 2018 | Apr 28, 2028 | U-2372: A method of reducing left ventricular mass index (LVMI) in a Fabry patient by administering migalastat U-2373: A method of reducing podocyte globotriaosylceramide (GL-3) in a Fabry patient by administering migalastat |
| Pat. No. 10076514 Methods of treating fabry disease in patients having the G9331A mutation in the GLA gene Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 18, 2018 | Mar 15, 2037 | U-2371: The treatment of Fabry patients |
| Pat. No. 10251873 Methods of treating Fabry patients having renal impairment Claim Types: Method of use Pat. Sub. Date(s): 001: May 7, 2019 | May 30, 2038 | U-2371: The treatment of Fabry patients |
| Pat. No. 10383864 Methods for treatment of Fabry disease Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 4, 2019 | May 16, 2027 | U-2371: The treatment of Fabry patients |
| Pat. No. 10406143 Methods for treatment of fabry disease Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 26, 2019 | May 16, 2027 | U-2371: The treatment of Fabry patients |
| Pat. No. 10471053 Methods of treating Fabry patients having renal impairment Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 6, 2019 | May 30, 2038 | U-2371: The treatment of Fabry patients |
| Pat. No. 10525045 Dosing regimens for the treatment of lysosomal storage diseases using pharmacological chaperones Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 17, 2020 | Apr 28, 2028 | U-2371: The treatment of Fabry patients |
| Pat. No. 10792278 Methods of treating Fabry patients having renal impairment Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 15, 2020 | May 30, 2038 | U-2371: The treatment of Fabry patients |
| Pat. No. 10792279 Methods of treating Fabry patients having renal impairment Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 15, 2020 | May 30, 2038 | U-2371: The treatment of Fabry patients |
| Pat. No. 10799491 Methods of treating Fabry patients having renal impairment Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 5, 2020 | May 30, 2038 | U-2371: The treatment of Fabry patients |
| Pat. No. 10806727 Methods of treating Fabry patients having renal impairment Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 5, 2020 | May 30, 2038 | U-2371: The treatment of Fabry patients |
| Pat. No. 10813921 Method to predict response to pharmacological chaperone treatment of diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 18, 2020 | Feb 12, 2029 | U-2371: The treatment of Fabry patients |
| Pat. No. 10849889 Methods of treating Fabry patients having renal impairment Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 17, 2020 | May 30, 2038 | U-2371: The treatment of Fabry patients |
| Pat. No. 10849890 Methods of treating Fabry patients having renal impairment Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 17, 2020 | May 30, 2038 | U-2371: The treatment of Fabry patients |
| Pat. No. 10857141 Methods of treating Fabry patients having renal impairment Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 17, 2020 | May 30, 2038 | U-2371: The treatment of Fabry patients |
| Pat. No. 10857142 Methods of treating Fabry patients having renal impairment Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 17, 2020 | May 30, 2038 | U-2371: The treatment of Fabry patients |
| Pat. No. 10874655 Methods of treating fabry patients having renal impairment Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 7, 2021 | May 30, 2038 | U-2371: The treatment of Fabry patients |
| Pat. No. 10874656 Methods of treating Fabry patients having renal impairment Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Jan 7, 2021 | May 30, 2038 | U-2371: The treatment of Fabry patients |
| Pat. No. 10874657 Methods of treating Fabry patients having renal impairment Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Jan 7, 2021 | May 30, 2038 | U-2371: The treatment of Fabry patients |
| Pat. No. 10925866 Dosing regimens for the treatment of lysosomal storage diseases using pharmacological chaperones Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 18, 2021 | Apr 28, 2028 | U-2371: The treatment of Fabry patients |
| Pat. No. 11033538 Dosing regimens for the treatment of lysosomal storage diseases using pharmacological chaperones Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 12, 2021 | Apr 28, 2028 | U-2371: The treatment of Fabry patients |
| Pat. No. 11234972 Methods of treating fabry disease in patients having the G9331A mutation in the GLA gene Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 25, 2022 | Mar 15, 2037 | U-2371: The treatment of Fabry patients |
| Pat. No. 11241422 Methods for treatment of Fabry disease Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 25, 2022 | May 16, 2027 | U-2371: The treatment of Fabry patients |
| Pat. No. 11278536 Methods of treating Fabry patients having renal impairment Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 7, 2022 | May 30, 2038 | U-2371: The treatment of Fabry patients |
| Pat. No. 11278537 Methods of treating Fabry patients having renal impairment Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 7, 2022 | May 30, 2038 | U-2371: The treatment of Fabry patients |
| Pat. No. 11278538 Methods of treating Fabry patients having renal impairment Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 7, 2022 | May 30, 2038 | U-2371: The treatment of Fabry patients |
| Pat. No. 11278539 Methods of treating Fabry patients having renal impairment Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 7, 2022 | May 30, 2038 | U-2371: The treatment of Fabry patients |
| Pat. No. 11278540 Methods of treating Fabry patients having renal impairment Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 7, 2022 | May 30, 2038 | U-2371: The treatment of Fabry patients |
| Pat. No. 11304940 DS* Methods of treating Fabry patients having renal impairment Claim Types: Compound Pat. Sub. Date(s): 001: Apr 19, 2022 | May 30, 2038 | |
| Pat. No. 11357761 Methods of treating Fabry patients having renal impairment Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 28, 2022 | May 30, 2038 | U-2371: The treatment of Fabry patients |
| Pat. No. 11357762 Methods of treating Fabry patients having renal impairment Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 28, 2022 | May 30, 2038 | U-2371: The treatment of Fabry patients |
| Pat. No. 11357763 Methods of treating fabry patients having renal impairment Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 28, 2022 | May 30, 2038 | U-2371: The treatment of Fabry patients |
| Pat. No. 11357764 DS* Methods of treating Fabry patients having renal impairment Claim Types: Compound Pat. Sub. Date(s): 001: Jun 28, 2022 | May 30, 2038 | |
| Pat. No. 11357765 DS* Methods of treating Fabry patients having renal impairment Claim Types: Compound Pat. Sub. Date(s): 001: Jun 28, 2022 | May 30, 2038 | |
| Pat. No. 11357784 Use of migalastat for treating Fabry disease in pregnant patients Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 28, 2022 | Feb 6, 2039 | U-2371: The treatment of Fabry patients |
| Pat. No. 11376244 DS* Methods of treating Fabry patients having renal impairment Claim Types: Compound Pat. Sub. Date(s): 001: Jul 25, 2022 | May 30, 2038 | |
| Pat. No. 11389436 Methods of treating fabry patients having renal impairment Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2022 | May 30, 2038 | U-2371: The treatment of Fabry patients |
| Pat. No. 11389437 Methods of treating Fabry patients having renal impairment Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2022 | May 30, 2038 | U-2371: The treatment of Fabry patients |
| Pat. No. 11426396 DS* Methods of treating Fabry patients having renal impairment Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 2, 2022 | May 30, 2038 | |
| Pat. No. 11458128 Methods of treating Fabry patients having renal impairment Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 13, 2022 | May 30, 2038 | U-2371: The treatment of Fabry patients |
| Pat. No. 11612593 DS* Methods of treating Fabry patients having renal impairment Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 17, 2023 | May 30, 2038 | |
| Pat. No. 11612594 DS* Methods of treating Fabry patients having renal impairment Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 17, 2023 | May 30, 2038 | |
| Pat. No. 11622962 DS* Methods of treating Fabry patients having renal impairment Claim Types: Composition Pat. Sub. Date(s): 001: Apr 17, 2023 | Mar 17, 2039 | |
| Pat. No. 11633387 DS* Methods of treating Fabry patients having renal impairment Claim Types: Compound Pat. Sub. Date(s): 001: May 12, 2023 | May 30, 2038 | |
| Pat. No. 11633388 Methods of treating Fabry patients having renal impairment Claim Types: Method of use Pat. Sub. Date(s): 001: May 12, 2023 | Mar 25, 2039 | U-2371: The treatment of Fabry patients |
| Pat. No. 11642334 Methods of treating Fabry patients having renal impairment Claim Types: Method of use Pat. Sub. Date(s): 001: May 12, 2023 | Feb 20, 2039 | U-2371: The treatment of Fabry patients |
| Pat. No. 11666564 Methods of treating Fabry patients having renal impairment Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 9, 2023 | May 30, 2038 | U-2371: The treatment of Fabry patients |
| Pat. No. 11786516 DS* Methods of treating Fabry patients having renal impairment Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 25, 2023 | May 30, 2038 | |
| Pat. No. 11813255 Methods of treating Fabry patients having renal impairment Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 8, 2023 | May 30, 2038 | U-2371: The treatment of Fabry patients |
| Pat. No. 11826360 DS* Methods of treating Fabry patients having renal impairment Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 8, 2023 | Feb 16, 2039 | |
| Pat. No. 11833164 Methods of treating Fabry disease in patients having a mutation in the GLA gene Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 8, 2023 | Jan 11, 2042 | U-2371: The treatment of Fabry patients |
| Pat. No. 11903938 DS* Methods of treating Fabry patients having renal impairment Claim Types: Compound; Method of use Pat. Sub. Date(s): 001: Mar 4, 2024 | Aug 17, 2038 | U-2371: The treatment of Fabry patients |
| Pat. No. 12042488 DS* Methods of treating Fabry patients having renal impairment Claim Types: Composition Pat. Sub. Date(s): 001: Jul 30, 2024 | May 30, 2038 | |
| Pat. No. 12042489 DS* Methods of treating Fabry patients having renal impairment Claim Types: Composition; Method of use Pat. Sub. Date(s): 001: Jul 30, 2024 | May 30, 2038 | U-2371: The treatment of Fabry patients |
| Pat. No. 12042490 Methods of treating Fabry patients having renal impairment Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 30, 2024 | May 30, 2038 | U-2371: The treatment of Fabry patients |
| Pat. No. 12109205 DS* Methods of treating Fabry patients having renal impairment Claim Types: Method of use; Compound Pat. Sub. Date(s): 001: Oct 15, 2024 | May 30, 2038 | U-2371: The treatment of Fabry patients |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Aug 10, 2023 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Aug 10, 2025 | ODE-205: Indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data |
AMICUS THERAP US
OPFOLDA (CAPSULE) (ORAL) MIGLUSTAT
Drug Classes: enzyme stabilizer == glucosylceramide synthase inhibitor
NDA Applicant: AMICUS THERAP US NDA No.: 215211 Prod. No.: 001 RX (65MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10208299 DS* DP* Highly potent acid alpha-glucosidase with enhanced carbohydrates Claim Types: Composition; Method of use Pat. Sub. Date(s): 001: Oct 26, 2023 | Sep 30, 2035 | U-3726: The treatment of pompe patients |
| Pat. No. 10512677 High concentration alpha-glucosidase compositions for the treatment of pompe disease Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 26, 2023 | Mar 7, 2033 | U-3726: The treatment of pompe patients |
| Pat. No. 10857212 Augmented acid alpha-glucosidase for the treatment of Pompe disease Claim Types: Method of use; Composition Pat. Sub. Date(s): 001: Oct 26, 2023 | Aug 12, 2037 | U-3726: The treatment of pompe patients |
| Pat. No. 10961522 Highly potent acid alpha-glucosidase with enhanced carbohydrates Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 26, 2023 | Sep 30, 2035 | U-3726: The treatment of pompe patients |
| Pat. No. 11278599 High concentration alpha-glucosidase compositions for the treatment of Pompe disease Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 26, 2023 | Mar 7, 2033 | U-3726: The treatment of pompe patients |
| Pat. No. 11278601 DP* Augmented acid alpha-glucosidase for the treatment of Pompe disease Claim Types: Method of use; Kit Pat. Sub. Date(s): 001: Oct 26, 2023 | Dec 29, 2036 | U-3726: The treatment of pompe patients |
| Pat. No. 11753632 Highly potent acid alpha-glucosidase with enhanced carbohydrates Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 26, 2023 | Sep 30, 2035 | U-3726: The treatment of pompe patients |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Sep 28, 2026 |
AMIVAS
ARTESUNATE (POWDER) (INTRAVENOUS) ARTESUNATE
NDA Applicant: AMIVAS NDA No.: 213036 Prod. No.: 001 RX (110MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 12121506 DP* Artesunate powders, pharmaceutical compositions and methods of manufacture Claim Types: Formulation claimed by its inherent performace characteristics; Process Pat. Sub. Date(s): 001: Oct 23, 2024 | Feb 16, 2044 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | May 26, 2025 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | May 26, 2027 | ODE-290: Indicated for the initial treatment of severe malaria in adult and pediatric patients to always be followed by a complete treatment course of an appropriate oral antimalarial regimen |
AMNEAL
CALCIUM GLUCONATE IN SODIUM CHLORIDE (SOLUTION) (INTRAVENOUS) CALCIUM GLUCONATE [GENERIC AP]
NDA Applicant: AMNEAL NDA No.: 217174 Prod. No.: 001 RX (1GM/50ML (20MG/ML)); 002 RX (2GM/100ML (20MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Mar 10, 2024 |
AMNEAL
FLUOROMETHOLONE (SUSPENSION/DROPS) (OPHTHALMIC) FLUOROMETHOLONE [GENERIC AB]
Drug Classes: corticosteroid
NDA Applicant: AMNEAL NDA No.: 216348 Prod. No.: 001 RX (0.1%)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Jul 7, 2024 |
AMNEAL
LYVISPAH (GRANULES) (ORAL) BACLOFEN
Drug Classes: gamma-aminobutyric acid (GABA)-ergic agonist
NDA Applicant: AMNEAL NDA No.: 215422 Prod. No.: 001 RX (5MG/PACKET); 002 RX (10MG/PACKET); 003 RX (20MG/PACKET)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10792262 DP* Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): All strengths: Dec 21, 2021 | Jul 29, 2039 | U-3263: Method for treating spasticity |
| Pat. No. 11491125 DP* Baclofen formulations and methods of minimizing patient exposure to metabolite variations Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Dec 5, 2022 | Sep 29, 2041 | U-3488: Treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity U-3489: Treatment of spasticity resulting from spinal cord injuries and other spinal cord diseases |
| Pat. No. 11654124 DP* Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Jun 14, 2023 | Jul 29, 2039 | |
| Pat. No. 11850225 DP* Baclofen formulations and methods of minimizing patient exposure to metabolite variations Claim Types: Formulation; Formulation claimed by its inherent performace characteristics; Method of use Pat. Sub. Date(s): All strengths: Jan 22, 2024 | Sep 29, 2041 | U-3488: Treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity U-3489: Treatment of spasticity resulting from spinal cord injuries and other spinal cord diseases |
| Pat. No. 11931328 DP* Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives Claim Types: Formulation Pat. Sub. Date(s): All strengths: Apr 2, 2024 | Jul 29, 2039 |
AMNEAL
ONGENTYS (CAPSULE) (ORAL) OPICAPONE
Drug Classes: catechol-O-methyltransferase (COMT) inhibitor
NDA Applicant: AMNEAL NDA No.: 212489 Prod. No.: 001 RX (25MG); 002 RX (50MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8168793 DS* DP* Nitrocatechol derivatives as COMT inhibitors Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): All strengths: May 19, 2020 | Apr 2, 2029 | U-3869: Adjunctive treatment to levodopa/carbidopa in patients with Parkinson's Disease experiencing off episodes |
| Pat. No. 8524746 Dosage regimen for COMT inhibitors Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 19, 2020 | Jul 14, 2029 | U-3869: Adjunctive treatment to levodopa/carbidopa in patients with Parkinson's Disease experiencing off episodes |
| Pat. No. 8907099 DS* Nitrocatechol derivatives as COMT inhibitors Claim Types: Compound Pat. Sub. Date(s): All strengths: May 19, 2020 | May 12, 2027 | |
| Pat. No. 9550759 Nitrocatechol derivatives as COMT inhibitors Claim Types: Method of improving a treatment; Method of use; Process Pat. Sub. Date(s): All strengths: May 19, 2020 | Jul 26, 2026 | U-3870: Adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing off episodes by increasing L-dopa amounts that reach the brain U-3871: Adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing off episodes by inhibiting comt in the periphery U-3872: Adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing off episodes by reducing o-methylation of l-dopa |
| Pat. No. 9630955 DS* DP* Chemical compound useful as intermediate for preparing a catechol-O-methyltransferase inhibitor Claim Types: New polymorph, salt or hydrate; Product-by-process; Formulation; Method of use Pat. Sub. Date(s): All strengths: May 19, 2020 | Dec 12, 2032 | U-3869: Adjunctive treatment to levodopa/carbidopa in patients with Parkinson's Disease experiencing off episodes |
| Pat. No. 9745290 DP* Dosage regimen for COMT inhibitors Claim Types: Composition; Formulation; Method of use; Kit Pat. Sub. Date(s): All strengths: May 19, 2020 | Oct 10, 2027 | U-3869: Adjunctive treatment to levodopa/carbidopa in patients with Parkinson's Disease experiencing off episodes |
| Pat. No. 10071085 DP* Pharmaceutical formulations comprising nitrocatechol derivatives and methods of making thereof Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 19, 2020 | Mar 31, 2030 | |
| Pat. No. 10583130 Pharmaceutical formulations compromising nitrocatechol derivatives and methods of making thereof Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 19, 2020 | Mar 31, 2030 | U-3869: Adjunctive treatment to levodopa/carbidopa in patients with Parkinson's Disease experiencing off episodes |
| Pat. No. 12129247 Administration regime for nitrocatechols Claim Types: Method of use; Dosaage regimen Pat. Sub. Date(s): All strengths: Nov 26, 2024 | Jan 11, 2032 | U-4038: Adjunctive treatment to levodopa/carbidopa in patients with parkinson's disease experiencing off episodes by administering without food |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Apr 24, 2025 |
AMNEAL
PYRIDOSTIGMINE BROMIDE (TABLET, EXTENDED RELEASE) (ORAL) PYRIDOSTIGMINE BROMIDE
Drug Classes: cholinesterase inhibitor
NDA Applicant: AMNEAL NDA No.: 217604 Prod. No.: 001 DISC (105MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10881617 DP* Extended release compositions comprising pyridostigmine Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 23, 2024 | Jun 18, 2038 | |
| Pat. No. 10925833 DP* Extended release compositions comprising pyridostigmine Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 23, 2024 | Jun 18, 2038 | |
| Pat. No. 10987311 DP* Extended release compositions comprising pyridostigmine Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 23, 2024 | Jun 18, 2038 | |
| Pat. No. 11229606 DP* Extended release compositions comprising pyridostigmine Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 23, 2024 | Jun 18, 2038 | |
| Pat. No. 11478425 DP* Extended release compositions comprising pyridostigmine Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 23, 2024 | Jun 18, 2038 | U-4012: Pretreatment against the lethal effects of soman nerve agent poisoning |
| Pat. No. 11666536 DP* Extended release compositions comprising pyridostigmine Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 23, 2024 | Jun 18, 2038 | |
| Pat. No. 11911515 DP* Extended release compositions comprising pyridostigmine Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 23, 2024 | Jun 18, 2038 | |
| Pat. No. 12042559 DP* Gastroretentive dosage forms for sustained drug delivery Claim Types: Formulation; Method of improving a treatment Pat. Sub. Date(s): 001: Oct 23, 2024 | Jun 18, 2038 |
AMNEAL
SAXAGLIPTIN (TABLET) (ORAL) SAXAGLIPTIN HYDROCHLORIDE [Has competitive generic]
NDA Applicant: AMNEAL NDA No.: 205941 Prod. No.: 001 DISC (EQ 2.5MG BASE); 002 DISC (EQ 5MG BASE)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: PC - Patent challenge | Jan 27, 2024 |
AMNEAL
TIGECYCLINE (POWDER) (INTRAVENOUS) TIGECYCLINE [GENERIC AP]
Drug Classes: tetracycline class antibacterial
NDA Applicant: AMNEAL NDA No.: 211158 Prod. No.: 001 RX (50MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9855335 DP* Tigecycline composition for injection Claim Types: Formulation; Product-by-process Pat. Sub. Date(s): 001: Sep 19, 2018 | Apr 7, 2033 |
AMNEAL
TRANEXAMIC ACID (SOLUTION) (INTRAVENOUS) TRANEXAMIC ACID [GENERIC AP]
NDA Applicant: AMNEAL NDA No.: 217155 Prod. No.: 001 RX (1GM/100ML (10MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Apr 16, 2024 |
AMNEAL
VANCOMYCIN HYDROCHLORIDE (FOR SOLUTION) (ORAL) VANCOMYCIN HYDROCHLORIDE [GENERIC AA]
Drug Classes: glycopeptide antibacterial
NDA Applicant: AMNEAL NDA No.: 215338 Prod. No.: 001 RX (EQ 250MG BASE/5ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Dec 20, 2023 |
AMNEAL PHARMS CO
TERIFLUNOMIDE (TABLET) (ORAL) TERIFLUNOMIDE [Has competitive generic]
Drug Classes: pyrimidine synthesis inhibitor
NDA Applicant: AMNEAL PHARMS CO NDA No.: 209613 Prod. No.: 001 DISC (7MG); 002 DISC (14MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: PC - Patent challenge | Sep 8, 2023 |
AMPHASTAR PHARMS INC
BAQSIMI (POWDER) (NASAL) GLUCAGON
Drug Classes: antihypoglycemic agent == gastrointestinal motility inhibitor
NDA Applicant: AMPHASTAR PHARMS INC NDA No.: 210134 Prod. No.: 001 RX (3MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10213487 DP* Nasal powder formulation for treatment of hypoglycemia Claim Types: Formulation; Process; Device; Method of use Pat. Sub. Date(s): 001: Aug 23, 2019 | Feb 16, 2036 | U-2604: Treatment of severe hypoglycemia in patients with diabetes |
| Pat. No. 10765602 DP* Medication delivery systems and methods Claim Types: Device; Method of administration; Container Pat. Sub. Date(s): 001: Oct 8, 2020 | Sep 23, 2039 | |
| Pat. No. 10894133 DP* Device for dispensing a fluid product Claim Types: Device Pat. Sub. Date(s): 001: Feb 10, 2021 | Jan 3, 2038 |
AMPHASTAR PHARMS INC
REXTOVY (SPRAY, METERED) (NASAL) NALOXONE HYDROCHLORIDE [Has competitive generic]
Drug Classes: opioid antagonist
NDA Applicant: AMPHASTAR PHARMS INC NDA No.: 208969 Prod. No.: 001 RX (4MG/SPRAY)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NP - New product | Mar 7, 2026 |
AMRING PHARMS
LYSTEDA (TABLET) (ORAL) TRANEXAMIC ACID [GENERIC AB]
NDA Applicant: AMRING PHARMS NDA No.: 022430 Prod. No.: 001 RX (650MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7947739 DP* Tranexamic acid formulations Claim Types: Formulation Pat. Sub. Date(s): 001: May 24, 2011 | Mar 4, 2025 | |
| Pat. No. 8022106 Tranexamic acid formulations Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 20, 2011 | Mar 4, 2025 | U-1182: Treatment of cyclic heavy menstrual bleeding |
| Pat. No. 8273795 Tranexamic acid formulations Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 25, 2012 | Mar 4, 2025 | U-1182: Treatment of cyclic heavy menstrual bleeding |
| Pat. No. 8487005 DP* Tranexamic acid formulations Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jul 16, 2013 | Mar 4, 2025 | U-1182: Treatment of cyclic heavy menstrual bleeding |
| Pat. No. 8791160 DP* Tranexamic acid formulations Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 25, 2014 | Mar 4, 2025 | U-1182: Treatment of cyclic heavy menstrual bleeding |
| Pat. No. 8809394 DP* Tranexamic acid formulations Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 16, 2014 | Mar 4, 2025 | U-1182: Treatment of cyclic heavy menstrual bleeding |
| Pat. No. 8957113 DP* Tranexamic acid formulations Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Feb 25, 2015 | Mar 4, 2025 | U-1182: Treatment of cyclic heavy menstrual bleeding |
| Pat. No. 9060939 DP* Tranexamic acid formulations Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jun 23, 2015 | Mar 4, 2025 |
AMYLYX
RELYVRIO (FOR SUSPENSION) (ORAL) SODIUM PHENYLBUTYRATE; TAURURSODIOL
NDA Applicant: AMYLYX NDA No.: 216660 Prod. No.: 001 DISC (3GM/PACKET; 1GM/PACKET)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9872865 Compositions for improving cell viability and methods of use thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 28, 2022 | Dec 24, 2033 | U-3460: Treatment of amyotrophic lateral sclerosis (ALS) in adults |
| Pat. No. 10251896 Compositions for improving cell viability and methods of use thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 28, 2022 | Dec 24, 2033 | U-3460: Treatment of amyotrophic lateral sclerosis (ALS) in adults |
| Pat. No. 10857162 Compositions for improving cell viability and methods of use thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 28, 2022 | Dec 24, 2033 | U-3460: Treatment of amyotrophic lateral sclerosis (ALS) in adults |
| Pat. No. 11071742 DP* Compositions for improving cell viability and methods of use thereof Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Oct 28, 2022 | Dec 24, 2033 | |
| Pat. No. 11583542 DP* Compositions of bile acids and phenylbutyrate compounds Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 3, 2023 | Jul 27, 2040 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Sep 29, 2027 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Sep 29, 2029 | ODE-411: Treatment of amyotrophic lateral sclerosis (ALS) in adults |
ANACOR PHARMS INC
EUCRISA (OINTMENT) (TOPICAL) CRISABOROLE
Drug Classes: phosphodiesterase 4 inhibitor
NDA Applicant: ANACOR PHARMS INC NDA No.: 207695 Prod. No.: 001 RX (2%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8039451 DS* DP* Boron-containing small molecules Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 12, 2017 | Dec 29, 2029 *PED | |
| Pat. No. 8168614 Boron-containing small molecules as anti-inflammatory agents Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 12, 2017 | Jul 20, 2030 *PED | U-1932: Method of treating mild to moderate atopic dermatitis. |
| Pat. No. 8501712 Boron-containing small molecules as anti-inflammatory agents Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 12, 2017 | Aug 16, 2027 *PED | U-1932: Method of treating mild to moderate atopic dermatitis. |
| Pat. No. 9682092 Boron-containing small molecules as anti-inflammatory agents Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 14, 2017 | Aug 16, 2027 *PED | U-1932: Method of treating mild to moderate atopic dermatitis. |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: D - New Dosing Schedule | Apr 3, 2026 | D-191: Addition of a once daily dosing regimen |
ANGELINI PHARMA
OLEPTRO (TABLET, EXTENDED RELEASE) (ORAL) TRAZODONE HYDROCHLORIDE
Drug Classes: selective serotonin reuptake inhibitor (SSRI)
NDA Applicant: ANGELINI PHARMA NDA No.: 022411 Prod. No.: 001 DISC (150MG**); 002 DISC (300MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7829120 DP* Trazodone composition for once a day administration Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Dec 6, 2010; 002: None | Mar 27, 2027 | U-796: Method of treating depression |
| Pat. No. 8133893 DS* DP* Trazodone and trazodone hydrochloride in purified form Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Mar 16, 2012; 002: None | Mar 13, 2029 |
ANI PHARMS
BACLOFEN (SUSPENSION) (ORAL) BACLOFEN [GENERIC AB]
Drug Classes: gamma-aminobutyric acid (GABA)-ergic agonist
NDA Applicant: ANI PHARMS NDA No.: 217252 Prod. No.: 001 RX (25MG/5ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: PC - Patent challenge | Dec 16, 2023 |
ANI PHARMS
PURIFIED CORTROPHIN GEL (INJECTABLE) (INJECTION) CORTICOTROPIN
Drug Classes: adrenocorticotropic hormone
NDA Applicant: ANI PHARMS NDA No.: 008975 Prod. No.: 001 DISC (40 UNITS/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 12102662 Methods For Storing And Warming Purified Corticotropin Compositions Claim Types: Process Pat. Sub. Date(s): 001: Oct 4, 2024 | Oct 27, 2043 | U-3904: Acute exacerbations of multiple sclerosis U-3905: Allergic conjunctivitis U-3906: Anterior segment inflammation U-3907: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: acute gouty arthritis U-3908: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: ankylosing spondylitis U-3909: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: juvenile rheumatoid arthritis U-3910: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis U-3911: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: rheumatoid arthritis U-3912: Atopic dermatitis U-3913: Chorioretinitis U-3914: Diffuse posterior uveitis and choroiditis U-3915: During an exacerbation or as maintenance therapy in selected cases of: systemic dermatomyositis (polymyositis) U-3916: During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus U-3917: Iridocyclitis U-3918: Iritis U-3919: Keratitis U-3920: Optic neuritis U-3921: Serum sickness U-3922: Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa U-3923: Severe erythema multiforme (stevens-johnson syndrome) U-3924: Severe psoriasis U-3925: Symptomatic sarcoidosis U-3926: To induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus |
ANI PHARMS
PURIFIED CORTROPHIN GEL (INJECTABLE) (INJECTION) CORTICOTROPIN
Drug Classes: adrenocorticotropic hormone
NDA Applicant: ANI PHARMS NDA No.: 008975 Prod. No.: 002 RX (80 UNITS/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11975047 Methods for storing and warming purified corticotropin compositions Claim Types: Process Pat. Sub. Date(s): 002: May 17, 2024 | Oct 27, 2043 | U-3904: Acute exacerbations of multiple sclerosis U-3905: Allergic conjunctivitis U-3906: Anterior segment inflammation U-3907: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: acute gouty arthritis U-3908: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: ankylosing spondylitis U-3909: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: juvenile rheumatoid arthritis U-3910: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis U-3911: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: rheumatoid arthritis U-3912: Atopic dermatitis U-3913: Chorioretinitis U-3914: Diffuse posterior uveitis and choroiditis U-3915: During an exacerbation or as maintenance therapy in selected cases of: systemic dermatomyositis (polymyositis) U-3916: During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus U-3917: Iridocyclitis U-3918: Iritis U-3919: Keratitis U-3920: Optic neuritis U-3921: Serum sickness U-3922: Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa U-3923: Severe erythema multiforme (stevens-johnson syndrome) U-3924: Severe psoriasis U-3925: Symptomatic sarcoidosis U-3926: To induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus |
| Pat. No. 12102662 Methods For Storing And Warming Purified Corticotropin Compositions Claim Types: Process Pat. Sub. Date(s): 002: Oct 4, 2024 | Oct 27, 2043 | U-3904: Acute exacerbations of multiple sclerosis U-3905: Allergic conjunctivitis U-3906: Anterior segment inflammation U-3907: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: acute gouty arthritis U-3908: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: ankylosing spondylitis U-3909: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: juvenile rheumatoid arthritis U-3910: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis U-3911: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: rheumatoid arthritis U-3912: Atopic dermatitis U-3913: Chorioretinitis U-3914: Diffuse posterior uveitis and choroiditis U-3915: During an exacerbation or as maintenance therapy in selected cases of: systemic dermatomyositis (polymyositis) U-3916: During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus U-3917: Iridocyclitis U-3918: Iritis U-3919: Keratitis U-3920: Optic neuritis U-3921: Serum sickness U-3922: Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa U-3923: Severe erythema multiforme (stevens-johnson syndrome) U-3924: Severe psoriasis U-3925: Symptomatic sarcoidosis U-3926: To induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus |
ANI PHARMS
VEREGEN (OINTMENT) (TOPICAL) SINECATECHINS
NDA Applicant: ANI PHARMS NDA No.: 021902 Prod. No.: 001 RX (15%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7858662 DP* Medicament for the treatment of viral skin and tumour diseases Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 3, 2011 | Oct 2, 2026 | U-172: Treatment of genital warts |
| Pat. No. 9770406 DP* Medicament for the treatment of viral skin and tumour diseases Claim Types: Composition; Method of use Pat. Sub. Date(s): 001: Oct 19, 2017 | Jul 12, 2025 | U-172: Treatment of genital warts |
ANTARES PHARMA INC
XYOSTED (AUTOINJECTOR) (SOLUTION) (SUBCUTANEOUS) TESTOSTERONE ENANTHATE
Drug Classes: androgen
NDA Applicant: ANTARES PHARMA INC NDA No.: 209863 Prod. No.: 001 RX (50MG/0.5ML (50MG/0.5ML)); 002 RX (75MG/0.5ML (75MG/0.5ML)); 003 RX (100MG/0.5ML (100MG/0.5ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8021335 DP* Prefilled syringe jet injector Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 24, 2018 | Oct 4, 2026 | |
| Pat. No. 8562564 DP* Prefilled syringe jet injector Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 24, 2018 | Jan 24, 2026 | |
| Pat. No. 9180259 DP* Prefilled syringe jet injector Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 24, 2018 | Jan 24, 2026 | |
| Pat. No. 9533102 DP* Prefilled syringe jet injector Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 24, 2018 | Jan 24, 2026 | |
| Pat. No. 9629959 DP* Prefilled syringe jet injector Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 24, 2018 | Jan 24, 2026 | |
| Pat. No. 9744302 DP* Needle assisted jet injection device having reduced trigger force Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 24, 2018 | Nov 19, 2035 | |
| Pat. No. 9950125 DP* Needle assisted jet injection administration of testosterone compositions Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Oct 24, 2018 | Sep 4, 2036 | U-2418: Method of administering testosterone enanthate subcutaneously |
| Pat. No. 10238662 DP* Needle assisted jet injection administration of testosterone compositions Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Jun 11, 2020 | Feb 19, 2035 | U-2418: Method of administering testosterone enanthate subcutaneously |
| Pat. No. 10279131 DP* Injection device with cammed RAM assembly Claim Types: Device Pat. Sub. Date(s): All strengths: Jun 11, 2020 | Jul 31, 2031 | |
| Pat. No. 10357609 DP* Needle assisted jet injection device having reduced trigger force Claim Types: Device Pat. Sub. Date(s): All strengths: Jun 11, 2020 | Aug 21, 2031 | |
| Pat. No. 10478560 DP* Prefilled syringe injector Claim Types: Device Pat. Sub. Date(s): All strengths: Jun 11, 2020 | Jan 24, 2026 | |
| Pat. No. 10646495 DP* Testosterone ester triglyceride formulations Claim Types: Compound; Formulation Pat. Sub. Date(s): All strengths: Jun 11, 2020 | Aug 30, 2038 | |
| Pat. No. 10821072 DP* Needle assisted jet injection administration of testosterone compositions Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Nov 23, 2020 | Jun 4, 2033 | U-2418: Method of administering testosterone enanthate subcutaneously |
| Pat. No. 10881798 DP* Needle assisted injection device having reduced trigger force Claim Types: Device Pat. Sub. Date(s): All strengths: Feb 4, 2021 | Feb 11, 2034 | |
| Pat. No. 10905827 DP* Injection device with cammed ram assembly Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 2, 2021 | Aug 21, 2031 | |
| Pat. No. 10912782 DP* Needle assisted injection administration of testosterone compositions Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Mar 2, 2021 | Feb 19, 2035 | U-2418: Method of administering testosterone enanthate subcutaneously |
| Pat. No. 11160751 DP* Hematocrit modulation through needle assisted jet injection of testosterone Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 6, 2022 | Oct 7, 2034 | U-2418: Method of administering testosterone enanthate subcutaneously |
| Pat. No. 11191908 DP* Syringe shock absorber for use in an injection device Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 6, 2022 | Oct 18, 2035 | |
| Pat. No. 11446440 DP* Needle assisted injection device having reduced trigger force Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 7, 2022 | Aug 21, 2031 | |
| Pat. No. 11446441 DP* Prefilled syringe injector Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 7, 2022 | Jan 24, 2026 | |
| Pat. No. 11497753 DP* Hazardous agent injection system Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 14, 2022 | Mar 19, 2030 | |
| Pat. No. 11813435 DP* Needle assisted injection device having reduced trigger force Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 22, 2023 | Feb 25, 2035 | |
| Pat. No. 11844804 Administration of testosterone compositions Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Jan 18, 2024 | Jun 4, 2033 | U-2418: Method of administering testosterone enanthate subcutaneously |
APELLIS PHARMS
EMPAVELI (SOLUTION) (SUBCUTANEOUS) PEGCETACOPLAN
Drug Classes: complement inhibitor
NDA Applicant: APELLIS PHARMS NDA No.: 215014 Prod. No.: 001 RX (1080MG/20ML (54MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7888323 DS* Potent compstatin analogs Claim Types: Compound Pat. Sub. Date(s): 001: Jun 9, 2021 | Dec 4, 2027 | |
| Pat. No. 7989589 DS* Compstatin analogs with improved activity Claim Types: Compound Pat. Sub. Date(s): 001: Jun 9, 2021 | Dec 4, 2027 | |
| Pat. No. 9169307 DS* Potent compstatin analogs Claim Types: Compound; Process; Method of use Pat. Sub. Date(s): 001: Jun 9, 2021 | Nov 18, 2027 | U-3123: Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (pnh) by administration of complement inhibitor pegcetacoplan |
| Pat. No. 10035822 DS* Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods Claim Types: Compound Pat. Sub. Date(s): 001: Jun 9, 2021 | Nov 15, 2033 | |
| Pat. No. 10125171 DS* Cell-reactive, long-acting, or targeted compstatin analogs and uses thereof Claim Types: Compound Pat. Sub. Date(s): 001: Jun 9, 2021 | Aug 2, 2033 | |
| Pat. No. 10875893 DS* Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods Claim Types: Compound; Method of use Pat. Sub. Date(s): 001: Jun 9, 2021 | Nov 15, 2033 | U-3124: Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (pnh) by administration of pegcetacoplan |
| Pat. No. 11040107 DP* Dosing regimens and related compositions and methods Claim Types: Method of use; Composition Pat. Sub. Date(s): 001: Jul 16, 2021 | Apr 9, 2038 | U-3172: Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) by administration of 1080 mg of pegcetacoplan U-3173: Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) by administration of 1080 mg of pegcetacoplan twice weekly U-3174: Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) by administration of 1080 mg of pegcetacoplan every three days |
| Pat. No. 11292815 DS* DP* Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Apr 29, 2022 | Nov 15, 2033 | U-3124: Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (pnh) by administration of pegcetacoplan U-3354: Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) by administration of pegcetacoplan so as to reduce the sensitivity of cells to complement-dependent damage |
| Pat. No. 11661441 DS* Cell-reactive, long-acting, or targeted compstatin analogs and uses thereof Claim Types: Method of use; Process Pat. Sub. Date(s): 001: Jun 23, 2023 | Jan 13, 2033 | U-3124: Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (pnh) by administration of pegcetacoplan |
| Pat. No. 11844841 DP* Dosing regimens and related compositions and methods Claim Types: Method of use; Formulation Pat. Sub. Date(s): 001: Jan 16, 2024 | Dec 9, 2038 | U-3172: Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) by administration of 1080 mg of pegcetacoplan U-3173: Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) by administration of 1080 mg of pegcetacoplan twice weekly U-3174: Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) by administration of 1080 mg of pegcetacoplan every three days |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Feb 8, 2026 | M-288: Information added to the labeling to describe the results of study APl2-308 |
| Exclusivity Code: NCE - New chemical entity | May 14, 2026 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | May 14, 2028 | ODE-351: Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) |
APELLIS PHARMS
SYFOVRE (SOLUTION) (INTRAVITREAL) PEGCETACOPLAN
Drug Classes: complement inhibitor
NDA Applicant: APELLIS PHARMS NDA No.: 217171 Prod. No.: 001 RX (15MG/0.1ML (15MG/0.1ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7888323 DS* Potent compstatin analogs Claim Types: Compound Pat. Sub. Date(s): 001: Mar 9, 2023 | Dec 4, 2027 | |
| Pat. No. 7989589 DS* Compstatin analogs with improved activity Claim Types: Compound Pat. Sub. Date(s): 001: Mar 9, 2023 | Dec 4, 2027 | |
| Pat. No. 8168584 Methods of treating age-related macular degeneration by compstatin and analogs thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 9, 2023 | Apr 7, 2027 | U-3540: Treatment of geographic atrophy secondary to age-related macular degeneration by intravitreal administration of pegcetacoplan U-3542: Treatment of geographic atrophy secondary to age-related macular degeneration by intravitreal administration of pegcetacoplan and also administering an anti-VEGF agent |
| Pat. No. 9056076 Method of treating age-related macular degeneration comprising administering a compstatin analog Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 9, 2023 | Oct 25, 2026 | U-3540: Treatment of geographic atrophy secondary to age-related macular degeneration by intravitreal administration of pegcetacoplan |
| Pat. No. 9169307 DS* Potent compstatin analogs Claim Types: Compound; Process; Method of use Pat. Sub. Date(s): 001: Mar 9, 2023 | Nov 18, 2027 | U-3541: Treatment of geographic atrophy secondary to age-related macular degeneration by administering complement inhibitor pegcetacoplan |
| Pat. No. 10035822 DS* Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods Claim Types: Compound Pat. Sub. Date(s): 001: Mar 9, 2023 | Nov 15, 2033 | |
| Pat. No. 10125171 DS* Cell-reactive, long-acting, or targeted compstatin analogs and uses thereof Claim Types: Compound Pat. Sub. Date(s): 001: Mar 9, 2023 | Aug 2, 2033 | |
| Pat. No. 10875893 DS* Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods Claim Types: Compound; Method of use Pat. Sub. Date(s): 001: Mar 9, 2023 | Nov 15, 2033 | U-3540: Treatment of geographic atrophy secondary to age-related macular degeneration by intravitreal administration of pegcetacoplan |
| Pat. No. 11292815 DS* DP* Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Mar 9, 2023 | Nov 15, 2033 | U-3540: Treatment of geographic atrophy secondary to age-related macular degeneration by intravitreal administration of pegcetacoplan |
| Pat. No. 11661441 DS* Cell-reactive, long-acting, or targeted compstatin analogs and uses thereof Claim Types: Method of use; Process Pat. Sub. Date(s): 001: Jun 26, 2023 | Jan 13, 2033 | U-3540: Treatment of geographic atrophy secondary to age-related macular degeneration by intravitreal administration of pegcetacoplan |
| Pat. No. 11903994 Dosing regimens Claim Types: Method of use; Dosaage regimen Pat. Sub. Date(s): 001: Mar 18, 2024 | Feb 22, 2037 | U-3826: Treatment of geographic atrophy secondary to age-related macular degeneration by intravitreal administration of 15 mg pegcetacoplan every other month U-3827: Treatment of geographic atrophy secondary to age-related macular degeneration by intravitreal administration of 15 mg pegcetacoplan monthly U-3828: Treatment of geographic atrophy secondary to age-related macular degeneration by intravitreal administration of 15 mg pegcetacoplan monthly or every other month |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | May 14, 2026 | |
| Exclusivity Code: NP - New product | Feb 22, 2026 |
APGDI
MYRBETRIQ (TABLET, EXTENDED RELEASE) (ORAL) MIRABEGRON [GENERIC AB]
Drug Classes: beta-3 adrenergic agonist
NDA Applicant: APGDI NDA No.: 202611 Prod. No.: 001 RX (25MG); 002 RX (50MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE44872 Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 16, 2014 | May 4, 2024 *PED | U-1527: For the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency |
| Pat. No. 7342117 DS* .alpha.-form or .beta.-form crystal of acetanilide derivative Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Jul 30, 2012; 002: None | May 4, 2024 *PED | |
| Pat. No. 7982049 DP* .alpha.-form or .beta.-form crystal of acetanilide derivative Claim Types: Composition; Method of use; Formulation Pat. Sub. Date(s): 001: Jul 30, 2012; 002: None | May 4, 2024 *PED | |
| Pat. No. 8772315 Pharmaceutical composition for treating overactive bladder Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: May 17, 2018 | Apr 30, 2029 *PED | U-2300: Use in combination with the muscarinic antagonist solifenacin succinate for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency |
| Pat. No. 8835474 Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 14, 2014 | May 4, 2024 *PED | U-1527: For the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency |
| Pat. No. 10842780 DP* Pharmaceutical composition for modified release Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Dec 11, 2020 | Mar 28, 2030 *PED | U-2996: Administration of an extended release tablet for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency U-3670: Administration of an extended release tablet for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older and weighing 35 kg or more |
| Pat. No. 11707451 Pharmaceutical composition for modified release Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): All strengths: Aug 21, 2023 | Mar 28, 2030 *PED | U-2996: Administration of an extended release tablet for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency U-3670: Administration of an extended release tablet for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older and weighing 35 kg or more |
| Pat. No. 12059409 DP* Claim Types: Pat. Sub. Date(s): All strengths: Aug 28, 2024 | Sep 28, 2029 | |
| Pat. No. 12097189 Pharmaceutical composition for modified release Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 2, 2024 | Sep 28, 2029 | U-2996: Administration of an extended release tablet for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency U-3670: Administration of an extended release tablet for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older and weighing 35 kg or more |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Sep 25, 2024 PED | I-855: Treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 3 years and older and weighing 35 kilograms or more |
APGDI
MYRBETRIQ GRANULES (FOR SUSPENSION, EXTENDED RELEASE) (ORAL) MIRABEGRON
Drug Classes: beta-3 adrenergic agonist
NDA Applicant: APGDI NDA No.: 213801 Prod. No.: 001 RX (8MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7342117 DS* .alpha.-form or .beta.-form crystal of acetanilide derivative Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Apr 22, 2021 | May 4, 2024 *PED | |
| Pat. No. 7982049 DP* .alpha.-form or .beta.-form crystal of acetanilide derivative Claim Types: Composition; Method of use; Formulation Pat. Sub. Date(s): 001: Apr 22, 2021 | May 4, 2024 *PED | |
| Pat. No. 10058536 DP* Pharmaceutical composition containing mirabegron Claim Types: Formulation; Method of administration Pat. Sub. Date(s): 001: Apr 22, 2021 | Sep 30, 2036 *PED | U-3108: Treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older by administration of an extended-release suspension formulation of mirabegron |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Sep 25, 2024 PED |
APIL
ATELVIA (TABLET, DELAYED RELEASE) (ORAL) RISEDRONATE SODIUM [GENERIC AB]
NDA Applicant: APIL NDA No.: 022560 Prod. No.: 001 RX (35MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7645459 DP* Dosage forms of bisphosphonates Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 1, 2010 | Jan 9, 2028 | U-662: Treatment of osteoporosis in postmenopausal women |
| Pat. No. 7645460 DP* Dosage forms of risedronate Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 1, 2010 | Jan 9, 2028 | U-662: Treatment of osteoporosis in postmenopausal women |
| Pat. No. 8246989 DP* Dosage forms of bisphosphonates Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 28, 2012 | Jan 16, 2026 |
APIL
FEMTRACE (TABLET) (ORAL) ESTRADIOL ACETATE
Drug Classes: estrogen
NDA Applicant: APIL NDA No.: 021633 Prod. No.: 001 DISC (0.45MG); 002 DISC (0.9MG); 003 DISC (1.8MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7572779 Oral pharmaceutical products containing 17.beta.-estradiol-3-lower alkanoate, method of administering the same and process of preparation Claim Types: Method of administration Pat. Sub. Date(s): All strengths: None | Oct 2, 2025 | U-904: Treatment of moderate to severe vasomotor symptoms associated with menopause |
APIL
LO LOESTRIN FE (TABLET) (ORAL) ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Drug Classes: progestin
NDA Applicant: APIL NDA No.: 022501 Prod. No.: 001 RX (0.01MG,0.01MG;1MG,N/A)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7704984 Extended estrogen dosing contraceptive regimen Claim Types: Method of administration Pat. Sub. Date(s): 001: Oct 29, 2010 | Feb 2, 2029 | U-1090: Lo Loestrin FE is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception |
APIL
LO MINASTRIN FE (TABLET, CHEWABLE, TABLET) (ORAL) ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Drug Classes: progestin
NDA Applicant: APIL NDA No.: 204654 Prod. No.: 001 DISC (0.01MG,0.01MG,N/A;1MG,N/A,N/A)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7704984 Extended estrogen dosing contraceptive regimen Claim Types: Method of administration Pat. Sub. Date(s): 001: None | Feb 2, 2029 | U-1: Prevention of pregnancy |
APOTEX
DASATINIB (TABLET) (ORAL) DASATINIB [GENERIC AB]
Drug Classes: kinase inhibitor
NDA Applicant: APOTEX NDA No.: 202103 Prod. No.: 001 RX (20MG); 002 RX (50MG); 003 RX (70MG); 004 RX (100MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: PC - Patent challenge | Mar 2, 2025 |
APOTEX
DASATINIB (TABLET) (ORAL) DASATINIB [GENERIC AB]
Drug Classes: kinase inhibitor
NDA Applicant: APOTEX NDA No.: 203180 Prod. No.: 001 RX (80MG); 002 RX (140MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: PC - Patent challenge | Mar 2, 2025 |
APOTEX
DEXAMETHASONE (TABLET) (ORAL) DEXAMETHASONE [GENERIC AB]
Drug Classes: corticosteroid
NDA Applicant: APOTEX NDA No.: 217695 Prod. No.: 003 RX (1MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Apr 29, 2024 |
APOTEX
IVRA (SOLUTION) (INTRAVENOUS) MELPHALAN HYDROCHLORIDE
Drug Classes: alkylating drug
NDA Applicant: APOTEX NDA No.: 217110 Prod. No.: 001 RX (EQ 90MG BASE/ML (EQ 90MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10537520 DP* Stable liquid formulations of melphalan Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 1, 2023 | Jun 29, 2036 |
APOTEX
TERIFLUNOMIDE (TABLET) (ORAL) TERIFLUNOMIDE [GENERIC AB]
Drug Classes: pyrimidine synthesis inhibitor
NDA Applicant: APOTEX NDA No.: 209601 Prod. No.: 001 RX (7MG); 002 RX (14MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: PC - Patent challenge | Sep 8, 2023 |
APPCO
CLOMIPHENE CITRATE (TABLET) (ORAL) CLOMIPHENE CITRATE [GENERIC AB]
Drug Classes: estrogen agonist/antagonist
NDA Applicant: APPCO NDA No.: 216739 Prod. No.: 001 RX (50MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | May 18, 2025 |
APRECIA PHARMS
SPRITAM (TABLET, FOR SUSPENSION) (ORAL) LEVETIRACETAM
NDA Applicant: APRECIA PHARMS NDA No.: 207958 Prod. No.: 001 RX (250MG); 002 RX (500MG); 003 RX (750MG); 004 RX (1GM)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9339489 DP* Rapid disperse dosage form containing levetiracetam Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jul 25, 2017; 002: Jun 16, 2016; 003: Jun 16, 2016; 004: Jun 16, 2016 | Mar 14, 2034 | U-1850: Method of administering levetiracetam |
| Pat. No. 9669009 Rapid disperse dosage form containing levetiracetam Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 28, 2017 | Mar 14, 2034 | U-1850: Method of administering levetiracetam U-2021: Method of administering levetiracetam under fasted conditions U-2022: Method of administering levetiracetam under fed conditions |
| Pat. No. 11160786 DP* Rapid disperse dosage form Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 30, 2021 | Mar 14, 2034 |
AQUESTIVE
EXSERVAN (FILM) (ORAL) RILUZOLE
Drug Classes: benzothiazole
NDA Applicant: AQUESTIVE NDA No.: 212640 Prod. No.: 001 DISC (50MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8603514 DP* Uniform films for rapid dissolve dosage form incorporating taste-masking compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 2, 2020 | Apr 3, 2024 | |
| Pat. No. 8765167 DP* Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Jun 2, 2020 | Feb 20, 2024 |
AQUESTIVE
LIBERVANT (FILM) (BUCCAL) DIAZEPAM
Drug Classes: benzodiazepine
NDA Applicant: AQUESTIVE NDA No.: 218623 Prod. No.: 001 RX (5MG); 002 RX (7.5MG); 003 RX (10MG); 004 RX (12.5MG); 005 RX (15MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11273131 DP* Pharmaceutical compositions with enhanced permeation Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 14, 2024 | Jun 18, 2038 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Apr 26, 2027 |
AQUESTIVE
ZUPLENZ (FILM) (ORAL) ONDANSETRON
Drug Classes: serotonin-3 (5-HT3) receptor antagonist
NDA Applicant: AQUESTIVE NDA No.: 022524 Prod. No.: 001 DISC (4MG); 002 DISC (8MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8580830 DP* Non-mucoadhesive film dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 3, 2013 | Nov 23, 2029 | |
| Pat. No. 9095577 DP* Stabilized amine-containing actives in oral film compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 26, 2015 | Jul 13, 2030 |
ARBOR PHARMS LLC
CETYLEV (TABLET, EFFERVESCENT) (ORAL) ACETYLCYSTEINE
Drug Classes: antidote == antidote for acetaminophen overdose == mucolytic
NDA Applicant: ARBOR PHARMS LLC NDA No.: 207916 Prod. No.: 001 DISC (500MG); 002 DISC (2.5GM)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8747894 DP* Effervescent compositions containing N-acetylcysteine Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Feb 8, 2016 | May 8, 2032 | U-1373: Method of treating acetaminophen overdose with acetylcysteine solutions |
| Pat. No. 9427421 DP* Effervescent compositions containing N-acetylcysteine Claim Types: Formulation; Product-by-process Pat. Sub. Date(s): All strengths: Sep 23, 2016 | May 8, 2032 | |
| Pat. No. 9561204 Effervescent compositions containing N-acetylcysteine Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 9, 2017 | May 8, 2032 | U-1373: Method of treating acetaminophen overdose with acetylcysteine solutions |
ARCUTIS
ZORYVE (CREAM) (TOPICAL) ROFLUMILAST
Drug Classes: phosphodiesterase 4 inhibitor
NDA Applicant: ARCUTIS NDA No.: 215985 Prod. No.: 001 RX (0.3%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9884050 DP* Inhibition of crystal growth of roflumilast Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Aug 19, 2022 | Jun 7, 2037 | |
| Pat. No. 9907788 Inhibition of crystal growth of roflumilast Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 19, 2022 | Jun 7, 2037 | U-3408: Topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. (1) U-3712: Topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age or older |
| Pat. No. 10940142 DP* Inhibition of crystal growth of roflumilast Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 19, 2022 | Jun 7, 2037 | |
| Pat. No. 11129818 Topical roflumilast formulation having improved delivery and plasma half life Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Aug 19, 2022 | Aug 25, 2037 | U-3408: Topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. (1) U-3712: Topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age or older |
| Pat. No. 11793796 DP* Inhibition of crystal growth of roflumilast Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 24, 2023 | Jun 7, 2037 | |
| Pat. No. 11819496 Topical roflumilast formulation having improved delivery and plasma half-life Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 21, 2023 | Jun 7, 2037 | U-3748: Topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age and older |
| Pat. No. 11992480 Method for reducing side effects from administration of phosphodiesterase-4 inhibitors Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Jun 26, 2024 | Jun 7, 2037 | U-3748: Topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age and older |
| Pat. No. 12005051 Topical roflumilast formulation having improved delivery and plasma half life Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Jul 9, 2024 | Jun 7, 2037 | U-3748: Topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age and older |
| Pat. No. 12005052 DP* Topical roflumilast formulation having improved delivery and plasma half-life Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 9, 2024 | Jun 7, 2037 | |
| Pat. No. 12011437 DP* Roflumilast formulations with an improved pharmacokinetic profile Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 9, 2024 | Jun 7, 2037 | |
| Pat. No. 12016848 DP* Roflumilast formulations with an improved pharmacokinetic profile Claim Types: Formulation; Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Jul 9, 2024 | Jun 7, 2037 | |
| Pat. No. 12042487 DP* Method for reducing side effects from administration of phosphodiesterase-4 inhibitors Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 21, 2024 | Jun 7, 2037 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Jul 29, 2025 | |
| Exclusivity Code: NPP - New patient population | Oct 5, 2026 |
ARCUTIS
ZORYVE (CREAM) (TOPICAL) ROFLUMILAST
Drug Classes: phosphodiesterase 4 inhibitor
NDA Applicant: ARCUTIS NDA No.: 215985 Prod. No.: 002 RX (0.15%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9884050 DP* Inhibition of crystal growth of roflumilast Claim Types: Composition; Formulation Pat. Sub. Date(s): 002: Aug 8, 2024 | Jun 7, 2037 | |
| Pat. No. 9907788 Inhibition of crystal growth of roflumilast Claim Types: Method of use Pat. Sub. Date(s): 002: Aug 8, 2024 | Jun 7, 2037 | U-3970: Topical treatment of mild to moderate atopic dermatitis |
| Pat. No. 10940142 DP* Inhibition of crystal growth of roflumilast Claim Types: Formulation Pat. Sub. Date(s): 002: Aug 8, 2024 | Jun 7, 2037 | |
| Pat. No. 11129818 Topical roflumilast formulation having improved delivery and plasma half life Claim Types: Method of improving a treatment Pat. Sub. Date(s): 002: Aug 8, 2024 | Aug 25, 2037 | U-3970: Topical treatment of mild to moderate atopic dermatitis |
| Pat. No. 11793796 DP* Inhibition of crystal growth of roflumilast Claim Types: Formulation Pat. Sub. Date(s): 002: Aug 8, 2024 | Jun 7, 2037 | |
| Pat. No. 11819496 Topical roflumilast formulation having improved delivery and plasma half-life Claim Types: Method of use Pat. Sub. Date(s): 002: Aug 8, 2024 | Jun 7, 2037 | U-3970: Topical treatment of mild to moderate atopic dermatitis |
| Pat. No. 11992480 Method for reducing side effects from administration of phosphodiesterase-4 inhibitors Claim Types: Method of improving a treatment Pat. Sub. Date(s): 002: Aug 8, 2024 | Jun 7, 2037 | U-3970: Topical treatment of mild to moderate atopic dermatitis |
| Pat. No. 12005051 Topical roflumilast formulation having improved delivery and plasma half life Claim Types: Method of improving a treatment Pat. Sub. Date(s): 002: Aug 8, 2024 | Jun 7, 2037 | U-3970: Topical treatment of mild to moderate atopic dermatitis |
| Pat. No. 12005052 DP* Topical roflumilast formulation having improved delivery and plasma half-life Claim Types: Formulation Pat. Sub. Date(s): 002: Aug 8, 2024 | Jun 7, 2037 | |
| Pat. No. 12011437 DP* Roflumilast formulations with an improved pharmacokinetic profile Claim Types: Formulation Pat. Sub. Date(s): 002: Aug 8, 2024 | Jun 7, 2037 | |
| Pat. No. 12016848 DP* Roflumilast formulations with an improved pharmacokinetic profile Claim Types: Formulation; Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 002: Aug 8, 2024 | Jun 7, 2037 | |
| Pat. No. 12042487 DP* Method for reducing side effects from administration of phosphodiesterase-4 inhibitors Claim Types: Formulation Pat. Sub. Date(s): 002: Aug 8, 2024 | Jun 7, 2037 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NS - New strength | Jul 9, 2027 |
ARCUTIS
ZORYVE (FOAM) (TOPICAL) ROFLUMILAST
Drug Classes: phosphodiesterase 4 inhibitor
NDA Applicant: ARCUTIS NDA No.: 217242 Prod. No.: 001 RX (0.3%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9884050 DP* Inhibition of crystal growth of roflumilast Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Dec 26, 2023 | Jun 7, 2037 | |
| Pat. No. 9907788 Inhibition of crystal growth of roflumilast Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 26, 2023 | Jun 7, 2037 | U-3773: Topical treatment of seborrheic dermatitis in patients 9 years of age and older |
| Pat. No. 10940142 DP* Inhibition of crystal growth of roflumilast Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 26, 2023 | Jun 7, 2037 | |
| Pat. No. 11129818 Topical roflumilast formulation having improved delivery and plasma half life Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Dec 26, 2023 | Aug 25, 2037 | U-3773: Topical treatment of seborrheic dermatitis in patients 9 years of age and older |
| Pat. No. 11707454 Topical roflumilast formulation having antifungal properties Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 26, 2023 | Dec 3, 2041 | U-3773: Topical treatment of seborrheic dermatitis in patients 9 years of age and older |
| Pat. No. 11793796 DP* Inhibition of crystal growth of roflumilast Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 26, 2023 | Jun 7, 2037 | |
| Pat. No. 11819496 Topical roflumilast formulation having improved delivery and plasma half-life Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 26, 2023 | Jun 7, 2037 | U-3773: Topical treatment of seborrheic dermatitis in patients 9 years of age and older |
| Pat. No. 11992480 Method for reducing side effects from administration of phosphodiesterase-4 inhibitors Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Jun 26, 2024 | Jun 7, 2037 | U-3773: Topical treatment of seborrheic dermatitis in patients 9 years of age and older |
| Pat. No. 12005051 Topical roflumilast formulation having improved delivery and plasma half life Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Jul 10, 2024 | Jun 7, 2037 | U-3773: Topical treatment of seborrheic dermatitis in patients 9 years of age and older |
| Pat. No. 12005052 DP* Topical roflumilast formulation having improved delivery and plasma half-life Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 10, 2024 | Jun 7, 2037 | |
| Pat. No. 12011437 DP* Roflumilast formulations with an improved pharmacokinetic profile Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 10, 2024 | Jun 7, 2037 | |
| Pat. No. 12016848 DP* Roflumilast formulations with an improved pharmacokinetic profile Claim Types: Formulation; Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Jul 10, 2024 | Jun 7, 2037 | |
| Pat. No. 12042487 DP* Method for reducing side effects from administration of phosphodiesterase-4 inhibitors Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 16, 2024 | Jun 7, 2037 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Dec 15, 2026 |
ARDELYX INC
IBSRELA (TABLET) (ORAL) TENAPANOR HYDROCHLORIDE
Drug Classes: sodium/hydrogen exchanger 3 (NHE3) inhibitor
NDA Applicant: ARDELYX INC NDA No.: 211801 Prod. No.: 001 RX (EQ 50MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8541448 DS* DP* Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Oct 10, 2019 | Aug 1, 2033 | |
| Pat. No. 8969377 DS* DP* Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Oct 10, 2019 | Dec 30, 2029 | |
| Pat. No. 9006281 Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 10, 2019 | May 2, 2030 | U-2626: Method of treating irritable bowel syndrome with constipation by administering tenapanor |
| Pat. No. 9408840 Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorder Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 10, 2019 | Dec 30, 2029 | U-2626: Method of treating irritable bowel syndrome with constipation by administering tenapanor |
| Pat. No. 12016856 DS* DP* Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders Claim Types: Compound Pat. Sub. Date(s): 001: Jul 24, 2024 | Dec 30, 2029 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Sep 12, 2024 |
ARDELYX INC
XPHOZAH (TABLET) (ORAL) TENAPANOR HYDROCHLORIDE
Drug Classes: sodium/hydrogen exchanger 3 (NHE3) inhibitor
NDA Applicant: ARDELYX INC NDA No.: 213931 Prod. No.: 002 RX (EQ 20MG BASE); 003 RX (EQ 30MG BASE) NDA No.: 213931 Prod. No.: 001 DISC (EQ 10MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8541448 DS* DP* Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Nov 14, 2023 | Aug 1, 2033 | |
| Pat. No. 8969377 DS* DP* Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Nov 14, 2023 | Dec 30, 2029 | |
| Pat. No. 10272079 NHE3-binding compounds and methods for inhibiting phosphate transport Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 14, 2023 | Apr 10, 2034 | U-3736: Reduction of serum phosphorus in adults U-381: Treatment of hyperphosphatemia |
| Pat. No. 10940146 NHE3-binding compounds and methods for inhibiting phosphate transport Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 14, 2023 | Apr 10, 2034 | U-3736: Reduction of serum phosphorus in adults U-381: Treatment of hyperphosphatemia |
| Pat. No. 12016856 DS* DP* Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders Claim Types: Compound Pat. Sub. Date(s): All strengths: Jul 24, 2024 | Dec 30, 2029 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Sep 12, 2024 | |
| Exclusivity Code: NP - New product | Oct 17, 2026 |
ARMSTRONG PHARMS
PRIMATENE MIST (AEROSOL, METERED) (INHALATION) EPINEPHRINE
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: ARMSTRONG PHARMS NDA No.: 205920 Prod. No.: 001 OTC (0.125MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8367734 DP* Stable epinephrine suspension formulation with high inhalation delivery efficiency Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 17, 2018 | Jan 26, 2026 |
ARRAY BIOPHARMA INC
BRAFTOVI (CAPSULE) (ORAL) ENCORAFENIB
NDA Applicant: ARRAY BIOPHARMA INC NDA No.: 210496 Prod. No.: 001 DISC (50MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8541575 DS* DP* 3,4-diarylpyrazoles as protein kinase inhibitors Claim Types: Compound; Method of use; Composition; Kit Pat. Sub. Date(s): 001: Jul 25, 2018 | Feb 26, 2030 | U-2335: Treatment of melanoma |
| Pat. No. 8946250 DS* DP* 3,4-diarylpyrazoles as protein kinase inhibitors Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jul 25, 2018 | Jul 23, 2029 | |
| Pat. No. 9314464 Compounds and compositions as protein kinase inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2018 | Jul 4, 2031 | U-2336: Treatment of melanoma mediated by a B-Raf protein kinase |
| Pat. No. 9387208 DP* Pharmaceutical formulations of (S)-methyl (1-((4-(3-(5-chloro-2-fluoro-3-(methylsulfonamido)phenyl)-1-isopropyl-1H- pyrazol-4-yl)pyrimidin-2-yl)amino)propan-2-yl)carbamate Claim Types: Formulation; Product-by-process Pat. Sub. Date(s): 001: Jul 25, 2018 | Nov 21, 2032 | |
| Pat. No. 9593099 DS* Compounds and compositions as protein kinase inhibitors Claim Types: Compound Pat. Sub. Date(s): 001: Jul 25, 2018 | Aug 27, 2030 | |
| Pat. No. 9593100 DP* Compounds and compositions as protein kinase inhibitors Claim Types: Composition Pat. Sub. Date(s): 001: Jul 25, 2018 | Aug 27, 2030 | |
| Pat. No. 9763941 Method of treating melanoma by administration of pharmaceutical formulations of (S)-methyl (1-((4-(3-(5-chloro-2-fluoro-3-(methylsulfonamido)phenyl)-1-isopropyl-1H- pyrazol-4-yl)pyrimidin-2-yl)amino)propan-2-yl)carbamate Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2018 | Nov 21, 2032 | U-2335: Treatment of melanoma |
| Pat. No. 9850229 Compounds and compositions as protein kinase inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2018 | Aug 27, 2030 | U-2337: Indicated in combination with binimetinib for the treatment of melanoma with a BRAF mutation |
| Pat. No. 9850230 Compounds and compositions as protein kinase inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2018 | Aug 27, 2030 | U-2334: Treatment of melanoma with a BRAF mutation |
| Pat. No. 10005761 Compounds and compositions as protein kinase inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2018 | Aug 27, 2030 | U-2335: Treatment of melanoma |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Oct 11, 2026 | I-928: Encorafenib in combination with binimetinib, is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation, as detected by an FDA-approved test |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 27, 2025 | ODE-194: Encorafenib is indicated in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 11, 2030 | ODE-445: Treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test |
ARRAY BIOPHARMA INC
BRAFTOVI (CAPSULE) (ORAL) ENCORAFENIB
NDA Applicant: ARRAY BIOPHARMA INC NDA No.: 210496 Prod. No.: 002 RX (75MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE49556 DS* DP* Compounds and compositions as protein kinase inhibitors Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 002: Jul 19, 2023 | Feb 27, 2030 | |
| Pat. No. 8541575 DS* DP* 3,4-diarylpyrazoles as protein kinase inhibitors Claim Types: Compound; Method of use; Composition; Kit Pat. Sub. Date(s): 002: Jul 25, 2018 | Feb 26, 2030 | U-2335: Treatment of melanoma U-2802: BRAFTOVI is a kinase inhibitor indicated in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy U-2803: BRAFTOVI is a kinase inhibitor indicated in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA- approved test U-3738: BRAFTOVI is a kinase inhibitor indicated in combination with binimetinib, for the treatment of patients with metastatic non small cell lung cancer with a braf V600E mutation, as detected by an FDA-approved test |
| Pat. No. 8946250 DS* DP* 3,4-diarylpyrazoles as protein kinase inhibitors Claim Types: Compound; Composition Pat. Sub. Date(s): 002: Jul 25, 2018 | Jul 23, 2029 | |
| Pat. No. 9314464 Compounds and compositions as protein kinase inhibitors Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 25, 2018 | Jul 4, 2031 | U-2336: Treatment of melanoma mediated by a B-Raf protein kinase U-2802: BRAFTOVI is a kinase inhibitor indicated in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy U-2803: BRAFTOVI is a kinase inhibitor indicated in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA- approved test U-3738: BRAFTOVI is a kinase inhibitor indicated in combination with binimetinib, for the treatment of patients with metastatic non small cell lung cancer with a braf V600E mutation, as detected by an FDA-approved test |
| Pat. No. 9387208 DP* Pharmaceutical formulations of (S)-methyl (1-((4-(3-(5-chloro-2-fluoro-3-(methylsulfonamido)phenyl)-1-isopropyl-1H- pyrazol-4-yl)pyrimidin-2-yl)amino)propan-2-yl)carbamate Claim Types: Formulation; Product-by-process Pat. Sub. Date(s): 002: Jul 25, 2018 | Nov 21, 2032 | |
| Pat. No. 9474754 Pharmaceutical combinations comprising a B-RAF inhibitor, and EGFR inhibitor and optionally a PI3K-.alpha. inhibitor Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: May 7, 2020 | Aug 5, 2033 | U-2802: BRAFTOVI is a kinase inhibitor indicated in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy |
| Pat. No. 9593099 DS* Compounds and compositions as protein kinase inhibitors Claim Types: Compound Pat. Sub. Date(s): 002: Jul 25, 2018 | Aug 27, 2030 | |
| Pat. No. 9593100 DP* Compounds and compositions as protein kinase inhibitors Claim Types: Composition Pat. Sub. Date(s): 002: Jul 25, 2018 | Aug 27, 2030 | |
| Pat. No. 9763941 Method of treating melanoma by administration of pharmaceutical formulations of (S)-methyl (1-((4-(3-(5-chloro-2-fluoro-3-(methylsulfonamido)phenyl)-1-isopropyl-1H- pyrazol-4-yl)pyrimidin-2-yl)amino)propan-2-yl)carbamate Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 25, 2018 | Nov 21, 2032 | U-2335: Treatment of melanoma |
| Pat. No. 9850229 Compounds and compositions as protein kinase inhibitors Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 25, 2018 | Aug 27, 2030 | U-2337: Indicated in combination with binimetinib for the treatment of melanoma with a BRAF mutation |
| Pat. No. 9850230 Compounds and compositions as protein kinase inhibitors Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 25, 2018 | Aug 27, 2030 | U-2334: Treatment of melanoma with a BRAF mutation U-2802: BRAFTOVI is a kinase inhibitor indicated in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy U-2803: BRAFTOVI is a kinase inhibitor indicated in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA- approved test U-3738: BRAFTOVI is a kinase inhibitor indicated in combination with binimetinib, for the treatment of patients with metastatic non small cell lung cancer with a braf V600E mutation, as detected by an FDA-approved test |
| Pat. No. 10005761 Compounds and compositions as protein kinase inhibitors Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 25, 2018 | Aug 27, 2030 | U-2335: Treatment of melanoma U-2802: BRAFTOVI is a kinase inhibitor indicated in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy U-2803: BRAFTOVI is a kinase inhibitor indicated in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA- approved test U-3738: BRAFTOVI is a kinase inhibitor indicated in combination with binimetinib, for the treatment of patients with metastatic non small cell lung cancer with a braf V600E mutation, as detected by an FDA-approved test |
| Pat. No. 10258622 Method of treating colorectal cancer by administration of pharmaceutical formulations of (S)-methyl (1-((4-(3-(5-chloro-2-fluoro-3-(methylsulfonamido)pheny1)-1-isopropyl-1H-- pyrazol-4-yl)pyrimidin-2-yl)amino)propan-2-yl) carbamate Claim Types: Method of use Pat. Sub. Date(s): 002: May 7, 2020 | Nov 21, 2032 | U-2802: BRAFTOVI is a kinase inhibitor indicated in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Oct 11, 2026 | I-928: Encorafenib in combination with binimetinib, is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation, as detected by an FDA-approved test |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 27, 2025 | ODE-194: Encorafenib is indicated in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 11, 2030 | ODE-445: Treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test |
ARRAY BIOPHARMA INC
MEKTOVI (TABLET) (ORAL) BINIMETINIB
NDA Applicant: ARRAY BIOPHARMA INC NDA No.: 210498 Prod. No.: 001 RX (15MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7777050 DS* DP* N3 alkylated benzimidazole derivatives as MEK inhibitors Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jul 25, 2018 | Mar 13, 2025 | |
| Pat. No. 9314464 Compounds and compositions as protein kinase inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2018 | Jul 4, 2031 | U-2332: Indicated in combination with encorafenib for the treatment of melanoma mediated by a B-Raf protein kinase U-3737: MEKTOVI is a kinase inhibitor indicated in combination with encorafenib, for the treatment of patients with metastatic non small cell lung cancer with a braf V600E mutation, as detected by an FDA-approved test |
| Pat. No. 9562016 DS* DP* Preparation of and formulation comprising a MEK inhibitor Claim Types: Product-by-process; Formulation; Composition Pat. Sub. Date(s): 001: Jul 25, 2018 | Oct 18, 2033 | |
| Pat. No. 9598376 Preparation of and formulation comprising a MEK inhibitor Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2018 | Oct 18, 2033 | U-2330: Method of treating melanoma |
| Pat. No. 9850229 Compounds and compositions as protein kinase inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2018 | Aug 27, 2030 | U-2333: Indicated in combination with encorafenib for the treatment of melanoma with a BRAF mutation |
| Pat. No. 9980944 Preparation of and formulation comprising a MEK inhibitor Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2018 | Oct 18, 2033 | U-2334: Treatment of melanoma with a BRAF mutation |
| Pat. No. 10005761 Compounds and compositions as protein kinase inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2018 | Aug 27, 2030 | U-2331: Indicated in combination with encorafenib for the treatment of melanoma U-3737: MEKTOVI is a kinase inhibitor indicated in combination with encorafenib, for the treatment of patients with metastatic non small cell lung cancer with a braf V600E mutation, as detected by an FDA-approved test |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Oct 11, 2026 | I-928: Encorafenib in combination with binimetinib, is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation, as detected by an FDA-approved test |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 27, 2025 | ODE-194: Encorafenib is indicated in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test |
ARS PHARMS OPERATION
NEFFY (SPRAY) (NASAL) EPINEPHRINE
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: ARS PHARMS OPERATION NDA No.: 214697 Prod. No.: 001 RX (2MG/SPRAY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10576156 DP* Compositions for drug administration Claim Types: Formulation; Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Aug 28, 2024 | Feb 6, 2038 | |
| Pat. No. 10682414 Intranasal epinephrine formulations and methods for the treatment of disease Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 28, 2024 | Feb 6, 2039 | U-3979: Nasal administration of epinephrine for the treatment of allergic reactions (type I), including anaphylaxis |
| Pat. No. 11173209 Compositions for drug administration Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 28, 2024 | Feb 6, 2038 | U-3979: Nasal administration of epinephrine for the treatment of allergic reactions (type I), including anaphylaxis |
| Pat. No. 11191838 DP* Intranasal epinephrine formulations and methods for the treatment of disease Claim Types: Method of use; Formulation Pat. Sub. Date(s): 001: Aug 28, 2024 | Feb 6, 2039 | U-3979: Nasal administration of epinephrine for the treatment of allergic reactions (type I), including anaphylaxis |
| Pat. No. 11717571 Intranasal epinephrine formulations and methods for the treatment of disease Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 28, 2024 | Feb 6, 2039 | U-3979: Nasal administration of epinephrine for the treatment of allergic reactions (type I), including anaphylaxis |
| Pat. No. 11744895 Intranasal epinephrine formulations and methods for the treatment of disease Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 28, 2024 | Feb 6, 2039 | U-3979: Nasal administration of epinephrine for the treatment of allergic reactions (type I), including anaphylaxis |
| Pat. No. 11918655 DP* Intranasal epinephrine formulations and methods for the treatment of disease Claim Types: Method of use; Formulation Pat. Sub. Date(s): 001: Aug 28, 2024 | Feb 6, 2039 | U-3979: Nasal administration of epinephrine for the treatment of allergic reactions (type I), including anaphylaxis |
ASCENDIS PHARMA BONE
YORVIPATH (SOLUTION) (SUBCUTANEOUS) PALOPEGTERIPARATIDE
NDA Applicant: ASCENDIS PHARMA BONE NDA No.: 216490 Prod. No.: 001 RX (EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML)); 002 RX (EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML)); 003 RX (EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8906847 DS* DP* Prodrug comprising a drug linker conjugate Claim Types: Prodrug Pat. Sub. Date(s): All strengths: Sep 5, 2024 | Apr 30, 2031 | U-3982: Treatment of hypoparathyroidism in adults |
| Pat. No. 11590207 Dosage regimen for a controlled-release PTH compound Claim Types: Method of use; Method of administration Pat. Sub. Date(s): All strengths: Sep 5, 2024 | Sep 28, 2037 | U-3982: Treatment of hypoparathyroidism in adults |
| Pat. No. 11759504 DP* PTH compounds with low peak-to-trough ratios Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 5, 2024 | Sep 28, 2037 | |
| Pat. No. 11857603 PTH compounds with low peak-to-trough ratios Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 5, 2024 | Sep 28, 2037 | U-3982: Treatment of hypoparathyroidism in adults |
| Pat. No. 11890326 DS* DP* Controlled-release PTH compound Claim Types: Compound Pat. Sub. Date(s): All strengths: Sep 5, 2024 | Sep 28, 2037 | |
| Pat. No. 11918628 DS* DP* Controlled-release PTH compound Claim Types: Compound; Formulation Pat. Sub. Date(s): All strengths: Sep 5, 2024 | Sep 28, 2037 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Aug 9, 2027 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Aug 9, 2031 | ODE-492: Treatment of hypoparathyroidism in adults |
ASSERTIO
CAMBIA (FOR SOLUTION) (ORAL) DICLOFENAC POTASSIUM [GENERIC AB]
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: ASSERTIO NDA No.: 022165 Prod. No.: 001 RX (50MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7759394 DS* DP* Diclofenac formulations and methods of use Claim Types: Method of administration Pat. Sub. Date(s): 001: None | Jun 16, 2026 | U-436: Acute treatment of migraine attacks with or without aura in adults |
| Pat. No. 8097651 DS* DP* Diclofenac formulations and methods of use Claim Types: Method of use Pat. Sub. Date(s): 001: None | Jun 16, 2026 | U-436: Acute treatment of migraine attacks with or without aura in adults |
| Pat. No. 8927604 Diclofenac formulations and methods of use Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 21, 2015 | Jun 16, 2026 | U-436: Acute treatment of migraine attacks with or without aura in adults |
| Pat. No. 9827197 DP* Diclofenac formulations and methods of use Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Dec 5, 2017 | Jun 16, 2026 |
ASSERTIO
ZIPSOR (CAPSULE) (ORAL) DICLOFENAC POTASSIUM [GENERIC AB]
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: ASSERTIO NDA No.: 022202 Prod. No.: 001 RX (25MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7662858 Method of treating post-surgical acute pain Claim Types: Method of administration Pat. Sub. Date(s): 001: None | Feb 24, 2029 | U-1035: Nonsteroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain |
| Pat. No. 7884095 Method of treating post-surgical acute pain Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 22, 2011 | Feb 24, 2029 | U-1111: Nonsteroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain |
| Pat. No. 7939518 Method of treating post-surgical acute pain Claim Types: Method of use Pat. Sub. Date(s): 001: May 19, 2011 | Feb 24, 2029 | U-980: Nonsteroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain |
| Pat. No. 8110606 Method of treating post-surgical acute pain Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 13, 2012 | Feb 24, 2029 | U-980: Nonsteroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain |
| Pat. No. 8623920 Method of treating post-surgical acute pain Claim Types: Method of administration Pat. Sub. Date(s): 001: Feb 5, 2014 | Feb 24, 2029 | U-1482: Diclofenac potassium for relief of mild to moderate acute pain |
| Pat. No. 9561200 Method of treating post-surgical acute pain Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 14, 2017 | Feb 24, 2029 | U-1482: Diclofenac potassium for relief of mild to moderate acute pain |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | May 25, 2024 |
ASTELLAS
ASTAGRAF XL (CAPSULE, EXTENDED RELEASE) (ORAL) TACROLIMUS [GENERIC AB]
Drug Classes: calcineurin inhibitor immunosuppressant
NDA Applicant: ASTELLAS NDA No.: 204096 Prod. No.: 001 RX (EQ 0.5MG BASE); 002 RX (EQ 1MG BASE); 003 RX (EQ 5MG BASE)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s) | May 24, 2025 |
ASTELLAS
CRESEMBA (CAPSULE) (ORAL) ISAVUCONAZONIUM SULFATE
NDA Applicant: ASTELLAS NDA No.: 207500 Prod. No.: 001 RX (186MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6812238 DS* N-substituted carbamoyloxyalkyl-azolium derivatives Claim Types: Composition; Method of use; Compound Pat. Sub. Date(s): 001: Apr 1, 2015 | Apr 30, 2026 *PED | |
| Pat. No. 10206879 DP* Active ingredient containing stabilised solid forms and method for the production thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 3, 2021 | Mar 14, 2028 *PED | |
| Pat. No. 10603280 DP* Active ingredient containing stabilised solid medicinal forms and methods for the production thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 3, 2021 | Mar 14, 2028 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Sep 6, 2020 PED | |
| Exclusivity Code: NPP - New patient population | Jun 8, 2027 PED | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Sep 6, 2022 PED | ODE-305: Treatment of invasive aspergillosis |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 8, 2031 PED | ODE-454: treatment of invasive mucormycosis in pediatric patients 6 years of age and older who weigh 16 kg and greater |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 8, 2031 PED | ODE-458: Treatment of invasive aspergillosis in pediatric patients 6 years of age and older who weigh 16 kilograms (kg) and greater |
| Exclusivity Code: ODE - Orphan drug exclusivity | Sep 6, 2022 PED | ODE-90: Treatment of invasive mucormycosis in patients 18 years of age and older |
ASTELLAS
CRESEMBA (CAPSULE) (ORAL) ISAVUCONAZONIUM SULFATE
NDA Applicant: ASTELLAS NDA No.: 207500 Prod. No.: 002 RX (74.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6812238 DS* N-substituted carbamoyloxyalkyl-azolium derivatives Claim Types: Composition; Method of use; Compound Pat. Sub. Date(s): 002: Jun 29, 2023 | Apr 30, 2026 *PED | |
| Pat. No. 10206879 DP* Active ingredient containing stabilised solid forms and method for the production thereof Claim Types: Formulation Pat. Sub. Date(s): 002: Dec 21, 2022 | Mar 14, 2028 *PED | |
| Pat. No. 10603280 DP* Active ingredient containing stabilised solid medicinal forms and methods for the production thereof Claim Types: Formulation Pat. Sub. Date(s): 002: Dec 21, 2022 | Mar 14, 2028 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Sep 6, 2020 PED | |
| Exclusivity Code: NPP - New patient population | Jun 8, 2027 PED | |
| Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s) | Sep 6, 2022 PED | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 8, 2031 PED | ODE-454: treatment of invasive mucormycosis in pediatric patients 6 years of age and older who weigh 16 kg and greater |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 8, 2031 PED | ODE-458: Treatment of invasive aspergillosis in pediatric patients 6 years of age and older who weigh 16 kilograms (kg) and greater |
ASTELLAS
CRESEMBA (POWDER) (INTRAVENOUS) ISAVUCONAZONIUM SULFATE
NDA Applicant: ASTELLAS NDA No.: 207501 Prod. No.: 001 RX (372MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6812238 DS* N-substituted carbamoyloxyalkyl-azolium derivatives Claim Types: Composition; Method of use; Compound Pat. Sub. Date(s): 001: Apr 1, 2015 | Apr 30, 2026 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Sep 6, 2020 PED | |
| Exclusivity Code: NPP - New patient population | Jun 8, 2027 PED | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Sep 6, 2022 PED | ODE-305: Treatment of invasive aspergillosis |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 8, 2031 PED | ODE-453: Treatment of invasive mucormycosis in pediatric patients 1 year of age and older |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 8, 2031 PED | ODE-459: Treatment of invasive aspergillosis in pediatric patients 1 year of age and older |
| Exclusivity Code: ODE - Orphan drug exclusivity | Sep 6, 2022 PED | ODE-90: Treatment of invasive mucormycosis in patients 18 years of age and older |
ASTELLAS
IZERVAY (SOLUTION) (INTRAVITREAL) AVACINCAPTAD PEGOL SODIUM
NDA Applicant: ASTELLAS NDA No.: 217225 Prod. No.: 001 RX (EQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7538211 DS* Aptamer therapeutics useful in the treatment of complement-related disorders Claim Types: Compound Pat. Sub. Date(s): 001: Aug 31, 2023 | Feb 14, 2025 | |
| Pat. No. 7579456 DS* Aptamer therapeutics useful in the treatment of complement-related disorders Claim Types: Composition Pat. Sub. Date(s): 001: Aug 31, 2023 | Feb 14, 2025 | |
| Pat. No. 7803931 DS* Aptamer therapeutics useful in the treatment of complement-related disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Aug 31, 2023 | Feb 14, 2025 | |
| Pat. No. 8236773 Aptamer therapeutics useful in the treatment of complement-related disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 31, 2023 | Nov 11, 2026 | U-3673: Treatment of geographic atrophy secondary to age-related macular degeneration by administerting avacincaptad pegol to the eye |
| Pat. No. 9617546 DS* Aptamer therapeutics useful in the treatment of complement-related disorders Claim Types: Compound; Method of use Pat. Sub. Date(s): 001: Aug 31, 2023 | Feb 14, 2025 | U-3673: Treatment of geographic atrophy secondary to age-related macular degeneration by administerting avacincaptad pegol to the eye |
| Pat. No. 10947544 DS* Aptamer therapeutics useful in the treatment of complement-related disorders Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Aug 31, 2023 | Feb 14, 2025 | U-3673: Treatment of geographic atrophy secondary to age-related macular degeneration by administerting avacincaptad pegol to the eye |
| Pat. No. 11273171 Methods for treating or preventing ophthalmological conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 31, 2023 | Jul 11, 2034 | U-3673: Treatment of geographic atrophy secondary to age-related macular degeneration by administerting avacincaptad pegol to the eye |
| Pat. No. 11491176 Methods for treating or preventing ophthalmological conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 31, 2023 | Jul 11, 2034 | U-3673: Treatment of geographic atrophy secondary to age-related macular degeneration by administerting avacincaptad pegol to the eye |
| Pat. No. 12016875 Methods for treating or preventing ophthalmological conditions Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Oct 1, 2024 | Jul 11, 2034 | U-3673: Treatment of geographic atrophy secondary to age-related macular degeneration by administerting avacincaptad pegol to the eye |
ASTELLAS
LEXISCAN (SOLUTION) (INTRAVENOUS) REGADENOSON [GENERIC AP]
Drug Classes: adenosine receptor agonist
NDA Applicant: ASTELLAS NDA No.: 022161 Prod. No.: 001 RX (0.4MG/5ML (0.08MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE47301 DP* Process for preparing an A2A-adenosine receptor agonist and its polymorphs Claim Types: Product-by-process; Formulation; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Apr 2, 2019 | Feb 2, 2027 | |
| Pat. No. 8106183 DS* Process for preparing an A.sub.2A-adenosine receptor agonist and its polymorphs Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Mar 8, 2012 | Feb 2, 2027 |
ASTELLAS
PROGRAF (CAPSULE) (ORAL) TACROLIMUS [GENERIC AB]
Drug Classes: calcineurin inhibitor immunosuppressant
NDA Applicant: ASTELLAS NDA No.: 050708 Prod. No.: 001 RX (EQ 1MG BASE); 002 RX (EQ 5MG BASE); 003 RX (EQ 0.5MG BASE)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity | May 24, 2025 | ODE-294: Prophylaxis of organ rejection in pediatric patients receiving allogeneic kidney or heart transplants, in combination with other immunosuppressants |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jul 16, 2028 | ODE-360: For prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic lung transplant |
ASTELLAS
PROGRAF (INJECTABLE) (INJECTION) TACROLIMUS
Drug Classes: calcineurin inhibitor immunosuppressant
NDA Applicant: ASTELLAS NDA No.: 050709 Prod. No.: 001 RX (EQ 5MG BASE/ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity | May 24, 2025 | ODE-294: Prophylaxis of organ rejection in pediatric patients receiving allogeneic kidney or heart transplants, in combination with other immunosuppressants |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jul 16, 2028 | ODE-360: For prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic lung transplant |
ASTELLAS
PROGRAF (FOR SUSPENSION) (ORAL) TACROLIMUS
Drug Classes: calcineurin inhibitor immunosuppressant
NDA Applicant: ASTELLAS NDA No.: 210115 Prod. No.: 001 RX (EQ 0.2MG BASE/PACKET); 002 RX (EQ 1MG BASE/PACKET)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity | May 24, 2025 | ODE-269: Prophylaxis of organ rejection in pediatric patients receiving allogeneic kidney transplant, liver transplants, and heart transplant, in combination with other immunosuppressants |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jul 16, 2028 | ODE-360: For prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic lung transplant |
ASTELLAS
VEOZAH (TABLET) (ORAL) FEZOLINETANT
Drug Classes: neurokinin 3 (NK3) receptor antagonist
NDA Applicant: ASTELLAS NDA No.: 216578 Prod. No.: 001 RX (45MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8871761 DS* NK-3 receptor selective antagonist compounds, pharmaceutical composition and methods for use in NK-3 receptors mediated disorders Claim Types: Compound Pat. Sub. Date(s): 001: Jun 6, 2023 | Apr 4, 2031 | |
| Pat. No. 9422299 DS* DP* Substituted [1,2,4]triazolo[4,3-a]pyrazines as selective NK-3 receptor antagonists Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jun 6, 2023 | Mar 28, 2034 | U-3622: Treatment of moderate to severe vasometer symptoms due to menopause |
| Pat. No. 9987274 N-acyl-(3-substituted)-(8-substituted)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazines as selective NK-3 receptor antagonists Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 6, 2023 | Mar 28, 2034 | U-3622: Treatment of moderate to severe vasometer symptoms due to menopause |
| Pat. No. 10836768 N-acyl-(3-substituted)-(8-substituted)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazines as selective NK-3 receptor antagonists Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 6, 2023 | Mar 28, 2034 | U-3621: Treatment of moderate to severe vasomotor symptoms due with menopause |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | May 12, 2028 |
ASTELLAS
VESICARE LS (SUSPENSION) (ORAL) SOLIFENACIN SUCCINATE
Drug Classes: muscarinic antagonist
NDA Applicant: ASTELLAS NDA No.: 209529 Prod. No.: 001 RX (1MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9918970 DP* Pharmaceutical composition comprising solifenacin Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 11, 2021 | May 18, 2031 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: W - Waiver | Nov 26, 2023 | Exclusivity on this application expiring on this date has been waived by sponsor |
ASTELLAS
XOSPATA (TABLET) (ORAL) GILTERITINIB FUMARATE
NDA Applicant: ASTELLAS NDA No.: 211349 Prod. No.: 001 RX (EQ 40MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8969336 DS* DP* Diamino heterocyclic carboxamide compound Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Dec 18, 2018 | Nov 28, 2032 | |
| Pat. No. 9487491 Diamino heterocyclic carboxamide compound Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 18, 2018 | Jul 28, 2030 | U-2456: Treatment of acute myeloid leukemia (AML) |
| Pat. No. 10786500 DP* Stable pharmaceutical composition for oral administration Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 28, 2020 | Jul 1, 2036 | |
| Pat. No. 11938130 DP* Stable pharmaceutical composition for oral administration Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 25, 2024 | Jul 1, 2036 | |
| Pat. No. 11938131 DP* Stable pharmaceutical composition for oral administration Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 25, 2024 | Jul 1, 2036 | |
| Pat. No. 11938132 DP* Stable pharmaceutical composition for oral administration Claim Types: Process; Product-by-process Pat. Sub. Date(s): 001: Apr 25, 2024 | Jul 1, 2036 | |
| Pat. No. 11938133 DP* Stable pharmaceutical composition for oral administration Claim Types: Process; Product-by-process Pat. Sub. Date(s): 001: Apr 25, 2024 | Jul 1, 2036 | |
| Pat. No. 11944620 DP* Stable pharmaceutical composition for oral administration Claim Types: Formulation; Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Apr 25, 2024 | Jul 1, 2036 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Nov 28, 2023 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 28, 2025 | ODE-222: Indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a fms-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test |
ASTELLAS
XTANDI (CAPSULE) (ORAL) ENZALUTAMIDE [GENERIC AB]
Drug Classes: androgen receptor inhibitor
NDA Applicant: ASTELLAS NDA No.: 203415 Prod. No.: 001 RX (40MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7709517 DS* DP* Diarylhydantoin compounds Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Sep 27, 2012 | Aug 13, 2027 | |
| Pat. No. 8183274 Treatment of hyperproliferative disorders with diarylhydantoin compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 27, 2012 | Aug 24, 2026 | U-1281: The treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel U-1588: The treatment of patients with metastatic castration-resistant prostate cancer (CRPC). U-2345: Treatment of patients with castration-resistant prostate cancer (CRPC) U-2708: The treatment of patients with metastatic castration-sensitive prostate cancer U-3763: Treatment of patients with non-metastatic castration-sensitive prostate cancer (NMCSPC) with biochemical recurrence (BCR) at high risk for metastasis |
| Pat. No. 9126941 Treatment of hyperproliferative disorders with diarylhydantoin compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 7, 2015 | May 15, 2026 | U-1588: The treatment of patients with metastatic castration-resistant prostate cancer (CRPC). U-2345: Treatment of patients with castration-resistant prostate cancer (CRPC) U-2708: The treatment of patients with metastatic castration-sensitive prostate cancer U-3763: Treatment of patients with non-metastatic castration-sensitive prostate cancer (NMCSPC) with biochemical recurrence (BCR) at high risk for metastasis |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Nov 17, 2026 | I-926: Treatment of patients with non-metastatic castration-sensitive prostate cancer (nmcspc) with biochemical recurrence at high risk for metastasis |
ASTELLAS
XTANDI (TABLET) (ORAL) ENZALUTAMIDE
Drug Classes: androgen receptor inhibitor
NDA Applicant: ASTELLAS NDA No.: 213674 Prod. No.: 001 RX (40MG); 002 RX (80MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7709517 DS* DP* Diarylhydantoin compounds Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Sep 3, 2020 | Aug 13, 2027 | |
| Pat. No. 8183274 Treatment of hyperproliferative disorders with diarylhydantoin compounds Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 3, 2020 | Aug 24, 2026 | U-2345: Treatment of patients with castration-resistant prostate cancer (CRPC) U-2708: The treatment of patients with metastatic castration-sensitive prostate cancer U-3763: Treatment of patients with non-metastatic castration-sensitive prostate cancer (NMCSPC) with biochemical recurrence (BCR) at high risk for metastasis |
| Pat. No. 9126941 Treatment of hyperproliferative disorders with diarylhydantoin compounds Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 3, 2020 | May 15, 2026 | U-2345: Treatment of patients with castration-resistant prostate cancer (CRPC) U-2708: The treatment of patients with metastatic castration-sensitive prostate cancer U-3763: Treatment of patients with non-metastatic castration-sensitive prostate cancer (NMCSPC) with biochemical recurrence (BCR) at high risk for metastasis |
| Pat. No. 11839689 DP* Formulations of enzalutamide Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 19, 2023 | Sep 11, 2033 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Nov 17, 2026 | I-926: Treatment of patients with non-metastatic castration-sensitive prostate cancer (nmcspc) with biochemical recurrence at high risk for metastasis |
ASTRAZENECA
AIRSUPRA (AEROSOL, METERED) (INHALATION) ALBUTEROL SULFATE; BUDESONIDE
Drug Classes: beta-2 adrenergic agonist == corticosteroid
NDA Applicant: ASTRAZENECA NDA No.: 214070 Prod. No.: 001 RX (EQ 0.09MG BASE/INH;0.08MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9415009 Compositions, methods and systems for respiratory delivery of two or more active agents Claim Types: Method of administration Pat. Sub. Date(s): 001: Jan 24, 2023 | May 28, 2030 | U-3509: As-needed treatment or prevention of bronchoconstriction and reduction of the risk of exacerbations in patients with asthma 18 years of age and older |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Jan 10, 2026 |
ASTRAZENECA
BEVESPI AEROSPHERE (AEROSOL, METERED) (INHALATION) FORMOTEROL FUMARATE; GLYCOPYRROLATE
Drug Classes: beta-2 adrenergic agonist == anticholinergic == antimuscarinic agent
NDA Applicant: ASTRAZENECA NDA No.: 208294 Prod. No.: 001 RX (0.0048MG/INH;0.0090MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8324266 Compositions, methods and systems for respiratory delivery of two or more active agents Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: May 20, 2016 | May 28, 2030 | U-2889: Use for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) |
| Pat. No. 8703806 Compositions, methods and propellant-based systems for respiratory delivery of glycopyrrolate and one or more active agents Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: May 20, 2016 | May 28, 2030 | U-2889: Use for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) |
| Pat. No. 8808713 DP* Compositions for pulmonary delivery of long-acting .beta..sub.2 adrenergic receptor agonists and associated methods and systems Claim Types: Formulation; Method of use; Method of administration Pat. Sub. Date(s): 001: May 20, 2016 | May 28, 2030 | U-2889: Use for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) |
| Pat. No. 8815258 Compositions, methods and systems for respiratory delivery of two or more active agents Claim Types: Method of use Pat. Sub. Date(s): 001: May 20, 2016 | Mar 17, 2031 | U-2889: Use for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) |
| Pat. No. 9415009 Compositions, methods and systems for respiratory delivery of two or more active agents Claim Types: Method of administration Pat. Sub. Date(s): 001: Sep 8, 2016 | May 28, 2030 | U-2889: Use for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) |
| Pat. No. 9463161 DP* Compositions for pulmonary delivery of long-acting muscarinic antagonists and associated methods and Claim Types: Method of administration; Formulation Pat. Sub. Date(s): 001: Oct 25, 2016 | May 28, 2030 | U-2889: Use for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) |
| Pat. No. 10716753 DP* Compositions for pulmonary delivery of long-acting muscarinic antagonists or long-acting B2 adrenergic receptor agonists and associated methods and systems Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 19, 2020 | May 28, 2030 | U-2889: Use for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) |
ASTRAZENECA
BRILINTA (TABLET) (ORAL) TICAGRELOR [GENERIC AB]
Drug Classes: P2Y12 platelet inhibitor
NDA Applicant: ASTRAZENECA NDA No.: 022433 Prod. No.: 001 RX (90MG); 002 RX (60MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE46276 DS* DP* Triazolo(4,5-D)pyrimidine compounds Claim Types: Compound; Composition; Process; Method of use Pat. Sub. Date(s): All strengths: Jan 17, 2017 | Apr 30, 2025 *PED | U-1935: Reduction of the rate of cardiovascular death, myocardial infarction, and stroke in patients with a history of myocardial infarction U-1936: Treatment of myocardial infarction and stroke in patients with acute coronary syndrome or a history of myocardial infarction U-1937: Treatment of myocardial infarction in patients with acute coronary syndrome or a history of myocardial infarction U-1938: Treatment of stroke in patients with acute coronary syndrome or a history of myocardial infarction U-2838: Reduction of the rate of a first myocardial infarction or stroke in patients with coronary artery disease at high risk for such events U-2839: Treatment of myocardial infarction or stroke in patients with coronary artery disease at high risk for such events U-2988: Reduction of the risk of stroke in patients with acute ischemic stroke or high-risk transient ischemic attack |
| Pat. No. 8425934 DP* Pharmaceutical compositions Claim Types: Formulation Pat. Sub. Date(s): 001: May 20, 2013; 002: Sep 30, 2015 | Oct 17, 2030 *PED | |
| Pat. No. 10300065 Method of treating or prevention of atherothrombotic events in patients with history of myocardial infarction Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 24, 2019 | Jul 27, 2036 *PED | U-2541: Reducing the rate of cardiovascular death, myocardial infarction (MI), and stroke in a patient receiving 75-100 mg aspirin daily with a history of MI by administering 60 mg ticagrelor twice daily U-2542: Reducing the rate of cardiovascular death, myocardial infarction, and stroke in a patient receiving 75-100 mg aspirin daily and having or who had acute coronary syndrome by administering 60 mg ticagrelor twice daily |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | May 5, 2024 PED | I-848: Reduce the risk of stroke in patients with acute ischemic stroke (NIH stroke scale score <=5) or high-risk transient ischemic attack (TIA) |
| Exclusivity Code: M - Miscellaneous | Nov 9, 2025 PED | M-283: Information added to section 8.4 of the labeling to include the result of study HESTIA3 |
ASTRAZENECA
CALQUENCE (CAPSULE) (ORAL) ACALABRUTINIB
Drug Classes: kinase inhibitor
NDA Applicant: ASTRAZENECA NDA No.: 210259 Prod. No.: 001 RX (100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7459554 DS* Imidazopyrazine tyrosine kinase inhibitors Claim Types: Compound Pat. Sub. Date(s): 001: Apr 13, 2018 | Nov 24, 2026 | |
| Pat. No. 9290504 DS* DP* 4-imidazopyridazin-1-yl-benzamides and 4-imidazotriazin-1-yl-benzamides as BTK inhibitors Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Nov 28, 2017 | Jul 11, 2032 | |
| Pat. No. 9758524 4-imidazopyridazin-1-yl-benzamides as BTK inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 28, 2017 | Jul 11, 2032 | U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy |
| Pat. No. 9796721 DS* DP* Crystal forms of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1- yl)-N-(pyridin-2-yl)benzamide Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Nov 28, 2017 | Jul 1, 2036 | U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy U-2666: Treatment of adult patients with chronic lymphocytic leukemia U-2667: Treatment of adult patients with small lymphocytic leukemia U-2668: Treatment of adult patients with previously untreated chronic lymphocytic leukemia in combination with obinutuzumab U-2669: Treatment of adult patients with previously untreated small lymphocytic leukemia in combination with obinutuzumab U-2670: Treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic leukemia U-2671: Treatment of adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic leukemia in combination with obinutuzumab |
| Pat. No. 10167291 DP* Pharmaceutical composition comprising a crystal form of (S)-4-(8-amino-3-(1-(but-2-ynoyl) pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide Claim Types: Composition; Method of use Pat. Sub. Date(s): 001: Jan 24, 2019 | Jul 1, 2036 | U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy U-2666: Treatment of adult patients with chronic lymphocytic leukemia U-2667: Treatment of adult patients with small lymphocytic leukemia U-2668: Treatment of adult patients with previously untreated chronic lymphocytic leukemia in combination with obinutuzumab U-2669: Treatment of adult patients with previously untreated small lymphocytic leukemia in combination with obinutuzumab U-2670: Treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic leukemia U-2671: Treatment of adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic leukemia in combination with obinutuzumab |
| Pat. No. 10239883 4-imidazopyridazin-1-yl-benzamides as BTK inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 12, 2019 | Jul 11, 2032 | U-2666: Treatment of adult patients with chronic lymphocytic leukemia U-2668: Treatment of adult patients with previously untreated chronic lymphocytic leukemia in combination with obinutuzumab |
| Pat. No. 10272083 Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor Claim Types: Method of use Pat. Sub. Date(s): 001: May 22, 2019 | Jan 21, 2035 | U-2519: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy by administering 100 mg of acalabrutinib twice daily U-2682: Treatment of adult patients with chronic lymphocytic leukemia by administering 100mg of acalabrutinib twice daily U-2683: Treatment of adult patients with small lymphocytic leukemia by administering 100mg of acalabrutinib twice daily U-2684: Treatment of adult patients with previously untreated chronic lymphocytic leukemia by administering 100 mg of acalabrutinib twice daily in combination with obinutuzumab U-2685: Treatment of adult patients with previously untreated small lymphocytic leukemia by administering 100 mg of acalabrutinib twice daily in combination with obinutuzumab U-2686: Treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic leukemia by administering 100 mg of acalabrutinib twice daily U-2687: Treatment of adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic leukemia in combination with obinutuzumab by administering 100 mg of acalabrutinib twice daily |
| Pat. No. 11771696 Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 30, 2023 | Jan 21, 2035 | U-3710: Treatment of adult patients with previously untreated chronic lymphocytic leukemia by orally administering 100 mg of acalabrutinib twice daily in combination with intravenous administration of obinutuzumab |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 31, 2024 | ODE-175: Treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 21, 2026 | ODE-274: Indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) |
ASTRAZENECA
CALQUENCE (TABLET) (ORAL) ACALABRUTINIB MALEATE
Drug Classes: kinase inhibitor
NDA Applicant: ASTRAZENECA NDA No.: 216387 Prod. No.: 001 RX (EQ 100MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7459554 DS* Imidazopyrazine tyrosine kinase inhibitors Claim Types: Compound Pat. Sub. Date(s): 001: Sep 1, 2022 | Nov 24, 2026 | |
| Pat. No. 9290504 DS* DP* 4-imidazopyridazin-1-yl-benzamides and 4-imidazotriazin-1-yl-benzamides as BTK inhibitors Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Sep 1, 2022 | Jul 11, 2032 | |
| Pat. No. 9758524 4-imidazopyridazin-1-yl-benzamides as BTK inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 1, 2022 | Jul 11, 2032 | U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy |
| Pat. No. 10239883 4-imidazopyridazin-1-yl-benzamides as BTK inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 1, 2022 | Jul 11, 2032 | U-2666: Treatment of adult patients with chronic lymphocytic leukemia U-2668: Treatment of adult patients with previously untreated chronic lymphocytic leukemia in combination with obinutuzumab |
| Pat. No. 10272083 Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 1, 2022 | Jan 21, 2035 | U-2519: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy by administering 100 mg of acalabrutinib twice daily U-2682: Treatment of adult patients with chronic lymphocytic leukemia by administering 100mg of acalabrutinib twice daily U-2683: Treatment of adult patients with small lymphocytic leukemia by administering 100mg of acalabrutinib twice daily U-2684: Treatment of adult patients with previously untreated chronic lymphocytic leukemia by administering 100 mg of acalabrutinib twice daily in combination with obinutuzumab U-2685: Treatment of adult patients with previously untreated small lymphocytic leukemia by administering 100 mg of acalabrutinib twice daily in combination with obinutuzumab U-2686: Treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic leukemia by administering 100 mg of acalabrutinib twice daily U-2687: Treatment of adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic leukemia in combination with obinutuzumab by administering 100 mg of acalabrutinib twice daily |
| Pat. No. 11059829 DS* DP* Crystal forms of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-- yl)-N-(pyridin-2-yl)benzamide maleate Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): 001: Sep 1, 2022 | Jul 1, 2036 | U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy U-2666: Treatment of adult patients with chronic lymphocytic leukemia U-2667: Treatment of adult patients with small lymphocytic leukemia U-2668: Treatment of adult patients with previously untreated chronic lymphocytic leukemia in combination with obinutuzumab U-2669: Treatment of adult patients with previously untreated small lymphocytic leukemia in combination with obinutuzumab U-2670: Treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic leukemia U-2671: Treatment of adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic leukemia in combination with obinutuzumab |
| Pat. No. 11771696 Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 30, 2023 | Jan 21, 2035 | U-3710: Treatment of adult patients with previously untreated chronic lymphocytic leukemia by orally administering 100 mg of acalabrutinib twice daily in combination with intravenous administration of obinutuzumab |
ASTRAZENECA
DALIRESP (TABLET) (ORAL) ROFLUMILAST [GENERIC AB]
Drug Classes: phosphodiesterase 4 inhibitor
NDA Applicant: ASTRAZENECA NDA No.: 022522 Prod. No.: 001 RX (500MCG); 002 RX (250MCG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8536206 Process for the preparation of roflumilast Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 15, 2013; 002: Mar 14, 2018 | Mar 8, 2024 | U-1115: Treatment to reduce the risk of copd exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations |
| Pat. No. 8604064 Process for the preparation of roflumilast Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 8, 2014; 002: Mar 14, 2018 | Mar 8, 2024 | U-1115: Treatment to reduce the risk of copd exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations |
| Pat. No. 8618142 DP* Process for the preparation of roflumilast Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 30, 2014; 002: Mar 14, 2018 | Mar 8, 2024 |
ASTRAZENECA
EPANOVA (CAPSULE) (ORAL) OMEGA-3-CARBOXYLIC ACIDS
NDA Applicant: ASTRAZENECA NDA No.: 205060 Prod. No.: 001 DISC (1GM CONTAINS AT LEAST 850MG OF POLYUNSATURATED FATTY ACIDS)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7960370 DP* Type A gelatin capsule containing PUFA in free acid form Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 3, 2014 | Dec 20, 2026 | |
| Pat. No. 8383678 DP* Type a gelatin capsule containing PUFA in free acid form Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jun 3, 2014 | Feb 7, 2025 | U-1511: Treatment of hypertriglyceridemia |
| Pat. No. 9012501 DP* Type A gelatin capsule containing PUFA in free acid form Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: May 20, 2015 | Feb 7, 2025 | U-1511: Treatment of hypertriglyceridemia |
| Pat. No. 9050308 DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form Claim Types: Method of treatment Pat. Sub. Date(s): 001: Jul 7, 2015 | Jan 4, 2033 | U-1511: Treatment of hypertriglyceridemia |
| Pat. No. 9050309 DS* DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 7, 2015 | Jan 4, 2033 | |
| Pat. No. 9132112 DP* Type A gelatin capsule containing PUFA in free acid form Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 30, 2015 | Feb 7, 2025 | U-1511: Treatment of hypertriglyceridemia |
| Pat. No. 10117844 DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 4, 2018 | Jan 4, 2033 | U-2447: Treatment of severe hypertriglyceridemia (500 mg/dl) in adult patients as an adjunct to diet |
ASTRAZENECA
KOSELUGO (CAPSULE) (ORAL) SELUMETINIB SULFATE
Drug Classes: kinase inhibitor
NDA Applicant: ASTRAZENECA NDA No.: 213756 Prod. No.: 001 RX (EQ 10MG BASE); 002 RX (EQ 25MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7425637 DS* N3 alkylated benzimidazole derivatives as MEK inhibitors Claim Types: Compound Pat. Sub. Date(s): All strengths: May 6, 2020 | Mar 13, 2025 | |
| Pat. No. 8178693 DS* DP* N3 alkylated benzimidazole derivatives as MEK inhibitors Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: May 6, 2020 | Mar 13, 2025 | |
| Pat. No. 9156795 DS* DP* Hydrogen sulfate salt Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): All strengths: May 6, 2020 | Dec 12, 2026 | |
| Pat. No. 9562017 DS* Hydrogen sulfate salt Claim Types: Method of use; Product-by-process of a new polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: May 6, 2020 | Dec 12, 2026 | U-2800: Treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN) |
| Pat. No. 11813246 DP* Pharmaceutical composition Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 7, 2023 | Mar 26, 2029 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Apr 10, 2025 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 10, 2027 | ODE-288: Indicated for the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN) |
ASTRAZENECA
LOKELMA (FOR SUSPENSION) (ORAL) SODIUM ZIRCONIUM CYCLOSILICATE
NDA Applicant: ASTRAZENECA NDA No.: 207078 Prod. No.: 001 RX (5GM/PACKET)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8802152 DS* Microporous zirconium silicate for the treatment of hyperkalemia Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 12, 2018 | Apr 19, 2032 | |
| Pat. No. 8808750 Microporous zirconium silicate for the treatment of hyperkalemia Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 12, 2018 | Feb 10, 2032 | U-2312: Treatment of hyperkalemia in adults |
| Pat. No. 8877255 DS* Microporous zirconium silicate for the treatment of hyperkalemia Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 12, 2018 | Oct 22, 2033 | |
| Pat. No. 9592253 DS* Extended use zirconium silicate compositions and methods of use thereof Claim Types: Product-by-process; Method of use Pat. Sub. Date(s): 001: Jun 12, 2018 | Oct 14, 2035 | U-2312: Treatment of hyperkalemia in adults |
| Pat. No. 9844567 Microporous zirconium silicate for the treatment of hyperkalemia Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 12, 2018 | Feb 10, 2032 | U-2312: Treatment of hyperkalemia in adults |
| Pat. No. 9861658 Microporous zirconium silicate for the treatment of hyperkalemia Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 12, 2018 | Feb 10, 2032 | U-2312: Treatment of hyperkalemia in adults |
| Pat. No. 9913860 DS* Microporous zirconium silicate for the treatment of hyperkalemia Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jan 23, 2019 | Oct 22, 2033 | U-2312: Treatment of hyperkalemia in adults |
| Pat. No. 10300087 DS* Extended use zirconium silicate compositions and methods of use thereof Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jul 25, 2019 | Oct 14, 2035 | U-2312: Treatment of hyperkalemia in adults |
| Pat. No. 10335432 Microporous zirconium silicate for the treatment of hyperkalemia Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2019 | Feb 10, 2032 | U-2312: Treatment of hyperkalemia in adults |
| Pat. No. 10398730 Microporous zirconium silicate for the treatment of hyperkalemia Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 1, 2019 | Feb 10, 2032 | U-2312: Treatment of hyperkalemia in adults |
| Pat. No. 10413569 DS* Microporous zirconium silicate for the treatment of hyperkalemia Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 1, 2019 | Feb 10, 2032 | |
| Pat. No. 10695365 DS* Microporous zirconium silicate for the treatment of hyperkalemia Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 28, 2020 | Oct 22, 2033 | |
| Pat. No. 11406662 DS* Microporous zirconium silicate for the treatment of hyperkalemia Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Sep 7, 2022 | Feb 10, 2032 | |
| Pat. No. 11738044 Extended use zirconium silicate compositions and methods of use thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 21, 2023 | Oct 14, 2035 | U-2312: Treatment of hyperkalemia in adults |
ASTRAZENECA
LOKELMA (FOR SUSPENSION) (ORAL) SODIUM ZIRCONIUM CYCLOSILICATE
NDA Applicant: ASTRAZENECA NDA No.: 207078 Prod. No.: 002 RX (10GM/PACKET)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8802152 DS* Microporous zirconium silicate for the treatment of hyperkalemia Claim Types: Formulation Pat. Sub. Date(s): 002: Jun 12, 2018 | Apr 19, 2032 | |
| Pat. No. 8808750 Microporous zirconium silicate for the treatment of hyperkalemia Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 12, 2018 | Feb 10, 2032 | U-2312: Treatment of hyperkalemia in adults |
| Pat. No. 8877255 DS* Microporous zirconium silicate for the treatment of hyperkalemia Claim Types: Formulation Pat. Sub. Date(s): 002: Jun 12, 2018 | Oct 22, 2033 | |
| Pat. No. 9592253 DS* Extended use zirconium silicate compositions and methods of use thereof Claim Types: Product-by-process; Method of use Pat. Sub. Date(s): 002: Jun 12, 2018 | Oct 14, 2035 | U-2312: Treatment of hyperkalemia in adults |
| Pat. No. 9844567 Microporous zirconium silicate for the treatment of hyperkalemia Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 12, 2018 | Feb 10, 2032 | U-2312: Treatment of hyperkalemia in adults |
| Pat. No. 9861658 Microporous zirconium silicate for the treatment of hyperkalemia Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 12, 2018 | Feb 10, 2032 | U-2312: Treatment of hyperkalemia in adults |
| Pat. No. 9913860 DS* Microporous zirconium silicate for the treatment of hyperkalemia Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Jan 23, 2019 | Oct 22, 2033 | U-2312: Treatment of hyperkalemia in adults |
| Pat. No. 10300087 DS* Extended use zirconium silicate compositions and methods of use thereof Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Jul 25, 2019 | Oct 14, 2035 | U-2312: Treatment of hyperkalemia in adults |
| Pat. No. 10398730 Microporous zirconium silicate for the treatment of hyperkalemia Claim Types: Method of use Pat. Sub. Date(s): 002: Oct 1, 2019 | Feb 10, 2032 | U-2312: Treatment of hyperkalemia in adults |
| Pat. No. 10413569 DS* Microporous zirconium silicate for the treatment of hyperkalemia Claim Types: Formulation Pat. Sub. Date(s): 002: Oct 1, 2019 | Feb 10, 2032 | |
| Pat. No. 10695365 DS* Microporous zirconium silicate for the treatment of hyperkalemia Claim Types: Formulation Pat. Sub. Date(s): 002: Jul 28, 2020 | Oct 22, 2033 | |
| Pat. No. 11406662 DS* Microporous zirconium silicate for the treatment of hyperkalemia Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 002: Sep 7, 2022 | Feb 10, 2032 | |
| Pat. No. 11738044 Extended use zirconium silicate compositions and methods of use thereof Claim Types: Method of use Pat. Sub. Date(s): 002: Sep 21, 2023 | Oct 14, 2035 | U-2312: Treatment of hyperkalemia in adults |
ASTRAZENECA
LYNPARZA (CAPSULE) (ORAL) OLAPARIB
Drug Classes: poly (ADP-ribose) polymerase (PARP) inhibitor
NDA Applicant: ASTRAZENECA NDA No.: 206162 Prod. No.: 001 DISC (50MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7449464 DS* DP* Phthalazinone derivatives Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 15, 2015 | Oct 11, 2024 | |
| Pat. No. 7981889 DS* DP* Phthalazinone derivatives Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 15, 2015 | Oct 11, 2024 | |
| Pat. No. 8143241 DNA damage repair inhibitors for treatment of cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 15, 2015 | Aug 12, 2027 | U-1634: Treatment of BRCA mutated ovarian cancer using PARP inhibitor |
| Pat. No. 8247416 DS* Phthalazinone derivative Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Jan 15, 2015 | Sep 24, 2028 | |
| Pat. No. 8859562 Use of RNAI inhibiting PARP activity for the manufacture of a medicament for the treatment of cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 15, 2015 | Aug 4, 2031 | U-1634: Treatment of BRCA mutated ovarian cancer using PARP inhibitor |
| Pat. No. 8912187 Phthalazinone derivatives Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 15, 2015 | Mar 12, 2024 | U-1634: Treatment of BRCA mutated ovarian cancer using PARP inhibitor |
ASTRAZENECA
LYNPARZA (TABLET) (ORAL) OLAPARIB
Drug Classes: poly (ADP-ribose) polymerase (PARP) inhibitor
NDA Applicant: ASTRAZENECA NDA No.: 208558 Prod. No.: 001 RX (100MG); 002 RX (150MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7449464 DS* DP* Phthalazinone derivatives Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Sep 15, 2017 | Sep 8, 2027 | |
| Pat. No. 7981889 DS* DP* Phthalazinone derivatives Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Sep 15, 2017 | Oct 11, 2024 | |
| Pat. No. 8071579 DNA damage repair inhibitors for the treatment of cancer Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 18, 2020 | Aug 12, 2027 | U-2480: Maintenance treatment of GBRCA- or SBRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy U-2482: Treatment of HR-negative, HER-2 negative, GBRCA-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting U-2483: Treatment of HR-positive, HER-2 negative, gbrca-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting, and with endocrine therapy or are inappropriate for endocrine therapy U-2716: Maintenance treatment of deleterious or suspected deleterious gbrca-mutated metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen U-2819: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation U-2820: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability U-2821: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation U-2822: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability U-2823: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation U-2824: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability U-2832: Treatment of deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone U-2833: Treatment of deleterious or suspected deleterious germline or somatic BRCA-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone U-3333: Adjuvant treatment of patients with GBRCA-mutated human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy U-3631: Treatment of deleterious or suspected deleterious brca-mutated metastatic castration-resistant prostate cancer in combination with abiraterone and prednisone or prednisolone U-3695: Maintenance treatment of deleterious or suspected deleterious germline or somatic BRCA-muted recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy |
| Pat. No. 8143241 DNA damage repair inhibitors for treatment of cancer Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 15, 2017 | Aug 12, 2027 | U-2480: Maintenance treatment of GBRCA- or SBRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy U-2482: Treatment of HR-negative, HER-2 negative, GBRCA-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting U-2483: Treatment of HR-positive, HER-2 negative, gbrca-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting, and with endocrine therapy or are inappropriate for endocrine therapy U-2716: Maintenance treatment of deleterious or suspected deleterious gbrca-mutated metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen U-2819: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation U-2820: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability U-2821: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation U-2822: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability U-2823: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation U-2824: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability U-2832: Treatment of deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone U-2833: Treatment of deleterious or suspected deleterious germline or somatic BRCA-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone U-3333: Adjuvant treatment of patients with GBRCA-mutated human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy U-3631: Treatment of deleterious or suspected deleterious brca-mutated metastatic castration-resistant prostate cancer in combination with abiraterone and prednisone or prednisolone U-3695: Maintenance treatment of deleterious or suspected deleterious germline or somatic BRCA-muted recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy |
| Pat. No. 8475842 DP* Immediate release pharmaceutical formulation of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-p- hthalazin-1-one Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 15, 2017 | Dec 31, 2029 | |
| Pat. No. 8859562 Use of RNAI inhibiting PARP activity for the manufacture of a medicament for the treatment of cancer Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 15, 2017 | Aug 4, 2031 | U-2101: Maintenance treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy U-2103: Maintenance treatment of BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy U-2480: Maintenance treatment of GBRCA- or SBRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy U-2482: Treatment of HR-negative, HER-2 negative, GBRCA-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting U-2483: Treatment of HR-positive, HER-2 negative, gbrca-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting, and with endocrine therapy or are inappropriate for endocrine therapy U-2716: Maintenance treatment of deleterious or suspected deleterious gbrca-mutated metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen U-2819: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation U-2820: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability U-2821: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation U-2822: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability U-2823: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation U-2824: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability U-2832: Treatment of deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone U-2833: Treatment of deleterious or suspected deleterious germline or somatic BRCA-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone U-3333: Adjuvant treatment of patients with GBRCA-mutated human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy U-3631: Treatment of deleterious or suspected deleterious brca-mutated metastatic castration-resistant prostate cancer in combination with abiraterone and prednisone or prednisolone U-3695: Maintenance treatment of deleterious or suspected deleterious germline or somatic BRCA-muted recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy |
| Pat. No. 8912187 Phthalazinone derivatives Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 15, 2017 | Mar 12, 2024 | U-2480: Maintenance treatment of GBRCA- or SBRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy U-2482: Treatment of HR-negative, HER-2 negative, GBRCA-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting U-2483: Treatment of HR-positive, HER-2 negative, gbrca-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting, and with endocrine therapy or are inappropriate for endocrine therapy U-2819: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation U-2820: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability U-2821: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation U-2822: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability U-2823: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation U-2824: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability U-3333: Adjuvant treatment of patients with GBRCA-mutated human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy U-3695: Maintenance treatment of deleterious or suspected deleterious germline or somatic BRCA-muted recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy |
| Pat. No. 9169235 Phthalazinone derivatives Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 18, 2020 | Mar 12, 2024 | U-2832: Treatment of deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone U-2833: Treatment of deleterious or suspected deleterious germline or somatic BRCA-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone U-3631: Treatment of deleterious or suspected deleterious brca-mutated metastatic castration-resistant prostate cancer in combination with abiraterone and prednisone or prednisolone |
| Pat. No. 9566276 Phthalazinone derivatives Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 22, 2020 | Mar 12, 2024 | U-2716: Maintenance treatment of deleterious or suspected deleterious gbrca-mutated metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen |
| Pat. No. 11633396 DP* Immediate release pharmaceutical formulation of 4-[3-(4- cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H- phthalazin-1-one Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 19, 2023 | Oct 7, 2029 | |
| Pat. No. 11970530 Methods of treating homologous recombination deficient cancer Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 28, 2024 | Oct 25, 2041 | U-3929: Maintenance treatment with 15 mg/kg of body weight bevacizumab every three weeks of advanced epithelial ovarian cancer in complete or partial response to first-line platinum-based chemotherapy and associated with hrd-positive status U-3930: Maintenance treatment with 15 mg/kg of body weight bevacizumab every three weeks of fallopian tube cancer in complete or partial response to first-line platinum-based chemotherapy and associated with hrd-positive status U-3931: Maintenance treatment with 15 mg/kg of body weight bevacizumab every three weeks of primary peritoneal cancer in complete or partial response to first-line platinum-based chemotherapy and associated with hrd-positive status |
| Pat. No. 11975001 DP* Immediate release pharmaceutical formulation of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 3, 2024 | Oct 7, 2029 | |
| Pat. No. 12048695 DP* Immediate release pharmaceutical formulation of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 23, 2024 | Oct 7, 2029 | |
| Pat. No. 12144810 DP* Immediate release pharmaceutical formulation of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 10, 2024 | Oct 7, 2029 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Mar 11, 2025 | I-885: For the adjuvant treatment of adult patients with deleterious or suspected deleterious GBRCA mutated HER2-negative high-risk early breast cancer who have previously been treated with neoadjuvant or adjuvant chemotherapy |
| Exclusivity Code: I - New Indication | May 31, 2026 | I-914: In combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAM) metastatic castration-resistant prostate cancer (MCRPC) |
| Exclusivity Code: ODE - Orphan drug exclusivity | Aug 17, 2024 | ODE-180: Maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy |
| Exclusivity Code: ODE - Orphan drug exclusivity | Aug 17, 2024 | ODE-181: Treatment of adult patients with deleterious or suspected deleterious germline brca-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 19, 2025 | ODE-226: Maintenance treatment of adults with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer in complete or partial response to first-line platinum-based chemotherapy |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 27, 2026 | ODE-283: Maintenance tx of adults w/ deleterious or suspected deleterious gbrcam metastatic pancreatic adenocarcinoma whose dz has not progressed on >=16wks of 1st line platinum based chemo regimen. select pts for therapy based on approved companion diagnostic |
| Exclusivity Code: ODE - Orphan drug exclusivity | May 8, 2027 | ODE-306: W/ bevacizumab for maint tx of adults w/ adv epithelial ovarian, fallopian tube, or primary peritoneal CA in complete or partial response to 1st line pt based chemo & whose CA is assoc w/ homologous recomb def + status defined by genomic instability |
ASTRAZENECA
SYMBICORT (AEROSOL, METERED) (INHALATION) BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE [GENERIC AB]
Drug Classes: corticosteroid == beta-2 adrenergic agonist
NDA Applicant: ASTRAZENECA NDA No.: 021929 Prod. No.: 001 RX (0.08MG/INH;0.0045MG/INH); 002 RX (0.16MG/INH;0.0045MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7587988 DP* Inhaler device counter Claim Types: Device Pat. Sub. Date(s): All strengths: None | Oct 10, 2026 *PED | |
| Pat. No. 8387615 DP* Inhaler cap strap Claim Types: Device Pat. Sub. Date(s): 001: Apr 4, 2013; 002: None | Sep 26, 2027 *PED | |
| Pat. No. 8528545 DP* Inhaler device that reduces the risk for miscounting a dosage Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 9, 2013 | Apr 16, 2029 *PED | |
| Pat. No. 8616196 DP* Inhalation device and a method for assembling said inhalation device Claim Types: Device; Process Pat. Sub. Date(s): All strengths: Jan 29, 2014 | Oct 7, 2029 *PED | |
| Pat. No. 8875699 DP* Inhaler cap strap Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2014 | May 10, 2025 *PED |
ASTRAZENECA
SYMBICORT AEROSPHERE (AEROSOL, METERED) (INHALATION) BUDESONIDE; FORMOTEROL FUMARATE
Drug Classes: corticosteroid == beta-2 adrenergic agonist
NDA Applicant: ASTRAZENECA NDA No.: 216579 Prod. No.: 001 RX (0.16MG/INH;0.0048MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9415009 Compositions, methods and systems for respiratory delivery of two or more active agents Claim Types: Method of administration Pat. Sub. Date(s): 001: May 12, 2023 | May 28, 2030 | U-3203: Maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) |
| Pat. No. 10716753 DP* Compositions for pulmonary delivery of long-acting muscarinic antagonists or long-acting B2 adrenergic receptor agonists and associated methods and systems Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: May 12, 2023 | May 28, 2030 | U-3203: Maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) |
ASTRAZENECA
TAGRISSO (TABLET) (ORAL) OSIMERTINIB MESYLATE
Drug Classes: kinase inhibitor
NDA Applicant: ASTRAZENECA NDA No.: 208065 Prod. No.: 001 RX (EQ 40MG BASE); 002 RX (EQ 80MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8946235 DS* DP* 2-(2,4,5-substituted-anilino) pyrimidine compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Dec 11, 2015 | Aug 8, 2032 | U-1777: Treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), who have progressed on or after EGFR TKI therapy U-2289: Treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21L858R mutations U-3016: Adjuvant therapy after tumor resection in patients with non-small cell lung cancer(NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19deletions or exon 21 L858R mutations U-3823: Treatment of patients with locally advanced or metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 L858R mutations in combination with pemetrexed and platinum-based chemotherapy U-4010: Treatment of patients with locally advanced, unresectable (stage iii) nsclc whose disease has not progressed during or following platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations |
| Pat. No. 9732058 DS* DP* 2-(2,4,5-substituted-anilino)pyrimidine compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Aug 29, 2017 | Jul 25, 2032 | U-1777: Treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), who have progressed on or after EGFR TKI therapy U-2289: Treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21L858R mutations U-3016: Adjuvant therapy after tumor resection in patients with non-small cell lung cancer(NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19deletions or exon 21 L858R mutations U-3823: Treatment of patients with locally advanced or metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 L858R mutations in combination with pemetrexed and platinum-based chemotherapy U-4010: Treatment of patients with locally advanced, unresectable (stage iii) nsclc whose disease has not progressed during or following platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations |
| Pat. No. 10183020 DP* Pharmaceutical compositions comprising AZD9291 Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Feb 12, 2019 | Jan 2, 2035 | U-1777: Treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), who have progressed on or after EGFR TKI therapy U-2289: Treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21L858R mutations U-3016: Adjuvant therapy after tumor resection in patients with non-small cell lung cancer(NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19deletions or exon 21 L858R mutations U-3823: Treatment of patients with locally advanced or metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 L858R mutations in combination with pemetrexed and platinum-based chemotherapy U-4010: Treatment of patients with locally advanced, unresectable (stage iii) nsclc whose disease has not progressed during or following platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations |
| Pat. No. 11524951 DS* DP* 2-(2,4,5-substituted-anilino)pyrimidine compounds Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Jan 11, 2023 | Jul 25, 2032 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Dec 18, 2023 | I-853: Indication of osimertinib as adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test |
| Exclusivity Code: I - New Indication | Feb 16, 2027 | I-941: In combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test |
| Exclusivity Code: I - New Indication | Sep 25, 2027 | I-952: Treatment of adult patients with locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 18, 2025 | ODE-176: Indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 18, 2027 | ODE-337: For adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test |
ASTRAZENECA
TRUQAP (TABLET) (ORAL) CAPIVASERTIB
NDA Applicant: ASTRAZENECA NDA No.: 218197 Prod. No.: 001 RX (160MG); 002 RX (200MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8101623 DS* DP* Substituted pyrrolo[2,3-d]pyrimidine as a protein kinase B inhibitor Claim Types: Compound; Composition; Method of use; Process Pat. Sub. Date(s): All strengths: Dec 13, 2023 | Mar 10, 2030 | U-3762: Treatment with fulvestrant of hr-pos. her2-neg. locally advanced or metastatic breast cancer with PIK3CA/AKT1/PTEN-alteration(s) following progression on endocrine therapy in the metastatic setting or recurrence on or within 12 months of adjuvant therapy |
| Pat. No. 8809336 Ortho-condensed pyridine and pyrimidine derivatives (e.g., purines) as protein kinases inhibitors Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 13, 2023 | Oct 25, 2025 | U-3762: Treatment with fulvestrant of hr-pos. her2-neg. locally advanced or metastatic breast cancer with PIK3CA/AKT1/PTEN-alteration(s) following progression on endocrine therapy in the metastatic setting or recurrence on or within 12 months of adjuvant therapy |
| Pat. No. 9006430 DP* Ortho-condensed pyridine and pyrimidine derivatives (e.g., purines) as protein Claim Types: Composition Pat. Sub. Date(s): All strengths: Dec 13, 2023 | Oct 25, 2025 | |
| Pat. No. 9487525 DS* DP* Crystalline forms of (s)-4-amino-n-(1-(4-chlorophenyl)-3-hydroxypropyl)-1-(7h-pyrrolo[2,3-d]pyrimidin-4-yl) piperidine-4-carboxamide Claim Types: New polymorph, salt or hydrate; Composition; Formulation Pat. Sub. Date(s): All strengths: Dec 13, 2023 | Apr 16, 2033 | |
| Pat. No. 10039766 Crystalline forms of (s)-4-amino-n-(1-(4-chlorophenyl)-3-hydroxypropyl)-1-(7h-pyrrolo[2,3-d] pyrimidin-4-y1) piperidine-4-carboxamide Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 13, 2023 | Apr 16, 2033 | U-3762: Treatment with fulvestrant of hr-pos. her2-neg. locally advanced or metastatic breast cancer with PIK3CA/AKT1/PTEN-alteration(s) following progression on endocrine therapy in the metastatic setting or recurrence on or within 12 months of adjuvant therapy |
| Pat. No. 10059714 DS* DP* Protein kinase B inhibitors Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Dec 13, 2023 | Oct 10, 2028 | |
| Pat. No. 10654855 Protein kinase B inhibitors Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 13, 2023 | Oct 10, 2028 | U-3762: Treatment with fulvestrant of hr-pos. her2-neg. locally advanced or metastatic breast cancer with PIK3CA/AKT1/PTEN-alteration(s) following progression on endocrine therapy in the metastatic setting or recurrence on or within 12 months of adjuvant therapy |
| Pat. No. 11760760 Protein kinase B inhibitors Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 13, 2023 | Oct 10, 2028 | U-3762: Treatment with fulvestrant of hr-pos. her2-neg. locally advanced or metastatic breast cancer with PIK3CA/AKT1/PTEN-alteration(s) following progression on endocrine therapy in the metastatic setting or recurrence on or within 12 months of adjuvant therapy |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Nov 16, 2028 |
ASTRAZENECA AB
BREZTRI AEROSPHERE (AEROSOL, METERED) (INHALATION) BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE
Drug Classes: corticosteroid == beta-2 adrenergic agonist == anticholinergic == antimuscarinic agent
NDA Applicant: ASTRAZENECA AB NDA No.: 212122 Prod. No.: 001 RX (0.16MG/INH;0.0048MG/INH;0.009MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8324266 Compositions, methods and systems for respiratory delivery of two or more active agents Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Aug 18, 2020 | May 28, 2030 | U-2889: Use for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) |
| Pat. No. 8703806 Compositions, methods and propellant-based systems for respiratory delivery of glycopyrrolate and one or more active agents Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Aug 18, 2020 | May 28, 2030 | U-2889: Use for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) |
| Pat. No. 8808713 DP* Compositions for pulmonary delivery of long-acting .beta..sub.2 adrenergic receptor agonists and associated methods and systems Claim Types: Formulation; Method of use; Method of administration Pat. Sub. Date(s): 001: Aug 18, 2020 | May 28, 2030 | U-2889: Use for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) |
| Pat. No. 8815258 Compositions, methods and systems for respiratory delivery of two or more active agents Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 18, 2020 | Mar 17, 2031 | U-2889: Use for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) |
| Pat. No. 9415009 Compositions, methods and systems for respiratory delivery of two or more active agents Claim Types: Method of administration Pat. Sub. Date(s): 001: Aug 18, 2020 | May 28, 2030 | U-2889: Use for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) |
| Pat. No. 9463161 DP* Compositions for pulmonary delivery of long-acting muscarinic antagonists and associated methods and Claim Types: Method of administration; Formulation Pat. Sub. Date(s): 001: Aug 18, 2020 | May 28, 2030 | U-2889: Use for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) |
| Pat. No. 10716753 DP* Compositions for pulmonary delivery of long-acting muscarinic antagonists or long-acting B2 adrenergic receptor agonists and associated methods and systems Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 18, 2020 | May 28, 2030 | U-2889: Use for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) |
| Pat. No. 11331442 DP* Drug delivery systems and related methods Claim Types: Device Pat. Sub. Date(s): 001: Jun 16, 2022 | Oct 5, 2038 | |
| Pat. No. 11833292 DP* Drug delivery systems and related methods Claim Types: Device Pat. Sub. Date(s): 001: Dec 21, 2023 | Oct 5, 2038 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NC - New combination | Jul 23, 2023 |
ASTRAZENECA AB
BYDUREON (FOR SUSPENSION, EXTENDED RELEASE) (SUBCUTANEOUS) EXENATIDE SYNTHETIC
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: ASTRAZENECA AB NDA No.: 022200 Prod. No.: 001 DISC (2MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6515117 DS* DP* C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Nov 17, 2017 | Apr 4, 2026 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 7456254 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Dec 30, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 7563871 DP* Polymer-based sustained release device Claim Types: Formulation Pat. Sub. Date(s): 001: None | Oct 15, 2024 *PED | |
| Pat. No. 7612176 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Oct 13, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8329648 Methods for treating diabetes and reducing body weight Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 10, 2013 | Feb 18, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2594: Reducing fasting plasma glucose in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2595: Reducing body weight in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2596: Reducing HBA1C in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 17, 2017 | Sep 21, 2028 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 8431685 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: May 29, 2013 | Oct 13, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8461105 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jul 10, 2013 | Oct 13, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Nov 17, 2017 | Dec 20, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 8906851 Method for treating diabetes Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2015 | Feb 18, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 9238076 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Feb 17, 2016 | Oct 15, 2024 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2599: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation as an adjunct to diet and exercise to provide a release profile having a ratio of C-max to C-avg of about 3 or less U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 9884092 Methods for treating diabetes and reducing body weight Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 6, 2018 | Feb 18, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2594: Reducing fasting plasma glucose in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2595: Reducing body weight in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2596: Reducing HBA1C in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Jan 22, 2025 PED |
ASTRAZENECA AB
BYDUREON BCISE (SUSPENSION, EXTENDED RELEASE) (SUBCUTANEOUS) EXENATIDE SYNTHETIC
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: ASTRAZENECA AB NDA No.: 209210 Prod. No.: 001 RX (2MG/0.85ML (2MG/0.85ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6515117 DS* DP* C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Aug 21, 2019 | Apr 4, 2026 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 7456254 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 3, 2017 | Dec 30, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 7563871 DP* Polymer-based sustained release device Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 3, 2017 | Oct 15, 2024 *PED | |
| Pat. No. 7612176 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 3, 2017 | Oct 13, 2025 *PED | U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8329648 Methods for treating diabetes and reducing body weight Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 3, 2017 | Feb 18, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2594: Reducing fasting plasma glucose in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2595: Reducing body weight in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2596: Reducing HBA1C in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 21, 2019 | Sep 21, 2028 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 8431685 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 3, 2017 | Oct 13, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8461105 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 3, 2017 | Oct 13, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8501698 Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Aug 21, 2019 | Dec 20, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 8895033 DP* Sustained release formulations using non-aqueous carriers Claim Types: Formulation; Method of use; Kit Pat. Sub. Date(s): 001: Nov 3, 2017 | Apr 4, 2031 *PED | U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin U-2601: Stimulating insulin release in adults with Type 2 diabetes mellitus by administering a pre-mixed exenatide formulation as an adjunct to diet and exercise U-2602: Delaying gastric emptying in adults with Type 2 diabetes mellitus by administering a pre-mixed exenatide formulation as an adjunct to diet and exercise U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8906851 Method for treating diabetes Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 3, 2017 | Feb 18, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 9238076 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 3, 2017 | Oct 15, 2024 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin U-2599: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation as an adjunct to diet and exercise to provide a release profile having a ratio of C-max to C-avg of about 3 or less U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 9884092 Methods for treating diabetes and reducing body weight Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 6, 2018 | Feb 18, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2594: Reducing fasting plasma glucose in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2595: Reducing body weight in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2596: Reducing HBA1C in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Jan 22, 2025 PED |
ASTRAZENECA AB
BYDUREON PEN (FOR SUSPENSION, EXTENDED RELEASE) (SUBCUTANEOUS) EXENATIDE SYNTHETIC
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: ASTRAZENECA AB NDA No.: 022200 Prod. No.: 002 DISC (2MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6515117 DS* DP* C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: Nov 15, 2017 | Apr 4, 2026 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 7456254 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Mar 28, 2014 | Dec 30, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 7563871 DP* Polymer-based sustained release device Claim Types: Formulation Pat. Sub. Date(s): 002: Mar 28, 2014 | Oct 15, 2024 *PED | |
| Pat. No. 7612176 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Mar 28, 2014 | Oct 13, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8216180 DP* Administering apparatus with functional drive element Claim Types: Device Pat. Sub. Date(s): 002: Mar 28, 2014 | Jul 12, 2028 *PED | |
| Pat. No. 8329648 Methods for treating diabetes and reducing body weight Claim Types: Method of use Pat. Sub. Date(s): 002: Mar 28, 2014 | Feb 18, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2594: Reducing fasting plasma glucose in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2595: Reducing body weight in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2596: Reducing HBA1C in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 15, 2017 | Sep 21, 2028 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 8431685 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Mar 28, 2014 | Oct 13, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8439864 DP* Device for administering fluid from a multi-chamber ampoule in incremental steps Claim Types: Device Pat. Sub. Date(s): 002: Mar 28, 2014 | Sep 25, 2028 *PED | |
| Pat. No. 8461105 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Mar 28, 2014 | Oct 13, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: Nov 15, 2017 | Dec 20, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 8690837 DP* Mixing device for a two-chamber ampoule Claim Types: Device Pat. Sub. Date(s): 002: Nov 15, 2017 | Nov 19, 2029 *PED | |
| Pat. No. 8721615 DP* Ampoule comprising an ampoule holder Claim Types: Device Pat. Sub. Date(s): 002: Nov 15, 2017 | Jul 18, 2030 *PED | |
| Pat. No. 8758292 DP* Administering apparatus with functional drive element Claim Types: Device Pat. Sub. Date(s): 002: Nov 15, 2017 | May 12, 2028 *PED | |
| Pat. No. 8827963 DP* Administering device with holding mechanism Claim Types: Device Pat. Sub. Date(s): 002: Nov 15, 2017 | Aug 4, 2029 *PED | |
| Pat. No. 8906851 Method for treating diabetes Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 6, 2015 | Feb 18, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8998876 DP* Ampoule comprising an ampoule holder Claim Types: Device Pat. Sub. Date(s): 002: Nov 15, 2017 | Jul 7, 2030 *PED | |
| Pat. No. 9238076 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Feb 17, 2016 | Oct 15, 2024 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2599: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation as an adjunct to diet and exercise to provide a release profile having a ratio of C-max to C-avg of about 3 or less U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 9320853 DP* Method for administering a fluid active substance from a multi-chamber ampoule Claim Types: Device; Process Pat. Sub. Date(s): 002: Nov 15, 2017 | Sep 25, 2028 *PED | |
| Pat. No. 9884092 Methods for treating diabetes and reducing body weight Claim Types: Method of use Pat. Sub. Date(s): 002: Mar 6, 2018 | Feb 18, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2594: Reducing fasting plasma glucose in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2595: Reducing body weight in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2596: Reducing HBA1C in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Jan 22, 2025 PED |
ASTRAZENECA AB
BYETTA (INJECTABLE) (SUBCUTANEOUS) EXENATIDE SYNTHETIC [GENERIC AP]
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: ASTRAZENECA AB NDA No.: 021773 Prod. No.: 001 RX (300MCG/1.2ML (250MCG/ML)); 002 RX (600MCG/2.4ML (250MCG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: M - Miscellaneous | Nov 4, 2024 | M-232: Information added to section 8.4 of the labeling to describe the results from pediatric studies |
ASTRAZENECA AB
FARXIGA (TABLET) (ORAL) DAPAGLIFLOZIN
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor
NDA Applicant: ASTRAZENECA AB NDA No.: 202293 Prod. No.: 001 RX (5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6515117 DS* DP* C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Feb 5, 2014 | Apr 4, 2026 *PED | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 7456254 Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 15, 2017 | Dec 30, 2025 *PED | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide |
| Pat. No. 7851502 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 5, 2014 | Feb 19, 2029 *PED | |
| Pat. No. 7919598 DS* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Feb 5, 2014 | Jun 16, 2030 *PED | |
| Pat. No. 8221786 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 5, 2014 | Sep 21, 2028 *PED | |
| Pat. No. 8329648 Methods for treating diabetes and reducing body weight Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 15, 2017 | Feb 18, 2027 *PED | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide U-2212: Reducing fasting plasma glucose in a human in need thereof in combination with a sustained-release composition containing exendin-4 U-2213: Reducing HBA1C in a human in need thereof in combination with a sustained-release composition containing exendin-4 |
| Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 5, 2014 | Sep 21, 2028 *PED | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8431685 Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 15, 2017 | Oct 13, 2025 *PED | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide |
| Pat. No. 8461105 Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 15, 2017 | Oct 13, 2025 *PED | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide |
| Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Feb 5, 2014 | Dec 20, 2027 *PED | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8685934 Methods for treating extreme insulin resistance in patients resistant to previous treatment with other anti-diabetic drugs employing an SGLT2 inhibitor and compositions thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 25, 2014 | Nov 26, 2030 *PED | U-1522: Treatment of Type 2 diabetes mellitus in a patient, wherein glycemic control (HBA1C < 7.0%) is not achievable using one or more of insulin, metformin, pioglitazone, or rosiglitazone |
| Pat. No. 8716251 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 2, 2014 | Sep 21, 2028 *PED | |
| Pat. No. 8721615 DP* DLR* Ampoule comprising an ampoule holder Claim Types: Device Pat. Sub. Date(s): 001: Nov 15, 2017 | Jul 18, 2030 *PED | |
| Pat. No. 8906851 Method for treating diabetes Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 15, 2017 | Feb 18, 2027 *PED | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide |
| Pat. No. 9238076 Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 15, 2017 | Apr 15, 2024 | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Apr 30, 2024 | I-857: To reduce the risk of sustained EGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression |
| Exclusivity Code: M - Miscellaneous | Nov 8, 2026 PED | M-298: Labeling revisions related to study D1699CC00001 |
| Exclusivity Code: NPP - New patient population | Dec 12, 2027 PED |
ASTRAZENECA AB
FARXIGA (TABLET) (ORAL) DAPAGLIFLOZIN
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor
NDA Applicant: ASTRAZENECA AB NDA No.: 202293 Prod. No.: 002 RX (10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6515117 DS* DP* C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: Feb 5, 2014 | Apr 4, 2026 *PED | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 7456254 Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Nov 15, 2017 | Dec 30, 2025 *PED | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide |
| Pat. No. 7851502 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation Pat. Sub. Date(s): 002: Feb 5, 2014 | Feb 19, 2029 *PED | |
| Pat. No. 7919598 DS* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 002: Feb 5, 2014 | Jun 16, 2030 *PED | |
| Pat. No. 8221786 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation Pat. Sub. Date(s): 002: Feb 5, 2014 | Sep 21, 2028 *PED | |
| Pat. No. 8329648 Methods for treating diabetes and reducing body weight Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 15, 2017 | Feb 18, 2027 *PED | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide U-2212: Reducing fasting plasma glucose in a human in need thereof in combination with a sustained-release composition containing exendin-4 U-2213: Reducing HBA1C in a human in need thereof in combination with a sustained-release composition containing exendin-4 |
| Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): 002: Feb 5, 2014 | Sep 21, 2028 *PED | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8431685 Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Nov 15, 2017 | Oct 13, 2025 *PED | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide |
| Pat. No. 8461105 Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Nov 15, 2017 | Oct 13, 2025 *PED | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide |
| Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: Feb 5, 2014 | Dec 20, 2027 *PED | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8685934 Methods for treating extreme insulin resistance in patients resistant to previous treatment with other anti-diabetic drugs employing an SGLT2 inhibitor and compositions thereof Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 25, 2014 | Nov 26, 2030 *PED | U-1522: Treatment of Type 2 diabetes mellitus in a patient, wherein glycemic control (HBA1C < 7.0%) is not achievable using one or more of insulin, metformin, pioglitazone, or rosiglitazone |
| Pat. No. 8716251 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation Pat. Sub. Date(s): 002: Jun 2, 2014 | Sep 21, 2028 *PED | |
| Pat. No. 8721615 DP* DLR* Ampoule comprising an ampoule holder Claim Types: Device Pat. Sub. Date(s): 002: Nov 15, 2017 | Jul 18, 2030 *PED | |
| Pat. No. 8906851 Method for treating diabetes Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 15, 2017 | Feb 18, 2027 *PED | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide |
| Pat. No. 9238076 Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Nov 15, 2017 | Apr 15, 2024 | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide |
| Pat. No. 10973836 Methods of treating heart failure with reduced ejection fraction Claim Types: Method of improving a treatment Pat. Sub. Date(s): 002: Apr 21, 2021 | Sep 9, 2040 *PED | U-3127: Reduction of the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure with reduced ejection fraction and without Type II diabetes |
| Pat. No. 11826376 Methods of treating heart failure with preserved ejection fraction employing dapagliflozin and compositions comprising the same Claim Types: Method of use Pat. Sub. Date(s): 002: Dec 19, 2023 | Jan 18, 2040 *PED | U-3766: Reduce the risk of cardiovascular death and hospitalization for heart failure and urgent heart failure visits in adults with heart failure with preserved ejection fraction and without Type II diabetes |
| Pat. No. 11903955 Methods of treating heart failure with reduced ejection fraction Claim Types: Method of use Pat. Sub. Date(s): 002: Mar 13, 2024 | Sep 9, 2040 *PED | U-3825: Reduce the risk of cardiovascular death and worsening heart failure in adults with heart failure with reduced ejection fraction, without type ii diabetes, and having an HBA1C of < 5.7% |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Apr 30, 2024 | I-857: To reduce the risk of sustained EGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression |
| Exclusivity Code: M - Miscellaneous | Nov 8, 2026 PED | M-298: Labeling revisions related to study D1699CC00001 |
| Exclusivity Code: NPP - New patient population | Dec 12, 2027 PED |
ASTRAZENECA AB
KOMBIGLYZE XR (TABLET, EXTENDED RELEASE) (ORAL) METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE [Has competitive generic]
Drug Classes: biguanide
NDA Applicant: ASTRAZENECA AB NDA No.: 200678 Prod. No.: 001 DISC (500MG;EQ 5MG BASE); 002 DISC (1GM;EQ 5MG BASE); 003 DISC (1GM;EQ 2.5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8628799 DP* Coated tablet formulation and method Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 31, 2014; 002: Mar 22, 2017; 003: Mar 22, 2017 | Jul 13, 2025 | |
| Pat. No. 9339472 DP* Coated tablet formulation and method Claim Types: Formulation Pat. Sub. Date(s): 001: May 26, 2016; 002: Mar 22, 2017; 003: Mar 22, 2017 | Jul 13, 2025 |
ASTRAZENECA AB
ONGLYZA (TABLET) (ORAL) SAXAGLIPTIN HYDROCHLORIDE [Has competitive generic]
NDA Applicant: ASTRAZENECA AB NDA No.: 022350 Prod. No.: 001 DISC (EQ 2.5MG BASE); 002 DISC (EQ 5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7951400 DP* Coated tablet formulation and method Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 29, 2011; 002: None | Nov 30, 2028 |
ASTRAZENECA AB
QTERN (TABLET) (ORAL) DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor
NDA Applicant: ASTRAZENECA AB NDA No.: 209091 Prod. No.: 001 RX (10MG;EQ 5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6515117 DS* DP* C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Mar 22, 2017 | Apr 4, 2026 *PED | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 7919598 DS* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Mar 22, 2017 | Jun 16, 2030 *PED | |
| Pat. No. 8221786 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 22, 2017 | Sep 21, 2028 *PED | |
| Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 22, 2017 | Sep 21, 2028 *PED | U-1976: Method for treating Type 2 diabetes mellitus (T2DM) in patients who have inadequate control with dapagliflozin U-1977: Method for treating Type 2 diabetes mellitus (T2DM) in patients who are already treated with dapagliflozin and saxagliptin U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Mar 22, 2017 | Dec 20, 2027 *PED | U-1976: Method for treating Type 2 diabetes mellitus (T2DM) in patients who have inadequate control with dapagliflozin U-1977: Method for treating Type 2 diabetes mellitus (T2DM) in patients who are already treated with dapagliflozin and saxagliptin U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8628799 DP* Coated tablet formulation and method Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 22, 2017 | Jul 13, 2025 | |
| Pat. No. 8716251 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 22, 2017 | Sep 21, 2028 *PED |
ASTRAZENECA AB
QTERN (TABLET) (ORAL) DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor
NDA Applicant: ASTRAZENECA AB NDA No.: 209091 Prod. No.: 002 RX (5MG;EQ 5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6515117 DS* DP* C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: May 24, 2019 | Apr 4, 2026 *PED | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 7919598 DS* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 002: May 24, 2019 | Jun 16, 2030 *PED | |
| Pat. No. 8221786 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation Pat. Sub. Date(s): 002: May 24, 2019 | Sep 21, 2028 *PED | |
| Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): 002: May 24, 2019 | Sep 21, 2028 *PED | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: May 24, 2019 | Dec 20, 2027 *PED | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8628799 DP* Coated tablet formulation and method Claim Types: Formulation Pat. Sub. Date(s): 002: May 24, 2019 | Jul 13, 2025 | |
| Pat. No. 8716251 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation Pat. Sub. Date(s): 002: May 24, 2019 | Sep 21, 2028 *PED |
ASTRAZENECA AB
QTERNMET XR (TABLET, EXTENDED RELEASE) (ORAL) DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor == biguanide
NDA Applicant: ASTRAZENECA AB NDA No.: 210874 Prod. No.: 001 DISC (2.5MG;1GM;EQ 2.5MG BASE); 002 DISC (5MG;1GM;EQ 2.5MG BASE); 003 DISC (5MG;1GM;EQ 5MG BASE); 004 DISC (10MG;1GM;EQ 5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6515117 DS* DP* C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): All strengths: May 24, 2019 | Apr 4, 2026 *PED | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 7919598 DS* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): All strengths: May 24, 2019 | Jun 16, 2030 *PED | |
| Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): All strengths: May 24, 2019 | Dec 20, 2027 *PED | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8628799 DP* Coated tablet formulation and method Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 24, 2019 | Jul 13, 2025 | |
| Pat. No. 8716251 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 24, 2019 | Sep 21, 2028 *PED | |
| Pat. No. 9616028 DP* Bilayer tablet formulations Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 24, 2019 | May 12, 2031 *PED |
ASTRAZENECA AB
WAINUA (AUTOINJECTOR) (SOLUTION) (SUBCUTANEOUS) EPLONTERSEN SODIUM
NDA Applicant: ASTRAZENECA AB NDA No.: 217388 Prod. No.: 001 RX (EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8101743 DS* DP* Modulation of transthyretin expression Claim Types: Compound Pat. Sub. Date(s): 001: Jan 18, 2024 | Apr 1, 2025 | |
| Pat. No. 9127276 DS* Conjugated antisense compounds and their use Claim Types: Compound Pat. Sub. Date(s): 001: Jan 18, 2024 | May 1, 2034 | |
| Pat. No. 9181549 DS* Conjugated antisense compounds and their use Claim Types: Compound Pat. Sub. Date(s): 001: Jan 18, 2024 | May 1, 2034 | |
| Pat. No. 10683499 DS* DP* Compositions and methods for modulating TTR expression Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jan 18, 2024 | Aug 25, 2034 | U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Dec 21, 2028 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 21, 2030 | ODE-461: Treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults |
ASTRAZENECA AB
XIGDUO XR (TABLET, EXTENDED RELEASE) (ORAL) DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor == biguanide
NDA Applicant: ASTRAZENECA AB NDA No.: 205649 Prod. No.: 001 RX (5MG;500MG); 002 RX (5MG;1GM); 003 RX (10MG;500MG); 004 RX (10MG;1GM); 005 RX (2.5MG;1GM)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6515117 DS* DP* C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): All strengths: Nov 24, 2014 | Apr 4, 2026 *PED | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 7919598 DS* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Nov 24, 2014; 002: Nov 24, 2014; 003: Nov 24, 2014; 004: Nov 24, 2014; 005: Aug 30, 2017 | Jun 16, 2030 *PED | |
| Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Nov 24, 2014; 002: Nov 24, 2014; 003: Nov 24, 2014; 004: Nov 24, 2014; 005: Aug 30, 2017 | Dec 20, 2027 *PED | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8685934 Methods for treating extreme insulin resistance in patients resistant to previous treatment with other anti-diabetic drugs employing an SGLT2 inhibitor and compositions thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 24, 2014; 002: Nov 24, 2014; 003: Nov 24, 2014; 004: Nov 24, 2014; 005: Aug 30, 2017 | Nov 26, 2030 *PED | U-1522: Treatment of Type 2 diabetes mellitus in a patient, wherein glycemic control (HBA1C < 7.0%) is not achievable using one or more of insulin, metformin, pioglitazone, or rosiglitazone |
| Pat. No. 9616028 DP* Bilayer tablet formulations Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 30, 2017 | May 12, 2031 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Dec 12, 2027 PED |
ATHENA
FIBRICOR (TABLET) (ORAL) FENOFIBRIC ACID
NDA Applicant: ATHENA NDA No.: 022418 Prod. No.: 001 DISC (35MG); 002 DISC (105MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7569612 Methods of use of fenofibric acid Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Aug 20, 2027 | U-1000: Adjunctive therapy to diet in patients with hyperlipidemias |
| Pat. No. 7741373 Methods of use of fenofibric acid Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Aug 20, 2027 | U-1059: Adjunctive therapy to diet to patients with hypertriglyceridemia |
| Pat. No. 7741374 Methods of use of fenofibric acid Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Aug 20, 2027 | U-1060: Adjunctive therapy to diet in patients with elevated cholesterol and/or lipid levels U-1061: Adjunctive therapy to diet in patients with mixed dyslipidemia |
| Pat. No. 7915247 Methods of use of fenofibric acid Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 30, 2011; 002: None | Aug 20, 2027 | U-1000: Adjunctive therapy to diet in patients with hyperlipidemias U-1059: Adjunctive therapy to diet to patients with hypertriglyceridemia U-1061: Adjunctive therapy to diet in patients with mixed dyslipidemia |
ATHENA
NEXICLON XR (TABLET, EXTENDED RELEASE) (ORAL) CLONIDINE
Drug Classes: alpha adrenergic agonist == central alpha-2 adrenergic agonist
NDA Applicant: ATHENA NDA No.: 022500 Prod. No.: 001 RX (EQ 0.17MG BASE) NDA No.: 022500 Prod. No.: 002 DISC (EQ 0.26MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8337890 DP* Modified release formulations containing drug-ion exchange resin complexes Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 1, 2020 | Apr 17, 2027 | |
| Pat. No. 8623409 DP* Clonidine formulation Claim Types: Formulation; Method of administration Pat. Sub. Date(s): All strengths: Jul 1, 2020 | Sep 8, 2031 |
ATHENA
QDOLO (SOLUTION) (ORAL) TRAMADOL HYDROCHLORIDE
Drug Classes: opioid agonist
NDA Applicant: ATHENA NDA No.: 214044 Prod. No.: 001 DISC (5MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11103452 DP* Tramadol hydrochloride solution Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 2, 2021 | Sep 1, 2040 | U-3197: Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate |
| Pat. No. 11752103 DP* Tramadol hydrochloride solution Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 14, 2023 | Sep 1, 2040 | U-3197: Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate |
AUCTA
MOTPOLY XR (CAPSULE, EXTENDED RELEASE) (ORAL) LACOSAMIDE
NDA Applicant: AUCTA NDA No.: 216185 Prod. No.: 001 RX (100MG); 002 RX (150MG); 003 RX (200MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11337943 DP* Lacosamide pharmaceutical composition and dosage form thereof Claim Types: Formulation; Method of use; Method of Use claimed by its inherent performace characteristics Pat. Sub. Date(s): All strengths: Aug 1, 2023 | Jun 5, 2040 | U-3660: Treatment of partial-onset seizures in adults and in pediatric patients weighing at least 50 kg U-3954: Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and in pediatric patients weighing at least 50 kg |
| Pat. No. 11883374 DP* Lacosamide pharmaceutical composition and dosage form thereof Claim Types: Device; Formulation; Formulation claimed by its inherent performace characteristics; Method of use Pat. Sub. Date(s): All strengths: Aug 21, 2024 | Jun 5, 2040 | U-3660: Treatment of partial-onset seizures in adults and in pediatric patients weighing at least 50 kg U-3954: Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and in pediatric patients weighing at least 50 kg |
| Pat. No. 12042474 DP* Lacosamide pharmaceutical composition and dosage form thereof Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 21, 2024 | Jun 5, 2040 | U-3660: Treatment of partial-onset seizures in adults and in pediatric patients weighing at least 50 kg U-3954: Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and in pediatric patients weighing at least 50 kg |
AURINIA
LUPKYNIS (CAPSULE) (ORAL) VOCLOSPORIN
Drug Classes: calcineurin-inhibitor immunosuppressant
NDA Applicant: AURINIA NDA No.: 213716 Prod. No.: 001 RX (7.9MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7332472 DS* DP* Cyclosporine analogue mixtures and their use as immunomodulating agents Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Feb 11, 2021 | Oct 17, 2025 | U-3056: Treatment of patients with active lupus nephritis |
| Pat. No. 10286036 Protocol for treatment of lupus nephritis Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Feb 11, 2021 | Dec 7, 2037 | U-3056: Treatment of patients with active lupus nephritis |
| Pat. No. 11622991 Protocol for treatment of lupus nephritis Claim Types: Method of use Pat. Sub. Date(s): 001: May 5, 2023 | Dec 7, 2037 | U-3056: Treatment of patients with active lupus nephritis |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jan 22, 2026 |
AUROBINDO PHARMA
AMPICILLIN TRIHYDRATE (CAPSULE) (ORAL) AMPICILLIN/AMPICILLIN TRIHYDRATE [Has competitive generic]
NDA Applicant: AUROBINDO PHARMA NDA No.: 216554 Prod. No.: 001 RX (EQ 250MG BASE); 002 RX (EQ 500MG BASE)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Jun 3, 2024 |
AUROBINDO PHARMA
PITAVASTATIN CALCIUM (TABLET) (ORAL) PITAVASTATIN CALCIUM [GENERIC AB]
Drug Classes: HMG CoA-reductase inhibitor
NDA Applicant: AUROBINDO PHARMA NDA No.: 206015 Prod. No.: 001 RX (EQ 1MG BASE); 002 RX (EQ 2MG BASE); 003 RX (EQ 4MG BASE)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: PC - Patent challenge | Feb 19, 2024 |
AUROBINDO PHARMA
SAXAGLIPTIN (TABLET) (ORAL) SAXAGLIPTIN HYDROCHLORIDE [GENERIC AB]
NDA Applicant: AUROBINDO PHARMA NDA No.: 205972 Prod. No.: 001 RX (EQ 2.5MG BASE); 002 RX (EQ 5MG BASE)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: PC - Patent challenge | Jan 27, 2024 |
AUROBINDO PHARMA
TERIFLUNOMIDE (TABLET) (ORAL) TERIFLUNOMIDE [GENERIC AB]
Drug Classes: pyrimidine synthesis inhibitor
NDA Applicant: AUROBINDO PHARMA NDA No.: 209638 Prod. No.: 001 RX (7MG); 002 RX (14MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: PC - Patent challenge | Sep 8, 2023 |
AUROBINDO PHARMA LTD
CEPHALEXIN (TABLET) (ORAL) CEPHALEXIN [GENERIC AB]
Drug Classes: cephalosporin antibacterial
NDA Applicant: AUROBINDO PHARMA LTD NDA No.: 218817 Prod. No.: 001 RX (EQ 250MG BASE); 002 RX (EQ 500MG BASE)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Apr 9, 2025 |
AUROBINDO PHARMA LTD
PREDNISOLONE (TABLET) (ORAL) PREDNISOLONE [GENERIC AB]
Drug Classes: corticosteroid
NDA Applicant: AUROBINDO PHARMA LTD NDA No.: 215673 Prod. No.: 001 RX (5MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Nov 18, 2023 |
AVADEL CNS
LUMRYZ (FOR SUSPENSION, EXTENDED RELEASE) (ORAL) SODIUM OXYBATE
Drug Classes: central nervous system depressant
NDA Applicant: AVADEL CNS NDA No.: 214755 Prod. No.: 001 RX (4.5GM/PACKET); 003 RX (7.5GM/PACKET); 004 RX (9GM/PACKET)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10272062 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 23, 2023 | Jul 21, 2037 | |
| Pat. No. 10736866 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 23, 2023 | Jul 21, 2037 | |
| Pat. No. 10925844 DP* Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): All strengths: May 23, 2023 | Feb 28, 2040 | |
| Pat. No. 10952986 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 23, 2023 | Jul 21, 2037 | U-3601: Treatment of a disorder treatable with gamma-hydroxybutyrate using a single, daily dose of a gamma-hydroxybutyrate formulation |
| Pat. No. 10973795 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 23, 2023 | Jul 21, 2037 | |
| Pat. No. 11000498 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): All strengths: May 23, 2023 | Jul 21, 2037 | U-3580: Treatment of narcolepsy using a dose proportional, oral pharmaceutical composition comprising gamma-hydroxybutyrate once daily |
| Pat. No. 11052061 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): All strengths: May 23, 2023 | Jul 21, 2037 | |
| Pat. No. 11065224 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): All strengths: May 23, 2023 | Jul 21, 2037 | |
| Pat. No. 11400065 Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 23, 2023 | Jul 21, 2037 | U-3579: Treatment of narcolepsy and associated disorders and symptoms using a composition comprising gamma-hydroxybutyrate once daily |
| Pat. No. 11504347 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): All strengths: May 23, 2023 | Jul 21, 2037 | |
| Pat. No. 11583510 Methods of administering gamma hydroxybutyrate formulations after a high-fat meal Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 23, 2023 | Feb 7, 2042 | U-3578: Treatment of narcolepsy, cataplexy or excessive daytime sleepiness using a once-nightly gamma-hydroxybutyrate formulation |
| Pat. No. 11602512 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 23, 2023 | Jul 21, 2037 | U-3577: Treatment of narcolepsy-related cataplexy or excessive daytime sleepiness using a single daily, bedtime dose of a gamma-hydroxybutyrate formulation |
| Pat. No. 11602513 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 23, 2023 | Jul 21, 2037 | U-3576: Treatment of narcolepsy-related cataplexy or excessive daytime sleepiness using a once-daily pharmaceutical formulation comprising an oxybate |
| Pat. No. 11766418 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Formulation; Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): All strengths: Sep 29, 2023 | Jul 21, 2037 | |
| Pat. No. 11779557 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 24, 2023 | Mar 16, 2042 | U-3705: Treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy who have an apnea/hypopnea index ≤15 with a once-nightly formulation of gamma-hydroxybutyrate |
| Pat. No. 11839597 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): All strengths: Jan 4, 2024 | Jul 21, 2037 | |
| Pat. No. 11896572 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 20, 2024 | Jul 21, 2037 | |
| Pat. No. 11986451 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 29, 2024 | Jul 21, 2037 | U-3934: Treatment of narcolepsy-related cataplexy or eds in a human patient with a once-nightly GHB formulation by initiating treatment with a dose equivalent to 4.5 g of sodium oxybate and uptitrating in increments equivalent to 1.5 g of sodium oxybate |
| Pat. No. 12097175 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 15, 2024 | Jul 21, 2037 | |
| Pat. No. 12097176 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 15, 2024 | Jul 21, 2037 | U-4006: Treatment of a disorder treatable with ghb using a single dose of a ghb formulation in an amount equivalent to 3 g to 12 g of sodium oxybate where the formulation contains an immediate release portion and a modified release portion |
| Pat. No. 12109186 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 15, 2024 | Jul 21, 2037 | |
| Pat. No. 12115142 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 22, 2024 | Jul 21, 2037 | |
| Pat. No. 12115143 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 22, 2024 | Jul 21, 2037 | |
| Pat. No. 12115144 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 22, 2024 | Jul 21, 2037 | |
| Pat. No. 12115145 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Method of use; Formulation Pat. Sub. Date(s): All strengths: Oct 22, 2024 | Jul 21, 2037 | |
| Pat. No. 12128021 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Dosaage regimen; Method of use Pat. Sub. Date(s): All strengths: Nov 12, 2024 | Jul 21, 2037 | U-4022: Treatment of a disorder in a human patient with a once-nightly GHB formulation by initiating treatment with a dose equivalent to 4.5 g of sodium oxybate and uptitrating in increments equivalent to 1.5 g of sodium oxybate |
| Pat. No. 12138239 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 15, 2024 | Jul 21, 2037 | |
| Pat. No. 12144793 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 22, 2024 | Jul 21, 2037 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | May 1, 2026 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | May 1, 2030 | ODE-431: Treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 16, 2031 | ODE-494: Treatment of cataplexy or excessive daytime sleepiness (EDS) in pediatric patients 7 years of age and older with narcolepsy |
AVADEL CNS
LUMRYZ (FOR SUSPENSION, EXTENDED RELEASE) (ORAL) SODIUM OXYBATE
Drug Classes: central nervous system depressant
NDA Applicant: AVADEL CNS NDA No.: 214755 Prod. No.: 002 RX (6GM/PACKET)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10272062 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Formulation Pat. Sub. Date(s): 002: May 23, 2023 | Jul 21, 2037 | |
| Pat. No. 10736866 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Formulation Pat. Sub. Date(s): 002: May 23, 2023 | Jul 21, 2037 | |
| Pat. No. 10925844 DP* Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 002: May 23, 2023 | Feb 28, 2040 | |
| Pat. No. 10952986 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Method of use Pat. Sub. Date(s): 002: May 23, 2023 | Jul 21, 2037 | U-3601: Treatment of a disorder treatable with gamma-hydroxybutyrate using a single, daily dose of a gamma-hydroxybutyrate formulation |
| Pat. No. 10973795 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Formulation Pat. Sub. Date(s): 002: May 23, 2023 | Jul 21, 2037 | |
| Pat. No. 11000498 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 002: May 23, 2023 | Jul 21, 2037 | U-3580: Treatment of narcolepsy using a dose proportional, oral pharmaceutical composition comprising gamma-hydroxybutyrate once daily |
| Pat. No. 11052061 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 002: May 23, 2023 | Jul 21, 2037 | |
| Pat. No. 11065224 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 002: May 23, 2023 | Jul 21, 2037 | |
| Pat. No. 11400065 Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state Claim Types: Method of use Pat. Sub. Date(s): 002: May 23, 2023 | Jul 21, 2037 | U-3579: Treatment of narcolepsy and associated disorders and symptoms using a composition comprising gamma-hydroxybutyrate once daily |
| Pat. No. 11504347 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 002: May 23, 2023 | Jul 21, 2037 | |
| Pat. No. 11583510 Methods of administering gamma hydroxybutyrate formulations after a high-fat meal Claim Types: Method of use Pat. Sub. Date(s): 002: May 23, 2023 | Feb 7, 2042 | U-3578: Treatment of narcolepsy, cataplexy or excessive daytime sleepiness using a once-nightly gamma-hydroxybutyrate formulation |
| Pat. No. 11602512 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Method of use Pat. Sub. Date(s): 002: May 23, 2023 | Jul 21, 2037 | U-3577: Treatment of narcolepsy-related cataplexy or excessive daytime sleepiness using a single daily, bedtime dose of a gamma-hydroxybutyrate formulation |
| Pat. No. 11602513 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Method of use Pat. Sub. Date(s): 002: May 23, 2023 | Jul 21, 2037 | U-3576: Treatment of narcolepsy-related cataplexy or excessive daytime sleepiness using a once-daily pharmaceutical formulation comprising an oxybate |
| Pat. No. 11766418 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Formulation; Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 002: Sep 29, 2023 | Jul 21, 2037 | |
| Pat. No. 11779557 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Method of use Pat. Sub. Date(s): 002: Oct 24, 2023 | Mar 16, 2042 | U-3705: Treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy who have an apnea/hypopnea index ≤15 with a once-nightly formulation of gamma-hydroxybutyrate |
| Pat. No. 11826335 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Method of use Pat. Sub. Date(s): 002: Dec 4, 2023 | Jul 21, 2037 | U-3751: Treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy with a once-nightly gamma-hydroxybutyrate formulation |
| Pat. No. 11839597 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 002: Jan 4, 2024 | Jul 21, 2037 | |
| Pat. No. 11896572 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Formulation Pat. Sub. Date(s): 002: Feb 20, 2024 | Jul 21, 2037 | |
| Pat. No. 11986451 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Method of use Pat. Sub. Date(s): 002: May 29, 2024 | Jul 21, 2037 | U-3934: Treatment of narcolepsy-related cataplexy or eds in a human patient with a once-nightly GHB formulation by initiating treatment with a dose equivalent to 4.5 g of sodium oxybate and uptitrating in increments equivalent to 1.5 g of sodium oxybate |
| Pat. No. 12097175 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Formulation Pat. Sub. Date(s): 002: Oct 15, 2024 | Jul 21, 2037 | |
| Pat. No. 12097176 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Method of use Pat. Sub. Date(s): 002: Oct 15, 2024 | Jul 21, 2037 | U-4006: Treatment of a disorder treatable with ghb using a single dose of a ghb formulation in an amount equivalent to 3 g to 12 g of sodium oxybate where the formulation contains an immediate release portion and a modified release portion |
| Pat. No. 12109186 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Formulation Pat. Sub. Date(s): 002: Oct 15, 2024 | Jul 21, 2037 | |
| Pat. No. 12115142 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Formulation Pat. Sub. Date(s): 002: Oct 22, 2024 | Jul 21, 2037 | |
| Pat. No. 12115143 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Formulation Pat. Sub. Date(s): 002: Oct 22, 2024 | Jul 21, 2037 | |
| Pat. No. 12115144 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Formulation Pat. Sub. Date(s): 002: Oct 22, 2024 | Jul 21, 2037 | |
| Pat. No. 12115145 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Method of use; Formulation Pat. Sub. Date(s): 002: Oct 22, 2024 | Jul 21, 2037 | |
| Pat. No. 12128021 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Dosaage regimen; Method of use Pat. Sub. Date(s): 002: Nov 12, 2024 | Jul 21, 2037 | U-4022: Treatment of a disorder in a human patient with a once-nightly GHB formulation by initiating treatment with a dose equivalent to 4.5 g of sodium oxybate and uptitrating in increments equivalent to 1.5 g of sodium oxybate |
| Pat. No. 12138239 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Formulation Pat. Sub. Date(s): 002: Nov 15, 2024 | Jul 21, 2037 | |
| Pat. No. 12144793 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Claim Types: Formulation Pat. Sub. Date(s): 002: Nov 22, 2024 | Jul 21, 2037 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | May 1, 2026 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | May 1, 2030 | ODE-431: Treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 16, 2031 | ODE-494: Treatment of cataplexy or excessive daytime sleepiness (EDS) in pediatric patients 7 years of age and older with narcolepsy |
AVANIR PHARMS
NUEDEXTA (CAPSULE) (ORAL) DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE [GENERIC AB]
Drug Classes: sigma-1 agonist == uncompetitive NMDA receptor antagonist == antiarrhythmic == CYP450 2D6 inhibitor
NDA Applicant: AVANIR PHARMS NDA No.: 021879 Prod. No.: 001 RX (20MG;10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7659282 Pharmaceutical compositions comprising dextromethorphan and quinidine for the treatment of neurological disorders Claim Types: Method of use Pat. Sub. Date(s): 001: None | Aug 13, 2026 | U-1093: Treatment of pseudobulbar affect |
AVEO PHARMS
FOTIVDA (CAPSULE) (ORAL) TIVOZANIB HYDROCHLORIDE
Drug Classes: kinase inhibitor
NDA Applicant: AVEO PHARMS NDA No.: 212904 Prod. No.: 001 RX (EQ 0.89MG BASE); 002 RX (EQ 1.34MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6821987 DS* DP* Quinoline derivatives and quinazoline derivatives having azolyl group Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): All strengths: Apr 6, 2021 | Apr 26, 2025 | U-3100: A method of treating adults with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies by inhibiting the angiogenesis of blood vessels with a vascular endothelial growth factor inhibitor |
| Pat. No. 7166722 DS* DP* N-{2-chloro-4-[(6,7-dimethoxy-4-quinolyl)oxy]phenyl}-n'-(5-methyl-3-isoxaz- olyl)urea salt in crystalline form Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): All strengths: Apr 6, 2021 | Nov 16, 2024 | |
| Pat. No. 11504365 Use of tivozanib to treat subjects with refractory cancer Claim Types: Dosaage regimen Pat. Sub. Date(s): All strengths: Dec 1, 2022 | Nov 5, 2039 | U-3476: Treatment of adults with moderate hepatic impairment and relapsed or refractory advanced renal cell carcinoma following two or more prior systemic anti-cancer therapies with 1mg tivozanib HCl orally for 21 days followed by no drug for 7 days |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Mar 10, 2026 |
AVERITAS
QUTENZA (PATCH) (TOPICAL) CAPSAICIN
NDA Applicant: AVERITAS NDA No.: 022395 Prod. No.: 001 RX (8%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8821920 DP* Therapeutic patch for transdermal delivery of capsaicin Claim Types: Device; Method of use; Process Pat. Sub. Date(s): 001: Jan 8, 2020 | Mar 26, 2030 | |
| Pat. No. 9226903 DP* Transdermal therapeutic system comprising an adhesive layer method for siliconizing the back layer or the system and use of said back layer Claim Types: Device; Process Pat. Sub. Date(s): 001: Jan 8, 2020 | Dec 15, 2028 | |
| Pat. No. 10034841 DP* Transdermal therapeutic system comprising an adhesive layer method for siliconizing the back layer of the system and use of said back layer Claim Types: Device Pat. Sub. Date(s): 001: Jan 8, 2020 | Sep 6, 2025 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jul 17, 2023 | I-838: Treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet |
AVID RADIOPHARMS INC
AMYVID (SOLUTION) (INTRAVENOUS) FLORBETAPIR F-18
NDA Applicant: AVID RADIOPHARMS INC NDA No.: 202008 Prod. No.: 003 RX (10-50ML (13.5-51mCi/ML)) NDA No.: 202008 Prod. No.: 001 DISC (10ML (13.5-51mCi/ML)); 002 DISC (10-30ML (13.5-51mCi/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7687052 DS* DP* Styrylpyridine derivatives and their use for binding and imaging amyloid plaques Claim Types: Compound; Formulation; Diagnostic or surgical method Pat. Sub. Date(s): 001: May 4, 2012; 002: None; 003: None | Apr 30, 2027 | |
| Pat. No. 8506929 DS* DP* Styrylpyridine derivatives and their use for binding and imaging amyloid plaques Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Sep 6, 2013; 002: None; 003: None | Apr 30, 2027 | U-1423: Amyvid is a radioactive diagnostic agent for positron emission tomography (PET) imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment |
AVID RADIOPHARMS INC
TAUVID (SOLUTION) (INTRAVENOUS) FLORTAUCIPIR F-18
NDA Applicant: AVID RADIOPHARMS INC NDA No.: 212123 Prod. No.: 001 DISC (30ML (8.1-51mCi/ML)); 002 DISC (50ML (8.1-51mCi/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8932557 DS* Imaging agents for detecting neurological dysfunction Claim Types: Compound; Process Pat. Sub. Date(s): All strengths: Jun 11, 2020 | May 26, 2032 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | May 28, 2025 |
AVID RADIOPHARMS INC
TAUVID (SOLUTION) (INTRAVENOUS) FLORTAUCIPIR F-18
NDA Applicant: AVID RADIOPHARMS INC NDA No.: 212123 Prod. No.: 003 RX (50ML (8.1-100mCi/ML)); 004 RX (100ML (8.1-100mCi/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8932557 DS* Imaging agents for detecting neurological dysfunction Claim Types: Compound; Process Pat. Sub. Date(s): All strengths: Sep 8, 2022 | May 26, 2032 |
AVION PHARMS
BALCOLTRA (TABLET) (ORAL) ETHINYL ESTRADIOL; LEVONORGESTREL [GENERIC AB3]
Drug Classes: progestin == progestin-containing intrauterine system
NDA Applicant: AVION PHARMS NDA No.: 208612 Prod. No.: 001 RX (0.02MG;0.1MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7838042 DS* Hypoallergenic metal amino acid chelates and metal amino acid chelate-containing compositions Claim Types: Method of administration; Process Pat. Sub. Date(s): 001: Nov 30, 2021 | Jun 1, 2027 | U-3251: Administration of ferrous bisglycinate tablets |
AVION PHARMS
DHIVY (TABLET) (ORAL) CARBIDOPA; LEVODOPA [Has competitive generic]
Drug Classes: aromatic amino acid decarboxylation inhibitor
NDA Applicant: AVION PHARMS NDA No.: 214869 Prod. No.: 001 RX (25MG;100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11033521 DP* Levodopa fractionated dose composition and use Claim Types: Method of use; Formulation Pat. Sub. Date(s): 001: Feb 22, 2022 | Mar 28, 2039 | U-219: Treatment of Parkinson's disease U-3304: Method of treating Parkinson's disease by orally administering segments of a functionally multiscored, bilayered tablet having carbidopa—25 mg/levodopa—100 mg, each segment having carbidopa—6.25 mg/levodopa—25 mg U-3305: Method of treating Parkinson's disease by orally administering a functionally multiscored, bilayered tablet having carbidopa—25 mg/levodopa—100 mg |
| Pat. No. 11439613 Levodopa fractionated dose composition and use Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 18, 2023 | Mar 28, 2039 | U-3557: Treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication |
| Pat. No. 11819485 Levodopa fractionated dose composition and use Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 7, 2023 | Mar 28, 2039 | U-3557: Treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication |
AVYXA HOLDINGS
CYCLOPHOSPHAMIDE (SOLUTION) (INTRAVENOUS) CYCLOPHOSPHAMIDE
Drug Classes: alkylating drug
NDA Applicant: AVYXA HOLDINGS NDA No.: 210852 Prod. No.: 001 RX (500MG/ML (500MG/ML)); 002 RX (1GM/2ML (500MG/ML)); 003 RX (2GM/4ML (500MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10849916 DP* Stable liquid formulations of cyclophosphamide and its impurities Claim Types: Compound; Formulation Pat. Sub. Date(s): All strengths: Jun 27, 2023 | Jul 13, 2035 | |
| Pat. No. 11382923 DP* Stable liquid formulations of cyclophosphamide and processes to prepare the same Claim Types: Composition Pat. Sub. Date(s): All strengths: Jun 27, 2023 | Dec 1, 2035 |
AVYXA HOLDINGS
DOCIVYX (SOLUTION) (INTRAVENOUS) DOCETAXEL
Drug Classes: microtubule inhibitor
NDA Applicant: AVYXA HOLDINGS NDA No.: 215813 Prod. No.: 001 RX (20MG/2ML (10MG/ML)); 002 RX (80MG/8ML (10MG/ML)); 003 RX (160MG/16ML (10MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10398785 DP* Pharmaceutical compositions containing taxane-cyclodextrin complexes, method of making and methods of use Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Jul 7, 2023 | Mar 14, 2036 |
AXSOME
AUVELITY (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Drug Classes: aminoketone == sigma-1 agonist == uncompetitive NMDA receptor antagonist
NDA Applicant: AXSOME NDA No.: 215430 Prod. No.: 001 RX (105MG;45MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8569328 DP* Compositions and methods comprising tilidine or related compounds and dextromethorphan Claim Types: Composition; Method of use; Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Oct 29, 2033 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 9168234 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 9198905 Compositions and methods for reducing dextrorphan plasma levels and related pharmacodynamic effects Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 9205083 Compositions and methods comprising erythrohydroxybupropion and related compounds for improving the efficacy of dextromethorphan Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 9238032 Compositions and methods comprising bupropion or related compounds for sustained delivery of dextromethorphan Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 9278095 Bupropion as a modulator of drug activity Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 9314462 Compositions and methods for increasing dextromethorphan plasma levels and related pharmacodynamic effects Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 9370513 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 9375429 Compositions and methods comprising erythrohydroxybupropion and related compounds for improving the efficacy of dextromethorphan Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 9408815 Bupropion as a modulator of drug activity Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 9421176 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 9457023 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 9457025 Compositions and methods comprising bupropion or related compounds for sustained delivery of dextromethorphan Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 9474731 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 9486450 Hydroxybupropion and related compounds as modulators of drug plasma levels Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 9700528 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 9700553 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 9707191 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 9763932 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 9861595 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 9867819 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 9968568 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 10058518 Bupropion as a modulator of drug activity Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 10064857 Bupropion as a modulator of drug activity Claim Types: Method of improving a treatment; Method of use Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 10080727 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 10092560 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 10092561 Compositions and methods comprising bupropion or related compounds for sustained delivery of dextromethorphan Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 10105327 Compositions and methods for increasing the metabolic lifetime of dextromethorphane and related pharmacodynamic effects Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 10105361 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 10251879 Bupropion as a modulator of drug activity Claim Types: Method of improving a treatment; Method of use Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 10463634 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 10512643 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 10548857 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 10596167 Compositions and methods comprising bupropion or related compounds for sustained delivery of dextromethorphan Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 10772850 Bupropion as a modulator of drug activity Claim Types: Method of improving a treatment; Method of use Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 10780064 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 16, 2022 | Jan 7, 2040 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 10780066 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 9, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 10786469 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 10786496 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 10799497 Combination of dextromethorphan and bupropion for treating depression Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 10806710 Bupropion as a modulator of drug activity Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 10864209 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 10874663 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 10874664 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 10874665 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 10881624 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects Claim Types: Method of improving a treatment; Method of use Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 10881657 Bupropion as a modulator of drug activity Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 10894046 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 10894047 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 10898453 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 10925842 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 16, 2022 | Jan 7, 2040 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 10933034 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 10940124 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 16, 2022 | Jan 7, 2040 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 10945973 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 10966941 Bupropion as a modulator of drug activity Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 10966942 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 16, 2022 | Jan 7, 2040 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 10966974 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11020389 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11058648 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11090300 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11096937 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11123343 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11129826 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11141388 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11141416 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11147808 Method of decreasing the fluctuation index of dextromethorphan Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11185515 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11191739 DP* Bupropion as a modulator of drug activity Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11197839 DP* Bupropion as a modulator of drug activity Claim Types: Composition Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11207281 Bupropion as a modulator of drug activity Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11213521 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11229640 Combination of dextromethorphan and bupropion for treating depression Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11234946 Bupropion as a modulator of drug activity Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11253491 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11253492 Bupropion as a modulator of drug activity Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11273133 Bupropion as a modulator of drug activity Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11273134 Bupropion as a modulator of drug activity Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11285118 Bupropion as a modulator of drug activity Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11285146 Bupropion as a modulator of drug activity Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11291638 Bupropion as a modulator of drug activity Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11291665 Bupropion as a modulator of drug activity Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11298351 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11298352 Bupropion as a modulator of drug activity Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11311534 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11344544 Bupropion as a modulator of drug activity Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11357744 Bupropion as a modulator of drug activity Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11364233 Bupropion as a modulator of drug activity Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11382874 Bupropion as a modulator of drug activity Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11419867 Bupropion as a modulator of drug activity Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11426370 Bupropion as a modulator of drug activity Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11426401 Bupropion as a modulator of drug activity Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11433067 DP* Bupropion as a modulator of drug activity Claim Types: Composition; Method of administration; Formulation Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11439636 Bupropion as a modulator of drug activity Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11478468 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 10, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11497721 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 2, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11510918 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 7, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11517542 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 21, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11517543 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 21, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11524007 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 21, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11524008 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 21, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11534414 DP* Bupropion as a modulator of drug activity Claim Types: Formulation; Method of administration Pat. Sub. Date(s): 001: Jan 23, 2023 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11541021 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 23, 2023 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11541048 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 23, 2023 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11596627 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 4, 2023 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11617728 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: May 3, 2023 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11617747 Bupropion as a modulator of drug activity Claim Types: Method of use; Method of improving a treatment Pat. Sub. Date(s): 001: May 3, 2023 | Nov 5, 2034 | U-3563: Dextromethorphan and bupropion in combination to increase dextromethorphan plasma levels |
| Pat. No. 11717518 Bupropion Dosage Forms With Reduced Food And Alcohol Dosing Effects Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 15, 2023 | Jan 20, 2043 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11730706 Treatment of depression in certain patient populations Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 28, 2023 | Jan 23, 2043 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11752144 Compounds and combinations thereof for treating neurological and psychiatric conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 14, 2023 | Feb 23, 2043 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11779579 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 12, 2023 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11839612 Compounds and combinations thereof for treating neurological and psychiatric conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 5, 2024 | Mar 2, 2043 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11844797 Combination of dextromethorphan and bupropion for treating depression Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 5, 2024 | Apr 20, 2043 | U-3778: Treatment of major depressive disorder by administering dextromethorphan and bupropion to a subject having moderate hepatic impairment |
| Pat. No. 11883373 Treatment of depression in certain patient populations Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 8, 2024 | Jan 23, 2043 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11896563 Bupropion and dextromethorphan for reduction of suicide risk in depression patients Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 16, 2024 | Dec 1, 2041 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11925636 Bupropion dosage forms with reduced food and alcohol dosing effects Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 14, 2024 | Jan 20, 2043 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11969421 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: May 7, 2024 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11986444 Treatment of poor metabolizers of dextromethorphan with a combination of bupropion and dextromethorphan Claim Types: Method of use; Method of Use claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: May 31, 2024 | Feb 15, 2043 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 12036191 Treatment of poor metabolizers of dextromethorphan with a combination of bupropion and dextromethorphan Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 5, 2024 | Feb 15, 2043 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 12042473 Compounds and combinations thereof for treating neurological and psychiatric conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 5, 2024 | Feb 23, 2043 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 12109178 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 15, 2024 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 12146889 Compounds and combinations thereof for treating neurological and psychiatric conditions Claim Types: Method of use; Dosaage regimen Pat. Sub. Date(s): 001: Nov 20, 2024 | Feb 23, 2043 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Aug 18, 2025 |
AXSOME MALTA
SUNOSI (TABLET) (ORAL) SOLRIAMFETOL HYDROCHLORIDE
Drug Classes: dopamine and norepinephrine reuptake inhibitor (DNRI)
NDA Applicant: AXSOME MALTA NDA No.: 211230 Prod. No.: 001 RX (EQ 75MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8440715 Treatment of sleep-wake disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 24, 2019 | Jun 11, 2031 | U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) |
| Pat. No. 8877806 Treatment of sleep-wake disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 24, 2019 | Jun 7, 2026 | U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) |
| Pat. No. 9604917 Treatment of sleep-wake disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 24, 2019 | Jun 7, 2026 | U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) |
| Pat. No. 10195151 DP* Formulations of (R)-2-amino-3-phenylpropyl carbamate Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 24, 2019 | Sep 5, 2037 | |
| Pat. No. 10351517 Treatment of sleep-wake disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 16, 2019 | Jun 7, 2026 | U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) |
| Pat. No. 10512609 Formulations of (R)-2-amino-3-phenylpropyl carbamate Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 22, 2020 | Sep 5, 2037 | U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) |
| Pat. No. 10912754 Methods and compositions for treating excessive sleepiness Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 10, 2021 | Jun 1, 2038 | U-3082: Treatment of excessive daytime sleepiness associated with obstructive sleep apnea (OSA) in an adult through a dosing regimen that includes oral administration of 75 mg once daily for at least 3 days followed by 150 mg once daily |
| Pat. No. 10940133 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Dosaage regimen Pat. Sub. Date(s): 001: Apr 7, 2021 | Mar 19, 2040 | U-3099: Treatment of excessive daytime sleepiness associated with obstructive sleep apnea (OSA) in a patient with moderate renal impairment |
| Pat. No. 10959976 Methods and compositions for treating excessive sleepiness Claim Types: Dosaage regimen Pat. Sub. Date(s): 001: Apr 27, 2021 | Jun 1, 2038 | U-3151: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) with a dosing regimen that includes a dose of 75 mg once daily for at least 3 days followed by 150 mg once daily |
| Pat. No. 11160779 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 13, 2023 | Mar 19, 2040 | U-3521: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having mild, moderate, or severe renal impairment |
| Pat. No. 11439597 DP* Formulations of (R)-2-amino-3-phenylpropyl carbamate Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Oct 13, 2022 | Sep 5, 2037 | |
| Pat. No. 11560354 DP* Compositions comprising (R)-2-amino-3-phenylpropyl carbamate and uses thereof Claim Types: Composition Pat. Sub. Date(s): 001: Feb 13, 2023 | Mar 6, 2039 | U-3520: Treatment of excessive daytime sleepiness by administering a composition comprising solriamfetol hydrochloride and 2-chloropropane, wherein the composition comprises less than about 5 ppm 2-chloropropane |
| Pat. No. 11648232 Methods and compositions for treating excessive sleepiness Claim Types: Method of use Pat. Sub. Date(s): 001: May 26, 2023 | Jun 1, 2038 | U-3602: Treatment of excessive daytime sleepiness with a dosing regimen that includes oral administration of 75 mg once daily for at least 3 days followed by 150 mg once daily |
| Pat. No. 11753368 Treatment of sleep-wake disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 14, 2023 | Jun 7, 2026 | U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) |
| Pat. No. 11771666 Methods of administering solriamfetol to lactating women Claim Types: Method of administration Pat. Sub. Date(s): 001: Oct 6, 2023 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 11771667 Methods of administering solriamfetol to lactating women Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 6, 2023 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 11779554 Methods of administering solriamfetol to lactating women Claim Types: Method of use; Method of Use claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Oct 12, 2023 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 11793776 Methods of administering solriamfetol to lactating women Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 27, 2023 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 11839598 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Dosaage regimen Pat. Sub. Date(s): 001: Dec 15, 2023 | Mar 19, 2040 | U-3765: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having moderate or severe renal impairment |
| Pat. No. 11839599 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Dosaage regimen Pat. Sub. Date(s): 001: Dec 15, 2023 | Mar 19, 2040 | U-3764: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having obstructive sleep apnea (OSA) and no, mild, moderate, or severe renal impairment |
| Pat. No. 11850226 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 29, 2023 | Mar 19, 2040 | U-3775: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having no, mild, moderate, or severe renal impairment |
| Pat. No. 11850227 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 29, 2023 | Mar 19, 2040 | U-3775: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having no, mild, moderate, or severe renal impairment |
| Pat. No. 11850228 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 29, 2023 | Mar 19, 2040 | U-3775: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having no, mild, moderate, or severe renal impairment |
| Pat. No. 11857528 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 19, 2024 | Mar 19, 2040 | U-3521: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having mild, moderate, or severe renal impairment |
| Pat. No. 11865098 Methods and compositions for treating excessive sleepiness Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 8, 2024 | Jun 1, 2038 | U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) |
| Pat. No. 11872203 Methods of administering solriamfetol to lactating women Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 19, 2024 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 11872204 Methods of administering solriamfetol to lactating women Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Jan 19, 2024 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 11969404 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Method of use Pat. Sub. Date(s): 001: May 2, 2024 | Mar 19, 2040 | U-3892: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having a history of bipolar disorders and moderate or severe renal impairment |
| Pat. No. 11986454 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Method of use Pat. Sub. Date(s): 001: May 31, 2024 | Mar 19, 2040 | U-3775: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having no, mild, moderate, or severe renal impairment |
| Pat. No. 11986455 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Method of use Pat. Sub. Date(s): 001: May 31, 2024 | Mar 19, 2040 | U-3521: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having mild, moderate, or severe renal impairment |
| Pat. No. 11998639 DP* Formulations of (R)-2-amino-3-phenylpropyl carbamate Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jun 10, 2024 | Sep 5, 2037 | U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) |
| Pat. No. 12005036 Methods of administering solriamfetol to lactating women Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Jun 13, 2024 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 12036194 Methods of administering solriamfetol to lactating women Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 5, 2024 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 12064411 Methods of administering solriamfetol to lactating women Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Aug 26, 2024 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 12090126 Methods of administering solriamfetol to lactating women Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 27, 2024 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 12102609 Methods of administering solriamfetol to lactating women Claim Types: Method of improving a treatment; Method of use Pat. Sub. Date(s): 001: Oct 15, 2024 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jun 17, 2024 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 17, 2026 | ODE-254: Indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy |
AXSOME MALTA
SUNOSI (TABLET) (ORAL) SOLRIAMFETOL HYDROCHLORIDE
Drug Classes: dopamine and norepinephrine reuptake inhibitor (DNRI)
NDA Applicant: AXSOME MALTA NDA No.: 211230 Prod. No.: 002 RX (EQ 150MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8440715 Treatment of sleep-wake disorders Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 24, 2019 | Jun 11, 2031 | U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) |
| Pat. No. 8877806 Treatment of sleep-wake disorders Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 24, 2019 | Jun 7, 2026 | U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) |
| Pat. No. 9604917 Treatment of sleep-wake disorders Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 24, 2019 | Jun 7, 2026 | U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) |
| Pat. No. 10195151 DP* Formulations of (R)-2-amino-3-phenylpropyl carbamate Claim Types: Formulation Pat. Sub. Date(s): 002: Jun 24, 2019 | Sep 5, 2037 | |
| Pat. No. 10351517 Treatment of sleep-wake disorders Claim Types: Method of use Pat. Sub. Date(s): 002: Aug 16, 2019 | Jun 7, 2026 | U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) |
| Pat. No. 10512609 Formulations of (R)-2-amino-3-phenylpropyl carbamate Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 22, 2020 | Sep 5, 2037 | U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) |
| Pat. No. 10912754 Methods and compositions for treating excessive sleepiness Claim Types: Method of use Pat. Sub. Date(s): 002: Mar 10, 2021 | Jun 1, 2038 | U-3082: Treatment of excessive daytime sleepiness associated with obstructive sleep apnea (OSA) in an adult through a dosing regimen that includes oral administration of 75 mg once daily for at least 3 days followed by 150 mg once daily |
| Pat. No. 10959976 Methods and compositions for treating excessive sleepiness Claim Types: Dosaage regimen Pat. Sub. Date(s): 002: Apr 27, 2021 | Jun 1, 2038 | U-3151: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) with a dosing regimen that includes a dose of 75 mg once daily for at least 3 days followed by 150 mg once daily |
| Pat. No. 11160779 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Method of use Pat. Sub. Date(s): 002: Feb 13, 2023 | Mar 19, 2040 | U-3521: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having mild, moderate, or severe renal impairment |
| Pat. No. 11439597 DP* Formulations of (R)-2-amino-3-phenylpropyl carbamate Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 002: Oct 13, 2022 | Sep 5, 2037 | |
| Pat. No. 11560354 DP* Compositions comprising (R)-2-amino-3-phenylpropyl carbamate and uses thereof Claim Types: Composition Pat. Sub. Date(s): 002: Feb 13, 2023 | Mar 6, 2039 | U-3520: Treatment of excessive daytime sleepiness by administering a composition comprising solriamfetol hydrochloride and 2-chloropropane, wherein the composition comprises less than about 5 ppm 2-chloropropane |
| Pat. No. 11648232 Methods and compositions for treating excessive sleepiness Claim Types: Method of use Pat. Sub. Date(s): 002: May 26, 2023 | Jun 1, 2038 | U-3602: Treatment of excessive daytime sleepiness with a dosing regimen that includes oral administration of 75 mg once daily for at least 3 days followed by 150 mg once daily |
| Pat. No. 11753368 Treatment of sleep-wake disorders Claim Types: Method of use Pat. Sub. Date(s): 002: Sep 14, 2023 | Jun 7, 2026 | U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) |
| Pat. No. 11771666 Methods of administering solriamfetol to lactating women Claim Types: Method of administration Pat. Sub. Date(s): 002: Oct 6, 2023 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 11771667 Methods of administering solriamfetol to lactating women Claim Types: Method of use Pat. Sub. Date(s): 002: Oct 6, 2023 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 11779554 Methods of administering solriamfetol to lactating women Claim Types: Method of use; Method of Use claimed by its inherent performace characteristics Pat. Sub. Date(s): 002: Oct 12, 2023 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 11793776 Methods of administering solriamfetol to lactating women Claim Types: Method of use Pat. Sub. Date(s): 002: Oct 27, 2023 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 11839598 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Dosaage regimen Pat. Sub. Date(s): 002: Dec 15, 2023 | Mar 19, 2040 | U-3765: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having moderate or severe renal impairment |
| Pat. No. 11839599 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Dosaage regimen Pat. Sub. Date(s): 002: Dec 15, 2023 | Mar 19, 2040 | U-3764: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having obstructive sleep apnea (OSA) and no, mild, moderate, or severe renal impairment |
| Pat. No. 11850226 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Method of use Pat. Sub. Date(s): 002: Dec 29, 2023 | Mar 19, 2040 | U-3775: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having no, mild, moderate, or severe renal impairment |
| Pat. No. 11850227 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Method of use Pat. Sub. Date(s): 002: Dec 29, 2023 | Mar 19, 2040 | U-3775: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having no, mild, moderate, or severe renal impairment |
| Pat. No. 11850228 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Method of use Pat. Sub. Date(s): 002: Dec 29, 2023 | Mar 19, 2040 | U-3775: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having no, mild, moderate, or severe renal impairment |
| Pat. No. 11857528 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 19, 2024 | Mar 19, 2040 | U-3521: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having mild, moderate, or severe renal impairment |
| Pat. No. 11865098 Methods and compositions for treating excessive sleepiness Claim Types: Method of use Pat. Sub. Date(s): 002: Feb 8, 2024 | Jun 1, 2038 | U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) |
| Pat. No. 11872203 Methods of administering solriamfetol to lactating women Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 19, 2024 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 11872204 Methods of administering solriamfetol to lactating women Claim Types: Method of improving a treatment Pat. Sub. Date(s): 002: Jan 19, 2024 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 11969404 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Method of use Pat. Sub. Date(s): 002: May 2, 2024 | Mar 19, 2040 | U-3892: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having a history of bipolar disorders and moderate or severe renal impairment |
| Pat. No. 11986454 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Method of use Pat. Sub. Date(s): 002: May 31, 2024 | Mar 19, 2040 | U-3775: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having no, mild, moderate, or severe renal impairment |
| Pat. No. 11986455 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Method of use Pat. Sub. Date(s): 002: May 31, 2024 | Mar 19, 2040 | U-3521: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having mild, moderate, or severe renal impairment |
| Pat. No. 11998639 DP* Formulations of (R)-2-amino-3-phenylpropyl carbamate Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Jun 10, 2024 | Sep 5, 2037 | U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) |
| Pat. No. 12005036 Methods of administering solriamfetol to lactating women Claim Types: Method of improving a treatment Pat. Sub. Date(s): 002: Jun 13, 2024 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 12036194 Methods of administering solriamfetol to lactating women Claim Types: Method of use Pat. Sub. Date(s): 002: Aug 5, 2024 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 12064411 Methods of administering solriamfetol to lactating women Claim Types: Method of improving a treatment Pat. Sub. Date(s): 002: Aug 26, 2024 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 12090126 Methods of administering solriamfetol to lactating women Claim Types: Method of use Pat. Sub. Date(s): 002: Sep 27, 2024 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 12102609 Methods of administering solriamfetol to lactating women Claim Types: Method of improving a treatment; Method of use Pat. Sub. Date(s): 002: Oct 15, 2024 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jun 17, 2024 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 17, 2026 | ODE-254: Indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy |
AYTU
KARBINAL ER (SUSPENSION, EXTENDED RELEASE) (ORAL) CARBINOXAMINE MALEATE
Drug Classes: histamine-1 (H1) receptor antagonist
NDA Applicant: AYTU NDA No.: 022556 Prod. No.: 001 RX (4MG/5ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8062667 DP* Modified release formulations containing drug-ion exchange resin complexes Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 18, 2013 | Mar 29, 2029 | |
| Pat. No. 9522191 DP* Modified release formulations containing drug--ion exchange resin complexes Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 22, 2016 | Jun 15, 2027 |
AYTU
ZOLPIMIST (SPRAY, METERED) (ORAL) ZOLPIDEM TARTRATE
Drug Classes: gamma-aminobutyric acid (GABA) A receptor positive modulator
NDA Applicant: AYTU NDA No.: 022196 Prod. No.: 001 DISC (5MG/SPRAY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8236285 DS* DP* Buccal, polar and non-polar spray containing zolpidem Claim Types: Method of administration Pat. Sub. Date(s): 001: None | Aug 7, 2032 | U-70: Treatment of transient insomnia |
AZURITY
AZMIRO (SOLUTION) (INTRAMUSCULAR) TESTOSTERONE CYPIONATE
Drug Classes: androgen
NDA Applicant: AZURITY NDA No.: 216318 Prod. No.: 001 RX (200MG/ML (200MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11311554 DP* Pharmaceutical compositions of testosterone Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: Jun 3, 2022 | Mar 25, 2039 | |
| Pat. No. 11642355 DP* Pharmaceutical compositions of testosterone Claim Types: Formulation; Device Pat. Sub. Date(s): 001: May 12, 2023 | Mar 25, 2039 | |
| Pat. No. 12138271 DP* Pharmaceutical compositions of testosterone Claim Types: Formulation; Drug in a container; Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Nov 14, 2024 | Mar 25, 2039 |
AZURITY
DANZITEN (TABLET) (ORAL) NILOTINIB TARTRATE
Drug Classes: kinase inhibitor
NDA Applicant: AZURITY NDA No.: 219293 Prod. No.: 001 RX (EQ 71MG BASE); 002 RX (EQ 95MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10874671 DP* Pharmaceutical compositions of nilotinib Claim Types: Composition; Product-by-process; Formulation; Kit; Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): All strengths: Nov 8, 2024 | Feb 18, 2040 | |
| Pat. No. 11793809 DP* Pharmaceutical compositions of nilotinib Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 8, 2024 | Feb 18, 2040 |
AZURITY
EDARBI (TABLET) (ORAL) AZILSARTAN KAMEDOXOMIL
Drug Classes: angiotensin II receptor blocker
NDA Applicant: AZURITY NDA No.: 200796 Prod. No.: 001 RX (EQ 40MG MEDOXOMIL); 002 RX (EQ 80MG MEDOXOMIL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7157584 DS* Benzimidazole derivative and use thereof Claim Types: Compound Pat. Sub. Date(s): All strengths: None | May 22, 2025 | |
| Pat. No. 7572920 DP* Benzimidazole derivative and use as a II receptor antagonist Claim Types: Composition; Method of use; Formulation; Process Pat. Sub. Date(s): All strengths: None | Jan 7, 2025 | U-3: Treatment of hypertension |
| Pat. No. 9066936 DP* Solid pharmaceutical composition comprising a benzimidazole-7-carboxylate derivative and a pH control agent Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Jul 30, 2015 | Mar 26, 2028 |
AZURITY
EDARBYCLOR (TABLET) (ORAL) AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE
Drug Classes: angiotensin II receptor blocker == thiazide-like diuretic
NDA Applicant: AZURITY NDA No.: 202331 Prod. No.: 001 RX (EQ 40MG MEDOXOMIL;12.5MG); 002 RX (EQ 40MG MEDOXOMIL;25MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7157584 DS* Benzimidazole derivative and use thereof Claim Types: Compound Pat. Sub. Date(s): 001: Jan 17, 2012; 002: None | May 22, 2025 | |
| Pat. No. 7572920 DP* Benzimidazole derivative and use as a II receptor antagonist Claim Types: Composition; Method of use; Formulation; Process Pat. Sub. Date(s): 001: Jan 17, 2012; 002: None | Jan 7, 2025 | U-3: Treatment of hypertension |
| Pat. No. 9066936 DP* Solid pharmaceutical composition comprising a benzimidazole-7-carboxylate derivative and a pH control agent Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Jul 30, 2015 | Mar 26, 2028 | |
| Pat. No. 9169238 DP* Solid pharmaceutical composition Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Nov 19, 2015 | Feb 4, 2030 | |
| Pat. No. 9387249 Methods of treating hypertension with at least one angiotensin II receptor blocker and chlorthalidone Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 15, 2019 | Jul 1, 2031 | U-3: Treatment of hypertension |
AZURITY
EPANED (SOLUTION) (ORAL) ENALAPRIL MALEATE [GENERIC AB]
NDA Applicant: AZURITY NDA No.: 208686 Prod. No.: 001 RX (1MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9669008 DP* Enalapril formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 9, 2017 | Mar 25, 2036 | |
| Pat. No. 9808442 Enalapril formulations Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 20, 2017 | Mar 25, 2036 | U-1723: Treatment of heart failure U-185: Method of treating hypertension U-1892: Method of treating left ventricular dysfunction U-3: Treatment of hypertension U-71: Method of treatment of heart failure |
| Pat. No. 10039745 DP* Enalapril formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 23, 2018 | Mar 25, 2036 | |
| Pat. No. 10154987 Enalapril formulations Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 4, 2019 | Mar 25, 2036 | U-1723: Treatment of heart failure U-185: Method of treating hypertension U-1892: Method of treating left ventricular dysfunction U-3: Treatment of hypertension U-71: Method of treatment of heart failure |
| Pat. No. 10772868 DP* Enalapril formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 23, 2020 | Mar 25, 2036 | |
| Pat. No. 10786482 DP* Enalapril formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 8, 2020 | Mar 25, 2036 | |
| Pat. No. 11040023 DP* Enalapril formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 25, 2021 | Mar 25, 2036 | |
| Pat. No. 11141405 DP* Enalapril formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 19, 2021 | Mar 25, 2036 | |
| Pat. No. 11173141 DP* Enalapril formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 8, 2022 | Mar 25, 2036 |
AZURITY
EPANED KIT (FOR SOLUTION) (ORAL) ENALAPRIL MALEATE
NDA Applicant: AZURITY NDA No.: 204308 Prod. No.: 001 DISC (1MG/ML**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8568747 DP* Enalapril compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 31, 2013 | Nov 6, 2032 | |
| Pat. No. 8778366 Enalapril compositions Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 16, 2014 | Nov 6, 2032 | U-1723: Treatment of heart failure U-185: Method of treating hypertension U-1892: Method of treating left ventricular dysfunction U-3: Treatment of hypertension U-71: Method of treatment of heart failure |
| Pat. No. 9855214 DP* Enalapril compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 10, 2018 | Nov 6, 2032 | |
| Pat. No. 9968553 Enalapril compositions Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 1, 2018 | Nov 6, 2032 | U-1723: Treatment of heart failure U-185: Method of treating hypertension U-1892: Method of treating left ventricular dysfunction U-3: Treatment of hypertension U-71: Method of treatment of heart failure |
AZURITY
EPRONTIA (SOLUTION) (ORAL) TOPIRAMATE [GENERIC AB]
NDA Applicant: AZURITY NDA No.: 214679 Prod. No.: 001 RX (25MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11433046 Compositions and methods for treating epilepsy, seizures and other conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 13, 2022 | Aug 21, 2040 | U-3413: Indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older U-3414: Indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older U-3415: Indicated for the preventive treatment of migraine in patients 12 years and older |
| Pat. No. 11633374 DP* Compositions and methods for treating epilepsy, seizures and other conditions Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 27, 2023 | Aug 21, 2040 | |
| Pat. No. 11826343 DP* Compositions and methods for treating epilepsy, seizures and other conditions Claim Types: Formulation; Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Dec 11, 2023 | Aug 21, 2040 | |
| Pat. No. 11911362 DP* Compositions and methods for treating epilepsy, seizures and other conditions Claim Types: Method of use; Formulation; Device Pat. Sub. Date(s): 001: Mar 12, 2024 | Aug 21, 2040 | U-3413: Indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older U-3414: Indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older U-3415: Indicated for the preventive treatment of migraine in patients 12 years and older |
AZURITY
EVEKEO ODT (TABLET, ORALLY DISINTEGRATING) (ORAL) AMPHETAMINE SULFATE
Drug Classes: adrenergic agonist == amphetamine anorectic == central nervous system (CNS) stimulant == central nervous system stimulant
NDA Applicant: AZURITY NDA No.: 209905 Prod. No.: 001 DISC (5MG); 002 DISC (10MG); 003 DISC (15MG); 004 DISC (20MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10130580 DP* Taste-masked pharmaceutical compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jan 31, 2019 | Apr 19, 2024 | |
| Pat. No. 10441554 DP* Oral amphetamine composition Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 15, 2019 | Mar 10, 2037 | |
| Pat. No. 11160772 DP* Oral amphetamine composition Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 9, 2021 | Mar 10, 2037 | |
| Pat. No. 11896562 Oral amphetamine composition Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 16, 2024 | Mar 10, 2037 | U-3299: Treatment of attention deficit hyperactivity disorder (ADHD) in pediatric patients |
AZURITY
EVEKEO ODT (TABLET, ORALLY DISINTEGRATING) (ORAL) AMPHETAMINE SULFATE
Drug Classes: adrenergic agonist == amphetamine anorectic == central nervous system (CNS) stimulant == central nervous system stimulant
NDA Applicant: AZURITY NDA No.: 209905 Prod. No.: 005 DISC (2.5MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10130580 DP* Taste-masked pharmaceutical compositions Claim Types: Formulation Pat. Sub. Date(s): 005: Jul 7, 2021 | Apr 19, 2024 | |
| Pat. No. 10441554 DP* Oral amphetamine composition Claim Types: Formulation Pat. Sub. Date(s): 005: Jul 7, 2021 | Mar 10, 2037 | |
| Pat. No. 11160772 DP* Oral amphetamine composition Claim Types: Formulation Pat. Sub. Date(s): 005: Dec 9, 2021 | Mar 10, 2037 |
AZURITY
FIRVANQ KIT (FOR SOLUTION) (ORAL) VANCOMYCIN HYDROCHLORIDE [GENERIC AB]
Drug Classes: glycopeptide antibacterial
NDA Applicant: AZURITY NDA No.: 208910 Prod. No.: 001 RX (EQ 25MG BASE/ML); 002 RX (EQ 50MG BASE/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10493028 DP* Composition and method for vancomycin oral liquid Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 5, 2019 | Mar 13, 2035 | |
| Pat. No. 10688046 DP* Composition and method for vancomycin oral liquid Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 10, 2020 | Mar 13, 2035 | |
| Pat. No. 10959946 DP* Composition and method for vancomycin oral liquid Claim Types: Formulation Pat. Sub. Date(s): All strengths: Apr 15, 2021 | Mar 13, 2035 | |
| Pat. No. 10959947 DP* Composition and method for vancomycin oral liquid Claim Types: Formulation Pat. Sub. Date(s): All strengths: Apr 15, 2021 | Mar 13, 2035 | U-3104: Treatment of C. difficile-associated diarrhea U-3105: Treatment of staphylococcal enterocolitis |
| Pat. No. 10959948 DP* Composition and method for vancomycin oral liquid Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Apr 15, 2021 | Mar 13, 2035 | U-3104: Treatment of C. difficile-associated diarrhea U-3105: Treatment of staphylococcal enterocolitis |
| Pat. No. 10959949 DP* Composition and method for vancomycin oral liquid Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Apr 15, 2021 | Mar 13, 2035 | U-3104: Treatment of C. difficile-associated diarrhea U-3105: Treatment of staphylococcal enterocolitis |
| Pat. No. 11638692 DP* Composition and method for vancomycin oral liquid Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 2, 2023 | Mar 13, 2035 |
AZURITY
FLEQSUVY (SUSPENSION) (ORAL) BACLOFEN [GENERIC AB]
Drug Classes: gamma-aminobutyric acid (GABA)-ergic agonist
NDA Applicant: AZURITY NDA No.: 215602 Prod. No.: 001 RX (25MG/5ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11324696 DP* Suspensions and diluents for metronidazole and baclofen Claim Types: Formulation Pat. Sub. Date(s): 001: May 16, 2022 | Sep 29, 2037 | |
| Pat. No. 11446246 Suspensions and diluents for metronidazole and baclofen Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 30, 2022 | Sep 8, 2037 | U-3433: Indicated for the treatment of spasticity resulting from multiple sclerosis |
AZURITY
HORIZANT (TABLET, EXTENDED RELEASE) (ORAL) GABAPENTIN ENACARBIL
NDA Applicant: AZURITY NDA No.: 022399 Prod. No.: 001 RX (600MG); 002 RX (300MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6818787 DS* DP* Prodrugs of GABA analogs, compositions and uses thereof Claim Types: Compound Pat. Sub. Date(s): 001: Apr 19, 2011; 002: Jan 5, 2012 | Apr 6, 2025 | |
| Pat. No. 8026279 DS* DP* Crystalline form of .gamma.-aminobutyric acid analog Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Oct 24, 2011; 002: Jan 5, 2012 | Nov 10, 2026 | |
| Pat. No. 8114909 Treating or preventing restless legs syndrome using prodrugs of GABA analogs Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 13, 2012; 002: None | Apr 11, 2026 | U-1231: Treatment of moderate-to-severe primary restless leg syndrome in adults |
| Pat. No. 8686034 Crystalline form of .gamma.-aminobutyric acid analog Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 28, 2014 | Jan 24, 2025 | U-1231: Treatment of moderate-to-severe primary restless leg syndrome in adults U-1247: Management of postherpetic neuralgia (PHN) in adults |
| Pat. No. 8795725 DP* GABA analog prodrug sustained release oral dosage forms Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Aug 27, 2014 | Jun 10, 2029 | U-1231: Treatment of moderate-to-severe primary restless leg syndrome in adults U-1247: Management of postherpetic neuralgia (PHN) in adults |
AZURITY
KATERZIA (SUSPENSION) (ORAL) AMLODIPINE BENZOATE
Drug Classes: calcium channel blocker == dihydropyridine calcium channel blocker
NDA Applicant: AZURITY NDA No.: 211340 Prod. No.: 001 RX (EQ 1MG BASE/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10695329 DP* Amlodipine formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 22, 2020 | Oct 16, 2037 | |
| Pat. No. 10799453 DP* Amlodipine formulations Claim Types: Product-by-process Pat. Sub. Date(s): 001: Nov 2, 2020 | Apr 11, 2039 | |
| Pat. No. 10894039 Amlodipine formulations Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 16, 2021 | Oct 6, 2037 | U-185: Method of treating hypertension U-3: Treatment of hypertension |
| Pat. No. 10952998 DP* Amlodipine formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 29, 2021 | Oct 6, 2037 | |
| Pat. No. 10959991 Amlodipine formulations Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 15, 2021 | Oct 6, 2037 | U-158: Angina U-39: Angina pectoris |
| Pat. No. 11364230 DP* Amlodipine formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 24, 2022 | Oct 6, 2037 | |
| Pat. No. 11471409 Amlodipine formulations Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 18, 2022 | Oct 6, 2037 | U-3447: A method of treating coronary artery disease U-3448: A method of treating hypertension |
| Pat. No. 11484498 DP* Amlodipine Formulations Claim Types: Product-by-process Pat. Sub. Date(s): 001: Nov 4, 2022 | Oct 6, 2037 | |
| Pat. No. 11701326 DP* Amlodipine formulations Claim Types: Product-by-process Pat. Sub. Date(s): 001: Jul 20, 2023 | Oct 6, 2037 | |
| Pat. No. 11918685 Amlodipine formulations Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 14, 2024 | Oct 6, 2037 | U-3447: A method of treating coronary artery disease U-3448: A method of treating hypertension |
| Pat. No. 12053461 DP* Amlodipine formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 15, 2024 | Oct 6, 2037 |
AZURITY
KONVOMEP (FOR SUSPENSION) (ORAL) OMEPRAZOLE; SODIUM BICARBONATE
Drug Classes: proton pump inhibitor
NDA Applicant: AZURITY NDA No.: 213593 Prod. No.: 001 RX (2MG/ML;84MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10751333 DP* Compositions and kits for omeprazole suspension Claim Types: Excipient; Formulation; Formulation claimed by its inherent performace characteristics; Kit Pat. Sub. Date(s): 001: Oct 21, 2022 | Jul 16, 2039 | |
| Pat. No. 11103492 DP* Compositions and kits for omeprazole suspension Claim Types: Excipient Pat. Sub. Date(s): 001: Oct 21, 2022 | Jul 16, 2039 | |
| Pat. No. 11633478 DP* Compositions and kits for Omeprazole suspension Claim Types: Excipient Pat. Sub. Date(s): 001: May 12, 2023 | Jul 16, 2039 | |
| Pat. No. 11771686 Compositions and kits for omeprazole suspension Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 30, 2023 | Mar 1, 2040 | U-623: Short term treatment of active benign gastric ulcer |
| Pat. No. 11911473 Compositions and kits for omeprazole suspension Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 14, 2024 | Jul 16, 2039 | U-623: Short term treatment of active benign gastric ulcer U-624: Reduction of risk of upper gastrointestinal bleeding in critically ill patients |
| Pat. No. 12042539 DP* Compositions and kits for Omeprazole suspension Claim Types: Excipient Pat. Sub. Date(s): 001: Aug 2, 2024 | Jul 16, 2039 |
AZURITY
MYHIBBIN (SUSPENSION) (ORAL) MYCOPHENOLATE MOFETIL
NDA Applicant: AZURITY NDA No.: 216482 Prod. No.: 001 RX (200MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11931455 DP* Pharmaceutical suspension for oral dosage Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: May 15, 2024 | Aug 16, 2039 | U-1752: Prophylaxis of organ rejection |
| Pat. No. 12097284 DP* Mycophenolate oral suspension Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 27, 2024 | Aug 16, 2039 | |
| Pat. No. 12097285 DP* Mycophenolate oral suspension Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 27, 2024 | Aug 16, 2039 | U-1752: Prophylaxis of organ rejection |
AZURITY
NYMALIZE (SOLUTION) (ORAL) NIMODIPINE
Drug Classes: dihydropyridine calcium channel blocker
NDA Applicant: AZURITY NDA No.: 203340 Prod. No.: 002 RX (6MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8517997 DP* Dispenser for medicaments and method and apparatus for making same Claim Types: Device Pat. Sub. Date(s): 002: Jul 8, 2020 | May 14, 2024 | |
| Pat. No. 10342787 DP* Non-aqueous liquid nimodipine compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: May 8, 2020 | Apr 16, 2038 | U-2804: A method for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms |
| Pat. No. 10576070 DP* Non-aqueous liquid nimodipine compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: May 8, 2020 | Apr 16, 2038 | U-2804: A method for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms |
| Pat. No. 11207306 Non-aqueous liquid nimodipine compositions Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 26, 2022 | Apr 16, 2038 | U-2804: A method for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms |
| Pat. No. 11413277 DP* Non-aqueous liquid nimodipine compositions Claim Types: Formulation claimed by its inherent performace characteristics; Method of improving a treatment Pat. Sub. Date(s): 002: Aug 25, 2022 | Apr 16, 2038 | U-2804: A method for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms |
| Pat. No. 11806338 DP* Non-aqueous liquid nimodipine compositions Claim Types: Formulation claimed by its inherent performace characteristics; Device Pat. Sub. Date(s): 002: Nov 17, 2023 | Apr 16, 2038 |
AZURITY
PREVDUO (SOLUTION) (INTRAVENOUS) GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE
Drug Classes: anticholinergic == antimuscarinic agent == cholinesterase inhibitor
NDA Applicant: AZURITY NDA No.: 216903 Prod. No.: 001 RX (0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10456354 DP* Ready-to-use injectable pharmaceutical compositions comprising neostigmine and glycopyrrolate Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 24, 2023 | Oct 25, 2038 | |
| Pat. No. 11110054 DP* Ready-to-use injectable pharmaceutical compositions comprising neostigmine and glycopyrrolate Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 24, 2023 | Oct 25, 2038 | |
| Pat. No. 11938217 DP* Ready-to-use injectable pharmaceutical compositions comprising neostigmine and glycopyrrolate Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): 001: Mar 28, 2024 | Oct 25, 2038 | |
| Pat. No. 12151020 DP* Ready-to-use Injectable Pharmaceutical Compositions Comprising Neostigmine And Glycopyrrolate Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 27, 2024 | Oct 25, 2038 |
AZURITY
QBRELIS (SOLUTION) (ORAL) LISINOPRIL
Drug Classes: angiotensin converting enzyme (ACE) inhibitor
NDA Applicant: AZURITY NDA No.: 208401 Prod. No.: 001 RX (1MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9463183 DP* Lisinopril formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 13, 2016 | Nov 6, 2035 | |
| Pat. No. 9616096 Lisinopril formulations Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 14, 2017 | Nov 6, 2035 | U-1723: Treatment of heart failure U-185: Method of treating hypertension U-1864: Treatment of myocardial infarction U-1991: Reduction of mortality in acute myocardial infarction U-3: Treatment of hypertension U-71: Method of treatment of heart failure U-8: Acute myocardial infarction |
| Pat. No. 9814751 DP* Lisinopril formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 21, 2017 | Nov 6, 2035 | |
| Pat. No. 10039800 Lisinopril formulations Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 23, 2018 | Nov 6, 2035 | U-1723: Treatment of heart failure U-185: Method of treating hypertension U-1864: Treatment of myocardial infarction U-1991: Reduction of mortality in acute myocardial infarction U-3: Treatment of hypertension U-71: Method of treatment of heart failure U-8: Acute myocardial infarction |
| Pat. No. 10265370 DP* Lisinopril formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 29, 2019 | Nov 6, 2035 | |
| Pat. No. 10406199 Lisinopril formulations Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 20, 2019 | Nov 6, 2035 | U-1723: Treatment of heart failure U-185: Method of treating hypertension U-1864: Treatment of myocardial infarction U-1991: Reduction of mortality in acute myocardial infarction U-3: Treatment of hypertension U-71: Method of treatment of heart failure U-8: Acute myocardial infarction |
| Pat. No. 10940177 DP* Lisinopril formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 15, 2021 | Nov 6, 2035 | |
| Pat. No. 11179434 DP* Lisinopril formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 23, 2021 | Nov 6, 2035 | |
| Pat. No. 11771733 DP* Lisinopril formulations Claim Types: Formulation; Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Oct 4, 2023 | Nov 6, 2035 | |
| Pat. No. 12128083 DP* Lisinopril formulations Claim Types: Formulation; Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Nov 12, 2024 | Nov 6, 2035 |
AZURITY
SOTYLIZE (SOLUTION) (ORAL) SOTALOL HYDROCHLORIDE
Drug Classes: antiarrhythmic
NDA Applicant: AZURITY NDA No.: 205108 Prod. No.: 001 RX (5MG/ML (5MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9724297 DP* Sotalol compositions and uses of the same Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 7, 2017 | Aug 31, 2035 | U-2096: SOTYLIZE is indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (Afib/AFL)] in patients with symptomatic Afib/AFL who are currently in sinus rhythm |
| Pat. No. 10206895 DP* Sotalol compositions and uses of the same Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Mar 7, 2019 | Apr 1, 2034 | U-2096: SOTYLIZE is indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (Afib/AFL)] in patients with symptomatic Afib/AFL who are currently in sinus rhythm U-2494: Indicated for the treatment of ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgement of the physician are life-threatening |
| Pat. No. 11013703 DP* Sotalol compositions and uses of the same Claim Types: Formulation Pat. Sub. Date(s): 001: May 26, 2021 | Apr 1, 2034 | |
| Pat. No. 11850222 Sotalol compositions and uses of the same Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 5, 2024 | Nov 19, 2034 | U-2096: SOTYLIZE is indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (Afib/AFL)] in patients with symptomatic Afib/AFL who are currently in sinus rhythm U-2494: Indicated for the treatment of ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgement of the physician are life-threatening |
AZURITY
THYQUIDITY (SOLUTION) (ORAL) LEVOTHYROXINE SODIUM
Drug Classes: L-thyroxine (T4)
NDA Applicant: AZURITY NDA No.: 214047 Prod. No.: 001 RX (100MCG/5ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9050307 DP* Method for the preparation of a levothyroxine solution Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Dec 14, 2020 | Aug 6, 2031 |
AZURITY
TRIPTODUR KIT (FOR SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) TRIPTORELIN PAMOATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: AZURITY NDA No.: 208956 Prod. No.: 001 RX (EQ 22.5MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10166181 DP* Slow release pharmaceutical composition made of microgranules Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 25, 2019 | Jun 30, 2029 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 29, 2024 | ODE-149: Treatment of pediatric patients 2 years of age and older with central precocious puberty |
AZURITY
VIVIMUSTA (SOLUTION) (INTRAVENOUS) BENDAMUSTINE HYDROCHLORIDE
Drug Classes: alkylating drug
NDA Applicant: AZURITY NDA No.: 212209 Prod. No.: 001 RX (100MG/4ML (25MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11844784 DP* Stable pharmaceutical compositions of bendamustine Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 19, 2023 | Jul 29, 2042 |
AZURITY
XATMEP (SOLUTION) (ORAL) METHOTREXATE SODIUM
Drug Classes: folate analog metabolic inhibitor
NDA Applicant: AZURITY NDA No.: 208400 Prod. No.: 001 RX (EQ 2.5MG BASE/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9259427 DP* Methotrexate composition Claim Types: Formulation; Process Pat. Sub. Date(s): 001: May 12, 2017 | Jan 2, 2033 | |
| Pat. No. 9855215 DP* Methotrexate composition Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 19, 2018 | Jan 2, 2033 | |
| Pat. No. 10231927 Methotrexate composition Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 1, 2019 | Jan 2, 2033 | U-1349: Treatment of juvenile rheumatoid arthritis U-1699: A method for treating acute lymphoblastic leukemia |
| Pat. No. 10610485 DP* Methotrexate composition Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 16, 2020 | Jan 2, 2033 | |
| Pat. No. 11116724 Methotrexate composition Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 23, 2021 | Jan 2, 2033 | U-1349: Treatment of juvenile rheumatoid arthritis U-1699: A method for treating acute lymphoblastic leukemia |
| Pat. No. 11969503 DP* Methotrexate composition Claim Types: Formulation Pat. Sub. Date(s): 001: May 15, 2024 | Jan 2, 2033 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 25, 2024 | ODE-137: Treatment of oligoarticular juvenile idiopathic arthritis (persistent oligoarthritis, psoriatic juvenile idiopathic arthritis, enthesitis-related arthritis, or undifferentiated arthritis) & polyarticular juvenile idiopathic arthritis in children 0-16 yrs |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 25, 2024 | ODE-138: Treatment of pediatric patients with acute lymphoblastic leukemia as a component of a combination chemotherapy maintenance regimen |
AZURITY
ZONISADE (SUSPENSION) (ORAL) ZONISAMIDE
Drug Classes: antiepileptic drug (AED)
NDA Applicant: AZURITY NDA No.: 214273 Prod. No.: 001 RX (100MG/5ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11478456 Oral Pharmaceutical Composition Comprising Zonisamide And Process Of Preparation Thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 26, 2022 | Aug 18, 2038 | U-3458: A method of treating seizures |
| Pat. No. 11529333 DP* Oral pharmaceutical composition comprising zonisamide and process of preparation thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 27, 2022 | Aug 18, 2038 |