Orange Book Companion
Patent Expiration View
Products whose next patent expiration is in 2021

Patents whose numbers are in italics have been extended under 35 USC 156. 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.


CLEVIPREX (EMULSION) (INTRAVENOUS) CLEVIDIPINE
Drug Classes: dihydropyridine calcium channel blocker
NDA Applicant: CHIESI USA INC      NDA No.: 022156  Prod. No.: 001 RX (25MG/50ML (0.5MG/ML)); 002 RX (50MG/100ML (0.5MG/ML)) NDA No.: 022156  Prod. No.: 003 DISC (125MG/250ML (0.5MG/ML))
PatentsExpirationPatented Use
Pat. No. 5856346 DS* DP* [Extended 5 years]
Short-acting dihydropyridines
Claim Types: Compound; Process; Composition; Formulation
Pat. Sub. Date(s): 001: None; 002: None; 003: Mar 6, 2014
Jan 5, 2021U-893: CLEVIPREX is a dihydropyridine calcium channel blocker indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable
Pat. No. 8658676 DP* Clevidipine emulsion formulations containing antimicrobial agents
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Mar 6, 2014
Oct 10, 2031 
Pat. No. 10010537 DP* Clevidipine emulsion formulations containing antimicrobial agents
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 12, 2018
Oct 10, 2031 

ADDERALL 10; ADDERALL 20; ADDERALL 5; ADDERALL 30; ADDERALL 7.5; ADDERALL 12.5; ADDERALL 15 (TABLET) (ORAL) AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: TEVA WOMENS      NDA No.: 011522  Prod. No.: 007 DISC (2.5MG;2.5MG;2.5MG;2.5MG**); 008 DISC (5MG;5MG;5MG;5MG**); 009 DISC (1.25MG;1.25MG;1.25MG;1.25MG**); 010 DISC (7.5MG;7.5MG;7.5MG;7.5MG**); 011 DISC (1.875MG;1.875MG;1.875MG;1.875MG**); 012 DISC (3.125MG;3.125MG;3.125MG;3.125MG**); 013 DISC (3.75MG;3.75MG;3.75MG;3.75MG**)
PatentsExpirationPatented Use
Pat. No. 6384020 Rapid immediate release oral dosage form
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Jan 6, 2021 *PED 

ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER; ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER (SOLUTION) (INTRAVENOUS) ESMOLOL HYDROCHLORIDE
Drug Classes: beta-adrenergic receptor inhibitor
NDA Applicant: HQ SPCLT PHARMA      NDA No.: 205703  Prod. No.: 001 RX (2.5GM/250ML (10MG/ML)); 002 RX (2GM/100ML (20MG/ML))
PatentsExpirationPatented Use
Pat. No. 6310094 DP* Ready-to-use esmolol solution
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: May 18, 2016
Jan 12, 2021 
Pat. No. 6528540 DP* Esmolol formulation
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: May 18, 2016
Jan 12, 2021 
Pat. No. 8829054 DP* Ready-to-use co-solvents pharmaceutical composition in modified flexible plastic container
Claim Types: Formulation; Drug in a container; Method of use; Process
Pat. Sub. Date(s): All strengths: May 18, 2016
Mar 15, 2033 
Pat. No. 8835505 DP* Ready-to-use co-solvents pharmaceutical composition in modified flexible plastic container
Claim Types: Drug in a container; Method of use, Process
Pat. Sub. Date(s): All strengths: May 18, 2016
Mar 15, 2033 

CARNITOR (INJECTABLE) (INJECTION) LEVOCARNITINE [GENERIC AP]
Drug Classes: carnitine analog
NDA Applicant: LEADIANT BIOSCI INC      NDA No.: 020182  Prod. No.: 001 RX (200MG/ML)
PatentsExpirationPatented Use
Pat. No. 6335369 Treating chronic uremic patients undergoing periodical dialysis
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Jan 18, 2021U-433: Use of levocarnitine in prevention and treatment of carnitine deficiency in patients with end stage renal disease who are undergoing dialysis
Pat. No. 6429230 Treating chronic uremic patients undergoing periodical dialysis
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Jan 18, 2021U-433: Use of levocarnitine in prevention and treatment of carnitine deficiency in patients with end stage renal disease who are undergoing dialysis
Pat. No. 6696493 Treating chronic uremic patients undergoing periodic dialysis
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Jan 18, 2021U-433: Use of levocarnitine in prevention and treatment of carnitine deficiency in patients with end stage renal disease who are undergoing dialysis

ORILISSA (TABLET) (ORAL) ELAGOLIX SODIUM
NDA Applicant: ABBVIE INC      NDA No.: 210450  Prod. No.: 001 RX (EQ 150MG BASE); 002 RX (EQ 200MG BASE)
PatentsExpirationPatented Use
Pat. No. 6872728 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods relating thereto
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Aug 20, 2018
Jan 25, 2021 
Pat. No. 7462625 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods relating thereto
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Aug 20, 2018
Jan 25, 2021U-2360: Management of moderate to severe pain associated with endometriosis
Pat. No. 7179815 Gonadotropin-releasing hormone receptor antagonists and methods relating thereto
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 20, 2018
Mar 7, 2021U-2360: Management of moderate to severe pain associated with endometriosis
Pat. No. 7176211 Gonadotropin-releasing hormone receptor antagonists and methods relating thereto
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 20, 2018
Jul 6, 2024U-2360: Management of moderate to severe pain associated with endometriosis
Pat. No. 7419983 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods related thereto
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Aug 20, 2018
Jul 6, 2024U-2360: Management of moderate to severe pain associated with endometriosis
Pat. No. 7056927 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods relating thereto
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Aug 20, 2018
Sep 10, 2024 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJul 23, 2023 

LATISSE (SOLUTION/DROPS) (TOPICAL) BIMATOPROST [GENERIC AT]
Drug Classes: prostaglandin analog
NDA Applicant: ALLERGAN      NDA No.: 022369  Prod. No.: 001 RX (0.03%)
PatentsExpirationPatented Use
Pat. No. 8541466 Compositions and methods for treating hair loss using non-naturally occurring prostaglandins
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 27, 2015
Jan 31, 2021U-1217: Method of increasing hair growth
Pat. No. 8906962 Compositions and methods for treating hair loss using non-naturally occurring prostaglandins
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 9, 2014
Jan 31, 2021U-1217: Method of increasing hair growth
Pat. No. 9579270 Compositions and methods for treating hair loss using non-naturally occurring prostaglandins
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 16, 2017
Jan 31, 2021U-1975: Method of increasing eyelash growth with bimatoprost
Pat. No. 8263054 Method of enhancing hair growth
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 17, 2012
Jan 15, 2023U-1277: Method of increasing eyelash growth including length, thickness, darkness and/or number of eyelashes by administering bimatoprost to an eyelid margin
Pat. No. 8632760 Method of enhancing hair growth
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 21, 2014
Jan 15, 2023U-1487: Method of increasing eyelash growth
Pat. No. 8758733 Topical treatment for chemotherapy induced eyelash loss or hypotrichosis using prostamide F2 alpha agonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 16, 2014
Jan 15, 2023U-1487: Method of increasing eyelash growth
Pat. No. 8986715 Method of enhancing hair growth
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 1, 2015
Jan 15, 2023U-1217: Method of increasing hair growth
Pat. No. 9216183 Topical treatment for chemotherapy induced eyelash loss or hypotrichosis using prostamide F2 alpha agonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 20, 2016
Jan 15, 2023U-1487: Method of increasing eyelash growth
Pat. No. 9226931 Topical treatment for chemotherapy induced eyelash loss or hypotrichosis using prostamide F2 alpha agonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 20, 2016
Jan 15, 2023U-1799: Method of increasing growth of hair including eyelashes
Pat. No. 8038988 DS* DP* Method of enhancing hair growth
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 31, 2011
Aug 25, 2023U-1208: Treatment of hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness
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

FORTICAL (SPRAY, METERED) (NASAL) CALCITONIN SALMON RECOMBINANT
Drug Classes: calcitonin
NDA Applicant: UPSHER SMITH LABS      NDA No.: 021406  Prod. No.: 001 DISC (200 IU/SPRAY**)
PatentsExpirationPatented Use
Pat. No. RE43580 DP* Nasal calcitonin formulations
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Apr 26, 2013
Feb 2, 2021U-227: Nasal administration
Pat. No. RE40812 DP* Nasal calcitonin formulation
Claim Types: Formulation; Method of administration; Process
Pat. Sub. Date(s): 001: None
Feb 2, 2021 
Pat. No. 6440392 DP* Nasal calcitonin formulations
Claim Types: Formulation; Process; ; Method of administration
Pat. Sub. Date(s): 001: None
Feb 2, 2021U-227: Nasal administration

CRESTOR (TABLET) (ORAL) ROSUVASTATIN CALCIUM [GENERIC AB]
Drug Classes: HMG CoA-reductase inhibitor
NDA Applicant: IPR      NDA No.: 021366  Prod. No.: 002 RX (5MG); 003 RX (10MG)
PatentsExpirationPatented Use
Pat. No. 6316460 DP* Pharmaceutical compositions
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: None
Feb 4, 2021 *PED 
Pat. No. 6858618 Use of rosuvastatin (zd-4522) in the treatment of heterozygous familial hypercholesterolemia
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Jun 17, 2022 *PEDU-1032: Use of rosuvastatin calcium for the primary prevention of cardiovascular disease in individuals without clinically evident coronary heart disease but with increased risk factors
U-1807: Treatment of pediatric patients 8 to 17 years of age with heterozygous familial hypercholesterolemia (HEFH)
U-618: Use of rosuvastatin calcium to reduce elevated total-c, LDL-c, ApoB,nonHDL-c or TG levels;to increase HDL-c; in adult patients with primary hyperlipidemia or mixed dyslipidemia; and to slow the progression of atherosclerosis
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityMay 27, 2023ODE-118: An adjunct to diet to reduce LDL-C, total-C, nonHDL-C and apob in children and adolescents 7 to 17 years of age with homozygous familial hypercholesterolemia, either alone or with other lipid-lowering treatments (e.g., LDL apheresis)

CRESTOR (TABLET) (ORAL) ROSUVASTATIN CALCIUM [GENERIC AB]
Drug Classes: HMG CoA-reductase inhibitor
NDA Applicant: IPR      NDA No.: 021366  Prod. No.: 004 RX (20MG)
PatentsExpirationPatented Use
Pat. No. 6316460 DP* Pharmaceutical compositions
Claim Types: Formulation; Process
Pat. Sub. Date(s): 004: None
Feb 4, 2021 *PED 
Pat. No. 6858618 Use of rosuvastatin (zd-4522) in the treatment of heterozygous familial hypercholesterolemia
Claim Types: Method of use
Pat. Sub. Date(s): 004: None
Jun 17, 2022 *PEDU-1032: Use of rosuvastatin calcium for the primary prevention of cardiovascular disease in individuals without clinically evident coronary heart disease but with increased risk factors
U-1807: Treatment of pediatric patients 8 to 17 years of age with heterozygous familial hypercholesterolemia (HEFH)
U-618: Use of rosuvastatin calcium to reduce elevated total-c, LDL-c, ApoB,nonHDL-c or TG levels;to increase HDL-c; in adult patients with primary hyperlipidemia or mixed dyslipidemia; and to slow the progression of atherosclerosis
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMay 27, 2019I-732: Treatment of pediatric patients 7 to 17 years of age with homozygous familial hypercholesterolemia to reduce LDL-C, total C, NonHDL-C and APOB as an adjunct to diet, either alone or with other lipid-lowering treatments
Exclusivity Code: ODE - Orphan drug exclusivityMay 27, 2023ODE-118: An adjunct to diet to reduce LDL-C, total-C, nonHDL-C and apob in children and adolescents 7 to 17 years of age with homozygous familial hypercholesterolemia, either alone or with other lipid-lowering treatments (e.g., LDL apheresis)

CRESTOR (TABLET) (ORAL) ROSUVASTATIN CALCIUM [GENERIC AB]
Drug Classes: HMG CoA-reductase inhibitor
NDA Applicant: IPR      NDA No.: 021366  Prod. No.: 005 RX (40MG)
PatentsExpirationPatented Use
Pat. No. 6316460 DP* Pharmaceutical compositions
Claim Types: Formulation; Process
Pat. Sub. Date(s): 005: None
Feb 4, 2021 *PED 
Pat. No. 6858618 Use of rosuvastatin (zd-4522) in the treatment of heterozygous familial hypercholesterolemia
Claim Types: Method of use
Pat. Sub. Date(s): 005: None
Jun 17, 2022 *PEDU-618: Use of rosuvastatin calcium to reduce elevated total-c, LDL-c, ApoB,nonHDL-c or TG levels;to increase HDL-c; in adult patients with primary hyperlipidemia or mixed dyslipidemia; and to slow the progression of atherosclerosis
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityMay 27, 2023ODE-118: An adjunct to diet to reduce LDL-C, total-C, nonHDL-C and apob in children and adolescents 7 to 17 years of age with homozygous familial hypercholesterolemia, either alone or with other lipid-lowering treatments (e.g., LDL apheresis)

CRIXIVAN (CAPSULE) (ORAL) INDINAVIR SULFATE
Drug Classes: HIV protease inhibitor
NDA Applicant: MERCK SHARP DOHME      NDA No.: 020685  Prod. No.: 001 RX (EQ 400MG BASE); 003 RX (EQ 200MG BASE) NDA No.: 020685  Prod. No.: 005 DISC (EQ 333MG BASE); 006 DISC (EQ 100MG BASE)
PatentsExpirationPatented Use
Pat. No. 6689761 Combination therapy for HIV infection
Claim Types: Composition; Method of use
Pat. Sub. Date(s): All strengths: None
Feb 10, 2021U-554: Treating HIV infection with indinavir sulfate in combination with antiretroviral agents

ENJUVIA (TABLET) (ORAL) ESTROGENS, CONJUGATED SYNTHETIC B
Drug Classes: estrogen
NDA Applicant: ASPEN      NDA No.: 021443  Prod. No.: 001 DISC (0.3MG); 002 DISC (0.45MG); 003 DISC (0.625MG**); 004 DISC (1.25MG**); 005 DISC (0.9MG)
PatentsExpirationPatented Use
Pat. No. 6855703 DS* DP* Pharmaceutical compositions of conjugated estrogens and methods of analyzing mixtures containing estrogenic compounds
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Feb 12, 2021U-904: Treatment of moderate to severe vasomotor symptoms associated with menopause
U-905: Treatment of moderate to severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, associated with menopause
Pat. No. 6660726 DS* DP* Estrogenic compounds, pharmaceutical compositions thereof, and methods of using same
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: None
Mar 8, 2021U-904: Treatment of moderate to severe vasomotor symptoms associated with menopause
U-905: Treatment of moderate to severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, associated with menopause

BRIVIACT (TABLET) (ORAL) BRIVARACETAM
NDA Applicant: UCB INC      NDA No.: 205836  Prod. No.: 001 RX (10MG); 002 RX (25MG); 003 RX (50MG); 004 RX (75MG); 005 RX (100MG)
PatentsExpirationPatented Use
Pat. No. 6784197 DS* DP* 2-oxo-1-pyrrolidine derivatives, processes for preparing them and their uses
Claim Types: Compound; Method of use; Composition
Pat. Sub. Date(s): All strengths: Feb 25, 2016
Feb 21, 2021U-2295: Treatment of partial-onset seizures in patients 4 years of age and older
Pat. No. 6911461 DS* DP* 2-oxo-1-pyrrolidine derivatives, processes for preparing them and their uses
Claim Types: Compound; Method of use; Composition
Pat. Sub. Date(s): All strengths: Feb 25, 2016
Feb 21, 2021U-2295: Treatment of partial-onset seizures in patients 4 years of age and older
Pat. No. 8492416 2-oxo-1-pyrrolidine derivatives, processes for preparing them and their uses
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 25, 2016
Feb 21, 2021U-2295: Treatment of partial-onset seizures in patients 4 years of age and older
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMay 12, 2021 

BRIVIACT (SOLUTION) (INTRAVENOUS) BRIVARACETAM
NDA Applicant: UCB INC      NDA No.: 205837  Prod. No.: 001 RX (50MG/5ML (10MG/ML))
PatentsExpirationPatented Use
Pat. No. 6784197 DS* DP* 2-oxo-1-pyrrolidine derivatives, processes for preparing them and their uses
Claim Types: Compound; Method of use; Composition
Pat. Sub. Date(s): 001: Feb 25, 2016
Feb 21, 2021U-1815: Treatment of partial-onset seizures as adjunctive therapy in patients with epilepsy aged 16 years and older with epilepsy
U-2130: Treatment of partial onset seizures in patients with epilepsy aged 16 years and older with epilepsy
Pat. No. 6911461 DS* DP* 2-oxo-1-pyrrolidine derivatives, processes for preparing them and their uses
Claim Types: Compound; Method of use; Composition
Pat. Sub. Date(s): 001: Feb 25, 2016
Feb 21, 2021U-1815: Treatment of partial-onset seizures as adjunctive therapy in patients with epilepsy aged 16 years and older with epilepsy
U-2130: Treatment of partial onset seizures in patients with epilepsy aged 16 years and older with epilepsy
Pat. No. 8492416 2-oxo-1-pyrrolidine derivatives, processes for preparing them and their uses
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 25, 2016
Feb 21, 2021U-1815: Treatment of partial-onset seizures as adjunctive therapy in patients with epilepsy aged 16 years and older with epilepsy
U-2130: Treatment of partial onset seizures in patients with epilepsy aged 16 years and older with epilepsy
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMay 12, 2021 

BRIVIACT (SOLUTION) (ORAL) BRIVARACETAM
NDA Applicant: UCB INC      NDA No.: 205838  Prod. No.: 001 RX (10MG/ML)
PatentsExpirationPatented Use
Pat. No. 6784197 DS* DP* 2-oxo-1-pyrrolidine derivatives, processes for preparing them and their uses
Claim Types: Compound; Method of use; Composition
Pat. Sub. Date(s): 001: Feb 25, 2016
Feb 21, 2021U-2295: Treatment of partial-onset seizures in patients 4 years of age and older
Pat. No. 6911461 DS* DP* 2-oxo-1-pyrrolidine derivatives, processes for preparing them and their uses
Claim Types: Compound; Method of use; Composition
Pat. Sub. Date(s): 001: Feb 25, 2016
Feb 21, 2021U-2295: Treatment of partial-onset seizures in patients 4 years of age and older
Pat. No. 8492416 2-oxo-1-pyrrolidine derivatives, processes for preparing them and their uses
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 25, 2016
Feb 21, 2021U-2295: Treatment of partial-onset seizures in patients 4 years of age and older
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMay 12, 2021 

ZOLADEX (IMPLANT) (IMPLANTATION) GOSERELIN ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TERSERA THERAPS LLC      NDA No.: 019726  Prod. No.: 001 RX (EQ 3.6MG BASE)
PatentsExpirationPatented Use
Pat. No. 7500964 DP* Automatically operable safety shield system for syringes
Claim Types: Device
Pat. Sub. Date(s): 001: None
Feb 26, 2021 
Pat. No. 7220247 DP* Automatically operable safety shield system for syringes
Claim Types: Device
Pat. Sub. Date(s): 001: None
Apr 9, 2022 
Pat. No. 7118552 DP* Automatically operable safety shield system for syringes
Claim Types: Device
Pat. Sub. Date(s): 001: None
Apr 13, 2022 

ZOLADEX (IMPLANT) (IMPLANTATION) GOSERELIN ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TERSERA THERAPS LLC      NDA No.: 020578  Prod. No.: 001 RX (EQ 10.8MG BASE)
PatentsExpirationPatented Use
Pat. No. 7500964 DP* Automatically operable safety shield system for syringes
Claim Types: Device
Pat. Sub. Date(s): 001: None
Feb 26, 2021 
Pat. No. 7220247 DP* Automatically operable safety shield system for syringes
Claim Types: Device
Pat. Sub. Date(s): 001: None
Apr 9, 2022 
Pat. No. 7118552 DP* Automatically operable safety shield system for syringes
Claim Types: Device
Pat. Sub. Date(s): 001: None
Apr 13, 2022 

ZYKADIA (CAPSULE) (ORAL) CERITINIB
Drug Classes: kinase inhibitor
NDA Applicant: NOVARTIS PHARMS CORP      NDA No.: 205755  Prod. No.: 001 DISC (150MG)
PatentsExpirationPatented Use
Pat. No. 7153964 DS* DP* Pyrimidine compounds
Claim Types: Compound; Process; Composition
Pat. Sub. Date(s): 001: May 13, 2014
Feb 26, 2021 
Pat. No. 8188276 DS* DP* 2,4-pyrimidinediamine compounds and their uses
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Jun 15, 2017
Jan 31, 2023 
Pat. No. 8835430 DS* DP* 2,4-pyrimidinediamine compounds and their uses
Claim Types: Compound; Composition; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Jun 15, 2017
Jan 31, 2023 
Pat. No. 9018204 DS* DP* 2,4-pyrimidinediamine compounds and their uses
Claim Types: Compound; Composition; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Jun 15, 2017
Jan 31, 2023 
Pat. No. 9416112 DS* DP* 2,4-pyrimidinediamine compounds and their uses
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jun 15, 2017
Jan 31, 2023 
Pat. No. 7893074 DS* DP* 2, 4-pyrimidinediamines useful in the treatment of neoplastic diseases, inflammatory and immune system disorders
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: May 13, 2014
Apr 25, 2026 
Pat. No. 7964592 DS* DP* 2,4-di (phenylamino) pyrimidines useful in the treatment of neoplastic diseases, inflammatory and immune system disorders
Claim Types: Compound; Process; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: May 13, 2014
Jan 13, 2027 
Pat. No. 8377921 Compounds and compositions as protein kinase inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 23, 2014
Nov 20, 2027U-1179: Treatment of a cancer mediated by an anaplastic lymphoma kinase (ALK)
Pat. No. 8399450 DS* DP* Compounds and compositions as protein kinase inhibitors
Claim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 001: Jun 15, 2017
Nov 20, 2027 
Pat. No. 8039479 DS* DP* Compounds and compositions as protein kinase inhibitors
Claim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 001: May 13, 2014
Jun 29, 2030 
Pat. No. 9309229 DS* DP* Crystalline forms of 5-chloro-N2-(2-isopropoxy-5-methyl-4-piperidin-4-yl-phenyl)-N4-[2-(propan- e-2-sulfonyl)-phenyl]-pyrimidine-2, 4-diamine
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: Apr 22, 2016
Jan 18, 2032 
Pat. No. 8703787 Methods of using ALK inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 23, 2014
Feb 2, 2032U-1179: Treatment of a cancer mediated by an anaplastic lymphoma kinase (ALK)
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousMay 26, 2020M-199: Information added to labeling regarding the treatment of patients with alk-positive non-small cell lung cancer (NSCLC) who had not received prior systemic therapy for metastatic disease.
Exclusivity Code: NCE - New chemical entityApr 29, 2019 
Exclusivity Code: ODE - Orphan drug exclusivityMay 26, 2024ODE-145: Treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test
Exclusivity Code: ODE - Orphan drug exclusivityApr 29, 2021ODE-66: Treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.

ZYKADIA (TABLET) (ORAL) CERITINIB
Drug Classes: kinase inhibitor
NDA Applicant: NOVARTIS PHARMS CORP      NDA No.: 211225  Prod. No.: 001 RX (150MG)
PatentsExpirationPatented Use
Pat. No. 7153964 DS* DP* Pyrimidine compounds
Claim Types: Compound; Process; Composition
Pat. Sub. Date(s): 001: Aug 2, 2019
Feb 26, 2021 
Pat. No. 8188276 DS* DP* 2,4-pyrimidinediamine compounds and their uses
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Aug 2, 2019
Jan 31, 2023 
Pat. No. 8835430 DS* DP* 2,4-pyrimidinediamine compounds and their uses
Claim Types: Compound; Composition; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Aug 2, 2019
Jan 31, 2023 
Pat. No. 9018204 DS* DP* 2,4-pyrimidinediamine compounds and their uses
Claim Types: Compound; Composition; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Aug 2, 2019
Jan 31, 2023 
Pat. No. 9416112 DS* DP* 2,4-pyrimidinediamine compounds and their uses
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Aug 2, 2019
Jan 31, 2023 
Pat. No. 7893074 DS* DP* 2, 4-pyrimidinediamines useful in the treatment of neoplastic diseases, inflammatory and immune system disorders
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 2, 2019
Apr 25, 2026 
Pat. No. 7964592 DS* DP* 2,4-di (phenylamino) pyrimidines useful in the treatment of neoplastic diseases, inflammatory and immune system disorders
Claim Types: Compound; Process; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 2, 2019
Jan 13, 2027 
Pat. No. 8377921 Compounds and compositions as protein kinase inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 2, 2019
Nov 20, 2027U-1179: Treatment of a cancer mediated by an anaplastic lymphoma kinase (ALK)
Pat. No. 8399450 DS* DP* Compounds and compositions as protein kinase inhibitors
Claim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 001: Aug 2, 2019
Nov 20, 2027 
Pat. No. 8039479 DS* DP* Compounds and compositions as protein kinase inhibitors
Claim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 001: Aug 2, 2019
Jun 29, 2030 
Pat. No. 9309229 DS* DP* Crystalline forms of 5-chloro-N2-(2-isopropoxy-5-methyl-4-piperidin-4-yl-phenyl)-N4-[2-(propan- e-2-sulfonyl)-phenyl]-pyrimidine-2, 4-diamine
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: Aug 2, 2019
Jan 18, 2032 
Pat. No. 8703787 Methods of using ALK inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 2, 2019
Feb 2, 2032U-1179: Treatment of a cancer mediated by an anaplastic lymphoma kinase (ALK)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityApr 29, 2019 

ANDROGEL (GEL; GEL, METERED) (TRANSDERMAL) TESTOSTERONE [GENERIC AB1]
Drug Classes: androgen
NDA Applicant: ABBVIE      NDA No.: 021015  Prod. No.: 001 RX (25MG/2.5GM PACKET); 002 RX (50MG/5GM PACKET); 003 RX (12.5MG/1.25GM ACTUATION)
PatentsExpirationPatented Use
Pat. No. 6503894 Pharmaceutical composition and method for treating hypogonadism
Claim Types: Formulation; Device; Method of administration
Pat. Sub. Date(s): All strengths: None
Mar 1, 2021 *PEDU-490: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
Pat. No. 9125816 Pharmaceutical composition and method for treating hypogonadism
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 14, 2015
Mar 2, 2021 *PEDU-490: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
Pat. No. 9132089 Pharmaceutical composition and method for treating hypogonadism
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 28, 2015
Mar 2, 2021 *PEDU-490: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone

ANDROGEL (GEL, METERED) (TRANSDERMAL) TESTOSTERONE [GENERIC AB]
Drug Classes: androgen
NDA Applicant: ABBVIE      NDA No.: 022309  Prod. No.: 001 RX (1.62% (20.25MG/1.25GM ACTUATION)); 002 RX (1.62% (20.25MG/1.25GM PACKET)); 003 RX (1.62% (40.5MG/2.5GM PACKET))
PatentsExpirationPatented Use
Pat. No. 6503894 Pharmaceutical composition and method for treating hypogonadism
Claim Types: Formulation; Device; Method of administration
Pat. Sub. Date(s): 001: None; 002: May 23, 2014; 003: May 23, 2014
Mar 2, 2021 *PEDU-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
Pat. No. 9125816 Pharmaceutical composition and method for treating hypogonadism
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 14, 2015
Mar 2, 2021 *PEDU-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
Pat. No. 9132089 Pharmaceutical composition and method for treating hypogonadism
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 28, 2015
Mar 2, 2021 *PEDU-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
Pat. No. 8466136 DP* Testosterone gel and method of use
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jun 24, 2013
Oct 12, 2026 
Pat. No. 8466137 Testosterone gel and method of use
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 24, 2013
Oct 12, 2026U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
Pat. No. 8466138 Testosterone gel and method of use
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 24, 2013
Oct 12, 2026U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
Pat. No. 8486925 DP* Testosterone gel and method of use
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 19, 2013
Oct 12, 2026 
Pat. No. 8729057 DP* Testosterone gel and method of use
Claim Types: Composition
Pat. Sub. Date(s): 001: None; 002: Jun 13, 2014; 003: Jun 13, 2014
Oct 12, 2026 
Pat. No. 8741881 Testosterone gel and method of use
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 25, 2014
Oct 12, 2026U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
Pat. No. 8754070 DP* Testosterone gel and method of use
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 16, 2014
Oct 12, 2026 
Pat. No. 8759329 DP* Testosterone gel and method of use
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 9, 2014
Oct 12, 2026 

OVIDREL (INJECTABLE) (SUBCUTANEOUS) CHORIOGONADOTROPIN ALFA
Drug Classes: gonadotropin
NDA Applicant: EMD SERONO      NDA No.: 021149  Prod. No.: 002 RX (EQ 0.25MG /0.5ML)
PatentsExpirationPatented Use
Pat. No. 6706681 DP* HCG liquid formulations
Claim Types: Composition; Process; Drug in a container
Pat. Sub. Date(s): 002: None
Mar 16, 2021 

ACTOPLUS MET XR (TABLET, EXTENDED RELEASE) (ORAL) METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
Drug Classes: biguanide; peroxisome proliferator-activated receptor (PPAR) alpha agonist; peroxisome proliferator-activated receptor (PPAR) gamma agonist; thiazolidinedione
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 022024  Prod. No.: 001 DISC (1GM;EQ 15MG BASE); 002 DISC (1GM;EQ 30MG BASE)
PatentsExpirationPatented Use
Pat. No. 6790459 Methods for treating diabetes via administration of controlled release metformin
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Mar 17, 2021U-974: Adjunct to diet and exercise to improve glycemic control in patients with Type 2 diabetes who are already treated with a pioglitazone and metformin
Pat. No. 6866866 DP* Controlled release metformin compositions
Claim Types: Composition; Formulation
Pat. Sub. Date(s): All strengths: None
Mar 17, 2021 
Pat. No. 8470368 DP* Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 10, 2013; 002: None
Sep 19, 2023 
Pat. No. 8668931 DP* Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Sep 19, 2023 
Pat. No. 9060941 DP* Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 21, 2015
Sep 19, 2023 
Pat. No. 7785627 DP* Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Jul 31, 2026 
Pat. No. 7959946 DP* Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 30, 2011; 002: None
Jul 31, 2026 

FORTAMET (TABLET, EXTENDED RELEASE) (ORAL) METFORMIN HYDROCHLORIDE
Drug Classes: biguanide
NDA Applicant: ANDRX LABS LLC      NDA No.: 021574  Prod. No.: 001 DISC (500MG**); 002 DISC (1GM**)
PatentsExpirationPatented Use
Pat. No. 6790459 Methods for treating diabetes via administration of controlled release metformin
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Mar 17, 2021U-604: Method of lowering blood glucose by once daily administration
Pat. No. 6866866 DP* Controlled release metformin compositions
Claim Types: Composition; Formulation
Pat. Sub. Date(s): All strengths: None
Mar 17, 2021 

XOPENEX (SOLUTION) (INHALATION) LEVALBUTEROL HYDROCHLORIDE [GENERIC AN]
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: OAK PHARMS INC      NDA No.: 020837  Prod. No.: 001 RX (EQ 0.021% BASE); 002 RX (EQ 0.042% BASE); 003 RX (EQ 0.0103% BASE)
PatentsExpirationPatented Use
Pat. No. 6451289 Albuterol formulations
Claim Types: Formulation; Drug in a container
Pat. Sub. Date(s): All strengths: None
Mar 21, 2021 

XOPENEX (SOLUTION) (INHALATION) LEVALBUTEROL HYDROCHLORIDE [GENERIC AN]
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: OAK PHARMS INC      NDA No.: 020837  Prod. No.: 004 RX (EQ 0.25% BASE)
PatentsExpirationPatented Use
Pat. No. 6451289 DP* Albuterol formulations
Claim Types: Formulation; Drug in a container
Pat. Sub. Date(s): 004: None
Mar 21, 2021 

IXEMPRA KIT (INJECTABLE) (INTRAVENOUS) IXABEPILONE
Drug Classes: microtubule inhibitor
NDA Applicant: R-PHARM US LLC      NDA No.: 022065  Prod. No.: 001 RX (15MG/VIAL); 002 RX (45MG/VIAL)
PatentsExpirationPatented Use
Pat. No. RE41911 DS* DP* [Extended 856 days (2.3 years)]
Epothilone derivatives
Claim Types: Compound; Method of use; Composition
Pat. Sub. Date(s): All strengths: None
Mar 28, 2021 *PEDU-961: Method of treating breast cancer by administering ixabepilone; a method of treating a cancer responsible to microtubule stabilization by administering ixabepilone
Pat. No. 6670384 DP* Methods of administering epothilone analogs for the treatment of cancer
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): All strengths: None
Jul 23, 2022 *PEDU-959: Method of treating cancer, IV admin, lyophilized ixabepilone diluted, every week or 3 weeks; lyophilized ixabepilone with solvent(dehydrated ethanol) diluted to concentration of 0.1mg/ml to 0.9mg/ml
U-960: Method of treating cancer in a patient comprising intravenously administering to the patient ixabepilone diluted in a parenteral diluent
Pat. No. 7022330 DP* Parenteral formulation for epothilone analogs
Claim Types: Product-by-process; Formulation; Method of use; Process
Pat. Sub. Date(s): All strengths: None
Jul 23, 2022 *PEDU-958: Method of treating patient comprising mixing first and second vials of product comprising lyophilized ixabepilone to provide an epothilone analog solution, diluting solution with a suitable diluent to prepare intravenous formulation for PT
Pat. No. RE41393 Treatment of refractory tumors using epothilone derivatives
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Aug 8, 2022 *PEDU-961: Method of treating breast cancer by administering ixabepilone; a method of treating a cancer responsible to microtubule stabilization by administering ixabepilone
Pat. No. 7312237 Combination of epothilone analogs and chemotherapeutic agents for the treatment of prolilferative diseases
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Feb 21, 2025 *PEDU-965: Use of ixabepilone in combination with capecitabine in treatment of metastasis breast cancer

DORIBAX (INJECTABLE) (INTRAVENOUS) DORIPENEM
Drug Classes: penem antibacterial
NDA Applicant: SHIONOGI INC      NDA No.: 022106  Prod. No.: 001 DISC (500MG/VIAL); 002 DISC (250MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 8247402 DS* DP* Crystal form of pyrrolidylthiocarbapenem derivative
Claim Types: New polymorph, salt or hydrate; Process; Composition
Pat. Sub. Date(s): 001: Sep 13, 2012; 002: None
Mar 30, 2021 

ONPATTRO (SOLUTION) (INTRAVENOUS) PATISIRAN SODIUM
NDA Applicant: ALNYLAM PHARMS INC      NDA No.: 210922  Prod. No.: 001 RX (EQ 10MG BASE/5ML (EQ 2MG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 8362231 DS* DP* RNA interference mediating small RNA molecules
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Sep 6, 2018
Mar 30, 2021 
Pat. No. 8372968 DS* DP* RNA interference mediating small RNA molecules
Claim Types: Compound; Product-by-process; Composition
Pat. Sub. Date(s): 001: Sep 6, 2018
Mar 30, 2021 
Pat. No. 8552171 DS* DP* RNA sequence-specific mediators of RNA interference
Claim Types: Composition
Pat. Sub. Date(s): 001: Sep 6, 2018
Mar 30, 2021 
Pat. No. 8778902 RNA interference mediating small RNA molecules
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 6, 2018
Mar 30, 2021U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis
Pat. No. 8895718 DS* DP* RNA interference mediating small RNA molecules
Claim Types: Composition; Product-by-process
Pat. Sub. Date(s): 001: Sep 6, 2018
Mar 30, 2021 
Pat. No. 8895721 DS* DP* RNA interference mediating small RNA molecules
Claim Types: Composition; Product-by-process
Pat. Sub. Date(s): 001: Sep 6, 2018
Mar 30, 2021 
Pat. No. 9193753 RNA sequence-specific mediators of RNA interference
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 6, 2018
Mar 30, 2021U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis
Pat. No. 9567582 DS* DP* RNA interference mediating small RNA molecules
Claim Types: Composition
Pat. Sub. Date(s): 001: Sep 6, 2018
Mar 30, 2021 
Pat. No. 9943538 DP* 2'-methoxy substituted oligomeric compounds and compositions for use in gene modulations
Claim Types: Composition
Pat. Sub. Date(s): 001: Sep 6, 2018
Nov 4, 2023 
Pat. No. 9943539 DP* 2'-methoxy substituted oligomeric compounds and compositions for use in gene modulations
Claim Types: Composition
Pat. Sub. Date(s): 001: Sep 6, 2018
Nov 4, 2023 
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. 8642076 DP* Lipid containing formulations
Claim Types: Compound; Formulation
Pat. Sub. Date(s): 001: Sep 6, 2018
Oct 3, 2027 
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. 8492359 DP* Lipid formulations for nucleic acid delivery
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 6, 2018
Apr 15, 2029 
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. 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. 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. 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. 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. 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. 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
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

PHOSLO (CAPSULE) (ORAL) CALCIUM ACETATE [Has competitive generic]
NDA Applicant: FRESENIUS MEDCL      NDA No.: 021160  Prod. No.: 002 DISC (667MG)
PatentsExpirationPatented Use
Pat. No. 6576665 Encapsulated calcium acetate caplet and a method for inhibiting gastrointestinal phosphorous absorption
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: None
Apr 3, 2021 

PHOSLO GELCAPS (CAPSULE) (ORAL) CALCIUM ACETATE [GENERIC AB]
NDA Applicant: FRESENIUS MEDCL      NDA No.: 021160  Prod. No.: 003 RX (667MG)
PatentsExpirationPatented Use
Pat. No. 6576665 Encapsulated calcium acetate caplet and a method for inhibiting gastrointestinal phosphorous absorption
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: None
Apr 3, 2021 
Pat. No. 6875445 DP* Encapsulated calcium acetate caplet and a method for inhibiting gastrointestinal phosphorous ab
Claim Types: Formulation; Process
Pat. Sub. Date(s): 003: Mar 17, 2015
Jul 30, 2021 

SEEBRI (POWDER) (INHALATION) GLYCOPYRROLATE
Drug Classes: anticholinergic
NDA Applicant: SUNOVION PHARMS INC      NDA No.: 207923  Prod. No.: 001 RX (15.6MCG/INH)
PatentsExpirationPatented Use
Pat. No. 7229607 Treatment of respiratory disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 4, 2015
Apr 9, 2021U-1773: Long - term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD)
Pat. No. 8029768 Treatment of respiratory diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 4, 2015
Apr 9, 2021U-1773: Long - term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD)
Pat. No. 7736670 DP* Method of making particles for use in a pharmaceutical composition
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Dec 4, 2015
Jun 27, 2021 
Pat. No. 8048451 DP* Pharmaceutical compositions for inhalation
Claim Types: Method of use; Product-by-process; Method of improving a treatment; Process
Pat. Sub. Date(s): 001: Dec 4, 2015
Jun 27, 2021 
Pat. No. 8303991 DP* Method of making particles for use in a pharmaceutical composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 4, 2015
Jun 27, 2021 
Pat. No. 8435567 DP* Pharmaceutical compositions of hydrophobic surface-modified active substance microparticles for inhalation
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 4, 2015
Jun 27, 2021 
Pat. No. 8580306 DP* Particles for use in a pharmaceutical composition
Claim Types: Formulation; ; Method of use; Process
Pat. Sub. Date(s): 001: Dec 4, 2015
Jun 27, 2021 
Pat. No. 8956661 DP* Method of making composite particles for use in pharmaceutical compositions and composite particles and compositions thereof
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Dec 4, 2015
Jun 27, 2021 
Pat. No. 9931304 DP* Method of making particles for use in a pharmaceutical composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: May 2, 2018
Jun 27, 2021 
Pat. No. 9962338 DP* Method of making particles for use in a pharmaceutical composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: May 29, 2018
Jun 27, 2021 
Pat. No. 8479730 DP* Inhaler device
Claim Types: Device
Pat. Sub. Date(s): 001: Dec 4, 2015
Oct 11, 2028 
Pat. No. 8182838 DP* Dry powder composition comprising co-jet milled particles for pulmonary inhalation
Claim Types: Product-by-process; Drug in a container; Process
Pat. Sub. Date(s): 001: Dec 4, 2015
Oct 20, 2028 

ALTABAX (OINTMENT) (TOPICAL) RETAPAMULIN
Drug Classes: pleuromutilin antibacterial
NDA Applicant: ALMIRALL      NDA No.: 022055  Prod. No.: 001 RX (1%)
PatentsExpirationPatented Use
Pat. No. RE43390 DS* DP* Pleuromutilin derivatives as antimicrobials
Claim Types: Compound; Process; Composition; Method of use; Formulation
Pat. Sub. Date(s): 001: Jul 9, 2012
Apr 12, 2021U-805: Treatment of impetigo due to staphylococcus aureus or streptococcus pyogenes
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
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 

REQUIP XL (TABLET, EXTENDED RELEASE) (ORAL) ROPINIROLE HYDROCHLORIDE [GENERIC AB]
Drug Classes: nonergot dopamine agonist
NDA Applicant: GLAXOSMITHKLINE LLC      NDA No.: 022008  Prod. No.: 001 RX (EQ 2MG BASE); 003 RX (EQ 4MG BASE); 004 RX (EQ 8MG BASE); 005 RX (EQ 12MG BASE); 006 RX (EQ 6MG BASE) NDA No.: 022008  Prod. No.: 002 DISC (EQ 3MG BASE**)
PatentsExpirationPatented Use
Pat. No. 8303986 DP* Hydrophilic/lipophilic polymeric matrix dosage formulation
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 26, 2012; 002: None; 003: None; 004: None; 005: None; 006: None
Apr 12, 2021 
Pat. No. 7927624 DP* Hydrophilic/lipophilic polymeric matrix dosage formulation
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: May 17, 2011; 002: None; 003: None; 004: None; 005: None; 006: None
Dec 2, 2021U-20: A process for treating a patient suffering from parkinson's syndrome and in need of treatment
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousMar 23, 2020M-203: Provides for revisions to the package insert to reflect results of two postmarketing requirement studies ROP111662 and ROP111569

OPTISON (INJECTABLE) (INJECTION) ALBUMIN HUMAN
Drug Classes: human serum albumin; radioactive diagnostic agent; ultrasound contrast agent
NDA Applicant: GE HEALTHCARE      NDA No.: 020899  Prod. No.: 001 RX (10MG/ML)
PatentsExpirationPatented Use
Pat. No. 6723303 DP* Ultrasound contrast agents including protein stabilized microspheres of perfluoropropane, perfluorobutane or perfluoropentane
Claim Types: Composition
Pat. Sub. Date(s): 001: None
Apr 20, 2021 

ZYDELIG (TABLET) (ORAL) IDELALISIB
Drug Classes: kinase inhibitor
NDA Applicant: GILEAD SCIENCES INC      NDA No.: 205858  Prod. No.: 001 RX (100MG); 002 RX (150MG)
PatentsExpirationPatented Use
Pat. No. 6800620 DS* Inhibitors of human phosphatidylinositol 3-kinase delta
Claim Types: Method of use; Compound
Pat. Sub. Date(s): All strengths: Aug 27, 2014
Apr 24, 2021U-1560: A method of disrupting leukocyte function, including as an inhibitor of pi3kdelta kinase
Pat. No. 6949535 DS* Inhibitors of human phosphatidyl-inositol 3-kinase delta
Claim Types: Method of use; Compound
Pat. Sub. Date(s): All strengths: Aug 27, 2014
Apr 24, 2021U-1560: A method of disrupting leukocyte function, including as an inhibitor of pi3kdelta kinase
Pat. No. 8138195 DS* DP* Inhibitors of human phosphatidylinositol 3-kinase delta
Claim Types: Compound; Method of use; Composition
Pat. Sub. Date(s): All strengths: Aug 21, 2014
Apr 24, 2021U-1549: For the treatment of patients with relapsed chronic lymphocytic leukemia
Pat. No. 8492389 DS* DP* Inhibitors of human phosphatidylinositol 3-kinase delta
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Aug 19, 2014; 002: Aug 21, 2014
Apr 24, 2021 
Pat. No. 8637533 DS* DP* Inhibitors of human phosphatidylinositol 3-kinase delta
Claim Types: Compound
Pat. Sub. Date(s): All strengths: Aug 21, 2014
Apr 24, 2021 
Pat. No. 8980901 5-fluoro-3-phenyl-2[1-(9H-purin-6-ylamino)propyl]-3H-quinazolin-4-one and 6-fluoro-3-phenyl-2-[1-(9H-purin-6-ylamino)ethyl]-3H-quinazolin-4-one as inhibitors of human phosphatidylinositol 3-kinase delta
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 10, 2015
May 12, 2025U-1678: For the treatment of patients with CLL, FL, or SLL
Pat. No. 9149477 5-fluoro-3-phenyl-2-[1-(9h-purin-6-ylamino)propyl]-3h-quinazolin-4-one as an inhibitor of human phosphatidylinositol 3-kinase delta
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 3, 2015
May 12, 2025U-1757: Inhibition on PI3K kinase
Pat. No. RE44599 Quinazolinones as inhibitors of human phosphatidylinositol 3-kinase delta
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 21, 2014
Jul 21, 2025U-1558: For the treatment of patients with relapsed follicular B-cell non-Hodgkin lymphoma or [relapsed] small lymphocytic lymphoma
U-1615: For the treatment of patients with CLL, FL, or SLL
Pat. No. RE44638 DS* DP* Quinazolinones as inhibitors of human phosphatidylinositol 3-kinase delta
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Aug 21, 2014
Aug 5, 2025 
Pat. No. 9492449 Therapies for hematologic malignancies
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 16, 2016
Mar 11, 2030U-1914: In combination with rituximab, for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL)
Pat. No. 8865730 DS* DP* Polymorphic forms of (S)-2-(1-(9H-purin-6-ylamino)propyl)-5-fluoro-3-phenylquinazolin-4(3H)-on- e
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Process; Method of use
Pat. Sub. Date(s): All strengths: Nov 18, 2014
Mar 5, 2033U-1615: For the treatment of patients with CLL, FL, or SLL
Pat. No. 9469643 DS* Polymorphic forms of (S)-2-(1-(9H-purin-6-ylamino)propyl)-5-fluoro-3-phenylquinazolin-4(3H)-on- e
Claim Types: New polymorph, salt or hydrate; Product-by-process
Pat. Sub. Date(s): All strengths: Nov 16, 2016
Sep 2, 2033 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJul 23, 2019 
Exclusivity Code: ODE - Orphan drug exclusivityJul 23, 2021ODE-70: Relapsed CLL, in combo. with rituximab, in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbidities; and relapsed sll in patients who have received at least 2 prior systemic therapies
Exclusivity Code: ODE - Orphan drug exclusivityJul 23, 2021ODE-71: Relapsed follicular B-cell non-hodgkin lymphoma (FL) in patients who have received at least two prior systemic therapies

VIBATIV (POWDER) (INTRAVENOUS) TELAVANCIN HYDROCHLORIDE
Drug Classes: lipoglycopeptide antibacterial
NDA Applicant: CUMBERLAND PHARMS      NDA No.: 022110  Prod. No.: 002 RX (EQ 750MG BASE/VIAL) NDA No.: 022110  Prod. No.: 001 DISC (EQ 250MG BASE/VIAL)
PatentsExpirationPatented Use
Pat. No. 7208471 DS* DP* Glycopeptide phosphonate derivatives
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: None
May 1, 2021 
Pat. No. 7351691 DS* DP* Glycopeptide phosphonate derivatives
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
May 1, 2021U-728: Method for treating bacterial infection
Pat. No. 7544364 DP* Pharmaceutical compositions containing a glycopeptide antibiotic and a cyclodextrin
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
May 1, 2021 
Pat. No. 7700550 Glycopeptide phosphonate derivatives
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
May 1, 2021U-282: Method of treating bacterial infections
Pat. No. 8101575 DP* Glycopeptide phosphonate derivatives
Claim Types: Composition
Pat. Sub. Date(s): All strengths: None
May 1, 2021 
Pat. No. 8158580 DP* Pharmaceutical compositions containing a glycopeptide antibiotic and a cyclodextrin
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 25, 2012; 002: None
May 1, 2021 
Pat. No. 7008923 Glycopeptide phosphonate derivatives
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
May 6, 2021U-1005: Method of treating a staphylococcal infection
Pat. No. 6872701 DP* Glycopeptide phosphonate derivatives
Claim Types: Formulation; Process; Product-by-process; Drug in a container
Pat. Sub. Date(s): All strengths: None
Jun 5, 2021 
Pat. No. 6858584 DP* Pharmaceutical compositions containing a glycopeptide antibiotic and a cyclodextrin
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Aug 24, 2022 
Pat. No. 6635618 DS* DP* [Extended 719 days (2 years)]
Glycopeptide phosphonate derivatives
Claim Types: Compound; Composition; Process; Method of use
Pat. Sub. Date(s): All strengths: None
Sep 11, 2023U-728: Method for treating bacterial infection
Pat. No. 7531623 DS* Hydrochloride salts of a glycopeptide phosphonate derivative
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): All strengths: None
Jan 1, 2027 

EXONDYS 51 (SOLUTION) (INTRAVENOUS) ETEPLIRSEN
Drug Classes: antisense oligonucleotide
NDA Applicant: SAREPTA THERAPS INC      NDA No.: 206488  Prod. No.: 001 RX (100MG/2ML (50MG/ML)); 002 RX (500MG/10ML (50MG/ML))
PatentsExpirationPatented Use
Pat. No. 9416361 DS* Splice-region antisense composition and method
Claim Types: Compound
Pat. Sub. Date(s): All strengths: Oct 17, 2016
May 4, 2021 
Pat. No. 8486907 DLR* Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 17, 2016
Jun 28, 2025U-1904: (i)treatment of duchenne muscular dystrophy; (ii)restoring/increasing functional dystrophin protein; or (iii) inducing skipping; each of (i)-(iii) in patients having a confirmed mutation of the dmd gene that is amenable to exon 51 skipping
Pat. No. 9018368 DS* DP* Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Oct 17, 2016
Jun 28, 2025 
Pat. No. 9243245 DS* Means and methods for counteracting muscle disorders
Claim Types: Formulation; Method of use; Kit
Pat. Sub. Date(s): All strengths: Aug 24, 2017
Oct 27, 2028U-2097: Treatment of DMD in patients having a mutation of the DMD gene that is amenable to exon 51 skipping
U-2098: Increasing production of functional dystrophin protein in DMD patients having a mutation of the DMD gene that is amenable to exon 51 skipping
Pat. No. 9506058 Compositions for treating muscular dystrophy
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Dec 1, 2016
Mar 14, 2034U-1918: Treatment of Duchenne muscular dystrophy in patients having a mutation of the DMD gene that is amenable to exon 51 skipping
U-1919: Restoring an mRNA reading frame to induce dystrophin protein production in patients having a mutation of the DMD gene that is amenable to exon 51 skipping
Pat. No. 10337003 Compositions for treating muscular dystrophy
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 10, 2019
Mar 14, 2034U-1918: Treatment of Duchenne muscular dystrophy in patients having a mutation of the DMD gene that is amenable to exon 51 skipping
Pat. No. 10364431 Compositions for treating muscular dystrophy
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 28, 2019
Mar 14, 2034U-1918: Treatment of Duchenne muscular dystrophy in patients having a mutation of the DMD gene that is amenable to exon 51 skipping
U-1919: Restoring an mRNA reading frame to induce dystrophin protein production in patients having a mutation of the DMD gene that is amenable to exon 51 skipping
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entitySep 19, 2021 
Exclusivity Code: ODE - Orphan drug exclusivitySep 19, 2023ODE-122: Treatment of duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping

ATRIPLA (TABLET) (ORAL) EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE [GENERIC AB]
Drug Classes: HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI); HIV nucleoside analog reverse transcriptase inhibitor (HIV-1 NRTI); HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD SCIENCES      NDA No.: 021937  Prod. No.: 001 RX (600MG;200MG;300MG)
PatentsExpirationPatented Use
Pat. No. 6642245 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
May 4, 2021 *PEDU-1170: Treatment of HIV-1 infection in pediatric patients 12 years of age and older
U-750: Treatment of HIV-1 infection in adults
Pat. No. 6703396 DS* DP* Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers
Claim Types: Compound; Formulation
Pat. Sub. Date(s): 001: None
Sep 9, 2021 *PED 
Pat. No. 8592397 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Jan 13, 2024U-1170: Treatment of HIV-1 infection in pediatric patients 12 years of age and older
U-750: Treatment of HIV-1 infection in adults
Pat. No. 8716264 DP* Compositions and methods for combination antiviral therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 30, 2014
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 9457036 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 10, 2016
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 9744181 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 19, 2017
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 9018192 Unitary pharmaceutical dosage form
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 28, 2015
Jun 13, 2026U-1170: Treatment of HIV-1 infection in pediatric patients 12 years of age and older
U-750: Treatment of HIV-1 infection in adults
Pat. No. 9545414 DP* Unitary pharmaceutical dosage form
Claim Types: Formulation; Method of use; Drug in a container; Method of administration
Pat. Sub. Date(s): 001: Feb 13, 2017
Jun 13, 2026U-1170: Treatment of HIV-1 infection in pediatric patients 12 years of age and older
U-750: Treatment of HIV-1 infection in adults
Pat. No. 8598185 DP* Unitary pharmaceutical dosage form
Claim Types: Formulation; Drug in a container
Pat. Sub. Date(s): 001: None
Apr 28, 2029 

DESCOVY (TABLET) (ORAL) EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitor (HIV-1 NRTI); HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD SCIENCES INC      NDA No.: 208215  Prod. No.: 001 RX (200MG;EQ 25MG BASE)
PatentsExpirationPatented Use
Pat. No. 6642245 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 2, 2016
May 4, 2021 *PEDU-257: Treatment of HIV infection
Pat. No. 6703396 DS* DP* Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers
Claim Types: Compound; Formulation
Pat. Sub. Date(s): 001: May 2, 2016
Sep 9, 2021 *PED 
Pat. No. 7803788 Prodrugs of phosphonate nucoleotide analogues
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 2, 2016
Feb 2, 2022U-257: Treatment of HIV infection
Pat. No. 7390791 DS* DP* Prodrugs of phosphonate nucleotide analogues
Claim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 001: May 2, 2016
May 7, 2022 
Pat. No. 8754065 DS* DP* Tenofovir alafenamide hemifumarate
Claim Types: Compound; New polymorph, salt or hydrate; Composition; Method of use; Process
Pat. Sub. Date(s): 001: May 2, 2016
Aug 15, 2032U-257: Treatment of HIV infection
Pat. No. 9296769 DS* DP* Tenofovir alafenamide hemifumarate
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Apr 26, 2016
Aug 15, 2032U-257: Treatment of HIV infection
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityNov 5, 2020 
Exclusivity Code: NPP - New patient populationSep 25, 2020 

EMTRIVA (CAPSULE) (ORAL) EMTRICITABINE [GENERIC AB]
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitor (HIV-1 NRTI)
NDA Applicant: GILEAD      NDA No.: 021500  Prod. No.: 001 RX (200MG)
PatentsExpirationPatented Use
Pat. No. 6642245 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
May 4, 2021 *PEDU-257: Treatment of HIV infection
U-541: Method of treatment of adults infected with HIV-1
Pat. No. 6703396 DS* DP* Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers
Claim Types: Compound; Formulation
Pat. Sub. Date(s): 001: None
Sep 9, 2021 *PED 

EMTRIVA (SOLUTION) (ORAL) EMTRICITABINE
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitor (HIV-1 NRTI)
NDA Applicant: GILEAD      NDA No.: 021896  Prod. No.: 001 RX (10MG/ML)
PatentsExpirationPatented Use
Pat. No. 6642245 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
May 4, 2021 *PEDU-257: Treatment of HIV infection
Pat. No. 6703396 DS* DP* Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers
Claim Types: Compound; Formulation
Pat. Sub. Date(s): 001: None
Sep 9, 2021 *PED 

GENVOYA (TABLET) (ORAL) COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Drug Classes: CYP3A inhibitor; HIV integrase strand transfer inhibitor (HIV-1 INSTI); HIV nucleoside analog reverse transcriptase inhibitor (HIV-1 NRTI); HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD SCIENCES INC      NDA No.: 207561  Prod. No.: 001 RX (150MG;150MG;200MG;EQ 10MG BASE)
PatentsExpirationPatented Use
Pat. No. 6642245 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 1, 2015
May 4, 2021 *PEDU-257: Treatment of HIV infection
Pat. No. 6703396 DS* DP* Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers
Claim Types: Compound; Formulation
Pat. Sub. Date(s): 001: Dec 1, 2015
Sep 9, 2021 *PED 
Pat. No. 7803788 Prodrugs of phosphonate nucoleotide analogues
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 1, 2015
Feb 2, 2022U-257: Treatment of HIV infection
Pat. No. 7390791 DS* DP* Prodrugs of phosphonate nucleotide analogues
Claim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 001: Dec 1, 2015
May 7, 2022 
Pat. No. 7176220 DS* DP* [Extended 1011 days (2.8 years)]
4-oxoquinoline compound and use thereof as pharmaceutical agent
Claim Types: Method of use; Compound; Composition
Pat. Sub. Date(s): 001: Dec 1, 2015
Aug 27, 2026U-257: Treatment of HIV infection
Pat. No. 7635704 DS* DP* Stable crystal of 4-oxoquinoline compound
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Dec 1, 2015
Oct 26, 2026U-257: Treatment of HIV infection
Pat. No. 8981103 DS* DP* Stable crystal of 4-oxoquinoline compound
Claim Types: New polymorph, salt or hydrate; Composition; Formulation
Pat. Sub. Date(s): 001: Dec 1, 2015
Oct 26, 2026 
Pat. No. 8148374 DS* DP* Modulators of pharmacokinetic properties of therapeutics
Claim Types: Composition; Compound; Method of use
Pat. Sub. Date(s): 001: Dec 1, 2015
Sep 3, 2029U-1279: Treatment of HIV infection using a composition containing a pharmacokinetic enhancer that inhibits cytochrome p450 monooxygenase
Pat. No. 9891239 DP* Modulators of pharmacokinetic properties of therapeutics
Claim Types: Composition; Method of use
Pat. Sub. Date(s): 001: Feb 27, 2018
Sep 3, 2029U-257: Treatment of HIV infection
Pat. No. 8633219 DP* Combination therapy
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Dec 1, 2015
Apr 24, 2030U-257: Treatment of HIV infection
Pat. No. 8754065 DS* DP* Tenofovir alafenamide hemifumarate
Claim Types: Compound; New polymorph, salt or hydrate; Composition; Method of use; Process
Pat. Sub. Date(s): 001: Dec 1, 2015
Aug 15, 2032U-257: Treatment of HIV infection
Pat. No. 9296769 DS* DP* Tenofovir alafenamide hemifumarate
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Apr 22, 2016
Aug 15, 2032U-257: Treatment of HIV infection
Pat. No. 10039718 DP* Use of solid carrier particles to improve the processability of a pharmaceutical agent
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Aug 28, 2018
Oct 4, 2032 
ExclusivityExpirationExclusivity Description
Exclusivity Code: D - New Dosing ScheduleDec 10, 2021D-173: Dosing recommendation for the use of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fixed dose combination in HIV-1 infected adult patients with end-stage-renal disease who are receiving chronic hemodialysis
Exclusivity Code: NCE - New chemical entityNov 5, 2020 
Exclusivity Code: NPP - New patient populationSep 25, 2020 

STRIBILD (TABLET) (ORAL) COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Drug Classes: CYP3A inhibitor; HIV integrase strand transfer inhibitor (HIV-1 INSTI); HIV nucleoside analog reverse transcriptase inhibitor (HIV-1 NRTI); HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD SCIENCES INC      NDA No.: 203100  Prod. No.: 001 RX (150MG;150MG;200MG;300MG)
PatentsExpirationPatented Use
Pat. No. 6642245 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
May 4, 2021 *PEDU-257: Treatment of HIV infection
Pat. No. 6703396 DS* DP* Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers
Claim Types: Compound; Formulation
Pat. Sub. Date(s): 001: None
Sep 9, 2021 *PED 
Pat. No. 8592397 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 8716264 DP* Compositions and methods for combination antiviral therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 2, 2014
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 9457036 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 10, 2016
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 9744181 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 19, 2017
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 7176220 DS* DP* [Extended 1011 days (2.8 years)]
4-oxoquinoline compound and use thereof as pharmaceutical agent
Claim Types: Method of use; Compound; Composition
Pat. Sub. Date(s): 001: None
Aug 27, 2026U-257: Treatment of HIV infection
Pat. No. 7635704 DS* DP* Stable crystal of 4-oxoquinoline compound
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: None
Oct 26, 2026U-257: Treatment of HIV infection
Pat. No. 8981103 DS* DP* Stable crystal of 4-oxoquinoline compound
Claim Types: New polymorph, salt or hydrate; Composition; Formulation
Pat. Sub. Date(s): 001: Apr 14, 2015
Oct 26, 2026 
Pat. No. 8148374 DS* DP* Modulators of pharmacokinetic properties of therapeutics
Claim Types: Composition; Compound; Method of use
Pat. Sub. Date(s): 001: None
Sep 3, 2029U-1279: Treatment of HIV infection using a composition containing a pharmacokinetic enhancer that inhibits cytochrome p450 monooxygenase
Pat. No. 9891239 DP* Modulators of pharmacokinetic properties of therapeutics
Claim Types: Composition; Method of use
Pat. Sub. Date(s): 001: Mar 6, 2018
Sep 3, 2029U-257: Treatment of HIV infection
Pat. No. 8633219 DP* Combination therapy
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Jan 24, 2014
Apr 24, 2030U-257: Treatment of HIV infection
Pat. No. 10039718 DP* Use of solid carrier particles to improve the processability of a pharmaceutical agent
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Sep 4, 2018
Oct 4, 2032 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationJan 27, 2020 

TRUVADA (TABLET) (ORAL) EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE [GENERIC AB]
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitor (HIV-1 NRTI); HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD      NDA No.: 021752  Prod. No.: 001 RX (200MG;300MG)
PatentsExpirationPatented Use
Pat. No. 6642245 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
May 4, 2021 *PEDU-1170: Treatment of HIV-1 infection in pediatric patients 12 years of age and older
U-248: Treatment of HIV
U-541: Method of treatment of adults infected with HIV-1
Pat. No. 6703396 DS* DP* Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers
Claim Types: Compound; Formulation
Pat. Sub. Date(s): 001: None
Sep 9, 2021 *PED 
Pat. No. 8592397 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Jan 13, 2024U-1170: Treatment of HIV-1 infection in pediatric patients 12 years of age and older
U-248: Treatment of HIV
U-541: Method of treatment of adults infected with HIV-1
Pat. No. 8716264 DP* Compositions and methods for combination antiviral therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 30, 2014
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 9457036 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 10, 2016
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 9744181 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 18, 2017
Jan 13, 2024U-257: Treatment of HIV infection

TRUVADA (TABLET) (ORAL) EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitor (HIV-1 NRTI); HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD      NDA No.: 021752  Prod. No.: 002 RX (100MG;150MG); 003 RX (133MG;200MG); 004 RX (167MG;250MG)
PatentsExpirationPatented Use
Pat. No. 6642245 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 31, 2016
May 4, 2021 *PEDU-1170: Treatment of HIV-1 infection in pediatric patients 12 years of age and older
U-248: Treatment of HIV
U-541: Method of treatment of adults infected with HIV-1
Pat. No. 6703396 DS* DP* Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers
Claim Types: Compound; Formulation
Pat. Sub. Date(s): All strengths: Mar 31, 2016
Sep 9, 2021 *PED 

ORAVERSE (INJECTABLE) (INJECTION) PHENTOLAMINE MESYLATE
Drug Classes: alpha adrenergic blocker
NDA Applicant: SEPTODONT HOLDING      NDA No.: 022159  Prod. No.: 001 RX (0.4MG/1.7ML)
PatentsExpirationPatented Use
Pat. No. 6764678 Local anesthetic methods and kits
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
May 11, 2021U-967: A method of reversing soft-tissue anesthesia i.e. anesthesia of the lip and tongue, and the associated functional deficits resulting from an intraoral submucosal injection of a local anesthetic
Pat. No. 6872390 DP* Local anesthetic methods and kits
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
May 11, 2021 
Pat. No. 7229630 DP* Stabilized formulations of alpha adrenergic receptor antagonists and the uses thereof
Claim Types: Formulation; Kit; Drug in a container
Pat. Sub. Date(s): 001: None
Jun 20, 2023 
Pat. No. 7569230 Stabilized formulations of alpha adrenergic receptor antagonists and the uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Oct 17, 2023U-967: A method of reversing soft-tissue anesthesia i.e. anesthesia of the lip and tongue, and the associated functional deficits resulting from an intraoral submucosal injection of a local anesthetic
Pat. No. 7575757 DP* Stabilized formulations of alpha adrenergic receptor antagonists and the uses thereof
Claim Types: Formulation; Drug in a container
Pat. Sub. Date(s): 001: None
Apr 21, 2025 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationMar 18, 2019 

SUSTOL (INJECTION, EXTENDED RELEASE) (SUBCUTANEOUS) GRANISETRON
Drug Classes: serotonin-3 (5-HT3) receptor antagonist
NDA Applicant: HERON THERAPS INC      NDA No.: 022445  Prod. No.: 001 RX (10MG/0.4ML (10MG/0.4ML))
PatentsExpirationPatented Use
Pat. No. 6790458 DP* Pharmaceutical compositions using semi-solid delivery vehicle
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): 001: Aug 31, 2016
May 11, 2021 
Pat. No. 6613355 DP* Semi-solid delivery vehicle and pharmaceutical compositions
Claim Types: Composition
Pat. Sub. Date(s): 001: Aug 31, 2016
Jun 28, 2021 
Pat. No. 8252304 DP* Semi-solid delivery vehicle and pharmaceutical compositions for delivery of granisetron
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 31, 2016
Sep 28, 2024 
Pat. No. 8252305 Methods of treating emesis utilizing semi-solid delivery pharmaceutical compositions comprising granisetron
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 31, 2016
Sep 28, 2024U-1891: Treatment or prevention of nausea and vomiting
Pat. No. 8715710 DP* Semi-solid delivery vehicle and pharmaceutical compositions for delivery of granisetron
Claim Types: Composition
Pat. Sub. Date(s): 001: Aug 30, 2016
Sep 28, 2024 
Pat. No. 9913910 Methods of treating nausea utilizing semi-solid delivery vehicle compositions comprising granisetron
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 28, 2018
Sep 28, 2024U-2253: Prophylactic treatment of nausea and vomiting, including prevention of acute and delayed nausea and vomiting associated chemotherapy
Pat. No. 10357570 Methods of treating nausea utilizing semi-solid delivery vehicle compositions comprising granisetron
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2019
Sep 28, 2024U-2253: Prophylactic treatment of nausea and vomiting, including prevention of acute and delayed nausea and vomiting associated chemotherapy
ExclusivityExpirationExclusivity Description
Exclusivity Code: NDF - New dosage formAug 9, 2019 

FIRMAGON (POWDER) (SUBCUTANEOUS) DEGARELIX ACETATE
NDA Applicant: FERRING      NDA No.: 022201  Prod. No.: 001 RX (EQ 80MG BASE/VIAL); 002 RX (EQ 120MG BASE/VIAL)
PatentsExpirationPatented Use
Pat. No. 5925730 DS* DP* [Extended 1498 days (4.1 years)]
GnRH antagonists
Claim Types: Compound; Composition; Method of use; Intermediate
Pat. Sub. Date(s): All strengths: None
May 18, 2021U-943: GNRH antagonist indicated for treatment of patients with advanced prostate cancer
Pat. No. 9579359 Method of treating prostate cancer with GnRH antagonist
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 30, 2017
Feb 10, 2029U-1978: Treatment of advanced prostate cancer with a reduced likelihood of causing a gonadotrophin releasing hormone agonist side-effect
Pat. No. 9415085 Method of treating prostate cancer with GnRH antagonist
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): All strengths: Sep 15, 2016
Apr 27, 2032U-1895: Method of treating prostate cancer

ZOMIG (SPRAY) (NASAL) ZOLMITRIPTAN
Drug Classes: serotonin 5-HT1B/1D receptor agonist (triptan)
NDA Applicant: ASTRAZENECA      NDA No.: 021450  Prod. No.: 003 RX (2.5MG/SPRAY); 004 RX (5MG/SPRAY)
PatentsExpirationPatented Use
Pat. No. 6750237 DP* Pharmaceutical formulations containing zolmitriptan
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 003: Apr 24, 2014; 004: None
May 28, 2021 *PED 
Pat. No. 7220767 DP* Pharmaceutical formulations containing zolmitriptan
Claim Types: Formulation; Device
Pat. Sub. Date(s): 003: Apr 24, 2014; 004: None
May 28, 2021 *PED 

CARAC (CREAM) (TOPICAL) FLUOROURACIL [GENERIC AB]
Drug Classes: nucleoside metabolic inhibitor
NDA Applicant: VALEANT PHARMS NORTH      NDA No.: 020985  Prod. No.: 001 RX (0.5%)
PatentsExpirationPatented Use
Pat. No. 6670335 DP* Fluorouracil-containing formulation
Claim Types: Formulation; Method of administration; Method of use
Pat. Sub. Date(s): 001: None
Jun 2, 2021U-68: Treatment of actinic keratosis

QUTENZA (PATCH) (TOPICAL) CAPSAICIN
NDA Applicant: AVERITAS      NDA No.: 022395  Prod. No.: 001 RX (8%)
PatentsExpirationPatented Use
Pat. No. 6239180 DP* [Extended 1671 days (4.6 years)]
Transdermal therapeutic device and method with capsaicin and capsaicin analogs
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jun 4, 2021 

FYCOMPA (TABLET) (ORAL) PERAMPANEL
Drug Classes: non-competitive AMPA glutamate receptor antagonist
NDA Applicant: EISAI INC      NDA No.: 202834  Prod. No.: 001 RX (2MG); 002 RX (4MG); 003 RX (6MG); 004 RX (8MG); 005 RX (10MG); 006 RX (12MG)
PatentsExpirationPatented Use
Pat. No. 6949571 DS* DP* 1,2-dihydropyridine compounds, process for preparation of the same and use thereof
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Nov 19, 2012
Jun 8, 2021U-106: Treatment of epilepsy
U-2088: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy
U-2089: Treatment of primary generalized tonic-clonic seizures as adjunctive therapy in patients with epilepsy
U-2428: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older
U-2429: Treatment of primary generalized tonic-clonic seizures as adjunctive therapy in patients with epilepsy 12 years of age and older
Pat. No. 8772497 DS* Method for producing 1, 2-dihydropyridine-2-one compound
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): All strengths: Aug 6, 2014
Jul 1, 2026 

FYCOMPA (SUSPENSION) (ORAL) PERAMPANEL
Drug Classes: non-competitive AMPA glutamate receptor antagonist
NDA Applicant: EISAI INC      NDA No.: 208277  Prod. No.: 001 RX (0.5MG/ML)
PatentsExpirationPatented Use
Pat. No. 6949571 DS* DP* 1,2-dihydropyridine compounds, process for preparation of the same and use thereof
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: May 27, 2016
Jun 8, 2021U-106: Treatment of epilepsy
U-2088: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy
U-2089: Treatment of primary generalized tonic-clonic seizures as adjunctive therapy in patients with epilepsy
U-2428: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older
U-2429: Treatment of primary generalized tonic-clonic seizures as adjunctive therapy in patients with epilepsy 12 years of age and older
Pat. No. 8772497 DS* Method for producing 1, 2-dihydropyridine-2-one compound
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: May 27, 2016
Jul 1, 2026 

ZONTIVITY (TABLET) (ORAL) VORAPAXAR SULFATE
Drug Classes: protease-activated receptor-1 (PAR-1) antagonist
NDA Applicant: TOPROL      NDA No.: 204886  Prod. No.: 001 RX (EQ 2.08MG BASE)
PatentsExpirationPatented Use
Pat. No. 7235567 DS* DP* Crystalline polymorph of a bisulfate salt of a thrombin receptor antagonist
Claim Types: New polymorph, salt or hydrate; Composition
Pat. Sub. Date(s): 001: Jun 5, 2014
Jun 13, 2021 
Pat. No. 7304078 DS* DP* Thrombin receptor antagonists
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Jun 5, 2014
Apr 6, 2024U-1512: Reduction of thrombotic cardiovascular events
Pat. No. 7713999 DS* DP* Thrombin receptor antagonists
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: May 14, 2018
May 30, 2024U-2291: Reduction of thrombotic cardiovascular events in patients with a history of myocardial infarction (MI) or with peripheral arterial disease (PAD)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMay 8, 2019 

TRILEPTAL (SUSPENSION) (ORAL) OXCARBAZEPINE [GENERIC AB]
Drug Classes: antiepileptic drug (AED)
NDA Applicant: NOVARTIS      NDA No.: 021285  Prod. No.: 001 RX (300MG/5ML)
PatentsExpirationPatented Use
Pat. No. 8119148 DP* Suspension comprising oxcarbazepine
Claim Types: Formulation; Method of use; Drug in a container
Pat. Sub. Date(s): 001: Mar 8, 2012
Jun 19, 2021 *PEDU-724: Method of treating seizures

INTUNIV (TABLET, EXTENDED RELEASE) (ORAL) GUANFACINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: central alpha-2 adrenergic agonist
NDA Applicant: SHIRE      NDA No.: 022037  Prod. No.: 001 RX (EQ 1MG BASE); 002 RX (EQ 2MG BASE); 003 RX (EQ 3MG BASE); 004 RX (EQ 4MG BASE)
PatentsExpirationPatented Use
Pat. No. 6287599 DP* Sustained release pharmaceutical dosage forms with minimized pH dependent dissolution profiles
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Jun 20, 2021 *PED 
Pat. No. 6811794 DP* Sustained release pharmaceutical dosage forms with minimized pH dependent dissolution profiles
Claim Types: Formulation; Method of use; Method of administration
Pat. Sub. Date(s): All strengths: None
Jan 4, 2023 *PEDU-494: Treatment of Attention-Deficit Hyperactivity Disorder

BROVANA (SOLUTION) (INHALATION) ARFORMOTEROL TARTRATE
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: SUNOVION      NDA No.: 021912  Prod. No.: 001 RX (EQ 0.015MG BASE/2ML)
PatentsExpirationPatented Use
Pat. No. 6667344 DP* Bronchodilating compositions and methods
Claim Types: Formulation; Drug in a container
Pat. Sub. Date(s): 001: Jun 1, 2012
Jun 22, 2021 
Pat. No. 6814953 Bronchodilating compositions and methods
Claim Types: Kit; Method of use
Pat. Sub. Date(s): 001: Jun 1, 2012
Jun 22, 2021U-793: For the long term treatment, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema
Pat. No. 7348362 DP* Bronchodilating .beta.-agonist compositions and methods
Claim Types: Drug in a container; Method of administration
Pat. Sub. Date(s): 001: Jul 11, 2013
Jun 22, 2021U-793: For the long term treatment, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema
Pat. No. 7462645 Bronchodilating beta-agonist compositions and methods
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 11, 2013
Jun 22, 2021U-793: For the long term treatment, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema
Pat. No. 7465756 DP* Bronchodilating beta-agonist compositions and methods
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 11, 2013
Jun 22, 2021 
Pat. No. 7473710 Bronchodilating beta-agonist compositions and methods
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jul 11, 2013
Jun 22, 2021U-793: For the long term treatment, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema
Pat. No. 7541385 Bronchodilating .beta.-agonist compositions and methods
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jul 11, 2013
Jun 22, 2021U-793: For the long term treatment, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema
Pat. No. 6472563 DS* Formoterol tartrate process and polymorph
Claim Types: New polymorph, salt or hydrate; Method of use; Composition; Formulation; Process
Pat. Sub. Date(s): 001: None
Nov 9, 2021 
Pat. No. 6720453 DS* Formoterol tartrate polymorph
Claim Types: New polymorph, salt or hydrate; Method of use; Composition; Formulation
Pat. Sub. Date(s): 001: None
Nov 9, 2021 
Pat. No. 7145036 DS* Formoterol tartrate polymorph
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: None
Nov 9, 2021 
Pat. No. 8110706 DP* Formoterol tartrate process and polymorph
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Feb 9, 2012
Nov 9, 2021 

PERFOROMIST (SOLUTION) (INHALATION) FORMOTEROL FUMARATE
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: MYLAN SPECLT      NDA No.: 022007  Prod. No.: 001 RX (0.02MG/2ML)
PatentsExpirationPatented Use
Pat. No. 6667344 DP* Bronchodilating compositions and methods
Claim Types: Formulation; Drug in a container
Pat. Sub. Date(s): 001: None
Jun 22, 2021 
Pat. No. 6814953 DP* Bronchodilating compositions and methods
Claim Types: Kit; Method of use
Pat. Sub. Date(s): 001: None
Jun 22, 2021U-813: Maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD)
Pat. No. 7348362 DP* Bronchodilating .beta.-agonist compositions and methods
Claim Types: Drug in a container; Method of administration
Pat. Sub. Date(s): 001: None
Jun 22, 2021 
Pat. No. 7462645 DP* Bronchodilating beta-agonist compositions and methods
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Jun 22, 2021U-813: Maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD)
Pat. No. 8623922 DP* Bronchodilating Beta-agonist compositions and methods
Claim Types: Formulation
Pat. Sub. Date(s): 001: May 30, 2014
Jun 22, 2021 
Pat. No. 9730890 DP* Bronchodilating beta-agonist compositions and methods
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 23, 2018
Jun 22, 2021 

SUTENT (CAPSULE) (ORAL) SUNITINIB MALATE
Drug Classes: kinase inhibitor
NDA Applicant: CPPI CV      NDA No.: 021938  Prod. No.: 001 RX (EQ 12.5MG BASE); 002 RX (EQ 25MG BASE); 003 RX (EQ 50MG BASE); 004 RX (EQ 37.5MG BASE)
PatentsExpirationPatented Use
Pat. No. 7211600 Methods of modulating c-kit tyrosine protein kinase function with indolinone compounds
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Jun 22, 2021 *PEDU-883: Treatment of gastrointestinal stromal tumor with sunitinib
Pat. No. 6573293 DS* DP* [Extended 826 days (2.3 years)]
Pyrrole substituted 2-indolinone protein kinase inhibitors
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: None
Aug 15, 2021 *PEDU-1154: Treatment of protein kinase related disorders, such as gastrointestinal stromal tumors, renal cell carcinoma and advanced pancreatic neuroendocrine tumors, with sunitinib
U-2171: Adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy
Pat. No. 7125905 DS* DP* Pyrrole substituted 2-indolinone protein kinase inhibitors
Claim Types: Compound
Pat. Sub. Date(s): 001: Jun 17, 2011; 002: None; 003: None; 004: None
Aug 15, 2021 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMay 16, 2021 PEDI-755: Adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy

AIRDUO DIGIHALER (POWDER) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: corticosteroid; beta-2 adrenergic agonist
NDA Applicant: TEVA PHARM      NDA No.: 208799  Prod. No.: 004 RX (0.055MG/INH;EQ 0.014MG BASE/INH)
PatentsExpirationPatented Use
Pat. No. 6701917 DP* Dose counter for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): 004: Aug 2, 2019
Jun 23, 2021 
Pat. No. 6718972 DP* Dose metering system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): 004: Aug 2, 2019
Jun 23, 2021 
Pat. No. 6748947 DP* De-agglomerator for breath-actuated dry powder inhaler
Claim Types: Device; Part of a dosage form
Pat. Sub. Date(s): 004: Aug 2, 2019
Jun 23, 2021 
Pat. No. 6871646 DP* De-agglomerator for breath-actuated dry powder inhaler
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 004: Aug 2, 2019
Jun 23, 2021 
Pat. No. 8006690 DP* Reservoir pressure system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): 004: Aug 2, 2019
Jun 23, 2021 
Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): 004: Aug 2, 2019
May 6, 2023 
Pat. No. 9616024 DP* Process for preparing a medicament
Claim Types: Product-by-process; Device
Pat. Sub. Date(s): 004: Aug 2, 2019
Sep 1, 2024 
Pat. No. 9987229 DP* Process for preparing a medicament
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 004: Aug 2, 2019
Sep 1, 2024 
Pat. No. 9463288 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 004: Aug 2, 2019
May 19, 2025 
Pat. No. 8651103 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 004: Aug 2, 2019
Mar 26, 2028 
Pat. No. 10195375 DP* Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): 004: Aug 2, 2019
Feb 14, 2031 
Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Device
Pat. Sub. Date(s): 004: Aug 2, 2019
May 18, 2031 
Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 004: Aug 2, 2019
May 18, 2031 
Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): 004: Aug 2, 2019
May 18, 2031 
Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 004: Aug 2, 2019
Jun 28, 2031 
Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 004: Aug 2, 2019
Jan 13, 2032 
Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): 004: Aug 2, 2019
Feb 25, 2032 
Pat. No. 9066957 DP* Dry powder inhaler
Claim Types: Device; Method of use
Pat. Sub. Date(s): 004: Aug 2, 2019
Oct 6, 2034U-645: Treatment of asthma
Pat. No. 9415008 DP* Dry powder inhaler
Claim Types: Device; Method of use
Pat. Sub. Date(s): 004: Aug 2, 2019
Oct 6, 2034U-645: Treatment of asthma
Pat. No. 9782550 DP* Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 004: Aug 2, 2019
Aug 28, 2035 
Pat. No. 9782551 DP* Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device
Pat. Sub. Date(s): 004: Aug 2, 2019
Aug 28, 2035 

AIRDUO DIGIHALER (POWDER) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: corticosteroid; beta-2 adrenergic agonist
NDA Applicant: TEVA PHARM      NDA No.: 208799  Prod. No.: 005 RX (0.113MG/INH;EQ 0.014MG BASE/INH); 006 RX (0.232MG/INH;EQ 0.014MG BASE/INH)
PatentsExpirationPatented Use
Pat. No. 6701917 DP* Dose counter for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Jun 23, 2021 
Pat. No. 6718972 DP* Dose metering system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Jun 23, 2021 
Pat. No. 6748947 DP* De-agglomerator for breath-actuated dry powder inhaler
Claim Types: Device; Part of a dosage form
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Jun 23, 2021 
Pat. No. 6871646 DP* De-agglomerator for breath-actuated dry powder inhaler
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Jun 23, 2021 
Pat. No. 8006690 DP* Reservoir pressure system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Jun 23, 2021 
Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
May 6, 2023 
Pat. No. 9616024 DP* Process for preparing a medicament
Claim Types: Product-by-process; Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Sep 1, 2024 
Pat. No. 9987229 DP* Process for preparing a medicament
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Sep 1, 2024 
Pat. No. 9463288 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
May 19, 2025 
Pat. No. 8651103 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Mar 26, 2028 
Pat. No. 10195375 DP* Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Feb 14, 2031 
Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
May 18, 2031 
Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
May 18, 2031 
Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
May 18, 2031 
Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Jun 28, 2031 
Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Jan 13, 2032 
Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Feb 25, 2032 
Pat. No. 9066957 DP* Dry powder inhaler
Claim Types: Device; Method of use
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Oct 6, 2034U-645: Treatment of asthma
Pat. No. 9782550 DP* Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Aug 28, 2035 
Pat. No. 9782551 DP* Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Aug 28, 2035 

AIRDUO RESPICLICK (POWDER) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: corticosteroid; beta-2 adrenergic agonist
NDA Applicant: TEVA PHARM      NDA No.: 208799  Prod. No.: 001 RX (0.055MG/INH;EQ 0.014MG BASE/INH)
PatentsExpirationPatented Use
Pat. No. 6701917 DP* Dose counter for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
Jun 23, 2021 
Pat. No. 6718972 DP* Dose metering system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
Jun 23, 2021 
Pat. No. 6748947 DP* De-agglomerator for breath-actuated dry powder inhaler
Claim Types: Device; Part of a dosage form
Pat. Sub. Date(s): 001: Jan 30, 2017
Jun 23, 2021 
Pat. No. 6871646 DP* De-agglomerator for breath-actuated dry powder inhaler
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Jan 30, 2017
Jun 23, 2021 
Pat. No. 8006690 DP* Reservoir pressure system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
Jun 23, 2021 
Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
May 6, 2023 
Pat. No. 9616024 DP* Process for preparing a medicament
Claim Types: Product-by-process; Device
Pat. Sub. Date(s): 001: May 10, 2017
Sep 1, 2024 
Pat. No. 9987229 DP* Process for preparing a medicament
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Jul 3, 2018
Sep 1, 2024 
Pat. No. 9463288 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
May 19, 2025 
Pat. No. 8651103 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
Mar 26, 2028 
Pat. No. 10195375 DP* Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): 001: Mar 5, 2019
Feb 14, 2031 
Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 31, 2017
May 18, 2031 
Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 13, 2018
May 18, 2031 
Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): 001: Dec 12, 2018
May 18, 2031 
Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
Jun 28, 2031 
Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
Jan 13, 2032 
Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
Feb 25, 2032 
Pat. No. 9066957 DP* Dry powder inhaler
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Jan 30, 2017
Oct 6, 2034U-645: Treatment of asthma
Pat. No. 9415008 DP* Dry powder inhaler
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Jan 30, 2017
Oct 6, 2034U-645: Treatment of asthma
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productJan 27, 2020 

AIRDUO RESPICLICK (POWDER) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: corticosteroid; beta-2 adrenergic agonist
NDA Applicant: TEVA PHARM      NDA No.: 208799  Prod. No.: 002 RX (0.113MG/INH;EQ 0.014MG BASE/INH); 003 RX (0.232MG/INH;EQ 0.014MG BASE/INH)
PatentsExpirationPatented Use
Pat. No. 6701917 DP* Dose counter for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Jun 23, 2021 
Pat. No. 6718972 DP* Dose metering system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Jun 23, 2021 
Pat. No. 6748947 DP* De-agglomerator for breath-actuated dry powder inhaler
Claim Types: Device; Part of a dosage form
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Jun 23, 2021 
Pat. No. 6871646 DP* De-agglomerator for breath-actuated dry powder inhaler
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Jun 23, 2021 
Pat. No. 8006690 DP* Reservoir pressure system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Jun 23, 2021 
Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
May 6, 2023 
Pat. No. 9616024 DP* Process for preparing a medicament
Claim Types: Product-by-process; Device
Pat. Sub. Date(s): All strengths: May 10, 2017
Sep 1, 2024 
Pat. No. 9987229 DP* Process for preparing a medicament
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): All strengths: Jul 3, 2018
Sep 1, 2024 
Pat. No. 9463288 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
May 19, 2025 
Pat. No. 8651103 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Mar 26, 2028 
Pat. No. 10195375 DP* Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): All strengths: Mar 5, 2019
Feb 14, 2031 
Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 31, 2017
May 18, 2031 
Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 13, 2018
May 18, 2031 
Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): All strengths: Dec 12, 2018
May 18, 2031 
Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Jun 28, 2031 
Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Jan 13, 2032 
Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Feb 25, 2032 
Pat. No. 9066957 DP* Dry powder inhaler
Claim Types: Device; Method of use
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Oct 6, 2034U-645: Treatment of asthma
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productJan 27, 2020 

ARMONAIR RESPICLICK (POWDER) (INHALATION) FLUTICASONE PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: TEVA PHARM      NDA No.: 208798  Prod. No.: 001 RX (0.055MG/INH); 003 RX (0.232MG/INH) NDA No.: 208798  Prod. No.: 002 DISC (0.113MG/INH)
PatentsExpirationPatented Use
Pat. No. 6701917 DP* Dose counter for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Jun 23, 2021 
Pat. No. 6718972 DP* Dose metering system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Jun 23, 2021 
Pat. No. 6748947 DP* De-agglomerator for breath-actuated dry powder inhaler
Claim Types: Device; Part of a dosage form
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Jun 23, 2021 
Pat. No. 6871646 DP* De-agglomerator for breath-actuated dry powder inhaler
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Jun 23, 2021 
Pat. No. 8006690 DP* Reservoir pressure system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Jun 23, 2021 
Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
May 6, 2023 
Pat. No. 9616024 DP* Process for preparing a medicament
Claim Types: Product-by-process; Device
Pat. Sub. Date(s): All strengths: May 10, 2017
Sep 1, 2024 
Pat. No. 9463288 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
May 19, 2025 
Pat. No. 8651103 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Mar 26, 2028 
Pat. No. 10195375 DP* Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): All strengths: Mar 5, 2019
Feb 14, 2031 
Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 31, 2017
May 18, 2031 
Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 13, 2018
May 18, 2031 
Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): All strengths: Dec 12, 2018
May 18, 2031 
Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Jun 28, 2031 
Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Jan 13, 2032 
Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Feb 25, 2032 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productJan 27, 2020 

PROAIR DIGIHALER (POWDER, METERED) (INHALATION) ALBUTEROL SULFATE
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: TEVA BRANDED PHARM      NDA No.: 205636  Prod. No.: 002 RX (EQ 0.09MG BASE/INH)
PatentsExpirationPatented Use
Pat. No. 6701917 DP* Dose counter for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): 002: Jan 9, 2019
Jun 23, 2021 
Pat. No. 6718972 DP* Dose metering system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): 002: Jan 9, 2019
Jun 23, 2021 
Pat. No. 6748947 DP* De-agglomerator for breath-actuated dry powder inhaler
Claim Types: Device; Part of a dosage form
Pat. Sub. Date(s): 002: Jan 9, 2019
Jun 23, 2021 
Pat. No. 6871646 DP* De-agglomerator for breath-actuated dry powder inhaler
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 002: Jan 9, 2019
Jun 23, 2021 
Pat. No. 8006690 DP* Reservoir pressure system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): 002: Jan 9, 2019
Jun 23, 2021 
Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): 002: Jan 9, 2019
May 6, 2023 
Pat. No. 9463288 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 002: Jan 9, 2019
May 19, 2025 
Pat. No. 8651103 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 002: Jan 9, 2019
Mar 26, 2028 
Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Device
Pat. Sub. Date(s): 002: Jan 9, 2019
May 18, 2031 
Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 002: Jan 9, 2019
May 18, 2031 
Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): 002: Jan 9, 2019
May 18, 2031 
Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 002: Jan 9, 2019
Jun 28, 2031 
Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 002: Jan 9, 2019
Jan 13, 2032 
Pat. No. 9782550 DP* Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 002: Jan 9, 2019
Aug 28, 2035 
Pat. No. 9782551 DP* Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device
Pat. Sub. Date(s): 002: Jan 9, 2019
Aug 28, 2035 

PROAIR RESPICLICK (POWDER, METERED) (INHALATION) ALBUTEROL SULFATE
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: TEVA BRANDED PHARM      NDA No.: 205636  Prod. No.: 001 RX (EQ 0.09MG BASE/INH)
PatentsExpirationPatented Use
Pat. No. 6701917 DP* Dose counter for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): 001: Apr 28, 2015
Jun 23, 2021 
Pat. No. 6718972 DP* Dose metering system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): 001: Apr 28, 2015
Jun 23, 2021 
Pat. No. 6748947 DP* De-agglomerator for breath-actuated dry powder inhaler
Claim Types: Device; Part of a dosage form
Pat. Sub. Date(s): 001: Apr 28, 2015
Jun 23, 2021 
Pat. No. 6871646 DP* De-agglomerator for breath-actuated dry powder inhaler
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Apr 28, 2015
Jun 23, 2021 
Pat. No. 8006690 DP* Reservoir pressure system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): 001: Apr 28, 2015
Jun 23, 2021 
Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): 001: Apr 28, 2015
May 6, 2023 
Pat. No. 9463288 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 8, 2016
May 19, 2025 
Pat. No. 8651103 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 001: Apr 28, 2015
Mar 26, 2028 
Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 31, 2017
May 18, 2031 
Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 14, 2018
May 18, 2031 
Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): 001: Dec 12, 2018
May 18, 2031 
Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 21, 2016
Jun 28, 2031 
Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 21, 2016
Jan 13, 2032 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationApr 28, 2019 

LIVALO (TABLET) (ORAL) PITAVASTATIN CALCIUM [GENERIC AB]
Drug Classes: HMG CoA-reductase inhibitor
NDA Applicant: KOWA CO      NDA No.: 022363  Prod. No.: 001 RX (EQ 1MG BASE); 002 RX (EQ 2MG BASE); 003 RX (EQ 4MG BASE)
PatentsExpirationPatented Use
Pat. No. 5856336 DS* [Extended 1823 days (5 years)]
Quinoline type mevalonolactones
Claim Types: Compound
Pat. Sub. Date(s): All strengths: None
Jun 25, 2021 *PEDU-998: Adjuncitve [sic, Adjunctive] therapy to diet to reduce elevated total cholesterol, low-density lipoprotein cholesterol, apolipoprotein B, triglycerides and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia
Pat. No. 8557993 DP* Crystalline forms of pitavastatin calcium
Claim Types: New polymorph, salt or hydrate; Process; Composition
Pat. Sub. Date(s): All strengths: Nov 12, 2013
Aug 2, 2024 *PED 
Pat. No. 7022713 Hyperlipemia therapeutic agent
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Aug 19, 2024 *PEDU-998: Adjuncitve [sic, Adjunctive] therapy to diet to reduce elevated total cholesterol, low-density lipoprotein cholesterol, apolipoprotein B, triglycerides and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationNov 16, 2022 PED 

APTIOM (TABLET) (ORAL) ESLICARBAZEPINE ACETATE
NDA Applicant: SUNOVION PHARMS INC      NDA No.: 022416  Prod. No.: 001 RX (200MG); 002 RX (400MG); 003 RX (600MG); 004 RX (800MG)
PatentsExpirationPatented Use
Pat. No. 5753646 DS* DP* [Extended 5 years]
Substituted dihydrodibenzo/b,f/azepines, method of their preparation, their use in the treatment of some central nervous system disorders, and pharmaceutical compositions containing them
Claim Types: Compound; Process; Method of use; Composition
Pat. Sub. Date(s): All strengths: None
Jun 27, 2021U-2041: Treatment of partial-onset seizures
Pat. No. 9206135 DS* Asymmetric catalytic reduction of oxcarbazepine
Claim Types: Compound; Product-by-process; Method of use
Pat. Sub. Date(s): All strengths: May 20, 2016
Apr 21, 2026 
Pat. No. 9643929 DP* Asymmetric catalytic reduction of oxcarbazepine
Claim Types: Composition
Pat. Sub. Date(s): All strengths: Jun 8, 2017
Apr 21, 2026 
Pat. No. 9763954 Therapeutical uses of eslicarbazepine
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 10, 2017
Sep 13, 2028U-2123: Treatment of partial-onset seizures in patients with epilepsy who have been previously treated with oxcarbazepine
Pat. No. 9566244 DP* Pharmaceutical composition comprising licarbazepine acetate
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Mar 8, 2017
Oct 23, 2028 
Pat. No. 8372431 DP* Pharmaceutical composition comprising licarbazepine acetate
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Apr 17, 2030 
Pat. No. 9750747 Treatments involving eslicarbazepine acetate or eslicarbazepine
Claim Types: Method of use; Method of use
Pat. Sub. Date(s): All strengths: Sep 28, 2017
Aug 24, 2032U-2041: Treatment of partial-onset seizures
U-2121: Treatment of partial-onset seizures in a patient suffering from or susceptible to absence seizures

FERRIPROX (TABLET) (ORAL) DEFERIPRONE
Drug Classes: iron chelator
NDA Applicant: APOPHARMA INC      NDA No.: 021825  Prod. No.: 001 RX (500MG)
PatentsExpirationPatented Use
Pat. No. 7049328 Use for deferiprone
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Oct 8, 2015
Jun 28, 2021U-735: Method of treating chronic iron overload

FERRIPROX (SOLUTION) (ORAL) DEFERIPRONE
Drug Classes: iron chelator
NDA Applicant: APOPHARMA INC      NDA No.: 208030  Prod. No.: 001 RX (100MG/ML); 002 RX (80MG/ML)
PatentsExpirationPatented Use
Pat. No. 7049328 Use for deferiprone
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Oct 6, 2015; 002: Jan 31, 2019
Jun 28, 2021U-735: Method of treating chronic iron overload
Pat. No. 8703156 DP* Liquid formulation for deferiprone with palatable taste
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 6, 2015; 002: Jan 31, 2019
Oct 29, 2029U-735: Method of treating chronic iron overload

NUZYRA (TABLET) (ORAL) OMADACYCLINE TOSYLATE
NDA Applicant: PARATEK PHARMS INC      NDA No.: 209816  Prod. No.: 001 RX (EQ 150MG BASE)
PatentsExpirationPatented Use
Pat. No. 9365500 9-aminomethyl substituted minocycline compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 23, 2019
Jun 29, 2021U-1569: Treatment of bacterial skin and skin structure infections
U-2576: Treatment of community acquired bacterial pneumonia
Pat. No. 7553828 DS* 9-aminomethyl substituted minocycline compounds
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jul 23, 2019
Jun 2, 2023 
Pat. No. 7326696 DS* Amino-methyl substituted tetracycline compounds
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jul 23, 2019
Sep 24, 2023 
Pat. No. 9265740 Minocycline compounds and methods of use thereof
Claim Types: Method of use; Composition
Pat. Sub. Date(s): 001: Jul 23, 2019
Mar 5, 2029U-1569: Treatment of bacterial skin and skin structure infections
Pat. No. 9724358 Minocycline compounds and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 23, 2019
Mar 5, 2029U-1569: Treatment of bacterial skin and skin structure infections
Pat. No. 10124014 Minocycline compounds and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 11, 2018
Mar 5, 2029U-2449: Treatment of bacterial skin and skin structure infection
Pat. No. 8383610 DS* Salts and polymorphs of 9-(2,2-dimethylpropyl-aminomethyl) minocycline
Claim Types: New polymorph, salt or hydrate; Composition
Pat. Sub. Date(s): 001: Jul 23, 2019
Sep 23, 2030 
Pat. No. 9314475 DP* Oral and injectable formulations of tetracycline compounds
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 23, 2019
Mar 18, 2031 
Pat. No. 10111890 9-aminomethyl minocycline compounds and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 28, 2018
Aug 3, 2037U-2444: Treatment of subjects having bacterial skin or skin structure infection
ExclusivityExpirationExclusivity Description
Exclusivity Code: GAIN - Generating Antibiotic Incentives NowOct 2, 2028 
Exclusivity Code: NCE - New chemical entityOct 2, 2023 

NUZYRA (POWDER) (INTRAVENOUS) OMADACYCLINE TOSYLATE
NDA Applicant: PARATEK PHARMS INC      NDA No.: 209817  Prod. No.: 001 RX (EQ 100MG BASE/VIAL)
PatentsExpirationPatented Use
Pat. No. 9365500 9-aminomethyl substituted minocycline compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 23, 2019
Jun 29, 2021U-1569: Treatment of bacterial skin and skin structure infections
U-2576: Treatment of community acquired bacterial pneumonia
Pat. No. 7553828 DS* 9-aminomethyl substituted minocycline compounds
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jul 23, 2019
Jun 2, 2023 
Pat. No. 7326696 DS* Amino-methyl substituted tetracycline compounds
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jul 23, 2019
Sep 24, 2023 
Pat. No. 9265740 DP* Minocycline compounds and methods of use thereof
Claim Types: Method of use; Composition
Pat. Sub. Date(s): 001: Jul 23, 2019
Mar 5, 2029 
Pat. No. 9724358 Minocycline compounds and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 23, 2019
Mar 5, 2029U-1569: Treatment of bacterial skin and skin structure infections
Pat. No. 10124014 Minocycline compounds and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 11, 2018
Mar 5, 2029U-2449: Treatment of bacterial skin and skin structure infection
ExclusivityExpirationExclusivity Description
Exclusivity Code: GAIN - Generating Antibiotic Incentives NowOct 2, 2028 
Exclusivity Code: NCE - New chemical entityOct 2, 2023 

RESCULA (SOLUTION/DROPS) (OPHTHALMIC) UNOPROSTONE ISOPROPYL
Drug Classes: prostaglandin analog
NDA Applicant: SUCAMPO PHARMA LLC      NDA No.: 021214  Prod. No.: 001 DISC (0.15%**)
PatentsExpirationPatented Use
Pat. No. 6458836 Treatment of ocular hypertension and glaucoma
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
Jul 9, 2021U-1315: The long term treatment of prophylactic management of ocular hypertension and glaucoma
U-333: Method of treating ocular hypertension

FASLODEX (INJECTABLE) (INTRAMUSCULAR) FULVESTRANT [GENERIC AO]
Drug Classes: estrogen receptor antagonist
NDA Applicant: ASTRAZENECA      NDA No.: 021344  Prod. No.: 001 RX (50MG/ML)
PatentsExpirationPatented Use
Pat. No. 6774122 Formulation
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Jul 9, 2021 *PEDU-1826: Treatment of HR-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer in combination with palbociclib in women with disease progression after endocrine therapy
U-2108: Treatment of hormone receptor positive HER2-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy
U-2163: Treatment of HR-positive, human epidermal growth factor receptor 2 (HER-2)-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy
U-2504: Treatment of HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib as initial endocrine based therapy or following disease progression on endocrine therapy
U-596: Treatment of hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy
Pat. No. 7456160 Formulation
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Jul 9, 2021 *PEDU-1826: Treatment of HR-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer in combination with palbociclib in women with disease progression after endocrine therapy
U-2108: Treatment of hormone receptor positive HER2-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy
U-2163: Treatment of HR-positive, human epidermal growth factor receptor 2 (HER-2)-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy
U-2504: Treatment of HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib as initial endocrine based therapy or following disease progression on endocrine therapy
U-596: Treatment of hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy
Pat. No. 8329680 Formulation
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 10, 2013
Jul 9, 2021 *PEDU-1826: Treatment of HR-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer in combination with palbociclib in women with disease progression after endocrine therapy
U-2108: Treatment of hormone receptor positive HER2-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy
U-2163: Treatment of HR-positive, human epidermal growth factor receptor 2 (HER-2)-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy
U-2504: Treatment of HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib as initial endocrine based therapy or following disease progression on endocrine therapy
U-596: Treatment of hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy
Pat. No. 8466139 Formulation
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Jul 9, 2021 *PEDU-1826: Treatment of HR-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer in combination with palbociclib in women with disease progression after endocrine therapy
U-2108: Treatment of hormone receptor positive HER2-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy
U-2163: Treatment of HR-positive, human epidermal growth factor receptor 2 (HER-2)-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy
U-2504: Treatment of HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib as initial endocrine based therapy or following disease progression on endocrine therapy
U-596: Treatment of hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationFeb 19, 2019I-725: Treatment of hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer in combination therapy with palbociclib and fulvestrant in women with disease progression following endocrine therapy.
Exclusivity Code: I - New IndicationAug 25, 2020I-749: Monotherapy for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced breast cancer in postmenopausal women not previously treated with endocrine therapy

ALPHAGAN P (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE
Drug Classes: alpha adrenergic agonist
NDA Applicant: ALLERGAN      NDA No.: 021770  Prod. No.: 001 RX (0.1%)
PatentsExpirationPatented Use
Pat. No. 10307368 DP* Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 24, 2019
Jul 10, 2021 
Pat. No. 6562873 DP* Compositions containing therapeutically active components having enhanced solubility
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 10, 2022 *PED 
Pat. No. 9295641 Compositions containing alpha-2-adrenergic agonist components
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 28, 2016
Jan 10, 2022 *PEDU-1833: Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension
Pat. No. 9687443 DP* Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 10, 2017
Jan 10, 2022 *PED 
Pat. No. 6627210 DP* Compositions containing .alpha.-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 18, 2022 *PED 
Pat. No. 6673337 DP* Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 26, 2022 *PED 
Pat. No. 6641834 DP* Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 28, 2022 *PED 
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 

BREVIBLOC IN PLASTIC CONTAINER; BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER (INJECTABLE) (INJECTION) ESMOLOL HYDROCHLORIDE [GENERIC AP]
Drug Classes: beta-adrenergic receptor inhibitor
NDA Applicant: BAXTER HLTHCARE      NDA No.: 019386  Prod. No.: 004 RX (1GM/100ML); 005 RX (2GM/100ML); 006 RX (10MG/ML) NDA No.: 019386  Prod. No.: 007 DISC (20MG/ML)
PatentsExpirationPatented Use
Pat. No. 6310094 Ready-to-use esmolol solution
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: None
Jul 12, 2021 *PED 
Pat. No. 6528540 Esmolol formulation
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: None
Jul 12, 2021 *PED 

NOVOLOG INNOLET (INJECTABLE) (SUBCUTANEOUS) INSULIN ASPART RECOMBINANT
Drug Classes: insulin analog
NDA Applicant: NOVO NORDISK INC      NDA No.: 020986  Prod. No.: 004 DISC (300 UNITS/3ML (100 UNITS/ML))
PatentsExpirationPatented Use
Pat. No. RE41956 DP* Dose setting limiter
Claim Types: Device
Pat. Sub. Date(s): 004: None
Jul 21, 2021 *PED 

AVYCAZ (POWDER) (IV (INFUSION)) AVIBACTAM SODIUM; CEFTAZIDIME
Drug Classes: beta lactamase inhibitor; cephalosporin antibacterial
NDA Applicant: ALLERGAN SALES LLC      NDA No.: 206494  Prod. No.: 001 RX (EQ 0.5GM BASE;2GM/VIAL)
PatentsExpirationPatented Use
Pat. No. 8178554 DS* DP* Heterocyclic compounds, their preparation and their use as medicaments, in particular as anti-bacterial agents
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Mar 17, 2015
Jul 24, 2021U-2245: A method of treating a bacterial infection in hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) patients comprising administering an effective amount of avibactam sodium
U-2509: A method of treating a bacterial infection in complicated intra-abdominal infection (CIAI) and complicated urinary tract infection (CUTI), including pyelonephritis, patients comprising administering an effective amount of avibactam sodium
U-282: Method of treating bacterial infections
Pat. No. 7112592 DS* DP* Azabicyclic compounds, preparation thereof and use as medicines, in particular as antibacterial agents
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Mar 17, 2015
Feb 24, 2022U-2244: A method of treating bacterial infections in hospital-acquired bacterial pneumonia and ventilator-associated bacterial pnenumonia (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
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. 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. 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. 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 

ZYVOX (TABLET) (ORAL) LINEZOLID [GENERIC AB]
Drug Classes: oxazolidinone antibacterial
NDA Applicant: PHARMACIA AND UPJOHN      NDA No.: 021130  Prod. No.: 002 RX (600MG) NDA No.: 021130  Prod. No.: 001 DISC (400MG**)
PatentsExpirationPatented Use
Pat. No. 6559305 DS* Linezolid--crystal form II
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: None
Jul 29, 2021 *PED 
Pat. No. 6514529 DP* Oxazolidinone tablet formulation
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Sep 15, 2021 *PED 

ZYVOX (SOLUTION) (INTRAVENOUS) LINEZOLID [GENERIC AP]
Drug Classes: oxazolidinone antibacterial
NDA Applicant: PHARMACIA AND UPJOHN      NDA No.: 021131  Prod. No.: 001 RX (200MG/100ML (2MG/ML)); 003 RX (600MG/300ML (2MG/ML)) NDA No.: 021131  Prod. No.: 002 DISC (400MG/200ML (2MG/ML))
PatentsExpirationPatented Use
Pat. No. 6559305 DS* Linezolid--crystal form II
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: None; 002: Aug 14, 2003; 003: Aug 14, 2003
Jul 29, 2021 *PED 

ZYVOX (FOR SUSPENSION) (ORAL) LINEZOLID [GENERIC AB]
Drug Classes: oxazolidinone antibacterial
NDA Applicant: PHARMACIA AND UPJOHN      NDA No.: 021132  Prod. No.: 001 RX (100MG/5ML)
PatentsExpirationPatented Use
Pat. No. 6559305 DS* Linezolid--crystal form II
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: None
Jul 29, 2021 *PED 

KYNAMRO (SOLUTION) (SUBCUTANEOUS) MIPOMERSEN SODIUM
Drug Classes: antisense oligonucleotide; apolipoprotein B-100 synthesis inhibitor
NDA Applicant: KASTLE THERAPS LLC      NDA No.: 203568  Prod. No.: 001 DISC (200MG/ML (200MG/ML))
PatentsExpirationPatented Use
Pat. No. 7407943 Antisense modulation of apolipoprotein B expression
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Aug 1, 2021U-1353: Adjunctive therapy to lipid-lowering medications and diet to reduce low density lipoprotein-cholesterol, apolipoprotein B, total cholesterol, and non-high density lipoprotein cholesterol in pts with homozygous familial hypercholesterolemia
Pat. No. 7015315 DS* Gapped oligonucleotides
Claim Types: Compound
Pat. Sub. Date(s): 001: None
Mar 21, 2023 
Pat. No. 7101993 DS* Oligonucleotides containing 2'-O-modified purines
Claim Types: Compound
Pat. Sub. Date(s): 001: None
Sep 5, 2023 
Pat. No. 7511131 DS* [Extended 412 days (1.1 years)]
Antisense modulation of apolipoprotein B expression
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: None
Jan 29, 2027 
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityJan 29, 2020ODE-41: Adjunct to lipid-lowering medications and diet to reduce LDL-C, apolipoprotein b (apo b), total cholesterol (TC), and non-high density lipoprotein-cholesterol (non-HDL-C) in patients with homozygous familial hypercholesterolemia (HOFH)

ARNUITY ELLIPTA (POWDER) (INHALATION) FLUTICASONE FUROATE
Drug Classes: corticosteroid
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 205625  Prod. No.: 001 RX (0.1MG/INH)
PatentsExpirationPatented Use
Pat. No. 7101866 DS* DP* Anti-inflammatory androstane derivative
Claim Types: Compound; New polymorph, salt or hydrate; Composition; Formulation; Method of use; Process; Drug in a container
Pat. Sub. Date(s): 001: Aug 28, 2014
Aug 3, 2021U-1559: Indicated for the once-daily maintenance treatment of asthma as prophylactic therapy in patients aged 12 years of age and older
Pat. No. 7629335 DP* Anti-inflammatory androstane derivative
Claim Types: Formulation; Device
Pat. Sub. Date(s): 001: Aug 28, 2014
Aug 3, 2021 
Pat. No. 9333310 DP* Medicament dispenser
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): 001: May 18, 2016
Oct 2, 2027 
Pat. No. 8113199 DP* Counter for use with a medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 28, 2014
Oct 23, 2027 
Pat. No. 8161968 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 28, 2014
Feb 5, 2028 
Pat. No. 8201556 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 28, 2014
Feb 5, 2029 
Pat. No. 8534281 DP* Manifold for use in medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 28, 2014
Mar 8, 2030 
Pat. No. 8746242 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 28, 2014
Oct 11, 2030 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationMay 17, 2021 

ARNUITY ELLIPTA (POWDER) (INHALATION) FLUTICASONE FUROATE
Drug Classes: corticosteroid
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 205625  Prod. No.: 002 RX (0.2MG/INH)
PatentsExpirationPatented Use
Pat. No. 7101866 DS* DP* Anti-inflammatory androstane derivative
Claim Types: Compound; New polymorph, salt or hydrate; Composition; Formulation; Method of use; Process; Drug in a container
Pat. Sub. Date(s): 002: Aug 28, 2014
Aug 3, 2021U-1559: Indicated for the once-daily maintenance treatment of asthma as prophylactic therapy in patients aged 12 years of age and older
Pat. No. 7629335 DP* Anti-inflammatory androstane derivative
Claim Types: Formulation; Device
Pat. Sub. Date(s): 002: Aug 28, 2014
Aug 3, 2021 
Pat. No. 9333310 DP* Medicament dispenser
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): 002: May 18, 2016
Oct 2, 2027 
Pat. No. 8113199 DP* Counter for use with a medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 002: Aug 28, 2014
Oct 23, 2027 
Pat. No. 8161968 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 002: Aug 28, 2014
Feb 5, 2028 
Pat. No. 8201556 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 002: Aug 28, 2014
Feb 5, 2029 
Pat. No. 8534281 DP* Manifold for use in medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 002: Aug 28, 2014
Mar 8, 2030 
Pat. No. 8746242 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 002: Aug 28, 2014
Oct 11, 2030 

ARNUITY ELLIPTA (POWDER) (INHALATION) FLUTICASONE FUROATE
Drug Classes: corticosteroid
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 205625  Prod. No.: 003 RX (0.05MG/INH)
PatentsExpirationPatented Use
Pat. No. 7101866 DS* DP* Anti-inflammatory androstane derivative
Claim Types: Compound; New polymorph, salt or hydrate; Composition; Formulation; Method of use; Process; Drug in a container
Pat. Sub. Date(s): 003: Jun 13, 2018
Aug 3, 2021U-2349: For once-daily maintenance treatment of asthma as prophylactic therapy in patients aged 5 years and older
Pat. No. 7629335 DP* Anti-inflammatory androstane derivative
Claim Types: Formulation; Device
Pat. Sub. Date(s): 003: Jun 13, 2018
Aug 3, 2021 
Pat. No. 9333310 DP* Medicament dispenser
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): 003: Jun 13, 2018
Oct 2, 2027 
Pat. No. 8113199 DP* Counter for use with a medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 003: Jun 13, 2018
Oct 23, 2027 
Pat. No. 8161968 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 003: Jun 13, 2018
Feb 5, 2028 
Pat. No. 8201556 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 003: Jun 13, 2018
Feb 5, 2029 
Pat. No. 8534281 DP* Manifold for use in medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 003: Jun 13, 2018
Mar 8, 2030 
Pat. No. 8746242 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 003: Jun 13, 2018
Oct 11, 2030 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NS - New strengthMay 17, 2021 

BREO ELLIPTA (POWDER) (INHALATION) FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
Drug Classes: corticosteroid; beta-2 adrenergic agonist
NDA Applicant: GLAXO GRP LTD      NDA No.: 204275  Prod. No.: 001 RX (0.1MG/INH;EQ 0.025MG BASE/INH)
PatentsExpirationPatented Use
Pat. No. 6537983 DP* Anti-inflammatory androstane derivatives
Claim Types: Formulation; Method of use; Drug in a container
Pat. Sub. Date(s): 001: Jun 4, 2013
Aug 3, 2021U-1401: Indicated for long-term, once-daily maintenance treatment of airflow obstruction in PTS with COPD, including chronic bronchitis and/or emphysema, also to reduce exacerbations of copd in pts with a history of exacerbations
U-1691: Indicated for the once-daily inhaled treatment for asthma in adults aged 18 years and older
Pat. No. 6759398 DP* Anti-inflammatory androstane derivative
Claim Types: Formulation; Method of use; Drug in a container
Pat. Sub. Date(s): 001: Jun 4, 2013
Aug 3, 2021U-1401: Indicated for long-term, once-daily maintenance treatment of airflow obstruction in PTS with COPD, including chronic bronchitis and/or emphysema, also to reduce exacerbations of copd in pts with a history of exacerbations
U-1691: Indicated for the once-daily inhaled treatment for asthma in adults aged 18 years and older
Pat. No. 6878698 Anti-inflammatory androstane derivatives
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jun 4, 2013
Aug 3, 2021U-1401: Indicated for long-term, once-daily maintenance treatment of airflow obstruction in PTS with COPD, including chronic bronchitis and/or emphysema, also to reduce exacerbations of copd in pts with a history of exacerbations
Pat. No. 7101866 DS* DP* Anti-inflammatory androstane derivative
Claim Types: Compound; New polymorph, salt or hydrate; Composition; Formulation; Method of use; Process; Drug in a container
Pat. Sub. Date(s): 001: Jun 4, 2013
Aug 3, 2021U-1401: Indicated for long-term, once-daily maintenance treatment of airflow obstruction in PTS with COPD, including chronic bronchitis and/or emphysema, also to reduce exacerbations of copd in pts with a history of exacerbations
U-1691: Indicated for the once-daily inhaled treatment for asthma in adults aged 18 years and older
Pat. No. 7629335 DP* Anti-inflammatory androstane derivative
Claim Types: Formulation; Device
Pat. Sub. Date(s): 001: Jun 4, 2013
Aug 3, 2021 
Pat. No. 7776895 DP* Inhalation devices for delivering phenethanolamine derivatives for the treatment of respiratory diseases
Claim Types: Device
Pat. Sub. Date(s): 001: Jun 4, 2013
Sep 11, 2022 
Pat. No. RE44874 DS* DP* Phenethanolamine derivatives for treatment of respiratory diseases
Claim Types: Compound; Composition; Formulation; Method of use; Process; Drug in a container
Pat. Sub. Date(s): 001: Jun 27, 2014
Mar 23, 2023U-1548: For the long-term, once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema, also to reduce exacerbations of COPD in patients with a history of exacerbations
U-1691: Indicated for the once-daily inhaled treatment for asthma in adults aged 18 years and older
Pat. No. 7439393 DS* DP* [Extended 983 days (2.7 years)]
Phenethanolamine derivatives for treatment of respiratory diseases
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Jun 4, 2013
May 21, 2025U-1401: Indicated for long-term, once-daily maintenance treatment of airflow obstruction in PTS with COPD, including chronic bronchitis and/or emphysema, also to reduce exacerbations of copd in pts with a history of exacerbations
U-1691: Indicated for the once-daily inhaled treatment for asthma in adults aged 18 years and older
U-2099: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including bronchitis and/or emphysema
U-2100: Indicated for the once-daily treatment of asthma in patients 18 years and older
Pat. No. 8511304 DP* Medicament dispenser
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Sep 6, 2013
Jun 14, 2027U-1424: Long-term, once daily maintenance treatment of airflow obstruction in pts with COPD, including chronic bronchitis and/or emphysema, also to reduce exacerbations of COPD in patients with a history of exacerbations
U-1691: Indicated for the once-daily inhaled treatment for asthma in adults aged 18 years and older
Pat. No. 9333310 DP* Medicament dispenser
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): 001: May 20, 2016
Oct 2, 2027 
Pat. No. 8113199 DP* Counter for use with a medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Jun 4, 2013
Oct 23, 2027 
Pat. No. 8161968 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Jun 4, 2013
Feb 5, 2028 
Pat. No. 8534281 DP* Manifold for use in medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Sep 18, 2013
Mar 8, 2030 
Pat. No. 8746242 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 8, 2014
Oct 11, 2030 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousMay 15, 2020M-202: Inclusion of data from the summit study for BREO ELLIPTA (fluticasone furoate/vilanterol trifenatate) inhalation powder in the package insert.

BREO ELLIPTA (POWDER) (INHALATION) FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
Drug Classes: corticosteroid; beta-2 adrenergic agonist
NDA Applicant: GLAXO GRP LTD      NDA No.: 204275  Prod. No.: 002 RX (0.2MG/INH;EQ 0.025MG BASE/INH)
PatentsExpirationPatented Use
Pat. No. 6537983 DP* Anti-inflammatory androstane derivatives
Claim Types: Formulation; Method of use; Drug in a container
Pat. Sub. Date(s): 002: May 7, 2015
Aug 3, 2021U-1691: Indicated for the once-daily inhaled treatment for asthma in adults aged 18 years and older
Pat. No. 6759398 DP* Anti-inflammatory androstane derivative
Claim Types: Formulation; Method of use; Drug in a container
Pat. Sub. Date(s): 002: May 7, 2015
Aug 3, 2021U-1691: Indicated for the once-daily inhaled treatment for asthma in adults aged 18 years and older
Pat. No. 7101866 DS* DP* Anti-inflammatory androstane derivative
Claim Types: Compound; New polymorph, salt or hydrate; Composition; Formulation; Method of use; Process; Drug in a container
Pat. Sub. Date(s): 002: May 7, 2015
Aug 3, 2021U-1691: Indicated for the once-daily inhaled treatment for asthma in adults aged 18 years and older
Pat. No. 7629335 DP* Anti-inflammatory androstane derivative
Claim Types: Formulation; Device
Pat. Sub. Date(s): 002: May 7, 2015
Aug 3, 2021 
Pat. No. 7776895 DP* Inhalation devices for delivering phenethanolamine derivatives for the treatment of respiratory diseases
Claim Types: Device
Pat. Sub. Date(s): 002: May 7, 2015
Sep 11, 2022 
Pat. No. RE44874 DS* DP* Phenethanolamine derivatives for treatment of respiratory diseases
Claim Types: Compound; Composition; Formulation; Method of use; Process; Drug in a container
Pat. Sub. Date(s): 002: May 7, 2015
Mar 23, 2023U-1691: Indicated for the once-daily inhaled treatment for asthma in adults aged 18 years and older
Pat. No. 7439393 DS* DP* [Extended 983 days (2.7 years)]
Phenethanolamine derivatives for treatment of respiratory diseases
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 002: May 7, 2015
May 21, 2025U-1691: Indicated for the once-daily inhaled treatment for asthma in adults aged 18 years and older
U-2099: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including bronchitis and/or emphysema
U-2100: Indicated for the once-daily treatment of asthma in patients 18 years and older
Pat. No. 8511304 DP* Medicament dispenser
Claim Types: Device; Method of use
Pat. Sub. Date(s): 002: May 7, 2015
Jun 14, 2027U-1691: Indicated for the once-daily inhaled treatment for asthma in adults aged 18 years and older
Pat. No. 9333310 DP* Medicament dispenser
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): 002: May 20, 2016
Oct 2, 2027 
Pat. No. 8113199 DP* Counter for use with a medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 002: May 7, 2015
Oct 23, 2027 
Pat. No. 8161968 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 002: May 7, 2015
Feb 5, 2028 
Pat. No. 8534281 DP* Manifold for use in medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 002: May 7, 2015
Mar 8, 2030 
Pat. No. 8746242 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 002: May 7, 2015
Oct 11, 2030 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousMay 15, 2020M-202: Inclusion of data from the summit study for BREO ELLIPTA (fluticasone furoate/vilanterol trifenatate) inhalation powder in the package insert.

ELESTRIN (GEL, METERED) (TRANSDERMAL) ESTRADIOL
Drug Classes: estrogen
NDA Applicant: MYLAN SPECIALITY LP      NDA No.: 021813  Prod. No.: 001 RX (0.06% (0.87GM/ACTIVATION))
PatentsExpirationPatented Use
Pat. No. 7470433 DP* Formulations for transdermal or transmucosal application
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Aug 3, 2021 
Pat. No. 7198801 DP* Formulations for transdermal or transmucosal application
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jun 25, 2022 

FLONASE SENSIMIST ALLERGY RELIEF (SPRAY, METERED) (NASAL) FLUTICASONE FUROATE
Drug Classes: corticosteroid
NDA Applicant: GLAXOSMITHKLINE CONS      NDA No.: 022051  Prod. No.: 002 OTC (0.0275MG/SPRAY)
PatentsExpirationPatented Use
Pat. No. 6858596 DP* Formulation containing anti-inflammatory androstane derivative
Claim Types: Formulation; Composition; Method of use
Pat. Sub. Date(s): 002: Aug 31, 2016
Aug 3, 2021U-1890: OTC use: allergy symptom reliever; temporarily relieves these symptoms due to hay fever or other upper respiratory allergies; nasal congestion, runny nose, sneezing, itchy nose, and (itchy water eyes (ages 12 and up))
Pat. No. 7101866 DS* DP* Anti-inflammatory androstane derivative
Claim Types: Compound; New polymorph, salt or hydrate; Composition; Formulation; Method of use; Process; Drug in a container
Pat. Sub. Date(s): 002: Aug 31, 2016
Aug 3, 2021U-1890: OTC use: allergy symptom reliever; temporarily relieves these symptoms due to hay fever or other upper respiratory allergies; nasal congestion, runny nose, sneezing, itchy nose, and (itchy water eyes (ages 12 and up))
Pat. No. 7541350 DP* Formulation containing anti-inflammatory androstane derivative
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Aug 31, 2016
Aug 3, 2021U-1890: OTC use: allergy symptom reliever; temporarily relieves these symptoms due to hay fever or other upper respiratory allergies; nasal congestion, runny nose, sneezing, itchy nose, and (itchy water eyes (ages 12 and up))
Pat. No. 9320862 DP* Fluid dispensing device
Claim Types: Device
Pat. Sub. Date(s): 002: Aug 31, 2016
Nov 6, 2024 
Pat. No. 8062264 DP* Fluid dispensing device
Claim Types: Device
Pat. Sub. Date(s): 002: Aug 31, 2016
Apr 5, 2026 
Pat. No. 8752543 DP* Fluid dispensing device
Claim Types: Device
Pat. Sub. Date(s): 002: Aug 31, 2016
Apr 5, 2026 
Pat. No. 8347879 DP* Fluid dispensing device
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): 002: Aug 31, 2016
Jul 15, 2028 
Pat. No. 8147461 DP* Fluid dispensing device
Claim Types: Device
Pat. Sub. Date(s): 002: Aug 31, 2016
Oct 15, 2028 

TRELEGY ELLIPTA (POWDER) (INHALATION) FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
Drug Classes: corticosteroid; anticholinergic; beta-2 adrenergic agonist
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 209482  Prod. No.: 001 RX (0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH)
PatentsExpirationPatented Use
Pat. No. 6537983 DP* Anti-inflammatory androstane derivatives
Claim Types: Formulation; Method of use; Drug in a container
Pat. Sub. Date(s): 001: Oct 6, 2017
Aug 3, 2021U-2125: The treatment of an inflammatory disorder of the respiratory tract by once-per-day administration of a pharmaceutical formulation comprising fluticasone furoate and a long-acting beta2 adrenoreceptor agonist
Pat. No. 6759398 DP* Anti-inflammatory androstane derivative
Claim Types: Formulation; Method of use; Drug in a container
Pat. Sub. Date(s): 001: Oct 6, 2017
Aug 3, 2021U-2125: The treatment of an inflammatory disorder of the respiratory tract by once-per-day administration of a pharmaceutical formulation comprising fluticasone furoate and a long-acting beta2 adrenoreceptor agonist
Pat. No. 6878698 Anti-inflammatory androstane derivatives
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Oct 6, 2017
Aug 3, 2021U-2134: The treatment of chronic obstructive pulmonary disease by once-per-day administration of a pharmaceutical formulation comprising fluticasone furoate and a long-acting beta2 adrenoreceptor
Pat. No. 7101866 DS* DP* Anti-inflammatory androstane derivative
Claim Types: Compound; New polymorph, salt or hydrate; Composition; Formulation; Method of use; Process; Drug in a container
Pat. Sub. Date(s): 001: Oct 6, 2017
Aug 3, 2021U-2126: Use of fluticasone furoate for the treatment of an inflammatory or allergic conditions, including chronic obstructive pulmonary disease
Pat. No. 7629335 DP* Anti-inflammatory androstane derivative
Claim Types: Formulation; Device
Pat. Sub. Date(s): 001: Oct 6, 2017
Aug 3, 2021 
Pat. No. 7776895 DP* Inhalation devices for delivering phenethanolamine derivatives for the treatment of respiratory diseases
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 6, 2017
Sep 11, 2022 
Pat. No. RE44874 DS* DP* Phenethanolamine derivatives for treatment of respiratory diseases
Claim Types: Compound; Composition; Formulation; Method of use; Process; Drug in a container
Pat. Sub. Date(s): 001: Oct 6, 2017
Mar 23, 2023U-2127: Indicated for the long-term, once-daily, maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema
Pat. No. 7498440 DS* DP* Muscarinic acetylcholine receptor antagonists
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Oct 6, 2017
Apr 27, 2025 
Pat. No. 8309572 Muscarinic acetylcholine receptor antagonists
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Oct 6, 2017
Apr 27, 2025U-2129: Method of inhibiting the binding of acetylcholine to an acetylcholine receptor in the respiratory tract of a human, comprising contacting the receptor with an effective amount of umeclidinium, via topical application
Pat. No. 7439393 DS* DP* [Extended 983 days (2.7 years)]
Phenethanolamine derivatives for treatment of respiratory diseases
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 6, 2017
May 21, 2025U-2127: Indicated for the long-term, once-daily, maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema
Pat. No. 8183257 Muscarinic acetylcholine receptor antagonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 6, 2017
Jul 27, 2025U-2128: Method of inhibiting the binding of acetylcholine to an acetylcholine receptor in the respiratory tract of a human, comprising contacting the receptor with an effective amount of umeclidinium, via inhalation
Pat. No. 8511304 DP* Medicament dispenser
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Oct 6, 2017
Jun 14, 2027 
Pat. No. 9333310 DP* Medicament dispenser
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): 001: Oct 6, 2017
Oct 2, 2027 
Pat. No. 8113199 DP* Counter for use with a medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 6, 2017
Oct 23, 2027 
Pat. No. 7488827 DS* DP* [Extended 965 days (2.6 years)]
Muscarinic acetylcholine receptor antagonists
Claim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 001: Oct 6, 2017
Dec 18, 2027 
Pat. No. 8161968 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 6, 2017
Feb 5, 2028 
Pat. No. 8534281 DP* Manifold for use in medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 6, 2017
Mar 8, 2030 
Pat. No. 8746242 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 6, 2017
Oct 11, 2030 
Pat. No. 9750726 DP* Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 6, 2017
Nov 29, 2030 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationApr 24, 2021I-775: Revised indication for fixed-dose combination of fluticasone furoate, umeclidinium, and vilanterol to treat airflow obstruction in chronic obstructive pulmonary disease (COPD) and to reduce COPD exacerbations in pts with history of exacerbations

RIOMET (SOLUTION) (ORAL) METFORMIN HYDROCHLORIDE
Drug Classes: biguanide
NDA Applicant: SUN PHARM INDS LTD      NDA No.: 021591  Prod. No.: 001 RX (500MG/5ML)
PatentsExpirationPatented Use
Pat. No. 6890957 DP* Liquid formulation of metformin
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Aug 7, 2021 

CAPRELSA (TABLET) (ORAL) VANDETANIB
Drug Classes: kinase inhibitor
NDA Applicant: GENZYME CORP      NDA No.: 022405  Prod. No.: 001 RX (100MG); 002 RX (300MG)
PatentsExpirationPatented Use
Pat. No. 7173038 DS* DP* Quinazoline derivatives as VEGF inhibitors
Claim Types: Compound; Process; Composition
Pat. Sub. Date(s): All strengths: None
Aug 14, 2021 
Pat. No. 8642608 Quinazoline derivatives as VEGF inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 5, 2018
Feb 6, 2022U-1490: For use in patients having symptomatic or progressive medullary thyroid cancer, with unresectable locally advanced or metastatic disease
Pat. No. RE42353 DS* DP* [Extended 1738 days (4.8 years)]
Quinazoline derivatives and pharmaceutical compositions containing them
Claim Types: Compound; Process; Composit
Pat. Sub. Date(s): All strengths: Jun 3, 2011
Jun 27, 2022 
Pat. No. 8067427 DP* Pharmaceutical compositions comprising ZD6474
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 21, 2011; 002: None
Aug 8, 2028 

BALCOLTRA (TABLET) (ORAL) ETHINYL ESTRADIOL; LEVONORGESTREL
Drug Classes: estrogen; progestin; progestin-containing intrauterine device (IUD)
NDA Applicant: AVION PHARMS      NDA No.: 208612  Prod. No.: 001 RX (0.02MG;0.1MG)
PatentsExpirationPatented Use
Pat. No. 6716814 DS* DP* Enhancing solubility of iron amino acid chelates and iron proteinates
Claim Types: Process
Pat. Sub. Date(s): 001: Jul 31, 2018
Aug 16, 2021 

ISTODAX (POWDER) (INTRAVENOUS) ROMIDEPSIN
Drug Classes: histone deacetylase (HDAC) inhibitor
NDA Applicant: CELGENE      NDA No.: 022393  Prod. No.: 001 RX (10MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 7608280 DS* Method of producing FR901228
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: None
Aug 22, 2021 
Pat. No. 7611724 DS* Method of producing FR901228
Claim Types: New polymorph, salt or hydrate; Product-by-process
Pat. Sub. Date(s): 001: None
Aug 22, 2021 

IMODIUM A-D EZ CHEWS (TABLET, CHEWABLE) (ORAL) LOPERAMIDE HYDROCHLORIDE
Drug Classes: opioid agonist
NDA Applicant: J AND J CONSUMER INC      NDA No.: 020448  Prod. No.: 001 DISC (2MG)
PatentsExpirationPatented Use
Pat. No. 6814978 DP* Process for preparing a soft tablet
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: None
Aug 26, 2021 

FARYDAK (CAPSULE) (ORAL) PANOBINOSTAT LACTATE
Drug Classes: histone deacetylase (HDAC) inhibitor
NDA Applicant: SECURA      NDA No.: 205353  Prod. No.: 001 RX (EQ 10MG BASE); 002 RX (EQ 15MG BASE); 003 RX (EQ 20MG BASE)
PatentsExpirationPatented Use
Pat. No. 6552065 DS* DP* Deacetylase inhibitors
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Mar 20, 2015
Aug 31, 2021 
Pat. No. 7067551 Deacetylase inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 20, 2015
Aug 31, 2021U-1669: Treatment of multiple myeloma, in combination with bortezomib and dexamethasone
Pat. No. 6833384 DS* DP* Deacetylase inhibitors
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Mar 20, 2015
Sep 30, 2021U-1669: Treatment of multiple myeloma, in combination with bortezomib and dexamethasone
Pat. No. 7989494 DS* DP* Polymorphs of N-hydroxy-3-[4-[[[2-(2-methyl-1H-indol-3-yl)ethyl]amino]methyl]phenyl]-2E- -2-propenamide
Claim Types: New polymorph, salt or hydrate; Method of use; Composition
Pat. Sub. Date(s): All strengths: Mar 20, 2015
Jan 17, 2028 
Pat. No. 8883842 Use of HDAC inhibitors for the treatment of myeloma
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 20, 2015
Jun 13, 2028U-1669: Treatment of multiple myeloma, in combination with bortezomib and dexamethasone
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityFeb 23, 2020 
Exclusivity Code: ODE - Orphan drug exclusivityFeb 23, 2022ODE-89: Treatment of patients with multiple myeloma who have received at least 2 prior regimens, including bortezomib and an immunomodulatory agent

INCIVEK (TABLET) (ORAL) TELAPREVIR
Drug Classes: hepatitis C virus (HCV) NS3/4A protease inhibitor
NDA Applicant: VERTEX PHARMS      NDA No.: 201917  Prod. No.: 001 DISC (375MG)
PatentsExpirationPatented Use
Pat. No. 8529882 Peptidomimetic protease inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 9, 2013
Aug 31, 2021U-1398: Method of treating chronic hepatitis C
Pat. No. 7820671 DS* DP* [Extended 87 days (0.2 years)]
Peptidomimetic protease inhibitors
Claim Types: Compound; Composition; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Jun 20, 2011
Feb 25, 2025 
Pat. No. 8431615 Dose forms
Claim Types: Method of administration
Pat. Sub. Date(s): 001: May 29, 2013
May 30, 2028U-1398: Method of treating chronic hepatitis C

TRIGLIDE (TABLET) (ORAL) FENOFIBRATE [Has competitive generic]
Drug Classes: peroxisome proliferator-activated receptor (PPAR) alpha agonist
NDA Applicant: SKYEPHARMA AG      NDA No.: 021350  Prod. No.: 002 RX (160MG) NDA No.: 021350  Prod. No.: 001 DISC (50MG)
PatentsExpirationPatented Use
Pat. No. 6696084 DS* DP* Spray drying process and compositions of fenofibrate
Claim Types: Product-by-process; Method of use; Process
Pat. Sub. Date(s): All strengths: None
Sep 11, 2021U-680: A method of treating dyslipidemia and dyslipoproteinemia using a dosage form that can provide an effective amount of fenofibrate to a patient in a fasted state which is at least 90% of the AUC amount provided by the dosage form

ABSORICA (CAPSULE) (ORAL) ISOTRETINOIN [Has competitive generic]
Drug Classes: retinoid
NDA Applicant: SUN PHARM INDS INC      NDA No.: 021951  Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (30MG); 004 RX (40MG); 005 RX (25MG); 006 RX (35MG)
PatentsExpirationPatented Use
Pat. No. 7435427 DP* Pharmaceutical semi-solid composition of isotretinoin
Claim Types: Formulation; Method of administration; Product-by-process
Pat. Sub. Date(s): 001: Jun 7, 2012; 002: Jun 7, 2012; 003: Jun 7, 2012; 004: Jun 7, 2012; 005: Apr 6, 2015; 006: Apr 6, 2015
Sep 21, 2021 
Pat. No. 8367102 Pharmaceutical semi-solid composition of isotretinoin
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 27, 2013; 002: None; 003: None; 004: None; 005: Apr 6, 2015; 006: Apr 6, 2015
Sep 21, 2021U-1347: Treatment of a skin disorder
Pat. No. 8952064 DP* Pharmaceutical semi-solid composition of isotretinoin
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 23, 2015
Sep 21, 2021 
Pat. No. 9078925 DP* Pharmaceutical semi-solid composition of isotretinoin
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 17, 2015
Sep 21, 2021 
Pat. No. 9089534 DP* Pharmaceutical semi-solid composition of isotretinoin
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 17, 2015
Sep 21, 2021 

JEVTANA KIT (SOLUTION) (INTRAVENOUS) CABAZITAXEL
Drug Classes: microtubule inhibitor
NDA Applicant: SANOFI AVENTIS US      NDA No.: 201023  Prod. No.: 001 RX (60MG/1.5ML (40MG/ML))
PatentsExpirationPatented Use
Pat. No. 5847170 DS* DP* [Extended 5 years]
Taxoids, their preparation and pharmaceutical compositions containing them
Claim Types: Compound; Composition; Process
Pat. Sub. Date(s): 001: None
Sep 26, 2021 *PED 
Pat. No. 7241907 DS* Acetone solvate of dimethoxy docetaxel and its process of preparation
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: None
Jun 10, 2026 *PED 
Pat. No. 8927592 Antitumoral use of cabazitaxel
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jan 12, 2015
Apr 27, 2031 *PEDU-1630: Treatment in combination with a corticoid such as prednisone of prostate cancer previously treated with docetaxel
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousNov 17, 2020 PEDM-201: Adjunct to thallium-201 myocardial perfusion in patients unable to exercise adequately
Exclusivity Code: M - MiscellaneousSep 14, 2020M-209: Information added to the labeling regarding cabazitaxel at 20 mg/m2 based on the results of the PROSELICA study

BELEODAQ (POWDER) (INTRAVENOUS) BELINOSTAT
Drug Classes: histone deacetylase (HDAC) inhibitor
NDA Applicant: ACROTECH      NDA No.: 206256  Prod. No.: 001 RX (500MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 6888027 DS* DP* Carbamic acid compounds comprising a sulfonamide linkage as HDAC inhibitors
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Aug 1, 2014
Sep 27, 2021U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJul 3, 2019 
Exclusivity Code: ODE - Orphan drug exclusivityJul 3, 2021ODE-68: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma

INNOPRAN XL (CAPSULE, EXTENDED RELEASE) (ORAL) PROPRANOLOL HYDROCHLORIDE [Has competitive generic]
Drug Classes: beta-adrenergic receptor inhibitor
NDA Applicant: ANI PHARMS INC      NDA No.: 021438  Prod. No.: 001 RX (80MG); 002 RX (120MG)
PatentsExpirationPatented Use
Pat. No. 6500454 DP* Timed, sustained release systems for propranolol
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Mar 18, 2003; 002: None
Oct 4, 2021 

JUBLIA (SOLUTION) (TOPICAL) EFINACONAZOLE
Drug Classes: azole antifungal
NDA Applicant: BAUSCH      NDA No.: 203567  Prod. No.: 001 RX (10%)
PatentsExpirationPatented Use
Pat. No. 7214506 Method for treating onychomycosis
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 20, 2014
Oct 5, 2021U-281: Antimycotic uses, specifically treatment of onychomycosis
Pat. No. 9566272 Compositions and methods for treating diseases of the nail
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 22, 2017
Jan 3, 2028U-1969: Topical treatment of onychomycosis of the toenail(s) due to trichophyton rubrum and trichophyton mentagrophytes
Pat. No. 9877955 Compositions and methods for treating diseases of the nail
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 31, 2018
Jan 3, 2028U-1969: Topical treatment of onychomycosis of the toenail(s) due to trichophyton rubrum and trichophyton mentagrophytes
Pat. No. 8039494 Compositions and methods for treating diseases of the nail
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 20, 2014
Jul 8, 2030U-281: Antimycotic uses, specifically treatment of onychomycosis
Pat. No. 9861698 DP* Compositions and methods for treating diseases of the nail
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jan 10, 2018
Jul 8, 2030 
Pat. No. 10105444 DP* Compositions and methods for treating diseases of the nail
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Jul 8, 2030 
Pat. No. 8486978 DP* Compositions and methods for treating diseases of the nail
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 20, 2014
Oct 24, 2030 
Pat. No. 9302009 DP* Compositions and methods for treating diseases of the nail
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 25, 2016
Oct 24, 2030 
Pat. No. 9662394 DP* Stabilized efinaconazole compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: May 30, 2017
Oct 2, 2034 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJun 6, 2019 

LENVIMA (CAPSULE) (ORAL) LENVATINIB MESYLATE
Drug Classes: kinase inhibitor
NDA Applicant: EISAI INC      NDA No.: 206947  Prod. No.: 001 RX (EQ 4MG BASE); 002 RX (EQ 10MG BASE)
PatentsExpirationPatented Use
Pat. No. 7253286 DS* DP* Nitrogen-containing aromatic derivatives
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Mar 10, 2015
Oct 19, 2021 
Pat. No. 7612208 DS* DP* Crystalline form of the salt of 4-(3-chloro-4-(cyclopropylaminocarbonyl)aminophenoxy)-7-methoxy-6-
Claim Types: New polymorph, salt or hydrate; Process; Composition
Pat. Sub. Date(s): All strengths: Mar 10, 2015
Sep 19, 2026 
Pat. No. 9006256 Antitumor agent for thyroid cancer
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: May 12, 2015
Jul 27, 2027U-1695: Method for treating thyroid carcinoma including differentiated thyroid cancer
Pat. No. 10259791 DS* High-purity quinoline derivative and method for manufacturing same
Claim Types: Impurity content limitation; Process
Pat. Sub. Date(s): All strengths: May 13, 2019
Aug 26, 2035 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMay 13, 2019I-734: Expanded indication for the use of Lenvima in combination with everolimus for the treatment of patients with advanced RCC following one prior anti-angiogenic therapy.
Exclusivity Code: I - New IndicationAug 15, 2021I-787: First-line treatment of patients with unresectable hepatocellular carcinoma (HCC)
Exclusivity Code: NCE - New chemical entityFeb 13, 2020 
Exclusivity Code: ODE - Orphan drug exclusivityAug 15, 2025ODE-196: Indicated for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC)
Exclusivity Code: ODE - Orphan drug exclusivityFeb 13, 2022ODE-87: Treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine refractory differentiated thyroid cancer

INVOKAMET XR (TABLET, EXTENDED RELEASE) (ORAL) CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor; biguanide
NDA Applicant: JANSSEN PHARMS      NDA No.: 205879  Prod. No.: 001 RX (50MG;500MG); 003 RX (150MG;500MG)
PatentsExpirationPatented Use
Pat. No. 6723340 DP* Optimal polymer mixtures for gastric retentive tablets
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Oct 14, 2016
Oct 25, 2021 
Pat. No. 8785403 DP* Glucopyranoside compound
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Oct 14, 2016
Jul 30, 2024 
Pat. No. 8222219 [Extended 255 days (0.7 years)]
Glucopyranoside compound
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 14, 2016
Apr 11, 2025U-2441: Reduction of risk of major adverse cardiovascular events in the treatment of Type 2 diabetes mellitus patients
U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 7943788 DS* DP* Glucopyranoside compound
Claim Types: Compound; Process; Composition
Pat. Sub. Date(s): All strengths: Oct 14, 2016
Jul 14, 2027 
Pat. No. 8513202 DS* DP* Crystalline form of 1-(.beta.-D-glucopyranosyl)-4-methyl-3-[5-(4-fluorophenyl)-2-thienylmethy- l]benzene hemihydrate
Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use
Pat. Sub. Date(s): All strengths: Oct 14, 2016
Dec 3, 2027U-2441: Reduction of risk of major adverse cardiovascular events in the treatment of Type 2 diabetes mellitus patients
U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 7943582 DS* DP* Crystalline form of 1-(.beta.-D-glucopyransoyl)-4-methyl-3-[5-(4-fluorophenyl)-2- thienylmethyl]benzene hemihydrate
Claim Types: New polymorph, salt or hydrate; Process; Method of use
Pat. Sub. Date(s): All strengths: Oct 14, 2016
Feb 26, 2029U-2441: Reduction of risk of major adverse cardiovascular events in the treatment of Type 2 diabetes mellitus patients
U-493: Treatment of Type 2 Diabetes Mellitus
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMay 20, 2019I-735: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus when treatment with both canagliflozin and metformin is appropriate
Exclusivity Code: I - New IndicationOct 29, 2021I-788: New indication for canagliflozin to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with Type 2 diabetes mellitus and established cardiovascular disease (CVD)

ADASUVE (POWDER) (INHALATION) LOXAPINE
NDA Applicant: ALEXZA PHARMS      NDA No.: 022549  Prod. No.: 001 RX (10MG)
PatentsExpirationPatented Use
Pat. No. 7052679 DP* Delivery of antipsychotics through an inhalation route
Claim Types: Formulation; Process; Product-by-process
Pat. Sub. Date(s): 001: Mar 29, 2013
Oct 26, 2021 
Pat. No. 7078020 DP* Delivery of antipsychotics through an inhalation route
Claim Types: Method of use; Kit
Pat. Sub. Date(s): 001: Mar 29, 2013
Oct 26, 2021U-1375: ADASUVE is a typical antipsychotic indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults
Pat. No. 7090830 DP* Drug condensation aerosols and kits
Claim Types: Kit; Formulation; Product-by-process
Pat. Sub. Date(s): 001: Mar 29, 2013
Oct 26, 2021 
Pat. No. 7585493 DP* Thin-film drug delivery article and method of use
Claim Types: Device; Process
Pat. Sub. Date(s): 001: Mar 29, 2013
Oct 26, 2021 
Pat. No. 7601337 DP* Delivery of antipsychotics through an inhalation route
Claim Types: Formulation; Product-by-process; Process
Pat. Sub. Date(s): 001: Mar 29, 2013
Oct 26, 2021 
Pat. No. 8173107 DP* Delivery of antipsychotics through an inhalation route
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 29, 2013
Oct 26, 2021 
Pat. No. 8235037 DP* Drug condensation aerosols and kits
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 29, 2013
Oct 26, 2021 
Pat. No. 8955512 DP* Method of forming an aerosol for inhalation delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 18, 2015
Oct 26, 2021 
Pat. No. 9439907 DP* Method of forming an aerosol for inhalation delivery
Claim Types: Device; Process
Pat. Sub. Date(s): 001: Oct 13, 2016
Oct 26, 2021 
Pat. No. 9440034 DP* Drug condensation aerosols and kits
Claim Types: Formulation; Kit; Method of administration
Pat. Sub. Date(s): 001: Oct 13, 2016
Oct 26, 2021 
Pat. No. 9687487 DS* DP* Aerosol forming device for use in inhalation therapy
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 14, 2017
Oct 26, 2021 
Pat. No. 6716416 DP* Delivery of antipsychotics through an inhalation route
Claim Types: Formulation; Product-by-process
Pat. Sub. Date(s): 001: Mar 29, 2013
May 20, 2022 
Pat. No. 8074644 DP* Method of forming an aerosol for inhalation delivery
Claim Types: Process
Pat. Sub. Date(s): 001: Mar 29, 2013
Jul 25, 2022 
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 
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. 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 

SAVELLA (TABLET) (ORAL) MILNACIPRAN HYDROCHLORIDE
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI)
NDA Applicant: ALLERGAN SALES LLC      NDA No.: 022256  Prod. No.: 001 RX (12.5MG); 002 RX (25MG); 003 RX (50MG); 004 RX (100MG)
PatentsExpirationPatented Use
Pat. No. 6992110 Methods of treating fibromyalgia syndrome, chronic fatigue syndrome and pain
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Nov 5, 2021U-882: Management of fibromyalgia (FM)
Pat. No. 7888342 Methods of treating fibromyalgia syndrome, chronic fatigue syndrome and pain
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 15, 2011; 002: None; 003: None; 004: None
Nov 5, 2021U-882: Management of fibromyalgia (FM)
Pat. No. 6602911 [Extended 435 days (1.2 years)]
Methods of treating fibromyalgia
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Jan 14, 2023U-882: Management of fibromyalgia (FM)
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

GADAVIST (SOLUTION) (INTRAVENOUS) GADOBUTROL
Drug Classes: gadolinium-based contrast agent
NDA Applicant: BAYER HLTHCARE      NDA No.: 201277  Prod. No.: 006 RX (1.20944GM/2ML (604.72MG/ML))
PatentsExpirationPatented Use
Pat. No. 5980864 DS* DP* [Extended 5 years]
1,4,7,10-tetraazacyclododecane butyltriols, processes for their production and pharmaceutical agents containing them
Claim Types: Composition; Method of use; Compound
Pat. Sub. Date(s): 006: Mar 17, 2016
Nov 9, 2021U-1119: Contrast agent for magnetic resonance imaging
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJul 12, 2022I-801: Use in cardiac MRI to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD)

EOVIST (SOLUTION) (INTRAVENOUS) GADOXETATE DISODIUM
NDA Applicant: BAYER HLTHCARE      NDA No.: 022090  Prod. No.: 001 RX (1.8143GM/10ML (181.43MG/ML)); 002 RX (2.72145GM/15ML (181.43MG/ML))
PatentsExpirationPatented Use
Pat. No. 6039931 [Extended 1698 days (4.7 years)]
Derivatized DTPA complexes, pharmaceutical agents containing these compounds, their use, and processes for their production
Claim Types: Diagnostic or surgical method
Pat. Sub. Date(s): 001: May 3, 2012; 002: Jun 5, 2018
Nov 13, 2021U-1239: Magnetic resonance imaging of the liver

AMTURNIDE (TABLET) (ORAL) ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE
Drug Classes: renin inhibitor; dihydropyridine calcium channel blocker; thiazide diuretic
NDA Applicant: NOVARTIS      NDA No.: 200045  Prod. No.: 001 DISC (EQ 150MG BASE;EQ 5MG BASE;12.5MG); 002 DISC (EQ 300MG BASE;EQ 5MG BASE;12.5MG); 003 DISC (EQ 300MG BASE;EQ 5MG BASE;25MG); 004 DISC (EQ 300MG BASE;EQ 10MG BASE;12.5MG); 005 DISC (EQ 300MG BASE;EQ 10MG BASE;25MG)
PatentsExpirationPatented Use
Pat. No. 8618174 DP* Synergistic combinations comprising a renin inhibitor for cardiovascular diseases
Claim Types: Composition; Formulation
Pat. Sub. Date(s): All strengths: None
Nov 15, 2021 
Pat. No. 8183295 DP* Pharmaceutical composition comprising a renin inhibitor, a calcium channel blocker and a diuretic
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 3, 2013; 002: None; 003: None; 004: None; 005: None
May 16, 2023 

ASACOL HD (TABLET, DELAYED RELEASE) (ORAL) MESALAMINE [GENERIC AB]
Drug Classes: aminosalicylate
NDA Applicant: APIL      NDA No.: 021830  Prod. No.: 001 RX (800MG)
PatentsExpirationPatented Use
Pat. No. 6893662 DP* Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Nov 15, 2021U-141: Treatment of ulcerative colitis
Pat. No. 8580302 DP* Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 13, 2013
Nov 15, 2021 
Pat. No. 9089492 DP* Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 22, 2015
Nov 15, 2021 

PROMACTA KIT (FOR SUSPENSION) (ORAL) ELTROMBOPAG OLAMINE
Drug Classes: thrombopoietin receptor agonist
NDA Applicant: NOVARTIS PHARMS CORP      NDA No.: 207027  Prod. No.: 002 RX (EQ 12.5MG ACID/PACKET)
PatentsExpirationPatented Use
Pat. No. 7332481 Thrombopoietin mimetics
Claim Types: Method of use
Pat. Sub. Date(s): 002: Apr 5, 2019
Nov 24, 2021 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1736: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (itp)
Pat. No. 7452874 DS* DP* Thrombopoietin mimetics
Claim Types: Compound; Composition; Process
Pat. Sub. Date(s): 002: Apr 5, 2019
Nov 24, 2021 *PED 
Pat. No. 7473686 DS* DP* Thrombopoietin mimetics
Claim Types: Compound; Composition; Method of use; Process
Pat. Sub. Date(s): 002: Apr 5, 2019
Nov 24, 2021 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1736: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (itp)
Pat. No. 7790704 Thrombopoietin mimetics
Claim Types: Method of use
Pat. Sub. Date(s): 002: Apr 5, 2019
Nov 24, 2021 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1736: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (itp)
Pat. No. 7160870 DS* DP* [Extended 347 days (1 years)]
Thrombopoietin mimetics
Claim Types: Compound; Composition; Method of use; Process
Pat. Sub. Date(s): 002: Apr 5, 2019
May 20, 2023 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1736: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (itp)
Pat. No. 7795293 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Claim Types: Method of use
Pat. Sub. Date(s): 002: Apr 5, 2019
Nov 21, 2023 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1736: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (itp)
Pat. No. 7547719 DS* DP* 3'-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-y- lidene]hy-drazino]-2'-hydroxy-[1,1'-piphenyl]-acid bis-(monoethanolamine)
Claim Types: Compound; Composition; Method of use; Formulation; Process
Pat. Sub. Date(s): 002: Apr 5, 2019
Jan 13, 2026 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-1736: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (itp)
U-2452: Combination with immunosuppressive therapy for first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia

ALLEGRA, CHILDREN'S ALLERGY (TABLET, ORALLY DISINTEGRATING) (ORAL) FEXOFENADINE HYDROCHLORIDE
Drug Classes: histamine-1 (H1) receptor antagonist
NDA Applicant: SANOFI AVENTIS US      NDA No.: 021909  Prod. No.: 002 DISC (30MG)
PatentsExpirationPatented Use
Pat. No. 6723348 DP* Orodispersible tablets containing fexofenadine
Claim Types: Formulation
Pat. Sub. Date(s): 002: Dec 18, 2013
Nov 26, 2021U-1466: Relief of symptoms associated with respiratory allergies adults and children 6 years of age and older

ALLEGRA, CHILDREN'S HIVES (TABLET, ORALLY DISINTEGRATING) (ORAL) FEXOFENADINE HYDROCHLORIDE
Drug Classes: histamine-1 (H1) receptor antagonist
NDA Applicant: SANOFI AVENTIS US      NDA No.: 021909  Prod. No.: 003 DISC (30MG)
PatentsExpirationPatented Use
Pat. No. 6723348 DP* Orodispersible tablets containing fexofenadine
Claim Types: Formulation
Pat. Sub. Date(s): 003: Dec 18, 2013
Nov 26, 2021 

CALDOLOR (SOLUTION) (INTRAVENOUS) IBUPROFEN
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: CUMBERLAND PHARMS      NDA No.: 022348  Prod. No.: 001 DISC (400MG/4ML (100MG/ML))
PatentsExpirationPatented Use
Pat. No. 6727286 DP* Pharmaceutical composition of 2-(4-isobutylphenyl) propionic acid
Claim Types: Formulation; Process; Method of use
Pat. Sub. Date(s): 001: None
Nov 27, 2021U-981: Management of mild to moderate pain, management of moderate to severe pain as an adjunct to opioid analgesics, reduction in fever through anti-inflammatory, analgesic, and antipyretic activity

CALDOLOR (SOLUTION) (INTRAVENOUS) IBUPROFEN
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: CUMBERLAND PHARMS      NDA No.: 022348  Prod. No.: 002 RX (800MG/8ML (100MG/ML))
PatentsExpirationPatented Use
Pat. No. 6727286 DP* Pharmaceutical composition of 2-(4-isobutylphenyl) propionic acid
Claim Types: Formulation; Process; Method of use
Pat. Sub. Date(s): 002: None
Nov 27, 2021U-981: Management of mild to moderate pain, management of moderate to severe pain as an adjunct to opioid analgesics, reduction in fever through anti-inflammatory, analgesic, and antipyretic activity
Pat. No. 8735452 Treating patients with intravenous ibuprofen
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 002: Jun 4, 2014
Sep 30, 2029U-981: Management of mild to moderate pain, management of moderate to severe pain as an adjunct to opioid analgesics, reduction in fever through anti-inflammatory, analgesic, and antipyretic activity
Pat. No. 8871810 Treating critically ill patients with intravenous ibuprofen
Claim Types: Method of use
Pat. Sub. Date(s): 002: Nov 12, 2014
Sep 30, 2029U-1599: Management of mild to moderate pain, management of moderate to severe pain as an adnunct to opioid analgesics, reduction in fever through anti inflammatory, analgesic, and antipyretic activity
Pat. No. 9114068 Treating patients with intravenous ibuprofen
Claim Types: Method of use
Pat. Sub. Date(s): 002: Sep 18, 2015
Sep 30, 2029U-1735: Methods of treating pain, inflammation and/or fever with intravenous ibuprofen such that mean arterial blood pressure does not increase the dosage interval
Pat. No. 9138404 Treating critically ill patients with intravenous ibuprofen
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Oct 27, 2015
Sep 30, 2029U-1756: Methods of treating pain, inflammation and/or fever in a critically ill patient with intravenous ibuprofen in need thereof
Pat. No. 9295639 Treating critically ill patients with intravenous ibuprofen
Claim Types: Method of use
Pat. Sub. Date(s): 002: May 2, 2016
Sep 30, 2029U-1756: Methods of treating pain, inflammation and/or fever in a critically ill patient with intravenous ibuprofen in need thereof
Pat. No. 9649284 Treating critically ill patients with intravenous ibuprofen
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Jun 9, 2017
Sep 30, 2029U-2018: Management of mild to moderate pain, management of moderate to severe pain as an adjunct to opioid analgesics in a critically ill patient with intravenous ibuprofen in need thereof
Pat. No. 9012508 Administration of intravenous ibuprofen
Claim Types: Method of use
Pat. Sub. Date(s): 002: May 4, 2015
Sep 14, 2030U-981: Management of mild to moderate pain, management of moderate to severe pain as an adjunct to opioid analgesics, reduction in fever through anti-inflammatory, analgesic, and antipyretic activity

KALETRA (SOLUTION) (ORAL) LOPINAVIR; RITONAVIR [GENERIC AA]
Drug Classes: HIV protease inhibitor; CYP3A inhibitor
NDA Applicant: ABBVIE      NDA No.: 021251  Prod. No.: 001 RX (80MG/ML;20MG/ML)
PatentsExpirationPatented Use
Pat. No. 8501219 DP* Flavoring systems for pharmaceutical compositions and methods of making such compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 26, 2013
Nov 28, 2021 
Pat. No. 6911214 DP* Flavoring systems for pharmaceutical compositions and methods of making such compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
May 28, 2022 *PEDU-895: Treatment of HIV infection in combination with other antiretroviral agents

NAVSTEL (SOLUTION) (IRRIGATION) CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; OXIGLUTATIONE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE
NDA Applicant: ALCON PHARMS LTD      NDA No.: 022193  Prod. No.: 001 DISC (0.154MG/ML;0.92MG/ML;0.2MG/ML;0.184MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML)
PatentsExpirationPatented Use
Pat. No. 7084130 DP* Intraocular irrigating solution having improved flow characteristics
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Nov 29, 2021U-891: Use as an intraocular irrigating solution during surgical procedures involving perfusion of the eye

SKELAXIN (TABLET) (ORAL) METAXALONE [GENERIC AB]
NDA Applicant: KING PHARMS      NDA No.: 013217  Prod. No.: 003 RX (800MG)
PatentsExpirationPatented Use
Pat. No. 7714006 Methods of modifying the bioavailability of metaxalone
Claim Types: Method of use
Pat. Sub. Date(s): 003: None
Dec 3, 2021U-1050: Use of metaxalone for treatment of musculoskeletal conditions
Pat. No. 7122566 Metaxalone products, method of manufacture, and method of use
Claim Types: Method of administration
Pat. Sub. Date(s): 003: None
Feb 6, 2026U-915: Treatment of musculoskeletal conditions

OFIRMEV (SOLUTION) (INTRAVENOUS) ACETAMINOPHEN [GENERIC AP]
NDA Applicant: MALLINCKRODT HOSP      NDA No.: 022450  Prod. No.: 001 RX (1GM/100ML (10MG/ML))
PatentsExpirationPatented Use
Pat. No. 6992218 DP* Method for obtaining aqueous formulations of oxidation-sensitive active principles
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Nov 12, 2010
Dec 6, 2021 *PED 
Pat. No. 9610265 Reduced dose intravenous acetaminophen
Claim Types: Method of administration
Pat. Sub. Date(s): 001: May 4, 2017
May 13, 2029 *PEDU-2263: Modified dosing regimen for the management of moderate to severe pain with adjunctive opioid analgesics
Pat. No. 9987238 Reduced dose intravenous acetaminophen
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 13, 2018
May 13, 2029 *PEDU-2261: Modified dosing regimen for the management of mild to moderate pain or management of moderate to severe pain as an adjunct to opioid analgesics
Pat. No. 9399012 Reduced dose intravenous acetaminophen
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 8, 2016
Mar 11, 2032 *PEDU-2261: Modified dosing regimen for the management of mild to moderate pain or management of moderate to severe pain as an adjunct to opioid analgesics
U-2262: Modified dosing regimen for the reduction of fever
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousJul 27, 2020 PEDM-196: Revisions to the package insert based on data from a randomized, placebo controlled, multicenter study of intravenous acetaminophen for the treatment of acute pain in pediatric patients to fulfill the post-marketing requirement 1704-1

TEFLARO (POWDER) (INTRAVENOUS) CEFTAROLINE FOSAMIL
Drug Classes: cephalosporin antibacterial
NDA Applicant: ALLERGAN SALES LLC      NDA No.: 200327  Prod. No.: 001 RX (400MG/VIAL); 002 RX (600MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 6906055 DS* DP* Phosphonocephem compound
Claim Types: Compound; Composition; Process; New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: None
Dec 15, 2021 
Pat. No. 7419973 DP* Phosphonocephem compound
Claim Types: Composition
Pat. Sub. Date(s): All strengths: None
Dec 15, 2021 
Pat. No. 6417175 DS* DP* [Extended 1211 days (3.3 years)]
Phosphonocephem derivatives, process for the preparation of the same, and use thereof
Claim Types: Compound; Method of use; Composition
Pat. Sub. Date(s): All strengths: None
Apr 11, 2022U-1676: Methods for 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 
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
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationMay 27, 2019 

BYSTOLIC (TABLET) (ORAL) NEBIVOLOL HYDROCHLORIDE
Drug Classes: beta-adrenergic receptor inhibitor
NDA Applicant: ALLERGAN SALES LLC      NDA No.: 021742  Prod. No.: 002 RX (EQ 2.5MG BASE); 003 RX (EQ 5MG BASE); 004 RX (EQ 10MG BASE); 005 RX (EQ 20MG BASE)
PatentsExpirationPatented Use
Pat. No. 6545040 DP* [Extended 618 days (1.7 years)]
Method of lowering the blood pressure
Claim Types: Composition; Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Dec 17, 2021U-3: Treatment of hypertension

VAZALORE (CAPSULE) (ORAL) ASPIRIN
Drug Classes: anti-platelet agent; nonsteroidal anti-inflammatory drug
NDA Applicant: PLX PHARMA      NDA No.: 203697  Prod. No.: 001 OTC (325MG)
PatentsExpirationPatented Use
Pat. No. 9351984 DP* Compositions comprising lecithin oils and NSAIDs for protecting the gastrointestinal tract and providing enhanced therapeutic activity
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Jul 11, 2016
Dec 19, 2021 
Pat. No. 8865187 DP* Compositions comprising lecithin oils and NSAIDS for protecting the gastrointestinal tract and providing enhanced therapeutic activity
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 10, 2014
Mar 23, 2022 
Pat. No. 9101637 Methods of treating inflammation with compositions comprising lecithin oils and NSAIDS for protecting the gastrointestinal tract and providing enhanced therapeutic activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 9, 2015
Mar 23, 2022U-1731: Temporary relief of minor aches and pains
U-1732: Temporary reduction of fever
U-1733: Treatment/prevention of cardiovascular disease
Pat. No. 9216150 DP* pH dependent carriers for targeted release of pharmaceuticals along the gastrointestinal tract, compositions therefrom, and making and using same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 14, 2016
Sep 29, 2032 
Pat. No. 9226892 pH dependent carriers for targeted release of pharmaceuticals along the gastrointestinal tract, compositions therefrom, and making and using same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 14, 2016
Sep 29, 2032U-1731: Temporary relief of minor aches and pains
U-1732: Temporary reduction of fever
U-1733: Treatment/prevention of cardiovascular disease

VOTRIENT (TABLET) (ORAL) PAZOPANIB HYDROCHLORIDE
Drug Classes: kinase inhibitor
NDA Applicant: NOVARTIS PHARMS CORP      NDA No.: 022465  Prod. No.: 001 RX (EQ 200MG BASE) NDA No.: 022465  Prod. No.: 002 DISC (EQ 400MG BASE)
PatentsExpirationPatented Use
Pat. No. 7262203 DS* DP* Pyrimidineamines as angiogenesis modulators
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: None
Dec 19, 2021 
Pat. No. 8114885 DS* DP* Chemical compounds
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Dec 19, 2021 
Pat. No. 7105530 DS* DP* [Extended 669 days (1.8 years)]
Pyrimidineamines as angiogenesis modulators
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Oct 19, 2023 
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityApr 26, 2019ODE-23: Advanced soft tissue sarcoma (STS) who have received prior chemotherapy

BEYAZ (TABLET) (ORAL) DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM [GENERIC AB]
Drug Classes: progestin; estrogen
NDA Applicant: BAYER HLTHCARE      NDA No.: 022532  Prod. No.: 001 RX (3MG,N/A;0.02MG,N/A;0.451MG,0.451MG)
PatentsExpirationPatented Use
Pat. No. 6958326 DP* Cyclodextrin-drospirenone inclusion complexes
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: None
Dec 20, 2021 
Pat. No. 7163931 Compositions of estrogen-cyclodextrin complexes
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Mar 3, 2022U-1: Prevention of pregnancy
Pat. No. 6441168 DS* [Extended 834 days (2.3 years)]
Stable crystalline salts of 5-methyltetrahydrofolic acid
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: None
Jul 30, 2022 
Pat. No. 8617597 DP* Pharmaceutical composition containing a tetrahydrofolic acid
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 29, 2014
Feb 8, 2030 

CAYSTON (FOR SOLUTION) (INHALATION) AZTREONAM
Drug Classes: monobactam antibacterial
NDA Applicant: GILEAD      NDA No.: 050814  Prod. No.: 001 RX (75MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 7208141 DP* Inhalable aztreonam aerosol for treatment and prevention of pulmonary bacterial infections
Claim Types: Formulation; Method of use; Method of administration
Pat. Sub. Date(s): 001: None
Dec 20, 2021U-1031: Improve respiratory symptoms in cystic fibrosis in patients with pseudomonas aeruginosa
Pat. No. 7214364 DP* Inhalable aztreonam lysinate formulation for treatment and prevention of pulmonary bacterial infections
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Dec 20, 2021 
Pat. No. 7427633 DP* Inhalable aztreonam lysinate formulation for treatment and prevention of pulmonary bacterial infections
Claim Types: Formulation; Method of use; Method of administration
Pat. Sub. Date(s): 001: None
Dec 20, 2021U-1031: Improve respiratory symptoms in cystic fibrosis in patients with pseudomonas aeruginosa
Pat. No. 8399496 DP* Inhalable aztreonam lysinate formulation for treatment and prevention of pulmonary bacterial infections
Claim Types: Formulation; Method of administration; Method of use
Pat. Sub. Date(s): 001: Apr 19, 2013
Dec 20, 2021U-1377: Improve respiratory symptoms in cystic fibrosis in patients with pseudomonas aeruginosa

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. 6962908 DP* Oral pharmaceutical products containing 17 -estradiol-3-lower alkanoate,method of administering the same and process of preparation
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Dec 21, 2021 
Pat. No. 7799771 DP* Oral pharmaceutical products containing 17beta-estradiol-3-lower alkanoate, method of administering the same and process of preparation
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 29, 2010; 002: None; 003: None
Dec 21, 2021 
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

VANOS (CREAM) (TOPICAL) FLUOCINONIDE [GENERIC AB]
Drug Classes: corticosteroid
NDA Applicant: MEDICIS      NDA No.: 021758  Prod. No.: 001 RX (0.1%)
PatentsExpirationPatented Use
Pat. No. 6765001 DP* Compositions and methods for enhancing corticosteroid delivery
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Dec 21, 2021 
Pat. No. 7794738 Compositions and methods for enhancing corticosteroid delivery
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
Sep 11, 2022U-1084: Relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older
Pat. No. 7220424 Compositions and methods for enhancing corticosteroid delivery
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
Jan 7, 2023U-861: Relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older
Pat. No. 8232264 DP* Compositions and methods for enhancing corticosteroid delivery
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 2, 2012
Mar 9, 2023 

CIPRO XR (TABLET, EXTENDED RELEASE) (ORAL) CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE
Drug Classes: quinolone antimicrobial
NDA Applicant: BAYER HLTHCARE      NDA No.: 021473  Prod. No.: 001 DISC (212.6MG;EQ 287.5MG BASE**); 002 DISC (425.2MG;EQ 574.9MG BASE**)
PatentsExpirationPatented Use
Pat. No. 7709022 DP* Sustained-release preparations of quinolone antibiotics and method for preparation thereof
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Dec 23, 2021 *PED 
Pat. No. 8187632 DP* Sustained-release preparations of quinolone antibiotics
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 20, 2013; 002: None
Dec 23, 2021 *PED 

EXPAREL (INJECTABLE, LIPOSOMAL) (INJECTION) BUPIVACAINE
Drug Classes: amide local anesthetic
NDA Applicant: PACIRA PHARMS INC      NDA No.: 022496  Prod. No.: 001 RX (133MG/10ML (13.3MG/ML)); 002 RX (266MG/20ML (13.3MG/ML))
PatentsExpirationPatented Use
Pat. No. 9585838 DP* Production of multivesicular liposomes
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): All strengths: Apr 3, 2017
Dec 24, 2021 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationApr 6, 2021I-771: Revision of the indication section of the package insert regarding an interscalene brachial plexus nerve block to produce postsurgical regional analgesia

ACCUNEB (SOLUTION) (INHALATION) ALBUTEROL SULFATE [GENERIC AN]
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: MYLAN SPECIALITY LP      NDA No.: 020949  Prod. No.: 001 RX (EQ 0.042% BASE); 002 RX (EQ 0.021% BASE)
PatentsExpirationPatented Use
Pat. No. 6702997 Albuterol inhalation solution, system, kit and method for relieving symptoms of pediatric asthma
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Dec 28, 2021U-558: Indicated for the relief of bronchospasm in patients 2-12 years of age with asthma (reversible obstructive airway disease)

DUONEB (SOLUTION) (INHALATION) ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
Drug Classes: beta-2 adrenergic agonist; anticholinergic
NDA Applicant: MYLAN SPECIALITY LP      NDA No.: 020950  Prod. No.: 001 DISC (EQ 0.083% BASE;0.017%**)
PatentsExpirationPatented Use
Pat. No. 6632842 Albuterol and ipratropium inhalation solution, system, kit and method for relieving symptoms of chronic obstructive pulmonary disease
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: None
Dec 28, 2021U-532: Treatment of bronchospasm associated with COPD in patients requiring more than one broncho dilator

PRADAXA (CAPSULE) (ORAL) DABIGATRAN ETEXILATE MESYLATE
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 022512  Prod. No.: 001 RX (EQ 75MG BASE); 002 RX (EQ 150MG BASE); 003 RX (EQ 110MG BASE)
PatentsExpirationPatented Use
Pat. No. 6087380 DS* DP* [Extended 1409 days (3.9 years)]
Disubstituted bicyclic heterocycles, the preparations and the use thereof as pharmaceutical compositions
Claim Types: Compound; Method of use
Pat. Sub. Date(s): 001: None; 002: None; 003: Dec 15, 2015
Dec 28, 2021U-1931: Prophylaxis or treatment of venous and arterial thrombotic disease
Pat. No. 9925174 DP* Administration form for the oral application of 3-[(2-{[4-(hexyloxycarbonyl-amino-imino-methyl)-phenylamino]-methyl}-1-methyl-1H-benzimidazol acid ethyl ester and the salts thereof
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Apr 12, 2018
Jun 14, 2023 
Pat. No. 7932273 DS* DP* 3-[(2-{[4-(hexyloxycarbonylaminoiminomethyl) phenylamino]methyl}-1-methyl-1H-benzimidazol-5-carbonyl)pyridin-2-ylamino- ]propionic acid ethylester methansulfonate and its use as a medicament
Claim Types: Composition; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Aug 1, 2011; 002: None; 003: Dec 15, 2015
Sep 7, 2025 
Pat. No. 7866474 DP* DLR* Film container
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 1, 2011
Aug 31, 2027 
Pat. No. 9034822 Methods of using antibodies during anticoagulant therapy of dabigatran and/or related compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 9, 2015; 002: Nov 9, 2015; 003: Dec 15, 2015
Jan 20, 2031U-1759: Method of reversing the anticoagulant effect of dabigatran using idarucizumab


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 efficacy 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: 18 September 2019
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