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 

RUBRACA (TABLET) (ORAL) RUCAPARIB CAMSYLATE
Drug Classes: poly (ADP-ribose) polymerase (PARP) inhibitor
NDA Applicant: CLOVIS ONCOLOGY INC      NDA No.: 209115  Prod. No.: 001 RX (EQ 200MG BASE); 002 RX (EQ 300MG BASE); 003 RX (EQ 250MG BASE)
PatentsExpirationPatented Use
Pat. No. 6495541 DS* DP* Tricyclic inhibitors of poly(ADP-ribose) polymerases
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Dec 21, 2016; 002: Dec 21, 2016; 003: May 9, 2017
Jan 10, 2021 
Pat. No. 7351701 Therapeutic compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 21, 2016; 002: Dec 21, 2016; 003: May 9, 2017
Jul 23, 2024U-2012: A method for treating ovarian cancer by administering rucaparib, wherein the cancer is associated with a deleterious BRCA mutation
U-2101: Maintenance treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
U-2273: A method for treating epithelial ovarian, fallopian tube, or primary peritoneal cancer, wherein the cancer is associated with a deleterious brca mutation
Pat. No. 7531530 Therapeutic compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 21, 2016; 002: Dec 21, 2016; 003: May 9, 2017
Jul 23, 2024U-2012: A method for treating ovarian cancer by administering rucaparib, wherein the cancer is associated with a deleterious BRCA mutation
U-2101: Maintenance treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
U-2273: A method for treating epithelial ovarian, fallopian tube, or primary peritoneal cancer, wherein the cancer is associated with a deleterious brca mutation
Pat. No. 8071579 DNA damage repair inhibitors for the treatment of cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 21, 2016; 002: Dec 21, 2016; 003: May 9, 2017
Aug 12, 2027U-2012: A method for treating ovarian cancer by administering rucaparib, wherein the cancer is associated with a deleterious BRCA mutation
U-2101: Maintenance treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
U-2273: A method for treating epithelial ovarian, fallopian tube, or primary peritoneal cancer, wherein the cancer is associated with a deleterious brca mutation
Pat. No. 8143241 DNA damage repair inhibitors for treatment of cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 21, 2016; 002: Dec 21, 2016; 003: May 9, 2017
Aug 12, 2027U-2012: A method for treating ovarian cancer by administering rucaparib, wherein the cancer is associated with a deleterious BRCA mutation
U-2101: Maintenance treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
U-2273: A method for treating epithelial ovarian, fallopian tube, or primary peritoneal cancer, wherein the cancer is associated with a deleterious brca mutation
Pat. No. 8754072 DS* DP* Salts and polymorphs of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6h-azepino[- 5,4,3-cd]indol-6-one
Claim Types: New polymorph, salt or hydrate; Composition
Pat. Sub. Date(s): 001: Dec 21, 2016; 002: Dec 21, 2016; 003: May 9, 2017
Feb 10, 2031 
Pat. No. 9045487 DS* DP* Salts and polymorphs of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[- 5,4,3-cd]indol-6-one
Claim Types: New polymorph, salt or hydrate; Composition
Pat. Sub. Date(s): 001: Dec 21, 2016; 002: Dec 21, 2016; 003: May 9, 2017
Feb 10, 2031 
Pat. No. 9861638 Salts and polymorphs of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[- 5,4,3-cd]indol-6-one
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 6, 2018
Feb 10, 2031U-2012: A method for treating ovarian cancer by administering rucaparib, wherein the cancer is associated with a deleterious BRCA mutation
U-2101: Maintenance treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
U-2273: A method for treating epithelial ovarian, fallopian tube, or primary peritoneal cancer, wherein the cancer is associated with a deleterious brca mutation
Pat. No. 10278974 DP* Salts and polymorphs of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[- 5,4,3-cd]indol-6-one
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: Jun 4, 2019
Feb 10, 2031 
Pat. No. 8859562 Use of RNAI inhibiting PARP activity for the manufacture of a medicament for the treatment of cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 21, 2016; 002: Dec 21, 2016; 003: May 9, 2017
Aug 4, 2031U-2012: A method for treating ovarian cancer by administering rucaparib, wherein the cancer is associated with a deleterious BRCA mutation
U-2101: Maintenance treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
U-2273: A method for treating epithelial ovarian, fallopian tube, or primary peritoneal cancer, wherein the cancer is associated with a deleterious brca mutation
Pat. No. 9987285 DP* High dosage strength tablets of rucaparib
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jun 28, 2018
Aug 17, 2035 
Pat. No. 10130636 High dosage strength tablets of rucaparib
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 17, 2018
Aug 17, 2035U-2012: A method for treating ovarian cancer by administering rucaparib, wherein the cancer is associated with a deleterious BRCA mutation
U-2101: Maintenance treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
U-2273: A method for treating epithelial ovarian, fallopian tube, or primary peritoneal cancer, wherein the cancer is associated with a deleterious brca mutation
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationApr 6, 2021I-772: For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy
Exclusivity Code: NCE - New chemical entityDec 19, 2021 
Exclusivity Code: ODE - Orphan drug exclusivityDec 19, 2023ODE-126: As monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies
Exclusivity Code: ODE - Orphan drug exclusivityApr 6, 2025ODE-168: For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy

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

HALAVEN (SOLUTION) (INTRAVENOUS) ERIBULIN MESYLATE
Drug Classes: microtubule inhibitor
NDA Applicant: EISAI INC      NDA No.: 201532  Prod. No.: 001 RX (1MG/2ML (0.5MG/ML))
PatentsExpirationPatented Use
Pat. No. 8097648 Methods and compositions for use in treating cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 15, 2012
Jan 22, 2021U-1096: Treatment of patients with metastatic breast cancer
Pat. No. 6214865 DS* [Extended 1495 days (4.1 years)]
Macrocyclic analogs and methods of their use and preparation
Claim Types: Compound; Process
Pat. Sub. Date(s): 001: Nov 30, 2010
Jul 20, 2023 
Pat. No. RE46965 DP* Intermediates for the preparation of analogs of Halichondrin B
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Aug 7, 2018
Jan 8, 2027 
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityJan 28, 2023ODE-107: Treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracyclne-containing regimen

ORILISSA (TABLET) (ORAL) ELAGOLIX SODIUM
NDA Applicant: ABBVIE INC      NDA No.: 210450  Prod. No.: 001 RX (EQ 150MG 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): 001: 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): 001: 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): 001: 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): 001: 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): 001: 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): 001: Aug 20, 2018
Sep 10, 2024 
Pat. No. 10537572 Methods of administering elagolix
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 19, 2020
Sep 1, 2036U-2735: Management of moderate to severe pain associated with endometriosis using 150mg elagolix while co-administering rifampin
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJul 23, 2023 

ORILISSA (TABLET) (ORAL) ELAGOLIX SODIUM
NDA Applicant: ABBVIE INC      NDA No.: 210450  Prod. No.: 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): 002: 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): 002: 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): 002: 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): 002: 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): 002: 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): 002: 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

AURYXIA (TABLET) (ORAL) FERRIC CITRATE
Drug Classes: iron replacement product; phosphate binder; decorporation agent
NDA Applicant: KERYX BIOPHARMS      NDA No.: 205874  Prod. No.: 001 RX (EQ 210MG IRON)
PatentsExpirationPatented Use
Pat. No. 5753706 DP* Methods for treating renal failure
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Oct 2, 2014
Feb 3, 2021U-1577: Control of serum phosphorous levels
Pat. No. 7767851 DS* DP* Ferric organic compounds, uses thereof and methods of making same
Claim Types: Product-by-process; Composition; Formulation
Pat. Sub. Date(s): 001: Oct 2, 2014
Feb 18, 2024 
Pat. No. 8299298 DP* Pharmaceutical-grade ferric organic compounds, uses thereof and method of making same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 2, 2014
Feb 18, 2024 
Pat. No. 8338642 DS* DP* Ferric organic compounds, uses thereof and methods of making same
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 2, 2014
Feb 18, 2024U-1577: Control of serum phosphorous levels
Pat. No. 8609896 DP* Ferric organic compounds, uses thereof and methods of making same
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Oct 2, 2014
Feb 18, 2024 
Pat. No. 8754257 DP* Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Oct 2, 2014
Feb 18, 2024 
Pat. No. 8754258 DP* Ferric organic compounds, uses thereof and methods of making same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 2, 2014
Feb 18, 2024 
Pat. No. 8846976 Ferric organic compounds, uses thereof and methods of making same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 3, 2014
Feb 18, 2024U-1577: Control of serum phosphorous levels
Pat. No. 8901349 Ferric organic compounds, uses thereof and methods of making same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 16, 2015
Feb 18, 2024U-1577: Control of serum phosphorous levels
Pat. No. 9050316 Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 9, 2015
Feb 18, 2024U-1577: Control of serum phosphorous levels
Pat. No. 9328133 DS* DP* Ferric organic compounds, uses thereof and methods of making same
Claim Types: Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Dec 30, 2016
Feb 18, 2024U-1577: Control of serum phosphorous levels
Pat. No. 9757416 DS* DP* Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Oct 5, 2017
Feb 18, 2024U-1577: Control of serum phosphorous levels
Pat. No. 8093423 Pharmaceutical-grade ferric organic compounds, uses thereof and method of making same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 2, 2014
Apr 21, 2026U-1577: Control of serum phosphorous levels
Pat. No. 9387191 DP* Ferric citrate dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 9, 2016
Jul 21, 2030 
Pat. No. 10300039 Ferric citrate dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 24, 2019
Jul 21, 2030U-2549: Control of serum phosphorus levels
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationNov 6, 2020I-790: Use of ferric citrate for the treatment of iron deficiency anemia in adult patients with CKD not on dialysis

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); 004 RX (20MG)
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.: 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 

CARDIZEM LA (TABLET, EXTENDED RELEASE) (ORAL) DILTIAZEM HYDROCHLORIDE [GENERIC AB]
Drug Classes: nondihydropyridine calcium channel blocker
NDA Applicant: BAUSCH      NDA No.: 021392  Prod. No.: 001 RX (120MG); 002 RX (180MG); 003 RX (240MG); 004 RX (300MG); 005 RX (360MG); 006 RX (420MG)
PatentsExpirationPatented Use
Pat. No. 6923984 DP* Cushioning wax beads for making solid shaped articles
Claim Types: Formulation; Method of use; Product-by-process
Pat. Sub. Date(s): All strengths: None
Feb 25, 2021 

COMPLERA (TABLET) (ORAL) EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitor (HIV-1 NRTI); HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI); HBV nucleoside analog reverse transcriptase inhibitor (HBV- NRTI)
NDA Applicant: GILEAD SCIENCES INC      NDA No.: 202123  Prod. No.: 001 RX (200MG;EQ 25MG BASE;300MG)
PatentsExpirationPatented Use
Pat. No. 6838464 DS* DP* 2,4-Di(hetero-)arylamino(-oxy)-5-substituted pyrimidines as antineaoplastic agents
Claim Types: Compound; Process; Composition; Method of use
Pat. Sub. Date(s): 001: Sep 6, 2011
Feb 26, 2021 
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: Sep 6, 2011
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: Sep 6, 2011
Sep 9, 2021 *PED 
Pat. No. 8101629 DP* Salt of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl- ]amino]benzonitrile
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 15, 2012
Aug 9, 2022 
Pat. No. 8080551 DS* DP* HIV inhibiting pyrimidines derivatives
Claim Types: Compound; Composition; Process
Pat. Sub. Date(s): 001: Jun 15, 2012
Apr 11, 2023 
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: 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. 7125879 DS* DP* [Extended 986 days (2.7 years)]
HIV inhibiting pyrimidines derivatives
Claim Types: Compound; Composition; Method of use; Formulation
Pat. Sub. Date(s): 001: Sep 6, 2011
Apr 21, 2025U-257: Treatment of HIV infection
Pat. No. 8841310 DP* Combinations of a pyrimidine containing NNRTI with RT inhibitors
Claim Types: Formulation; Method of use; Kit
Pat. Sub. Date(s): 001: Oct 20, 2014
Dec 9, 2025U-257: Treatment of HIV infection

EDURANT (TABLET) (ORAL) RILPIVIRINE HYDROCHLORIDE
Drug Classes: HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI)
NDA Applicant: JANSSEN PRODS      NDA No.: 202022  Prod. No.: 001 RX (EQ 25MG BASE)
PatentsExpirationPatented Use
Pat. No. 6838464 DS* DP* 2,4-Di(hetero-)arylamino(-oxy)-5-substituted pyrimidines as antineaoplastic agents
Claim Types: Compound; Process; Composition; Method of use
Pat. Sub. Date(s): 001: Jun 11, 2011
Feb 26, 2021 
Pat. No. 8101629 DP* Salt of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl- ]amino]benzonitrile
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 21, 2012
Aug 9, 2022 
Pat. No. 8080551 DS* DP* HIV inhibiting pyrimidines derivatives
Claim Types: Compound; Composition; Process
Pat. Sub. Date(s): 001: Jan 12, 2012
Apr 11, 2023 
Pat. No. 7638522 DP* Salt of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl- ]amino] benzonitrile
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 16, 2011
Apr 14, 2023 
Pat. No. 7125879 DS* DP* [Extended 986 days (2.7 years)]
HIV inhibiting pyrimidines derivatives
Claim Types: Compound; Composition; Method of use; Formulation
Pat. Sub. Date(s): 001: Jun 16, 2011
Apr 21, 2025U-1153: In combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naive adult patients, as set forth in the labeling, including I&U section
U-1307: In combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naive adult patients with HIV-1 RNA less than or equal to 100,000 at the start of therapy
U-1740: In combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naive patients with HIV-1 RNA less than or equal to 100,000 at the start of thearpy [sic, therapy]
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousFeb 1, 2021M-223: Information added to section 8.1 of the labeling regarding pregnant patients who are already on a stable rilpivirine regimen prior to pregnancy and who are virologically suppressed (HIV-1 RNA less than 50 copies/ml)

JULUCA (TABLET) (ORAL) DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE
Drug Classes: HIV integrase strand transfer inhibitor (HIV-1 INSTI); HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI)
NDA Applicant: VIIV HLTHCARE      NDA No.: 210192  Prod. No.: 001 RX (EQ 50MG BASE;EQ 25MG BASE)
PatentsExpirationPatented Use
Pat. No. 6838464 DS* DP* 2,4-Di(hetero-)arylamino(-oxy)-5-substituted pyrimidines as antineaoplastic agents
Claim Types: Compound; Process; Composition; Method of use
Pat. Sub. Date(s): 001: Dec 20, 2017
Feb 26, 2021 
Pat. No. 8101629 DP* Salt of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl- ]amino]benzonitrile
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 20, 2017
Aug 9, 2022 
Pat. No. 8080551 DS* DP* HIV inhibiting pyrimidines derivatives
Claim Types: Compound; Composition; Process
Pat. Sub. Date(s): 001: Dec 20, 2017
Apr 11, 2023 
Pat. No. 7125879 DS* DP* [Extended 986 days (2.7 years)]
HIV inhibiting pyrimidines derivatives
Claim Types: Compound; Composition; Method of use; Formulation
Pat. Sub. Date(s): 001: Dec 20, 2017
Apr 21, 2025U-257: Treatment of HIV infection
Pat. No. 8129385 DS* DP* Substituted 5-hydroxy-3,4,6,9,9a, 10-hexanhydro-2h-1-oxa04a,8a-diaza-anthracene-6,10-dioness
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Dec 20, 2017
Oct 5, 2027 
Pat. No. 9242986 DS* DP* Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Dec 20, 2017
Dec 8, 2029 
Pat. No. 10426780 DS* DP* Antiviral therapy
Claim Types: Formulation; Method of use; Method of administration; Kit
Pat. Sub. Date(s): 001: Oct 25, 2019
Jan 24, 2031U-257: Treatment of HIV infection
ExclusivityExpirationExclusivity Description
Exclusivity Code: NC - New combinationNov 21, 2020 

ODEFSEY (TABLET) (ORAL) EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitor (HIV-1 NRTI); HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI); HBV nucleoside analog reverse transcriptase inhibitor (HBV- NRTI)
NDA Applicant: GILEAD SCIENCES INC      NDA No.: 208351  Prod. No.: 001 RX (200MG;EQ 25MG BASE;EQ 25MG BASE)
PatentsExpirationPatented Use
Pat. No. 6838464 DS* DP* 2,4-Di(hetero-)arylamino(-oxy)-5-substituted pyrimidines as antineaoplastic agents
Claim Types: Compound; Process; Composition; Method of use
Pat. Sub. Date(s): 001: Mar 24, 2016
Feb 26, 2021 
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: Mar 24, 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: Mar 24, 2016
Sep 9, 2021 *PED 
Pat. No. 7803788 Prodrugs of phosphonate nucoleotide analogues
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 24, 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: Mar 24, 2016
May 7, 2022 
Pat. No. 8101629 DP* Salt of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl- ]amino]benzonitrile
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 24, 2016
Aug 9, 2022 
Pat. No. 8080551 DS* DP* HIV inhibiting pyrimidines derivatives
Claim Types: Compound; Composition; Process
Pat. Sub. Date(s): 001: Mar 24, 2016
Apr 11, 2023 
Pat. No. 7125879 DS* DP* [Extended 986 days (2.7 years)]
HIV inhibiting pyrimidines derivatives
Claim Types: Compound; Composition; Method of use; Formulation
Pat. Sub. Date(s): 001: Mar 24, 2016
Apr 21, 2025U-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: Mar 24, 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 19, 2016
Aug 15, 2032U-257: Treatment of HIV infection
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousAug 21, 2020M-206: Information added to labeling regarding 48 week efficacy, resistance and safety data on virologically suppressed HIV-1 infected adults switching from COMPLERA to ODEFSEY
Exclusivity Code: M - MiscellaneousAug 21, 2020M-207: Information added to labeling regarding 48 week efficacy, resistance and safety data on virologically suppressed HIV-1 infected adults switching from ATRIPLA to ODEFSEY
Exclusivity Code: NCE - New chemical entityNov 5, 2020 

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      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: 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      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)

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 

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 

XEPI (CREAM) (TOPICAL) OZENOXACIN
Drug Classes: quinolone antimicrobial
NDA Applicant: FERRER INTERNACIONAL      NDA No.: 208945  Prod. No.: 001 RX (1%)
PatentsExpirationPatented Use
Pat. No. 6335447 DS* Quinolonecarboxylic acid derivatives or salts thereof
Claim Types: Compound
Pat. Sub. Date(s): 001: Jan 19, 2018
Apr 6, 2021 
Pat. No. 9399014 Pharmaceutical topical compositions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 19, 2018
Dec 15, 2029U-805: Treatment of impetigo due to staphylococcus aureus or streptococcus pyogenes
Pat. No. 9180200 DP* Pharmaceutical topical compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jan 19, 2018
Jan 29, 2032U-805: Treatment of impetigo due to staphylococcus aureus or streptococcus pyogenes
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityDec 11, 2022 

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 

ABRAXANE (FOR SUSPENSION) (IV (INFUSION)) PACLITAXEL
Drug Classes: microtubule inhibitor
NDA Applicant: ABRAXIS BIOSCIENCE      NDA No.: 021660  Prod. No.: 001 RX (100MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 8853260 DP* Formulations of pharmacological agents, methods for the preparation thereof and methods for the use thereof
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 14, 2014
Apr 10, 2021 *PEDU-1092: Treatment of breast cancer
U-1290: Treatment of lung cancer
U-1434: Treatment of pancreatic cancer
Pat. No. 7923536 Compositions and methods of delivery of pharmacological agents
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 15, 2011
Jun 9, 2024 *PEDU-1117: Treatment of breast cancer
U-1290: Treatment of lung cancer
U-1434: Treatment of pancreatic cancer
Pat. No. 8138229 DP* Compositions and methods of delivery of pharmacological agents
Claim Types: Formulation; Drug in a container; Method of administration
Pat. Sub. Date(s): 001: Mar 27, 2012
Jun 9, 2024 *PEDU-1092: Treatment of breast cancer
U-1290: Treatment of lung cancer
U-1434: Treatment of pancreatic cancer
Pat. No. 8314156 Compositions and methods of delivery of pharmacological agents
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 28, 2012
Jun 9, 2024 *PEDU-1290: Treatment of lung cancer
U-1434: Treatment of pancreatic cancer
Pat. No. 7820788 DP* Compositions and methods of delivery of pharmacological agents
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 12, 2010
Apr 27, 2025 *PEDU-1092: Treatment of breast cancer
U-1290: Treatment of lung cancer
U-1434: Treatment of pancreatic cancer
Pat. No. 7758891 Combinations and modes of administration of therapeutic agents and combination therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 2, 2013
Aug 21, 2026 *PEDU-1434: Treatment of pancreatic cancer
Pat. No. 8268348 Combinations and modes of administration of therapeutic agents and combination therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 24, 2012
Aug 21, 2026 *PEDU-1290: Treatment of lung cancer
Pat. No. 9101543 Combinations and modes of administration of therapeutic agents and combination therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 18, 2015
Aug 21, 2026 *PEDU-1434: Treatment of pancreatic cancer
Pat. No. 8034375 Combinations and modes of administration of therapeutic agents and combination therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 24, 2012
Feb 13, 2027 *PEDU-1290: Treatment of lung cancer
Pat. No. 9393318 Methods of treating cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 22, 2016
Sep 4, 2032 *PEDU-1290: Treatment of lung cancer
Pat. No. 9597409 Methods of treating cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 17, 2017
Sep 4, 2032 *PEDU-1290: Treatment of lung cancer
Pat. No. 9511046 Methods of treating pancreatic cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 29, 2016
Jul 12, 2034 *PEDU-1434: Treatment of pancreatic cancer
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityMar 6, 2021 PEDODE-52: Treatment of metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine.

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); 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**); 003 DISC (EQ 4MG 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: 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: transthyretin-directed 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. 10533174 DP* Splice-region antisense composition and method
Claim Types: Composition
Pat. Sub. Date(s): All strengths: Jan 31, 2020
May 4, 2021 
Pat. No. RE47751 Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 18, 2019
Jun 28, 2025U-1918: Treatment of Duchenne muscular dystrophy in patients having a mutation of the DMD gene that is amenable to exon 51 skipping
U-2664: Treatment of Duchenne muscular dystrophy (DMD) in patients having a mutation of the DMD gene that is amenable to exon 51 skipping by inducing skipping of exon 51
U-2673: Treatment of Duchenne muscular dystrophy (DMD) in patients having a mutation of the DMD gene that is amenable to exon 51 skipping by correcting a defective gene for dystrophin
U-2674: Treatment of Duchenne muscular dystrophy (DMD) in patients having a mutation of the DMD gene that is amenable to exon 51 skipping by restoring or increasing functional dystrophin protein production
Pat. No. RE47769 DP* Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Dec 18, 2019
Jun 28, 2025 
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

VYONDYS 53 (SOLUTION) (INTRAVENOUS) GOLODIRSEN
NDA Applicant: SAREPTA THERAPS INC      NDA No.: 211970  Prod. No.: 001 RX (100MG/2ML (50MG/ML))
PatentsExpirationPatented Use
Pat. No. 9416361 DS* Splice-region antisense composition and method
Claim Types: Compound
Pat. Sub. Date(s): 001: Dec 18, 2019
May 4, 2021 
Pat. No. 10533174 DP* Splice-region antisense composition and method
Claim Types: Composition
Pat. Sub. Date(s): 001: Jan 31, 2020
May 4, 2021 
Pat. No. RE47691 DP* Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 18, 2019
Jun 28, 2025 
Pat. No. 9024007 DS* DP* Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Dec 18, 2019
Jun 28, 2025 
Pat. No. 9994851 DS* DP* Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Dec 18, 2019
Jun 28, 2025 
Pat. No. 10227590 DS* DP* Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Dec 18, 2019
Jun 28, 2025 
Pat. No. 10266827 Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 18, 2019
Jun 28, 2025U-2675: Treatment of Duchenne muscular dystrophy (DMD) in patients having a confirmed mutation of the dmd gene that is amenable to exon 53 skipping
Pat. No. 10421966 DS* DP* Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Dec 18, 2019
Jun 28, 2025 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityDec 12, 2024 
Exclusivity Code: ODE - Orphan drug exclusivityDec 12, 2026ODE-280: Indicated for the treatment of duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 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-1663: Treatment of HIV-1 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-1663: Treatment of HIV-1 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-1259: Prophylaxis of HIV-1 infection
U-1663: Treatment of HIV-1 infection
U-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-1259: Prophylaxis of HIV-1 infection
U-1663: Treatment of HIV-1 infection
U-257: Treatment of HIV infection
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationOct 3, 2022I-812: For use in at risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis to reduce the risk of HIV-1 infection from sexual acquisition, excluding individuals at risk from receptive vaginal sex
Exclusivity Code: NCE - New chemical entityNov 5, 2020 
Exclusivity Code: NPP - New patient populationSep 25, 2020 
Exclusivity Code: ODE - Orphan drug exclusivitySep 28, 2024ODE-284: In combination with other antiretroviral agents, for the treatment of HIV-1 infection in pediatric patients under 12 years of age weighing at least 35kg
Exclusivity Code: ODE - Orphan drug exclusivitySep 28, 2024ODE-285: In combination with other antiretroviral agents other than protease inhibitors that require a CYP3A inhibitor, for the treatment of HIV-1 infection in pediatric patients under 12 years of age weighing at least 25kg and less than 35kg

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 

TARCEVA (TABLET) (ORAL) ERLOTINIB HYDROCHLORIDE [GENERIC AB]
Drug Classes: kinase inhibitor
NDA Applicant: OSI PHARMS      NDA No.: 021743  Prod. No.: 001 RX (EQ 25MG BASE); 002 RX (EQ 100MG BASE); 003 RX (EQ 150MG BASE)
PatentsExpirationPatented Use
Pat. No. 6900221 DS* DP* Stable polymorph on N-(3-ethynylphenyl)-6, 7-bis (2methoxyethoxy)-4-quinazolinaminehydrochloride, methods of production, and pharmaceutical uses thereof
Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process
Pat. Sub. Date(s): All strengths: None
May 9, 2021 *PEDU-1046: Maintenance treatment of patients with locally advanced or metastatic NSCLC whose disease has not progressed after four cycles platinum-based chemotherapy
U-1403: First-line treatment of metastatic non small-cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test
U-659: Treatment of locally advanced or metastatic non small-cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen
U-875: First-line treatment of locally advanced unresectable or metastatic pancreatic cancer, in combination with gemcitabine
Pat. No. 7087613 Treating abnormal cell growth with a stable polymorph of N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine hydrochloride
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
May 9, 2021 *PEDU-1045: Maintenance treatment in patients with locally advanced or metastatic NSCLC who have not progressed on 1st-line treatment wth platinum-based chemotherapy
U-1403: First-line treatment of metastatic non small-cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test
U-659: Treatment of locally advanced or metastatic non small-cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen

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 

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

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

SELZENTRY (TABLET) (ORAL) MARAVIROC
Drug Classes: CCR5 co-receptor antagonist
NDA Applicant: VIIV HLTHCARE      NDA No.: 022128  Prod. No.: 001 RX (150MG); 002 RX (300MG); 003 RX (25MG); 004 RX (75MG)
PatentsExpirationPatented Use
Pat. No. 7576097 DS* Tropane derivatives useful in therapy
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: None; 002: None; 003: Nov 23, 2016; 004: Nov 23, 2016
May 25, 2021 
Pat. No. 6667314 DS* DP* [Extended 73 days (0.2 years)]
Tropane derivatives useful in therapy
Claim Types: Compound; Composition; Method of use; Process
Pat. Sub. Date(s): 001: None; 002: None; 003: Nov 23, 2016; 004: Nov 23, 2016
Aug 6, 2021U-824: Method of treating patients infected with CCR5-tropic HIV-1
Pat. No. 7368460 Tropane derivatives useful in therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: None; 002: None; 003: Nov 23, 2016; 004: Nov 23, 2016
Nov 25, 2022U-824: Method of treating patients infected with CCR5-tropic HIV-1

SELZENTRY (SOLUTION) (ORAL) MARAVIROC
Drug Classes: CCR5 co-receptor antagonist
NDA Applicant: VIIV HLTHCARE      NDA No.: 208984  Prod. No.: 001 RX (20MG/ML)
PatentsExpirationPatented Use
Pat. No. 7576097 DS* Tropane derivatives useful in therapy
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Oct 23, 2016
May 25, 2021 
Pat. No. 6667314 DS* DP* [Extended 73 days (0.2 years)]
Tropane derivatives useful in therapy
Claim Types: Compound; Composition; Method of use; Process
Pat. Sub. Date(s): 001: Nov 23, 2016
Aug 6, 2021U-824: Method of treating patients infected with CCR5-tropic HIV-1
Pat. No. 7368460 Tropane derivatives useful in therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 23, 2016
Nov 25, 2022U-824: Method of treating patients infected with CCR5-tropic HIV-1

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 
Pat. No. 8263059 Compositions and kits for the removal of irritating compounds from bodily surfaces
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 8, 2020
Sep 5, 2023U-2705: Method of using capsaicin in combination with a gel composition for removal of capsaicin from a treatment area or unintended area
Pat. No. 8889113 Compositions and kits for the removal of irritating compounds from bodily surfaces
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 8, 2020
Sep 5, 2023U-2705: Method of using capsaicin in combination with a gel composition for removal of capsaicin from a treatment area or unintended area
Pat. No. 10463598 DP* Compositions and kits for the removal of irritating compounds from bodily surfaces
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 8, 2020
Sep 5, 2023 
Pat. No. 10034841 DP* Transdermal therapeutic system comprising an adhesive layer method for siliconizing the back layer of the system and use of said back layer
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 8, 2020
Sep 6, 2025 
Pat. No. 9226903 DP* Transdermal therapeutic system comprising an adhesive layer method for siliconizing the back layer or the system and use of said back layer
Claim Types: Device; Process
Pat. Sub. Date(s): 001: Jan 8, 2020
Dec 15, 2028 
Pat. No. 8821920 DP* Therapeutic patch for transdermal delivery of capsaicin
Claim Types: Device; Method of use; Process
Pat. Sub. Date(s): 001: Jan 8, 2020
Mar 26, 2030 

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)

OSENI (TABLET) (ORAL) ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE
Drug Classes: dipeptidyl peptidase-4 (DPP-4) inhibitor; peroxisome proliferator-activated receptor (PPAR) alpha agonist; peroxisome proliferator-activated receptor (PPAR) gamma agonist; thiazolidinedione
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 022426  Prod. No.: 001 RX (EQ 25MG BASE;EQ 15MG BASE); 002 RX (EQ 25MG BASE;EQ 30MG BASE); 003 RX (EQ 25MG BASE;EQ 45MG BASE); 004 RX (EQ 12.5MG BASE;EQ 15MG BASE); 005 RX (EQ 12.5MG BASE;EQ 30MG BASE); 006 RX (EQ 12.5MG BASE;EQ 45MG BASE)
PatentsExpirationPatented Use
Pat. No. 6329404 DP* [Extended 5 years]
Pharmaceutical composition
Claim Types: Composition; Method of use
Pat. Sub. Date(s): 001: Jan 19, 2017; 002: Jan 19, 2017; 003: Jan 19, 2017; 004: Jan 19, 2017; 005: Jan 19, 2017; 006: Feb 22, 2013
Jun 19, 2021U-1334: Methods of treating diabetes comprising administering an insulin sensitivity enhancer such as pioglitazone in combination with an insulin secretion enhancer
Pat. No. 8173663 [Extended 262 days (0.7 years)]
Dipeptidyl peptidase inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Mar 15, 2025U-1338: Method of treating diabetes comprising administering a compound such as alogliptin
Pat. No. 8288539 DS* [Extended 101 days (0.3 years)]
Dipeptidyl peptidase inhibitors
Claim Types: Compound
Pat. Sub. Date(s): All strengths: None
Mar 15, 2025 
Pat. No. 7807689 DS* DP* Dipeptidyl peptidase inhibitors
Claim Types: Compound; Composition; Drug in a container; Method of use
Pat. Sub. Date(s): All strengths: None
Jun 27, 2028U-1337: Method of treating diabetes comprising administering alogliptin
Pat. No. 8637079 DP* Solid preparation comprising alogliptin and pioglitazone
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 13, 2014
Jun 4, 2029 

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

DICLEGIS (TABLET, DELAYED RELEASE) (ORAL) DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: antihistamine; Vitamin B6 analog
NDA Applicant: DUCHESNAY      NDA No.: 021876  Prod. No.: 001 RX (10MG;10MG)
PatentsExpirationPatented Use
Pat. No. 6340695 DP* Rapid onset formulation
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Apr 16, 2013
Jun 21, 2021U-1382: Treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management

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. 10561808 Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form
Pat. Sub. Date(s): 004: Mar 19, 2020
Jan 1, 2032 
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 
Pat. No. 10569034 Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 004: Mar 12, 2020
Aug 16, 2036 

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. 10561808 Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form
Pat. Sub. Date(s): All strengths: Mar 19, 2020
Jan 1, 2032 
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 
Pat. No. 10569034 Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): All strengths: Mar 12, 2020
Aug 16, 2036 

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 DISC (0.055MG/INH); 002 DISC (0.113MG/INH); 003 DISC (0.232MG/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. 10561808 Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form
Pat. Sub. Date(s): All strengths: Mar 19, 2020
Jan 1, 2032 
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. 10561808 Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form
Pat. Sub. Date(s): 002: Mar 19, 2020
Jan 1, 2032 
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 
Pat. No. 10569034 Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 002: Mar 12, 2020
Aug 16, 2036 

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 

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); 002 RX (1GM)
PatentsExpirationPatented Use
Pat. No. 7049328 Use for deferiprone
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Oct 8, 2015; 002: Jan 31, 2020
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

BESIVANCE (SUSPENSION/DROPS) (OPHTHALMIC) BESIFLOXACIN HYDROCHLORIDE
Drug Classes: quinolone antimicrobial
NDA Applicant: BAUSCH AND LOMB      NDA No.: 022308  Prod. No.: 001 RX (EQ 0.6% BASE)
PatentsExpirationPatented Use
Pat. No. 6685958 DP* Quinolone carboxylic acid compositions and related methods of treatment
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Jun 29, 2021U-80: Method of treating ocular bacterial infections
Pat. No. 8937062 Compositions and methods for treating, reducing, ameliorating, or preventing infections caused by antibacterial drug-resistant bacteria
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 3, 2015
Nov 13, 2029U-80: Method of treating ocular bacterial infections
Pat. No. 8604020 DP* Fluoroquinolone carboxylic acid molecular crystals
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Dec 16, 2013
Mar 12, 2030 
Pat. No. 8415342 Besifloxacin ophthalmic composition for the treatment or control of infection
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 11, 2013
Nov 7, 2030U-80: Method of treating ocular bacterial infections
Pat. No. 8481526 DS* Fluoroquinolone carboxylic acid molecular crystals
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: Jul 19, 2013
Jan 9, 2031 

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
Pat. No. 10383884 9-aminomethyl minocycline compounds and use thereof in treating community-acquired bacterial pneumonia (CABP)
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 17, 2019
Oct 31, 2037U-2576: Treatment of community acquired bacterial pneumonia
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
Pat. No. 10383884 9-aminomethyl minocycline compounds and use thereof in treating community-acquired bacterial pneumonia (CABP)
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 17, 2019
Oct 31, 2037U-2576: Treatment of community acquired bacterial pneumonia
ExclusivityExpirationExclusivity Description
Exclusivity Code: GAIN - Generating Antibiotic Incentives NowOct 2, 2028 
Exclusivity Code: NCE - New chemical entityOct 2, 2023 

NATROBA (SUSPENSION) (TOPICAL) SPINOSAD
Drug Classes: pediculicide
NDA Applicant: PARAPRO LLC      NDA No.: 022408  Prod. No.: 001 RX (0.9%)
PatentsExpirationPatented Use
Pat. No. 7030095 DP* Pediculicidal and ovacidal treatment compositions and methods for killing head lice and their eggs
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Jul 2, 2021U-1105: Topical treatment of head lice infestation in patients four (4) years of age and older
Pat. No. 6063771 DP* [Extended 1494 days (4.1 years)]
Formulations for controlling human lice
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Mar 24, 2015
Jul 25, 2023U-1670: NATROBA topical suspension is a pediculicide indicated for the topical treatment of head lice infestation in patients six (6) months of age and older.

MYCAMINE (INJECTABLE) (INTRAVENOUS) MICAFUNGIN SODIUM [GENERIC AP]
Drug Classes: echinocandin antifungal
NDA Applicant: ASTELLAS      NDA No.: 021506  Prod. No.: 002 RX (EQ 50MG BASE/VIAL); 003 RX (EQ 100MG BASE/VIAL)
PatentsExpirationPatented Use
Pat. No. 6774104 DP* Stabilized pharmaceutical composition in lyophilized form
Claim Types: ; Composition; Process; Product-by-process; Method of use
Pat. Sub. Date(s): All strengths: None
Jul 8, 2021 *PEDU-650: Treatment of esophageal candidiasis and prophylaxis of candida infections in HSCT patients
U-845: Treatment of patients with candidemia, acute disseminated candidiasis, candida peritonitis and abscesses
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJun 20, 2023 PEDI-821: Treatment of candidemia, acute disseminated candidiasis, candida peritonitis and abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age

BRILINTA (TABLET) (ORAL) TICAGRELOR [GENERIC AB]
Drug Classes: P2Y12 platelet inhibitor
NDA Applicant: ASTRAZENECA PHARMS      NDA No.: 022433  Prod. No.: 001 RX (90MG); 002 RX (60MG)
PatentsExpirationPatented Use
Pat. No. 7265124 DS* DP* Cristalline and amorphous form of a triazolo (4,5-D) pyridimine compound
Claim Types: New polymorph, salt or hydrate; Process; Method of use
Pat. Sub. Date(s): 001: Aug 12, 2011; 002: None
Jul 9, 2021U-1171: Reduction of the rate of thrombotic events in patients with acute coronary syndrome
U-1860: Reduction of the rate of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome or a history of myocardial infarction
U-1868: Treatment of arterial thrombotic complications selected from the group consisting of unstable angina, thrombotic or embolic stroke, transient ischaemic attacks, peripheral vascular disease and myocardial infarction
U-1869: Treatment of an arterial thrombotic complication in a patient with coronary artery, cerebrovascular or peripheral vascular disease
Pat. No. RE46276 DS* DP* [Extended 1794 days (4.9 years)]
Triazolo(4,5-D)pyrimidine compounds
Claim Types: Compound; Composition; Process; Method of use
Pat. Sub. Date(s): All strengths: Jan 17, 2017
Oct 30, 2024U-1935: Reduction of the rate of cardiovascular death, myocardial infarction, and stroke in patients with a history of myocardial infarction
U-1936: Treatment of myocardial infarction and stroke in patients with acute coronary syndrome or a history of myocardial infarction
U-1937: Treatment of myocardial infarction in patients with acute coronary syndrome or a history of myocardial infarction
U-1938: Treatment of stroke in patients with acute coronary syndrome or a history of myocardial infarction
Pat. No. 8425934 DP* Pharmaceutical compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: May 20, 2013; 002: Sep 30, 2015
Apr 17, 2030 
Pat. No. 10300065 Method of treating or prevention of atherothrombotic events in patients with history of myocardial infarction
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 24, 2019
Jan 27, 2036U-2541: Reducing the rate of cardiovascular death, myocardial infarction (MI), and stroke in a patient receiving 75-100 mg aspirin daily with a history of MI by administering 60 mg ticagrelor twice daily
U-2542: Reducing the rate of cardiovascular death, myocardial infarction, and stroke in a patient receiving 75-100 mg aspirin daily and having or who had acute coronary syndrome by administering 60 mg ticagrelor twice daily

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

XENLETA (TABLET) (ORAL) LEFAMULIN ACETATE
NDA Applicant: NABRIVA      NDA No.: 211672  Prod. No.: 001 RX (EQ 600MG BASE)
PatentsExpirationPatented Use
Pat. No. 6753445 DS* DP* Pleuromutilin derivatives having antibacterial activity
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Sep 17, 2019
Jul 9, 2021U-2619: Treatment of adults with community-acquired bacterial pneumonia caused by susceptible microorganisms
Pat. No. 8153689 DS* DP* Pleuromutilin derivatives for the treatment of diseases mediated by microbes
Claim Types: Composition
Pat. Sub. Date(s): 001: Sep 17, 2019
Mar 19, 2028 
Pat. No. 8071643 DS* DP* Pleuromutilin derivatives for the treatment of diseases mediated by microbes
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Sep 17, 2019
Jan 16, 2029 
Pat. No. 9120727 DS* DP* Process for the preparation of pleuromutilins
Claim Types: Compound; New polymorph, salt or hydrate; Composition; Process
Pat. Sub. Date(s): 001: Sep 17, 2019
May 23, 2031 
ExclusivityExpirationExclusivity Description
Exclusivity Code: GAIN - Generating Antibiotic Incentives NowAug 19, 2029 
Exclusivity Code: NCE - New chemical entityAug 19, 2024 

XENLETA (SOLUTION) (INTRAVENOUS) LEFAMULIN ACETATE
NDA Applicant: NABRIVA      NDA No.: 211673  Prod. No.: 001 RX (EQ 150MG BASE/15ML (EQ 10MG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 6753445 DS* DP* Pleuromutilin derivatives having antibacterial activity
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Sep 17, 2019
Jul 9, 2021U-2619: Treatment of adults with community-acquired bacterial pneumonia caused by susceptible microorganisms
Pat. No. 8153689 DS* DP* Pleuromutilin derivatives for the treatment of diseases mediated by microbes
Claim Types: Composition
Pat. Sub. Date(s): 001: Sep 17, 2019
Mar 19, 2028 
Pat. No. 8071643 DS* DP* Pleuromutilin derivatives for the treatment of diseases mediated by microbes
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Sep 17, 2019
Jan 16, 2029 
ExclusivityExpirationExclusivity Description
Exclusivity Code: GAIN - Generating Antibiotic Incentives NowAug 19, 2029 
Exclusivity Code: NCE - New chemical entityAug 19, 2024 

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 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 

VICTOZA (SOLUTION) (SUBCUTANEOUS) LIRAGLUTIDE RECOMBINANT
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO NORDISK INC      NDA No.: 022341  Prod. No.: 001 RX (18MG/3ML (6MG/ML))
PatentsExpirationPatented Use
Pat. No. RE41956 DP* Dose setting limiter
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 28, 2012
Jul 21, 2021 *PED 
Pat. No. 8846618 DP* Stable formulation of modified GLP-1
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Mar 16, 2015
Dec 27, 2022 *PED 
Pat. No. 6268343 DS* DP* [Extended 5 years]
Derivatives of GLP-1 analogs
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: None
Feb 22, 2023 *PEDU-968: A method for improving glycemic control in adults with Type 2 diabetes mellitus
Pat. No. 8579869 DP* Needle mounting system and a method for mounting a needle assembly
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 29, 2019
Dec 30, 2023 *PED 
Pat. No. 7762994 DP* Needle mounting system and a method for mounting a needle assembly
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 29, 2019
Nov 23, 2024 *PED 
Pat. No. 8114833 DS* DP* Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Mar 13, 2012
Feb 13, 2026 *PED 
Pat. No. 9265893 DP* Injection button
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 14, 2016
Mar 23, 2033 *PED 
Pat. No. 9968659 Liraglutide in cardiovascular conditions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 12, 2018
Jul 9, 2037 *PEDU-2313: Method of reducing the risk of cardiovascular death, non-fatal myocardial infarction, and/or non-fatal stroke in adults with Type 2 diabetes mellitus and established cardiovascular disease by administering liraglutide
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationAug 25, 2020I-750: Reduce the risk of major adverse cardiovascular events in adults with Type 2 diabetes mellitus and established cardiovascular disease
Exclusivity Code: NPP - New patient populationDec 17, 2022 PED 

AVYCAZ (POWDER) (IV (INFUSION)) AVIBACTAM SODIUM; CEFTAZIDIME
Drug Classes: beta lactamase inhibitor; cephalosporin antibacterial
NDA Applicant: ALLERGAN      NDA No.: 206494  Prod. No.: 001 RX (EQ 0.5GM BASE;2GM/VIAL)
PatentsExpirationPatented Use
Pat. No. 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
Jan 7, 2026U-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: apolipoprotein B-100 synthesis inhibitor; transthyretin-directed antisense oligonucleotide
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 [GENERIC AB]
Drug Classes: biguanide
NDA Applicant: RANBAXY      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. 10583110 Antitumoral use of cabazitaxel
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 17, 2020
Oct 27, 2030U-2753: Increasing survival in metastatic castration-resistant prostate cancer patients previously treated with docetaxel by administering as a 3 week cycle cabazitaxel after 5 mg dexchlorpheniramine, 8 mg dexamethasone, and an H2-agonist
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: 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. 10512640 Compositions and methods for treating diseases of the nail
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 8, 2020
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 
Pat. No. 10342875 DP* Stabilized efinaconazole compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jul 12, 2019
Oct 2, 2034U-2720: Antimycotic uses, specifically treatment of onychomycosis; topical treatment of the toenail(s) due to trichophyton rubrum and trichophyton mentagrophytes
Pat. No. 10478601 DP* Applicator
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Dec 17, 2019
Apr 25, 2035U-2721: Topical treatment of tinea unguium by using an applicator for applying a solution for treating tinea unguium to an affected part of a patient

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 
Pat. No. 10407393 DS* High-purity quinoline derivative and method for manufacturing same
Claim Types: New polymorph, salt or hydrate with purity limitation
Pat. Sub. Date(s): All strengths: Oct 4, 2019
Aug 26, 2035 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationAug 15, 2021I-787: First-line treatment of patients with unresectable hepatocellular carcinoma (HCC)
Exclusivity Code: I - New IndicationSep 17, 2022I-807: Treatment of advanced endometrial carcinoma that is not microsatellite instability-high or mismatch repair deficient, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation
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-2632: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure 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-2632: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure 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-2632: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of Type 2 diabetes mellitus patients
U-493: Treatment of Type 2 Diabetes Mellitus
ExclusivityExpirationExclusivity Description
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      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 

ROZEREM (TABLET) (ORAL) RAMELTEON [GENERIC AB]
Drug Classes: melatonin receptor agonist
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 021782  Prod. No.: 001 RX (8MG)
PatentsExpirationPatented Use
Pat. No. 10098866 DP* Pharmaceutical preparation containing copolyvidone
Claim Types: Formulation; Process; Method of use
Pat. Sub. Date(s): 001: Nov 6, 2018
Nov 16, 2021U-2433: Method of treating a biological rhythm disorder, such as insomnia

PROMACTA (TABLET) (ORAL) ELTROMBOPAG OLAMINE
Drug Classes: thrombopoietin receptor agonist
NDA Applicant: NOVARTIS      NDA No.: 022291  Prod. No.: 001 RX (EQ 25MG ACID)
PatentsExpirationPatented Use
Pat. No. 7332481 Thrombopoietin mimetics
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
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-2451: 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): 001: None
Nov 24, 2021 *PED 
Pat. No. 7473686 DS* DP* Thrombopoietin mimetics
Claim Types: Compound; Composition; Method of use; Process
Pat. Sub. Date(s): 001: None
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-2451: 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): 001: None
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-2451: 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): 001: None
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-2451: 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): 001: None
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-2451: 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): 001: None
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-2451: 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
Pat. No. 8052993 DP* 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: Formulation; Process; Method of use
Pat. Sub. Date(s): 001: Dec 7, 2011
Feb 1, 2028 *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-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 8052994 DP* 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: Formulation; Process; Method of use
Pat. Sub. Date(s): 001: Jul 10, 2015
Feb 1, 2028 *PEDU-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
Pat. No. 8062665 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1 ,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2'-hydroxy-[1,1- '-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Claim Types: Formulation; Process; Method of use
Pat. Sub. Date(s): 001: Jul 10, 2015
Feb 1, 2028 *PEDU-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
Pat. No. 8071129 DP* 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: Formulation; Process; Method of use
Pat. Sub. Date(s): 001: Jul 10, 2015
Feb 1, 2028 *PEDU-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
Pat. No. 8828430 DP* 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: Formulation; Process; Method of use
Pat. Sub. Date(s): 001: Oct 7, 2014
Feb 1, 2028 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityNov 16, 2025ODE-210: Indicated in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia
Exclusivity Code: ODE - Orphan drug exclusivityFeb 26, 2022 PEDODE-75: Treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.

PROMACTA (TABLET) (ORAL) ELTROMBOPAG OLAMINE
Drug Classes: thrombopoietin receptor agonist
NDA Applicant: NOVARTIS      NDA No.: 022291  Prod. No.: 002 RX (EQ 50MG ACID)
PatentsExpirationPatented Use
Pat. No. 7332481 Thrombopoietin mimetics
Claim Types: Method of use
Pat. Sub. Date(s): 002: None
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-2451: 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: None
Nov 24, 2021 *PED 
Pat. No. 7473686 DS* DP* Thrombopoietin mimetics
Claim Types: Compound; Composition; Method of use; Process
Pat. Sub. Date(s): 002: None
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-2451: 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: None
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-2451: 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: None
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-2451: 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: None
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-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (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: None
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-2451: 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
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 8052993 DP* 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: Formulation; Process; Method of use
Pat. Sub. Date(s): 002: Jul 10, 2015
Feb 1, 2028 *PEDU-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
Pat. No. 8052994 DP* 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: Formulation; Process; Method of use
Pat. Sub. Date(s): 002: Dec 7, 2011
Feb 1, 2028 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 8062665 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1 ,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2'-hydroxy-[1,1- '-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Claim Types: Formulation; Process; Method of use
Pat. Sub. Date(s): 002: Jul 10, 2015
Feb 1, 2028 *PEDU-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
Pat. No. 8071129 DP* 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: Formulation; Process; Method of use
Pat. Sub. Date(s): 002: Jul 10, 2015
Feb 1, 2028 *PEDU-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
Pat. No. 8828430 DP* 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: Formulation; Process; Method of use
Pat. Sub. Date(s): 002: Oct 7, 2014
Feb 1, 2028 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityNov 16, 2025ODE-210: Indicated in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia
Exclusivity Code: ODE - Orphan drug exclusivityFeb 26, 2022 PEDODE-75: Treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.

PROMACTA (TABLET) (ORAL) ELTROMBOPAG OLAMINE
Drug Classes: thrombopoietin receptor agonist
NDA Applicant: NOVARTIS      NDA No.: 022291  Prod. No.: 003 RX (EQ 75MG ACID)
PatentsExpirationPatented Use
Pat. No. 7332481 Thrombopoietin mimetics
Claim Types: Method of use
Pat. Sub. Date(s): 003: None
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-2451: 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): 003: None
Nov 24, 2021 *PED 
Pat. No. 7473686 DS* DP* Thrombopoietin mimetics
Claim Types: Compound; Composition; Method of use; Process
Pat. Sub. Date(s): 003: None
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-2451: 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): 003: None
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-2451: 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): 003: None
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-2451: 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): 003: None
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-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (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): 003: None
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-2451: 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
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 8052993 DP* 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: Formulation; Process; Method of use
Pat. Sub. Date(s): 003: Jul 10, 2015
Feb 1, 2028 *PEDU-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)