Company names starting with "A"

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.


AAA USA INC
LUTATHERA (SOLUTION) (INTRAVENOUS) LUTETIUM LU 177 DOTATATE
NDA Applicant: AAA USA INC      NDA No.:
208700  Prod. No.: 001 RX (10mCi/ML)
PatentsExpirationPatented Use
Pat. No. 10596276 DP* Stable, concentrated radionuclide complex solutions
Claim Types: Product-by-proces; Process
Pat. Sub. Date(s): 001: Apr 13, 2020
Jul 25, 2038 
Pat. No. 10596278 DP* Stable, concentrated radionuclide complex solutions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 13, 2020
Jul 25, 2038 
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityJan 26, 2025ODE-166: Treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETS) including foregut, midgut, and hindgut neuroendocrine tumors in adults

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)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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, 2029U-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, 2036U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productNov 22, 2024 
Exclusivity Code: ODE - Orphan drug exclusivityNov 22, 2028ODE-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%)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-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, 2024U-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, 2024U-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, 2024U-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%)
PatentsExpirationPatented 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%)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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, 2027U-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)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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, 2028U-3499: Treatment of acute bacterial skin and skin structure infections (ABSSSI) in adult and pediatric patients using a two-dose regimen of dalbavancin
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMay 23, 2024 GAIN 
Exclusivity Code: NPP - New patient populationJul 22, 2024 

ABBVIE
DURYSTA (IMPLANT) (OPHTHALMIC) BIMATOPROST
Drug Classes: prostaglandin analog
NDA Applicant: ABBVIE      NDA No.:
211911  Prod. No.: 001 RX (10MCG)
PatentsExpirationPatented 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, 2027U-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, 2025U-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, 2034U-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, 2024U-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)
PatentsExpirationPatented 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, 2026U-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, 2031U-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 

ABBVIE
GELNIQUE (GEL) (TRANSDERMAL) OXYBUTYNIN CHLORIDE
Drug Classes: muscarinic antagonist
NDA Applicant: ABBVIE      NDA No.:
022204  Prod. No.: 001 DISC (10% (100MG/PACKET))
PatentsExpirationPatented 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, 2031U-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, 2029U-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, 2029U-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))
PatentsExpirationPatented 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, 2027U-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, 2027U-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, 2025U-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, 2028U-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, 2025U-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, 2028U-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, 2028U-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, 2028U-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%)
PatentsExpirationPatented Use
Pat. No. 8664215 Ocular allergy treatments with alcaftadine
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 21, 2014
Dec 23, 2027U-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, 2027U-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%)
PatentsExpirationPatented Use
Pat. No. 8101161 Method of enhancing hair growth
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 10, 2012
May 25, 2024U-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)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationMay 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**)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationMay 12, 2026 

ABBVIE
LINZESS (CAPSULE) (ORAL) LINACLOTIDE
Drug Classes: guanylate cyclase-C agonist
NDA Applicant: ABBVIE      NDA No.:
202811  Prod. No.: 001 RX (145MCG)
PatentsExpirationPatented 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, 2026U-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, 2024U-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, 2031U-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, 2033U-1515: Method of treating irritable bowel syndrome with constipation in adult patients.
U-1516: Method of treating chronic idiopathic constipation in adult patients.
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJun 12, 2026I-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)
PatentsExpirationPatented 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, 2026U-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, 2024U-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, 2031U-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, 2033U-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)
PatentsExpirationPatented 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, 2026U-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, 2024U-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, 2031U-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, 2033U-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, 2031U-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJun 12, 2026I-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%)
PatentsExpirationPatented 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, 2025U-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, 2025U-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, 2025U-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, 2025U-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, 2025U-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, 2025U-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, 2025U-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, 2025U-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)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityOct 30, 2026 PEDODE-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 exclusivityOct 30, 2026 PEDODE-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 exclusivityDec 10, 2028 PEDODE-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)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityDec 10, 2028 PEDODE-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.: 002 RX (14MG); 003 RX (21MG); 004 RX (28MG) NDA No.: 022525  Prod. No.: 001 DISC (7MG)
PatentsExpirationPatented 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 *PEDU-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)
PatentsExpirationPatented 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 *PEDU-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, 2029U-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 *PEDU-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 *PEDU-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, 2025U-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, 2025U-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)
PatentsExpirationPatented 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 *PEDU-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, 2029U-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 *PEDU-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 *PEDU-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, 2025U-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 *PEDU-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, 2025U-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)
PatentsExpirationPatented 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 *PEDU-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, 2029U-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, 2025U-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, 2025U-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)
PatentsExpirationPatented 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 *PEDU-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, 2029U-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 *PEDU-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 *PEDU-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, 2025U-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 *PEDU-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, 2025U-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)
PatentsExpirationPatented 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, 2034U-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, 2034U-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, 2028U-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, 2040U-3655: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) using 300 mg elagolix while co-administering omeprazole
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJul 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)
PatentsExpirationPatented 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, 2024U-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, 2029U-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, 2036U-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, 2036U-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, 2040U-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, 2038U-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, 2034U-3672: Management of moderate to severe pain associated with endometriosis using 150 mg elagolix for up to 24 months
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJul 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)
PatentsExpirationPatented 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, 2024U-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, 2029U-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, 2034U-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, 2040U-3654: Management of moderate to severe pain associated with endometriosis using 150 mg or 200 mg elagolix while co-administering omeprazole
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJul 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)
PatentsExpirationPatented 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, 2032U-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, 2031U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationApr 17, 2026I-909: Preventive treatment of migraine in adults
Exclusivity Code: NCE - New chemical entitySep 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%)
PatentsExpirationPatented 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, 2024U-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, 2024U-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, 2024U-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)
PatentsExpirationPatented Use
Pat. No. RE47221 DS* Tricyclic compounds
Claim Types: Compound
Pat. Sub. Date(s): 001: Sep 13, 2019
Dec 1, 2030 
Pat. No. 8962629 DS* Tricyclic compounds
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Sep 13, 2019
Jan 15, 2031U-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
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, 2036U-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, 2036U-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, 2036U-3275: Treatment of adults 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, 2036U-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
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, 2036U-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, 2036U-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, 2036U-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, 2038U-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, 2038U-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, 2036U-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, 2036U-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
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, 2036U-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, 2036U-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationDec 14, 2024I-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 IndicationJan 14, 2025I-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 IndicationMar 16, 2025I-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 IndicationApr 29, 2025I-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 IndicationMay 18, 2026I-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: NCE - New chemical entityAug 16, 2024 

ABBVIE
RINVOQ (TABLET, EXTENDED RELEASE) (ORAL) UPADACITINIB
Drug Classes: Janus kinase (JAK) inhibitor
NDA Applicant: ABBVIE      NDA No.:
211675  Prod. No.: 002 RX (30MG)
PatentsExpirationPatented Use
Pat. No. RE47221 DS* Tricyclic compounds
Claim Types: Compound
Pat. Sub. Date(s): 002: Feb 10, 2022
Dec 1, 2030 
Pat. No. 8962629 DS* Tricyclic compounds
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 002: Feb 10, 2022
Jan 15, 2031U-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, 2036U-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, 2036U-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, 2038U-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, 2038U-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, 2036U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJan 14, 2025I-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 IndicationMar 16, 2025I-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 IndicationMay 18, 2026I-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: NCE - New chemical entityAug 16, 2024 

ABBVIE
RINVOQ (TABLET, EXTENDED RELEASE) (ORAL) UPADACITINIB
Drug Classes: Janus kinase (JAK) inhibitor
NDA Applicant: ABBVIE      NDA No.:
211675  Prod. No.: 003 RX (45MG)
PatentsExpirationPatented Use
Pat. No. RE47221 DS* Tricyclic compounds
Claim Types: Compound
Pat. Sub. Date(s): 003: Apr 14, 2022
Dec 1, 2030 
Pat. No. 8962629 DS* Tricyclic compounds
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 003: Apr 14, 2022
Jan 15, 2031U-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, 2038U-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, 2038U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMar 16, 2025I-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 IndicationMay 18, 2026I-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: NCE - New chemical entityAug 16, 2024 

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)
PatentsExpirationPatented 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, 2029U-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**)
PatentsExpirationPatented 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, 2029U-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, 2030U-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, 2031U-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)
PatentsExpirationPatented 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, 2031U-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)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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, 2032U-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, 2031U-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, 2031U-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, 2041U-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, 2041U-3786: Acute treatment of migraine with or without aura in a patient with severe renal impairment
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityDec 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)
PatentsExpirationPatented 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, 2032U-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, 2031U-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, 2031U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityDec 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)
PatentsExpirationPatented 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, 2030U-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, 2033U-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, 2033U-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, 2033U-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, 2033U-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, 2033U-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousOct 16, 2023M-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 exclusivityJun 8, 2025ODE-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 exclusivityNov 21, 2025ODE-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 exclusivityMay 15, 2026ODE-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)
PatentsExpirationPatented 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, 2025U-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, 2028U-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, 2025U-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, 2028U-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, 2025U-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, 2028U-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, 2028U-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, 2025U-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)
PatentsExpirationPatented 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, 2025U-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, 2028U-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, 2025U-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, 2028U-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, 2025U-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, 2028U-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, 2028U-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, 2025U-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, 2033U-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)
PatentsExpirationPatented 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, 2029U-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, 2032U-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, 2032U-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, 2028U-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, 2029U-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, 2032U-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, 2032U-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, 2030U-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, 2031U-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, 2028U-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, 2033U-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, 2033U-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**)
PatentsExpirationPatented 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, 2029U-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, 2032U-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, 2032U-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, 2028U-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, 2029U-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, 2032U-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, 2032U-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, 2030U-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, 2031U-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, 2028U-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, 2035U-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, 2035U-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, 2035U-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, 2032U-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)
PatentsExpirationPatented 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, 2029U-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, 2029U-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, 2029U-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, 2029U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationDec 16, 2025I-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)
PatentsExpirationPatented 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, 2029U-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, 2029U-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, 2029U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationDec 16, 2025I-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)
PatentsExpirationPatented 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, 2029U-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, 2029U-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, 2029U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationDec 16, 2025I-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%)
PatentsExpirationPatented Use
Pat. No. 10610518 Presbyopia treatments
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 24, 2021
Apr 24, 2039U-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, 2039U-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: D - New Dosing ScheduleMar 28, 2026D-187: Addition of second dose for treatment of presbyopia in adults
Exclusivity Code: NP - New productOct 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))
ExclusivityExpirationExclusivity 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**)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityOct 18, 2023ODE-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)
PatentsExpirationPatented 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, 2031U-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)
PatentsExpirationPatented 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, 2028U-3611: Treatment of pediatric patients with central precocious puberty
ExclusivityExpirationExclusivity Description
Exclusivity Code: NS - New strengthApr 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))
PatentsExpirationPatented 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, 2034U-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, 2031U-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, 2031U-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, 2038U-2754: Treatment of post-operative nausea and vomiting
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityFeb 26, 2025 

ACACIA
BYFAVO (POWDER) (INTRAVENOUS) REMIMAZOLAM BESYLATE
NDA Applicant: ACACIA      NDA No.:
212295  Prod. No.: 001 RX (EQ 20MG BASE/VIAL)
PatentsExpirationPatented 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, 2033U-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, 2031U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less
Pat. No. 9777007 DP* Short-acting benzodiazepine salts and their polymorphic forms
Claim Types: Composition
Pat. Sub. Date(s): 001: Oct 23, 2020
Jul 10, 2027 
Pat. No. 9827251 Dosing regimen for sedation with CNS 7056 (remimazolam)
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 23, 2020
Nov 7, 2031U-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, 2031U-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, 2031U-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, 2031U-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, 2027U-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, 2031U-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, 2027U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityOct 6, 2025 

ACADIA PHARMS INC
DAYBUE (SOLUTION) (ORAL) TROFINETIDE
NDA Applicant: ACADIA PHARMS INC      NDA No.:
217026  Prod. No.: 001 RX (200MG/ML)
PatentsExpirationPatented 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, 2032U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMar 10, 2028 
Exclusivity Code: ODE - Orphan drug exclusivityMar 10, 2030ODE-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)
PatentsExpirationPatented 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, 2026U-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, 2024U-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, 2024U-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, 2024U-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, 2024U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis

ACADIA PHARMS INC
NUPLAZID (TABLET) (ORAL) PIMAVANSERIN TARTRATE [GENERIC AB]
Drug Classes: atypical antipsychotic
NDA Applicant: ACADIA PHARMS INC      NDA No.:
207318  Prod. No.: 002 RX (EQ 10MG BASE)
PatentsExpirationPatented 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, 2026U-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, 2024U-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, 2024U-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, 2024U-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, 2024U-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, 2037U-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, 2037U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis

ACADIA PHARMS INC
NUPLAZID (CAPSULE) (ORAL) PIMAVANSERIN TARTRATE [GENERIC AB]
Drug Classes: atypical antipsychotic
NDA Applicant: ACADIA PHARMS INC      NDA No.:
210793  Prod. No.: 001 RX (EQ 34MG BASE)
PatentsExpirationPatented 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, 2026U-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, 2024U-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, 2024U-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, 2024U-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, 2024U-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, 2038U-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)
PatentsExpirationPatented 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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productMay 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)
ExclusivityExpirationExclusivity Description
Exclusivity Code: PC - Patent challengeSep 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)
PatentsExpirationPatented 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, 2036U-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)
PatentsExpirationPatented 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, 2024U-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, 2024U-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, 2034U-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)
PatentsExpirationPatented 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, 2030U-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)
PatentsExpirationPatented 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, 2030U-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%)
PatentsExpirationPatented 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, 2035U-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, 2035U-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, 2035U-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 

ACORDA
INBRIJA (POWDER) (INHALATION) LEVODOPA
Drug Classes: aromatic amino acid
NDA Applicant: ACORDA      NDA No.:
209184  Prod. No.: 001 RX (42MG)
PatentsExpirationPatented Use
Pat. No. RE43711 Pulmonary delivery for levodopa
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jan 18, 2019
Feb 3, 2029U-2484: Intermittent treatment of off episodes in patients with Parkinson's Disease treated with carbidopa/levodopa by inhalation of levodopa powder particles
Pat. No. 7182961 DP* Particulate compositions for pulmonary delivery
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 18, 2019
Feb 22, 2024 
Pat. No. 8545878 DP* Capsules containing high doses of levodopa for pulmonary use
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 18, 2019
Nov 16, 2032 
Pat. No. 8685442 DP* Capsules containing high doses of levodopa for pulmonary use
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 18, 2019
Nov 16, 2032 
Pat. No. 8945612 DP* Capsules containing high doses of levodopa for pulmonary use
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 18, 2019
Nov 16, 2032 
Pat. No. 9393210 DP* Capsules containing high doses of levodopa for pulmonary use
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 18, 2019
Nov 16, 2032 

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)
PatentsExpirationPatented 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, 2026U-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)
PatentsExpirationPatented 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, 2030U-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))
PatentsExpirationPatented 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, 2025U-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, 2025U-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 )
PatentsExpirationPatented 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)
PatentsExpirationPatented 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, 2029U-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, 2028U-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, 2027U-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, 2026U-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
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)
ExclusivityExpirationExclusivity 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)
PatentsExpirationPatented 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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivitySep 5, 2024ODE-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)
PatentsExpirationPatented 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, 2026U-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, 2029U-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, 2030U-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, 2036U-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, 2036U-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)
PatentsExpirationPatented 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, 2026U-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, 2029U-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, 2030U-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)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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, 2027U-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)
PatentsExpirationPatented 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, 2028U-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, 2030U-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, 2025U-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, 2025U-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, 2025U-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, 2025U-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, 2030U-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, 2030U-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, 2030U-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, 2030U-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, 2034U-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, 2034U-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, 2038U-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, 2030U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityAug 24, 2024ODE-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 RX (EQ 129MG BASE); 002 RX (EQ 193MG BASE)
PatentsExpirationPatented 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, 2028U-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, 2025U-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, 2025U-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, 2025U-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, 2025U-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, 2025U-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, 2025U-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, 2038U-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, 2038U-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, 2038U-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, 2038U-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, 2038U-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, 2038U-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, 2038U-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)
PatentsExpirationPatented 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, 2028U-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, 2025U-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, 2025U-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, 2025U-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, 2025U-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, 2025U-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, 2025U-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, 2038U-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, 2038U-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, 2038U-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, 2038U-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, 2038U-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, 2038U-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))
PatentsExpirationPatented Use
Pat. No. 11141540 DP* Syringe devices
Claim Types: Device; Method of administration
Pat. Sub. Date(s): All strengths: Jun 16, 2022
Oct 20, 2036U-3379: A method for administering a therapeutic dose of epinephrine

ADAMIS PHARMS CORP
ZIMHI (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) NALOXONE HYDROCHLORIDE
Drug Classes: opioid antagonist
NDA Applicant: ADAMIS PHARMS CORP      NDA No.:
212854  Prod. No.: 001 RX (5MG/0.5ML (5MG/0.5ML))
PatentsExpirationPatented Use
Pat. No. 11027072 DP* Emergency devices
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): 001: Jun 6, 2022
May 24, 2039 
Pat. No. 11571518 DP* Emergency devices
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Feb 10, 2023
Jun 14, 2041U-3515: A method for administering a therapeutic dose of an opioid antagonist comprising an emergency syringe device
U-3516: A method for administering a therapeutic dose of an opioid antagonist comprising an emergency syringe device including a needle guard
U-3517: A method for administering a therapeutic dose of an opioid antagonist comprising an emergency syringe device including a window configured to allow the user to view the opioid antagonist in the syringe

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)
PatentsExpirationPatented 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, 2029U-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)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityJan 26, 2024ODE-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)
PatentsExpirationPatented Use
Pat. No. 10532036 Combination composition
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 29, 2023
Sep 22, 2025U-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, 2039U-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, 2039U-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productMar 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)
PatentsExpirationPatented 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
Jan 22, 2035U-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
Dec 31, 2034U-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
Jan 22, 2035U-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
Jan 22, 2035U-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
Jan 22, 2035U-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
Jan 22, 2035U-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
Jan 22, 2035U-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
Jan 22, 2035U-3638: A method for treating and/or reducing the risk of acute myocardial infarction

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)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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, 2032U-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, 2032U-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, 2032U-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, 2032U-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, 2038U-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, 2033U-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, 2041U-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityFeb 17, 2027 
Exclusivity Code: ODE - Orphan drug exclusivityFeb 17, 2029ODE-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)
PatentsExpirationPatented 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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityJun 26, 2026ODE-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))
PatentsExpirationPatented 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, 2031U-2430: Treatment of polyneuropathy of hereditary transthyretin amyloidosis
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityOct 5, 2023 
Exclusivity Code: ODE - Orphan drug exclusivityOct 5, 2025ODE-212: Indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults

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%)
PatentsExpirationPatented 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, 2033U-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, 2033U-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, 2033U-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, 2033U-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, 2033U-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, 2033U-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, 2033U-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, 2033U-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, 2033U-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, 2033U-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, 2033U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productOct 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%)
PatentsExpirationPatented 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, 2033U-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, 2033U-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, 2033U-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, 2033U-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, 2033U-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, 2033U-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, 2033U-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)
PatentsExpirationPatented 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, 2032U-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)
PatentsExpirationPatented 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, 2030U-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, 2026U-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, 2026U-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, 2034U-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, 2030U-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, 2026U-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, 2034U-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, 2030U-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, 2026U-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, 2026U-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, 2030U-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, 2030U-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)
PatentsExpirationPatented 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, 2030U-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, 2026U-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, 2026U-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, 2034U-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, 2034U-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, 2030U-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, 2026U-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, 2034U-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, 2030U-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, 2026U-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, 2026U-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, 2030U-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, 2030U-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%)
PatentsExpirationPatented 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 polymerase inhibi
NDA Applicant: ALEMBIC      NDA No.:
212361  Prod. No.: 001 RX (5%)
ExclusivityExpirationExclusivity Description
Exclusivity Code: CGT - Competitive generic therapyJun 12, 2024 

ALEXZA PHARMS
ADASUVE (POWDER) (INHALATION) LOXAPINE
NDA Applicant: ALEXZA PHARMS      NDA No.:
022549  Prod. No.: 001 RX (10MG)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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, 2028U-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))
PatentsExpirationPatented 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, 2030U-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, 2029U-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, 2029U-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, 2037U-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)
ExclusivityExpirationExclusivity Description
Exclusivity Code: PC - Patent challengeFeb 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)
PatentsExpirationPatented 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, 2029U-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))
PatentsExpirationPatented 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, 2030U-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, 2032U-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, 2033U-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, 2035U-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, 2030U-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, 2032U-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, 2035U-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, 2035U-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, 2033U-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, 2039U-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, 2035U-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))
PatentsExpirationPatented 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, 2030U-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, 2032U-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, 2033U-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, 2035U-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, 2030U-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, 2032U-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, 2035U-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, 2035U-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, 2033U-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, 2039U-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, 2035U-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))
PatentsExpirationPatented 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, 2030U-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, 2032U-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, 2033U-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, 2035U-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, 2030U-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, 2032U-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, 2035U-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, 2035U-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, 2033U-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, 2039U-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, 2035U-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))
PatentsExpirationPatented 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, 2030U-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, 2030U-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, 2035U-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, 2039U-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)
PatentsExpirationPatented 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, 2032U-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, 2031U-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, 2031U-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, 2031U-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, 2031U-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, 2031U-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, 2031U-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, 2031U-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, 2031U-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMay 28, 2026 

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)
PatentsExpirationPatented 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, 2026U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityFeb 25, 2025 GAIN 
Exclusivity Code: NPP - New patient populationDec 20, 2025 

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)
PatentsExpirationPatented 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 *PEDU-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)
PatentsExpirationPatented 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 *PEDU-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)
PatentsExpirationPatented 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, 2024U-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)
PatentsExpirationPatented 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, 2034U-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)
PatentsExpirationPatented 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%)
PatentsExpirationPatented 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, 2033U-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 RX (1%)
PatentsExpirationPatented 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, 2024U-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%)
PatentsExpirationPatented 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, 2029U-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, 2038U-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, 2038U-3015: Topical treatment of actinic keratosis of the face or scalp
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityDec 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)
PatentsExpirationPatented 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, 2031U-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, 2029U-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, 2033U-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, 2028U-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityOct 1, 2023 

ALMIRALL
VERDESO (AEROSOL, FOAM) (TOPICAL) DESONIDE
Drug Classes: corticosteroid
NDA Applicant: ALMIRALL      NDA No.:
021978  Prod. No.: 001 DISC (0.05%)
PatentsExpirationPatented 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, 2027U-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, 2025U-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, 2025U-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))
PatentsExpirationPatented 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, 2029U-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, 2028U-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, 2028U-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, 2032U-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, 2028U-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, 2036U-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, 2032U-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, 2035U-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, 2036U-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, 2036U-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, 2035U-3396: AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJun 13, 2027 
Exclusivity Code: ODE - Orphan drug exclusivityJun 13, 2029ODE-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))
PatentsExpirationPatented 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, 2029U-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, 2028U-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, 2033U-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, 2033U-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, 2034U-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, 2033U-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, 2028U-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, 2034U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityNov 20, 2024 
Exclusivity Code: ODE - Orphan drug exclusivityNov 20, 2026ODE-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))
PatentsExpirationPatented 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, 2030U-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, 2029U-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, 2029U-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, 2030U-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, 2029U-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, 2029U-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, 2029U-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, 2029U-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, 2035U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityAug 10, 2023 
Exclusivity Code: ODE - Orphan drug exclusivityAug 10, 2025ODE-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))
PatentsExpirationPatented 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, 2029U-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, 2028U-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, 2028U-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, 2034U-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, 2034U-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, 2035U-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, 2034U-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, 2035U-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, 2035U-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, 2034U-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, 2038U-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, 2035U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationOct 6, 2025I-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 entityNov 23, 2025 
Exclusivity Code: ODE - Orphan drug exclusivityNov 23, 2027ODE-339: Treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients
Exclusivity Code: ODE - Orphan drug exclusivityOct 6, 2029ODE-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**)
PatentsExpirationPatented Use
Pat. No. 7682633 Pharmaceutical composition
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Jun 19, 2027U-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, 2027U-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, 2029U-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, 2025U-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))
PatentsExpirationPatented 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, 2038U-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, 2039U-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, 2039U-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, 2038U-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)
PatentsExpirationPatented 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, 2033U-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, 2033U-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))
PatentsExpirationPatented 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, 2028U-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, 2027U-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, 2027U-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, 2027U-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, 2027U-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMay 31, 2026I-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 populationNov 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))
PatentsExpirationPatented 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, 2028U-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, 2027U-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, 2027U-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, 2027U-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, 2027U-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMay 31, 2026I-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 populationNov 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))
PatentsExpirationPatented 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, 2028U-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, 2027U-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, 2027U-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, 2027U-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, 2027U-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMay 31, 2026I-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 populationNov 19, 2024 
Exclusivity Code: NS - New strengthApr 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))
PatentsExpirationPatented 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, 2028U-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, 2027U-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, 2027U-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, 2027U-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, 2027U-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMay 31, 2026I-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
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))
ExclusivityExpirationExclusivity Description
Exclusivity Code: CGT - Competitive generic therapyApr 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))
ExclusivityExpirationExclusivity Description
Exclusivity Code: CGT - Competitive generic therapyApr 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))
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityApr 30, 2024 

AM REGENT
TRALEMENT; MULTRYS (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)); 003 RX (EQ 60MCG COPPER/ML;EQ 3MCG BASE/ML;EQ 6MCG SELENIUM/ML;EQ 1000MCG BASE/ML (1ML))
PatentsExpirationPatented 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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityApr 30, 2024 

AMARIN PHARMS
VASCEPA (CAPSULE) (ORAL) ICOSAPENT ETHYL [GENERIC AB]
NDA Applicant: AMARIN PHARMS      NDA No.:
202057  Prod. No.: 001 RX (1GM)
PatentsExpirationPatented Use
Pat. No. 8293727 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8293728 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
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. 8314086 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8318715 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 29, 2012
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8357677 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8367652 Methods of treating hypertriglyceridemia
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Feb 7, 2013
Feb 9, 2030U-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, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8399446 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 17, 2013
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8410086 Compositions and methods for lowering triglycerides
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Jun 15, 2030U-2688: Use of VASCEPA to lower triglycerides and ldl-c in an adult patient with elevated triglyceride (TG) levels (about 200 mg/dl to less than about 500 mg/dl) and on statin therapy
Pat. No. 8415335 Methods of treating hypertriglyceridemia
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Apr 17, 2013
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8426399 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8431560 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8440650 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8445003 Stable pharmaceutical composition and methods of using same
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8445013 Stable pharmaceutical composition and methods of using same
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8454994 Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Apr 29, 2030U-2689: Use of VASCEPA to treat mixed dyslipidemia in an adult patient with elevated triglyceride (TG) levels (>=150 mg/dl) and on statin therapy
Pat. No. 8455472 Compositions and methods for lowering triglycerides without raising LDL-C levels in a subject on concomitant statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Jun 15, 2030U-2690: Use of VASCEPA to lower triglycerides in an adult patient with elevated triglyceride (TG) levels (about 200 mg/dl to less than about 500 mg/dl) and on statin therapy
Pat. No. 8501225 Stable pharmaceutical composition and methods of using same
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8518929 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8524698 Methods of treating hypertriglyceridemia
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Sep 11, 2013
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8546372 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 1, 2013
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8551521 Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 9, 2013
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8563608 Methods for lowering triglycerides without raising LDL-C levels in a subject on concomitant statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 22, 2013
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8617593 Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 14, 2014
Apr 29, 2030U-1478: Method of reducing TG levels in patient on statin therapy suffering from severe hypertriglyceridemia
U-2691: Use of VASCEPA to treat hypertriglyceridemia in an adult patient with elevated triglyceride (TG) levels (>= 150 mg/dl) and on statin therapy
Pat. No. 8617594 Stable pharmaceutical composition and methods of using same
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8618166 Methods of treating mixed dyslipidemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Apr 29, 2030U-2689: Use of VASCEPA to treat mixed dyslipidemia in an adult patient with elevated triglyceride (TG) levels (>=150 mg/dl) and on statin therapy
Pat. No. 8623406 Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 14, 2014
Apr 29, 2030U-1478: Method of reducing TG levels in patient on statin therapy suffering from severe hypertriglyceridemia
U-2692: Use of VASCEPA to reduce triglycerides in an adult patient with elevated triglyceride (TG) levels (>= 150 mg/dl) and on statin therapy
Pat. No. 8642077 Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Apr 29, 2030U-2693: Use of VASCEPA to reduce triglycerides in a mixed dyslipidemia adult patient with elevated triglyceride (TG) levels (>= 150 mg/dl) and on statin therapy
Pat. No. 8669245 Compositions and methods for lowering triglycerides without raising LDL-C levels in a subject on concomitant statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Jun 15, 2030U-2694: Use of VASCEPA to lower triglycerides in a mixed dyslipidemia adult patient with elevated triglyceride (TG) levels (about 200 mg/dl to less than about 500 mg/dl) and on statin therapy
Pat. No. 8680144 Methods of treating mixed dyslipidemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Feb 9, 2030U-2695: Use of VASCEPA to treat mixed hypertriglyceridemia in an adult patient with elevated triglyceride (TG) levels (>= 150 mg/dl) and on statin therapy
Pat. No. 8691871 Methods of treating mixed dyslipidemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Apr 29, 2030U-2689: Use of VASCEPA to treat mixed dyslipidemia in an adult patient with elevated triglyceride (TG) levels (>=150 mg/dl) and on statin therapy
Pat. No. 8703185 Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Apr 29, 2030U-2691: Use of VASCEPA to treat hypertriglyceridemia in an adult patient with elevated triglyceride (TG) levels (>= 150 mg/dl) and on statin therapy
Pat. No. 8709475 Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Apr 29, 2030U-2689: Use of VASCEPA to treat mixed dyslipidemia in an adult patient with elevated triglyceride (TG) levels (>=150 mg/dl) and on statin therapy
Pat. No. 8710041 Compositions and methods for lowering triglycerides in a subject on concomitant statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Jun 15, 2030U-2690: Use of VASCEPA to lower triglycerides in an adult patient with elevated triglyceride (TG) levels (about 200 mg/dl to less than about 500 mg/dl) and on statin therapy
Pat. No. 9198892 Composition and/or method for preventing onset and/or recurrence of cardiovascular events
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Jan 10, 2020
Sep 25, 2027U-2706: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of onset and/or recurrence of cardiovascular events in a patient who has escaped the unstable period after cardiovascular angioplasty
Pat. No. 9603826 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Jun 28, 2033U-2696: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of cardiovascular death, coronary revascularization, and unstable angina in an adult patient with elevated triglyceride levels (TG >= 150 mg/dl to about 500 mg/dl)
Pat. No. 9610272 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Jun 28, 2033U-2697: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of cardiovascular death and/or unstable angina in an adult patient with elevated triglyceride levels (TG >= 150 mg/dl to about 500 mg/dl)
Pat. No. 9623001 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Jun 28, 2033U-2698: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of cardiovascular death and/or coronary revascularization in an adult patient with elevated triglyceride levels (TG >= 150 mg/dl to about 500 mg/dl)
Pat. No. 9693984 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Jun 28, 2033U-2697: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of cardiovascular death and/or unstable angina in an adult patient with elevated triglyceride levels (TG >= 150 mg/dl to about 500 mg/dl)
Pat. No. 9693985 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Jun 28, 2033U-2696: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of cardiovascular death, coronary revascularization, and unstable angina in an adult patient with elevated triglyceride levels (TG >= 150 mg/dl to about 500 mg/dl)
Pat. No. 9693986 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Jun 28, 2033U-2698: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of cardiovascular death and/or coronary revascularization in an adult patient with elevated triglyceride levels (TG >= 150 mg/dl to about 500 mg/dl)
Pat. No. 9700537 Composition for preventing the occurrence of cardiovascular event in multiple risk patient
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 10, 2020
May 31, 2027U-2707: Use of VASCEPA as an adjunct to statin therapy to reduce the occurrence of a cardiovascular event in an adult patient with hypercholesterolemia
Pat. No. 9918954 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Jun 28, 2033U-2699: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a cardiovascular event (coronary revascularization, unstable angina, stroke and/or myocardial infarction) in an adult patient with elevated triglyceride levels
Pat. No. 10010517 Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Apr 29, 2030U-2690: Use of VASCEPA to lower triglycerides in an adult patient with elevated triglyceride (TG) levels (about 200 mg/dl to less than about 500 mg/dl) and on statin therapy
Pat. No. 10265287 Methods of reducing triglycerides and LDL-C
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Apr 29, 2030U-2700: Use of VASCEPA to reduce triglycerides in an adult patient with elevated triglyceride (TG) levels (about 200 mg/dl to less than about 500 mg/dl) and on rosuvastatin therapy
Pat. No. 10278935 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Jun 28, 2033U-2701: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of coronary revascularization and/or unstable angina in an adult patient with elevated triglyceride levels (TG >= 150 mg/dl to about 500 mg/dl)
Pat. No. 10278936 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Jun 28, 2033U-2702: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a cardiovascular event (cardiovascular death, coronary revascularization and/or unstable angina) in an adult patient with elevated triglyceride levels
Pat. No. 10278937 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Jun 28, 2033U-2703: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a cv event (cv death, coronary revascularization, unstable angina, stroke and/or myocardial infarction) in an adult patient with elevated triglyceride levels and diabetes mellitus
Pat. No. 10383840 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Jun 28, 2033U-2704: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a cardiovascular event in an adult patient with elevated triglyceride levels and at least one risk factor for cardiovascular disease
Pat. No. 10555924 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 26, 2020
Jun 28, 2033U-2743: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of unstable angina in an adult patient with established cardiovascular disease
Pat. No. 10555925 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 26, 2020
Jun 28, 2033U-2744: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of stroke in an adult patient with established cardiovascular disease
Pat. No. 10568861 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 20, 2020
Jun 28, 2033U-2756: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of cardiovascular death in an adult patient with established cardiovascular disease
Pat. No. 10576054 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 27, 2020
Jun 28, 2033U-2762: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a major cardiovascular event in an adult patient with diabetes mellitus and two or more additional risk factors for cardiovascular disease
Pat. No. 10668042 Methods of reducing the risk of cardiovascular events in a subject
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 26, 2020
Jun 28, 2033U-2841: Use of VASCEPA with high intensity statin therapy to reduce the risk of a cv event in an adult patient with elevated triglyceride levels and (1) established CV disease, or (2) diabetes mellitus and two or more additional risk factors for CV disease
Pat. No. 10786478 Methods of reducing the risk of cardiovascular events in a subject
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 16, 2020
Jun 28, 2033U-2959: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a third and further cardiovascular event in an adult patient with elevated tg levels (>=150 mg/dl) and established cardiovascular disease
U-2960: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a second or further cardiovascular (CV) event in an adult patient with elevated tg levels (>= 150 mg/dl) and diabetes mellitus and 2 or more additional risk factors for CV disease
Pat. No. 10792267 Methods of treating mixed dyslipidemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 16, 2020
Apr 29, 2030U-2961: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of myocardial infarction, stroke, both in an adult patient with Type 2 diabetes mellitus
Pat. No. 10792270 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 16, 2020
Jun 28, 2033U-2962: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of coronary revascularization in an adult patient with established cardiovascular disease
Pat. No. 10842766 Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 11, 2020
Apr 29, 2030U-2997: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of stroke in an adult patient with elevated triglycerides and atrial fibrillation
Pat. No. 10842768 Compositions and methods for lowering triglycerides
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 11, 2020
Jun 15, 2030U-2688: Use of VASCEPA to lower triglycerides and ldl-c in an adult patient with elevated triglyceride (TG) levels (about 200 mg/dl to less than about 500 mg/dl) and on statin therapy
Pat. No. 10881632 Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 4, 2021
Apr 29, 2030U-3052: Use of VASCEPA to reduce triglyceride levels in an adult patient on statin therapy and having atrial fibrillation and triglyceride levels of greater than 500 mg/dl
Pat. No. 10894028 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 4, 2021
Jun 28, 2033U-3053: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of myocardial infarction in an adult patient with elevated triglyceride levels and established cv disease or diabetes mellitus and two or more additional risk factors for CV disease
Pat. No. 11000499 Methods of reducing the risk of cardiovascular events in a subject
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 10, 2021
Jun 28, 2033U-3126: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a second and further cardiovascular event in an adult patient with established cardiovascular disease
Pat. No. 11103477 Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 21, 2021
Apr 29, 2030U-3209: Use of VASCEPA as an adjunct to statin therapy to reduce the risk myocardial infarction in an adult patient having atrial fibrillation or atrial flutter and elevated triglyceride levels
Pat. No. 11116742 Methods of reducing the risk of cardiovascular events in a subject
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 8, 2021
Jun 28, 2033U-3221: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a cardiovascular event in a patient with prior percutaneous coronary intervention
Pat. No. 11154526 Methods of treating mixed dyslipidemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 8, 2021
Apr 29, 2030U-3240: Use of VASCEPA to reduce triglyceride levels in an adult patient having triglyceride levels of at least about 500 mg/dl, on anticoagulant/antiplatelet/thrombolytic therapy, and having atrial fibrillation and/or atrial flutter
Pat. No. 11213504 Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 3, 2022
Apr 29, 2030U-3292: Use of VASCEPA to reduce triglyceride levels in an adult patient on statin therapy and having atrial fibrillation or atrial flutter and triglyceride levels of about 500 mg/dl to about 2,000 mg/dl
Pat. No. 11298333 Methods of reducing the risk of cardiovascular events in a subject
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 11, 2022
Jun 28, 2033U-3358: Use of VASCEPA to reduce the incidence of MI in an adult patient on statin therapy and with elevated triglyceride levels (>150 mg/dl), wherein the patient experiences atrial fibrillation and/or flutter instead of an incidence of MI
Pat. No. 11369582 Methods of reducing the risk of cardiovascular events in a subject
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 28, 2022
Jun 28, 2033U-2841: Use of VASCEPA with high intensity statin therapy to reduce the risk of a cv event in an adult patient with elevated triglyceride levels and (1) established CV disease, or (2) diabetes mellitus and two or more additional risk factors for CV disease
Pat. No. 11717504 Methods of reducing the risk of cardiovascular events in a subject
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 18, 2023
Apr 29, 2030U-3669: Use of VASCEPA to reduce the incidence of stroke in an adult patient on statin therapy and with elevated triglyceride levels (>150 mg/dl), wherein the patient experiences atrial fibrillation and/or flutter instead of an incidence of stroke

AMARIN PHARMS
VASCEPA (CAPSULE) (ORAL) ICOSAPENT ETHYL [GENERIC AB]
NDA Applicant: AMARIN PHARMS      NDA No.:
202057  Prod. No.: 002 RX (500MG)
PatentsExpirationPatented Use
Pat. No. 8293727 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2017
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8293728 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2017
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8298554 DP* Stable pharmaceutical composition and methods of using same
Claim Types: Formulation
Pat. Sub. Date(s): 002: Jun 26, 2017
Apr 29, 2030 
Pat. No. 8314086 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2017
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8318715 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2017
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8357677 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2017
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8367652 Methods of treating hypertriglyceridemia
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Jun 26, 2017
Feb 9, 2030U-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): 002: Jun 26, 2017
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8399446 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2017
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8410086 Compositions and methods for lowering triglycerides
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 6, 2020
Jun 15, 2030U-2688: Use of VASCEPA to lower triglycerides and ldl-c in an adult patient with elevated triglyceride (TG) levels (about 200 mg/dl to less than about 500 mg/dl) and on statin therapy
Pat. No. 8415335 Methods of treating hypertriglyceridemia
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Jun 26, 2017
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8426399 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2017
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8440650 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2017
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8445003 Stable pharmaceutical composition and methods of using same
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Jun 26, 2017
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8445013 Stable pharmaceutical composition and methods of using same
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Jun 26, 2017
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8454994 Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 6, 2020
Apr 29, 2030U-2689: Use of VASCEPA to treat mixed dyslipidemia in an adult patient with elevated triglyceride (TG) levels (>=150 mg/dl) and on statin therapy
Pat. No. 8501225 Stable pharmaceutical composition and methods of using same
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Jun 26, 2017
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8518929 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2017
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8524698 Methods of treating hypertriglyceridemia
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Jun 26, 2017
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8546372 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2017
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8551521 Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2017
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8563608 Methods for lowering triglycerides without raising LDL-C levels in a subject on concomitant statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2017
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8617593 Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2017
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
U-2691: Use of VASCEPA to treat hypertriglyceridemia in an adult patient with elevated triglyceride (TG) levels (>= 150 mg/dl) and on statin therapy
Pat. No. 8617594 Stable pharmaceutical composition and methods of using same
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Jun 26, 2017
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8623406 Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2017
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
U-2692: Use of VASCEPA to reduce triglycerides in an adult patient with elevated triglyceride (TG) levels (>= 150 mg/dl) and on statin therapy
Pat. No. 8642077 Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 6, 2020
Apr 29, 2030U-2693: Use of VASCEPA to reduce triglycerides in a mixed dyslipidemia adult patient with elevated triglyceride (TG) levels (>= 150 mg/dl) and on statin therapy
Pat. No. 8669245 Compositions and methods for lowering triglycerides without raising LDL-C levels in a subject on concomitant statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 6, 2020
Jun 15, 2030U-2694: Use of VASCEPA to lower triglycerides in a mixed dyslipidemia adult patient with elevated triglyceride (TG) levels (about 200 mg/dl to less than about 500 mg/dl) and on statin therapy
Pat. No. 8680144 Methods of treating mixed dyslipidemia
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 6, 2020
Feb 9, 2030U-2695: Use of VASCEPA to treat mixed hypertriglyceridemia in an adult patient with elevated triglyceride (TG) levels (>= 150 mg/dl) and on statin therapy
Pat. No. 8691871 Methods of treating mixed dyslipidemia
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 6, 2020
Apr 29, 2030U-2689: Use of VASCEPA to treat mixed dyslipidemia in an adult patient with elevated triglyceride (TG) levels (>=150 mg/dl) and on statin therapy
Pat. No. 8703185 Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 6, 2020
Apr 29, 2030U-2691: Use of VASCEPA to treat hypertriglyceridemia in an adult patient with elevated triglyceride (TG) levels (>= 150 mg/dl) and on statin therapy
Pat. No. 8709475 Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 6, 2020
Apr 29, 2030U-2689: Use of VASCEPA to treat mixed dyslipidemia in an adult patient with elevated triglyceride (TG) levels (>=150 mg/dl) and on statin therapy
Pat. No. 8710041 Compositions and methods for lowering triglycerides in a subject on concomitant statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 6, 2020
Jun 15, 2030U-2690: Use of VASCEPA to lower triglycerides in an adult patient with elevated triglyceride (TG) levels (about 200 mg/dl to less than about 500 mg/dl) and on statin therapy
Pat. No. 9198892 Composition and/or method for preventing onset and/or recurrence of cardiovascular events
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 002: Jan 10, 2020
Sep 25, 2027U-2706: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of onset and/or recurrence of cardiovascular events in a patient who has escaped the unstable period after cardiovascular angioplasty
Pat. No. 9603826 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 6, 2020
Jun 28, 2033U-2696: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of cardiovascular death, coronary revascularization, and unstable angina in an adult patient with elevated triglyceride levels (TG >= 150 mg/dl to about 500 mg/dl)
Pat. No. 9610272 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 6, 2020
Jun 28, 2033U-2697: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of cardiovascular death and/or unstable angina in an adult patient with elevated triglyceride levels (TG >= 150 mg/dl to about 500 mg/dl)
Pat. No. 9623001 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 6, 2020
Jun 28, 2033U-2698: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of cardiovascular death and/or coronary revascularization in an adult patient with elevated triglyceride levels (TG >= 150 mg/dl to about 500 mg/dl)
Pat. No. 9693984 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 6, 2020
Jun 28, 2033U-2697: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of cardiovascular death and/or unstable angina in an adult patient with elevated triglyceride levels (TG >= 150 mg/dl to about 500 mg/dl)
Pat. No. 9693985 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 6, 2020
Jun 28, 2033U-2696: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of cardiovascular death, coronary revascularization, and unstable angina in an adult patient with elevated triglyceride levels (TG >= 150 mg/dl to about 500 mg/dl)
Pat. No. 9693986 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 6, 2020
Jun 28, 2033U-2698: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of cardiovascular death and/or coronary revascularization in an adult patient with elevated triglyceride levels (TG >= 150 mg/dl to about 500 mg/dl)
Pat. No. 9700537 Composition for preventing the occurrence of cardiovascular event in multiple risk patient
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 10, 2020
May 31, 2027U-2707: Use of VASCEPA as an adjunct to statin therapy to reduce the occurrence of a cardiovascular event in an adult patient with hypercholesterolemia
Pat. No. 9918954 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 6, 2020
Jun 28, 2033U-2699: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a cardiovascular event (coronary revascularization, unstable angina, stroke and/or myocardial infarction) in an adult patient with elevated triglyceride levels
Pat. No. 10010517 Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 6, 2020
Apr 29, 2030U-2690: Use of VASCEPA to lower triglycerides in an adult patient with elevated triglyceride (TG) levels (about 200 mg/dl to less than about 500 mg/dl) and on statin therapy
Pat. No. 10265287 Methods of reducing triglycerides and LDL-C
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 6, 2020
Apr 29, 2030U-2700: Use of VASCEPA to reduce triglycerides in an adult patient with elevated triglyceride (TG) levels (about 200 mg/dl to less than about 500 mg/dl) and on rosuvastatin therapy
Pat. No. 10278935 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 6, 2020
Jun 28, 2033U-2701: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of coronary revascularization and/or unstable angina in an adult patient with elevated triglyceride levels (TG >= 150 mg/dl to about 500 mg/dl)
Pat. No. 10278936 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 6, 2020
Jun 28, 2033U-2702: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a cardiovascular event (cardiovascular death, coronary revascularization and/or unstable angina) in an adult patient with elevated triglyceride levels
Pat. No. 10278937 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 6, 2020
Jun 28, 2033U-2703: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a cv event (cv death, coronary revascularization, unstable angina, stroke and/or myocardial infarction) in an adult patient with elevated triglyceride levels and diabetes mellitus
Pat. No. 10383840 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 6, 2020
Jun 28, 2033U-2704: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a cardiovascular event in an adult patient with elevated triglyceride levels and at least one risk factor for cardiovascular disease
Pat. No. 10555924 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease
Claim Types: Method of use
Pat. Sub. Date(s): 002: Feb 26, 2020
Jun 28, 2033U-2743: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of unstable angina in an adult patient with established cardiovascular disease
Pat. No. 10555925 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease
Claim Types: Method of use
Pat. Sub. Date(s): 002: Feb 26, 2020
Jun 28, 2033U-2744: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of stroke in an adult patient with established cardiovascular disease
Pat. No. 10568861 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease
Claim Types: Method of use
Pat. Sub. Date(s): 002: Mar 20, 2020
Jun 28, 2033U-2756: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of cardiovascular death in an adult patient with established cardiovascular disease
Pat. No. 10576054 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease
Claim Types: Method of use
Pat. Sub. Date(s): 002: Mar 27, 2020
Jun 28, 2033U-2762: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a major cardiovascular event in an adult patient with diabetes mellitus and two or more additional risk factors for cardiovascular disease
Pat. No. 10668042 Methods of reducing the risk of cardiovascular events in a subject
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2020
Jun 28, 2033U-2841: Use of VASCEPA with high intensity statin therapy to reduce the risk of a cv event in an adult patient with elevated triglyceride levels and (1) established CV disease, or (2) diabetes mellitus and two or more additional risk factors for CV disease
Pat. No. 10786478 Methods of reducing the risk of cardiovascular events in a subject
Claim Types: Method of use
Pat. Sub. Date(s): 002: Oct 16, 2020
Jun 28, 2033U-2959: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a third and further cardiovascular event in an adult patient with elevated tg levels (>=150 mg/dl) and established cardiovascular disease
U-2960: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a second or further cardiovascular (CV) event in an adult patient with elevated tg levels (>= 150 mg/dl) and diabetes mellitus and 2 or more additional risk factors for CV disease
Pat. No. 10792267 Methods of treating mixed dyslipidemia
Claim Types: Method of use
Pat. Sub. Date(s): 002: Oct 16, 2020
Apr 29, 2030U-2961: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of myocardial infarction, stroke, both in an adult patient with Type 2 diabetes mellitus
Pat. No. 10792270 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease
Claim Types: Method of use
Pat. Sub. Date(s): 002: Oct 16, 2020
Jun 28, 2033U-2962: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of coronary revascularization in an adult patient with established cardiovascular disease
Pat. No. 10842766 Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 002: Dec 11, 2020
Apr 29, 2030U-2997: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of stroke in an adult patient with elevated triglycerides and atrial fibrillation
Pat. No. 10842768 Compositions and methods for lowering triglycerides
Claim Types: Method of use
Pat. Sub. Date(s): 002: Dec 11, 2020
Jun 15, 2030U-2688: Use of VASCEPA to lower triglycerides and ldl-c in an adult patient with elevated triglyceride (TG) levels (about 200 mg/dl to less than about 500 mg/dl) and on statin therapy
Pat. No. 10881632 Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 002: Feb 4, 2021
Apr 29, 2030U-3052: Use of VASCEPA to reduce triglyceride levels in an adult patient on statin therapy and having atrial fibrillation and triglyceride levels of greater than 500 mg/dl
Pat. No. 10894028 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease
Claim Types: Method of use
Pat. Sub. Date(s): 002: Feb 4, 2021
Jun 28, 2033U-3053: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of myocardial infarction in an adult patient with elevated triglyceride levels and established cv disease or diabetes mellitus and two or more additional risk factors for CV disease
Pat. No. 11000499 Methods of reducing the risk of cardiovascular events in a subject
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 10, 2021
Jun 28, 2033U-3126: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a second and further cardiovascular event in an adult patient with established cardiovascular disease
Pat. No. 11103477 Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 002: Sep 21, 2021
Apr 29, 2030U-3209: Use of VASCEPA as an adjunct to statin therapy to reduce the risk myocardial infarction in an adult patient having atrial fibrillation or atrial flutter and elevated triglyceride levels
Pat. No. 11116742 Methods of reducing the risk of cardiovascular events in a subject
Claim Types: Method of use
Pat. Sub. Date(s): 002: Oct 8, 2021
Jun 28, 2033U-3221: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a cardiovascular event in a patient with prior percutaneous coronary intervention
Pat. No. 11154526 Methods of treating mixed dyslipidemia
Claim Types: Method of use
Pat. Sub. Date(s): 002: Nov 8, 2021
Apr 29, 2030U-3240: Use of VASCEPA to reduce triglyceride levels in an adult patient having triglyceride levels of at least about 500 mg/dl, on anticoagulant/antiplatelet/thrombolytic therapy, and having atrial fibrillation and/or atrial flutter
Pat. No. 11213504 Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 002: Feb 3, 2022
Apr 29, 2030U-3292: Use of VASCEPA to reduce triglyceride levels in an adult patient on statin therapy and having atrial fibrillation or atrial flutter and triglyceride levels of about 500 mg/dl to about 2,000 mg/dl
Pat. No. 11298333 Methods of reducing the risk of cardiovascular events in a subject
Claim Types: Method of use
Pat. Sub. Date(s): 002: May 11, 2022
Jun 28, 2033U-3358: Use of VASCEPA to reduce the incidence of MI in an adult patient on statin therapy and with elevated triglyceride levels (>150 mg/dl), wherein the patient experiences atrial fibrillation and/or flutter instead of an incidence of MI
Pat. No. 11369582 Methods of reducing the risk of cardiovascular events in a subject
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jul 28, 2022
Jun 28, 2033U-2841: Use of VASCEPA with high intensity statin therapy to reduce the risk of a cv event in an adult patient with elevated triglyceride levels and (1) established CV disease, or (2) diabetes mellitus and two or more additional risk factors for CV disease
Pat. No. 11717504 Methods of reducing the risk of cardiovascular events in a subject
Claim Types: Method of use
Pat. Sub. Date(s): 002: Aug 18, 2023
Apr 29, 2030U-3669: Use of VASCEPA to reduce the incidence of stroke in an adult patient on statin therapy and with elevated triglyceride levels (>150 mg/dl), wherein the patient experiences atrial fibrillation and/or flutter instead of an incidence of stroke

AMGEN
SENSIPAR (TABLET) (ORAL) CINACALCET HYDROCHLORIDE [GENERIC AB]
Drug Classes: calcium-sensing receptor agonist
NDA Applicant: AMGEN      NDA No.:
021688  Prod. No.: 001 RX (EQ 30MG BASE); 002 RX (EQ 60MG BASE); 003 RX (EQ 90MG BASE)
PatentsExpirationPatented Use
Pat. No. 7829595 DP* Rapid dissolution formulation of a calcium receptor-active compound
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Dec 2, 2010; 002: None; 003: None
Sep 22, 2026U-1098: Method of treating hyperparathyroidism; method of treating hypercalcemia
Pat. No. 9375405 DP* Rapid dissolution formulation of a calcium receptor-active compound
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 22, 2016
Sep 22, 2026 

AMGEN INC
CORLANOR (TABLET) (ORAL) IVABRADINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: hyperpolarization-activated cyclic nucleotide-gated channel blocker
NDA Applicant: AMGEN INC      NDA No.:
206143  Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 7.5MG BASE)
PatentsExpirationPatented Use
Pat. No. 7361649 DS* DP* .beta.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use
Pat. Sub. Date(s): All strengths: May 11, 2015
Aug 22, 2026 *PEDU-1694: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride
Pat. No. 7361650 DS* DP* .gamma.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use
Pat. Sub. Date(s): All strengths: May 11, 2015
Aug 22, 2026 *PEDU-1694: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride
Pat. No. 7867996 DS* DP* [Extended 293 days (0.8 years)]
.gamma.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
Claim Types: New polymorph, salt or hydrate; Method of use; Composition
Pat. Sub. Date(s): All strengths: May 11, 2015
Jun 12, 2027 *PEDU-1694: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride
Pat. No. 7879842 DS* DP* Beta-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Pat. Sub. Date(s): All strengths: May 11, 2015
Aug 22, 2026 *PEDU-1694: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride

AMGEN INC
CORLANOR (SOLUTION) (ORAL) IVABRADINE
Drug Classes: hyperpolarization-activated cyclic nucleotide-gated channel blocker
NDA Applicant: AMGEN INC      NDA No.:
209964  Prod. No.: 001 RX (5MG/5ML (1MG/ML))
PatentsExpirationPatented Use
Pat. No. 7361649 DS* DP* .beta.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use
Pat. Sub. Date(s): 001: May 3, 2019
Feb 22, 2026U-1694: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride
Pat. No. 7361650 DS* DP* .gamma.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use
Pat. Sub. Date(s): 001: May 3, 2019
Feb 22, 2026U-1694: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride
Pat. No. 7867996 DS* DP* [Extended 293 days (0.8 years)]
.gamma.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
Claim Types: New polymorph, salt or hydrate; Method of use; Composition
Pat. Sub. Date(s): 001: May 3, 2019
Dec 12, 2026U-1694: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride
Pat. No. 7879842 DS* DP* Beta-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Pat. Sub. Date(s): 001: May 3, 2019
Feb 22, 2026U-1694: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityOct 22, 2026 PEDODE-234: Indicated for the treatment of stable symptomatic heart failure due to dilated cardiomyopathy (DCM) in pediatric patients aged 6 months and older, who are in sinus rhythm with an elevated heart rate

AMGEN INC
LUMAKRAS (TABLET) (ORAL) SOTORASIB
NDA Applicant: AMGEN INC      NDA No.:
214665  Prod. No.: 001 RX (120MG); 002 RX (320MG)
PatentsExpirationPatented Use
Pat. No. 10519146 DS* DP* KRAS G12C inhibitors and methods of using the same
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Feb 17, 2022; 002: Feb 14, 2023
May 21, 2038 
Pat. No. 11236091 DS* DP* Solid state forms
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Pat. Sub. Date(s): 001: Feb 23, 2022; 002: Feb 14, 2023
May 20, 2040U-3306: Treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy
Pat. No. 11426404 Dosing of KRAS inhibitor for treatment of cancers
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 27, 2022; 002: Feb 14, 2023
Sep 15, 2040U-3306: Treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy
Pat. No. 11827635 DS* DP* Solid state forms
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Pat. Sub. Date(s): All strengths: Dec 18, 2023
May 20, 2040U-3306: Treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMay 28, 2026 
Exclusivity Code: ODE - Orphan drug exclusivityMay 28, 2028ODE-352: Treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy

AMGEN INC
OTEZLA (TABLET) (ORAL) APREMILAST [GENERIC AB]
Drug Classes: phosphodiesterase 4 inhibitor
NDA Applicant: AMGEN INC      NDA No.:
205437  Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (30MG)
PatentsExpirationPatented Use
Pat. No. 7427638 DS* DP* [Extended 1186 days (3.2 years)]
(+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminois- oindoline-1,3-dione:, and methods of synthesis and compositions thereof
Claim Types: Composition; Formulation
Pat. Sub. Date(s): All strengths: Apr 15, 2014
Feb 16, 2028 
Pat. No. 9872854 Methods for the treatment of psoriatic arthritis using apremilast
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 21, 2018
May 29, 2034U-2232: Treatment of psoriatic arthritis using a dosage titration schedule
U-2233: Treatment of psoriatic arthritis with apremilast using a dosage titration schedule and a second active agent
Pat. No. 10092541 Methods for the treatment of diseases ameliorated by PDE4 inhibition using dosage titration of apremilast
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 9, 2018
May 29, 2034U-2403: Treatment of psoriasis using a dosage titration schedule
U-2659: Treatment of adult patients with oral ulcers associated with Behcet's disease using a dosage titration schedule
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationDec 20, 2024I-884: Revisions to the labeling to include data for subjects with mild to moderate plaque psoriasis, and to allow for an expansion of the indication
Exclusivity Code: M - MiscellaneousJul 20, 2026M-299: Clinical study information added to the label about the treatment of moderate to severe genital psoriasis
Exclusivity Code: ODE - Orphan drug exclusivityJul 19, 2026ODE-248: Treatment of adult patients with oral ulcers associated with Behcets disease

AMICUS THERAP US
GALAFOLD (CAPSULE) (ORAL) MIGALASTAT HYDROCHLORIDE
NDA Applicant: AMICUS THERAP US      NDA No.:
208623  Prod. No.: 001 RX (EQ 123MG BASE)
PatentsExpirationPatented Use
Pat. No. RE48608 Method to predict response to pharmacological chaperone treatment of diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 22, 2021
Feb 12, 2029U-2371: The treatment of Fabry patients
Pat. No. 8592362 DLR* Method to predict response to pharmacological chaperone treatment of diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 5, 2018
Feb 12, 2029U-2371: The treatment of Fabry patients
Pat. No. 9000011 Methods for treatment of Fabry disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 5, 2018
May 16, 2027U-2371: The treatment of Fabry patients
Pat. No. 9095584 Method to predict response to pharmacological chaperone treatment of diseases
Claim Types: Method of use; Diagnostic or surgical method
Pat. Sub. Date(s): 001: Sep 5, 2018
Feb 12, 2029U-2371: The treatment of Fabry patients
Pat. No. 9480682 Methods for treatment of Fabry disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 5, 2018
May 16, 2027U-2371: The treatment of Fabry patients
Pat. No. 9987263 Methods for treatment of Fabry disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 5, 2018
May 16, 2027U-2371: The treatment of Fabry patients
Pat. No. 9999618 Dosing regimens for the treatment of lysosomal storage diseases using pharmacological chaperones
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 5, 2018
Apr 28, 2028U-2372: A method of reducing left ventricular mass index (LVMI) in a Fabry patient by administering migalastat
U-2373: A method of reducing podocyte globotriaosylceramide (GL-3) in a Fabry patient by administering migalastat
Pat. No. 10076514 Methods of treating fabry disease in patients having the G9331A mutation in the GLA gene
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 18, 2018
Mar 15, 2037U-2371: The treatment of Fabry patients
Pat. No. 10251873 Methods of treating Fabry patients having renal impairment
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 7, 2019
May 30, 2038U-2371: The treatment of Fabry patients
Pat. No. 10383864 Methods for treatment of Fabry disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 4, 2019
May 16, 2027U-2371: The treatment of Fabry patients
Pat. No. 10406143 Methods for treatment of fabry disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 26, 2019
May 16, 2027U-2371: The treatment of Fabry patients
Pat. No. 10471053 Methods of treating Fabry patients having renal impairment
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 6, 2019
May 30, 2038U-2371: The treatment of Fabry patients
Pat. No. 10525045 Dosing regimens for the treatment of lysosomal storage diseases using pharmacological chaperones
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 17, 2020
Apr 28, 2028U-2371: The treatment of Fabry patients
Pat. No. 10792278 Methods of treating Fabry patients having renal impairment
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 15, 2020
May 30, 2038U-2371: The treatment of Fabry patients
Pat. No. 10792279 Methods of treating Fabry patients having renal impairment
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 15, 2020
May 30, 2038U-2371: The treatment of Fabry patients
Pat. No. 10799491 Methods of treating Fabry patients having renal impairment
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 5, 2020
May 30, 2038U-2371: The treatment of Fabry patients
Pat. No. 10806727 Methods of treating Fabry patients having renal impairment
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 5, 2020
May 30, 2038U-2371: The treatment of Fabry patients
Pat. No. 10813921 Method to predict response to pharmacological chaperone treatment of diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 18, 2020
Feb 12, 2029U-2371: The treatment of Fabry patients
Pat. No. 10849889 Methods of treating Fabry patients having renal impairment
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 17, 2020
May 30, 2038U-2371: The treatment of Fabry patients
Pat. No. 10849890 Methods of treating Fabry patients having renal impairment
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 17, 2020
May 30, 2038U-2371: The treatment of Fabry patients
Pat. No. 10857141 Methods of treating Fabry patients having renal impairment
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 17, 2020
May 30, 2038U-2371: The treatment of Fabry patients
Pat. No. 10857142 Methods of treating Fabry patients having renal impairment
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 17, 2020
May 30, 2038U-2371: The treatment of Fabry patients
Pat. No. 10874655 Methods of treating fabry patients having renal impairment
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 7, 2021
May 30, 2038U-2371: The treatment of Fabry patients
Pat. No. 10874656 Methods of treating Fabry patients having renal impairment
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Jan 7, 2021
May 30, 2038U-2371: The treatment of Fabry patients
Pat. No. 10874657 Methods of treating Fabry patients having renal impairment
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Jan 7, 2021
May 30, 2038U-2371: The treatment of Fabry patients
Pat. No. 10925866 Dosing regimens for the treatment of lysosomal storage diseases using pharmacological chaperones
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 18, 2021
Apr 28, 2028U-2371: The treatment of Fabry patients
Pat. No. 11033538 Dosing regimens for the treatment of lysosomal storage diseases using pharmacological chaperones
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 12, 2021
Apr 28, 2028U-2371: The treatment of Fabry patients
Pat. No. 11234972 Methods of treating fabry disease in patients having the G9331A mutation in the GLA gene
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 25, 2022
Mar 15, 2037U-2371: The treatment of Fabry patients
Pat. No. 11241422 Methods for treatment of Fabry disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 25, 2022
May 16, 2027U-2371: The treatment of Fabry patients
Pat. No. 11278536 Methods of treating Fabry patients having renal impairment
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 7, 2022
May 30, 2038U-2371: The treatment of Fabry patients
Pat. No. 11278537 Methods of treating Fabry patients having renal impairment
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 7, 2022
May 30, 2038U-2371: The treatment of Fabry patients
Pat. No. 11278538 Methods of treating Fabry patients having renal impairment
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 7, 2022
May 30, 2038U-2371: The treatment of Fabry patients
Pat. No. 11278539 Methods of treating Fabry patients having renal impairment
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 7, 2022
May 30, 2038U-2371: The treatment of Fabry patients
Pat. No. 11278540 Methods of treating Fabry patients having renal impairment
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 7, 2022
May 30, 2038U-2371: The treatment of Fabry patients
Pat. No. 11304940 DS* Methods of treating Fabry patients having renal impairment
Claim Types: Compound
Pat. Sub. Date(s): 001: Apr 19, 2022
May 30, 2038 
Pat. No. 11357761 Methods of treating Fabry patients having renal impairment
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 28, 2022
May 30, 2038U-2371: The treatment of Fabry patients
Pat. No. 11357762 Methods of treating Fabry patients having renal impairment
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 28, 2022
May 30, 2038U-2371: The treatment of Fabry patients
Pat. No. 11357763 Methods of treating fabry patients having renal impairment
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 28, 2022
May 30, 2038U-2371: The treatment of Fabry patients
Pat. No. 11357764 DS* Methods of treating Fabry patients having renal impairment
Claim Types: Compound
Pat. Sub. Date(s): 001: Jun 28, 2022
May 30, 2038 
Pat. No. 11357765 DS* Methods of treating Fabry patients having renal impairment
Claim Types: Compound
Pat. Sub. Date(s): 001: Jun 28, 2022
May 30, 2038 
Pat. No. 11357784 Use of migalastat for treating Fabry disease in pregnant patients
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 28, 2022
Feb 6, 2039U-2371: The treatment of Fabry patients
Pat. No. 11376244 DS* Methods of treating Fabry patients having renal impairment
Claim Types: Compound
Pat. Sub. Date(s): 001: Jul 25, 2022
May 30, 2038 
Pat. No. 11389436 Methods of treating fabry patients having renal impairment
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2022
May 30, 2038U-2371: The treatment of Fabry patients
Pat. No. 11389437 Methods of treating Fabry patients having renal impairment
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2022
May 30, 2038U-2371: The treatment of Fabry patients
Pat. No. 11426396 DS* Methods of treating Fabry patients having renal impairment
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 2, 2022
May 30, 2038 
Pat. No. 11458128 Methods of treating Fabry patients having renal impairment
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 13, 2022
May 30, 2038U-2371: The treatment of Fabry patients
Pat. No. 11612593 DS* Methods of treating Fabry patients having renal impairment
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 17, 2023
May 30, 2038 
Pat. No. 11612594 DS* Methods of treating Fabry patients having renal impairment
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 17, 2023
May 30, 2038 
Pat. No. 11622962 DS* Methods of treating Fabry patients having renal impairment
Claim Types: Composition
Pat. Sub. Date(s): 001: Apr 17, 2023
Mar 17, 2039 
Pat. No. 11633387 DS* Methods of treating Fabry patients having renal impairment
Claim Types: Compound
Pat. Sub. Date(s): 001: May 12, 2023
May 30, 2038 
Pat. No. 11633388 Methods of treating Fabry patients having renal impairment
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 12, 2023
Mar 25, 2039U-2371: The treatment of Fabry patients
Pat. No. 11642334 Methods of treating Fabry patients having renal impairment
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 12, 2023
Feb 20, 2039U-2371: The treatment of Fabry patients
Pat. No. 11666564 Methods of treating Fabry patients having renal impairment
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 9, 2023
May 30, 2038U-2371: The treatment of Fabry patients
Pat. No. 11786516 DS* Methods of treating Fabry patients having renal impairment
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 25, 2023
May 30, 2038 
Pat. No. 11813255 Methods of treating Fabry patients having renal impairment
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 8, 2023
May 30, 2038U-2371: The treatment of Fabry patients
Pat. No. 11826360 DS* Methods of treating Fabry patients having renal impairment
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 8, 2023
Feb 16, 2039 
Pat. No. 11833164 Methods of treating Fabry disease in patients having a mutation in the GLA gene
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 8, 2023
Jan 11, 2042U-2371: The treatment of Fabry patients
Pat. No. 11903938 DS* Methods of treating Fabry patients having renal impairment
Claim Types: Compound; Method of use
Pat. Sub. Date(s): 001: Mar 4, 2024
Aug 17, 2038U-2371: The treatment of Fabry patients
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityAug 10, 2023 
Exclusivity Code: ODE - Orphan drug exclusivityAug 10, 2025ODE-205: Indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data

AMICUS THERAP US
OPFOLDA (CAPSULE) (ORAL) MIGLUSTAT
Drug Classes: glucosylceramide synthase inhibitor
NDA Applicant: AMICUS THERAP US      NDA No.:
215211  Prod. No.: 001 RX (65MG)
PatentsExpirationPatented Use
Pat. No. 10208299 DS* DP* Highly potent acid alpha-glucosidase with enhanced carbohydrates
Claim Types: Composition; Method of use
Pat. Sub. Date(s): 001: Oct 26, 2023
Sep 30, 2035U-3726: The treatment of pompe patients
Pat. No. 10512677 High concentration alpha-glucosidase compositions for the treatment of pompe disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 26, 2023
Mar 7, 2033U-3726: The treatment of pompe patients
Pat. No. 10857212 Augmented acid alpha-glucosidase for the treatment of Pompe disease
Claim Types: Method of use; Composition
Pat. Sub. Date(s): 001: Oct 26, 2023
Aug 12, 2037U-3726: The treatment of pompe patients
Pat. No. 10961522 Highly potent acid alpha-glucosidase with enhanced carbohydrates
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 26, 2023
Sep 30, 2035U-3726: The treatment of pompe patients
Pat. No. 11278599 High concentration alpha-glucosidase compositions for the treatment of Pompe disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 26, 2023
Mar 7, 2033U-3726: The treatment of pompe patients
Pat. No. 11278601 DP* Augmented acid alpha-glucosidase for the treatment of Pompe disease
Claim Types: Method of use; Kit
Pat. Sub. Date(s): 001: Oct 26, 2023
Dec 29, 2036U-3726: The treatment of pompe patients
Pat. No. 11753632 Highly potent acid alpha-glucosidase with enhanced carbohydrates
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 26, 2023
Sep 30, 2035U-3726: The treatment of pompe patients
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productSep 28, 2026 

AMIVAS
ARTESUNATE (POWDER) (INTRAVENOUS) ARTESUNATE
NDA Applicant: AMIVAS      NDA No.:
213036  Prod. No.: 001 RX (110MG/VIAL)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMay 26, 2025 
Exclusivity Code: ODE - Orphan drug exclusivityMay 26, 2027ODE-290: Indicated for the initial treatment of severe malaria in adult and pediatric patients to always be followed by a complete treatment course of an appropriate oral antimalarial regimen

AMNEAL
CALCIUM GLUCONATE IN SODIUM CHLORIDE (SOLUTION) (INTRAVENOUS) CALCIUM GLUCONATE [GENERIC AP]
NDA Applicant: AMNEAL      NDA No.:
217174  Prod. No.: 001 RX (1GM/50ML (20MG/ML)); 002 RX (2GM/100ML (20MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Code: CGT - Competitive generic therapyMar 10, 2024 

AMNEAL
FLUOROMETHOLONE (SUSPENSION/DROPS) (OPHTHALMIC) FLUOROMETHOLONE [GENERIC AB]
Drug Classes: corticosteroid
NDA Applicant: AMNEAL      NDA No.:
216348  Prod. No.: 001 RX (0.1%)
ExclusivityExpirationExclusivity Description
Exclusivity Code: CGT - Competitive generic therapyJul 7, 2024 

AMNEAL
LYVISPAH (GRANULES) (ORAL) BACLOFEN
Drug Classes: gamma-aminobutyric acid (GABA)-ergic agonist
NDA Applicant: AMNEAL      NDA No.:
215422  Prod. No.: 001 RX (5MG/PACKET); 002 RX (10MG/PACKET); 003 RX (20MG/PACKET)
PatentsExpirationPatented Use
Pat. No. 10792262 DP* Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives
Claim Types: Formulation; Process; Method of use
Pat. Sub. Date(s): All strengths: Dec 21, 2021
Jul 29, 2039U-3263: Method for treating spasticity
Pat. No. 11491125 DP* Baclofen formulations and methods of minimizing patient exposure to metabolite variations
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Dec 5, 2022
Sep 29, 2041U-3488: Treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity
U-3489: Treatment of spasticity resulting from spinal cord injuries and other spinal cord diseases
Pat. No. 11654124 DP* Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Jun 14, 2023
Jul 29, 2039 
Pat. No. 11850225 DP* Baclofen formulations and methods of minimizing patient exposure to metabolite variations
Claim Types: Formulation; Formulation claimed by its inherent performace characteristics; Method of use
Pat. Sub. Date(s): All strengths: Jan 22, 2024
Sep 29, 2041U-3488: Treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity
U-3489: Treatment of spasticity resulting from spinal cord injuries and other spinal cord diseases

AMNEAL
SAXAGLIPTIN (TABLET) (ORAL) SAXAGLIPTIN HYDROCHLORIDE [Has competitive generic]
NDA Applicant: AMNEAL      NDA No.:
205941  Prod. No.: 001 DISC (EQ 2.5MG BASE); 002 DISC (EQ 5MG BASE)
ExclusivityExpirationExclusivity Description
Exclusivity Code: PC - Patent challengeJan 27, 2024 

AMNEAL
TIGECYCLINE (POWDER) (INTRAVENOUS) TIGECYCLINE [GENERIC AP]
Drug Classes: tetracycline class antibacterial
NDA Applicant: AMNEAL      NDA No.:
211158  Prod. No.: 001 RX (50MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 9855335 DP* Tigecycline composition for injection
Claim Types: Formulation; Product-by-process
Pat. Sub. Date(s): 001: Sep 19, 2018
Apr 7, 2033 

AMNEAL
TRANEXAMIC ACID (SOLUTION) (INTRAVENOUS) TRANEXAMIC ACID [GENERIC AP]
NDA Applicant: AMNEAL      NDA No.:
217155  Prod. No.: 001 RX (1GM/100ML (10MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Code: CGT - Competitive generic therapyApr 16, 2024 

AMNEAL
VANCOMYCIN HYDROCHLORIDE (FOR SOLUTION) (ORAL) VANCOMYCIN HYDROCHLORIDE [GENERIC AA]
Drug Classes: glycopeptide antibacterial
NDA Applicant: AMNEAL      NDA No.:
215338  Prod. No.: 001 RX (EQ 250MG BASE/5ML)
ExclusivityExpirationExclusivity Description
Exclusivity Code: CGT - Competitive generic therapyDec 20, 2023 

AMNEAL PHARMS CO
TERIFLUNOMIDE (TABLET) (ORAL) TERIFLUNOMIDE [GENERIC AB]
Drug Classes: pyrimidine synthesis inhibitor
NDA Applicant: AMNEAL PHARMS CO      NDA No.:
209613  Prod. No.: 001 RX (7MG); 002 RX (14MG)
ExclusivityExpirationExclusivity Description
Exclusivity Code: PC - Patent challengeSep 8, 2023 

AMPHASTAR PHARMS INC
BAQSIMI (POWDER) (NASAL) GLUCAGON
Drug Classes: antihypoglycemic agent == gastrointestinal motility inhibitor
NDA Applicant: AMPHASTAR PHARMS INC      NDA No.:
210134  Prod. No.: 001 RX (3MG)
PatentsExpirationPatented Use
Pat. No. 10213487 DP* Nasal powder formulation for treatment of hypoglycemia
Claim Types: Formulation; Process; Device; Method of use
Pat. Sub. Date(s): 001: Aug 23, 2019
Feb 16, 2036U-2604: Treatment of severe hypoglycemia in patients with diabetes
Pat. No. 10765602 DP* Medication delivery systems and methods
Claim Types: Device; Method of administration; Container
Pat. Sub. Date(s): 001: Oct 8, 2020
Sep 23, 2039 
Pat. No. 10894133 DP* Device for dispensing a fluid product
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 10, 2021
Jan 3, 2038 

AMPHASTAR PHARMS INC
REXTOVY (SPRAY, METERED) (NASAL) NALOXONE HYDROCHLORIDE [Has competitive generic]
Drug Classes: opioid antagonist
NDA Applicant: AMPHASTAR PHARMS INC      NDA No.:
208969  Prod. No.: 001 DISC (4MG/SPRAY)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productMar 7, 2026 

AMRING PHARMS
LYSTEDA (TABLET) (ORAL) TRANEXAMIC ACID [GENERIC AB]
NDA Applicant: AMRING PHARMS      NDA No.:
022430  Prod. No.: 001 RX (650MG)
PatentsExpirationPatented Use
Pat. No. 7947739 DP* Tranexamic acid formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: May 24, 2011
Mar 4, 2025 
Pat. No. 8022106 Tranexamic acid formulations
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 20, 2011
Mar 4, 2025U-1182: Treatment of cyclic heavy menstrual bleeding
Pat. No. 8273795 Tranexamic acid formulations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 25, 2012
Mar 4, 2025U-1182: Treatment of cyclic heavy menstrual bleeding
Pat. No. 8487005 DP* Tranexamic acid formulations
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jul 16, 2013
Mar 4, 2025U-1182: Treatment of cyclic heavy menstrual bleeding
Pat. No. 8791160 DP* Tranexamic acid formulations
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 25, 2014
Mar 4, 2025U-1182: Treatment of cyclic heavy menstrual bleeding
Pat. No. 8809394 DP* Tranexamic acid formulations
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 16, 2014
Mar 4, 2025U-1182: Treatment of cyclic heavy menstrual bleeding
Pat. No. 8957113 DP* Tranexamic acid formulations
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Feb 25, 2015
Mar 4, 2025U-1182: Treatment of cyclic heavy menstrual bleeding
Pat. No. 9060939 DP* Tranexamic acid formulations
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jun 23, 2015
Mar 4, 2025 

AMYLYX
RELYVRIO (FOR SUSPENSION) (ORAL) SODIUM PHENYLBUTYRATE; TAURURSODIOL
NDA Applicant: AMYLYX      NDA No.:
216660  Prod. No.: 001 RX (3GM/PACKET; 1GM/PACKET)
PatentsExpirationPatented Use
Pat. No. 9872865 Compositions for improving cell viability and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 28, 2022
Dec 24, 2033U-3460: Treatment of amyotrophic lateral sclerosis (ALS) in adults
Pat. No. 10251896 Compositions for improving cell viability and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 28, 2022
Dec 24, 2033U-3460: Treatment of amyotrophic lateral sclerosis (ALS) in adults
Pat. No. 10857162 Compositions for improving cell viability and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 28, 2022
Dec 24, 2033U-3460: Treatment of amyotrophic lateral sclerosis (ALS) in adults
Pat. No. 11071742 DP* Compositions for improving cell viability and methods of use thereof
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Oct 28, 2022
Dec 24, 2033 
Pat. No. 11583542 DP* Compositions of bile acids and phenylbutyrate compounds
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 3, 2023
Jul 27, 2040 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entitySep 29, 2027 
Exclusivity Code: ODE - Orphan drug exclusivitySep 29, 2029ODE-411: Treatment of amyotrophic lateral sclerosis (ALS) in adults

ANACOR PHARMS INC
EUCRISA (OINTMENT) (TOPICAL) CRISABOROLE
Drug Classes: phosphodiesterase 4 inhibitor
NDA Applicant: ANACOR PHARMS INC      NDA No.:
207695  Prod. No.: 001 RX (2%)
PatentsExpirationPatented Use
Pat. No. 8039451 DS* DP* [Extended 1114 days (3.1 years)]
Boron-containing small molecules
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jan 12, 2017
Dec 29, 2029 *PED 
Pat. No. 8168614 Boron-containing small molecules as anti-inflammatory agents
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 12, 2017
Jul 20, 2030 *PEDU-1932: Method of treating mild to moderate atopic dermatitis.
Pat. No. 8501712 Boron-containing small molecules as anti-inflammatory agents
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 12, 2017
Aug 16, 2027 *PEDU-1932: Method of treating mild to moderate atopic dermatitis.
Pat. No. 9682092 Boron-containing small molecules as anti-inflammatory agents
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 14, 2017
Aug 16, 2027 *PEDU-1932: Method of treating mild to moderate atopic dermatitis.
ExclusivityExpirationExclusivity Description
Exclusivity Code: D - New Dosing ScheduleApr 3, 2026D-191: Addition of a once daily dosing regimen

ANGELINI PHARMA
OLEPTRO (TABLET, EXTENDED RELEASE) (ORAL) TRAZODONE HYDROCHLORIDE
Drug Classes: selective serotonin reuptake inhibitor (SSRI)
NDA Applicant: ANGELINI PHARMA      NDA No.:
022411  Prod. No.: 001 DISC (150MG**); 002 DISC (300MG**)
PatentsExpirationPatented Use
Pat. No. 7829120 DP* Trazodone composition for once a day administration
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Dec 6, 2010; 002: None
Mar 27, 2027U-796: Method of treating depression
Pat. No. 8133893 DS* DP* Trazodone and trazodone hydrochloride in purified form
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Mar 16, 2012; 002: None
Mar 13, 2029 

ANI PHARMS
BACLOFEN (SUSPENSION) (ORAL) BACLOFEN [GENERIC AB]
Drug Classes: gamma-aminobutyric acid (GABA)-ergic agonist
NDA Applicant: ANI PHARMS      NDA No.:
217252  Prod. No.: 001 RX (25MG/5ML)
ExclusivityExpirationExclusivity Description
Exclusivity Code: PC - Patent challengeDec 16, 2023 

ANI PHARMS
VEREGEN (OINTMENT) (TOPICAL) SINECATECHINS
NDA Applicant: ANI PHARMS      NDA No.:
021902  Prod. No.: 001 RX (15%)
PatentsExpirationPatented Use
Pat. No. 7858662 DP* Medicament for the treatment of viral skin and tumour diseases
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 3, 2011
Oct 2, 2026U-172: Treatment of genital warts
Pat. No. 9770406 DP* Medicament for the treatment of viral skin and tumour diseases
Claim Types: Composition; Method of use
Pat. Sub. Date(s): 001: Oct 19, 2017
Jul 12, 2025U-172: Treatment of genital warts

ANTARES PHARMA INC
XYOSTED (AUTOINJECTOR) (SOLUTION) (SUBCUTANEOUS) TESTOSTERONE ENANTHATE
Drug Classes: androgen
NDA Applicant: ANTARES PHARMA INC      NDA No.:
209863  Prod. No.: 001 RX (50MG/0.5ML (50MG/0.5ML)); 002 RX (75MG/0.5ML (75MG/0.5ML)); 003 RX (100MG/0.5ML (100MG/0.5ML))
PatentsExpirationPatented Use
Pat. No. 8021335 DP* Prefilled syringe jet injector
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 24, 2018
Oct 4, 2026 
Pat. No. 8562564 DP* Prefilled syringe jet injector
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 24, 2018
Jan 24, 2026 
Pat. No. 9180259 DP* Prefilled syringe jet injector
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 24, 2018
Jan 24, 2026 
Pat. No. 9533102 DP* Prefilled syringe jet injector
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 24, 2018
Jan 24, 2026 
Pat. No. 9629959 DP* Prefilled syringe jet injector
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 24, 2018
Jan 24, 2026 
Pat. No. 9744302 DP* Needle assisted jet injection device having reduced trigger force
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 24, 2018
Nov 19, 2035 
Pat. No. 9950125 DP* Needle assisted jet injection administration of testosterone compositions
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Oct 24, 2018
Sep 4, 2036U-2418: Method of administering testosterone enanthate subcutaneously
Pat. No. 10238662 DP* Needle assisted jet injection administration of testosterone compositions
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Jun 11, 2020
Feb 19, 2035U-2418: Method of administering testosterone enanthate subcutaneously
Pat. No. 10279131 DP* Injection device with cammed RAM assembly
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jun 11, 2020
Jul 31, 2031 
Pat. No. 10357609 DP* Needle assisted jet injection device having reduced trigger force
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jun 11, 2020
Aug 21, 2031 
Pat. No. 10478560 DP* Prefilled syringe injector
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jun 11, 2020
Jan 24, 2026 
Pat. No. 10646495 DP* Testosterone ester triglyceride formulations
Claim Types: Compound; Formulation
Pat. Sub. Date(s): All strengths: Jun 11, 2020
Aug 30, 2038 
Pat. No. 10821072 DP* Needle assisted jet injection administration of testosterone compositions
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Nov 23, 2020
Jun 4, 2033U-2418: Method of administering testosterone enanthate subcutaneously
Pat. No. 10881798 DP* Needle assisted injection device having reduced trigger force
Claim Types: Device
Pat. Sub. Date(s): All strengths: Feb 4, 2021
Feb 11, 2034 
Pat. No. 10905827 DP* Injection device with cammed ram assembly
Claim Types: Device
Pat. Sub. Date(s): All strengths: Mar 2, 2021
Aug 21, 2031 
Pat. No. 10912782 DP* Needle assisted injection administration of testosterone compositions
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Mar 2, 2021
Feb 19, 2035U-2418: Method of administering testosterone enanthate subcutaneously
Pat. No. 11160751 DP* Hematocrit modulation through needle assisted jet injection of testosterone
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 6, 2022
Oct 7, 2034U-2418: Method of administering testosterone enanthate subcutaneously
Pat. No. 11191908 DP* Syringe shock absorber for use in an injection device
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 6, 2022
Oct 18, 2035 
Pat. No. 11446440 DP* Needle assisted injection device having reduced trigger force
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 7, 2022
Aug 21, 2031 
Pat. No. 11446441 DP* Prefilled syringe injector
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 7, 2022
Jan 24, 2026 
Pat. No. 11497753 DP* Hazardous agent injection system
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 14, 2022
Mar 19, 2030 
Pat. No. 11813435 DP* Needle assisted injection device having reduced trigger force
Claim Types: Device
Pat. Sub. Date(s): All strengths: Nov 22, 2023
Feb 25, 2035 
Pat. No. 11844804 Administration of testosterone compositions
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Jan 18, 2024
Jun 4, 2033U-2418: Method of administering testosterone enanthate subcutaneously

APELLIS PHARMS
EMPAVELI (SOLUTION) (SUBCUTANEOUS) PEGCETACOPLAN
Drug Classes: complement inhibitor
NDA Applicant: APELLIS PHARMS      NDA No.:
215014  Prod. No.: 001 RX (1080MG/20ML (54MG/ML))
PatentsExpirationPatented Use
Pat. No. 7888323 DS* Potent compstatin analogs
Claim Types: Compound
Pat. Sub. Date(s): 001: Jun 9, 2021
Dec 4, 2027 
Pat. No. 7989589 DS* Compstatin analogs with improved activity
Claim Types: Compound
Pat. Sub. Date(s): 001: Jun 9, 2021
Dec 4, 2027 
Pat. No. 9169307 DS* Potent compstatin analogs
Claim Types: Compound; Process; Method of use
Pat. Sub. Date(s): 001: Jun 9, 2021
Nov 18, 2027U-3123: Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (pnh) by administration of complement inhibitor pegcetacoplan
Pat. No. 10035822 DS* Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods
Claim Types: Compound
Pat. Sub. Date(s): 001: Jun 9, 2021
Nov 15, 2033 
Pat. No. 10125171 DS* Cell-reactive, long-acting, or targeted compstatin analogs and uses thereof
Claim Types: Compound
Pat. Sub. Date(s): 001: Jun 9, 2021
Aug 2, 2033 
Pat. No. 10875893 DS* Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods
Claim Types: Compound; Method of use
Pat. Sub. Date(s): 001: Jun 9, 2021
Nov 15, 2033U-3124: Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (pnh) by administration of pegcetacoplan
Pat. No. 11040107 DP* Dosing regimens and related compositions and methods
Claim Types: Method of use; Composition
Pat. Sub. Date(s): 001: Jul 16, 2021
Apr 9, 2038U-3172: Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) by administration of 1080 mg of pegcetacoplan
U-3173: Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) by administration of 1080 mg of pegcetacoplan twice weekly
U-3174: Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) by administration of 1080 mg of pegcetacoplan every three days
Pat. No. 11292815 DS* DP* Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Apr 29, 2022
Nov 15, 2033U-3124: Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (pnh) by administration of pegcetacoplan
U-3354: Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) by administration of pegcetacoplan so as to reduce the sensitivity of cells to complement-dependent damage
Pat. No. 11661441 DS* Cell-reactive, long-acting, or targeted compstatin analogs and uses thereof
Claim Types: Method of use; Process
Pat. Sub. Date(s): 001: Jun 23, 2023
Jan 13, 2033U-3124: Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (pnh) by administration of pegcetacoplan
Pat. No. 11844841 DP* Dosing regimens and related compositions and methods
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Jan 16, 2024
Dec 9, 2038U-3172: Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) by administration of 1080 mg of pegcetacoplan
U-3173: Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) by administration of 1080 mg of pegcetacoplan twice weekly
U-3174: Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) by administration of 1080 mg of pegcetacoplan every three days
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousFeb 8, 2026M-288: Information added to the labeling to describe the results of study APl2-308
Exclusivity Code: NCE - New chemical entityMay 14, 2026 
Exclusivity Code: ODE - Orphan drug exclusivityMay 14, 2028ODE-351: Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH)

APELLIS PHARMS
SYFOVRE (SOLUTION) (INTRAVITREAL) PEGCETACOPLAN
Drug Classes: complement inhibitor
NDA Applicant: APELLIS PHARMS      NDA No.:
217171  Prod. No.: 001 RX (15MG/0.1ML (15MG/0.1ML))
PatentsExpirationPatented Use
Pat. No. 7888323 DS* Potent compstatin analogs
Claim Types: Compound
Pat. Sub. Date(s): 001: Mar 9, 2023
Dec 4, 2027 
Pat. No. 7989589 DS* Compstatin analogs with improved activity
Claim Types: Compound
Pat. Sub. Date(s): 001: Mar 9, 2023
Dec 4, 2027 
Pat. No. 8168584 Methods of treating age-related macular degeneration by compstatin and analogs thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 9, 2023
Apr 7, 2027U-3540: Treatment of geographic atrophy secondary to age-related macular degeneration by intravitreal administration of pegcetacoplan
U-3542: Treatment of geographic atrophy secondary to age-related macular degeneration by intravitreal administration of pegcetacoplan and also administering an anti-VEGF agent
Pat. No. 9056076 Method of treating age-related macular degeneration comprising administering a compstatin analog
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 9, 2023
Oct 25, 2026U-3540: Treatment of geographic atrophy secondary to age-related macular degeneration by intravitreal administration of pegcetacoplan
Pat. No. 9169307 DS* Potent compstatin analogs
Claim Types: Compound; Process; Method of use
Pat. Sub. Date(s): 001: Mar 9, 2023
Nov 18, 2027U-3541: Treatment of geographic atrophy secondary to age-related macular degeneration by administering complement inhibitor pegcetacoplan
Pat. No. 10035822 DS* Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods
Claim Types: Compound
Pat. Sub. Date(s): 001: Mar 9, 2023
Nov 15, 2033 
Pat. No. 10125171 DS* Cell-reactive, long-acting, or targeted compstatin analogs and uses thereof
Claim Types: Compound
Pat. Sub. Date(s): 001: Mar 9, 2023
Aug 2, 2033 
Pat. No. 10875893 DS* Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods
Claim Types: Compound; Method of use
Pat. Sub. Date(s): 001: Mar 9, 2023
Nov 15, 2033U-3540: Treatment of geographic atrophy secondary to age-related macular degeneration by intravitreal administration of pegcetacoplan
Pat. No. 11292815 DS* DP* Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Mar 9, 2023
Nov 15, 2033U-3540: Treatment of geographic atrophy secondary to age-related macular degeneration by intravitreal administration of pegcetacoplan
Pat. No. 11661441 DS* Cell-reactive, long-acting, or targeted compstatin analogs and uses thereof
Claim Types: Method of use; Process
Pat. Sub. Date(s): 001: Jun 26, 2023
Jan 13, 2033U-3540: Treatment of geographic atrophy secondary to age-related macular degeneration by intravitreal administration of pegcetacoplan
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMay 14, 2026 
Exclusivity Code: NP - New productFeb 22, 2026 

APGDI
MYRBETRIQ (TABLET, EXTENDED RELEASE) (ORAL) MIRABEGRON [GENERIC AB]
Drug Classes: beta-3 adrenergic agonist
NDA Applicant: APGDI      NDA No.:
202611  Prod. No.: 001 RX (25MG); 002 RX (50MG)
PatentsExpirationPatented Use
Pat. No. RE44872 Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 16, 2014
May 4, 2024 *PEDU-1527: For the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency
Pat. No. 7342117 DS* .alpha.-form or .beta.-form crystal of acetanilide derivative
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Jul 30, 2012; 002: None
May 4, 2024 *PED 
Pat. No. 7982049 DP* .alpha.-form or .beta.-form crystal of acetanilide derivative
Claim Types: Composition; Method of use; Formulation
Pat. Sub. Date(s): 001: Jul 30, 2012; 002: None
May 4, 2024 *PED 
Pat. No. 8772315 Pharmaceutical composition for treating overactive bladder
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: May 17, 2018
Apr 30, 2029 *PEDU-2300: Use in combination with the muscarinic antagonist solifenacin succinate for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency
Pat. No. 8835474 Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 14, 2014
May 4, 2024 *PEDU-1527: For the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency
Pat. No. 10842780 DP* Pharmaceutical composition for modified release
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Dec 11, 2020
Mar 28, 2030 *PEDU-2996: Administration of an extended release tablet for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency
U-3670: Administration of an extended release tablet for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older and weighing 35 kg or more
Pat. No. 11707451 Pharmaceutical composition for modified release
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): All strengths: Aug 21, 2023
Mar 28, 2030 *PEDU-2996: Administration of an extended release tablet for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency
U-3670: Administration of an extended release tablet for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older and weighing 35 kg or more
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationSep 25, 2024 PEDI-855: Treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 3 years and older and weighing 35 kilograms or more

APGDI
MYRBETRIQ GRANULES (FOR SUSPENSION, EXTENDED RELEASE) (ORAL) MIRABEGRON
Drug Classes: beta-3 adrenergic agonist
NDA Applicant: APGDI      NDA No.:
213801  Prod. No.: 001 RX (8MG/ML)
PatentsExpirationPatented Use
Pat. No. 7342117 DS* .alpha.-form or .beta.-form crystal of acetanilide derivative
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Apr 22, 2021
May 4, 2024 *PED 
Pat. No. 7982049 DP* .alpha.-form or .beta.-form crystal of acetanilide derivative
Claim Types: Composition; Method of use; Formulation
Pat. Sub. Date(s): 001: Apr 22, 2021
May 4, 2024 *PED 
Pat. No. 10058536 DP* Pharmaceutical composition containing mirabegron
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): 001: Apr 22, 2021
Oct 1, 2036 *PEDU-3108: Treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older by administration of an extended-release suspension formulation of mirabegron
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productSep 25, 2024 PED 

APIL
ATELVIA (TABLET, DELAYED RELEASE) (ORAL) RISEDRONATE SODIUM [GENERIC AB]
NDA Applicant: APIL      NDA No.:
022560  Prod. No.: 001 RX (35MG)
PatentsExpirationPatented Use
Pat. No. 7645459 DP* Dosage forms of bisphosphonates
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 1, 2010
Jan 9, 2028U-662: Treatment of osteoporosis in postmenopausal women
Pat. No. 7645460 DP* Dosage forms of risedronate
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 1, 2010
Jan 9, 2028U-662: Treatment of osteoporosis in postmenopausal women
Pat. No. 8246989 DP* Dosage forms of bisphosphonates
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 28, 2012
Jan 16, 2026 

APIL
FEMTRACE (TABLET) (ORAL) ESTRADIOL ACETATE
Drug Classes: estrogen
NDA Applicant: APIL      NDA No.:
021633  Prod. No.: 001 DISC (0.45MG); 002 DISC (0.9MG); 003 DISC (1.8MG)
PatentsExpirationPatented Use
Pat. No. 7572779 Oral pharmaceutical products containing 17.beta.-estradiol-3-lower alkanoate, method of administering the same and process of preparation
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: None
Oct 2, 2025U-904: Treatment of moderate to severe vasomotor symptoms associated with menopause

APIL
LO LOESTRIN FE (TABLET) (ORAL) ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Drug Classes: progestin
NDA Applicant: APIL      NDA No.:
022501  Prod. No.: 001 RX (0.01MG,0.01MG;1MG,N/A)
PatentsExpirationPatented Use
Pat. No. 7704984 Extended estrogen dosing contraceptive regimen
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Oct 29, 2010
Feb 2, 2029U-1090: Lo Loestrin FE is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception

APIL
LO MINASTRIN FE (TABLET, CHEWABLE, TABLET) (ORAL) ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Drug Classes: progestin
NDA Applicant: APIL      NDA No.:
204654  Prod. No.: 001 DISC (0.01MG,0.01MG,N/A;1MG,N/A,N/A)
PatentsExpirationPatented Use
Pat. No. 7704984 Extended estrogen dosing contraceptive regimen
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
Feb 2, 2029U-1: Prevention of pregnancy

APOTEX
DEXAMETHASONE (TABLET) (ORAL) DEXAMETHASONE [GENERIC AB]
Drug Classes: corticosteroid
NDA Applicant: APOTEX      NDA No.:
217695  Prod. No.: 003 RX (1MG)
ExclusivityExpirationExclusivity Description
Exclusivity Code: CGT - Competitive generic therapyApr 29, 2024 

APOTEX
MELPHALAN HYDROCHLORIDE (SOLUTION) (INTRAVENOUS) MELPHALAN HYDROCHLORIDE
Drug Classes: alkylating drug
NDA Applicant: APOTEX      NDA No.:
217110  Prod. No.: 001 RX (EQ 90MG BASE/ML (EQ 90MG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 10537520 DP* Stable liquid formulations of melphalan
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 1, 2023
Jun 29, 2036 

APOTEX
TERIFLUNOMIDE (TABLET) (ORAL) TERIFLUNOMIDE [GENERIC AB]
Drug Classes: pyrimidine synthesis inhibitor
NDA Applicant: APOTEX      NDA No.:
209601  Prod. No.: 001 RX (7MG); 002 RX (14MG)
ExclusivityExpirationExclusivity Description
Exclusivity Code: PC - Patent challengeSep 8, 2023 

APRECIA PHARMS
SPRITAM (TABLET, FOR SUSPENSION) (ORAL) LEVETIRACETAM
NDA Applicant: APRECIA PHARMS      NDA No.:
207958  Prod. No.: 001 RX (250MG); 002 RX (500MG); 003 RX (750MG); 004 RX (1GM)
PatentsExpirationPatented Use
Pat. No. 9339489 DP* Rapid disperse dosage form containing levetiracetam
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jul 25, 2017; 002: Jun 16, 2016; 003: Jun 16, 2016; 004: Jun 16, 2016
Mar 14, 2034U-1850: Method of administering levetiracetam
Pat. No. 9669009 Rapid disperse dosage form containing levetiracetam
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 28, 2017
Mar 14, 2034U-1850: Method of administering levetiracetam
U-2021: Method of administering levetiracetam under fasted conditions
U-2022: Method of administering levetiracetam under fed conditions
Pat. No. 11160786 DP* Rapid disperse dosage form
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 30, 2021
Mar 14, 2034 

AQUESTIVE
EXSERVAN (FILM) (ORAL) RILUZOLE
Drug Classes: benzothiazole
NDA Applicant: AQUESTIVE      NDA No.:
212640  Prod. No.: 001 RX (50MG)
PatentsExpirationPatented Use
Pat. No. 8603514 DP* Uniform films for rapid dissolve dosage form incorporating taste-masking compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 2, 2020
Apr 3, 2024 
Pat. No. 8765167 DP* Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Jun 2, 2020
Feb 20, 2024 

AQUESTIVE
ZUPLENZ (FILM) (ORAL) ONDANSETRON
Drug Classes: serotonin-3 (5-HT3) receptor antagonist
NDA Applicant: AQUESTIVE      NDA No.:
022524  Prod. No.: 001 DISC (4MG); 002 DISC (8MG)
PatentsExpirationPatented Use
Pat. No. 8580830 DP* Non-mucoadhesive film dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Dec 3, 2013
Nov 23, 2029 
Pat. No. 9095577 DP* Stabilized amine-containing actives in oral film compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Aug 26, 2015
Jul 13, 2030 

ARBOR PHARMS LLC
CETYLEV (TABLET, EFFERVESCENT) (ORAL) ACETYLCYSTEINE
Drug Classes: antidote == antidote for acetaminophen overdose == mucolytic
NDA Applicant: ARBOR PHARMS LLC      NDA No.:
207916  Prod. No.: 001 DISC (500MG); 002 DISC (2.5GM)
PatentsExpirationPatented Use
Pat. No. 8747894 DP* Effervescent compositions containing N-acetylcysteine
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Feb 8, 2016
May 8, 2032U-1373: Method of treating acetaminophen overdose with acetylcysteine solutions
Pat. No. 9427421 DP* Effervescent compositions containing N-acetylcysteine
Claim Types: Formulation; Product-by-process
Pat. Sub. Date(s): All strengths: Sep 23, 2016
May 8, 2032 
Pat. No. 9561204 Effervescent compositions containing N-acetylcysteine
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 9, 2017
May 8, 2032U-1373: Method of treating acetaminophen overdose with acetylcysteine solutions

ARCUTIS
ZORYVE (CREAM) (TOPICAL) ROFLUMILAST
Drug Classes: phosphodiesterase 4 inhibitor
NDA Applicant: ARCUTIS      NDA No.:
215985  Prod. No.: 001 RX (0.3%)
PatentsExpirationPatented Use
Pat. No. 9884050 DP* Inhibition of crystal growth of roflumilast
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Aug 19, 2022
Jun 7, 2037 
Pat. No. 9907788 Inhibition of crystal growth of roflumilast
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 19, 2022
Jun 7, 2037U-3408: Topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. (1)
U-3712: Topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age or older
Pat. No. 10940142 DP* Inhibition of crystal growth of roflumilast
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 19, 2022
Jun 7, 2037 
Pat. No. 11129818 Topical roflumilast formulation having improved delivery and plasma half life
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Aug 19, 2022
Aug 25, 2037U-3408: Topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. (1)
U-3712: Topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age or older
Pat. No. 11793796 DP* Inhibition of crystal growth of roflumilast
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 24, 2023
Jun 7, 2037 
Pat. No. 11819496 Topical roflumilast formulation having improved delivery and plasma half-life
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 21, 2023
Jun 7, 2037U-3748: Topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age and older
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productJul 29, 2025 
Exclusivity Code: NPP - New patient populationOct 5, 2026 

ARCUTIS
ZORYVE (FOAM) (TOPICAL) ROFLUMILAST
Drug Classes: phosphodiesterase 4 inhibitor
NDA Applicant: ARCUTIS      NDA No.:
217242  Prod. No.: 001 RX (0.3%)
PatentsExpirationPatented Use
Pat. No. 9884050 DP* Inhibition of crystal growth of roflumilast
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Dec 26, 2023
Jun 7, 2037 
Pat. No. 9907788 Inhibition of crystal growth of roflumilast
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 26, 2023
Jun 7, 2037U-3773: Topical treatment of seborrheic dermatitis in patients 9 years of age and older
Pat. No. 10940142 DP* Inhibition of crystal growth of roflumilast
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 26, 2023
Jun 7, 2037 
Pat. No. 11129818 Topical roflumilast formulation having improved delivery and plasma half life
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Dec 26, 2023
Aug 25, 2037U-3773: Topical treatment of seborrheic dermatitis in patients 9 years of age and older
Pat. No. 11707454 Topical roflumilast formulation having antifungal properties
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 26, 2023
Dec 3, 2041U-3773: Topical treatment of seborrheic dermatitis in patients 9 years of age and older
Pat. No. 11793796 DP* Inhibition of crystal growth of roflumilast
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 26, 2023
Jun 7, 2037 
Pat. No. 11819496 Topical roflumilast formulation having improved delivery and plasma half-life
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 26, 2023
Jun 7, 2037U-3773: Topical treatment of seborrheic dermatitis in patients 9 years of age and older
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productDec 15, 2026 

ARDELYX INC
IBSRELA (TABLET) (ORAL) TENAPANOR HYDROCHLORIDE
Drug Classes: sodium/hydrogen exchanger 3 (NHE3) inhibitor
NDA Applicant: ARDELYX INC      NDA No.:
211801  Prod. No.: 001 RX (EQ 50MG BASE)
PatentsExpirationPatented Use
Pat. No. 8541448 DS* DP* [Extended 1273 days (3.5 years)]
Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Oct 10, 2019
Aug 1, 2033 
Pat. No. 8969377 DS* DP* Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Oct 10, 2019
Dec 30, 2029 
Pat. No. 9006281 Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 10, 2019
May 2, 2030U-2626: Method of treating irritable bowel syndrome with constipation by administering tenapanor
Pat. No. 9408840 Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorder
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 10, 2019
Dec 30, 2029U-2626: Method of treating irritable bowel syndrome with constipation by administering tenapanor
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entitySep 12, 2024 

ARDELYX INC
XPHOZAH (TABLET) (ORAL) TENAPANOR HYDROCHLORIDE
Drug Classes: sodium/hydrogen exchanger 3 (NHE3) inhibitor
NDA Applicant: ARDELYX INC      NDA No.:
213931  Prod. No.: 001 RX (EQ 10MG BASE); 002 RX (EQ 20MG BASE); 003 RX (EQ 30MG BASE)
PatentsExpirationPatented Use
Pat. No. 8541448 DS* DP* [Extended 1273 days (3.5 years)]
Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Nov 14, 2023
Aug 1, 2033 
Pat. No. 8969377 DS* DP* Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Nov 14, 2023
Dec 30, 2029 
Pat. No. 10272079 NHE3-binding compounds and methods for inhibiting phosphate transport
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 14, 2023
Apr 10, 2034U-3736: Reduction of serum phosphorus in adults
U-381: Treatment of hyperphosphatemia
Pat. No. 10940146 NHE3-binding compounds and methods for inhibiting phosphate transport
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 14, 2023
Apr 10, 2034U-3736: Reduction of serum phosphorus in adults
U-381: Treatment of hyperphosphatemia
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entitySep 12, 2024 
Exclusivity Code: NP - New productOct 17, 2026 

ARMSTRONG PHARMS
PRIMATENE MIST (AEROSOL, METERED) (INHALATION) EPINEPHRINE
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: ARMSTRONG PHARMS      NDA No.:
205920  Prod. No.: 001 OTC (0.125MG/INH)
PatentsExpirationPatented Use
Pat. No. 8367734 DP* Stable epinephrine suspension formulation with high inhalation delivery efficiency
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 17, 2018
Jan 26, 2026 

ARRAY BIOPHARMA INC
BRAFTOVI (CAPSULE) (ORAL) ENCORAFENIB
NDA Applicant: ARRAY BIOPHARMA INC      NDA No.:
210496  Prod. No.: 001 DISC (50MG)
PatentsExpirationPatented Use
Pat. No. 8541575 DS* DP* 3,4-diarylpyrazoles as protein kinase inhibitors
Claim Types: Compound; Method of use; Composition; Kit
Pat. Sub. Date(s): 001: Jul 25, 2018
Feb 26, 2030U-2335: Treatment of melanoma
Pat. No. 8946250 DS* DP* 3,4-diarylpyrazoles as protein kinase inhibitors
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jul 25, 2018
Jul 23, 2029 
Pat. No. 9314464 Compounds and compositions as protein kinase inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2018
Jul 4, 2031U-2336: Treatment of melanoma mediated by a B-Raf protein kinase
Pat. No. 9387208 DP* Pharmaceutical formulations of (S)-methyl (1-((4-(3-(5-chloro-2-fluoro-3-(methylsulfonamido)phenyl)-1-isopropyl-1H- pyrazol-4-yl)pyrimidin-2-yl)amino)propan-2-yl)carbamate
Claim Types: Formulation; Product-by-process
Pat. Sub. Date(s): 001: Jul 25, 2018
Nov 21, 2032 
Pat. No. 9593099 DS* Compounds and compositions as protein kinase inhibitors
Claim Types: Compound
Pat. Sub. Date(s): 001: Jul 25, 2018
Aug 27, 2030 
Pat. No. 9593100 DP* Compounds and compositions as protein kinase inhibitors
Claim Types: Composition
Pat. Sub. Date(s): 001: Jul 25, 2018
Aug 27, 2030 
Pat. No. 9763941 Method of treating melanoma by administration of pharmaceutical formulations of (S)-methyl (1-((4-(3-(5-chloro-2-fluoro-3-(methylsulfonamido)phenyl)-1-isopropyl-1H- pyrazol-4-yl)pyrimidin-2-yl)amino)propan-2-yl)carbamate
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2018
Nov 21, 2032U-2335: Treatment of melanoma
Pat. No. 9850229 Compounds and compositions as protein kinase inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2018
Aug 27, 2030U-2337: Indicated in combination with binimetinib for the treatment of melanoma with a BRAF mutation
Pat. No. 9850230 Compounds and compositions as protein kinase inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2018
Aug 27, 2030U-2334: Treatment of melanoma with a BRAF mutation
Pat. No. 10005761 Compounds and compositions as protein kinase inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2018
Aug 27, 2030U-2335: Treatment of melanoma
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationOct 11, 2026I-928: Encorafenib in combination with binimetinib, is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation, as detected by an FDA-approved test
Exclusivity Code: ODE - Orphan drug exclusivityJun 27, 2025ODE-194: Encorafenib is indicated in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test
Exclusivity Code: ODE - Orphan drug exclusivityOct 11, 2030ODE-445: Treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test

ARRAY BIOPHARMA INC
BRAFTOVI (CAPSULE) (ORAL) ENCORAFENIB
NDA Applicant: ARRAY BIOPHARMA INC      NDA No.:
210496  Prod. No.: 002 RX (75MG)
PatentsExpirationPatented Use
Pat. No. RE49556 DS* DP* Compounds and compositions as protein kinase inhibitors
Claim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 002: Jul 19, 2023
Feb 27, 2030 
Pat. No. 8541575 DS* DP* 3,4-diarylpyrazoles as protein kinase inhibitors
Claim Types: Compound; Method of use; Composition; Kit
Pat. Sub. Date(s): 002: Jul 25, 2018
Feb 26, 2030U-2335: Treatment of melanoma
U-2802: BRAFTOVI is a kinase inhibitor indicated in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy
U-2803: BRAFTOVI is a kinase inhibitor indicated in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA- approved test
U-3738: BRAFTOVI is a kinase inhibitor indicated in combination with binimetinib, for the treatment of patients with metastatic non small cell lung cancer with a braf V600E mutation, as detected by an FDA-approved test
Pat. No. 8946250 DS* DP* 3,4-diarylpyrazoles as protein kinase inhibitors
Claim Types: Compound; Composition
Pat. Sub. Date(s): 002: Jul 25, 2018
Jul 23, 2029 
Pat. No. 9314464 Compounds and compositions as protein kinase inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jul 25, 2018
Jul 4, 2031U-2336: Treatment of melanoma mediated by a B-Raf protein kinase
U-2802: BRAFTOVI is a kinase inhibitor indicated in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy
U-2803: BRAFTOVI is a kinase inhibitor indicated in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA- approved test
U-3738: BRAFTOVI is a kinase inhibitor indicated in combination with binimetinib, for the treatment of patients with metastatic non small cell lung cancer with a braf V600E mutation, as detected by an FDA-approved test
Pat. No. 9387208 DP* Pharmaceutical formulations of (S)-methyl (1-((4-(3-(5-chloro-2-fluoro-3-(methylsulfonamido)phenyl)-1-isopropyl-1H- pyrazol-4-yl)pyrimidin-2-yl)amino)propan-2-yl)carbamate
Claim Types: Formulation; Product-by-process
Pat. Sub. Date(s): 002: Jul 25, 2018
Nov 21, 2032 
Pat. No. 9474754 Pharmaceutical combinations comprising a B-RAF inhibitor, and EGFR inhibitor and optionally a PI3K-.alpha. inhibitor
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: May 7, 2020
Aug 5, 2033U-2802: BRAFTOVI is a kinase inhibitor indicated in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy
Pat. No. 9593099 DS* Compounds and compositions as protein kinase inhibitors
Claim Types: Compound
Pat. Sub. Date(s): 002: Jul 25, 2018
Aug 27, 2030 
Pat. No. 9593100 DP* Compounds and compositions as protein kinase inhibitors
Claim Types: Composition
Pat. Sub. Date(s): 002: Jul 25, 2018
Aug 27, 2030 
Pat. No. 9763941 Method of treating melanoma by administration of pharmaceutical formulations of (S)-methyl (1-((4-(3-(5-chloro-2-fluoro-3-(methylsulfonamido)phenyl)-1-isopropyl-1H- pyrazol-4-yl)pyrimidin-2-yl)amino)propan-2-yl)carbamate
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jul 25, 2018
Nov 21, 2032U-2335: Treatment of melanoma
Pat. No. 9850229 Compounds and compositions as protein kinase inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jul 25, 2018
Aug 27, 2030U-2337: Indicated in combination with binimetinib for the treatment of melanoma with a BRAF mutation
Pat. No. 9850230 Compounds and compositions as protein kinase inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jul 25, 2018
Aug 27, 2030U-2334: Treatment of melanoma with a BRAF mutation
U-2802: BRAFTOVI is a kinase inhibitor indicated in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy
U-2803: BRAFTOVI is a kinase inhibitor indicated in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA- approved test
U-3738: BRAFTOVI is a kinase inhibitor indicated in combination with binimetinib, for the treatment of patients with metastatic non small cell lung cancer with a braf V600E mutation, as detected by an FDA-approved test
Pat. No. 10005761 Compounds and compositions as protein kinase inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jul 25, 2018
Aug 27, 2030U-2335: Treatment of melanoma
U-2802: BRAFTOVI is a kinase inhibitor indicated in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy
U-2803: BRAFTOVI is a kinase inhibitor indicated in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA- approved test
U-3738: BRAFTOVI is a kinase inhibitor indicated in combination with binimetinib, for the treatment of patients with metastatic non small cell lung cancer with a braf V600E mutation, as detected by an FDA-approved test
Pat. No. 10258622 Method of treating colorectal cancer by administration of pharmaceutical formulations of (S)-methyl (1-((4-(3-(5-chloro-2-fluoro-3-(methylsulfonamido)pheny1)-1-isopropyl-1H-- pyrazol-4-yl)pyrimidin-2-yl)amino)propan-2-yl) carbamate
Claim Types: Method of use
Pat. Sub. Date(s): 002: May 7, 2020
Nov 21, 2032U-2802: BRAFTOVI is a kinase inhibitor indicated in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationOct 11, 2026I-928: Encorafenib in combination with binimetinib, is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation, as detected by an FDA-approved test
Exclusivity Code: ODE - Orphan drug exclusivityJun 27, 2025ODE-194: Encorafenib is indicated in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test
Exclusivity Code: ODE - Orphan drug exclusivityOct 11, 2030ODE-445: Treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test

ARRAY BIOPHARMA INC
MEKTOVI (TABLET) (ORAL) BINIMETINIB
NDA Applicant: ARRAY BIOPHARMA INC      NDA No.:
210498  Prod. No.: 001 RX (15MG)
PatentsExpirationPatented Use
Pat. No. 7777050 DS* DP* N3 alkylated benzimidazole derivatives as MEK inhibitors
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jul 25, 2018
Mar 13, 2025 
Pat. No. 9314464 Compounds and compositions as protein kinase inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2018
Jul 4, 2031U-2332: Indicated in combination with encorafenib for the treatment of melanoma mediated by a B-Raf protein kinase
U-3737: MEKTOVI is a kinase inhibitor indicated in combination with encorafenib, for the treatment of patients with metastatic non small cell lung cancer with a braf V600E mutation, as detected by an FDA-approved test
Pat. No. 9562016 DS* DP* Preparation of and formulation comprising a MEK inhibitor
Claim Types: Product-by-process; Formulation; Composition
Pat. Sub. Date(s): 001: Jul 25, 2018
Oct 18, 2033 
Pat. No. 9598376 Preparation of and formulation comprising a MEK inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2018
Oct 18, 2033U-2330: Method of treating melanoma
Pat. No. 9850229 Compounds and compositions as protein kinase inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2018
Aug 27, 2030U-2333: Indicated in combination with encorafenib for the treatment of melanoma with a BRAF mutation
Pat. No. 9980944 Preparation of and formulation comprising a MEK inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2018
Oct 18, 2033U-2334: Treatment of melanoma with a BRAF mutation
Pat. No. 10005761 Compounds and compositions as protein kinase inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2018
Aug 27, 2030U-2331: Indicated in combination with encorafenib for the treatment of melanoma
U-3737: MEKTOVI is a kinase inhibitor indicated in combination with encorafenib, for the treatment of patients with metastatic non small cell lung cancer with a braf V600E mutation, as detected by an FDA-approved test
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationOct 11, 2026I-928: Encorafenib in combination with binimetinib, is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation, as detected by an FDA-approved test
Exclusivity Code: ODE - Orphan drug exclusivityJun 27, 2025ODE-194: Encorafenib is indicated in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test

ASSERTIO
CAMBIA (FOR SOLUTION) (ORAL) DICLOFENAC POTASSIUM [GENERIC AB]
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: ASSERTIO      NDA No.:
022165  Prod. No.: 001 RX (50MG)
PatentsExpirationPatented Use
Pat. No. 7759394 DS* DP* Diclofenac formulations and methods of use
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
Jun 16, 2026U-436: Acute treatment of migraine attacks with or without aura in adults
Pat. No. 8097651 DS* DP* Diclofenac formulations and methods of use
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Jun 16, 2026U-436: Acute treatment of migraine attacks with or without aura in adults
Pat. No. 8927604 Diclofenac formulations and methods of use
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 21, 2015
Jun 16, 2026U-436: Acute treatment of migraine attacks with or without aura in adults
Pat. No. 9827197 DP* Diclofenac formulations and methods of use
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Dec 5, 2017
Jun 16, 2026 

ASSERTIO
ZIPSOR (CAPSULE) (ORAL) DICLOFENAC POTASSIUM [GENERIC AB]
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: ASSERTIO      NDA No.:
022202  Prod. No.: 001 RX (25MG)
PatentsExpirationPatented Use
Pat. No. 7662858 Method of treating post-surgical acute pain
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
Feb 24, 2029U-1035: Nonsteroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain
Pat. No. 7884095 Method of treating post-surgical acute pain
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 22, 2011
Feb 24, 2029U-1111: Nonsteroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain
Pat. No. 7939518 Method of treating post-surgical acute pain
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 19, 2011
Feb 24, 2029U-980: Nonsteroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain
Pat. No. 8110606 Method of treating post-surgical acute pain
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 13, 2012
Feb 24, 2029U-980: Nonsteroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain
Pat. No. 8623920 Method of treating post-surgical acute pain
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Feb 5, 2014
Feb 24, 2029U-1482: Diclofenac potassium for relief of mild to moderate acute pain
Pat. No. 9561200 Method of treating post-surgical acute pain
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 14, 2017
Feb 24, 2029U-1482: Diclofenac potassium for relief of mild to moderate acute pain
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationMay 25, 2024 

ASTELLAS
ASTAGRAF XL (CAPSULE, EXTENDED RELEASE) (ORAL) TACROLIMUS [GENERIC AB]
Drug Classes: calcineurin inhibitor immunosuppressant
NDA Applicant: ASTELLAS      NDA No.:
204096  Prod. No.: 001 RX (EQ 0.5MG BASE); 002 RX (EQ 1MG BASE); 003 RX (EQ 5MG BASE)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s)May 24, 2025 

ASTELLAS
CRESEMBA (CAPSULE) (ORAL) ISAVUCONAZONIUM SULFATE
NDA Applicant: ASTELLAS      NDA No.:
207500  Prod. No.: 001 RX (186MG)
PatentsExpirationPatented Use
Pat. No. 6812238 DS* [Extended 5 years]
N-substituted carbamoyloxyalkyl-azolium derivatives
Claim Types: Composition; Method of use; Compound
Pat. Sub. Date(s): 001: Apr 1, 2015
May 1, 2026 *PED 
Pat. No. 10206879 DP* Active ingredient containing stabilised solid forms and method for the production thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 3, 2021
Mar 14, 2028 *PED 
Pat. No. 10603280 DP* Active ingredient containing stabilised solid medicinal forms and methods for the production thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 3, 2021
Mar 14, 2028 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entitySep 6, 2020 PED 
Exclusivity Code: NPP - New patient populationJun 8, 2027 PED 
Exclusivity Code: ODE - Orphan drug exclusivitySep 6, 2022 PEDODE-305: Treatment of invasive aspergillosis
Exclusivity Code: ODE - Orphan drug exclusivityJun 8, 2031 PEDODE-454: treatment of invasive mucormycosis in pediatric patients 6 years of age and older who weigh 16 kg and greater
Exclusivity Code: ODE - Orphan drug exclusivityJun 8, 2031 PEDODE-458: Treatment of invasive aspergillosis in pediatric patients 6 years of age and older who weigh 16 kilograms (kg) and greater
Exclusivity Code: ODE - Orphan drug exclusivitySep 6, 2022 PEDODE-90: Treatment of invasive mucormycosis in patients 18 years of age and older

ASTELLAS
CRESEMBA (CAPSULE) (ORAL) ISAVUCONAZONIUM SULFATE
NDA Applicant: ASTELLAS      NDA No.:
207500  Prod. No.: 002 RX (74.5MG)
PatentsExpirationPatented Use
Pat. No. 6812238 DS* [Extended 5 years]
N-substituted carbamoyloxyalkyl-azolium derivatives
Claim Types: Composition; Method of use; Compound
Pat. Sub. Date(s): 002: Jun 29, 2023
May 1, 2026 *PED 
Pat. No. 10206879 DP* Active ingredient containing stabilised solid forms and method for the production thereof
Claim Types: Formulation
Pat. Sub. Date(s): 002: Dec 21, 2022
Mar 14, 2028 *PED 
Pat. No. 10603280 DP* Active ingredient containing stabilised solid medicinal forms and methods for the production thereof
Claim Types: Formulation
Pat. Sub. Date(s): 002: Dec 21, 2022
Mar 14, 2028 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entitySep 6, 2020 PED 
Exclusivity Code: NPP - New patient populationJun 8, 2027 PED 
Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s)Sep 6, 2022 PED 
Exclusivity Code: ODE - Orphan drug exclusivityJun 8, 2031 PEDODE-454: treatment of invasive mucormycosis in pediatric patients 6 years of age and older who weigh 16 kg and greater
Exclusivity Code: ODE - Orphan drug exclusivityJun 8, 2031 PEDODE-458: Treatment of invasive aspergillosis in pediatric patients 6 years of age and older who weigh 16 kilograms (kg) and greater

ASTELLAS
CRESEMBA (POWDER) (INTRAVENOUS) ISAVUCONAZONIUM SULFATE
NDA Applicant: ASTELLAS      NDA No.:
207501  Prod. No.: 001 RX (372MG)
PatentsExpirationPatented Use
Pat. No. 6812238 DS* [Extended 5 years]
N-substituted carbamoyloxyalkyl-azolium derivatives
Claim Types: Composition; Method of use; Compound
Pat. Sub. Date(s): 001: Apr 1, 2015
May 1, 2026 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entitySep 6, 2020 PED 
Exclusivity Code: NPP - New patient populationJun 8, 2027 PED 
Exclusivity Code: ODE - Orphan drug exclusivitySep 6, 2022 PEDODE-305: Treatment of invasive aspergillosis
Exclusivity Code: ODE - Orphan drug exclusivityJun 8, 2031 PEDODE-453: Treatment of invasive mucormycosis in pediatric patients 1 year of age and older
Exclusivity Code: ODE - Orphan drug exclusivityJun 8, 2031 PEDODE-459: Treatment of invasive aspergillosis in pediatric patients 1 year of age and older
Exclusivity Code: ODE - Orphan drug exclusivitySep 6, 2022 PEDODE-90: Treatment of invasive mucormycosis in patients 18 years of age and older

ASTELLAS
IZERVAY (SOLUTION) (INTRAVITREAL) AVACINCAPTAD PEGOL SODIUM
NDA Applicant: ASTELLAS      NDA No.:
217225  Prod. No.: 001 RX (EQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML))
PatentsExpirationPatented Use
Pat. No. 7538211 DS* Aptamer therapeutics useful in the treatment of complement-related disorders
Claim Types: Compound
Pat. Sub. Date(s): 001: Aug 31, 2023
Feb 14, 2025 
Pat. No. 7579456 DS* Aptamer therapeutics useful in the treatment of complement-related disorders
Claim Types: Composition
Pat. Sub. Date(s): 001: Aug 31, 2023
Feb 14, 2025 
Pat. No. 7803931 DS* Aptamer therapeutics useful in the treatment of complement-related disorders
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Aug 31, 2023
Feb 14, 2025 
Pat. No. 8236773 Aptamer therapeutics useful in the treatment of complement-related disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 31, 2023
Nov 11, 2026U-3673: Treatment of geographic atrophy secondary to age-related macular degeneration by administerting avacincaptad pegol to the eye
Pat. No. 9617546 DS* Aptamer therapeutics useful in the treatment of complement-related disorders
Claim Types: Compound; Method of use
Pat. Sub. Date(s): 001: Aug 31, 2023
Feb 14, 2025U-3673: Treatment of geographic atrophy secondary to age-related macular degeneration by administerting avacincaptad pegol to the eye
Pat. No. 10947544 DS* Aptamer therapeutics useful in the treatment of complement-related disorders
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Aug 31, 2023
Feb 14, 2025U-3673: Treatment of geographic atrophy secondary to age-related macular degeneration by administerting avacincaptad pegol to the eye
Pat. No. 11273171 Methods for treating or preventing ophthalmological conditions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 31, 2023
Jul 11, 2034U-3673: Treatment of geographic atrophy secondary to age-related macular degeneration by administerting avacincaptad pegol to the eye
Pat. No. 11491176 Methods for treating or preventing ophthalmological conditions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 31, 2023
Jul 11, 2034U-3673: Treatment of geographic atrophy secondary to age-related macular degeneration by administerting avacincaptad pegol to the eye

ASTELLAS
LEXISCAN (SOLUTION) (INTRAVENOUS) REGADENOSON [GENERIC AP]
Drug Classes: adenosine receptor agonist
NDA Applicant: ASTELLAS      NDA No.:
022161  Prod. No.: 001 RX (0.4MG/5ML (0.08MG/ML))
PatentsExpirationPatented Use
Pat. No. RE47301 DP* Process for preparing an A2A-adenosine receptor agonist and its polymorphs
Claim Types: Product-by-process; Formulation; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Apr 2, 2019
Feb 2, 2027 
Pat. No. 8106183 DS* Process for preparing an A.sub.2A-adenosine receptor agonist and its polymorphs
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: Mar 8, 2012
Feb 2, 2027 

ASTELLAS
PROGRAF (CAPSULE) (ORAL) TACROLIMUS [GENERIC AB]
Drug Classes: calcineurin inhibitor immunosuppressant
NDA Applicant: ASTELLAS      NDA No.:
050708  Prod. No.: 001 RX (EQ 1MG BASE); 002 RX (EQ 5MG BASE); 003 RX (EQ 0.5MG BASE)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityMay 24, 2025ODE-294: Prophylaxis of organ rejection in pediatric patients receiving allogeneic kidney or heart transplants, in combination with other immunosuppressants
Exclusivity Code: ODE - Orphan drug exclusivityJul 16, 2028ODE-360: For prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic lung transplant

ASTELLAS
PROGRAF (INJECTABLE) (INJECTION) TACROLIMUS
Drug Classes: calcineurin inhibitor immunosuppressant
NDA Applicant: ASTELLAS      NDA No.:
050709  Prod. No.: 001 RX (EQ 5MG BASE/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityMay 24, 2025ODE-294: Prophylaxis of organ rejection in pediatric patients receiving allogeneic kidney or heart transplants, in combination with other immunosuppressants
Exclusivity Code: ODE - Orphan drug exclusivityJul 16, 2028ODE-360: For prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic lung transplant

ASTELLAS
PROGRAF (FOR SUSPENSION) (ORAL) TACROLIMUS
Drug Classes: calcineurin inhibitor immunosuppressant
NDA Applicant: ASTELLAS      NDA No.:
210115  Prod. No.: 001 RX (EQ 0.2MG BASE/PACKET); 002 RX (EQ 1MG BASE/PACKET)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityMay 24, 2025ODE-269: Prophylaxis of organ rejection in pediatric patients receiving allogeneic kidney transplant, liver transplants, and heart transplant, in combination with other immunosuppressants
Exclusivity Code: ODE - Orphan drug exclusivityJul 16, 2028ODE-360: For prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic lung transplant

ASTELLAS
VEOZAH (TABLET) (ORAL) FEZOLINETANT
NDA Applicant: ASTELLAS      NDA No.:
216578  Prod. No.: 001 RX (45MG)
PatentsExpirationPatented Use
Pat. No. 8871761 DS* NK-3 receptor selective antagonist compounds, pharmaceutical composition and methods for use in NK-3 receptors mediated disorders
Claim Types: Compound
Pat. Sub. Date(s): 001: Jun 6, 2023
Apr 4, 2031 
Pat. No. 9422299 DS* DP* Substituted [1,2,4]triazolo[4,3-a]pyrazines as selective NK-3 receptor antagonists
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Jun 6, 2023
Mar 28, 2034U-3622: Treatment of moderate to severe vasometer symptoms due to menopause
Pat. No. 9987274 N-acyl-(3-substituted)-(8-substituted)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazines as selective NK-3 receptor antagonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 6, 2023
Mar 28, 2034U-3622: Treatment of moderate to severe vasometer symptoms due to menopause
Pat. No. 10836768 N-acyl-(3-substituted)-(8-substituted)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazines as selective NK-3 receptor antagonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 6, 2023
Mar 28, 2034U-3621: Treatment of moderate to severe vasomotor symptoms due with menopause
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMay 12, 2028 

ASTELLAS
VESICARE LS (SUSPENSION) (ORAL) SOLIFENACIN SUCCINATE
Drug Classes: muscarinic antagonist
NDA Applicant: ASTELLAS      NDA No.:
209529  Prod. No.: 001 RX (1MG/ML)
PatentsExpirationPatented Use
Pat. No. 9918970 DP* Pharmaceutical composition comprising solifenacin
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 11, 2021
May 18, 2031 
ExclusivityExpirationExclusivity Description
Exclusivity Code: W - WaiverNov 26, 2023Exclusivity on this application expiring on this date has been waived by sponsor

ASTELLAS
XOSPATA (TABLET) (ORAL) GILTERITINIB FUMARATE
NDA Applicant: ASTELLAS      NDA No.:
211349  Prod. No.: 001 RX (EQ 40MG BASE)
PatentsExpirationPatented Use
Pat. No. 8969336 DS* DP* [Extended 671 days (1.8 years)]
Diamino heterocyclic carboxamide compound
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Dec 18, 2018
Jan 27, 2031 
Pat. No. 9487491 Diamino heterocyclic carboxamide compound
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 18, 2018
Jul 28, 2030U-2456: Treatment of acute myeloid leukemia (AML)
Pat. No. 10786500 DP* Stable pharmaceutical composition for oral administration
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 28, 2020
Jul 1, 2036 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityNov 28, 2023 
Exclusivity Code: ODE - Orphan drug exclusivityNov 28, 2025ODE-222: Indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a fms-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test

ASTELLAS
XTANDI (CAPSULE) (ORAL) ENZALUTAMIDE
Drug Classes: androgen receptor inhibitor
NDA Applicant: ASTELLAS      NDA No.:
203415  Prod. No.: 001 RX (40MG)
PatentsExpirationPatented Use
Pat. No. 7709517 DS* DP* Diarylhydantoin compounds
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Sep 27, 2012
Aug 13, 2027 
Pat. No. 8183274 [Extended 101 days (0.3 years)]
Treatment of hyperproliferative disorders with diarylhydantoin compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 27, 2012
Aug 24, 2026U-1281: The treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel
U-1588: The treatment of patients with metastatic castration-resistant prostate cancer (CRPC).
U-2345: Treatment of patients with castration-resistant prostate cancer (CRPC)
U-2708: The treatment of patients with metastatic castration-sensitive prostate cancer
U-3763: Treatment of patients with non-metastatic castration-sensitive prostate cancer (NMCSPC) with biochemical recurrence (BCR) at high risk for metastasis
Pat. No. 9126941 Treatment of hyperproliferative disorders with diarylhydantoin compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 7, 2015
May 15, 2026U-1588: The treatment of patients with metastatic castration-resistant prostate cancer (CRPC).
U-2345: Treatment of patients with castration-resistant prostate cancer (CRPC)
U-2708: The treatment of patients with metastatic castration-sensitive prostate cancer
U-3763: Treatment of patients with non-metastatic castration-sensitive prostate cancer (NMCSPC) with biochemical recurrence (BCR) at high risk for metastasis
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationNov 17, 2026I-926: Treatment of patients with non-metastatic castration-sensitive prostate cancer (nmcspc) with biochemical recurrence at high risk for metastasis

ASTELLAS
XTANDI (TABLET) (ORAL) ENZALUTAMIDE
Drug Classes: androgen receptor inhibitor
NDA Applicant: ASTELLAS      NDA No.:
213674  Prod. No.: 001 RX (40MG); 002 RX (80MG)
PatentsExpirationPatented Use
Pat. No. 7709517 DS* DP* Diarylhydantoin compounds
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Sep 3, 2020
Aug 13, 2027 
Pat. No. 8183274 [Extended 101 days (0.3 years)]
Treatment of hyperproliferative disorders with diarylhydantoin compounds
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 3, 2020
Aug 24, 2026U-2345: Treatment of patients with castration-resistant prostate cancer (CRPC)
U-2708: The treatment of patients with metastatic castration-sensitive prostate cancer
U-3763: Treatment of patients with non-metastatic castration-sensitive prostate cancer (NMCSPC) with biochemical recurrence (BCR) at high risk for metastasis
Pat. No. 9126941 Treatment of hyperproliferative disorders with diarylhydantoin compounds
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 3, 2020
May 15, 2026U-2345: Treatment of patients with castration-resistant prostate cancer (CRPC)
U-2708: The treatment of patients with metastatic castration-sensitive prostate cancer
U-3763: Treatment of patients with non-metastatic castration-sensitive prostate cancer (NMCSPC) with biochemical recurrence (BCR) at high risk for metastasis
Pat. No. 11839689 DP* Formulations of enzalutamide
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Dec 19, 2023
Sep 11, 2033 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationNov 17, 2026I-926: Treatment of patients with non-metastatic castration-sensitive prostate cancer (nmcspc) with biochemical recurrence at high risk for metastasis

ASTRAZENECA
AIRSUPRA (AEROSOL, METERED) (INHALATION) ALBUTEROL SULFATE; BUDESONIDE
Drug Classes: beta-2 adrenergic agonist == corticosteroid
NDA Applicant: ASTRAZENECA      NDA No.:
214070  Prod. No.: 001 RX (EQ 0.09MG BASE/INH;0.08MG/INH)
PatentsExpirationPatented Use
Pat. No. 9415009 Compositions, methods and systems for respiratory delivery of two or more active agents
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jan 24, 2023
May 28, 2030U-3509: As-needed treatment or prevention of bronchoconstriction and reduction of the risk of exacerbations in patients with asthma 18 years of age and older
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productJan 10, 2026 

ASTRAZENECA
BEVESPI AEROSPHERE (AEROSOL, METERED) (INHALATION) FORMOTEROL FUMARATE; GLYCOPYRROLATE
Drug Classes: beta-2 adrenergic agonist == anticholinergic == antimuscarinic agent
NDA Applicant: ASTRAZENECA      NDA No.:
208294  Prod. No.: 001 RX (0.0048MG/INH;0.0090MG/INH)
PatentsExpirationPatented Use
Pat. No. 8324266 Compositions, methods and systems for respiratory delivery of two or more active agents
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: May 20, 2016
May 28, 2030U-2889: Use for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
Pat. No. 8703806 Compositions, methods and propellant-based systems for respiratory delivery of glycopyrrolate and one or more active agents
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: May 20, 2016
May 28, 2030U-2889: Use for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
Pat. No. 8808713 DP* Compositions for pulmonary delivery of long-acting .beta..sub.2 adrenergic receptor agonists and associated methods and systems
Claim Types: Formulation; Method of use; Method of administration
Pat. Sub. Date(s): 001: May 20, 2016
May 28, 2030U-2889: Use for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
Pat. No. 8815258 Compositions, methods and systems for respiratory delivery of two or more active agents
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 20, 2016
Mar 17, 2031U-2889: Use for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
Pat. No. 9415009 Compositions, methods and systems for respiratory delivery of two or more active agents
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Sep 8, 2016
May 28, 2030U-2889: Use for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
Pat. No. 9463161 DP* Compositions for pulmonary delivery of long-acting muscarinic antagonists and associated methods and
Claim Types: Method of administration; Formulation
Pat. Sub. Date(s): 001: Oct 25, 2016
May 28, 2030U-2889: Use for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
Pat. No. 10716753 DP* Compositions for pulmonary delivery of long-acting muscarinic antagonists or long-acting B2 adrenergic receptor agonists and associated methods and systems
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 19, 2020
May 28, 2030U-2889: Use for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)

ASTRAZENECA
BRILINTA (TABLET) (ORAL) TICAGRELOR [GENERIC AB]
Drug Classes: P2Y12 platelet inhibitor
NDA Applicant: ASTRAZENECA      NDA No.:
022433  Prod. No.: 001 RX (90MG); 002 RX (60MG)
PatentsExpirationPatented Use
Pat. No. RE46276 DS* DP* [Extended 1794 days (4.9 years)]
Triazolo(4,5-D)pyrimidine compounds
Claim Types: Compound; Composition; Process; Method of use
Pat. Sub. Date(s): All strengths: Jan 17, 2017
Apr 30, 2025 *PEDU-1935: Reduction of the rate of cardiovascular death, myocardial infarction, and stroke in patients with a history of myocardial infarction
U-1936: Treatment of myocardial infarction and stroke in patients with acute coronary syndrome or a history of myocardial infarction
U-1937: Treatment of myocardial infarction in patients with acute coronary syndrome or a history of myocardial infarction
U-1938: Treatment of stroke in patients with acute coronary syndrome or a history of myocardial infarction
U-2838: Reduction of the rate of a first myocardial infarction or stroke in patients with coronary artery disease at high risk for such events
U-2839: Treatment of myocardial infarction or stroke in patients with coronary artery disease at high risk for such events
U-2988: Reduction of the risk of stroke in patients with acute ischemic stroke or high-risk transient ischemic attack
Pat. No. 8425934 DP* Pharmaceutical compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: May 20, 2013; 002: Sep 30, 2015
Oct 17, 2030 *PED 
Pat. No. 10300065 Method of treating or prevention of atherothrombotic events in patients with history of myocardial infarction
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 24, 2019
Jul 27, 2036 *PEDU-2541: Reducing the rate of cardiovascular death, myocardial infarction (MI), and stroke in a patient receiving 75-100 mg aspirin daily with a history of MI by administering 60 mg ticagrelor twice daily
U-2542: Reducing the rate of cardiovascular death, myocardial infarction, and stroke in a patient receiving 75-100 mg aspirin daily and having or who had acute coronary syndrome by administering 60 mg ticagrelor twice daily
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMay 5, 2024 PEDI-848: Reduce the risk of stroke in patients with acute ischemic stroke (NIH stroke scale score <=5) or high-risk transient ischemic attack (TIA)
Exclusivity Code: M - MiscellaneousNov 9, 2025 PEDM-283: Information added to section 8.4 of the labeling to include the result of study HESTIA3

ASTRAZENECA
CALQUENCE (CAPSULE) (ORAL) ACALABRUTINIB
Drug Classes: kinase inhibitor
NDA Applicant: ASTRAZENECA      NDA No.:
210259  Prod. No.: 001 RX (100MG)
PatentsExpirationPatented Use
Pat. No. 7459554 DS* Imidazopyrazine tyrosine kinase inhibitors
Claim Types: Compound
Pat. Sub. Date(s): 001: Apr 13, 2018
Nov 24, 2026 
Pat. No. 9290504 DS* DP* 4-imidazopyridazin-1-yl-benzamides and 4-imidazotriazin-1-yl-benzamides as BTK inhibitors
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Nov 28, 2017
Jul 11, 2032 
Pat. No. 9758524 4-imidazopyridazin-1-yl-benzamides as BTK inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 28, 2017
Jul 11, 2032U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy
Pat. No. 9796721 DS* DP* Crystal forms of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1- yl)-N-(pyridin-2-yl)benzamide
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 28, 2017
Jul 1, 2036U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy
U-2666: Treatment of adult patients with chronic lymphocytic leukemia
U-2667: Treatment of adult patients with small lymphocytic leukemia
U-2668: Treatment of adult patients with previously untreated chronic lymphocytic leukemia in combination with obinutuzumab
U-2669: Treatment of adult patients with previously untreated small lymphocytic leukemia in combination with obinutuzumab
U-2670: Treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic leukemia
U-2671: Treatment of adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic leukemia in combination with obinutuzumab
Pat. No. 10167291 DP* Pharmaceutical composition comprising a crystal form of (S)-4-(8-amino-3-(1-(but-2-ynoyl) pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide
Claim Types: Composition; Method of use
Pat. Sub. Date(s): 001: Jan 24, 2019
Jul 1, 2036U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy
U-2666: Treatment of adult patients with chronic lymphocytic leukemia
U-2667: Treatment of adult patients with small lymphocytic leukemia
U-2668: Treatment of adult patients with previously untreated chronic lymphocytic leukemia in combination with obinutuzumab
U-2669: Treatment of adult patients with previously untreated small lymphocytic leukemia in combination with obinutuzumab
U-2670: Treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic leukemia
U-2671: Treatment of adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic leukemia in combination with obinutuzumab
Pat. No. 10239883 4-imidazopyridazin-1-yl-benzamides as BTK inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 12, 2019
Jul 11, 2032U-2666: Treatment of adult patients with chronic lymphocytic leukemia
U-2668: Treatment of adult patients with previously untreated chronic lymphocytic leukemia in combination with obinutuzumab
Pat. No. 10272083 Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 22, 2019
Jan 21, 2035U-2519: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy by administering 100 mg of acalabrutinib twice daily
U-2682: Treatment of adult patients with chronic lymphocytic leukemia by administering 100mg of acalabrutinib twice daily
U-2683: Treatment of adult patients with small lymphocytic leukemia by administering 100mg of acalabrutinib twice daily
U-2684: Treatment of adult patients with previously untreated chronic lymphocytic leukemia by administering 100 mg of acalabrutinib twice daily in combination with obinutuzumab
U-2685: Treatment of adult patients with previously untreated small lymphocytic leukemia by administering 100 mg of acalabrutinib twice daily in combination with obinutuzumab
U-2686: Treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic leukemia by administering 100 mg of acalabrutinib twice daily
U-2687: Treatment of adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic leukemia in combination with obinutuzumab by administering 100 mg of acalabrutinib twice daily
Pat. No. 11771696 Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 30, 2023
Jan 21, 2035U-3710: Treatment of adult patients with previously untreated chronic lymphocytic leukemia by orally administering 100 mg of acalabrutinib twice daily in combination with intravenous administration of obinutuzumab
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityOct 31, 2024ODE-175: Treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy
Exclusivity Code: ODE - Orphan drug exclusivityNov 21, 2026ODE-274: Indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

ASTRAZENECA
CALQUENCE (TABLET) (ORAL) ACALABRUTINIB MALEATE
Drug Classes: kinase inhibitor
NDA Applicant: ASTRAZENECA      NDA No.:
216387  Prod. No.: 001 RX (EQ 100MG BASE)
PatentsExpirationPatented Use
Pat. No. 7459554 DS* Imidazopyrazine tyrosine kinase inhibitors
Claim Types: Compound
Pat. Sub. Date(s): 001: Sep 1, 2022
Nov 24, 2026 
Pat. No. 9290504 DS* DP* 4-imidazopyridazin-1-yl-benzamides and 4-imidazotriazin-1-yl-benzamides as BTK inhibitors
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Sep 1, 2022
Jul 11, 2032 
Pat. No. 9758524 4-imidazopyridazin-1-yl-benzamides as BTK inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 1, 2022
Jul 11, 2032U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy
Pat. No. 10239883 4-imidazopyridazin-1-yl-benzamides as BTK inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 1, 2022
Jul 11, 2032U-2666: Treatment of adult patients with chronic lymphocytic leukemia
U-2668: Treatment of adult patients with previously untreated chronic lymphocytic leukemia in combination with obinutuzumab
Pat. No. 10272083 Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 1, 2022
Jan 21, 2035U-2519: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy by administering 100 mg of acalabrutinib twice daily
U-2682: Treatment of adult patients with chronic lymphocytic leukemia by administering 100mg of acalabrutinib twice daily
U-2683: Treatment of adult patients with small lymphocytic leukemia by administering 100mg of acalabrutinib twice daily
U-2684: Treatment of adult patients with previously untreated chronic lymphocytic leukemia by administering 100 mg of acalabrutinib twice daily in combination with obinutuzumab
U-2685: Treatment of adult patients with previously untreated small lymphocytic leukemia by administering 100 mg of acalabrutinib twice daily in combination with obinutuzumab
U-2686: Treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic leukemia by administering 100 mg of acalabrutinib twice daily
U-2687: Treatment of adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic leukemia in combination with obinutuzumab by administering 100 mg of acalabrutinib twice daily
Pat. No. 11059829 DS* DP* Crystal forms of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-- yl)-N-(pyridin-2-yl)benzamide maleate
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Pat. Sub. Date(s): 001: Sep 1, 2022
Jul 1, 2036U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy
U-2666: Treatment of adult patients with chronic lymphocytic leukemia
U-2667: Treatment of adult patients with small lymphocytic leukemia
U-2668: Treatment of adult patients with previously untreated chronic lymphocytic leukemia in combination with obinutuzumab
U-2669: Treatment of adult patients with previously untreated small lymphocytic leukemia in combination with obinutuzumab
U-2670: Treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic leukemia
U-2671: Treatment of adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic leukemia in combination with obinutuzumab
Pat. No. 11771696 Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 30, 2023
Jan 21, 2035U-3710: Treatment of adult patients with previously untreated chronic lymphocytic leukemia by orally administering 100 mg of acalabrutinib twice daily in combination with intravenous administration of obinutuzumab

ASTRAZENECA
DALIRESP (TABLET) (ORAL) ROFLUMILAST [GENERIC AB]
Drug Classes: phosphodiesterase 4 inhibitor
NDA Applicant: ASTRAZENECA      NDA No.:
022522  Prod. No.: 001 RX (500MCG); 002 RX (250MCG)
PatentsExpirationPatented Use
Pat. No. 8536206 Process for the preparation of roflumilast
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 15, 2013; 002: Mar 14, 2018
Mar 8, 2024U-1115: Treatment to reduce the risk of copd exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations
Pat. No. 8604064 Process for the preparation of roflumilast
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 8, 2014; 002: Mar 14, 2018
Mar 8, 2024U-1115: Treatment to reduce the risk of copd exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations
Pat. No. 8618142 DP* Process for the preparation of roflumilast
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 30, 2014; 002: Mar 14, 2018
Mar 8, 2024 

ASTRAZENECA
EPANOVA (CAPSULE) (ORAL) OMEGA-3-CARBOXYLIC ACIDS
NDA Applicant: ASTRAZENECA      NDA No.:
205060  Prod. No.: 001 DISC (1GM CONTAINS AT LEAST 850MG OF POLYUNSATURATED FATTY ACIDS)
PatentsExpirationPatented Use
Pat. No. 7960370 DP* [Extended 681 days (1.9 years)]
Type A gelatin capsule containing PUFA in free acid form
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 3, 2014
Dec 20, 2026 
Pat. No. 8383678 DP* Type a gelatin capsule containing PUFA in free acid form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jun 3, 2014
Feb 7, 2025U-1511: Treatment of hypertriglyceridemia
Pat. No. 9012501 DP* Type A gelatin capsule containing PUFA in free acid form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: May 20, 2015
Feb 7, 2025U-1511: Treatment of hypertriglyceridemia
Pat. No. 9050308 DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form
Claim Types: Method of treatment
Pat. Sub. Date(s): 001: Jul 7, 2015
Jan 4, 2033U-1511: Treatment of hypertriglyceridemia
Pat. No. 9050309 DS* DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 7, 2015
Jan 4, 2033 
Pat. No. 9132112 DP* Type A gelatin capsule containing PUFA in free acid form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 30, 2015
Feb 7, 2025U-1511: Treatment of hypertriglyceridemia
Pat. No. 10117844 DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 4, 2018
Jan 4, 2033U-2447: Treatment of severe hypertriglyceridemia (500 mg/dl) in adult patients as an adjunct to diet

ASTRAZENECA
KOSELUGO (CAPSULE) (ORAL) SELUMETINIB SULFATE
Drug Classes: kinase inhibitor
NDA Applicant: ASTRAZENECA      NDA No.:
213756  Prod. No.: 001 RX (EQ 10MG BASE); 002 RX (EQ 25MG BASE)
PatentsExpirationPatented Use
Pat. No. 7425637 DS* N3 alkylated benzimidazole derivatives as MEK inhibitors
Claim Types: Compound
Pat. Sub. Date(s): All strengths: May 6, 2020
Mar 13, 2025 
Pat. No. 8178693 DS* DP* N3 alkylated benzimidazole derivatives as MEK inhibitors
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: May 6, 2020
Mar 13, 2025 
Pat. No. 9156795 DS* DP* Hydrogen sulfate salt
Claim Types: New polymorph, salt or hydrate; Composition
Pat. Sub. Date(s): All strengths: May 6, 2020
Dec 12, 2026 
Pat. No. 9562017 DS* Hydrogen sulfate salt
Claim Types: Method of use; Product-by-process of a new polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: May 6, 2020
Dec 12, 2026U-2800: Treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN)
Pat. No. 11813246 DP* Pharmaceutical composition
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Dec 7, 2023
Mar 26, 2029 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityApr 10, 2025 
Exclusivity Code: ODE - Orphan drug exclusivityApr 10, 2027ODE-288: Indicated for the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN)

ASTRAZENECA
LOKELMA (FOR SUSPENSION) (ORAL) SODIUM ZIRCONIUM CYCLOSILICATE
NDA Applicant: ASTRAZENECA      NDA No.:
207078  Prod. No.: 001 RX (5GM/PACKET)
PatentsExpirationPatented Use
Pat. No. 8802152 DS* Microporous zirconium silicate for the treatment of hyperkalemia
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 12, 2018
Apr 19, 2032 
Pat. No. 8808750 Microporous zirconium silicate for the treatment of hyperkalemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 12, 2018
Feb 10, 2032U-2312: Treatment of hyperkalemia in adults
Pat. No. 8877255 DS* Microporous zirconium silicate for the treatment of hyperkalemia
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 12, 2018
Oct 22, 2033 
Pat. No. 9592253 DS* Extended use zirconium silicate compositions and methods of use thereof
Claim Types: Product-by-process; Method of use
Pat. Sub. Date(s): 001: Jun 12, 2018
Oct 14, 2035U-2312: Treatment of hyperkalemia in adults
Pat. No. 9844567 Microporous zirconium silicate for the treatment of hyperkalemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 12, 2018
Feb 10, 2032U-2312: Treatment of hyperkalemia in adults
Pat. No. 9861658 Microporous zirconium silicate for the treatment of hyperkalemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 12, 2018
Feb 10, 2032U-2312: Treatment of hyperkalemia in adults
Pat. No. 9913860 DS* Microporous zirconium silicate for the treatment of hyperkalemia
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jan 23, 2019
Oct 22, 2033U-2312: Treatment of hyperkalemia in adults
Pat. No. 10300087 DS* Extended use zirconium silicate compositions and methods of use thereof
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jul 25, 2019
Oct 14, 2035U-2312: Treatment of hyperkalemia in adults
Pat. No. 10335432 Microporous zirconium silicate for the treatment of hyperkalemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2019
Feb 10, 2032U-2312: Treatment of hyperkalemia in adults
Pat. No. 10398730 Microporous zirconium silicate for the treatment of hyperkalemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 1, 2019
Feb 10, 2032U-2312: Treatment of hyperkalemia in adults
Pat. No. 10413569 DS* Microporous zirconium silicate for the treatment of hyperkalemia
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 1, 2019
Feb 10, 2032 
Pat. No. 10695365 DS* Microporous zirconium silicate for the treatment of hyperkalemia
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 28, 2020
Oct 22, 2033 
Pat. No. 11406662 DS* Microporous zirconium silicate for the treatment of hyperkalemia
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Sep 7, 2022
Feb 10, 2032 
Pat. No. 11738044 Extended use zirconium silicate compositions and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 21, 2023
Oct 14, 2035U-2312: Treatment of hyperkalemia in adults

ASTRAZENECA
LOKELMA (FOR SUSPENSION) (ORAL) SODIUM ZIRCONIUM CYCLOSILICATE
NDA Applicant: ASTRAZENECA      NDA No.:
207078  Prod. No.: 002 RX (10GM/PACKET)
PatentsExpirationPatented Use
Pat. No. 8802152 DS* Microporous zirconium silicate for the treatment of hyperkalemia
Claim Types: Formulation
Pat. Sub. Date(s): 002: Jun 12, 2018
Apr 19, 2032 
Pat. No. 8808750 Microporous zirconium silicate for the treatment of hyperkalemia
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 12, 2018
Feb 10, 2032U-2312: Treatment of hyperkalemia in adults
Pat. No. 8877255 DS* Microporous zirconium silicate for the treatment of hyperkalemia
Claim Types: Formulation
Pat. Sub. Date(s): 002: Jun 12, 2018
Oct 22, 2033 
Pat. No. 9592253 DS* Extended use zirconium silicate compositions and methods of use thereof
Claim Types: Product-by-process; Method of use
Pat. Sub. Date(s): 002: Jun 12, 2018
Oct 14, 2035U-2312: Treatment of hyperkalemia in adults
Pat. No. 9844567 Microporous zirconium silicate for the treatment of hyperkalemia
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 12, 2018
Feb 10, 2032U-2312: Treatment of hyperkalemia in adults
Pat. No. 9861658 Microporous zirconium silicate for the treatment of hyperkalemia
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 12, 2018
Feb 10, 2032U-2312: Treatment of hyperkalemia in adults
Pat. No. 9913860 DS* Microporous zirconium silicate for the treatment of hyperkalemia
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Jan 23, 2019
Oct 22, 2033U-2312: Treatment of hyperkalemia in adults
Pat. No. 10300087 DS* Extended use zirconium silicate compositions and methods of use thereof
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Jul 25, 2019
Oct 14, 2035U-2312: Treatment of hyperkalemia in adults
Pat. No. 10398730 Microporous zirconium silicate for the treatment of hyperkalemia
Claim Types: Method of use
Pat. Sub. Date(s): 002: Oct 1, 2019
Feb 10, 2032U-2312: Treatment of hyperkalemia in adults
Pat. No. 10413569 DS* Microporous zirconium silicate for the treatment of hyperkalemia
Claim Types: Formulation
Pat. Sub. Date(s): 002: Oct 1, 2019
Feb 10, 2032 
Pat. No. 10695365 DS* Microporous zirconium silicate for the treatment of hyperkalemia
Claim Types: Formulation
Pat. Sub. Date(s): 002: Jul 28, 2020
Oct 22, 2033 
Pat. No. 11406662 DS* Microporous zirconium silicate for the treatment of hyperkalemia
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 002: Sep 7, 2022
Feb 10, 2032 
Pat. No. 11738044 Extended use zirconium silicate compositions and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 002: Sep 21, 2023
Oct 14, 2035U-2312: Treatment of hyperkalemia in adults

ASTRAZENECA
LYNPARZA (CAPSULE) (ORAL) OLAPARIB
Drug Classes: poly (ADP-ribose) polymerase (PARP) inhibitor
NDA Applicant: ASTRAZENECA      NDA No.:
206162  Prod. No.: 001 DISC (50MG)
PatentsExpirationPatented Use
Pat. No. 7449464 DS* DP* [Extended 1275 days (3.5 years)]
Phthalazinone derivatives
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jan 15, 2015
Oct 11, 2024 
Pat. No. 7981889 DS* DP* Phthalazinone derivatives
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jan 15, 2015
Oct 11, 2024 
Pat. No. 8143241 DNA damage repair inhibitors for treatment of cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 15, 2015
Aug 12, 2027U-1634: Treatment of BRCA mutated ovarian cancer using PARP inhibitor
Pat. No. 8247416 DS* Phthalazinone derivative
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: Jan 15, 2015
Sep 24, 2028 
Pat. No. 8859562 Use of RNAI inhibiting PARP activity for the manufacture of a medicament for the treatment of cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 15, 2015
Aug 4, 2031U-1634: Treatment of BRCA mutated ovarian cancer using PARP inhibitor
Pat. No. 8912187 Phthalazinone derivatives
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 15, 2015
Mar 12, 2024U-1634: Treatment of BRCA mutated ovarian cancer using PARP inhibitor

ASTRAZENECA
LYNPARZA (TABLET) (ORAL) OLAPARIB
Drug Classes: poly (ADP-ribose) polymerase (PARP) inhibitor
NDA Applicant: ASTRAZENECA      NDA No.:
208558  Prod. No.: 001 RX (100MG); 002 RX (150MG)
PatentsExpirationPatented Use
Pat. No. 7449464 DS* DP* [Extended 1275 days (3.5 years)]
Phthalazinone derivatives
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Sep 15, 2017
Sep 8, 2027 
Pat. No. 7981889 DS* DP* Phthalazinone derivatives
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Sep 15, 2017
Oct 11, 2024 
Pat. No. 8071579 DNA damage repair inhibitors for the treatment of cancer
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 18, 2020
Aug 12, 2027U-2480: Maintenance treatment of GBRCA- or SBRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy
U-2482: Treatment of HR-negative, HER-2 negative, GBRCA-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting
U-2483: Treatment of HR-positive, HER-2 negative, gbrca-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting, and with endocrine therapy or are inappropriate for endocrine therapy
U-2716: Maintenance treatment of deleterious or suspected deleterious gbrca-mutated metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen
U-2819: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation
U-2820: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability
U-2821: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation
U-2822: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability
U-2823: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation
U-2824: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability
U-2832: Treatment of deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone
U-2833: Treatment of deleterious or suspected deleterious germline or somatic BRCA-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone
U-3333: Adjuvant treatment of patients with GBRCA-mutated human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy
U-3631: Treatment of deleterious or suspected deleterious brca-mutated metastatic castration-resistant prostate cancer in combination with abiraterone and prednisone or prednisolone
U-3695: Maintenance treatment of deleterious or suspected deleterious germline or somatic BRCA-muted recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
Pat. No. 8143241 DNA damage repair inhibitors for treatment of cancer
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 15, 2017
Aug 12, 2027U-2480: Maintenance treatment of GBRCA- or SBRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy
U-2482: Treatment of HR-negative, HER-2 negative, GBRCA-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting
U-2483: Treatment of HR-positive, HER-2 negative, gbrca-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting, and with endocrine therapy or are inappropriate for endocrine therapy
U-2716: Maintenance treatment of deleterious or suspected deleterious gbrca-mutated metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen
U-2819: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation
U-2820: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability
U-2821: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation
U-2822: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability
U-2823: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation
U-2824: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability
U-2832: Treatment of deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone
U-2833: Treatment of deleterious or suspected deleterious germline or somatic BRCA-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone
U-3333: Adjuvant treatment of patients with GBRCA-mutated human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy
U-3631: Treatment of deleterious or suspected deleterious brca-mutated metastatic castration-resistant prostate cancer in combination with abiraterone and prednisone or prednisolone
U-3695: Maintenance treatment of deleterious or suspected deleterious germline or somatic BRCA-muted recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
Pat. No. 8475842 DP* Immediate release pharmaceutical formulation of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-p- hthalazin-1-one
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 15, 2017
Dec 31, 2029 
Pat. No. 8859562 Use of RNAI inhibiting PARP activity for the manufacture of a medicament for the treatment of cancer
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 15, 2017
Aug 4, 2031U-2101: Maintenance treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
U-2103: Maintenance treatment of BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
U-2480: Maintenance treatment of GBRCA- or SBRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy
U-2482: Treatment of HR-negative, HER-2 negative, GBRCA-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting
U-2483: Treatment of HR-positive, HER-2 negative, gbrca-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting, and with endocrine therapy or are inappropriate for endocrine therapy
U-2716: Maintenance treatment of deleterious or suspected deleterious gbrca-mutated metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen
U-2819: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation
U-2820: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability
U-2821: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation
U-2822: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability
U-2823: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation
U-2824: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability
U-2832: Treatment of deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone
U-2833: Treatment of deleterious or suspected deleterious germline or somatic BRCA-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone
U-3333: Adjuvant treatment of patients with GBRCA-mutated human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy
U-3631: Treatment of deleterious or suspected deleterious brca-mutated metastatic castration-resistant prostate cancer in combination with abiraterone and prednisone or prednisolone
U-3695: Maintenance treatment of deleterious or suspected deleterious germline or somatic BRCA-muted recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
Pat. No. 8912187 Phthalazinone derivatives
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 15, 2017
Mar 12, 2024U-2480: Maintenance treatment of GBRCA- or SBRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy
U-2482: Treatment of HR-negative, HER-2 negative, GBRCA-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting
U-2483: Treatment of HR-positive, HER-2 negative, gbrca-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting, and with endocrine therapy or are inappropriate for endocrine therapy
U-2819: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation
U-2820: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability
U-2821: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation
U-2822: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability
U-2823: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation
U-2824: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability
U-3333: Adjuvant treatment of patients with GBRCA-mutated human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy
U-3695: Maintenance treatment of deleterious or suspected deleterious germline or somatic BRCA-muted recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
Pat. No. 9169235 Phthalazinone derivatives
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 18, 2020
Mar 12, 2024U-2832: Treatment of deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone
U-2833: Treatment of deleterious or suspected deleterious germline or somatic BRCA-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone
U-3631: Treatment of deleterious or suspected deleterious brca-mutated metastatic castration-resistant prostate cancer in combination with abiraterone and prednisone or prednisolone
Pat. No. 9566276 Phthalazinone derivatives
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 22, 2020
Mar 12, 2024U-2716: Maintenance treatment of deleterious or suspected deleterious gbrca-mutated metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen
Pat. No. 11633396 DP* Immediate release pharmaceutical formulation of 4-[3-(4- cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H- phthalazin-1-one
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 19, 2023
Oct 7, 2029 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMar 11, 2025I-885: For the adjuvant treatment of adult patients with deleterious or suspected deleterious GBRCA mutated HER2-negative high-risk early breast cancer who have previously been treated with neoadjuvant or adjuvant chemotherapy
Exclusivity Code: I - New IndicationMay 31, 2026I-914: In combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAM) metastatic castration-resistant prostate cancer (MCRPC)
Exclusivity Code: ODE - Orphan drug exclusivityAug 17, 2024ODE-180: Maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
Exclusivity Code: ODE - Orphan drug exclusivityAug 17, 2024ODE-181: Treatment of adult patients with deleterious or suspected deleterious germline brca-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy
Exclusivity Code: ODE - Orphan drug exclusivityDec 19, 2025ODE-226: Maintenance treatment of adults with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer in complete or partial response to first-line platinum-based chemotherapy
Exclusivity Code: ODE - Orphan drug exclusivityDec 27, 2026ODE-283: Maintenance tx of adults w/ deleterious or suspected deleterious gbrcam metastatic pancreatic adenocarcinoma whose dz has not progressed on >=16wks of 1st line platinum based chemo regimen. select pts for therapy based on approved companion diagnostic
Exclusivity Code: ODE - Orphan drug exclusivityMay 8, 2027ODE-306: W/ bevacizumab for maint tx of adults w/ adv epithelial ovarian, fallopian tube, or primary peritoneal CA in complete or partial response to 1st line pt based chemo & whose CA is assoc w/ homologous recomb def + status defined by genomic instability

ASTRAZENECA
SYMBICORT (AEROSOL, METERED) (INHALATION) BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE [GENERIC AB]
Drug Classes: corticosteroid == beta-2 adrenergic agonist
NDA Applicant: ASTRAZENECA      NDA No.:
021929  Prod. No.: 001 RX (0.08MG/INH;0.0045MG/INH); 002 RX (0.16MG/INH;0.0045MG/INH)
PatentsExpirationPatented Use
Pat. No. 7587988 DP* Inhaler device counter
Claim Types: Device
Pat. Sub. Date(s): All strengths: None
Oct 10, 2026 *PED 
Pat. No. 8387615 DP* Inhaler cap strap
Claim Types: Device
Pat. Sub. Date(s): 001: Apr 4, 2013; 002: None
Sep 26, 2027 *PED 
Pat. No. 8528545 DP* Inhaler device that reduces the risk for miscounting a dosage
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 9, 2013
Apr 16, 2029 *PED 
Pat. No. 8616196 DP* Inhalation device and a method for assembling said inhalation device
Claim Types: Device; Process
Pat. Sub. Date(s): All strengths: Jan 29, 2014
Oct 7, 2029 *PED 
Pat. No. 8875699 DP* Inhaler cap strap
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2014
May 10, 2025 *PED 

ASTRAZENECA
SYMBICORT AEROSPHERE (AEROSOL, METERED) (INHALATION) BUDESONIDE; FORMOTEROL FUMARATE
Drug Classes: corticosteroid == beta-2 adrenergic agonist
NDA Applicant: ASTRAZENECA      NDA No.:
216579  Prod. No.: 001 RX (0.16MG/INH;0.0048MG/INH)
PatentsExpirationPatented Use
Pat. No. 9415009 Compositions, methods and systems for respiratory delivery of two or more active agents
Claim Types: Method of administration
Pat. Sub. Date(s): 001: May 12, 2023
May 28, 2030U-3203: Maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
Pat. No. 10716753 DP* Compositions for pulmonary delivery of long-acting muscarinic antagonists or long-acting B2 adrenergic receptor agonists and associated methods and systems
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: May 12, 2023
May 28, 2030U-3203: Maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)

ASTRAZENECA
TAGRISSO (TABLET) (ORAL) OSIMERTINIB MESYLATE
Drug Classes: kinase inhibitor
NDA Applicant: ASTRAZENECA      NDA No.:
208065  Prod. No.: 001 RX (EQ 40MG BASE); 002 RX (EQ 80MG BASE)
PatentsExpirationPatented Use
Pat. No. 8946235 DS* DP* 2-(2,4,5-substituted-anilino) pyrimidine compounds
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Dec 11, 2015
Aug 8, 2032U-1777: Treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), who have progressed on or after EGFR TKI therapy
U-2289: Treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21L858R mutations
U-3016: Adjuvant therapy after tumor resection in patients with non-small cell lung cancer(NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19deletions or exon 21 L858R mutations
Pat. No. 9732058 DS* DP* 2-(2,4,5-substituted-anilino)pyrimidine compounds
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Aug 29, 2017
Jul 25, 2032U-1777: Treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), who have progressed on or after EGFR TKI therapy
U-2289: Treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21L858R mutations
U-3016: Adjuvant therapy after tumor resection in patients with non-small cell lung cancer(NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19deletions or exon 21 L858R mutations
Pat. No. 10183020 DP* Pharmaceutical compositions comprising AZD9291
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Feb 12, 2019
Jan 2, 2035U-1777: Treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), who have progressed on or after EGFR TKI therapy
U-2289: Treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21L858R mutations
U-3016: Adjuvant therapy after tumor resection in patients with non-small cell lung cancer(NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19deletions or exon 21 L858R mutations
Pat. No. 11524951 DS* DP* 2-(2,4,5-substituted-anilino)pyrimidine compounds
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Jan 11, 2023
Jul 25, 2032 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationDec 18, 2023I-853: Indication of osimertinib as adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
Exclusivity Code: ODE - Orphan drug exclusivityApr 18, 2025ODE-176: Indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
Exclusivity Code: ODE - Orphan drug exclusivityDec 18, 2027ODE-337: For adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test

ASTRAZENECA
TRUQAP (TABLET) (ORAL) CAPIVASERTIB
NDA Applicant: ASTRAZENECA      NDA No.:
218197  Prod. No.: 001 RX (160MG); 002 RX (200MG)
PatentsExpirationPatented Use
Pat. No. 8101623 DS* DP* Substituted pyrrolo[2,3-d]pyrimidine as a protein kinase B inhibitor
Claim Types: Compound; Composition; Method of use; Process
Pat. Sub. Date(s): All strengths: Dec 13, 2023
Mar 10, 2030U-3762: Treatment with fulvestrant of hr-pos. her2-neg. locally advanced or metastatic breast cancer with PIK3CA/AKT1/PTEN-alteration(s) following progression on endocrine therapy in the metastatic setting or recurrence on or within 12 months of adjuvant therapy
Pat. No. 8809336 Ortho-condensed pyridine and pyrimidine derivatives (e.g., purines) as protein kinases inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 13, 2023
Oct 25, 2025U-3762: Treatment with fulvestrant of hr-pos. her2-neg. locally advanced or metastatic breast cancer with PIK3CA/AKT1/PTEN-alteration(s) following progression on endocrine therapy in the metastatic setting or recurrence on or within 12 months of adjuvant therapy
Pat. No. 9006430 DP* Ortho-condensed pyridine and pyrimidine derivatives (e.g., purines) as protein
Claim Types: Composition
Pat. Sub. Date(s): All strengths: Dec 13, 2023
Oct 25, 2025 
Pat. No. 9487525 DS* DP* Crystalline forms of (s)-4-amino-n-(1-(4-chlorophenyl)-3-hydroxypropyl)-1-(7h-pyrrolo[2,3-d]pyrimidin-4-yl) piperidine-4-carboxamide
Claim Types: New polymorph, salt or hydrate; Composition; Formulation
Pat. Sub. Date(s): All strengths: Dec 13, 2023
Apr 16, 2033 
Pat. No. 10039766 Crystalline forms of (s)-4-amino-n-(1-(4-chlorophenyl)-3-hydroxypropyl)-1-(7h-pyrrolo[2,3-d] pyrimidin-4-y1) piperidine-4-carboxamide
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 13, 2023
Apr 16, 2033U-3762: Treatment with fulvestrant of hr-pos. her2-neg. locally advanced or metastatic breast cancer with PIK3CA/AKT1/PTEN-alteration(s) following progression on endocrine therapy in the metastatic setting or recurrence on or within 12 months of adjuvant therapy
Pat. No. 10059714 DS* DP* Protein kinase B inhibitors
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Dec 13, 2023
Oct 10, 2028 
Pat. No. 10654855 Protein kinase B inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 13, 2023
Oct 10, 2028U-3762: Treatment with fulvestrant of hr-pos. her2-neg. locally advanced or metastatic breast cancer with PIK3CA/AKT1/PTEN-alteration(s) following progression on endocrine therapy in the metastatic setting or recurrence on or within 12 months of adjuvant therapy
Pat. No. 11760760 Protein kinase B inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 13, 2023
Oct 10, 2028U-3762: Treatment with fulvestrant of hr-pos. her2-neg. locally advanced or metastatic breast cancer with PIK3CA/AKT1/PTEN-alteration(s) following progression on endocrine therapy in the metastatic setting or recurrence on or within 12 months of adjuvant therapy
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityNov 16, 2028 

ASTRAZENECA AB
BREZTRI AEROSPHERE (AEROSOL, METERED) (INHALATION) BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE
Drug Classes: corticosteroid == beta-2 adrenergic agonist == anticholinergic == antimuscarinic agent
NDA Applicant: ASTRAZENECA AB      NDA No.:
212122  Prod. No.: 001 RX (0.16MG/INH;0.0048MG/INH;0.009MG/INH)
PatentsExpirationPatented Use
Pat. No. 8324266 Compositions, methods and systems for respiratory delivery of two or more active agents
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Aug 18, 2020
May 28, 2030U-2889: Use for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
Pat. No. 8703806 Compositions, methods and propellant-based systems for respiratory delivery of glycopyrrolate and one or more active agents
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Aug 18, 2020
May 28, 2030U-2889: Use for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
Pat. No. 8808713 DP* Compositions for pulmonary delivery of long-acting .beta..sub.2 adrenergic receptor agonists and associated methods and systems
Claim Types: Formulation; Method of use; Method of administration
Pat. Sub. Date(s): 001: Aug 18, 2020
May 28, 2030U-2889: Use for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
Pat. No. 8815258 Compositions, methods and systems for respiratory delivery of two or more active agents
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 18, 2020
Mar 17, 2031U-2889: Use for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
Pat. No. 9415009 Compositions, methods and systems for respiratory delivery of two or more active agents
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Aug 18, 2020
May 28, 2030U-2889: Use for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
Pat. No. 9463161 DP* Compositions for pulmonary delivery of long-acting muscarinic antagonists and associated methods and
Claim Types: Method of administration; Formulation
Pat. Sub. Date(s): 001: Aug 18, 2020
May 28, 2030U-2889: Use for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
Pat. No. 10716753 DP* Compositions for pulmonary delivery of long-acting muscarinic antagonists or long-acting B2 adrenergic receptor agonists and associated methods and systems
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 18, 2020
May 28, 2030U-2889: Use for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
Pat. No. 11331442 DP* Drug delivery systems and related methods
Claim Types: Device
Pat. Sub. Date(s): 001: Jun 16, 2022
Oct 5, 2038 
Pat. No. 11833292 DP* Drug delivery systems and related methods
Claim Types: Device
Pat. Sub. Date(s): 001: Dec 21, 2023
Oct 5, 2038 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NC - New combinationJul 23, 2023 

ASTRAZENECA AB
BYDUREON (FOR SUSPENSION, EXTENDED RELEASE) (SUBCUTANEOUS) EXENATIDE SYNTHETIC
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: ASTRAZENECA AB      NDA No.:
022200  Prod. No.: 001 DISC (2MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 6515117 DS* DP* [Extended 5 years]
C-aryl glucoside SGLT2 inhibitors and method
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 17, 2017
Apr 4, 2026 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
Pat. No. 7456254 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Dec 30, 2025 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 7563871 DP* Polymer-based sustained release device
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Oct 15, 2024 *PED 
Pat. No. 7612176 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Oct 13, 2025 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 8329648 Methods for treating diabetes and reducing body weight
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 10, 2013
Feb 18, 2027 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2594: Reducing fasting plasma glucose in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2595: Reducing body weight in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2596: Reducing HBA1C in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 17, 2017
Sep 21, 2028 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
Pat. No. 8431685 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: May 29, 2013
Oct 13, 2025 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 8461105 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jul 10, 2013
Oct 13, 2025 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 17, 2017
Dec 20, 2027 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
Pat. No. 8906851 Method for treating diabetes
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2015
Feb 18, 2027 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 9238076 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Feb 17, 2016
Oct 15, 2024 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-2599: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation as an adjunct to diet and exercise to provide a release profile having a ratio of C-max to C-avg of about 3 or less
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 9884092 Methods for treating diabetes and reducing body weight
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 6, 2018
Feb 18, 2027 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2594: Reducing fasting plasma glucose in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2595: Reducing body weight in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2596: Reducing HBA1C in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationJan 22, 2025 PED 

ASTRAZENECA AB
BYDUREON BCISE (SUSPENSION, EXTENDED RELEASE) (SUBCUTANEOUS) EXENATIDE SYNTHETIC
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: ASTRAZENECA AB      NDA No.:
209210  Prod. No.: 001 RX (2MG/0.85ML (2MG/0.85ML))
PatentsExpirationPatented Use
Pat. No. 6515117 DS* DP* [Extended 5 years]
C-aryl glucoside SGLT2 inhibitors and method
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 21, 2019
Apr 4, 2026 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
Pat. No. 7456254 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 3, 2017
Dec 30, 2025 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 7563871 DP* Polymer-based sustained release device
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 3, 2017
Oct 15, 2024 *PED 
Pat. No. 7612176 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 3, 2017
Oct 13, 2025 *PEDU-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 8329648 Methods for treating diabetes and reducing body weight
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 3, 2017
Feb 18, 2027 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2594: Reducing fasting plasma glucose in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2595: Reducing body weight in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2596: Reducing HBA1C in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 21, 2019
Sep 21, 2028 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
Pat. No. 8431685 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 3, 2017
Oct 13, 2025 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 8461105 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 3, 2017
Oct 13, 2025 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 8501698 Crystal structures of SGLT2 inhibitors and processes for preparing same
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 21, 2019
Dec 20, 2027 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
Pat. No. 8895033 DP* Sustained release formulations using non-aqueous carriers
Claim Types: Formulation; Method of use; Kit
Pat. Sub. Date(s): 001: Nov 3, 2017
Apr 4, 2031 *PEDU-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin
U-2601: Stimulating insulin release in adults with Type 2 diabetes mellitus by administering a pre-mixed exenatide formulation as an adjunct to diet and exercise
U-2602: Delaying gastric emptying in adults with Type 2 diabetes mellitus by administering a pre-mixed exenatide formulation as an adjunct to diet and exercise
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 8906851 Method for treating diabetes
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 3, 2017
Feb 18, 2027 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 9238076 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 3, 2017
Oct 15, 2024 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin
U-2599: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation as an adjunct to diet and exercise to provide a release profile having a ratio of C-max to C-avg of about 3 or less
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 9884092 Methods for treating diabetes and reducing body weight
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 6, 2018
Feb 18, 2027 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2594: Reducing fasting plasma glucose in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2595: Reducing body weight in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2596: Reducing HBA1C in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationJan 22, 2025 PED 

ASTRAZENECA AB
BYDUREON PEN (FOR SUSPENSION, EXTENDED RELEASE) (SUBCUTANEOUS) EXENATIDE SYNTHETIC
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: ASTRAZENECA AB      NDA No.:
022200  Prod. No.: 002 DISC (2MG)
PatentsExpirationPatented Use
Pat. No. 6515117 DS* DP* [Extended 5 years]
C-aryl glucoside SGLT2 inhibitors and method
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 002: Nov 15, 2017
Apr 4, 2026 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
Pat. No. 7456254 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Mar 28, 2014
Dec 30, 2025 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 7563871 DP* Polymer-based sustained release device
Claim Types: Formulation
Pat. Sub. Date(s): 002: Mar 28, 2014
Oct 15, 2024 *PED 
Pat. No. 7612176 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Mar 28, 2014
Oct 13, 2025 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 8216180 DP* Administering apparatus with functional drive element
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 28, 2014
Jul 12, 2028 *PED 
Pat. No. 8329648 Methods for treating diabetes and reducing body weight
Claim Types: Method of use
Pat. Sub. Date(s): 002: Mar 28, 2014
Feb 18, 2027 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2594: Reducing fasting plasma glucose in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2595: Reducing body weight in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2596: Reducing HBA1C in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): 002: Nov 15, 2017
Sep 21, 2028 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
Pat. No. 8431685 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Mar 28, 2014
Oct 13, 2025 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 8439864 DP* Device for administering fluid from a multi-chamber ampoule in incremental steps
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 28, 2014
Sep 25, 2028 *PED 
Pat. No. 8461105 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Mar 28, 2014
Oct 13, 2025 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Pat. Sub. Date(s): 002: Nov 15, 2017
Dec 20, 2027 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
Pat. No. 8690837 DP* Mixing device for a two-chamber ampoule
Claim Types: Device
Pat. Sub. Date(s): 002: Nov 15, 2017
Nov 19, 2029 *PED 
Pat. No. 8721615 DP* Ampoule comprising an ampoule holder
Claim Types: Device
Pat. Sub. Date(s): 002: Nov 15, 2017
Jul 18, 2030 *PED 
Pat. No. 8758292 DP* Administering apparatus with functional drive element
Claim Types: Device
Pat. Sub. Date(s): 002: Nov 15, 2017
May 12, 2028 *PED 
Pat. No. 8827963 DP* Administering device with holding mechanism
Claim Types: Device
Pat. Sub. Date(s): 002: Nov 15, 2017
Aug 4, 2029 *PED 
Pat. No. 8906851 Method for treating diabetes
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 6, 2015
Feb 18, 2027 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 8998876 DP* Ampoule comprising an ampoule holder
Claim Types: Device
Pat. Sub. Date(s): 002: Nov 15, 2017
Jul 7, 2030 *PED 
Pat. No. 9238076 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Feb 17, 2016
Oct 15, 2024 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-2599: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation as an adjunct to diet and exercise to provide a release profile having a ratio of C-max to C-avg of about 3 or less
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 9320853 DP* Method for administering a fluid active substance from a multi-chamber ampoule
Claim Types: Device; Process
Pat. Sub. Date(s): 002: Nov 15, 2017
Sep 25, 2028 *PED 
Pat. No. 9884092 Methods for treating diabetes and reducing body weight
Claim Types: Method of use
Pat. Sub. Date(s): 002: Mar 6, 2018
Feb 18, 2027 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2594: Reducing fasting plasma glucose in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2595: Reducing body weight in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2596: Reducing HBA1C in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationJan 22, 2025 PED 

ASTRAZENECA AB
BYETTA (INJECTABLE) (SUBCUTANEOUS) EXENATIDE SYNTHETIC
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: ASTRAZENECA AB      NDA No.:
021773  Prod. No.: 001 RX (300MCG/1.2ML (250MCG/ML)); 002 RX (600MCG/2.4ML (250MCG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousNov 4, 2024M-232: Information added to section 8.4 of the labeling to describe the results from pediatric studies

ASTRAZENECA AB
FARXIGA (TABLET) (ORAL) DAPAGLIFLOZIN
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor
NDA Applicant: ASTRAZENECA AB      NDA No.:
202293  Prod. No.: 001 RX (5MG)
PatentsExpirationPatented Use
Pat. No. 6515117 DS* DP* [Extended 5 years]
C-aryl glucoside SGLT2 inhibitors and method
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Feb 5, 2014
Oct 4, 2025U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 7456254 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 15, 2017
Jun 30, 2025U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Pat. No. 7851502 DP* Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 5, 2014
Aug 19, 2028 
Pat. No. 7919598 DS* Crystal structures of SGLT2 inhibitors and processes for preparing same
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: Feb 5, 2014
Dec 16, 2029 
Pat. No. 8221786 DP* Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 5, 2014
Mar 21, 2028 
Pat. No. 8329648 Methods for treating diabetes and reducing body weight
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 15, 2017
Aug 18, 2026U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
U-2212: Reducing fasting plasma glucose in a human in need thereof in combination with a sustained-release composition containing exendin-4
U-2213: Reducing HBA1C in a human in need thereof in combination with a sustained-release composition containing exendin-4
Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 5, 2014
Mar 21, 2028U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 8431685 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 15, 2017
Apr 13, 2025U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Pat. No. 8461105 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 15, 2017
Apr 13, 2025U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Feb 5, 2014
Jun 20, 2027U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 8685934 Methods for treating extreme insulin resistance in patients resistant to previous treatment with other anti-diabetic drugs employing an SGLT2 inhibitor and compositions thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 25, 2014
May 26, 2030U-1522: Treatment of Type 2 diabetes mellitus in a patient, wherein glycemic control (HBA1C < 7.0%) is not achievable using one or more of insulin, metformin, pioglitazone, or rosiglitazone
Pat. No. 8716251 DP* Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 2, 2014
Mar 21, 2028 
Pat. No. 8721615 DP* DLR* Ampoule comprising an ampoule holder
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 15, 2017
Jan 18, 2030 
Pat. No. 8906851 Method for treating diabetes
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 15, 2017
Aug 18, 2026U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Pat. No. 9238076 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 15, 2017
Apr 15, 2024U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationApr 30, 2024I-857: To reduce the risk of sustained EGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression
Exclusivity Code: M - MiscellaneousMay 8, 2026M-298: Labeling revisions related to study D1699CC00001

ASTRAZENECA AB
FARXIGA (TABLET) (ORAL) DAPAGLIFLOZIN
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor
NDA Applicant: ASTRAZENECA AB      NDA No.:
202293  Prod. No.: 002 RX (10MG)
PatentsExpirationPatented Use
Pat. No. 6515117 DS* DP* [Extended 5 years]
C-aryl glucoside SGLT2 inhibitors and method
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 002: Feb 5, 2014
Oct 4, 2025U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 7456254 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Nov 15, 2017
Jun 30, 2025U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Pat. No. 7851502 DP* Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Formulation
Pat. Sub. Date(s): 002: Feb 5, 2014
Aug 19, 2028 
Pat. No. 7919598 DS* Crystal structures of SGLT2 inhibitors and processes for preparing same
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 002: Feb 5, 2014
Dec 16, 2029 
Pat. No. 8221786 DP* Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Formulation
Pat. Sub. Date(s): 002: Feb 5, 2014
Mar 21, 2028 
Pat. No. 8329648 Methods for treating diabetes and reducing body weight
Claim Types: Method of use
Pat. Sub. Date(s): 002: Nov 15, 2017
Aug 18, 2026U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
U-2212: Reducing fasting plasma glucose in a human in need thereof in combination with a sustained-release composition containing exendin-4
U-2213: Reducing HBA1C in a human in need thereof in combination with a sustained-release composition containing exendin-4
Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): 002: Feb 5, 2014
Mar 21, 2028U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 8431685 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Nov 15, 2017
Apr 13, 2025U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Pat. No. 8461105 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Nov 15, 2017
Apr 13, 2025U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Pat. Sub. Date(s): 002: Feb 5, 2014
Jun 20, 2027U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 8685934 Methods for treating extreme insulin resistance in patients resistant to previous treatment with other anti-diabetic drugs employing an SGLT2 inhibitor and compositions thereof
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 25, 2014
May 26, 2030U-1522: Treatment of Type 2 diabetes mellitus in a patient, wherein glycemic control (HBA1C < 7.0%) is not achievable using one or more of insulin, metformin, pioglitazone, or rosiglitazone
Pat. No. 8716251 DP* Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Formulation
Pat. Sub. Date(s): 002: Jun 2, 2014
Mar 21, 2028 
Pat. No. 8721615 DP* DLR* Ampoule comprising an ampoule holder
Claim Types: Device
Pat. Sub. Date(s): 002: Nov 15, 2017
Jan 18, 2030 
Pat. No. 8906851 Method for treating diabetes
Claim Types: Method of use
Pat. Sub. Date(s): 002: Nov 15, 2017
Aug 18, 2026U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Pat. No. 9238076 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Nov 15, 2017
Apr 15, 2024U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Pat. No. 10973836 Methods of treating heart failure with reduced ejection fraction
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 002: Apr 21, 2021
Mar 9, 2040U-3127: Reduction of the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure with reduced ejection fraction and without Type II diabetes
Pat. No. 11826376 Methods of treating heart failure with preserved ejection fraction employing dapagliflozin and compositions comprising the same
Claim Types: Method of use
Pat. Sub. Date(s): 002: Dec 19, 2023
Jul 18, 2039U-3766: Reduce the risk of cardiovascular death and hospitalization for heart failure and urgent heart failure visits in adults with heart failure with preserved ejection fraction and without Type II diabetes
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationApr 30, 2024I-857: To reduce the risk of sustained EGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression
Exclusivity Code: M - MiscellaneousMay 8, 2026M-298: Labeling revisions related to study D1699CC00001

ASTRAZENECA AB
KOMBIGLYZE XR (TABLET, EXTENDED RELEASE) (ORAL) METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE [Has competitive generic]
Drug Classes: biguanide
NDA Applicant: ASTRAZENECA AB      NDA No.:
200678  Prod. No.: 001 DISC (500MG;EQ 5MG BASE); 002 DISC (1GM;EQ 5MG BASE); 003 DISC (1GM;EQ 2.5MG BASE)
PatentsExpirationPatented Use
Pat. No. 8628799 DP* Coated tablet formulation and method
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 31, 2014; 002: Mar 22, 2017; 003: Mar 22, 2017
Jul 13, 2025 
Pat. No. 9339472 DP* Coated tablet formulation and method
Claim Types: Formulation
Pat. Sub. Date(s): 001: May 26, 2016; 002: Mar 22, 2017; 003: Mar 22, 2017
Jul 13, 2025 

ASTRAZENECA AB
ONGLYZA (TABLET) (ORAL) SAXAGLIPTIN HYDROCHLORIDE [Has competitive generic]
NDA Applicant: ASTRAZENECA AB      NDA No.:
022350  Prod. No.: 001 DISC (EQ 2.5MG BASE); 002 DISC (EQ 5MG BASE)
PatentsExpirationPatented Use
Pat. No. 7951400 DP* Coated tablet formulation and method
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 29, 2011; 002: None
Nov 30, 2028 

ASTRAZENECA AB
QTERN (TABLET) (ORAL) DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor
NDA Applicant: ASTRAZENECA AB      NDA No.:
209091  Prod. No.: 001 RX (10MG;EQ 5MG BASE)
PatentsExpirationPatented Use
Pat. No. 6515117 DS* DP* [Extended 5 years]
C-aryl glucoside SGLT2 inhibitors and method
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Mar 22, 2017
Oct 4, 2025U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 7919598 DS* Crystal structures of SGLT2 inhibitors and processes for preparing same
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: Mar 22, 2017
Dec 16, 2029 
Pat. No. 8221786 DP* Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 22, 2017
Mar 21, 2028 
Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 22, 2017
Mar 21, 2028U-1976: Method for treating Type 2 diabetes mellitus (T2DM) in patients who have inadequate control with dapagliflozin
U-1977: Method for treating Type 2 diabetes mellitus (T2DM) in patients who are already treated with dapagliflozin and saxagliptin
U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Mar 22, 2017
Jun 20, 2027U-1976: Method for treating Type 2 diabetes mellitus (T2DM) in patients who have inadequate control with dapagliflozin
U-1977: Method for treating Type 2 diabetes mellitus (T2DM) in patients who are already treated with dapagliflozin and saxagliptin
U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 8628799 DP* Coated tablet formulation and method
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 22, 2017
Jul 13, 2025 
Pat. No. 8716251 DP* Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 22, 2017
Mar 21, 2028 

ASTRAZENECA AB
QTERN (TABLET) (ORAL) DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor
NDA Applicant: ASTRAZENECA AB      NDA No.:
209091  Prod. No.: 002 RX (5MG;EQ 5MG BASE)
PatentsExpirationPatented Use
Pat. No. 6515117 DS* DP* [Extended 5 years]
C-aryl glucoside SGLT2 inhibitors and method
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 002: May 24, 2019
Oct 4, 2025U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 7919598 DS* Crystal structures of SGLT2 inhibitors and processes for preparing same
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 002: May 24, 2019
Dec 16, 2029 
Pat. No. 8221786 DP* Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Formulation
Pat. Sub. Date(s): 002: May 24, 2019
Mar 21, 2028 
Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): 002: May 24, 2019
Mar 21, 2028U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Pat. Sub. Date(s): 002: May 24, 2019
Jun 20, 2027U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 8628799 DP* Coated tablet formulation and method
Claim Types: Formulation
Pat. Sub. Date(s): 002: May 24, 2019
Jul 13, 2025 
Pat. No. 8716251 DP* Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Formulation
Pat. Sub. Date(s): 002: May 24, 2019
Mar 21, 2028 

ASTRAZENECA AB
QTERNMET XR (TABLET, EXTENDED RELEASE) (ORAL) DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor == biguanide
NDA Applicant: ASTRAZENECA AB      NDA No.:
210874  Prod. No.: 001 DISC (2.5MG;1GM;EQ 2.5MG BASE); 002 DISC (5MG;1GM;EQ 2.5MG BASE); 003 DISC (5MG;1GM;EQ 5MG BASE); 004 DISC (10MG;1GM;EQ 5MG BASE)
PatentsExpirationPatented Use
Pat. No. 6515117 DS* DP* [Extended 5 years]
C-aryl glucoside SGLT2 inhibitors and method
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): All strengths: May 24, 2019
Oct 4, 2025U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 7919598 DS* Crystal structures of SGLT2 inhibitors and processes for preparing same
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): All strengths: May 24, 2019
Dec 16, 2029 
Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Pat. Sub. Date(s): All strengths: May 24, 2019
Jun 20, 2027U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 8628799 DP* Coated tablet formulation and method
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 24, 2019
Jul 13, 2025 
Pat. No. 8716251 DP* Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 24, 2019
Mar 21, 2028 
Pat. No. 9616028 DP* Bilayer tablet formulations
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 24, 2019
Nov 12, 2030 

ASTRAZENECA AB
WAINUA (AUTOINJECTOR) (SOLUTION) (SUBCUTANEOUS) EPLONTERSEN SODIUM
NDA Applicant: ASTRAZENECA AB      NDA No.:
217388  Prod. No.: 001 RX (EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML))
PatentsExpirationPatented Use
Pat. No. 8101743 DS* DP* Modulation of transthyretin expression
Claim Types: Compound
Pat. Sub. Date(s): 001: Jan 18, 2024
Apr 1, 2025 
Pat. No. 9127276 DS* Conjugated antisense compounds and their use
Claim Types: Compound
Pat. Sub. Date(s): 001: Jan 18, 2024
May 1, 2034 
Pat. No. 9181549 DS* Conjugated antisense compounds and their use
Claim Types: Compound
Pat. Sub. Date(s): 001: Jan 18, 2024
May 1, 2034 
Pat. No. 10683499 DS* DP* Compositions and methods for modulating TTR expression
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Jan 18, 2024
Aug 25, 2034U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityDec 21, 2028 
Exclusivity Code: ODE - Orphan drug exclusivityDec 21, 2030ODE-461: Treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults

ASTRAZENECA AB
XIGDUO XR (TABLET, EXTENDED RELEASE) (ORAL) DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor == biguanide
NDA Applicant: ASTRAZENECA AB      NDA No.:
205649  Prod. No.: 001 RX (5MG;500MG); 002 RX (5MG;1GM); 003 RX (10MG;500MG); 004 RX (10MG;1GM); 005 RX (2.5MG;1GM)
PatentsExpirationPatented Use
Pat. No. 6515117 DS* DP* [Extended 5 years]
C-aryl glucoside SGLT2 inhibitors and method
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): All strengths: Nov 24, 2014
Oct 4, 2025U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 7919598 DS* Crystal structures of SGLT2 inhibitors and processes for preparing same
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: Nov 24, 2014; 002: Nov 24, 2014; 003: Nov 24, 2014; 004: Nov 24, 2014; 005: Aug 30, 2017
Dec 16, 2029 
Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 24, 2014; 002: Nov 24, 2014; 003: Nov 24, 2014; 004: Nov 24, 2014; 005: Aug 30, 2017
Jun 20, 2027U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 8685934 Methods for treating extreme insulin resistance in patients resistant to previous treatment with other anti-diabetic drugs employing an SGLT2 inhibitor and compositions thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 24, 2014; 002: Nov 24, 2014; 003: Nov 24, 2014; 004: Nov 24, 2014; 005: Aug 30, 2017
May 26, 2030U-1522: Treatment of Type 2 diabetes mellitus in a patient, wherein glycemic control (HBA1C < 7.0%) is not achievable using one or more of insulin, metformin, pioglitazone, or rosiglitazone
Pat. No. 9616028 DP* Bilayer tablet formulations
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Aug 30, 2017
Nov 12, 2030 

ATHENA
FIBRICOR (TABLET) (ORAL) FENOFIBRIC ACID
NDA Applicant: ATHENA      NDA No.:
022418  Prod. No.: 001 DISC (35MG); 002 DISC (105MG)
PatentsExpirationPatented Use
Pat. No. 7569612 Methods of use of fenofibric acid
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Aug 20, 2027U-1000: Adjunctive therapy to diet in patients with hyperlipidemias
Pat. No. 7741373 Methods of use of fenofibric acid
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Aug 20, 2027U-1059: Adjunctive therapy to diet to patients with hypertriglyceridemia
Pat. No. 7741374 Methods of use of fenofibric acid
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Aug 20, 2027U-1060: Adjunctive therapy to diet in patients with elevated cholesterol and/or lipid levels
U-1061: Adjunctive therapy to diet in patients with mixed dyslipidemia
Pat. No. 7915247 Methods of use of fenofibric acid
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 30, 2011; 002: None
Aug 20, 2027U-1000: Adjunctive therapy to diet in patients with hyperlipidemias
U-1059: Adjunctive therapy to diet to patients with hypertriglyceridemia
U-1061: Adjunctive therapy to diet in patients with mixed dyslipidemia

ATHENA
NEXICLON XR (TABLET, EXTENDED RELEASE) (ORAL) CLONIDINE
Drug Classes: alpha adrenergic agonist == central alpha-2 adrenergic agonist
NDA Applicant: ATHENA      NDA No.:
022500  Prod. No.: 001 RX (EQ 0.17MG BASE) NDA No.: 022500  Prod. No.: 002 DISC (EQ 0.26MG BASE)
PatentsExpirationPatented Use
Pat. No. 8337890 DP* Modified release formulations containing drug-ion exchange resin complexes
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 1, 2020
Apr 17, 2027 
Pat. No. 8623409 DP* Clonidine formulation
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): All strengths: Jul 1, 2020
Sep 8, 2031 

ATHENA
QDOLO (SOLUTION) (ORAL) TRAMADOL HYDROCHLORIDE
Drug Classes: opioid agonist
NDA Applicant: ATHENA      NDA No.:
214044  Prod. No.: 001 RX (5MG/ML)
PatentsExpirationPatented Use
Pat. No. 11103452 DP* Tramadol hydrochloride solution
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 2, 2021
Sep 1, 2040U-3197: Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate
Pat. No. 11752103 DP* Tramadol hydrochloride solution
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 14, 2023
Sep 1, 2040U-3197: Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate

AUCTA
MOTPOLY XR (CAPSULE, EXTENDED RELEASE) (ORAL) LACOSAMIDE
NDA Applicant: AUCTA      NDA No.:
216185  Prod. No.: 001 RX (100MG); 002 RX (150MG); 003 RX (200MG)
PatentsExpirationPatented Use
Pat. No. 11337943 DP* Lacosamide pharmaceutical composition and dosage form thereof
Claim Types: Formulation; Method of use; Method of Use claimed by its inherent performace characteristics
Pat. Sub. Date(s): All strengths: Aug 1, 2023
Jun 5, 2040U-3660: Treatment of partial-onset seizures in adults and in pediatric patients weighing at least 50 kg

AURINIA
LUPKYNIS (CAPSULE) (ORAL) VOCLOSPORIN
Drug Classes: calcineurin-inhibitor immunosuppressant
NDA Applicant: AURINIA      NDA No.:
213716  Prod. No.: 001 RX (7.9MG)
PatentsExpirationPatented Use
Pat. No. 7332472 DS* DP* Cyclosporine analogue mixtures and their use as immunomodulating agents
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Feb 11, 2021
Oct 17, 2024U-3056: Treatment of patients with active lupus nephritis
Pat. No. 10286036 Protocol for treatment of lupus nephritis
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Feb 11, 2021
Dec 7, 2037U-3056: Treatment of patients with active lupus nephritis
Pat. No. 11622991 Protocol for treatment of lupus nephritis
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 5, 2023
Dec 7, 2037U-3056: Treatment of patients with active lupus nephritis
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJan 22, 2026 

AUROBINDO PHARMA
AMPICILLIN TRIHYDRATE (CAPSULE) (ORAL) AMPICILLIN/AMPICILLIN TRIHYDRATE [Has competitive generic]
NDA Applicant: AUROBINDO PHARMA      NDA No.:
216554  Prod. No.: 001 RX (EQ 250MG BASE); 002 RX (EQ 500MG BASE)
ExclusivityExpirationExclusivity Description
Exclusivity Code: CGT - Competitive generic therapyJun 3, 2024 

AUROBINDO PHARMA
PITAVASTATIN CALCIUM (TABLET) (ORAL) PITAVASTATIN CALCIUM [GENERIC AB]
Drug Classes: HMG CoA-reductase inhibitor
NDA Applicant: AUROBINDO PHARMA      NDA No.:
206015  Prod. No.: 001 RX (EQ 1MG BASE); 002 RX (EQ 2MG BASE); 003 RX (EQ 4MG BASE)
ExclusivityExpirationExclusivity Description
Exclusivity Code: PC - Patent challengeFeb 19, 2024 

AUROBINDO PHARMA
SAXAGLIPTIN (TABLET) (ORAL) SAXAGLIPTIN HYDROCHLORIDE [GENERIC AB]
NDA Applicant: AUROBINDO PHARMA      NDA No.:
205972  Prod. No.: 001 RX (EQ 2.5MG BASE); 002 RX (EQ 5MG BASE)
ExclusivityExpirationExclusivity Description
Exclusivity Code: PC - Patent challengeJan 27, 2024 

AUROBINDO PHARMA
TERIFLUNOMIDE (TABLET) (ORAL) TERIFLUNOMIDE [GENERIC AB]
Drug Classes: pyrimidine synthesis inhibitor
NDA Applicant: AUROBINDO PHARMA      NDA No.:
209638  Prod. No.: 001 RX (7MG); 002 RX (14MG)
ExclusivityExpirationExclusivity Description
Exclusivity Code: PC - Patent challengeSep 8, 2023 

AUROBINDO PHARMA LTD
PREDNISOLONE (TABLET) (ORAL) PREDNISOLONE [GENERIC AB]
Drug Classes: corticosteroid
NDA Applicant: AUROBINDO PHARMA LTD      NDA No.:
215673  Prod. No.: 001 RX (5MG)
ExclusivityExpirationExclusivity Description
Exclusivity Code: CGT - Competitive generic therapyNov 18, 2023 

AVADEL CNS
LUMRYZ (FOR SUSPENSION, EXTENDED RELEASE) (ORAL) SODIUM OXYBATE
Drug Classes: central nervous system depressant
NDA Applicant: AVADEL CNS      NDA No.:
214755  Prod. No.: 001 RX (4.5GM/PACKET); 003 RX (7.5GM/PACKET); 004 RX (9GM/PACKET)
PatentsExpirationPatented Use
Pat. No. 10272062 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 23, 2023
Jul 21, 2037 
Pat. No. 10736866 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 23, 2023
Jul 21, 2037 
Pat. No. 10925844 DP* Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): All strengths: May 23, 2023
Feb 28, 2040 
Pat. No. 10952986 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: May 23, 2023
Jul 21, 2037U-3601: Treatment of a disorder treatable with gamma-hydroxybutyrate using a single, daily dose of a gamma-hydroxybutyrate formulation
Pat. No. 10973795 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 23, 2023
Jul 21, 2037 
Pat. No. 11000498 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): All strengths: May 23, 2023
Jul 21, 2037U-3580: Treatment of narcolepsy using a dose proportional, oral pharmaceutical composition comprising gamma-hydroxybutyrate once daily
Pat. No. 11052061 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): All strengths: May 23, 2023
Jul 21, 2037 
Pat. No. 11065224 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): All strengths: May 23, 2023
Jul 21, 2037 
Pat. No. 11400065 Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: May 23, 2023
Jul 21, 2037U-3579: Treatment of narcolepsy and associated disorders and symptoms using a composition comprising gamma-hydroxybutyrate once daily
Pat. No. 11504347 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): All strengths: May 23, 2023
Jul 21, 2037 
Pat. No. 11583510 Methods of administering gamma hydroxybutyrate formulations after a high-fat meal
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: May 23, 2023
Feb 7, 2042U-3578: Treatment of narcolepsy, cataplexy or excessive daytime sleepiness using a once-nightly gamma-hydroxybutyrate formulation
Pat. No. 11602512 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: May 23, 2023
Jul 21, 2037U-3577: Treatment of narcolepsy-related cataplexy or excessive daytime sleepiness using a single daily, bedtime dose of a gamma-hydroxybutyrate formulation
Pat. No. 11602513 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: May 23, 2023
Jul 21, 2037U-3576: Treatment of narcolepsy-related cataplexy or excessive daytime sleepiness using a once-daily pharmaceutical formulation comprising an oxybate
Pat. No. 11766418 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Claim Types: Formulation; Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): All strengths: Sep 29, 2023
Jul 21, 2037 
Pat. No. 11779557 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 24, 2023
Mar 16, 2042U-3705: Treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy who have an apnea/hypopnea index ≤15 with a once-nightly formulation of gamma-hydroxybutyrate
Pat. No. 11839597 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): All strengths: Jan 4, 2024
Jul 21, 2037 
Pat. No. 11896572 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 20, 2024
Jul 21, 2037 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productMay 1, 2026 
Exclusivity Code: ODE - Orphan drug exclusivityMay 1, 2030ODE-431: Treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy

AVADEL CNS
LUMRYZ (FOR SUSPENSION, EXTENDED RELEASE) (ORAL) SODIUM OXYBATE
Drug Classes: central nervous system depressant
NDA Applicant: AVADEL CNS      NDA No.:
214755  Prod. No.: 002 RX (6GM/PACKET)
PatentsExpirationPatented Use
Pat. No. 10272062 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Claim Types: Formulation
Pat. Sub. Date(s): 002: May 23, 2023
Jul 21, 2037 
Pat. No. 10736866 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Claim Types: Formulation
Pat. Sub. Date(s): 002: May 23, 2023
Jul 21, 2037 
Pat. No. 10925844 DP* Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): 002: May 23, 2023
Feb 28, 2040 
Pat. No. 10952986 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Claim Types: Method of use
Pat. Sub. Date(s): 002: May 23, 2023
Jul 21, 2037U-3601: Treatment of a disorder treatable with gamma-hydroxybutyrate using a single, daily dose of a gamma-hydroxybutyrate formulation
Pat. No. 10973795 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Claim Types: Formulation
Pat. Sub. Date(s): 002: May 23, 2023
Jul 21, 2037 
Pat. No. 11000498 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): 002: May 23, 2023
Jul 21, 2037U-3580: Treatment of narcolepsy using a dose proportional, oral pharmaceutical composition comprising gamma-hydroxybutyrate once daily
Pat. No. 11052061 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): 002: May 23, 2023
Jul 21, 2037 
Pat. No. 11065224 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): 002: May 23, 2023
Jul 21, 2037 
Pat. No. 11400065 Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state
Claim Types: Method of use
Pat. Sub. Date(s): 002: May 23, 2023
Jul 21, 2037U-3579: Treatment of narcolepsy and associated disorders and symptoms using a composition comprising gamma-hydroxybutyrate once daily
Pat. No. 11504347 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): 002: May 23, 2023
Jul 21, 2037 
Pat. No. 11583510 Methods of administering gamma hydroxybutyrate formulations after a high-fat meal
Claim Types: Method of use
Pat. Sub. Date(s): 002: May 23, 2023
Feb 7, 2042U-3578: Treatment of narcolepsy, cataplexy or excessive daytime sleepiness using a once-nightly gamma-hydroxybutyrate formulation
Pat. No. 11602512 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Claim Types: Method of use
Pat. Sub. Date(s): 002: May 23, 2023
Jul 21, 2037U-3577: Treatment of narcolepsy-related cataplexy or excessive daytime sleepiness using a single daily, bedtime dose of a gamma-hydroxybutyrate formulation
Pat. No. 11602513 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Claim Types: Method of use
Pat. Sub. Date(s): 002: May 23, 2023
Jul 21, 2037U-3576: Treatment of narcolepsy-related cataplexy or excessive daytime sleepiness using a once-daily pharmaceutical formulation comprising an oxybate
Pat. No. 11766418 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Claim Types: Formulation; Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): 002: Sep 29, 2023
Jul 21, 2037 
Pat. No. 11779557 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Claim Types: Method of use
Pat. Sub. Date(s): 002: Oct 24, 2023
Mar 16, 2042U-3705: Treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy who have an apnea/hypopnea index ≤15 with a once-nightly formulation of gamma-hydroxybutyrate
Pat. No. 11826335 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Claim Types: Method of use
Pat. Sub. Date(s): 002: Dec 4, 2023
Jul 21, 2037U-3751: Treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy with a once-nightly gamma-hydroxybutyrate formulation
Pat. No. 11839597 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): 002: Jan 4, 2024
Jul 21, 2037 
Pat. No. 11896572 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Claim Types: Formulation
Pat. Sub. Date(s): 002: Feb 20, 2024
Jul 21, 2037 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productMay 1, 2026 
Exclusivity Code: ODE - Orphan drug exclusivityMay 1, 2030ODE-431: Treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy

AVANIR PHARMS
NUEDEXTA (CAPSULE) (ORAL) DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE [GENERIC AB]
Drug Classes: sigma-1 agonist == uncompetitive NMDA receptor antagonist == antiarrhythmic == CYP450 2D6 inhibitor
NDA Applicant: AVANIR PHARMS      NDA No.:
021879  Prod. No.: 001 RX (20MG;10MG)
PatentsExpirationPatented Use
Pat. No. 7659282 Pharmaceutical compositions comprising dextromethorphan and quinidine for the treatment of neurological disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Aug 13, 2026U-1093: Treatment of pseudobulbar affect

AVEO PHARMS
FOTIVDA (CAPSULE) (ORAL) TIVOZANIB HYDROCHLORIDE
Drug Classes: kinase inhibitor
NDA Applicant: AVEO PHARMS      NDA No.:
212904  Prod. No.: 001 RX (EQ 0.89MG BASE); 002 RX (EQ 1.34MG BASE)
PatentsExpirationPatented Use
Pat. No. 6821987 DS* DP* Quinoline derivatives and quinazoline derivatives having azolyl group
Claim Types: Compound; Method of use; Composition
Pat. Sub. Date(s): All strengths: Apr 6, 2021
Apr 26, 2024U-3100: A method of treating adults with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies by inhibiting the angiogenesis of blood vessels with a vascular endothelial growth factor inhibitor
Pat. No. 7166722 DS* DP* N-{2-chloro-4-[(6,7-dimethoxy-4-quinolyl)oxy]phenyl}-n'-(5-methyl-3-isoxaz- olyl)urea salt in crystalline form
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): All strengths: Apr 6, 2021
Nov 16, 2024 
Pat. No. 11504365 Use of tivozanib to treat subjects with refractory cancer
Claim Types: Dosaage regimen
Pat. Sub. Date(s): All strengths: Dec 1, 2022
Nov 5, 2039U-3476: Treatment of adults with moderate hepatic impairment and relapsed or refractory advanced renal cell carcinoma following two or more prior systemic anti-cancer therapies with 1mg tivozanib HCl orally for 21 days followed by no drug for 7 days
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMar 10, 2026 

AVERITAS
QUTENZA (PATCH) (TOPICAL) CAPSAICIN
NDA Applicant: AVERITAS      NDA No.:
022395  Prod. No.: 001 RX (8%)
PatentsExpirationPatented Use
Pat. No. 8821920 DP* Therapeutic patch for transdermal delivery of capsaicin
Claim Types: Device; Method of use; Process
Pat. Sub. Date(s): 001: Jan 8, 2020
Mar 26, 2030 
Pat. No. 9226903 DP* Transdermal therapeutic system comprising an adhesive layer method for siliconizing the back layer or the system and use of said back layer
Claim Types: Device; Process
Pat. Sub. Date(s): 001: Jan 8, 2020
Dec 15, 2028 
Pat. No. 10034841 DP* Transdermal therapeutic system comprising an adhesive layer method for siliconizing the back layer of the system and use of said back layer
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 8, 2020
Sep 6, 2025 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJul 17, 2023I-838: Treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet

AVID RADIOPHARMS INC
AMYVID (SOLUTION) (INTRAVENOUS) FLORBETAPIR F-18
NDA Applicant: AVID RADIOPHARMS INC      NDA No.:
202008  Prod. No.: 003 RX (10-50ML (13.5-51mCi/ML)) NDA No.: 202008  Prod. No.: 001 DISC (10ML (13.5-51mCi/ML)); 002 DISC (10-30ML (13.5-51mCi/ML))
PatentsExpirationPatented Use
Pat. No. 7687052 DS* DP* Styrylpyridine derivatives and their use for binding and imaging amyloid plaques
Claim Types: Compound; Formulation; Diagnostic or surgical method
Pat. Sub. Date(s): 001: May 4, 2012; 002: None; 003: None
Apr 30, 2027 
Pat. No. 8506929 DS* DP* Styrylpyridine derivatives and their use for binding and imaging amyloid plaques
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Sep 6, 2013; 002: None; 003: None
Apr 30, 2027U-1423: Amyvid is a radioactive diagnostic agent for positron emission tomography (PET) imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment

AVID RADIOPHARMS INC
TAUVID (SOLUTION) (INTRAVENOUS) FLORTAUCIPIR F-18
NDA Applicant: AVID RADIOPHARMS INC      NDA No.:
212123  Prod. No.: 001 RX (30ML (8.1-51mCi/ML)); 002 RX (50ML (8.1-51mCi/ML))
PatentsExpirationPatented Use
Pat. No. 8932557 DS* Imaging agents for detecting neurological dysfunction
Claim Types: Compound; Process
Pat. Sub. Date(s): All strengths: Jun 11, 2020
May 26, 2032 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMay 28, 2025 

AVID RADIOPHARMS INC
TAUVID (SOLUTION) (INTRAVENOUS) FLORTAUCIPIR F-18
NDA Applicant: AVID RADIOPHARMS INC      NDA No.:
212123  Prod. No.: 003 RX (50ML (8.1-100mCi/ML)); 004 RX (100ML (8.1-100mCi/ML))
PatentsExpirationPatented Use
Pat. No. 8932557 DS* Imaging agents for detecting neurological dysfunction
Claim Types: Compound; Process
Pat. Sub. Date(s): All strengths: Sep 8, 2022
May 26, 2032 

AVION PHARMS
BALCOLTRA (TABLET) (ORAL) ETHINYL ESTRADIOL; LEVONORGESTREL [GENERIC AB3]
Drug Classes: progestin == progestin-containing intrauterine system
NDA Applicant: AVION PHARMS      NDA No.:
208612  Prod. No.: 001 RX (0.02MG;0.1MG)
PatentsExpirationPatented Use
Pat. No. 7838042 DS* Hypoallergenic metal amino acid chelates and metal amino acid chelate-containing compositions
Claim Types: Method of administration; Process
Pat. Sub. Date(s): 001: Nov 30, 2021
Jun 1, 2027U-3251: Administration of ferrous bisglycinate tablets

AVION PHARMS
DHIVY (TABLET) (ORAL) CARBIDOPA; LEVODOPA [Has competitive generic]
Drug Classes: aromatic amino acid decarboxylation inhibitor
NDA Applicant: AVION PHARMS      NDA No.:
214869  Prod. No.: 001 RX (25MG;100MG)
PatentsExpirationPatented Use
Pat. No. 11033521 DP* Levodopa fractionated dose composition and use
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Feb 22, 2022
Mar 28, 2039U-219: Treatment of Parkinson's disease
U-3304: Method of treating Parkinson's disease by orally administering segments of a functionally multiscored, bilayered tablet having carbidopa—25 mg/levodopa—100 mg, each segment having carbidopa—6.25 mg/levodopa—25 mg
U-3305: Method of treating Parkinson's disease by orally administering a functionally multiscored, bilayered tablet having carbidopa—25 mg/levodopa—100 mg
Pat. No. 11439613 Levodopa fractionated dose composition and use
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 18, 2023
Mar 28, 2039U-3557: Treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication
Pat. No. 11819485 Levodopa fractionated dose composition and use
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 7, 2023
Mar 28, 2039U-3557: Treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication

AVYXA HOLDINGS
DOCETAXEL (SOLUTION) (INTRAVENOUS) DOCETAXEL
Drug Classes: microtubule inhibitor
NDA Applicant: AVYXA HOLDINGS      NDA No.:
215813  Prod. No.: 001 DISC (20MG/2ML (10MG/ML)); 002 DISC (80MG/8ML (10MG/ML)); 003 DISC (160MG/16ML (10MG/ML))
PatentsExpirationPatented Use
Pat. No. 10398785 DP* Pharmaceutical compositions containing taxane-cyclodextrin complexes, method of making and methods of use
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Jul 7, 2023
Mar 14, 2036 

AXSOME
AUVELITY (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Drug Classes: aminoketone == sigma-1 agonist == uncompetitive NMDA receptor antagonist
NDA Applicant: AXSOME      NDA No.:
215430  Prod. No.: 001 RX (105MG;45MG)
PatentsExpirationPatented Use
Pat. No. 8569328 DP* Compositions and methods comprising tilidine or related compounds and dextromethorphan
Claim Types: Composition; Method of use; Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Oct 29, 2033U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9168234 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9198905 Compositions and methods for reducing dextrorphan plasma levels and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9205083 Compositions and methods comprising erythrohydroxybupropion and related compounds for improving the efficacy of dextromethorphan
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9238032 Compositions and methods comprising bupropion or related compounds for sustained delivery of dextromethorphan
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9278095 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9314462 Compositions and methods for increasing dextromethorphan plasma levels and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9370513 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9375429 Compositions and methods comprising erythrohydroxybupropion and related compounds for improving the efficacy of dextromethorphan
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9408815 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9421176 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9457023 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9457025 Compositions and methods comprising bupropion or related compounds for sustained delivery of dextromethorphan
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9474731 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9486450 Hydroxybupropion and related compounds as modulators of drug plasma levels
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9700528 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9700553 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9707191 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9763932 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9861595 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9867819 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9968568 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10058518 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10064857 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment; Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10080727 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10092560 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10092561 Compositions and methods comprising bupropion or related compounds for sustained delivery of dextromethorphan
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10105327 Compositions and methods for increasing the metabolic lifetime of dextromethorphane and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10105361 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10251879 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment; Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10463634 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10512643 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10548857 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10596167 Compositions and methods comprising bupropion or related compounds for sustained delivery of dextromethorphan
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10772850 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment; Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10780064 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Jan 7, 2040U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10780066 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 9, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10786469 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10786496 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10799497 Combination of dextromethorphan and bupropion for treating depression
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10806710 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10864209 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10874663 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10874664 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10874665 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10881624 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment; Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10881657 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10894046 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10894047 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10898453 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10925842 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Jan 7, 2040U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10933034 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10940124 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Jan 7, 2040U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10945973 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10966941 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10966942 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Jan 7, 2040U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10966974 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11020389 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11058648 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11090300 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11096937 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11123343 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11129826 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11141388 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11141416 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11147808 Method of decreasing the fluctuation index of dextromethorphan
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11185515 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11191739 DP* Bupropion as a modulator of drug activity
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11197839 DP* Bupropion as a modulator of drug activity
Claim Types: Composition
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11207281 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11213521 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11229640 Combination of dextromethorphan and bupropion for treating depression
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11234946 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11253491 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11253492 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11273133 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11273134 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11285118 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11285146 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11291638 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11291665 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11298351 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11298352 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11311534 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11344544 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11357744 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11364233 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11382874 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11419867 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11426370 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11426401 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11433067 DP* Bupropion as a modulator of drug activity
Claim Types: Composition; Method of administration; Formulation
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11439636 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11478468 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 10, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11497721 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 2, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11510918 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 7, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11517542 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 21, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11517543 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 21, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11524007 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 21, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11524008 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 21, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11534414 DP* Bupropion as a modulator of drug activity
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): 001: Jan 23, 2023
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11541021 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 23, 2023
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11541048 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 23, 2023
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11596627 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 4, 2023
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11617728 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 3, 2023
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11617747 Bupropion as a modulator of drug activity
Claim Types: Method of use; Method of improving a treatment
Pat. Sub. Date(s): 001: May 3, 2023
Nov 5, 2034U-3563: Dextromethorphan and bupropion in combination to increase dextromethorphan plasma levels
Pat. No. 11717518 Bupropion Dosage Forms With Reduced Food And Alcohol Dosing Effects
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 15, 2023
Jan 20, 2043U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11730706 Treatment of depression in certain patient populations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 28, 2023
Jan 23, 2043U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11752144 Compounds and combinations thereof for treating neurological and psychiatric conditions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 14, 2023
Feb 23, 2043U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11779579 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 12, 2023
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11839612 Compounds and combinations thereof for treating neurological and psychiatric conditions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 5, 2024
Mar 2, 2043U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11844797 Combination of dextromethorphan and bupropion for treating depression
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 5, 2024
Apr 20, 2043U-3778: Treatment of major depressive disorder by administering dextromethorphan and bupropion to a subject having moderate hepatic impairment
Pat. No. 11883373 Treatment of depression in certain patient populations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 8, 2024
Jan 23, 2043U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11896563 Bupropion and dextromethorphan for reduction of suicide risk in depression patients
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 16, 2024
Dec 1, 2041U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productAug 18, 2025 

AXSOME MALTA
SUNOSI (TABLET) (ORAL) SOLRIAMFETOL HYDROCHLORIDE
Drug Classes: dopamine and norepinephrine reuptake inhibitor (DNRI)
NDA Applicant: AXSOME MALTA      NDA No.:
211230  Prod. No.: 001 RX (EQ 75MG BASE)
PatentsExpirationPatented Use
Pat. No. 8440715 [Extended 1386 days (3.8 years)]
Treatment of sleep-wake disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 24, 2019
Jun 11, 2031U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA)
Pat. No. 8877806 Treatment of sleep-wake disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 24, 2019
Jun 7, 2026U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA)
Pat. No. 9604917 Treatment of sleep-wake disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 24, 2019
Jun 7, 2026U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA)
Pat. No. 10195151 DP* Formulations of (R)-2-amino-3-phenylpropyl carbamate
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 24, 2019
Sep 5, 2037 
Pat. No. 10351517 Treatment of sleep-wake disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 16, 2019
Jun 7, 2026U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA)
Pat. No. 10512609 Formulations of (R)-2-amino-3-phenylpropyl carbamate
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 22, 2020
Sep 5, 2037U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA)
Pat. No. 10912754 Methods and compositions for treating excessive sleepiness
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 10, 2021
Jun 1, 2038U-3082: Treatment of excessive daytime sleepiness associated with obstructive sleep apnea (OSA) in an adult through a dosing regimen that includes oral administration of 75 mg once daily for at least 3 days followed by 150 mg once daily
Pat. No. 10940133 Methods of providing solriamfetol therapy to subjects with impaired renal function
Claim Types: Dosaage regimen
Pat. Sub. Date(s): 001: Apr 7, 2021
Mar 19, 2040U-3099: Treatment of excessive daytime sleepiness associated with obstructive sleep apnea (OSA) in a patient with moderate renal impairment
Pat. No. 10959976 Methods and compositions for treating excessive sleepiness
Claim Types: Dosaage regimen
Pat. Sub. Date(s): 001: Apr 27, 2021
Jun 1, 2038U-3151: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) with a dosing regimen that includes a dose of 75 mg once daily for at least 3 days followed by 150 mg once daily
Pat. No. 11160779 Methods of providing solriamfetol therapy to subjects with impaired renal function
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 13, 2023
Mar 19, 2040U-3521: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having mild, moderate, or severe renal impairment
Pat. No. 11439597 DP* Formulations of (R)-2-amino-3-phenylpropyl carbamate
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): 001: Oct 13, 2022
Sep 5, 2037 
Pat. No. 11560354 DP* Compositions comprising (R)-2-amino-3-phenylpropyl carbamate and uses thereof
Claim Types: Composition
Pat. Sub. Date(s): 001: Feb 13, 2023
Mar 6, 2039U-3520: Treatment of excessive daytime sleepiness by administering a composition comprising solriamfetol hydrochloride and 2-chloropropane, wherein the composition comprises less than about 5 ppm 2-chloropropane
Pat. No. 11648232 Methods and compositions for treating excessive sleepiness
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 26, 2023
Jun 1, 2038U-3602: Treatment of excessive daytime sleepiness with a dosing regimen that includes oral administration of 75 mg once daily for at least 3 days followed by 150 mg once daily
Pat. No. 11753368 Treatment of sleep-wake disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 14, 2023
Jun 7, 2026U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA)
Pat. No. 11771666 Methods of administering solriamfetol to lactating women
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Oct 6, 2023
Dec 30, 2042U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol
Pat. No. 11771667 Methods of administering solriamfetol to lactating women
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 6, 2023
Dec 30, 2042U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol
Pat. No. 11779554 Methods of administering solriamfetol to lactating women
Claim Types: Method of use; Method of Use claimed by its inherent performace characteristics
Pat. Sub. Date(s): 001: Oct 12, 2023
Dec 30, 2042U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol
Pat. No. 11793776 Methods of administering solriamfetol to lactating women
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 27, 2023
Dec 30, 2042U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol
Pat. No. 11839598 Methods of providing solriamfetol therapy to subjects with impaired renal function
Claim Types: Dosaage regimen
Pat. Sub. Date(s): 001: Dec 15, 2023
Mar 19, 2040U-3765: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having moderate or severe renal impairment
Pat. No. 11839599 Methods of providing solriamfetol therapy to subjects with impaired renal function
Claim Types: Dosaage regimen
Pat. Sub. Date(s): 001: Dec 15, 2023
Mar 19, 2040U-3764: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having obstructive sleep apnea (OSA) and no, mild, moderate, or severe renal impairment
Pat. No. 11850226 Methods of providing solriamfetol therapy to subjects with impaired renal function
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 29, 2023
Mar 19, 2040U-3775: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having no, mild, moderate, or severe renal impairment
Pat. No. 11850227 Methods of providing solriamfetol therapy to subjects with impaired renal function
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 29, 2023
Mar 19, 2040U-3775: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having no, mild, moderate, or severe renal impairment
Pat. No. 11850228 Methods of providing solriamfetol therapy to subjects with impaired renal function
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 29, 2023
Mar 19, 2040U-3775: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having no, mild, moderate, or severe renal impairment
Pat. No. 11857528 Methods of providing solriamfetol therapy to subjects with impaired renal function
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 19, 2024
Mar 19, 2040U-3521: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having mild, moderate, or severe renal impairment
Pat. No. 11865098 Methods and compositions for treating excessive sleepiness
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 8, 2024
Jun 1, 2038U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA)
Pat. No. 11872203 Methods of administering solriamfetol to lactating women
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 19, 2024
Dec 30, 2042U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol
Pat. No. 11872204 Methods of administering solriamfetol to lactating women
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Jan 19, 2024
Dec 30, 2042U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJun 17, 2024 
Exclusivity Code: ODE - Orphan drug exclusivityJun 17, 2026ODE-254: Indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy

AXSOME MALTA
SUNOSI (TABLET) (ORAL) SOLRIAMFETOL HYDROCHLORIDE
Drug Classes: dopamine and norepinephrine reuptake inhibitor (DNRI)
NDA Applicant: AXSOME MALTA      NDA No.:
211230  Prod. No.: 002 RX (EQ 150MG BASE)
PatentsExpirationPatented Use
Pat. No. 8440715 [Extended 1386 days (3.8 years)]
Treatment of sleep-wake disorders
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 24, 2019
Jun 11, 2031U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA)
Pat. No. 8877806 Treatment of sleep-wake disorders
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 24, 2019
Jun 7, 2026U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA)
Pat. No. 9604917 Treatment of sleep-wake disorders
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 24, 2019
Jun 7, 2026U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA)
Pat. No. 10195151 DP* Formulations of (R)-2-amino-3-phenylpropyl carbamate
Claim Types: Formulation
Pat. Sub. Date(s): 002: Jun 24, 2019
Sep 5, 2037 
Pat. No. 10351517 Treatment of sleep-wake disorders
Claim Types: Method of use
Pat. Sub. Date(s): 002: Aug 16, 2019
Jun 7, 2026U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA)
Pat. No. 10512609 Formulations of (R)-2-amino-3-phenylpropyl carbamate
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 22, 2020
Sep 5, 2037U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA)
Pat. No. 10912754 Methods and compositions for treating excessive sleepiness
Claim Types: Method of use
Pat. Sub. Date(s): 002: Mar 10, 2021
Jun 1, 2038U-3082: Treatment of excessive daytime sleepiness associated with obstructive sleep apnea (OSA) in an adult through a dosing regimen that includes oral administration of 75 mg once daily for at least 3 days followed by 150 mg once daily
Pat. No. 10959976 Methods and compositions for treating excessive sleepiness
Claim Types: Dosaage regimen
Pat. Sub. Date(s): 002: Apr 27, 2021
Jun 1, 2038U-3151: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) with a dosing regimen that includes a dose of 75 mg once daily for at least 3 days followed by 150 mg once daily
Pat. No. 11160779 Methods of providing solriamfetol therapy to subjects with impaired renal function
Claim Types: Method of use
Pat. Sub. Date(s): 002: Feb 13, 2023
Mar 19, 2040U-3521: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having mild, moderate, or severe renal impairment
Pat. No. 11439597 DP* Formulations of (R)-2-amino-3-phenylpropyl carbamate
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): 002: Oct 13, 2022
Sep 5, 2037 
Pat. No. 11560354 DP* Compositions comprising (R)-2-amino-3-phenylpropyl carbamate and uses thereof
Claim Types: Composition
Pat. Sub. Date(s): 002: Feb 13, 2023
Mar 6, 2039U-3520: Treatment of excessive daytime sleepiness by administering a composition comprising solriamfetol hydrochloride and 2-chloropropane, wherein the composition comprises less than about 5 ppm 2-chloropropane
Pat. No. 11648232 Methods and compositions for treating excessive sleepiness
Claim Types: Method of use
Pat. Sub. Date(s): 002: May 26, 2023
Jun 1, 2038U-3602: Treatment of excessive daytime sleepiness with a dosing regimen that includes oral administration of 75 mg once daily for at least 3 days followed by 150 mg once daily
Pat. No. 11753368 Treatment of sleep-wake disorders
Claim Types: Method of use
Pat. Sub. Date(s): 002: Sep 14, 2023
Jun 7, 2026U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA)
Pat. No. 11771666 Methods of administering solriamfetol to lactating women
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Oct 6, 2023
Dec 30, 2042U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol
Pat. No. 11771667 Methods of administering solriamfetol to lactating women
Claim Types: Method of use
Pat. Sub. Date(s): 002: Oct 6, 2023
Dec 30, 2042U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol
Pat. No. 11779554 Methods of administering solriamfetol to lactating women
Claim Types: Method of use; Method of Use claimed by its inherent performace characteristics
Pat. Sub. Date(s): 002: Oct 12, 2023
Dec 30, 2042U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol
Pat. No. 11793776 Methods of administering solriamfetol to lactating women
Claim Types: Method of use
Pat. Sub. Date(s): 002: Oct 27, 2023
Dec 30, 2042U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol
Pat. No. 11839598 Methods of providing solriamfetol therapy to subjects with impaired renal function
Claim Types: Dosaage regimen
Pat. Sub. Date(s): 002: Dec 15, 2023
Mar 19, 2040U-3765: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having moderate or severe renal impairment
Pat. No. 11839599 Methods of providing solriamfetol therapy to subjects with impaired renal function
Claim Types: Dosaage regimen
Pat. Sub. Date(s): 002: Dec 15, 2023
Mar 19, 2040U-3764: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having obstructive sleep apnea (OSA) and no, mild, moderate, or severe renal impairment
Pat. No. 11850226 Methods of providing solriamfetol therapy to subjects with impaired renal function
Claim Types: Method of use
Pat. Sub. Date(s): 002: Dec 29, 2023
Mar 19, 2040U-3775: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having no, mild, moderate, or severe renal impairment
Pat. No. 11850227 Methods of providing solriamfetol therapy to subjects with impaired renal function
Claim Types: Method of use
Pat. Sub. Date(s): 002: Dec 29, 2023
Mar 19, 2040U-3775: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having no, mild, moderate, or severe renal impairment
Pat. No. 11850228 Methods of providing solriamfetol therapy to subjects with impaired renal function
Claim Types: Method of use
Pat. Sub. Date(s): 002: Dec 29, 2023
Mar 19, 2040U-3775: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having no, mild, moderate, or severe renal impairment
Pat. No. 11857528 Methods of providing solriamfetol therapy to subjects with impaired renal function
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 19, 2024
Mar 19, 2040U-3521: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having mild, moderate, or severe renal impairment
Pat. No. 11865098 Methods and compositions for treating excessive sleepiness
Claim Types: Method of use
Pat. Sub. Date(s): 002: Feb 8, 2024
Jun 1, 2038U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA)
Pat. No. 11872203 Methods of administering solriamfetol to lactating women
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 19, 2024
Dec 30, 2042U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol
Pat. No. 11872204 Methods of administering solriamfetol to lactating women
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 002: Jan 19, 2024
Dec 30, 2042U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJun 17, 2024 
Exclusivity Code: ODE - Orphan drug exclusivityJun 17, 2026ODE-254: Indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy

AYTU
KARBINAL ER (SUSPENSION, EXTENDED RELEASE) (ORAL) CARBINOXAMINE MALEATE
Drug Classes: histamine-1 (H1) receptor antagonist
NDA Applicant: AYTU      NDA No.:
022556  Prod. No.: 001 RX (4MG/5ML)
PatentsExpirationPatented Use
Pat. No. 8062667 DP* Modified release formulations containing drug-ion exchange resin complexes
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 18, 2013
Mar 29, 2029 
Pat. No. 9522191 DP* Modified release formulations containing drug--ion exchange resin complexes
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 22, 2016
Jun 15, 2027 

AYTU
ZOLPIMIST (SPRAY, METERED) (ORAL) ZOLPIDEM TARTRATE
Drug Classes: gamma-aminobutyric acid (GABA)-ergic agonist
NDA Applicant: AYTU      NDA No.:
022196  Prod. No.: 001 DISC (5MG/SPRAY)
PatentsExpirationPatented Use
Pat. No. 8236285 DS* DP* Buccal, polar and non-polar spray containing zolpidem
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
Aug 7, 2032U-70: Treatment of transient insomnia

AZURITY
EDARBI (TABLET) (ORAL) AZILSARTAN KAMEDOXOMIL
Drug Classes: angiotensin II receptor blocker
NDA Applicant: AZURITY      NDA No.:
200796  Prod. No.: 001 RX (EQ 40MG MEDOXOMIL); 002 RX (EQ 80MG MEDOXOMIL)
PatentsExpirationPatented Use
Pat. No. 7157584 DS* Benzimidazole derivative and use thereof
Claim Types: Compound
Pat. Sub. Date(s): All strengths: None
May 22, 2025 
Pat. No. 7572920 DP* Benzimidazole derivative and use as a II receptor antagonist
Claim Types: Composition; Method of use; Formulation; Process
Pat. Sub. Date(s): All strengths: None
Jan 7, 2025U-3: Treatment of hypertension
Pat. No. 9066936 DP* Solid pharmaceutical composition comprising a benzimidazole-7-carboxylate derivative and a pH control agent
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Jul 30, 2015
Mar 26, 2028 

AZURITY
EDARBYCLOR (TABLET) (ORAL) AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE
Drug Classes: angiotensin II receptor blocker == thiazide-like diuretic
NDA Applicant: AZURITY      NDA No.:
202331  Prod. No.: 001 RX (EQ 40MG MEDOXOMIL;12.5MG); 002 RX (EQ 40MG MEDOXOMIL;25MG)
PatentsExpirationPatented Use
Pat. No. 7157584 DS* Benzimidazole derivative and use thereof
Claim Types: Compound
Pat. Sub. Date(s): 001: Jan 17, 2012; 002: None
May 22, 2025 
Pat. No. 7572920 DP* Benzimidazole derivative and use as a II receptor antagonist
Claim Types: Composition; Method of use; Formulation; Process
Pat. Sub. Date(s): 001: Jan 17, 2012; 002: None
Jan 7, 2025U-3: Treatment of hypertension
Pat. No. 9066936 DP* Solid pharmaceutical composition comprising a benzimidazole-7-carboxylate derivative and a pH control agent
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Jul 30, 2015
Mar 26, 2028 
Pat. No. 9169238 DP* Solid pharmaceutical composition
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Nov 19, 2015
Feb 4, 2030 
Pat. No. 9387249 Methods of treating hypertension with at least one angiotensin II receptor blocker and chlorthalidone
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 15, 2019
Jul 1, 2031U-3: Treatment of hypertension

AZURITY
EPANED (SOLUTION) (ORAL) ENALAPRIL MALEATE [GENERIC AB]
NDA Applicant: AZURITY      NDA No.:
208686  Prod. No.: 001 RX (1MG/ML)
PatentsExpirationPatented Use
Pat. No. 9669008 DP* Enalapril formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 9, 2017
Mar 25, 2036 
Pat. No. 9808442 Enalapril formulations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 20, 2017
Mar 25, 2036U-1723: Treatment of heart failure
U-185: Method of treating hypertension
U-1892: Method of treating left ventricular dysfunction
U-3: Treatment of hypertension
U-71: Method of treatment of heart failure
Pat. No. 10039745 DP* Enalapril formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 23, 2018
Mar 25, 2036 
Pat. No. 10154987 Enalapril formulations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 4, 2019
Mar 25, 2036U-1723: Treatment of heart failure
U-185: Method of treating hypertension
U-1892: Method of treating left ventricular dysfunction
U-3: Treatment of hypertension
U-71: Method of treatment of heart failure
Pat. No. 10772868 DP* Enalapril formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 23, 2020
Mar 25, 2036 
Pat. No. 10786482 DP* Enalapril formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 8, 2020
Mar 25, 2036 
Pat. No. 11040023 DP* Enalapril formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 25, 2021
Mar 25, 2036 
Pat. No. 11141405 DP* Enalapril formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 19, 2021
Mar 25, 2036 
Pat. No. 11173141 DP* Enalapril formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 8, 2022
Mar 25, 2036 

AZURITY
EPRONTIA (SOLUTION) (ORAL) TOPIRAMATE
NDA Applicant: AZURITY      NDA No.:
214679  Prod. No.: 001 RX (25MG/ML)
PatentsExpirationPatented Use
Pat. No. 11433046 Compositions and methods for treating epilepsy, seizures and other conditions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 13, 2022
Aug 21, 2040U-3413: Indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older
U-3414: Indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older
U-3415: Indicated for the preventive treatment of migraine in patients 12 years and older
Pat. No. 11633374 DP* Compositions and methods for treating epilepsy, seizures and other conditions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 27, 2023
Aug 21, 2040 
Pat. No. 11826343 DP* Compositions and methods for treating epilepsy, seizures and other conditions
Claim Types: Formulation; Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): 001: Dec 11, 2023
Aug 21, 2040 

AZURITY
EVEKEO ODT (TABLET, ORALLY DISINTEGRATING) (ORAL) AMPHETAMINE SULFATE
Drug Classes: adrenergic agonist == amphetamine anorectic == central nervous system (CNS) stimulant == central nervous system stimulant
NDA Applicant: AZURITY      NDA No.:
209905  Prod. No.: 001 RX (5MG); 002 RX (10MG); 003 RX (15MG); 004 RX (20MG)
PatentsExpirationPatented Use
Pat. No. 10130580 DP* Taste-masked pharmaceutical compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jan 31, 2019
Apr 19, 2024 
Pat. No. 10441554 DP* Oral amphetamine composition
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Oct 15, 2019
Mar 10, 2037 
Pat. No. 11160772 DP* Oral amphetamine composition
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Dec 9, 2021
Mar 10, 2037 
Pat. No. 11896562 Oral amphetamine composition
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 16, 2024
Mar 10, 2037U-3299: Treatment of attention deficit hyperactivity disorder (ADHD) in pediatric patients

AZURITY
EVEKEO ODT (TABLET, ORALLY DISINTEGRATING) (ORAL) AMPHETAMINE SULFATE
Drug Classes: adrenergic agonist == amphetamine anorectic == central nervous system (CNS) stimulant == central nervous system stimulant
NDA Applicant: AZURITY      NDA No.:
209905  Prod. No.: 005 DISC (2.5MG**)
PatentsExpirationPatented Use
Pat. No. 10130580 DP* Taste-masked pharmaceutical compositions
Claim Types: Formulation
Pat. Sub. Date(s): 005: Jul 7, 2021
Apr 19, 2024 
Pat. No. 10441554 DP* Oral amphetamine composition
Claim Types: Formulation
Pat. Sub. Date(s): 005: Jul 7, 2021
Mar 10, 2037 
Pat. No. 11160772 DP* Oral amphetamine composition
Claim Types: Formulation
Pat. Sub. Date(s): 005: Dec 9, 2021
Mar 10, 2037 

AZURITY
FIRVANQ KIT (FOR SOLUTION) (ORAL) VANCOMYCIN HYDROCHLORIDE [GENERIC AB]
Drug Classes: glycopeptide antibacterial
NDA Applicant: AZURITY      NDA No.:
208910  Prod. No.: 001 RX (EQ 25MG BASE/ML); 002 RX (EQ 50MG BASE/ML)
PatentsExpirationPatented Use
Pat. No. 10493028 DP* Composition and method for vancomycin oral liquid
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Dec 5, 2019
Mar 13, 2035 
Pat. No. 10688046 DP* Composition and method for vancomycin oral liquid
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jul 10, 2020
Mar 13, 2035 
Pat. No. 10959946 DP* Composition and method for vancomycin oral liquid
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Apr 15, 2021
Mar 13, 2035 
Pat. No. 10959947 DP* Composition and method for vancomycin oral liquid
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Apr 15, 2021
Mar 13, 2035U-3104: Treatment of C. difficile-associated diarrhea
U-3105: Treatment of staphylococcal enterocolitis
Pat. No. 10959948 DP* Composition and method for vancomycin oral liquid
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Apr 15, 2021
Mar 13, 2035U-3104: Treatment of C. difficile-associated diarrhea
U-3105: Treatment of staphylococcal enterocolitis
Pat. No. 10959949 DP* Composition and method for vancomycin oral liquid
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Apr 15, 2021
Mar 13, 2035U-3104: Treatment of C. difficile-associated diarrhea
U-3105: Treatment of staphylococcal enterocolitis
Pat. No. 11638692 DP* Composition and method for vancomycin oral liquid
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 2, 2023
Mar 13, 2035 

AZURITY
FLEQSUVY (SUSPENSION) (ORAL) BACLOFEN [GENERIC AB]
Drug Classes: gamma-aminobutyric acid (GABA)-ergic agonist
NDA Applicant: AZURITY      NDA No.:
215602  Prod. No.: 001 RX (25MG/5ML)
PatentsExpirationPatented Use
Pat. No. 11324696 DP* Suspensions and diluents for metronidazole and baclofen
Claim Types: Formulation
Pat. Sub. Date(s): 001: May 16, 2022
Sep 29, 2037 
Pat. No. 11446246 Suspensions and diluents for metronidazole and baclofen
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 30, 2022
Sep 8, 2037U-3433: Indicated for the treatment of spasticity resulting from multiple sclerosis

AZURITY
HORIZANT (TABLET, EXTENDED RELEASE) (ORAL) GABAPENTIN ENACARBIL
NDA Applicant: AZURITY      NDA No.:
022399  Prod. No.: 001 RX (600MG); 002 RX (300MG)
PatentsExpirationPatented Use
Pat. No. 6818787 DS* DP* [Extended 882 days (2.4 years)]
Prodrugs of GABA analogs, compositions and uses thereof
Claim Types: Compound
Pat. Sub. Date(s): 001: Apr 19, 2011; 002: Jan 5, 2012
Apr 6, 2025 
Pat. No. 8026279 DS* DP* Crystalline form of .gamma.-aminobutyric acid analog
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Oct 24, 2011; 002: Jan 5, 2012
Nov 10, 2026 
Pat. No. 8114909 Treating or preventing restless legs syndrome using prodrugs of GABA analogs
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 13, 2012; 002: None
Apr 11, 2026U-1231: Treatment of moderate-to-severe primary restless leg syndrome in adults
Pat. No. 8686034 Crystalline form of .gamma.-aminobutyric acid analog
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 28, 2014
Jan 24, 2025U-1231: Treatment of moderate-to-severe primary restless leg syndrome in adults
U-1247: Management of postherpetic neuralgia (PHN) in adults
Pat. No. 8795725 DP* GABA analog prodrug sustained release oral dosage forms
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Aug 27, 2014
Jun 10, 2029U-1231: Treatment of moderate-to-severe primary restless leg syndrome in adults
U-1247: Management of postherpetic neuralgia (PHN) in adults

AZURITY
KATERZIA (SUSPENSION) (ORAL) AMLODIPINE BENZOATE
Drug Classes: calcium channel blocker == dihydropyridine calcium channel blocker
NDA Applicant: AZURITY      NDA No.:
211340  Prod. No.: 001 RX (EQ 1MG BASE/ML)
PatentsExpirationPatented Use
Pat. No. 10695329 DP* Amlodipine formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 22, 2020
Oct 16, 2037 
Pat. No. 10799453 DP* Amlodipine formulations
Claim Types: Product-by-process
Pat. Sub. Date(s): 001: Nov 2, 2020
Apr 11, 2039 
Pat. No. 10894039 Amlodipine formulations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 16, 2021
Oct 6, 2037U-185: Method of treating hypertension
U-3: Treatment of hypertension
Pat. No. 10952998 DP* Amlodipine formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 29, 2021
Oct 6, 2037 
Pat. No. 10959991 Amlodipine formulations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 15, 2021
Oct 6, 2037U-158: Angina
U-39: Angina pectoris
Pat. No. 11364230 DP* Amlodipine formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 24, 2022
Oct 6, 2037 
Pat. No. 11471409 Amlodipine formulations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 18, 2022
Oct 6, 2037U-3447: A method of treating coronary artery disease
U-3448: A method of treating hypertension
Pat. No. 11484498 DP* Amlodipine Formulations
Claim Types: Product-by-process
Pat. Sub. Date(s): 001: Nov 4, 2022
Oct 6, 2037 
Pat. No. 11701326 DP* Amlodipine formulations
Claim Types: Product-by-process
Pat. Sub. Date(s): 001: Jul 20, 2023
Oct 6, 2037 

AZURITY
KONVOMEP (FOR SUSPENSION) (ORAL) OMEPRAZOLE; SODIUM BICARBONATE
Drug Classes: proton pump inhibitor
NDA Applicant: AZURITY      NDA No.:
213593  Prod. No.: 001 RX (2MG/ML;84MG/ML)
PatentsExpirationPatented Use
Pat. No. 10751333 DP* Compositions and kits for omeprazole suspension
Claim Types: Excipient; Formulation; Formulation claimed by its inherent performace characteristics; Kit
Pat. Sub. Date(s): 001: Oct 21, 2022
Jul 16, 2039 
Pat. No. 11103492 DP* Compositions and kits for omeprazole suspension
Claim Types: Excipient
Pat. Sub. Date(s): 001: Oct 21, 2022
Jul 16, 2039 
Pat. No. 11633478 DP* Compositions and kits for Omeprazole suspension
Claim Types: Excipient
Pat. Sub. Date(s): 001: May 12, 2023
Jul 16, 2039 
Pat. No. 11771686 Compositions and kits for omeprazole suspension
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 30, 2023
Mar 1, 2040U-623: Short term treatment of active benign gastric ulcer

AZURITY
NYMALIZE (SOLUTION) (ORAL) NIMODIPINE
Drug Classes: dihydropyridine calcium channel blocker
NDA Applicant: AZURITY      NDA No.:
203340  Prod. No.: 002 RX (6MG/ML)
PatentsExpirationPatented Use
Pat. No. 8517997 DP* Dispenser for medicaments and method and apparatus for making same
Claim Types: Device
Pat. Sub. Date(s): 002: Jul 8, 2020
May 14, 2024 
Pat. No. 10342787 DP* Non-aqueous liquid nimodipine compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: May 8, 2020
Apr 16, 2038U-2804: A method for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms
Pat. No. 10576070 DP* Non-aqueous liquid nimodipine compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: May 8, 2020
Apr 16, 2038U-2804: A method for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms
Pat. No. 11207306 Non-aqueous liquid nimodipine compositions
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 26, 2022
Apr 16, 2038U-2804: A method for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms
Pat. No. 11413277 DP* Non-aqueous liquid nimodipine compositions
Claim Types: Formulation claimed by its inherent performace characteristics; Method of improving a treatment
Pat. Sub. Date(s): 002: Aug 25, 2022
Apr 16, 2038U-2804: A method for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms
Pat. No. 11806338 DP* Non-aqueous liquid nimodipine compositions
Claim Types: Formulation claimed by its inherent performace characteristics; Device
Pat. Sub. Date(s): 002: Nov 17, 2023
Apr 16, 2038 

AZURITY
PREVDUO (SOLUTION) (INTRAVENOUS) GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE
Drug Classes: anticholinergic == antimuscarinic agent == cholinesterase inhibitor
NDA Applicant: AZURITY      NDA No.:
216903  Prod. No.: 001 RX (0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML))
PatentsExpirationPatented Use
Pat. No. 10456354 DP* Ready-to-use injectable pharmaceutical compositions comprising neostigmine and glycopyrrolate
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 24, 2023
Oct 25, 2038 
Pat. No. 11110054 DP* Ready-to-use injectable pharmaceutical compositions comprising neostigmine and glycopyrrolate
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 24, 2023
Oct 25, 2038 

AZURITY
QBRELIS (SOLUTION) (ORAL) LISINOPRIL
Drug Classes: angiotensin converting enzyme (ACE) inhibitor
NDA Applicant: AZURITY      NDA No.:
208401  Prod. No.: 001 RX (1MG/ML)
PatentsExpirationPatented Use
Pat. No. 9463183 DP* Lisinopril formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 13, 2016
Nov 6, 2035 
Pat. No. 9616096 Lisinopril formulations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 14, 2017
Nov 6, 2035U-1723: Treatment of heart failure
U-185: Method of treating hypertension
U-1864: Treatment of myocardial infarction
U-1991: Reduction of mortality in acute myocardial infarction
U-3: Treatment of hypertension
U-71: Method of treatment of heart failure
U-8: Acute myocardial infarction
Pat. No. 9814751 DP* Lisinopril formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 21, 2017
Nov 6, 2035 
Pat. No. 10039800 Lisinopril formulations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 23, 2018
Nov 6, 2035U-1723: Treatment of heart failure
U-185: Method of treating hypertension
U-1864: Treatment of myocardial infarction
U-1991: Reduction of mortality in acute myocardial infarction
U-3: Treatment of hypertension
U-71: Method of treatment of heart failure
U-8: Acute myocardial infarction
Pat. No. 10265370 DP* Lisinopril formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 29, 2019
Nov 6, 2035 
Pat. No. 10406199 Lisinopril formulations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 20, 2019
Nov 6, 2035U-1723: Treatment of heart failure
U-185: Method of treating hypertension
U-1864: Treatment of myocardial infarction
U-1991: Reduction of mortality in acute myocardial infarction
U-3: Treatment of hypertension
U-71: Method of treatment of heart failure
U-8: Acute myocardial infarction
Pat. No. 10940177 DP* Lisinopril formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 15, 2021
Nov 6, 2035 
Pat. No. 11179434 DP* Lisinopril formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 23, 2021
Nov 6, 2035 
Pat. No. 11771733 DP* Lisinopril formulations
Claim Types: Formulation; Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): 001: Oct 4, 2023
Nov 6, 2035 

AZURITY
SOTYLIZE (SOLUTION) (ORAL) SOTALOL HYDROCHLORIDE
Drug Classes: antiarrhythmic
NDA Applicant: AZURITY      NDA No.:
205108  Prod. No.: 001 RX (5MG/ML (5MG/ML))
PatentsExpirationPatented Use
Pat. No. 9724297 DP* Sotalol compositions and uses of the same
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 7, 2017
Aug 31, 2035U-2096: SOTYLIZE is indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (Afib/AFL)] in patients with symptomatic Afib/AFL who are currently in sinus rhythm
Pat. No. 10206895 DP* Sotalol compositions and uses of the same
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Mar 7, 2019
Apr 1, 2034U-2096: SOTYLIZE is indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (Afib/AFL)] in patients with symptomatic Afib/AFL who are currently in sinus rhythm
U-2494: Indicated for the treatment of ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgement of the physician are life-threatening
Pat. No. 11013703 DP* Sotalol compositions and uses of the same
Claim Types: Formulation
Pat. Sub. Date(s): 001: May 26, 2021
Apr 1, 2034 
Pat. No. 11850222 Sotalol compositions and uses of the same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 5, 2024
Nov 19, 2034U-2096: SOTYLIZE is indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (Afib/AFL)] in patients with symptomatic Afib/AFL who are currently in sinus rhythm
U-2494: Indicated for the treatment of ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgement of the physician are life-threatening

AZURITY
THYQUIDITY (SOLUTION) (ORAL) LEVOTHYROXINE SODIUM
Drug Classes: L-thyroxine (T4)
NDA Applicant: AZURITY      NDA No.:
214047  Prod. No.: 001 RX (100MCG/5ML)
PatentsExpirationPatented Use
Pat. No. 9050307 DP* Method for the preparation of a levothyroxine solution
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Dec 14, 2020
Aug 6, 2031 

AZURITY
TRIPTODUR KIT (FOR SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) TRIPTORELIN PAMOATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: AZURITY      NDA No.:
208956  Prod. No.: 001 RX (EQ 22.5MG BASE/VIAL)
PatentsExpirationPatented Use
Pat. No. 10166181 DP* Slow release pharmaceutical composition made of microgranules
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 25, 2019
Jun 30, 2029 
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityJun 29, 2024ODE-149: Treatment of pediatric patients 2 years of age and older with central precocious puberty

AZURITY
XATMEP (SOLUTION) (ORAL) METHOTREXATE SODIUM
Drug Classes: folate analog metabolic inhibitor
NDA Applicant: AZURITY      NDA No.:
208400  Prod. No.: 001 RX (EQ 2.5MG BASE/ML)
PatentsExpirationPatented Use
Pat. No. 9259427 DP* Methotrexate composition
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: May 12, 2017
Jan 2, 2033 
Pat. No. 9855215 DP* Methotrexate composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 19, 2018
Jan 2, 2033 
Pat. No. 10231927 Methotrexate composition
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 1, 2019
Jan 2, 2033U-1349: Treatment of juvenile rheumatoid arthritis
U-1699: A method for treating acute lymphoblastic leukemia
Pat. No. 10610485 DP* Methotrexate composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 16, 2020
Jan 2, 2033 
Pat. No. 11116724 Methotrexate composition
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 23, 2021
Jan 2, 2033U-1349: Treatment of juvenile rheumatoid arthritis
U-1699: A method for treating acute lymphoblastic leukemia
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityApr 25, 2024ODE-137: Treatment of oligoarticular juvenile idiopathic arthritis (persistent oligoarthritis, psoriatic juvenile idiopathic arthritis, enthesitis-related arthritis, or undifferentiated arthritis) & polyarticular juvenile idiopathic arthritis in children 0-16 yrs
Exclusivity Code: ODE - Orphan drug exclusivityApr 25, 2024ODE-138: Treatment of pediatric patients with acute lymphoblastic leukemia as a component of a combination chemotherapy maintenance regimen

AZURITY
ZONISADE (SUSPENSION) (ORAL) ZONISAMIDE
Drug Classes: antiepileptic drug (AED)
NDA Applicant: AZURITY      NDA No.:
214273  Prod. No.: 001 RX (100MG/5ML)
PatentsExpirationPatented Use
Pat. No. 11478456 Oral Pharmaceutical Composition Comprising Zonisamide And Process Of Preparation Thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 26, 2022
Aug 18, 2038U-3458: A method of treating seizures
Pat. No. 11529333 DP* Oral pharmaceutical composition comprising zonisamide and process of preparation thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 27, 2022
Aug 18, 2038 


DS*=Drug Substance and DP*=Drug Product: patent submitted for the product after Aug. 18, 2003.
** Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
DLR* NDA holder has requested delisting of the patent. However, FDA will not delist if doing so would adversely affect an ANDA applicant's eligibility for 180-day generic exclusivity. ANDA applicants must provide a patent certification for the patent, but 505(b)(2) applicants do not need to do so.
Last edited: 12 March 2024
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