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 | |
| 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 | |
| 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
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 [Extended 1611 days (4.4 years)] 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 [Extended 953 days (2.6 years)] 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* [Extended 945 days (2.6 years)] 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* [Extended 945 days (2.6 years)] 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* [Extended 945 days (2.6 years)] 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 [Extended 149 days (0.4 years)] 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 [Extended 149 days (0.4 years)] 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* [Extended 5 years] 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 |
| 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* [Extended 5 years] 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 |
| 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* [Extended 5 years] 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 |
| 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); 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): 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
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* [Extended 989 days (2.7 years)] 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 |
| 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* [Extended 989 days (2.7 years)] 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 | |
| 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* [Extended 989 days (2.7 years)] 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 | |
| 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* [Extended 989 days (2.7 years)] 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 | |
| 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
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* [Extended 774 days (2.1 years)] 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* [Extended 774 days (2.1 years)] 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 | |
| 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* [Extended 1068 days (2.9 years)] 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 |
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* [Extended 1068 days (2.9 years)] 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* [Extended 93 days (0.3 years)] 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* [Extended 93 days (0.3 years)] 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* [Extended 905 days (2.5 years)] (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* [Extended 905 days (2.5 years)] (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* [Extended 905 days (2.5 years)] (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
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 |
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 [Extended 1084 days (3 years)] 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 [Extended 798 days (2.2 years)] 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 | |
| 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* [Extended 1315 days (3.6 years)] 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* [Extended 1315 days (3.6 years)] 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* [Extended 1315 days (3.6 years)] 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 | |
| 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 |
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 |
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* [Extended 1778 days (4.9 years)] 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 [GENERIC AB]
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* [Extended 1150 days (3.2 years)] 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* [Extended 1150 days (3.2 years)] 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* [Extended 1306 days (3.6 years)] 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* [Extended 1306 days (3.6 years)] 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 |
ADAMAS OPERATIONS
GOCOVRI (CAPSULE, EXTENDED RELEASE) (ORAL) AMANTADINE HYDROCHLORIDE
Drug Classes: influenza A M2 protein inhibitor
NDA Applicant: ADAMAS OPERATIONS NDA No.: 208944 Prod. No.: 001 RX (EQ 68.5MG BASE); 002 RX (EQ 137MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8389578 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Sep 21, 2017 | Jan 22, 2028 | U-2105: Treatment of dyskinesia in patients with Parkinson's disease receiving immediate release levodopa-based therapy, with or without concomitant dopaminergic medications |
| Pat. No. 8741343 Method of administering amantadine prior to a sleep period Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Sep 21, 2017 | Dec 2, 2030 | U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications |
| Pat. No. 8796337 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Sep 21, 2017 | Nov 23, 2025 | U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications |
| Pat. No. 8889740 DP* Composition and method for treating neurological disease Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 21, 2017 | Nov 23, 2025 | |
| Pat. No. 8895614 DP* Composition and method for treating neurological disease Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 21, 2017 | Nov 23, 2025 | |
| Pat. No. 8895615 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Sep 21, 2017 | Nov 23, 2025 | U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications |
| Pat. No. 8895616 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Sep 21, 2017 | Nov 23, 2025 | U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications |
| Pat. No. 8895617 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Sep 21, 2017 | Nov 23, 2025 | U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications |
| Pat. No. 8895618 DP* Composition and method for treating neurological disease Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 21, 2017 | Nov 23, 2025 | |
| Pat. No. 9867791 Method of administering amantadine prior to a sleep period Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Jan 16, 2018 | Dec 2, 2030 | U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications |
| Pat. No. 9867792 Method of administering amantadine prior to a sleep period Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Jan 16, 2018 | Dec 2, 2030 | U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications |
| Pat. No. 9867793 Method of administering amantadine prior to a sleep period Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Jan 16, 2018 | Dec 2, 2030 | U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications |
| Pat. No. 9877933 Method of administering amantadine prior to a sleep period Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Jan 30, 2018 | Dec 2, 2030 | U-2224: Treatment of dyskinesia and increasing on time without troublesome dyskinesia in patients with Parkinson's Disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications |
| Pat. No. 10154971 Methods of administering amantadine Claim Types: Method of improving a treatment Pat. Sub. Date(s): All strengths: Dec 18, 2018 | Dec 4, 2034 | U-2459: Treatment of dyskinesia and decreasing off time in patients with Parkinson's Disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications |
| Pat. No. 10646456 Methods of administering amantadine Claim Types: Method of improving a treatment Pat. Sub. Date(s): All strengths: Jul 14, 2020 | Jun 17, 2034 | U-2808: Treatment of dyskinesia, decreasing off time, and increasing on time without troublesome dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications |
| Pat. No. 11065213 DP* Amantadine compositions and preparations thereof Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): All strengths: Jul 20, 2021 | Aug 23, 2038 | |
| Pat. No. 11077073 Methods of using amantadine compositions Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 4, 2021 | Aug 23, 2038 | U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications U-2224: Treatment of dyskinesia and increasing on time without troublesome dyskinesia in patients with Parkinson's Disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications U-3180: Decreasing off time in patients with parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications |
| Pat. No. 11197835 Method of administering amantadine prior to a sleep period Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 12, 2022 | Dec 2, 2030 | U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications |
| Pat. No. 11903908 Methods of administering amantadine Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 8, 2024 | Jun 17, 2034 | U-3822: As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's Disease experiencing 'off' episodes |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Aug 24, 2024 | ODE-153: Treatment of dyskinesia in patients with parkinson's disease receiving levodopa-based therapy with or without concomitant dopaminergic medications |
ADAMAS OPERATIONS
OSMOLEX ER (TABLET, EXTENDED RELEASE) (ORAL) AMANTADINE HYDROCHLORIDE
Drug Classes: influenza A M2 protein inhibitor
NDA Applicant: ADAMAS OPERATIONS NDA No.: 209410 Prod. No.: 001 DISC (EQ 129MG BASE); 002 DISC (EQ 193MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8252331 DP* Osmotic device containing amantadine and an osmotic salt Claim Types: Formulation Pat. Sub. Date(s): All strengths: Mar 1, 2018 | Mar 13, 2030 | |
| Pat. No. 8389578 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2021 | Jan 22, 2028 | U-219: Treatment of Parkinson's disease U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease |
| Pat. No. 8574626 DP* Osmotic device containing amantadine and an osmotic salt Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Mar 1, 2018 | Nov 28, 2025 | U-20: A process for treating a patient suffering from parkinson's syndrome and in need of treatment |
| Pat. No. 8796337 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2021 | Nov 23, 2025 | U-219: Treatment of Parkinson's disease U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease |
| Pat. No. 8889740 DP* Composition and method for treating neurological disease Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 10, 2021 | Nov 23, 2025 | |
| Pat. No. 8895614 DP* Composition and method for treating neurological disease Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 10, 2021 | Nov 23, 2025 | |
| Pat. No. 8895615 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2021 | Nov 23, 2025 | U-219: Treatment of Parkinson's disease U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease |
| Pat. No. 8895616 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2021 | Nov 23, 2025 | U-219: Treatment of Parkinson's disease U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease |
| Pat. No. 8895617 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2021 | Nov 23, 2025 | U-219: Treatment of Parkinson's disease U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease |
| Pat. No. 8895618 DP* Composition and method for treating neurological disease Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 10, 2021 | Nov 23, 2025 | |
| Pat. No. 8987333 DP* Composition and method for treating neurological disease Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 10, 2021 | Nov 23, 2025 | |
| Pat. No. 9072697 Composition and method for treating neurological disease Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 10, 2021 | Nov 23, 2025 | U-219: Treatment of Parkinson's disease U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease |
| Pat. No. 10213393 Composition and method for treating neurological disease Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 13, 2019 | Feb 15, 2038 | U-20: A process for treating a patient suffering from parkinson's syndrome and in need of treatment |
| Pat. No. 10213394 Composition and method for treating neurological disease Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 13, 2019 | Feb 15, 2038 | U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients |
| Pat. No. 10500170 Composition and method for treating neurological disease Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 17, 2019 | Feb 15, 2038 | U-20: A process for treating a patient suffering from parkinson's syndrome and in need of treatment |
| Pat. No. 10500171 Composition and method for treating neurological disease Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 17, 2019 | Feb 15, 2038 | U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients |
| Pat. No. 10500172 Composition and method for treating neurological disease Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 17, 2019 | Feb 15, 2038 | U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients |
| Pat. No. 10512617 Composition and method for treating neurological disease Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 2, 2020 | Feb 15, 2038 | U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients |
| Pat. No. 11890261 Composition and method for treating neurological disease Claim Types: Method of use; Method of Use claimed by its inherent performace characteristics Pat. Sub. Date(s): All strengths: Mar 4, 2024 | Feb 15, 2038 | U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients |
ADAMAS OPERATIONS
OSMOLEX ER (TABLET, EXTENDED RELEASE) (ORAL) AMANTADINE HYDROCHLORIDE
Drug Classes: influenza A M2 protein inhibitor
NDA Applicant: ADAMAS OPERATIONS NDA No.: 209410 Prod. No.: 003 DISC (EQ 258MG BASE); 004 DISC (EQ 161MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8252331 DP* Osmotic device containing amantadine and an osmotic salt Claim Types: Formulation Pat. Sub. Date(s): 003: Mar 1, 2018; 004: Oct 29, 2020 | Mar 13, 2030 | |
| Pat. No. 8389578 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2021 | Jan 22, 2028 | U-219: Treatment of Parkinson's disease U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease |
| Pat. No. 8574626 DP* Osmotic device containing amantadine and an osmotic salt Claim Types: Formulation; Method of use Pat. Sub. Date(s): 003: Mar 1, 2018; 004: Oct 29, 2020 | Nov 28, 2025 | U-20: A process for treating a patient suffering from parkinson's syndrome and in need of treatment |
| Pat. No. 8796337 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2021 | Nov 23, 2025 | U-219: Treatment of Parkinson's disease U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease |
| Pat. No. 8889740 DP* Composition and method for treating neurological disease Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 10, 2021 | Nov 23, 2025 | |
| Pat. No. 8895614 DP* Composition and method for treating neurological disease Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 10, 2021 | Nov 23, 2025 | |
| Pat. No. 8895615 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2021 | Nov 23, 2025 | U-219: Treatment of Parkinson's disease U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease |
| Pat. No. 8895616 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2021 | Nov 23, 2025 | U-219: Treatment of Parkinson's disease U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease |
| Pat. No. 8895617 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2021 | Nov 23, 2025 | U-219: Treatment of Parkinson's disease U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease |
| Pat. No. 8895618 DP* Composition and method for treating neurological disease Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 10, 2021 | Nov 23, 2025 | |
| Pat. No. 8987333 DP* Composition and method for treating neurological disease Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 10, 2021 | Nov 23, 2025 | |
| Pat. No. 9072697 Composition and method for treating neurological disease Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 10, 2021 | Nov 23, 2025 | U-219: Treatment of Parkinson's disease U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease |
| Pat. No. 10213393 Composition and method for treating neurological disease Claim Types: Method of use Pat. Sub. Date(s): 003: Mar 13, 2019; 004: Oct 29, 2020 | Feb 15, 2038 | U-20: A process for treating a patient suffering from parkinson's syndrome and in need of treatment |
| Pat. No. 10213394 Composition and method for treating neurological disease Claim Types: Method of use Pat. Sub. Date(s): 003: Mar 13, 2019; 004: Oct 29, 2020 | Feb 15, 2038 | U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients |
| Pat. No. 10500170 Composition and method for treating neurological disease Claim Types: Method of use Pat. Sub. Date(s): 003: Dec 17, 2019; 004: Oct 29, 2020 | Feb 15, 2038 | U-20: A process for treating a patient suffering from parkinson's syndrome and in need of treatment |
| Pat. No. 10500171 Composition and method for treating neurological disease Claim Types: Method of use Pat. Sub. Date(s): 003: Dec 17, 2019; 004: Oct 29, 2020 | Feb 15, 2038 | U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients |
| Pat. No. 10500172 Composition and method for treating neurological disease Claim Types: Method of use Pat. Sub. Date(s): 003: Dec 17, 2019; 004: Oct 29, 2020 | Feb 15, 2038 | U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients |
| Pat. No. 10512617 Composition and method for treating neurological disease Claim Types: Method of use Pat. Sub. Date(s): 003: Jan 2, 2020; 004: Oct 29, 2020 | Feb 15, 2038 | U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients |
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 RX (EQ 2.5MG BASE;3.5MG ); 002 RX (EQ 5MG BASE;7MG); 003 RX (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 LTD
COMBOGESIC (TABLET) (ORAL) ACETAMINOPHEN; IBUPROFEN
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: AFT PHARMS LTD NDA No.: 209471 Prod. No.: 001 DISC (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* [Extended 1655 days (4.5 years)] 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 RX (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 | |
| 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 |
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 polymera
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 |
| 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
AVYCAZ (POWDER) (INTRAVENOUS) AVIBACTAM SODIUM; CEFTAZIDIME
Drug Classes: beta lactamase inhibitor == cephalosporin antibacterial
NDA Applicant: ALLERGAN NDA No.: 206494 Prod. No.: 001 RX (EQ 0.5GM BASE;2GM/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7112592 DS* DP* [Extended 1413 days (3.9 years)] 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 |
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. 9161926 DP* Topical dapsone and dapsone/adaplene compositions and methods for use thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 1, 2016 | Nov 18, 2033 | |
| Pat. No. 9517219 Topical dapsone and dapsone/adapalene compositions and methods for use thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 16, 2016 | Nov 18, 2033 | U-1033: Topical treatment of acne vulgaris |
| 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 |
| 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* [Extended 190 days (0.5 years)] 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 |
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-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): 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-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): 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 | |
| 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 | |
| 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 | |
| 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. 8367652 Methods of treating hypertriglyceridemia Claim Types: Method of administration Pat. Sub. Date(s): 001: Feb 7, 2013 | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8377920 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. 8399446 Methods of treating hypertriglyceridemia Claim Types: Method of use |