Orange Book Companion
Patent Expiration View
Products whose next patent expiration is in 2020

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.


CLARINEX (TABLET) (ORAL) DESLORATADINE [GENERIC AB]
Drug Classes: histamine-1 (H1) receptor antagonist
NDA Applicant: MERCK SHARP DOHME      NDA No.: 021165  Prod. No.: 001 RX (5MG)
PatentsExpirationPatented Use
Pat. No. 6100274 8-chloro-6,11-dihydro-11-](4-piperidylidine)-5H-benzo [5,6]cyclohepta[1,2-bpyridine oral compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 7, 2020 *PED 
Pat. No. 7405223 Treating allergic and inflammatory conditions
Claim Types: Method of administration; Method of use
Pat. Sub. Date(s): 001: None
Jan 7, 2020 *PEDU-886: Administering desloratadine to treat the symptoms of perennial allergic rhinitis, seasonal allergic rhinitis, or chronic idiopathic urticaria

CLARINEX (TABLET, ORALLY DISINTEGRATING) (ORAL) DESLORATADINE [GENERIC AB]
Drug Classes: histamine-1 (H1) receptor antagonist
NDA Applicant: MERCK SHARP DOHME      NDA No.: 021312  Prod. No.: 001 RX (5MG); 002 RX (2.5MG)
PatentsExpirationPatented Use
Pat. No. 6100274 DP* 8-chloro-6,11-dihydro-11-](4-piperidylidine)-5H-benzo [5,6]cyclohepta[1,2-bpyridine oral compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Jan 7, 2020 *PED 
Pat. No. 7618649 DP* Extended release oral dosage composition
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Jun 19, 2021 *PEDU-1017: A method of treating nasal and non-nasal symptoms of seasonal allergic rhinitis

CLARINEX-D 12 HOUR (TABLET, EXTENDED RELEASE) (ORAL) DESLORATADINE; PSEUDOEPHEDRINE SULFATE
Drug Classes: histamine-1 (H1) receptor antagonist; alpha adrenergic agonist
NDA Applicant: MERCK SHARP DOHME      NDA No.: 021313  Prod. No.: 001 RX (2.5MG;120MG)
PatentsExpirationPatented Use
Pat. No. 6100274 DP* 8-chloro-6,11-dihydro-11-](4-piperidylidine)-5H-benzo [5,6]cyclohepta[1,2-bpyridine oral compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 7, 2020 *PED 
Pat. No. 8187630 DP* Extended release oral dosage composition
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): 001: Jun 28, 2012
Dec 19, 2020U-1017: A method of treating nasal and non-nasal symptoms of seasonal allergic rhinitis
Pat. No. 6709676 DP* Extended release oral dosage composition
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Feb 18, 2021U-707: Allergic rhinitis
Pat. No. 7618649 DP* Extended release oral dosage composition
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Jun 19, 2021 *PEDU-1017: A method of treating nasal and non-nasal symptoms of seasonal allergic rhinitis

CLARINEX D 24 HOUR (TABLET, EXTENDED RELEASE) (ORAL) DESLORATADINE; PSEUDOEPHEDRINE SULFATE [GENERIC AB]
Drug Classes: histamine-1 (H1) receptor antagonist; alpha adrenergic agonist
NDA Applicant: MERCK SHARP DOHME      NDA No.: 021605  Prod. No.: 001 RX (5MG;240MG)
PatentsExpirationPatented Use
Pat. No. 6100274 DP* 8-chloro-6,11-dihydro-11-](4-piperidylidine)-5H-benzo [5,6]cyclohepta[1,2-bpyridine oral compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 7, 2020 *PED 
Pat. No. 7618649 DP* Extended release oral dosage composition
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Jun 19, 2021 *PEDU-1017: A method of treating nasal and non-nasal symptoms of seasonal allergic rhinitis
Pat. No. 6979463 DP* Stable extended release oral dosage composition
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Mar 28, 2022 
Pat. No. 7820199 DP* Stable extended release oral dosage composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 23, 2010
Sep 28, 2022 *PED 

MICARDIS (TABLET) (ORAL) TELMISARTAN [GENERIC AB]
Drug Classes: angiotensin II receptor blocker
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 020850  Prod. No.: 001 RX (40MG); 003 RX (20MG)
PatentsExpirationPatented Use
Pat. No. 6358986 Polymorphs of telmisartan
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Jan 10, 2020 

MICARDIS (TABLET) (ORAL) TELMISARTAN [GENERIC AB]
Drug Classes: angiotensin II receptor blocker
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 020850  Prod. No.: 002 RX (80MG)
PatentsExpirationPatented Use
Pat. No. 6358986 Polymorphs of telmisartan
Claim Types: Formulation
Pat. Sub. Date(s): 002: None
Jan 10, 2020 
Pat. No. 7998953 Use of inhibitors of the renin-angiotensin system
Claim Types: Method of use
Pat. Sub. Date(s): 002: Sep 9, 2011
Jun 6, 2020U-1177: Reduction of cardiac tissue damage associated with myocardial infarction
Pat. No. 8003679 Use of inhibitors of the renin-angiotensin system
Claim Types: Method of use
Pat. Sub. Date(s): 002: Sep 9, 2011
Oct 6, 2022U-1176: Treatment or prevention of stroke

MICARDIS HCT (TABLET) (ORAL) HYDROCHLOROTHIAZIDE; TELMISARTAN [GENERIC AB]
Drug Classes: thiazide diuretic; angiotensin II receptor blocker
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 021162  Prod. No.: 001 RX (12.5MG;40MG); 002 RX (12.5MG;80MG)
PatentsExpirationPatented Use
Pat. No. 6358986 Polymorphs of telmisartan
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Jan 10, 2020 

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, 2020 
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. 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 
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

NEXAVAR (TABLET) (ORAL) SORAFENIB TOSYLATE
Drug Classes: kinase inhibitor
NDA Applicant: BAYER HLTHCARE      NDA No.: 021923  Prod. No.: 001 RX (EQ 200MG BASE)
PatentsExpirationPatented Use
Pat. No. 7235576 DS* DP* Omega-carboxyaryl substituted diphenyl ureas as raf kinase inhibitors
Claim Types: Compound; Method of use
Pat. Sub. Date(s): 001: None
Jan 12, 2020 
Pat. No. 7351834 DS* [Extended 898 days (2.5 years)]
.omega.-Carboxyaryl substituted diphenyl ureas as raf kinase inhibitors
Claim Types: Compound; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: None
Jan 12, 2020 
Pat. No. 7897623 DP* Omega-carboxyl aryl substituted ureas as P38 kinase inhibitors
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: None
Jan 12, 2020 
Pat. No. 8124630 .omega.-carboxyaryl substituted diphenyl ureas as raf kinase inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 16, 2013
Jan 12, 2020U-1459: Treatment of carcinoma of the thyroid
Pat. No. 8841330 Omega-carboxyaryl substituted diphenyl ureas as raf kinase inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 15, 2015
Jan 12, 2020U-1696: Treatment of unresectable hepatocellular carcinoma
Pat. No. 8618141 Aryl ureas with angiogenesis inhibiting activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 30, 2014
Feb 11, 2023U-1480: Treatment of advanced renal cell carcinoma
Pat. No. 8877933 DS* DP* Thermodynamically stable form of a tosylate salt
Claim Types: New polymorph, salt or hydrate; Process; Composition; Formulation; Method of use; Product-by-process
Pat. Sub. Date(s): 001: Dec 22, 2014
Dec 24, 2027U-1624: Treatment of unresectable hepatocellular carcinoma, advanced renal cell carcinoma, or differentiated thyroid carcinoma.
Pat. No. 9737488 DP* Pharmaceutical composition for the treatment of cancer
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Sep 20, 2017
Sep 10, 2028U-1480: Treatment of advanced renal cell carcinoma
U-1696: Treatment of unresectable hepatocellular carcinoma
U-2107: Treatment of locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityNov 22, 2020ODE-56: Treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DCT) that is refractory to radioactive iodine treatment.

TRIESENCE (INJECTABLE) (INTRAVITREAL) TRIAMCINOLONE ACETONIDE
Drug Classes: corticosteroid
NDA Applicant: NOVARTIS PHARMS CORP      NDA No.: 022048  Prod. No.: 001 RX (40MG/ML (40MG/ML))
PatentsExpirationPatented Use
Pat. No. 6395294 DP* Method of visualization of the vitreous during vitrectomy
Claim Types: Diagnostic or surgical method
Pat. Sub. Date(s): 001: None
Jan 13, 2020U-846: Use for delineation (visualization) during a vitrectomy surgical procedure
Pat. No. 8211880 Low viscosity, highly flocculated triamcinolone acetonide suspensions for intravitreal injection
Claim Types: Method of use; Diagnostic or surgical method
Pat. Sub. Date(s): 001: Aug 6, 2012
Mar 10, 2029U-1257: Treatment of ophthalmic disorders
U-1258: Visualization during vitrectomy procedures
Pat. No. 8128960 DP* Low viscosity, highly flocculated triamcinolone acetonide suspensions for intravitreal injection
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Dec 17, 2029 

GLUCOVANCE (TABLET) (ORAL) GLYBURIDE; METFORMIN HYDROCHLORIDE [Has competitive generic]
Drug Classes: sulfonylurea; biguanide
NDA Applicant: BRISTOL MYERS SQUIBB      NDA No.: 021178  Prod. No.: 001 DISC (1.25MG;250MG**); 002 DISC (2.5MG;500MG); 003 DISC (5MG;500MG)
PatentsExpirationPatented Use
Pat. No. 6303146 Solid oral dosage form comprising a combination of metformin and glibenclamide
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Jan 14, 2020 *PEDU-412: Treatment of Type 2 diabetes

LUZU (CREAM) (TOPICAL) LULICONAZOLE
Drug Classes: azole antifungal
NDA Applicant: MEDICIS      NDA No.: 204153  Prod. No.: 001 RX (1%)
PatentsExpirationPatented Use
Pat. No. 5900488 DS* DP* [Extended 1291 days (3.5 years)]
Method for treating mycosis using imidazolylacetonitrile derivatives
Claim Types: Compound; Composition; Process; Method of use
Pat. Sub. Date(s): 001: Dec 6, 2013
Jan 18, 2020 
Pat. No. 9012484 DS* DP* Crystal and pharmaceutical preparation containing the same crystal
Claim Types: New polymorph, salt or hydrate; Product-by-process; Method of use; Process
Pat. Sub. Date(s): 001: Apr 22, 2015
Sep 6, 2033U-540: Treatment of fungal infections
Pat. No. 9199977 DS* DP* Crystal having crystal habits and pharmaceutical composition obtained by processing the crystal
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: Feb 5, 2016
Sep 6, 2033 
Pat. No. 9453006 DS* Crystalline form having specific crystal habit and pharmaceutical composition containing this crystalline form as active ingredient
Claim Types: New polymorph, salt or hydrate; Process; Method of use
Pat. Sub. Date(s): 001: Sep 29, 2016
Sep 6, 2033 
Pat. No. 8980931 DP* Method of evaluating pharmaceutical preparation containing luliconazole and index substance
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 23, 2015
Apr 28, 2034 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityNov 14, 2018 
Exclusivity Code: NPP - New patient populationFeb 20, 2021 

KALETRA (TABLET) (ORAL) LOPINAVIR; RITONAVIR
Drug Classes: HIV protease inhibitor; CYP3A inhibitor
NDA Applicant: ABBVIE      NDA No.: 021906  Prod. No.: 001 RX (200MG;50MG); 002 RX (100MG;25MG)
PatentsExpirationPatented Use
Pat. No. 7148359 DP* Polymorph of a pharmaceutical
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: None
Jan 19, 2020 *PED 
Pat. No. 7364752 DP* Solid dispersion pharamaceutical formulations
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
May 10, 2021 *PEDU-688: Treatment of HIV-infection in combination with other antiretroviral agents
Pat. No. 8268349 DP* Solid pharmaceutical dosage form
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Feb 25, 2025 *PED 
Pat. No. 8399015 DP* Solid pharmaceutical dosage form
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 5, 2013; 002: None
Feb 25, 2025 *PED 
Pat. No. 8691878 Solid pharmaceutical dosage form
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 10, 2014
Feb 25, 2025 *PEDU-1513: Treatment of HIV-1 infection in combination with other antiretroviral agents
Pat. No. 8309613 Solid pharmaceutical dosage form
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 5, 2012; 002: None
Jun 24, 2025 *PEDU-688: Treatment of HIV-infection in combination with other antiretroviral agents
Pat. No. 8470347 DP* Self-emulsifying active substance formulation and use of this formulation
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 12, 2013; 002: None
Mar 17, 2027 *PED 
Pat. No. 8377952 Solid pharmaceutical dosage formulation
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Mar 18, 2013; 002: None
Apr 22, 2028 *PEDU-1372: Administration without food for treatment of CYP1A2-1 infection [in October this said "HIV-1 infection"]
Pat. No. 8025899 DP* Solid pharmaceutical dosage form
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 11, 2011; 002: None
Jun 14, 2028 *PED 

NORVIR (TABLET) (ORAL) RITONAVIR [GENERIC AB]
Drug Classes: CYP3A inhibitor; HIV protease inhibitor
NDA Applicant: ABBVIE      NDA No.: 022417  Prod. No.: 001 RX (100MG)
PatentsExpirationPatented Use
Pat. No. 7148359 DP* Polymorph of a pharmaceutical
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: None
Jan 19, 2020 *PED 
Pat. No. 7364752 DP* Solid dispersion pharamaceutical formulations
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
May 10, 2021 *PEDU-688: Treatment of HIV-infection in combination with other antiretroviral agents
Pat. No. 8268349 DP* Solid pharmaceutical dosage form
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 26, 2012
Feb 25, 2025 *PED 
Pat. No. 8399015 DP* Solid pharmaceutical dosage form
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 8, 2013
Feb 25, 2025 *PED 
Pat. No. 8691878 Solid pharmaceutical dosage form
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 10, 2014
Feb 25, 2025 *PEDU-688: Treatment of HIV-infection in combination with other antiretroviral agents
Pat. No. 8470347 DP* Self-emulsifying active substance formulation and use of this formulation
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 12, 2013
Mar 17, 2027 *PED 

TECHNIVIE (TABLET) (ORAL) OMBITASVIR; PARITAPREVIR; RITONAVIR
Drug Classes: hepatitis C virus (HCV) NS5A inhibitor; hepatitis C virus (HCV) NS3/4A protease inhibitor; CYP3A inhibitor; HIV protease inhibitor
NDA Applicant: ABBVIE INC      NDA No.: 207931  Prod. No.: 001 RX (12.5MG;75MG;50MG)
PatentsExpirationPatented Use
Pat. No. 7148359 DP* Polymorph of a pharmaceutical
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Aug 6, 2015
Jan 19, 2020 *PED 
Pat. No. 7364752 DP* Solid dispersion pharamaceutical formulations
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 6, 2015
May 10, 2021 *PED 
Pat. No. 8268349 DP* Solid pharmaceutical dosage form
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 6, 2015
Feb 25, 2025 *PED 
Pat. No. 8399015 DP* Solid pharmaceutical dosage form
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 6, 2015
Feb 25, 2025 *PED 
Pat. No. 8642538 DS* DP* Macrocyclic hepatitis C serine protease inhibitors
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Aug 6, 2015
Sep 10, 2029U-1638: Treatment of HCV infection using paritaprevir
Pat. No. 9006387 Anti-viral compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 6, 2015
Jun 10, 2030U-1687: Treatment of hcv infection using ombitasvir
Pat. No. 9044480 Compositions and methods for treating HCV
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 6, 2015
Apr 10, 2031U-1638: Treatment of HCV infection using paritaprevir
Pat. No. 8686026 DP* Solid compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 6, 2015
Jun 9, 2031 
Pat. No. 8420596 DS* DP* Macrocyclic hepatitis C serine protease inhibitors
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Aug 6, 2015
Oct 10, 2031 *PED 
Pat. No. 8691938 DS* DP* Anti-viral compounds
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Aug 6, 2015
Apr 13, 2032 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJul 24, 2018I-743: Information added to the labeling for the addition of the treatment of chronic hepatitis C virus (HCV) genotype 4 (GT4) infected patients with compensated cirrhosis based on results from study M11-665
Exclusivity Code: NCE - New chemical entityDec 19, 2019 
Exclusivity Code: NP - New productJul 24, 2018 

BELBUCA (FILM) (BUCCAL) BUPRENORPHINE HYDROCHLORIDE
Drug Classes: partial opioid agonist
NDA Applicant: BDSI      NDA No.: 207932  Prod. No.: 001 RX (EQ 0.075MG BASE); 002 RX (EQ 0.15MG BASE); 003 RX (EQ 0.3MG BASE); 004 RX (EQ 0.45MG BASE); 005 RX (EQ 0.6MG BASE); 006 RX (EQ 0.75MG BASE); 007 RX (EQ 0.9MG BASE)
PatentsExpirationPatented Use
Pat. No. 7579019 Pharmaceutical carrier device suitable for delivery of pharmaceutical compounds to mucosal surfaces
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Nov 20, 2015
Jan 22, 2020U-1769: Treatment of pain by transmucosal delivery of buprenorphine
Pat. No. 8147866 DP* Transmucosal delivery devices with enhanced uptake
Claim Types: Method of administration; Formulation
Pat. Sub. Date(s): All strengths: Nov 20, 2015
Jul 23, 2027U-1769: Treatment of pain by transmucosal delivery of buprenorphine
Pat. No. 9655843 DP* Transmucosal delivery devices with enhanced uptake
Claim Types: Method of administration; Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jun 13, 2017
Jul 23, 2027U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 9901539 Transmucosal drug delivery devices for use in chronic pain relief
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 28, 2018
Dec 21, 2032U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productOct 23, 2018 

BUNAVAIL (FILM) (BUCCAL) BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Drug Classes: partial opioid agonist; opioid antagonist
NDA Applicant: BDSI      NDA No.: 205637  Prod. No.: 001 RX (EQ 2.1MG BASE;EQ 0.3MG BASE); 002 RX (EQ 4.2MG BASE;EQ 0.7MG BASE); 003 RX (EQ 6.3MG BASE;EQ 1MG BASE)
PatentsExpirationPatented Use
Pat. No. 7579019 Pharmaceutical carrier device suitable for delivery of pharmaceutical compounds to mucosal surfaces
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Jun 20, 2014
Jan 22, 2020U-1521: Maintenance treatment of opioid dependence
Pat. No. 8147866 DP* Transmucosal delivery devices with enhanced uptake
Claim Types: Method of administration; Formulation
Pat. Sub. Date(s): All strengths: Jun 20, 2014
Jul 23, 2027U-1521: Maintenance treatment of opioid dependence
Pat. No. 9655843 DP* Transmucosal delivery devices with enhanced uptake
Claim Types: Method of administration; Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jun 13, 2017
Jul 23, 2027U-2017: Treatment of opioid dependence
Pat. No. 8703177 DP* Abuse-resistant mucoadhesive devices for delivery of buprenorphine
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jun 20, 2014
Aug 20, 2032 
Pat. No. 9522188 DP* Abuse resistant transmucosal drug delivery device
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Dec 20, 2016
Apr 24, 2035 

ONSOLIS (FILM) (BUCCAL) FENTANYL CITRATE
Drug Classes: opioid agonist
NDA Applicant: BDSI      NDA No.: 022266  Prod. No.: 001 DISC (EQ 0.2MG BASE); 002 DISC (EQ 0.4MG BASE); 003 DISC (EQ 0.6MG BASE); 004 DISC (EQ 0.8MG BASE); 005 DISC (EQ 1.2MG BASE)
PatentsExpirationPatented Use
Pat. No. 7579019 Pharmaceutical carrier device suitable for delivery of pharmaceutical compounds to mucosal surfaces
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: None
Jan 22, 2020U-767: Management of breakthrough pain in patients with cancer
Pat. No. 9597288 DP* Transmucosal delivery devices with enhanced uptake
Claim Types: Method of administration; Formulation; Method of use
Pat. Sub. Date(s): All strengths: Apr 3, 2017
Jul 23, 2027U-767: Management of breakthrough pain in patients with cancer

DALIRESP (TABLET) (ORAL) ROFLUMILAST [GENERIC AB]
Drug Classes: phosphodiesterase 4 inhibitor
NDA Applicant: ASTRAZENECA PHARMS      NDA No.: 022522  Prod. No.: 001 RX (500MCG)
PatentsExpirationPatented Use
Pat. No. 5712298 DS* DP* [Extended 5 years]
Fluoroalkoxy-substituted benzamides and their use as cyclic nucleotide phosphodiesterase inhibitors
Claim Types: Compound; Composition; Method of use; Process
Pat. Sub. Date(s): 001: None
Jan 27, 2020U-1115: Treatment to reduce the risk of copd exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations
Pat. No. 8431154 DP* Oral dosage form containing a PDE 4 inhibitor as an active ingredient and polyvinylpyrrolidone as excipient
Claim Types: Product-by-process
Pat. Sub. Date(s): 001: None
Feb 19, 2023 
Pat. No. 9468598 DP* Oral dosage form containing a PDE 4 inhibitor as an active ingredient and polyvinylpyrrolidon as excipient
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 3, 2016
Feb 19, 2023 
Pat. No. 8536206 Process for the preparation of roflumilast
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 15, 2013
Mar 8, 2024U-1115: Treatment to reduce the risk of copd exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations
Pat. No. 8604064 Process for the preparation of roflumilast
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 8, 2014
Mar 8, 2024U-1115: Treatment to reduce the risk of copd exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations
Pat. No. 8618142 DP* Process for the preparation of roflumilast
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 30, 2014
Mar 8, 2024 
ExclusivityExpirationExclusivity Description
Exclusivity Code: D - New Dosing ScheduleJan 23, 2021D-171: Revised dosing to include up-titration as a strategy to improve tolerability and thereby reduce treatment discontinuation for roflumilast maintenance dosage of 500 mcg daily
Exclusivity Code: M - MiscellaneousAug 31, 2020M-208: Information added to the labeling to include results of a randomized, double-blind, placebo-controlled study in patients with severe COPD associated with chronic bronchitis and a history of exacerbations

DALIRESP (TABLET) (ORAL) ROFLUMILAST
Drug Classes: phosphodiesterase 4 inhibitor
NDA Applicant: ASTRAZENECA PHARMS      NDA No.: 022522  Prod. No.: 002 RX (250MCG)
PatentsExpirationPatented Use
Pat. No. 5712298 DS* DP* [Extended 5 years]
Fluoroalkoxy-substituted benzamides and their use as cyclic nucleotide phosphodiesterase inhibitors
Claim Types: Compound; Composition; Method of use; Process
Pat. Sub. Date(s): 002: Mar 14, 2018
Jan 27, 2020U-1115: Treatment to reduce the risk of copd exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations
Pat. No. 8431154 DP* Oral dosage form containing a PDE 4 inhibitor as an active ingredient and polyvinylpyrrolidone as excipient
Claim Types: Product-by-process
Pat. Sub. Date(s): 002: Mar 14, 2018
Feb 19, 2023 
Pat. No. 9468598 DP* Oral dosage form containing a PDE 4 inhibitor as an active ingredient and polyvinylpyrrolidon as excipient
Claim Types: Formulation
Pat. Sub. Date(s): 002: Mar 14, 2018
Feb 19, 2023 
Pat. No. 8536206 Process for the preparation of roflumilast
Claim Types: Method of use
Pat. Sub. Date(s): 002: Mar 14, 2018
Mar 8, 2024U-1115: Treatment to reduce the risk of copd exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations
Pat. No. 8604064 Process for the preparation of roflumilast
Claim Types: Method of use
Pat. Sub. Date(s): 002: Mar 14, 2018
Mar 8, 2024U-1115: Treatment to reduce the risk of copd exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations
Pat. No. 8618142 DP* Process for the preparation of roflumilast
Claim Types: Formulation
Pat. Sub. Date(s): 002: Mar 14, 2018
Mar 8, 2024 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NS - New strengthJan 23, 2021 

ENSTILAR (AEROSOL, FOAM) (TOPICAL) BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
Drug Classes: corticosteroid; vitamin D analog
NDA Applicant: LEO PHARMA AS      NDA No.: 207589  Prod. No.: 001 RX (0.064%;0.005%)
PatentsExpirationPatented Use
Pat. No. 6753013 DP* Pharmaceutical composition
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 12, 2015
Jan 27, 2020U-1761: Plaque psoriasis
Pat. No. 9119781 DP* Pharmaceutical spray composition comprising a vitamin D analogue and a corticosteroid
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 12, 2015
Jun 10, 2031U-1761: Plaque psoriasis
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productOct 16, 2018 

TACLONEX (OINTMENT) (TOPICAL) BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE [GENERIC AB]
Drug Classes: corticosteroid; vitamin D analog
NDA Applicant: LEO PHARMA AS      NDA No.: 021852  Prod. No.: 001 RX (0.064%;0.005%)
PatentsExpirationPatented Use
Pat. No. 6753013 DP* Pharmaceutical composition
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Jan 27, 2020U-193: Psoriasis
U-88: Treatment of moderate plaque psoriasis

TACLONEX (SUSPENSION) (TOPICAL) BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE
Drug Classes: corticosteroid; vitamin D analog
NDA Applicant: LEO PHARMA AS      NDA No.: 022185  Prod. No.: 001 RX (0.064%;0.005%)
PatentsExpirationPatented Use
Pat. No. 6753013 DP* Pharmaceutical composition
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Jan 27, 2020U-1761: Plaque psoriasis
U-193: Psoriasis
U-88: Treatment of moderate plaque psoriasis
Pat. No. 6787529 DP* Topical composition
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Jan 27, 2020U-1761: Plaque psoriasis
U-193: Psoriasis
U-88: Treatment of moderate plaque psoriasis

VASCEPA (CAPSULE) (ORAL) ICOSAPENT ETHYL
NDA Applicant: AMARIN PHARMS      NDA No.: 202057  Prod. No.: 001 RX (1GM)
PatentsExpirationPatented Use
Pat. No. 8188146 DS* DP* Highly purified ethyl EPA and other EPA derivatives
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 27, 2020 
Pat. No. 8293727 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8293728 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8314086 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8318715 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 29, 2012
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8357677 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8367652 Methods of treating hypertriglyceridemia
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Feb 7, 2013
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8377920 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8399446 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 17, 2013
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8415335 Methods of treating hypertriglyceridemia
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Apr 17, 2013
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8426399 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8431560 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8440650 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8298554 DP* Stable pharmaceutical composition and methods of using same
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Apr 29, 2030 
Pat. No. 8445003 Stable pharmaceutical composition and methods of using same
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8445013 Stable pharmaceutical composition and methods of using same
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8501225 Stable pharmaceutical composition and methods of using same
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8518929 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8524698 Methods of treating hypertriglyceridemia
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Sep 11, 2013
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8546372 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 1, 2013
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8551521 Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 9, 2013
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8563608 Methods for lowering triglycerides without raising LDL-C levels in a subject on concomitant statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 22, 2013
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8617593 Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 14, 2014
Apr 29, 2030U-1478: Method of reducing TG levels in patient on statin therapy suffering from severe hypertriglyceridemia
Pat. No. 8617594 Stable pharmaceutical composition and methods of using same
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8623406 Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 14, 2014
Apr 29, 2030U-1478: Method of reducing TG levels in patient on statin therapy suffering from severe hypertriglyceridemia

VASCEPA (CAPSULE) (ORAL) ICOSAPENT ETHYL
NDA Applicant: AMARIN PHARMS      NDA No.: 202057  Prod. No.: 002 RX (500MG)
PatentsExpirationPatented Use
Pat. No. 8188146 DS* DP* Highly purified ethyl EPA and other EPA derivatives
Claim Types: Formulation
Pat. Sub. Date(s): 002: Jun 26, 2017
Jan 27, 2020 
Pat. No. 8293727 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2017
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8293728 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2017
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8314086 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2017
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8318715 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2017
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8357677 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2017
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8367652 Methods of treating hypertriglyceridemia
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Jun 26, 2017
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8377920 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2017
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8399446 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2017
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8415335 Methods of treating hypertriglyceridemia
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Jun 26, 2017
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8426399 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2017
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8440650 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2017
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8298554 DP* Stable pharmaceutical composition and methods of using same
Claim Types: Formulation
Pat. Sub. Date(s): 002: Jun 26, 2017
Apr 29, 2030 
Pat. No. 8445003 Stable pharmaceutical composition and methods of using same
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Jun 26, 2017
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8445013 Stable pharmaceutical composition and methods of using same
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Jun 26, 2017
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8501225 Stable pharmaceutical composition and methods of using same
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Jun 26, 2017
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8518929 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2017
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8524698 Methods of treating hypertriglyceridemia
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Jun 26, 2017
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8546372 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2017
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8551521 Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2017
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8563608 Methods for lowering triglycerides without raising LDL-C levels in a subject on concomitant statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2017
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8617593 Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2017
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8617594 Stable pharmaceutical composition and methods of using same
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Jun 26, 2017
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8623406 Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2017
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia

CALCIJEX (INJECTABLE) (INJECTION) CALCITRIOL
Drug Classes: vitamin D3 analog
NDA Applicant: ABBVIE      NDA No.: 018874  Prod. No.: 001 DISC (0.001MG/ML**); 002 DISC (0.002MG/ML**)
PatentsExpirationPatented Use
Pat. No. 6051567 Low oxygen content compositions of 1.alpha., 25-dihydroxycholecalciferol
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Feb 2, 2020 *PED 
Pat. No. 6265392 Low oxygen content compositions of 1.alpha., 25-dihydroxycholeclciferol
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Feb 2, 2020 *PED 
Pat. No. 6274169 Low oxygen content compostions of 1.alpha., 25-dihydroxycholecalciferol
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): All strengths: None
Feb 2, 2020 *PED 

ERAXIS (POWDER) (INTRAVENOUS) ANIDULAFUNGIN
Drug Classes: echinocandin antifungal
NDA Applicant: VICURON      NDA No.: 021632  Prod. No.: 001 RX (50MG/VIAL); 002 RX (100MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 5965525 DS* DP* [Extended 1223 days (3.4 years)]
Cyclic peptide antifungal agents
Claim Types: Compound; Method of use; Composition
Pat. Sub. Date(s): All strengths: None
Feb 17, 2020U-540: Treatment of fungal infections
Pat. No. 6960564 DP* Echinocandin pharmaceutical formulations containing micelle-forming surfactants
Claim Types: Formulation; Process; Method of use
Pat. Sub. Date(s): All strengths: None
Apr 12, 2021U-540: Treatment of fungal infections
Pat. No. 7709444 DP* Echinocandin pharmaceutical formulations containing micelle-forming surfactants
Claim Types: Formulation; Process; Method of use
Pat. Sub. Date(s): All strengths: None
Apr 12, 2021U-540: Treatment of fungal infections

SILENOR (TABLET) (ORAL) DOXEPIN HYDROCHLORIDE
Drug Classes: tricyclic antidepressant (TCA)
NDA Applicant: PERNIX THERAPS LLC      NDA No.: 022036  Prod. No.: 001 RX (EQ 3MG BASE); 002 RX (EQ 6MG BASE)
PatentsExpirationPatented Use
Pat. No. 6211229 Treatment of transient and short term insomnia
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: None
Feb 17, 2020U-620: Treatment of insomnia
Pat. No. 9486437 Methods of using low-dose doxepin for the improvement of sleep
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Dec 2, 2016
May 18, 2027U-620: Treatment of insomnia
Pat. No. 9861607 Methods of using low-dose doxepin for the improvement of sleep
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 24, 2018
May 18, 2027U-620: Treatment of insomnia
Pat. No. 9572814 Methods of improving the pharmacokinetics of doxepin
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 21, 2017
Jul 20, 2027U-620: Treatment of insomnia
Pat. No. 7915307 Methods of improving the pharmacokinetics of doxepin
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: None
Aug 24, 2027U-620: Treatment of insomnia
Pat. No. 9907780 DP* Low-dose doxepin formulations and methods of making and using the same
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Mar 26, 2018
Apr 11, 2028 
Pat. No. 9107898 Methods of using low-dose doxepin for the improvement of sleep
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 9, 2015
May 1, 2028U-620: Treatment of insomnia
Pat. No. 9532971 DP* Low-dose doxepin formulations and methods of making and using the same
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jan 13, 2017
Jun 1, 2029 
Pat. No. 8513299 Methods of using low-dose doxepin for the improvement of sleep
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 20, 2013; 002: None
Sep 7, 2030U-620: Treatment of insomnia

ZYMAR (SOLUTION/DROPS) (OPHTHALMIC) GATIFLOXACIN
Drug Classes: quinolone antimicrobial
NDA Applicant: ALLERGAN      NDA No.: 021493  Prod. No.: 001 RX (0.3%)
PatentsExpirationPatented Use
Pat. No. 6333045 DP* Aqueous liquid pharmaceutical composition comprised of gatifloxacin
Claim Types: Formulation; Method of use Process
Pat. Sub. Date(s): 001: None
Feb 20, 2020 *PED 

AKYNZEO (CAPSULE) (ORAL) NETUPITANT; PALONOSETRON HYDROCHLORIDE
Drug Classes: substance P/neurokinin-1 (NK-1) receptor antagonist; serotonin-3 (5-HT3) receptor antagonist
NDA Applicant: HELSINN HLTHCARE      NDA No.: 205718  Prod. No.: 001 RX (300MG;EQ 0.5MG BASE)
PatentsExpirationPatented Use
Pat. No. 6297375 DS* 4-phenyl-pyridine derivatives
Claim Types: Compound
Pat. Sub. Date(s): 001: Nov 6, 2014
Feb 22, 2020 
Pat. No. 8623826 Compositions and methods for treating centrally mediated nausea and vomiting
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Nov 6, 2014
Nov 18, 2030U-2293: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy
Pat. No. 8951969 DP* Compositions and methods for treating centrally mediated nausea and vomiting
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 6, 2015
Nov 18, 2030 
Pat. No. 9186357 Compositions and methods for treating centrally mediated nausea and vomiting
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Dec 2, 2015
Nov 18, 2030U-2293: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy
Pat. No. 9943515 Compositions and methods for treating centrally mediated nausea and vomiting
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 16, 2018
Nov 18, 2030U-2293: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy
Pat. No. 9271975 Compositions and methods for treating centrally mediated nausea and vomiting
Claim Types: Method of administration; Method of use
Pat. Sub. Date(s): 001: Jul 14, 2016
Sep 9, 2031U-2293: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy
Pat. No. 9951016 DS* DP* Crystalline forms of an NK-1 antagonist
Claim Types: Formulation; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: May 16, 2018
Sep 25, 2035 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityOct 10, 2019 

DETROL LA (CAPSULE, EXTENDED RELEASE) (ORAL) TOLTERODINE TARTRATE [GENERIC AB]
Drug Classes: muscarinic antagonist
NDA Applicant: PHARMACIA AND UPJOHN      NDA No.: 021228  Prod. No.: 001 RX (2MG); 002 RX (4MG)
PatentsExpirationPatented Use
Pat. No. 6770295 DP* Therapeutic formulation for administering tolterodine with controlled release
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): All strengths: None
Feb 26, 2020 *PEDU-544: Treatment of overactive bladder. Treatment of urinary incontinence.
Pat. No. 6630162 DP* Pharmaceutical formulation and its use
Claim Types: Formulation; Method of use; Method of administration
Pat. Sub. Date(s): All strengths: None
May 11, 2020 *PEDU-544: Treatment of overactive bladder. Treatment of urinary incontinence.
Pat. No. 6911217 DP* Controlled release bead, a method of producing the same and multiple unit formulationcomprising it
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Apr 30, 2013; 002: None
May 11, 2020 *PEDU-544: Treatment of overactive bladder. Treatment of urinary incontinence.

ONZETRA XSAIL (POWDER) (INHALATION) SUMATRIPTAN SUCCINATE
Drug Classes: serotonin 5-HT1B/1D receptor agonist (triptan)
NDA Applicant: AVANIR PHARMS      NDA No.: 206099  Prod. No.: 001 RX (EQ 11MG BASE)
PatentsExpirationPatented Use
Pat. No. 6715485 DP* Nasal delivery device
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 23, 2016
Mar 3, 2020 
Pat. No. 8555877 DP* Nasal delivery device
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 23, 2016
Mar 3, 2020 
Pat. No. 8047202 DP* Nasal devices
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 23, 2016
Jul 2, 2023 
Pat. No. 8327844 Nasal delivery method
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 23, 2016
Oct 3, 2023U-1809: Method of drug delivery via the nasal cavity
Pat. No. 9119932 DP* Nasal delivery device
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): 001: Feb 23, 2016
Apr 23, 2024 
Pat. No. 7975690 DP* Nasal devices
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 23, 2016
Aug 18, 2025U-1809: Method of drug delivery via the nasal cavity
Pat. No. 8590530 DP* Nasal delivery devices
Claim Types: Device; Drug in a container; Method of use
Pat. Sub. Date(s): 001: Feb 23, 2016
Sep 15, 2025U-1809: Method of drug delivery via the nasal cavity
Pat. No. 9108015 DP* Nasal delivery devices
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 23, 2016
Sep 15, 2025 
Pat. No. 8875704 DP* Nasal administration
Claim Types: Device; Method of use; Drug in a container
Pat. Sub. Date(s): 001: Feb 23, 2016
Apr 7, 2028U-1809: Method of drug delivery via the nasal cavity
Pat. No. 10076615 Nasal delivery
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Oct 12, 2018
Jul 30, 2029U-2010: Acute treatment of migraine by delivering a powdered substance comprising sumatriptan via a breath-powered delivery device
U-2011: Treatment of migraine via delivery of sumatriptan via the nasal cavity
U-2404: Method of delivering sumatriptan to a nasal cavity
Pat. No. 8550073 DP* Nasal delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 23, 2016
Oct 22, 2029 
Pat. No. 8899229 DP* Powder delivery devices
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 23, 2016
Aug 18, 2030 
Pat. No. 9649456 DP* Nasal administration
Claim Types: Method of administration; Device
Pat. Sub. Date(s): 001: May 26, 2017
Oct 21, 2030U-1719: Acute treatment of migraine
U-2010: Acute treatment of migraine by delivering a powdered substance comprising sumatriptan via a breath-powered delivery device
U-2011: Treatment of migraine via delivery of sumatriptan via the nasal cavity
Pat. No. 8978647 DP* Nasal delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 23, 2016
Dec 6, 2030 
Pat. No. 10076614 DP* Nasal delivery devices
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 12, 2018
Oct 20, 2034 

XHANCE (SPRAY, METERED) (NASAL) FLUTICASONE PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: OPTINOSE US INC      NDA No.: 209022  Prod. No.: 001 RX (0.093MG)
PatentsExpirationPatented Use
Pat. No. 6715485 DP* Nasal delivery device
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 17, 2017
Mar 3, 2020 
Pat. No. 8555878 DP* Nasal delivery device
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 17, 2017
Mar 20, 2020 
Pat. No. 9468727 DP* Nasal delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 17, 2017
Jul 30, 2020 
Pat. No. 9072857 DP* Nasal delivery device
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 17, 2017
Apr 10, 2021 
Pat. No. 8522778 DP* Nasal devices
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 17, 2017
May 11, 2022 
Pat. No. 8327844 Nasal delivery method
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 17, 2017
Oct 8, 2023U-2133: Method of delivering fluticasone propionate to a nasal airway
Pat. No. 7975690 Nasal devices
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 17, 2017
Dec 29, 2025U-2133: Method of delivering fluticasone propionate to a nasal airway
Pat. No. 10076615 Nasal delivery
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Oct 12, 2018
Jul 30, 2029U-2133: Method of delivering fluticasone propionate to a nasal airway
Pat. No. 8550073 DP* Nasal delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 17, 2017
Oct 22, 2029 
Pat. No. 8978647 DP* Nasal delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 17, 2017
Aug 6, 2030 
Pat. No. 10076614 DP* Nasal delivery devices
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 12, 2018
Oct 20, 2034 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productSep 18, 2020 

RENOVA (CREAM) (TOPICAL) TRETINOIN
Drug Classes: retinoid
NDA Applicant: VALEANT PHARMS NORTH      NDA No.: 021108  Prod. No.: 001 RX (0.02%)
PatentsExpirationPatented Use
Pat. No. 6531141 Oil-in-water emulsion containing tretinoin
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Mar 7, 2020 

FERAHEME (SOLUTION) (INTRAVENOUS) FERUMOXYTOL
Drug Classes: iron replacement product
NDA Applicant: AMAG PHARMS INC      NDA No.: 022180  Prod. No.: 001 RX (EQ 510MG IRON/17ML (EQ 30MG IRON/ML))
PatentsExpirationPatented Use
Pat. No. 7553479 DS* DP* Heat stable colloidal iron oxides coated with reduced carbohydrates and uses thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Mar 8, 2020 
Pat. No. 7871597 DS* DP* Polyol and polyether iron oxide complexes as pharmacological and/or MRI contrast agents
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Feb 15, 2011
Mar 8, 2020 
Pat. No. 8501158 Polyol and polyether iron oxide complexes as pharmacological and/or MRI contrast agents
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Aug 6, 2013
Mar 8, 2020U-1422: Method of treating patients needing an iron supplement
Pat. No. 8591864 DP* Polyol and polyether iron oxide complexes as pharmacological and/or MRI contrast agents
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 12, 2013
Mar 8, 2020 
Pat. No. 8926947 DS* DP* Polyol and polyether iron oxide complexes as pharmacological and/or MRI contrast agents
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Jan 8, 2015
Mar 8, 2020 
Pat. No. 6599498 DS* DP* [Extended 1209 days (3.3 years)]
Heat stable colloidal iron oxides coated with reduced carbohydrates and carbohdrate derivatives
Claim Types: Method of administration; Process; Formulation
Pat. Sub. Date(s): 001: None
Jun 30, 2023 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationFeb 2, 2021I-767: Treatment of iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron

SOMATULINE DEPOT (SOLUTION) (SUBCUTANEOUS) LANREOTIDE ACETATE
Drug Classes: somatostatin analog
NDA Applicant: IPSEN PHARMA      NDA No.: 022074  Prod. No.: 001 RX (EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)); 002 RX (EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)); 003 RX (EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML))
PatentsExpirationPatented Use
Pat. No. 5595760 DP* [Extended 5 years]
Sustained release of peptides from pharmaceutical compositions
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): All strengths: None
Mar 8, 2020U-831: Method of administering lanreotide acetate
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationSep 15, 2020I-754: To reduce the frequency of short-acting somatostatin analog rescue therapy when used for the treatment of adults with carcinoid syndrome
Exclusivity Code: ODE - Orphan drug exclusivitySep 15, 2024ODE-156: Treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy
Exclusivity Code: ODE - Orphan drug exclusivityDec 16, 2021ODE-82: Treatment of patients with unresectable,well- or moderately-differentiated locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors to improve progression-free survival

AFINITOR DISPERZ (TABLET, FOR SUSPENSION) (ORAL) EVEROLIMUS
Drug Classes: kinase inhibitor; mTor inhibitor immunosuppressant
NDA Applicant: NOVARTIS PHARM      NDA No.: 203985  Prod. No.: 001 RX (2MG); 002 RX (3MG); 003 RX (5MG)
PatentsExpirationPatented Use
Pat. No. 5665772 DS* DP* [Extended 5 years]
O-alkylated rapamycin derivatives and their use, particularly as immunosuppressants
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Sep 26, 2012; 002: None; 003: None
Mar 9, 2020 *PED 
Pat. No. 7297703 DP* Macrolides
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Sep 26, 2012; 002: None; 003: None
Jun 6, 2020 *PED 
Pat. No. 8778962 Treatment of solid tumors with rapamycin derivatives
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 28, 2014
Aug 18, 2022 *PEDU-1541: Treatment of patients with tuberous sclerosis complex (TSC) who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected.
U-2280: Adjunctive treatment of patients with TSC-associated partial-onset seizures
Pat. No. 8617598 DP* Pharmaceutical compositions comprising colloidal silicon dioxide
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): All strengths: Mar 27, 2014
Mar 27, 2023 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationApr 10, 2021I-773: For the adjunctive treatment of adult and pediatric patients age 2 years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures
Exclusivity Code: ODE - Orphan drug exclusivityApr 10, 2025ODE-169: For the adjunctive treatment of adult and pediatric patients aged 2 years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures
Exclusivity Code: ODE - Orphan drug exclusivityApr 29, 2018 PEDODE-4: Treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis who require therapeutic intervention but are not candidates for curative surgical resection

CYMBALTA (CAPSULE, DELAYED REL PELLETS) (ORAL) DULOXETINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI)
NDA Applicant: LILLY      NDA No.: 021427  Prod. No.: 001 RX (EQ 20MG BASE); 002 RX (EQ 30MG BASE); 004 RX (EQ 60MG BASE)
PatentsExpirationPatented Use
Pat. No. 6596756 Treatment of fibromyalgia
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Mar 10, 2020 *PEDU-882: Management of fibromyalgia (FM)

TOTECT (INJECTABLE) (INJECTION) DEXRAZOXANE HYDROCHLORIDE [Has competitive generic]
Drug Classes: cytoprotective agent
NDA Applicant: CLINIGEN HLTHCARE      NDA No.: 022025  Prod. No.: 001 RX (EQ 500MG BASE/VIAL)
PatentsExpirationPatented Use
Pat. No. 6727253 Treatment of accidental extravasation of anthracyclines
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Mar 13, 2020U-829: Treatment of extravasation resulting from IV anthracycline chemotherapy

RAYOS (TABLET, DELAYED RELEASE) (ORAL) PREDNISONE [GENERIC AB]
Drug Classes: corticosteroid
NDA Applicant: HORIZON PHARMA      NDA No.: 202020  Prod. No.: 001 RX (1MG)
PatentsExpirationPatented Use
Pat. No. 6488960 DP* Corticosteroid formulation
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 22, 2012
Mar 14, 2020U-1267: Treatment of rheumatoid arthritis by delayed release formulation of 1mg or 2mg of prednisone
Pat. No. 6677326 DP* Corticosteroid formulation comprising less than 2.5 mg prednisolone for once daily administration
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 22, 2012
Mar 14, 2020U-1268: Treatment of pulmonary, gastrointestinal and/or rheumatological diseases or conditions by use of delayed release formulations of 1mg or 2mg prednisone
Pat. No. 8309124 Delayed release tablet with defined core geometry
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Nov 13, 2012
Apr 23, 2024U-1292: Treatment of diseases or conditions by the use of a delayed release 1, 2, or 5 mg prednisone tablet
Pat. No. 8394407 DP* Delayed release tablet with defined core geometry
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): 001: Mar 12, 2013
Apr 23, 2024U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet
Pat. No. 9040085 Delayed release tablet with defined core geometry
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 25, 2015
Apr 23, 2024U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet
Pat. No. 9186332 Delayed release tablet with defined core geometry
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 4, 2015
Apr 23, 2024U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet
Pat. No. 9504699 Delayed-release glucocorticoid treatment of rheumatoid disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 7, 2016
Aug 3, 2027U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet

RAYOS (TABLET, DELAYED RELEASE) (ORAL) PREDNISONE [GENERIC AB]
Drug Classes: corticosteroid
NDA Applicant: HORIZON PHARMA      NDA No.: 202020  Prod. No.: 002 RX (2MG)
PatentsExpirationPatented Use
Pat. No. 6488960 DP* Corticosteroid formulation
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: None
Mar 14, 2020U-1267: Treatment of rheumatoid arthritis by delayed release formulation of 1mg or 2mg of prednisone
Pat. No. 6677326 DP* Corticosteroid formulation comprising less than 2.5 mg prednisolone for once daily administration
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: None
Mar 14, 2020U-1268: Treatment of pulmonary, gastrointestinal and/or rheumatological diseases or conditions by use of delayed release formulations of 1mg or 2mg prednisone
Pat. No. 8309124 Delayed release tablet with defined core geometry
Claim Types: Method of administration
Pat. Sub. Date(s): 002: None
Apr 23, 2024 
Pat. No. 8394407 DP* Delayed release tablet with defined core geometry
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): 002: None
Apr 23, 2024U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet
Pat. No. 9040085 Delayed release tablet with defined core geometry
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 25, 2015
Apr 23, 2024U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet
Pat. No. 9186332 Delayed release tablet with defined core geometry
Claim Types: Method of use
Pat. Sub. Date(s): 002: Dec 4, 2015
Apr 23, 2024U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet
Pat. No. 9504699 Delayed-release glucocorticoid treatment of rheumatoid disease
Claim Types: Method of use
Pat. Sub. Date(s): 002: Dec 7, 2016
Aug 3, 2027U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet

LONSURF (TABLET) (ORAL) TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE
Drug Classes: thymidine phosphorylase inhibitor; nucleoside analog antiviral; nucleoside metabolic inhibitor
NDA Applicant: TAIHO ONCOLOGY      NDA No.: 207981  Prod. No.: 001 RX (EQ 6.14MG BASE;15MG); 002 RX (EQ 8.19MG BASE;20MG)
PatentsExpirationPatented Use
Pat. No. 6479500 Agents for alleviating side effects
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 21, 2015
Mar 16, 2020U-1751: Treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-vegf biological therapy, and if RAS wild-type, an anti-EGFR therapy
Pat. No. RE46284 Method of administrating an anticancer drug containing .alpha., .alpha., .alpha.-trifluorothymidine and thymidine phosphorylase inhibitor
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): All strengths: Feb 7, 2017
Dec 16, 2026U-1751: Treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-vegf biological therapy, and if RAS wild-type, an anti-EGFR therapy
Pat. No. 9527833 DS* DP* Stable crystal form of tipiracil hydrochloride and crystallization method for the same
Claim Types: New polymorph, salt or hydrate; Composition; Process
Pat. Sub. Date(s): All strengths: Jan 27, 2017
Jun 17, 2034 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entitySep 22, 2020 

KOVANAZE (SPRAY, METERED) (NASAL) OXYMETAZOLINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE
Drug Classes: vasoconstrictor; ester local anesthetic
NDA Applicant: ST RENATUS      NDA No.: 208032  Prod. No.: 001 RX (0.1MG/SPRAY;6MG/SPRAY)
PatentsExpirationPatented Use
Pat. No. 6413499 Methods and kits for maxillary dental anesthesia by means of a nasal deliverable anesthetic
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 20, 2016
Mar 20, 2020U-1876: Method of anesthetizing at least a portion of the maxillary dental arch
Pat. No. 8580282 DP* Dental anesthetic comprising tetracaine and a vasoconstrictor for intranasal administration
Claim Types: Formulation; Method of use; Device; Method of administration
Pat. Sub. Date(s): 001: Jul 20, 2016
Apr 2, 2030U-1876: Method of anesthetizing at least a portion of the maxillary dental arch
Pat. No. 9308191 DP* Dental anesthetic comprising tetracaine and a vasoconstrictor for intranasal administration
Claim Types: Formulation; Method of use; Method of administration
Pat. Sub. Date(s): 001: Jul 20, 2016
Apr 2, 2030U-1876: Method of anesthetizing at least a portion of the maxillary dental arch
ExclusivityExpirationExclusivity Description
Exclusivity Code: NC - New combinationJun 29, 2019 

PREFEST (TABLET) (ORAL) ESTRADIOL; NORGESTIMATE
Drug Classes: estrogen; progestin
NDA Applicant: TEVA WOMENS      NDA No.: 021040  Prod. No.: 001 DISC (1MG,1MG;N/A,0.09MG**)
PatentsExpirationPatented Use
Pat. No. 6747019 Low dose estrogen interrupted hormone replacement therapy
Claim Types: Kit; Method of use
Pat. Sub. Date(s): 001: None
Mar 20, 2020U-311: Hormone replacement
Pat. No. 7320970 DP* Low dose estrogen interrupted hormone replacement therapy
Claim Types: Method of use; Kit
Pat. Sub. Date(s): 001: None
Mar 30, 2020U-844: PREFEST is indicated in women who have a uterus for the treatment of moderate to severe vasomotor symptoms associated with menopause; treatment of vulvar and vaginal atrophy; prevention of osteoporosis

TAYTULLA (CAPSULE) (ORAL) ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Drug Classes: estrogen; progestin
NDA Applicant: APIL      NDA No.: 204426  Prod. No.: 001 RX (0.02MG;1MG)
PatentsExpirationPatented Use
Pat. No. 6652880 DP* Oral pharmaceutical compositions containing long-chain triglycerides and liphophilic surfactants
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Mar 29, 2020 

MOXEZA (SOLUTION/DROPS) (OPHTHALMIC) MOXIFLOXACIN HYDROCHLORIDE [GENERIC AT2]
Drug Classes: quinolone antimicrobial
NDA Applicant: NOVARTIS PHARMS CORP      NDA No.: 022428  Prod. No.: 001 RX (EQ 0.5% BASE)
PatentsExpirationPatented Use
Pat. No. 6716830 DP* Ophthalmic antibiotic compositions containing moxifloxacin
Claim Types: Composition
Pat. Sub. Date(s): 001: None
Mar 29, 2020 *PED 
Pat. No. 7671070 DP* Method of treating ophthalmic infections with moxifloxacin compositions
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Mar 29, 2020 *PEDU-709: Method of combating bacteria in a patient
Pat. No. 8450311 DP* Pharmaceutical compositions containing a fluoroquinolone antibiotic drug
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 10, 2013
May 29, 2029 
Pat. No. 9114168 DP* Pharmaceutical compositions containing a fluoroquinolone antibiotic drug
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 8, 2015
May 29, 2029 

VIGAMOX (SOLUTION/DROPS) (OPHTHALMIC) MOXIFLOXACIN HYDROCHLORIDE [GENERIC AT1]
Drug Classes: quinolone antimicrobial
NDA Applicant: NOVARTIS PHARMS CORP      NDA No.: 021598  Prod. No.: 001 RX (EQ 0.5% BASE)
PatentsExpirationPatented Use
Pat. No. 6716830 DP* Ophthalmic antibiotic compositions containing moxifloxacin
Claim Types: Composition
Pat. Sub. Date(s): 001: None
Mar 29, 2020 *PED 
Pat. No. 7671070 Method of treating ophthalmic infections with moxifloxacin compositions
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Mar 29, 2020 *PEDU-709: Method of combating bacteria in a patient

LEVO-T (TABLET) (ORAL) LEVOTHYROXINE SODIUM [GENERIC AB1,AB2,AB3]
Drug Classes: L-thyroxine (T4)
NDA Applicant: CEDIPROF INC      NDA No.: 021342  Prod. No.: 001 RX (0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 002 RX (0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 003 RX (0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 004 RX (0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 005 RX (0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 006 RX (0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 007 RX (0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 008 RX (0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 009 RX (0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 010 RX (0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 011 RX (0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium)
PatentsExpirationPatented Use
Pat. No. 6399101 Stable thyroid hormone preparations and method of making same
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: None
Mar 30, 2020 

MARQIBO KIT (INJECTABLE, LIPOSOMAL) (INTRAVENOUS) VINCRISTINE SULFATE
Drug Classes: vinca alkaloid
NDA Applicant: TALON THERAP      NDA No.: 202497  Prod. No.: 001 RX (5MG/5ML (1MG/ML))
PatentsExpirationPatented Use
Pat. No. 6723338 Compositions and methods for treating lymphoma
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 6, 2012
Mar 31, 2020U-1271: Treatment of adult patients with Philadelphia chromosome-negative(ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies
Pat. No. 7887836 Compositions and methods for treating lymphoma
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 6, 2012
Mar 31, 2020U-1271: Treatment of adult patients with Philadelphia chromosome-negative(ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies
Pat. No. 7247316 DP* Compositions and methods for treating lymphoma
Claim Types: Kit
Pat. Sub. Date(s): 001: Sep 6, 2012
Sep 25, 2020 
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityAug 9, 2019ODE-28: Treatment of adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies

AUGMENTIN XR (TABLET, EXTENDED RELEASE) (ORAL) AMOXICILLIN; CLAVULANATE POTASSIUM [GENERIC AB]
Drug Classes: penicillin class antibacterial
NDA Applicant: DR REDDYS LABS INC      NDA No.: 050785  Prod. No.: 001 RX (1GM;EQ 62.5MG BASE)
PatentsExpirationPatented Use
Pat. No. 6746692 DP* Modified release pharmaceutical formulation comprising amoxycillin
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Apr 4, 2020 
Pat. No. 6783773 DP* Composition comprising amoxicillin and potassium clavulanate
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Apr 4, 2020 
Pat. No. 6878386 Method of treating a bacterial infection comprising amoxycillin and potassium clavulanate
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Apr 4, 2020U-926: Mgt specific bacterial infections. treatment pts w/ community acquired pneumonia or bacterial sinusitis due to confirmed, or suspected b-lactamase producing pathogens & S. pneumoniae with reduced susceptibility to penicillin (mic=2mc/ml)
Pat. No. 7217430 DP* Compositions and methods of treatment comprising amoxicillin and potassium clavulanate with xanthan
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Apr 4, 2020U-926: Mgt specific bacterial infections. treatment pts w/ community acquired pneumonia or bacterial sinusitis due to confirmed, or suspected b-lactamase producing pathogens & S. pneumoniae with reduced susceptibility to penicillin (mic=2mc/ml)
Pat. No. 7250176 Method of treating a bacterial infection
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Apr 4, 2020U-926: Mgt specific bacterial infections. treatment pts w/ community acquired pneumonia or bacterial sinusitis due to confirmed, or suspected b-lactamase producing pathogens & S. pneumoniae with reduced susceptibility to penicillin (mic=2mc/ml)

QBREXZA (CLOTH) (TOPICAL) GLYCOPYRRONIUM TOSYLATE
Drug Classes: anticholinergic
NDA Applicant: DERMIRA INC      NDA No.: 210361  Prod. No.: 001 RX (EQ 2.4% BASE)
PatentsExpirationPatented Use
Pat. No. 6433003 Method for treating hyperhidrosis in mammals
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 20, 2018
Apr 10, 2020U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older
Pat. No. 10052267 DP* Topical glycopyrrolate formulations
Claim Types: Formulation; Device; Method of use
Pat. Sub. Date(s): 001: Sep 20, 2018
Oct 17, 2028U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older
Pat. No. 8618160 DP* Topical glycopyrrolate formulations
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Sep 20, 2018
Dec 10, 2029U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older
Pat. No. 9744105 DP* Topical glycopyrrolate formulations
Claim Types: Formulation; Device; Method of use
Pat. Sub. Date(s): 001: Sep 20, 2018
Jul 18, 2030U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older
Pat. No. 8859610 DP* Crystalline glycopyrrolate tosylate
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Sep 20, 2018
Feb 28, 2033U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older
Pat. No. 9006462 DP* Glycopyrrolate salts
Claim Types: Formulation; Device
Pat. Sub. Date(s): 001: Sep 20, 2018
Feb 28, 2033 
Pat. No. 9259414 Glycopyrrolate salts
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 20, 2018
Feb 28, 2033U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older
Pat. No. 10004717 DP* Glycopyrrolate salts
Claim Types: Formulation; Method of use; Device
Pat. Sub. Date(s): 001: Sep 20, 2018
Feb 28, 2033U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older

ZOLOFT (CONCENTRATE) (ORAL) SERTRALINE HYDROCHLORIDE [GENERIC AA]
Drug Classes: selective serotonin reuptake inhibitor (SSRI)
NDA Applicant: PFIZER      NDA No.: 020990  Prod. No.: 001 RX (EQ 20MG BASE/ML)
PatentsExpirationPatented Use
Pat. No. 6727283 DP* Sertraline oral concentrate
Claim Types: Formulation; Process; Method of use
Pat. Sub. Date(s): 001: None
Apr 11, 2020 *PEDU-580: Treatment of disorders of the serotonergic system such as depression and anxiety-related disorders
Pat. No. 7067555 DP* Sertraline oral concentrate
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: None
Apr 11, 2020 *PED 

ABILIFY (TABLET, ORALLY DISINTEGRATING) (ORAL) ARIPIPRAZOLE
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 021729  Prod. No.: 002 DISC (10MG**); 003 DISC (15MG**)
PatentsExpirationPatented Use
Pat. No. 9358207 DP* Flashmelt oral dosage formulation
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jun 30, 2016
Apr 12, 2020 
Pat. No. 8518421 DP* Flashmelt oral dosage formulation
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 26, 2013
Jul 24, 2021 *PED 
Pat. No. 7053092 5-HT1a receptor subtype agonist
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Jan 28, 2022U-839: Treatment of major depressive disorder (MDD)
Pat. No. 9089567 Method of treating cognitive impairments and schizophrenias
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 26, 2015
Jan 28, 2022U-543: Treatment of schizophrenia
Pat. No. 8642600 Method of treating autism
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 5, 2014
Jul 28, 2022 *PEDU-1492: Treatment of irritability associated with autistic disorder
Pat. No. 9359302 DS* DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate; Process; Product-by-process; Composition; Method of use; Kit; Formulation
Pat. Sub. Date(s): All strengths: Jun 30, 2016
Sep 25, 2022U-1859: Treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, adjunctive treatment of major depressive disorder, and treatment of irritability associated with autistic disorder
Pat. No. 8580796 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: None
Mar 25, 2023 *PED 
Pat. No. 8642760 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: Compound
Pat. Sub. Date(s): All strengths: Mar 5, 2014
Mar 25, 2023 *PED 
Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Aug 2, 2016
Dec 25, 2023U-1529: Adjunctive treatment of major depressive disorder (MDD)
Pat. No. 8017615 DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: Composition; Product-by-process; Process
Pat. Sub. Date(s): All strengths: None
Dec 16, 2024 *PED 
Pat. No. 9125939 Carbostyril derivatives and mood stabilizers for treating mood disorders
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 7, 2015
Jul 28, 2026U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder
Pat. No. 8759350 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jul 22, 2014
Mar 2, 2027U-1529: Adjunctive treatment of major depressive disorder (MDD)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityDec 12, 2021ODE-80: Treatment of pediatric patients with Tourette's

ABILIFY (TABLET, ORALLY DISINTEGRATING) (ORAL) ARIPIPRAZOLE
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 021729  Prod. No.: 004 DISC (20MG**); 005 DISC (30MG**)
PatentsExpirationPatented Use
Pat. No. 9358207 DP* Flashmelt oral dosage formulation
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jun 30, 2016
Apr 12, 2020 
Pat. No. 8518421 DP* Flashmelt oral dosage formulation
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 26, 2013
Jul 24, 2021 *PED 
Pat. No. 7053092 5-HT1a receptor subtype agonist
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Jan 28, 2022U-839: Treatment of major depressive disorder (MDD)
Pat. No. 8642600 Method of treating autism
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 5, 2014
Jul 28, 2022 *PEDU-1492: Treatment of irritability associated with autistic disorder
Pat. No. 9359302 DS* DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate; Process; Product-by-process; Composition; Method of use; Kit; Formulation
Pat. Sub. Date(s): All strengths: Jun 30, 2016
Sep 25, 2022U-1859: Treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, adjunctive treatment of major depressive disorder, and treatment of irritability associated with autistic disorder
Pat. No. 8580796 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: None
Mar 25, 2023 *PED 
Pat. No. 8642760 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: Compound
Pat. Sub. Date(s): All strengths: Mar 5, 2014
Mar 25, 2023 *PED 
Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Aug 2, 2016
Dec 25, 2023U-1529: Adjunctive treatment of major depressive disorder (MDD)
Pat. No. 8017615 DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: Composition; Product-by-process; Process
Pat. Sub. Date(s): All strengths: None
Dec 16, 2024 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityDec 12, 2021ODE-80: Treatment of pediatric patients with Tourette's

ULTRAM (TABLET) (ORAL) TRAMADOL HYDROCHLORIDE [GENERIC AB]
Drug Classes: opioid agonist
NDA Applicant: JANSSEN PHARMS      NDA No.: 020281  Prod. No.: 002 RX (50MG) NDA No.: 020281  Prod. No.: 001 DISC (100MG)
PatentsExpirationPatented Use
Pat. No. 6339105 Analgesic regimen
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: None
Apr 12, 2020 *PEDU-435: A titration dosing regimen for the treatment of pain using an initial dose of about 25mg

DELZICOL (CAPSULE, DELAYED RELEASE) (ORAL) MESALAMINE
Drug Classes: aminosalicylate
NDA Applicant: APIL      NDA No.: 204412  Prod. No.: 001 RX (400MG)
PatentsExpirationPatented Use
Pat. No. 6649180 DP* Hard capsule formed of cellulose ether film with a specific content of methoxyl and hydroxypropoxyl groups
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 12, 2013
Apr 13, 2020 

GATTEX KIT (POWDER) (SUBCUTANEOUS) TEDUGLUTIDE RECOMBINANT
Drug Classes: glucagon-like peptide-2 (GLP-2) analog
NDA Applicant: NPS PHARMS INC      NDA No.: 203441  Prod. No.: 001 RX (5MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 5789379 DS* DP* [Extended 5 years]
Glucagon-like peptide-2 analogs
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Jan 18, 2013
Apr 14, 2020U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support
Pat. No. 7056886 DP* GLP-2 formulations
Claim Types: Formulation; Process; Kit; Method of use
Pat. Sub. Date(s): 001: Jan 18, 2013
Sep 18, 2022U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support
Pat. No. 7847061 Treatment of short bowel syndrome patients with colon-in-continuity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 18, 2013
Nov 1, 2025U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support
Pat. No. 9060992 Treatment of short bowel syndrome patients with colon-in-continuity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 17, 2015
Nov 1, 2025U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support
Pat. No. 9539310 Treatment of short bowel syndrome patients with colon-in-continuity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 11, 2017
Nov 1, 2025U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support
Pat. No. 9545434 Treatment of short bowel syndrome patients with colon-in-continuity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 19, 2017
Nov 1, 2025U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support
Pat. No. 9545435 Treatment of short bowel syndrome patients with colon-in-continuity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 19, 2017
Nov 1, 2025U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support
Pat. No. 9555079 Treatment of short bowel syndrome patients with colon-in-continuity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 2, 2017
Nov 1, 2025U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support
Pat. No. 9572867 Treatment of short bowel syndrome patients with colon-in-continuity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 22, 2017
Nov 1, 2025U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support
Pat. No. 9592273 Treatment of short bowel syndrome patients with colon-in-continuity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 27, 2017
Nov 1, 2025U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support
Pat. No. 9592274 Treatment of short bowel syndrome patients with colon-in-continuity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 27, 2017
Nov 1, 2025U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support
Pat. No. 9968655 Treatment of short bowel syndrome patients with colon-in-continuity
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 23, 2018
Nov 1, 2025U-2308: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support
Pat. No. 9968656 Treatment of short bowel syndrome patients with colon-in-continuity
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 23, 2018
Nov 1, 2025U-2308: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support
Pat. No. 9968658 Treatment of short bowel syndrome patients with colon-in-continuity
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 30, 2018
Nov 1, 2025U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support
Pat. No. 9974835 Treatment of short bowel syndrome patients with colon-in-continuity
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 30, 2018
Nov 1, 2025U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support
Pat. No. 9974837 Treatment of short bowel syndrome patients with colon-in-continuity
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 30, 2018
Nov 1, 2025U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support
Pat. No. 9981014 Treatment of short bowel syndrome patients with colon-in-continuity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 6, 2018
Nov 1, 2025U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support
Pat. No. 9981016 Treatment of short bowel syndrome patients with colon-in-continuity
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 30, 2018
Nov 1, 2025U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support
Pat. No. 9987334 Treatment of short bowel syndrome patients with colon-in-continuity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 6, 2018
Nov 1, 2025U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support
Pat. No. 9987335 Treatment of short bowel syndrome patients with colon-in-continuity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 29, 2018
Nov 1, 2025U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support
Pat. No. 9993528 Treatment of short bowel syndrome patients with colon-in-continuity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 29, 2018
Nov 1, 2025U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityDec 21, 2019ODE-37: Treatment of adult patients with short bowel syndrome (SBS) who are dependent on parenteral support

SAFYRAL (TABLET) (ORAL) DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM [GENERIC AB]
Drug Classes: progestin; estrogen
NDA Applicant: BAYER HLTHCARE      NDA No.: 022574  Prod. No.: 001 RX (3MG,N/A;0.03MG,N/A;0.451MG,0.451MG)
PatentsExpirationPatented Use
Pat. No. 6441168 DS* [Extended 834 days (2.3 years)]
Stable crystalline salts of 5-methyltetrahydrofolic acid
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: None
Apr 17, 2020 
Pat. No. 6958326 DP* Cyclodextrin-drospirenone inclusion complexes
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: None
Dec 20, 2021 
Pat. No. 7163931 Compositions of estrogen-cyclodextrin complexes
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Mar 3, 2022U-1: Prevention of pregnancy
Pat. No. 8617597 DP* Pharmaceutical composition containing a tetrahydrofolic acid
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 29, 2014
Feb 8, 2030 

VIAGRA (TABLET) (ORAL) SILDENAFIL CITRATE [GENERIC AB]
Drug Classes: phosphodiesterase-5 (PDE-5) inhibitor
NDA Applicant: PFIZER INC      NDA No.: 020895  Prod. No.: 001 RX (EQ 25MG BASE); 002 RX (EQ 50MG BASE); 003 RX (EQ 100MG BASE)
PatentsExpirationPatented Use
Pat. No. 6469012 Pyrazolopyrimidinones for the treatment of impotence
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Apr 22, 2020 *PEDU-155: Treatment of erectile dysfunction

GELNIQUE (GEL) (TRANSDERMAL) OXYBUTYNIN CHLORIDE [GENERIC AB]
Drug Classes: muscarinic antagonist
NDA Applicant: ALLERGAN SALES LLC      NDA No.: 022204  Prod. No.: 001 RX (10% (100MG/PACKET))
PatentsExpirationPatented Use
Pat. No. 7029694 DP* Compositions and methods for transdermal oxybutynin therapy
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: None
Apr 26, 2020U-318: Treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence
Pat. No. 7179483 Compositions and methods for transdermal oxybutynin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Apr 26, 2020U-318: Treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence
Pat. No. 8241662 Unoccluded topical oxybutynin gel composition and methods for transdermal oxybutynin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 22, 2012
Apr 26, 2020U-318: Treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence
Pat. No. 9259388 Method for treating overactive bladders and a device for storage and administration of topical oxybutynin compositions
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Mar 16, 2016
Nov 6, 2029U-1644: Treatment of overactive bladder by application of oxybutynin chloride gel to skin
Pat. No. 8920392 Method for treating overactive bladders and a device for storage and administration of topical oxybutynin compositions
Claim Types: Drug in a container; Method of use; Method of administration
Pat. Sub. Date(s): 001: Jan 27, 2015
Mar 26, 2031U-1644: Treatment of overactive bladder by application of oxybutynin chloride gel to skin

GELNIQUE 3% (GEL, METERED) (TRANSDERMAL) OXYBUTYNIN
Drug Classes: muscarinic antagonist
NDA Applicant: ALLERGAN SALES LLC      NDA No.: 202513  Prod. No.: 001 DISC (3%)
PatentsExpirationPatented Use
Pat. No. 7029694 DP* Compositions and methods for transdermal oxybutynin therapy
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Apr 27, 2012
Apr 26, 2020U-318: Treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence
Pat. No. 7179483 Compositions and methods for transdermal oxybutynin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 27, 2012
Apr 26, 2020U-318: Treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence
Pat. No. 8241662 Unoccluded topical oxybutynin gel composition and methods for transdermal oxybutynin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 23, 2012
Apr 26, 2020U-318: Treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence
Pat. No. 7198801 DP* Formulations for transdermal or transmucosal application
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 27, 2012
Jun 25, 2022 

OXYTROL (FILM, EXTENDED RELEASE) (TRANSDERMAL) OXYBUTYNIN
Drug Classes: muscarinic antagonist
NDA Applicant: ALLERGAN SALES LLC      NDA No.: 021351  Prod. No.: 002 RX (3.9MG/24HR)
PatentsExpirationPatented Use
Pat. No. 6743441 DP* Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy
Claim Types: Method of use; Device
Pat. Sub. Date(s): 002: None
Apr 26, 2020U-318: Treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence
Pat. No. 7081249 DP* Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 002: None
Apr 26, 2020U-318: Treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence
Pat. No. 7081250 DP* Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 002: None
Apr 26, 2020U-318: Treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence
Pat. No. 7081251 DP* Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 002: None
Apr 26, 2020U-318: Treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence
Pat. No. 7081252 DP* Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 002: None
Apr 26, 2020U-318: Treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence
Pat. No. 7179483 DS* DP* Compositions and methods for transdermal oxybutynin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 002: None
Apr 26, 2020U-318: Treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence

OXYTROL FOR WOMEN (FILM, EXTENDED RELEASE) (TRANSDERMAL) OXYBUTYNIN
Drug Classes: muscarinic antagonist
NDA Applicant: ALLERGAN SALES LLC      NDA No.: 202211  Prod. No.: 001 OTC (3.9MG/24HR)
PatentsExpirationPatented Use
Pat. No. 6743441 DP* Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy
Claim Types: Method of use; Device
Pat. Sub. Date(s): 001: None
Apr 26, 2020U-1329: Treatment of patients with an overactive bladder
Pat. No. 7081249 DP* Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: None
Apr 26, 2020U-1329: Treatment of patients with an overactive bladder
Pat. No. 7081250 DP* Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: None
Apr 26, 2020U-1329: Treatment of patients with an overactive bladder
Pat. No. 7081251 DP* Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: None
Apr 26, 2020U-1329: Treatment of patients with an overactive bladder
Pat. No. 7081252 DP* Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: None
Apr 26, 2020U-1329: Treatment of patients with an overactive bladder
Pat. No. 7179483 Compositions and methods for transdermal oxybutynin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Apr 26, 2020U-1329: Treatment of patients with an overactive bladder

MINIVELLE (FILM, EXTENDED RELEASE) (TRANSDERMAL) ESTRADIOL [GENERIC AB]
Drug Classes: estrogen
NDA Applicant: NOVEN      NDA No.: 203752  Prod. No.: 001 RX (0.0375MG/24HR); 002 RX (0.075MG/24HR); 003 RX (0.05MG/24HR); 004 RX (0.1MG/24HR)
PatentsExpirationPatented Use
Pat. No. 6841716 DP* Patch
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 27, 2012; 002: None; 003: None; 004: None
Apr 27, 2020 
Pat. No. 9730900 Transdermal estrogen device and delivery
Claim Types: Method of administration; Process
Pat. Sub. Date(s): All strengths: Aug 18, 2017
Jul 10, 2028U-2086: A method for administering estradiol comprising a monolithic transdermal drug delivery system consisting of (i) a backing layer and (ii) a single adhesive polymer matrix layer as claimed in US Patent No. 9730900
Pat. No. 9833419 DP* Transdermal estrogen device and delivery
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Dec 14, 2017
Jul 10, 2028 
Pat. No. 8231906 DS* DP* Transdermal estrogen device and delivery
Claim Types: Formulation; Method of administration; Process
Pat. Sub. Date(s): 001: Mar 22, 2013; 002: None; 003: None; 004: None
Jul 4, 2030 

MINIVELLE (FILM, EXTENDED RELEASE) (TRANSDERMAL) ESTRADIOL [GENERIC AB]
Drug Classes: estrogen
NDA Applicant: NOVEN      NDA No.: 203752  Prod. No.: 005 RX (0.025MG/24HR)
PatentsExpirationPatented Use
Pat. No. 6841716 DP* Patch
Claim Types: Formulation
Pat. Sub. Date(s): 005: May 8, 2015
Apr 27, 2020 
Pat. No. 9724310 DS* DP* Transdermal estrogen device and delivery
Claim Types: Formulation
Pat. Sub. Date(s): 005: Aug 18, 2017
Jul 10, 2028 
Pat. No. 9730900 DP* Transdermal estrogen device and delivery
Claim Types: Method of administration; Process
Pat. Sub. Date(s): 005: Aug 18, 2017
Jul 10, 2028U-2086: A method for administering estradiol comprising a monolithic transdermal drug delivery system consisting of (i) a backing layer and (ii) a single adhesive polymer matrix layer as claimed in US Patent No. 9730900
Pat. No. 9833419 DP* Transdermal estrogen device and delivery
Claim Types: Formulation
Pat. Sub. Date(s): 005: Dec 14, 2017
Jul 10, 2028 
Pat. No. 8231906 DS* DP* Transdermal estrogen device and delivery
Claim Types: Formulation; Method of administration; Process
Pat. Sub. Date(s): 005: May 8, 2015
Jul 4, 2030 

MUCINEX (TABLET, EXTENDED RELEASE) (ORAL) GUAIFENESIN [GENERIC OTC]
NDA Applicant: RB HLTH      NDA No.: 021282  Prod. No.: 001 OTC (600MG); 002 OTC (1.2GM)
PatentsExpirationPatented Use
Pat. No. 6372252 Guaifenesin sustained release formulation and tablets
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Apr 28, 2020U-489: Expectorant
Pat. No. 6955821 DP* Sustained release formulations of guaifenesin and additional drug ingredients
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Apr 28, 2020U-489: Expectorant
Pat. No. 7838032 DP* Sustained release of guaifenesin
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 21, 2010; 002: None
Apr 28, 2020 

MUCINEX D (TABLET, EXTENDED RELEASE) (ORAL) GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE [GENERIC OTC]
Drug Classes: alpha adrenergic agonist
NDA Applicant: RB HLTH      NDA No.: 021585  Prod. No.: 001 OTC (600MG;60MG); 002 OTC (1.2GM;120MG)
PatentsExpirationPatented Use
Pat. No. 6372252 DP* Guaifenesin sustained release formulation and tablets
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Apr 28, 2020 
Pat. No. 6955821 DP* Sustained release formulations of guaifenesin and additional drug ingredients
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Apr 28, 2020U-686: Expectorant and nasal decongestant
Pat. No. 7838032 DP* Sustained release of guaifenesin
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 21, 2010; 002: None
Apr 28, 2020 

MUCINEX DM (TABLET, EXTENDED RELEASE) (ORAL) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN [GENERIC OTC]
Drug Classes: sigma-1 agonist; uncompetitive NMDA receptor antagonist
NDA Applicant: RB HLTH      NDA No.: 021620  Prod. No.: 001 OTC (60MG;1.2GM); 002 OTC (30MG;600MG)
PatentsExpirationPatented Use
Pat. No. 6372252 DP* Guaifenesin sustained release formulation and tablets
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Apr 28, 2020 
Pat. No. 6955821 DP* Sustained release formulations of guaifenesin and additional drug ingredients
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Apr 28, 2020U-685: Expectorant and cough suppressant
Pat. No. 7838032 DP* Sustained release of guaifenesin
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 21, 2010; 002: None
Apr 28, 2020 

ABLAVAR (SOLUTION) (INTRAVENOUS) GADOFOSVESET TRISODIUM
Drug Classes: paramagnetic contrast agent
NDA Applicant: LANTHEUS MEDCL      NDA No.: 021711  Prod. No.: 001 DISC (2440MG/10ML (244MG/ML)); 002 DISC (3660MG/15ML (244MG/ML))
PatentsExpirationPatented Use
Pat. No. 6676929 DP* [Extended 1805 days (4.9 years)]
Diagnostic imaging contrast agents with extended blood retention
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: None
May 4, 2020 

INSPRA (TABLET) (ORAL) EPLERENONE [GENERIC AB]
Drug Classes: aldosterone antagonist
NDA Applicant: SEARLE, GD LLC      NDA No.: 021437  Prod. No.: 001 RX (25MG); 002 RX (50MG) NDA No.: 021437  Prod. No.: 003 DISC (100MG)
PatentsExpirationPatented Use
Pat. No. 6410524 Combination therapy of angiotensin converting enzyme inhibitor and aldosterone antagonist for reducing morbidity and mortality from cardiovascular disease
Claim Types: Composition; Method of use
Pat. Sub. Date(s): All strengths: None
May 5, 2020 *PEDU-467: Use of eplerenone in combination with an angiotensin converting enzyme (ACE) inhibitor for treating hypertension
Pat. No. 6747020 Methods of treating heart failure and hypertension using combinations of eplerenone and an angiotensin converting enzyme inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
May 5, 2020 *PEDU-587: Use of eplerenone in combination with an angiotensin converting enzyme (ACE) inhibitor (and optionally a diuretic) for treating congestive heart failure and hypertension
Pat. No. 6410054 Immediate release eplerenone compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Jun 8, 2020 *PEDU-3: Treatment of hypertension
U-537: Treatment of conditions related to hyperaldosteronism such as hypertension and cardiac insufficiency, with eplerenone
Pat. No. 6495165 Eplerenone compositions having improved bioavailability
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Jun 8, 2020 *PEDU-3: Treatment of hypertension
U-537: Treatment of conditions related to hyperaldosteronism such as hypertension and cardiac insufficiency, with eplerenone
Pat. No. 6534093 Immediate release eplerenone compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Jun 8, 2020 *PEDU-3: Treatment of hypertension
U-537: Treatment of conditions related to hyperaldosteronism such as hypertension and cardiac insufficiency, with eplerenone
Pat. No. 6558707 DP* Immediate release eplerenone compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Jun 8, 2020 *PEDU-537: Treatment of conditions related to hyperaldosteronism such as hypertension and cardiac insufficiency, with eplerenone
Pat. No. 7157101 DP* Micronized eplerenone compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Jun 8, 2020 *PEDU-664: Treatment of conditions for which an aldosterone receptor blocker is indicated, such as hypertension, heart failure, and post-myocardial infarction

CHANTIX (TABLET) (ORAL) VARENICLINE TARTRATE
Drug Classes: nicotinic receptor partial agonist
NDA Applicant: PF PRISM CV      NDA No.: 021928  Prod. No.: 001 RX (EQ 0.5MG BASE); 002 RX (EQ 1MG BASE)
PatentsExpirationPatented Use
Pat. No. 6410550 DS* DP* [Extended 544 days (1.5 years)]
Aryl fused azapolycyclic compounds
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: None
May 10, 2020U-56: Aid to smoking cessation
Pat. No. 6890927 DS* DP* Tartrate salts of 5,8, 14-triazateracyclo[10.3.1.02,11 04.9]-hexadeca-2(11),3,5,7,9-pentaene and pharmaceutical compositions thereof
Claim Types: Compound; Composition; Method of use; Process
Pat. Sub. Date(s): All strengths: None
May 6, 2022U-56: Aid to smoking cessation
Pat. No. 7265119 DS* DP* Tartrate salts of 5,8,14-triazatetracyclo[10.3.1.0.sup.2,11.0.sup.4.9]-hexadeca-2(11),3,5,7- ,9-pentaene and pharmaceutical compositions thereof
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Pat. Sub. Date(s): All strengths: None
Aug 3, 2022U-56: Aid to smoking cessation
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousAug 12, 2019M-183: Changes to the dosage and administration and clinical studies sections of the labeling to support the reduce-to-quit paradigm
Exclusivity Code: M - MiscellaneousDec 16, 2019M-192: Provides for data evaluating the neuropsychiatric safety and efficacy of varenicline for smoking cessation in subjects with and without a history of psychiatric disorders

LUVOX CR (CAPSULE, EXTENDED RELEASE) (ORAL) FLUVOXAMINE MALEATE [Has competitive generic]
Drug Classes: selective serotonin reuptake inhibitor (SSRI)
NDA Applicant: JAZZ PHARMS      NDA No.: 022033  Prod. No.: 001 DISC (100MG); 002 DISC (150MG)
PatentsExpirationPatented Use
Pat. No. 7465462 DP* Multiparticulate controlled release selective serotonin reuptake inhibitor formulations
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
May 10, 2020U-929: Treatment of obsessive compulsive disorder treatable with an ssri

TOBI PODHALER (POWDER) (INHALATION) TOBRAMYCIN
Drug Classes: aminoglycoside antibacterial
NDA Applicant: MYLAN SPECIALITY LP      NDA No.: 201688  Prod. No.: 001 RX (28MG)
PatentsExpirationPatented Use
Pat. No. 7442388 DP* Phospholipid-based powders for drug delivery
Claim Types: Formulation; Method of administration; Process
Pat. Sub. Date(s): 001: Apr 19, 2013
May 10, 2020 
Pat. No. 8349294 DP* Stable metal ion-lipid powdered pharmaceutical compositions for drug delivery and methods of use
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 19, 2013
May 10, 2020 
Pat. No. 7368102 DP* Pulmonary delivery of aminoglycosides
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): 001: Apr 19, 2013
Dec 19, 2022U-909: Treatment of cystic fibrosis patients with pseudomonas aeruginosa
Pat. No. 8715623 DP* Pulmonary delivery of aminoglycoside
Claim Types: Formulation; Method of use; Method of administration
Pat. Sub. Date(s): 001: Oct 20, 2014
Dec 19, 2022U-909: Treatment of cystic fibrosis patients with pseudomonas aeruginosa
Pat. No. 7516741 DP* Aerosolization apparatus with feedback mechanism
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Apr 19, 2013
Jan 11, 2024 
Pat. No. 8069851 DP* Aeorosolization apparatus with air inlet shield
Claim Types: Device
Pat. Sub. Date(s): 001: Apr 19, 2013
Sep 24, 2024 
Pat. No. 7559325 DP* Aerosolization apparatus with air inlet shield
Claim Types: Device
Pat. Sub. Date(s): 001: Apr 19, 2013
Oct 27, 2025 

LYMPHOSEEK KIT (INJECTABLE) (INJECTION) TECHNETIUM TC-99M TILMANOCEPT
NDA Applicant: CARDINAL HEALTH 414      NDA No.: 202207  Prod. No.: 001 RX (N/A)
PatentsExpirationPatented Use
Pat. No. 6409990 DS* Macromolecular carrier for drug and diagnostic agent delivery
Claim Types: Compound; Process; Formulation
Pat. Sub. Date(s): 001: None
May 12, 2020 
Pat. No. 9439985 DS* DP* Compositions for radiolabeling diethylenetriaminepentaacetic acid (DTPA)-dextran
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 14, 2016
Sep 27, 2033 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMar 13, 2018 
Exclusivity Code: ODE - Orphan drug exclusivityJun 13, 2021ODE-67: Guiding sentinel lymph node biopsy, using a hand-held gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity

DEPO-SUBQ PROVERA 104 (INJECTABLE) (SUBCUTANEOUS) MEDROXYPROGESTERONE ACETATE
Drug Classes: progestin
NDA Applicant: PHARMACIA AND UPJOHN      NDA No.: 021583  Prod. No.: 001 RX (104MG/0.65ML)
PatentsExpirationPatented Use
Pat. No. 6495534 DP* Stabilized aqueous suspensions for parenteral use
Claim Types: Composition; Process; Formulation
Pat. Sub. Date(s): 001: None
May 15, 2020 

FORTOVASE (CAPSULE) (ORAL) SAQUINAVIR
Drug Classes: HIV protease inhibitor
NDA Applicant: HOFFMANN LA ROCHE      NDA No.: 020828  Prod. No.: 001 DISC (200MG**)
PatentsExpirationPatented Use
Pat. No. 6352717 Process for encapsulating shear sensitive fill masses into capsules and capsules containing shear sensitive fill masses
Claim Types: Formulation; Process; Product-by-process
Pat. Sub. Date(s): 001: None
May 16, 2020 *PED 

SAMSCA (TABLET) (ORAL) TOLVAPTAN
Drug Classes: vasopressin V2-receptor antagonist
NDA Applicant: OTSUKA AMERICA PHARM      NDA No.: 022275  Prod. No.: 001 RX (15MG); 002 RX (30MG) NDA No.: 022275  Prod. No.: 003 DISC (60MG**)
PatentsExpirationPatented Use
Pat. No. 5753677 [Extended 5 years]
Benzoheterocyclic compounds
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
May 19, 2020U-978: Method of treating hyponatremia
Pat. No. 8501730 DS* Process for preparing benzazepine compounds or salts thereof
Claim Types: Product-by-process
Pat. Sub. Date(s): All strengths: Sep 27, 2013
Sep 1, 2026 

DULERA (AEROSOL, METERED) (INHALATION) FORMOTEROL FUMARATE; MOMETASONE FUROATE
Drug Classes: beta-2 adrenergic agonist; corticosteroid
NDA Applicant: MERCK SHARP DOHME      NDA No.: 022518  Prod. No.: 001 RX (0.005MG/INH;0.1MG/INH); 002 RX (0.005MG/INH;0.2MG/INH)
PatentsExpirationPatented Use
Pat. No. 7067502 DP* Combinations of formoterol and mometasone furoate for asthma
Claim Types: Formulation; Method of use; Kit
Pat. Sub. Date(s): All strengths: None
May 21, 2020U-1068: Treatment of asthma
Pat. No. 7566705 DP* Combination of formoterol and mometasone furoate for asthma
Claim Types: Formulation; Kit
Pat. Sub. Date(s): All strengths: None
May 21, 2020U-1068: Treatment of asthma
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousDec 20, 2020M-214: Information added to the clinical trials section of the labeling regarding a postmarketing safety and efficacy study evaluating the risk of serious asthma-related events

ATROVENT HFA (AEROSOL, METERED) (INHALATION) IPRATROPIUM BROMIDE
Drug Classes: anticholinergic
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 021527  Prod. No.: 001 RX (0.021MG/INH)
PatentsExpirationPatented Use
Pat. No. 6739333 DP* Stainless steel canister for propellant-driven metering aerosols
Claim Types: Device
Pat. Sub. Date(s): 001: None
May 26, 2020 
Pat. No. 6983743 DP* Stainless steel canister for propellant-driven metering aerosols
Claim Types: Device
Pat. Sub. Date(s): 001: None
May 26, 2020 
Pat. No. 8474447 DP* Inhaler device
Claim Types: Device
Pat. Sub. Date(s): 001: May 28, 2015
Jan 17, 2030 

EGRIFTA (POWDER) (SUBCUTANEOUS) TESAMORELIN ACETATE
Drug Classes: growth hormone releasing factor (GRG) analog
NDA Applicant: THERATECHNOLOGIES      NDA No.: 022505  Prod. No.: 001 RX (EQ 1MG BASE/VIAL)
PatentsExpirationPatented Use
Pat. No. 5861379 DS* DP* [Extended 5 years]
Chimeric fatty body-pro-GRF analogs with increased biological potency
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: None
May 26, 2020U-1100: Reduction of excess abdominal fat in HIV-infected patients with lipodystrophy
Pat. No. 7144577 Treatment of HIV-associated dysmorphia/dysmetabolic syndrome (HADDS) with or without lipodystrophy
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Jul 14, 2020U-1100: Reduction of excess abdominal fat in HIV-infected patients with lipodystrophy
Pat. No. 7316997 GH secretagogues and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Aug 14, 2023U-1100: Reduction of excess abdominal fat in HIV-infected patients with lipodystrophy

VARITHENA (SOLUTION) (INTRAVENOUS) POLIDOCANOL
Drug Classes: sclerosing agent
NDA Applicant: PROVENSIS      NDA No.: 205098  Prod. No.: 001 RX (180MG/18ML (10MG/ML))
PatentsExpirationPatented Use
Pat. No. 6572873 Generation of therapeutic microfoam
Claim Types: Process
Pat. Sub. Date(s): 001: None
May 26, 2020U-1461: A method of generating an injectable foam of controlled density and bubble size
Pat. No. 6942165 DP* Generation of therapeutic microfoam
Claim Types: Device
Pat. Sub. Date(s): 001: None
May 26, 2020 
Pat. No. 7025290 DP* Generation of therapeutic microfoam
Claim Types: Device; Process
Pat. Sub. Date(s): 001: None
May 26, 2020U-1461: A method of generating an injectable foam of controlled density and bubble size
Pat. No. 7357336 Generation of therapeutic microfoam
Claim Types: Process
Pat. Sub. Date(s): 001: None
May 26, 2020U-1461: A method of generating an injectable foam of controlled density and bubble size
Pat. No. 7604185 DS* DP* Generation of therapeutic microfoam
Claim Types: Composition; Method of use
Pat. Sub. Date(s): 001: None
May 26, 2020U-1462: A method of using a sclerosing agent for the treatment of incompetent great saphenous veins, accessory saphenous veins and visible varicosities of the great saphenous (GSV) system above and below the knee
Pat. No. 7842282 Generation of therapeutic microfoam
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
May 26, 2020U-1461: A method of generating an injectable foam of controlled density and bubble size
Pat. No. 7842283 DP* Generation of therapeutic microfoam
Claim Types: Device
Pat. Sub. Date(s): 001: None
May 26, 2020 
Pat. No. 8323677 DS* Therapeutic foam
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
May 26, 2020 
Pat. No. 8734833 DS* DP* Therapeutic foam
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 19, 2014
May 26, 2020 
Pat. No. 6846412 DP* Combination filter assembly
Claim Types: Device; Process
Pat. Sub. Date(s): 001: None
Jul 19, 2022 
Pat. No. 8122917 DP* Apparatus and method for dispensing foam
Claim Types: Device; Kit
Pat. Sub. Date(s): 001: None
Sep 9, 2024 
Pat. No. 7731986 DS* DP* Therapeutic foam
Claim Types: Formulation; Drug in a container; Device; Process; Method of use
Pat. Sub. Date(s): 001: None
Nov 17, 2024U-1463: A method of intravenous injection using ultrasound guidance, administered via a single cannula into the lumen of the target incompetent trunk veins or by direct injection into varicosities
Pat. No. 7814943 DP* Apparatus and method for dispensing foam
Claim Types: Device; Kit; Method of use
Pat. Sub. Date(s): 001: None
Nov 19, 2027U-1461: A method of generating an injectable foam of controlled density and bubble size
Pat. No. 9480652 DP* Aerosol valve
Claim Types: Device; Process
Pat. Sub. Date(s): 001: Nov 30, 2016
May 12, 2032 

AMBIEN CR (TABLET, EXTENDED RELEASE) (ORAL) ZOLPIDEM TARTRATE [GENERIC AB]
Drug Classes: gamma-aminobutyric acid (GABA) A agonist
NDA Applicant: SANOFI AVENTIS US      NDA No.: 021774  Prod. No.: 001 RX (12.5MG); 002 RX (6.25MG)
PatentsExpirationPatented Use
Pat. No. 6514531 DP* Controlled-release dosage forms comprising zolpidem or a salt thereof
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Jun 1, 2020 *PED 

ARCAPTA NEOHALER (POWDER) (INHALATION) INDACATEROL MALEATE
Drug Classes: beta2-adrenergic agonist
NDA Applicant: SUNOVION PHARMS INC      NDA No.: 022383  Prod. No.: 001 RX (EQ 75MCG BASE)
PatentsExpirationPatented Use
Pat. No. 8067437 Beta-2-adrenoreceptor agonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 26, 2013
Jun 2, 2020U-1168: The long term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema
Pat. No. 8658673 DS* DP* BETA2-adrenoreceptor agonists
Claim Types: Composition; Method of use; Formulation
Pat. Sub. Date(s): 001: Jul 28, 2015
Jun 2, 2020U-1168: The long term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema
Pat. No. 8796307 DS* DP* Beta2-adrenoreceptor agonists
Claim Types: Composition
Pat. Sub. Date(s): 001: Dec 9, 2015
Jun 2, 2020 
Pat. No. 6878721 DS* DP* [Extended 1599 days (4.4 years)]
Beta2-adrenoceptor agonists
Claim Types: Compound; Composition; Method of use; Process
Pat. Sub. Date(s): 001: None
Feb 25, 2025U-1168: The long term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema
Pat. No. 8479730 DP* Inhaler device
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 6, 2013
Oct 11, 2028 

UTIBRON (POWDER) (INHALATION) GLYCOPYRROLATE ; INDACATEROL MALEATE
Drug Classes: anticholinergic; beta2-adrenergic agonist
NDA Applicant: SUNOVION PHARMS INC      NDA No.: 207930  Prod. No.: 001 RX (15.6MCG/INH;27.5MCG/INH)
PatentsExpirationPatented Use
Pat. No. 7820694 DP* Beta-2-adrenoreceptor agonists
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Dec 4, 2015
Jun 2, 2020U-1773: Long - term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD)
Pat. No. 8067437 Beta-2-adrenoreceptor agonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 4, 2015
Jun 2, 2020U-1773: Long - term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD)
Pat. No. 8283362 DP* Beta-2-adrenoreceptor agonists
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Dec 4, 2015
Jun 2, 2020U-1773: Long - term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD)
Pat. No. 8658673 DP* BETA2-adrenoreceptor agonists
Claim Types: Composition; Method of use; Formulation
Pat. Sub. Date(s): 001: Dec 4, 2015
Jun 2, 2020U-1773: Long - term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD)
Pat. No. 8796307 DP* Beta2-adrenoreceptor agonists
Claim Types: Composition
Pat. Sub. Date(s): 001: Dec 4, 2015
Jun 2, 2020 
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. 6878721 DS* DP* [Extended 1599 days (4.4 years)]
Beta2-adrenoceptor agonists
Claim Types: Compound; Composition; Method of use; Process
Pat. Sub. Date(s): 001: Dec 4, 2015
Feb 25, 2025U-1773: Long - term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD)
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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productOct 29, 2018 

LIALDA (TABLET, DELAYED RELEASE) (ORAL) MESALAMINE [GENERIC AB]
Drug Classes: aminosalicylate
NDA Applicant: SHIRE      NDA No.: 022000  Prod. No.: 001 RX (1.2GM)
PatentsExpirationPatented Use
Pat. No. 6773720 DP* Mesalazine controlled release oral pharmaceutical compositions
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: None
Jun 8, 2020 

UCERIS (TABLET, EXTENDED RELEASE) (ORAL) BUDESONIDE [GENERIC AB]
Drug Classes: corticosteroid
NDA Applicant: VALEANT PHARMS INTL      NDA No.: 203634  Prod. No.: 001 RX (9MG)
PatentsExpirationPatented Use
Pat. No. RE43799 DP* Controlled release and taste masking oral pharmaceutical composition
Claim Types: Composition; Method of use
Pat. Sub. Date(s): 001: Jan 18, 2013
Jun 9, 2020U-1325: Induction of remission in patients with active, mild to moderate ulcerative colitis
Pat. No. 7410651 DP* Controlled release and taste masking oral pharmaceutical composition
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jan 18, 2013
Jun 9, 2020U-1325: Induction of remission in patients with active, mild to moderate ulcerative colitis
Pat. No. 7431943 DP* Controlled release and taste masking oral pharmaceutical compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 18, 2013
Jun 9, 2020 
Pat. No. 8293273 DP* Controlled release and taste masking oral pharmaceutical composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 18, 2013
Jun 9, 2020 
Pat. No. 8784888 DP* Controlled release and taste masking oral pharmaceutical composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 28, 2014
Jun 9, 2020 
Pat. No. 9320716 DP* Controlled release and taste masking oral pharmaceutical compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: May 5, 2016
Jun 9, 2020U-1325: Induction of remission in patients with active, mild to moderate ulcerative colitis
Pat. No. 9532954 DP* Controlled release and taste masking oral pharmaceutical compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jan 20, 2017
Jun 9, 2020U-1325: Induction of remission in patients with active, mild to moderate ulcerative colitis
Pat. No. 10064878 DP* Controlled release and taste masking oral pharmaceutical compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 24, 2018
Jun 9, 2020U-1325: Induction of remission in patients with active, mild to moderate ulcerative colitis
Pat. No. 10105374 DP* Controlled release and taste masking oral pharmaceutical compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 9, 2018
Jun 9, 2020U-1325: Induction of remission in patients with active, mild to moderate ulcerative colitis
Pat. No. 8895064 DP* Controlled release and taste masking oral pharmaceutical composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 25, 2014
Sep 7, 2031 
Pat. No. 9132093 DP* Controlled release and taste making oral pharmaceutical composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 16, 2015
Sep 7, 2031 
Pat. No. 9192581 DP* Controlled release and taste masking oral pharmaceutical composition
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Dec 3, 2015
Sep 7, 2031U-1325: Induction of remission in patients with active, mild to moderate ulcerative colitis

QSYMIA (CAPSULE, EXTENDED RELEASE) (ORAL) PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
Drug Classes: sympathomimetic amine anorectic
NDA Applicant: VIVUS      NDA No.: 022580  Prod. No.: 001 RX (EQ 3.75MG BASE;23MG); 002 RX (EQ 7.5MG BASE;46MG); 003 RX (EQ 11.25MG BASE;69MG); 004 RX (EQ 15MG BASE;92MG)
PatentsExpirationPatented Use
Pat. No. 7056890 DP* Combination therapy for effecting weight loss and treating obesity
Claim Types: Formulation; Method of use; Kit
Pat. Sub. Date(s): 001: Aug 16, 2012; 002: None; 003: None; 004: None
Jun 14, 2020U-1262: Use of QSYMIA (phentermine and topiramate) for weight management, including, but not limited to effecting weight loss, treating obesity, and/or treating overweight
Pat. No. 7553818 Combination therapy for effecting weight loss and treating obesity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 16, 2012; 002: None; 003: None; 004: None
Jun 14, 2020U-1262: Use of QSYMIA (phentermine and topiramate) for weight management, including, but not limited to effecting weight loss, treating obesity, and/or treating overweight
Pat. No. 7659256 DP* Combination therapy for effecting weight loss and treating obesity
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Aug 16, 2012; 002: None; 003: None; 004: None
Jun 14, 2020U-1262: Use of QSYMIA (phentermine and topiramate) for weight management, including, but not limited to effecting weight loss, treating obesity, and/or treating overweight
Pat. No. 7674776 DP* Combination therapy for effecting weight loss and treating obesity
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 16, 2012; 002: None; 003: None; 004: None
Jun 14, 2020U-1262: Use of QSYMIA (phentermine and topiramate) for weight management, including, but not limited to effecting weight loss, treating obesity, and/or treating overweight
Pat. No. 8895057 Escalating dosing regimen for effecting weight loss and treating obesity
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Dec 18, 2014
Jun 9, 2028U-1262: Use of QSYMIA (phentermine and topiramate) for weight management, including, but not limited to effecting weight loss, treating obesity, and/or treating overweight
Pat. No. 8895058 DP* Low dose topiramate/phentermine composition and methods of use thereof
Claim Types: Formulation; Drug in a container
Pat. Sub. Date(s): All strengths: Dec 18, 2014
Jun 9, 2028 
Pat. No. 9011905 DP* Low dose topiramate/phentermine composition and methods of use thereof
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 13, 2015
Jun 9, 2028 
Pat. No. 9011906 Escalating dosing regimen for effecting weight loss and treating obesity
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): All strengths: May 13, 2015
Jun 9, 2028U-1262: Use of QSYMIA (phentermine and topiramate) for weight management, including, but not limited to effecting weight loss, treating obesity, and/or treating overweight
Pat. No. 8580298 DP* Low dose topiramate/phentermine composition and methods of use thereof
Claim Types: Formulation; Drug in a container
Pat. Sub. Date(s): 001: Nov 14, 2013; 002: None; 003: None; 004: None
May 15, 2029 
Pat. No. 8580299 Escalating dosing regimen for effecting weight loss and treating obesity
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Nov 14, 2013; 002: None; 003: None; 004: None
Jun 14, 2029U-1262: Use of QSYMIA (phentermine and topiramate) for weight management, including, but not limited to effecting weight loss, treating obesity, and/or treating overweight

DEXILANT (CAPSULE, DELAYED RELEASE) (ORAL) DEXLANSOPRAZOLE [GENERIC AB]
Drug Classes: proton pump inhibitor
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 022287  Prod. No.: 001 RX (30MG); 002 RX (60MG)
PatentsExpirationPatented Use
Pat. No. 9145389 DS* DP* Benzimidazole compound crystal
Claim Types: New polymorph, salt or hydrate; Product-by-process; Composition
Pat. Sub. Date(s): All strengths: Oct 27, 2015
Jun 15, 2020 
Pat. No. 6462058 DS* DP* Benzimidazole compound crystal
Claim Types: New polymorph, salt or hydrate; Composition; Process; Method of use
Pat. Sub. Date(s): All strengths: None
Dec 15, 2020 *PEDU-949: Healing of all grades of erosive esophagitis (EE) for up to 8 weeks
U-950: Maintain healing of erosive esophagitis (EE) for up to 6 months
U-951: Treatment of heartburn associated with non-erosive gastroesophageal reflux disease (GERD) for 4 weeks
Pat. No. 6939971 Benzimidazole compound crystal
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Dec 15, 2020 *PEDU-949: Healing of all grades of erosive esophagitis (EE) for up to 8 weeks
U-950: Maintain healing of erosive esophagitis (EE) for up to 6 months
U-951: Treatment of heartburn associated with non-erosive gastroesophageal reflux disease (GERD) for 4 weeks
Pat. No. 7285668 DS* Process for the crystallization of (R)- or (S)-lansoprazole
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): All strengths: None
Dec 15, 2020 *PED 
Pat. No. 6664276 DS* DP* [Extended 959 days (2.6 years)]
Benzimidazole compound crystal
Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process
Pat. Sub. Date(s): All strengths: None
Jul 30, 2023 *PEDU-1507: To maintain healing of EE and relief of heartburn
U-949: Healing of all grades of erosive esophagitis (EE) for up to 8 weeks
U-950: Maintain healing of erosive esophagitis (EE) for up to 6 months
U-951: Treatment of heartburn associated with non-erosive gastroesophageal reflux disease (GERD) for 4 weeks
Pat. No. 8722084 DP* Controlled release preparation
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jun 9, 2014
Apr 15, 2024 *PED 
Pat. No. 8784885 DP* Controlled release preparation
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Aug 19, 2014
Apr 15, 2024 *PEDU-1552: For healing of all grades of erosive esophagitis (EE)
U-1553: To maintain healing of EE and relief of heartburn
U-1554: For the treatment of heartburn associated with symptomatic non-erosive gastroesophageal disease (GERD)
Pat. No. 9238029 DP* Multiple PPI dosage form
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 11, 2016
Jan 17, 2026 
Pat. No. 9011926 DP* Method for producing granules
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): All strengths: May 1, 2015
Feb 24, 2026 
Pat. No. 8461187 DP* Multiple PPI dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Jul 17, 2026 *PED 
Pat. No. 7790755 DP* Controlled release preparation
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 29, 2010; 002: None
Feb 2, 2027 *PED 
Pat. No. 8105626 DP* Granules containing acid-unstable chemical in large amount
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 28, 2012; 002: None
Mar 27, 2027 *PED 
Pat. No. 8871273 DP* Method for producing granules
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Dec 1, 2014
Jan 11, 2028 
Pat. No. 8173158 Methods of treating gastrointestinal disorders independent of the intake of food
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 1, 2012; 002: None
Sep 17, 2030 *PEDU-949: Healing of all grades of erosive esophagitis (EE) for up to 8 weeks
U-950: Maintain healing of erosive esophagitis (EE) for up to 6 months
U-951: Treatment of heartburn associated with non-erosive gastroesophageal reflux disease (GERD) for 4 weeks
Pat. No. 9233103 Methods for treating heartburn, gastric bleeding or hemorrhage in patients receiving clopidogrel therapy
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 11, 2016
Mar 5, 2032U-1805: Use of dexlansoprazole in patients taking clopidogrel without meaningful cyp2c19 interactions
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationJul 8, 2019 

GLUMETZA (TABLET, EXTENDED RELEASE) (ORAL) METFORMIN HYDROCHLORIDE [GENERIC AB3]
Drug Classes: biguanide
NDA Applicant: SANTARUS INC      NDA No.: 021748  Prod. No.: 001 RX (500MG)
PatentsExpirationPatented Use
Pat. No. 6488962 DS* DP* Tablet shapes to enhance gastric retention of swellable controlled-release oral dosage forms
Claim Types: Composition
Pat. Sub. Date(s): 001: None
Jun 20, 2020 
Pat. No. 6723340 DS* DP* Optimal polymer mixtures for gastric retentive tablets
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Oct 25, 2021 

GRALISE (TABLET) (ORAL) GABAPENTIN [Has competitive generic]
Drug Classes: antiepileptic drug (AED)
NDA Applicant: ASSERTIO      NDA No.: 022544  Prod. No.: 001 RX (300MG); 002 RX (600MG)
PatentsExpirationPatented Use
Pat. No. 6488962 DP* Tablet shapes to enhance gastric retention of swellable controlled-release oral dosage forms
Claim Types: Composition
Pat. Sub. Date(s): 001: Mar 28, 2011; 002: None
Jun 20, 2020 
Pat. No. 6723340 DP* Optimal polymer mixtures for gastric retentive tablets
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 28, 2011; 002: None
Oct 25, 2021 
Pat. No. 7731989 DP* Gastric retained gabapentin dosage form
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 28, 2011; 002: None
Oct 25, 2022 
Pat. No. 8192756 DP* Gastric retained gabapentin dosage form
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): All strengths: Jun 8, 2012
Oct 25, 2022U-1114: Treatment with gabapentin, including treatment of neuropathic pain, including neuropathic pain associated with postherpetic neuralgia
Pat. No. 8252332 DP* Gastric retained gabapentin dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 17, 2012; 002: None
Oct 25, 2022U-1114: Treatment with gabapentin, including treatment of neuropathic pain, including neuropathic pain associated with postherpetic neuralgia
Pat. No. 8333992 DP* Gastric retained gabapentin dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jan 17, 2013; 002: None
Oct 25, 2022U-1114: Treatment with gabapentin, including treatment of neuropathic pain, including neuropathic pain associated with postherpetic neuralgia
Pat. No. 7438927 Methods of treatment using a gastric retained gabapentin dosage
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 28, 2011; 002: None
Feb 26, 2024U-1114: Treatment with gabapentin, including treatment of neuropathic pain, including neuropathic pain associated with postherpetic neuralgia
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityJan 28, 2018ODE-6: For the management of postherpetic neuralgia

PROQUIN XR (TABLET, EXTENDED RELEASE) (ORAL) CIPROFLOXACIN HYDROCHLORIDE
Drug Classes: quinolone antimicrobial
NDA Applicant: DEPOMED INC      NDA No.: 021744  Prod. No.: 001 DISC (EQ 500MG BASE)
PatentsExpirationPatented Use
Pat. No. 6488962 DP* Tablet shapes to enhance gastric retention of swellable controlled-release oral dosage forms
Claim Types: Composition
Pat. Sub. Date(s): 001: None
Jun 20, 2020 

SYNJARDY XR (TABLET, EXTENDED RELEASE) (ORAL) EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor; biguanide
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 208658  Prod. No.: 001 RX (5MG;1GM); 002 RX (10MG;1GM); 003 RX (12.5MG;1GM); 004 RX (25MG;1GM)
PatentsExpirationPatented Use
Pat. No. 6488962 DP* Tablet shapes to enhance gastric retention of swellable controlled-release oral dosage forms
Claim Types: Composition
Pat. Sub. Date(s): All strengths: Jan 4, 2017
Jun 20, 2020 
Pat. No. 7579449 DS* Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture
Claim Types: Compound
Pat. Sub. Date(s): All strengths: Jan 4, 2017
Nov 5, 2025 
Pat. No. 7713938 DS* DP* Crystalline form of 1-chloro-4-(.beta.-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy- )-benzyl]-benzene, a method for its preparation and the use thereof for
Claim Types: New polymorph, salt or hydrate; Composition; Process
Pat. Sub. Date(s): All strengths: Jan 4, 2017
Apr 15, 2027 
Pat. No. 9949998 Pharmaceutical composition, methods for treating and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: May 16, 2018
Jun 11, 2034U-2290: Method of treating Type 2 diabetes mellitus in a patient with renal impairment (45 ml/min/1.73 m2<=EGFR<60 ml/min/1.73 m2) by once daily administration of 10 mg or 25 mg of empagliflozin
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationDec 2, 2019I-739: To reduce the risk of cardiovascular death in adult patients with Type 2 diabetes mellitus and established cardiovascular disease
Exclusivity Code: NCE - New chemical entityAug 1, 2019 

XARTEMIS XR (TABLET, EXTENDED RELEASE) (ORAL) ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Drug Classes: antidote for acetaminophen overdose; mucolytic antidote for acetaminophen overdose; opioid agonist
NDA Applicant: MALLINCKRODT INC      NDA No.: 204031  Prod. No.: 001 DISC (325MG;7.5MG)
PatentsExpirationPatented Use
Pat. No. 6488962 DP* Tablet shapes to enhance gastric retention of swellable controlled-release oral dosage forms
Claim Types: Composition
Pat. Sub. Date(s): 001: Apr 3, 2014
Jun 20, 2020 
Pat. No. 7976870 Gastric retentive oral dosage form with restricted drug release in the lower gastrointestinal tract
Claim Types: Method of administration; Method of use
Pat. Sub. Date(s): 001: Apr 3, 2014
Jun 1, 2027U-1498: Method of treating patients with gastric retentive dosage form
Pat. No. 8372432 DP* Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Apr 3, 2014
Mar 11, 2029U-1499: Management of acute pain in patients requiring opioid analgesia
Pat. No. 8394408 DP* Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 3, 2014
Mar 11, 2029 
Pat. No. 8668929 Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 3, 2014
Mar 11, 2029U-1499: Management of acute pain in patients requiring opioid analgesia
Pat. No. 8377453 DP* Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Apr 3, 2014
Nov 19, 2029U-1499: Management of acute pain in patients requiring opioid analgesia
Pat. No. 8597681 DP* Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans
Claim Types: Formulation; Product-by-process
Pat. Sub. Date(s): 001: Apr 3, 2014
Dec 21, 2030 
Pat. No. 8980319 DP* Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 3, 2015
Dec 21, 2030 
Pat. No. 8658631 DP* Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 3, 2014
May 16, 2032 
Pat. No. 8741885 DP* Gastric retentive extended release pharmaceutical compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jun 17, 2014
May 16, 2032U-1499: Management of acute pain in patients requiring opioid analgesia
Pat. No. 8992975 DP* Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 3, 2015
May 16, 2032 
Pat. No. 9050335 DP* Pharmaceutical compositions for extended release of oxycodone and acetaminophen resulting in a quick onset and prolonged period of analgesia
Claim Types: Formuation
Pat. Sub. Date(s): 001: Jun 25, 2015
May 16, 2032 
Pat. No. 9468636 Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 16, 2016
May 16, 2032U-1499: Management of acute pain in patients requiring opioid analgesia

XYREM (SOLUTION) (ORAL) SODIUM OXYBATE [GENERIC AA]
Drug Classes: central nervous system depressant
NDA Applicant: JAZZ PHARMS      NDA No.: 021196  Prod. No.: 001 RX (500MG/ML)
PatentsExpirationPatented Use
Pat. No. 7851506 Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Jun 22, 2020 *PEDU-1101: Method of treating excessive daytime sleepiness in patients with narcolepsy
U-1102: Method of treating cataplexy in patients with narcolepsy
Pat. No. 8263650 DP* Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Claim Types: Formulation; Method of use; Kit
Pat. Sub. Date(s): 001: Sep 20, 2012
Jun 22, 2020 *PEDU-1101: Method of treating excessive daytime sleepiness in patients with narcolepsy
U-1102: Method of treating cataplexy in patients with narcolepsy
Pat. No. 8324275 Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 5, 2012
Jun 22, 2020 *PEDU-1101: Method of treating excessive daytime sleepiness in patients with narcolepsy
U-1102: Method of treating cataplexy in patients with narcolepsy
Pat. No. 8859619 DP* Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Claim Types: Formulation; Drug in a container
Pat. Sub. Date(s): 001: Oct 28, 2014
Jun 22, 2020 *PED 
Pat. No. 8952062 Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Feb 19, 2015
Jun 22, 2020 *PEDU-1101: Method of treating excessive daytime sleepiness in patients with narcolepsy
U-1102: Method of treating cataplexy in patients with narcolepsy
Pat. No. 9539330 DP* Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Claim Types: Formulation; Drug in a container
Pat. Sub. Date(s): 001: Feb 8, 2017
Jun 22, 2020 *PED 
Pat. No. 6780889 DP* Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 4, 2021 *PED 
Pat. No. 7262219 DP* Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 4, 2021 *PED 
Pat. No. 7895059 Sensitive drug distribution system and method
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Jun 17, 2023 *PEDU-1110: Method of treating a patient with a prescription drug using a computer database in a computer system for distribution
Pat. No. 8457988 Sensitive drug distribution system and method
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jul 2, 2013
Jun 17, 2023 *PEDU-1110: Method of treating a patient with a prescription drug using a computer database in a computer system for distribution
Pat. No. 8589182 Sensitive drug distribution system and method
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Jun 17, 2023 *PEDU-1110: Method of treating a patient with a prescription drug using a computer database in a computer system for distribution
Pat. No. 8731963 Sensitive drug distribution system and method
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: May 30, 2014
Jun 17, 2023 *PEDU-1110: Method of treating a patient with a prescription drug using a computer database in a computer system for distribution
Pat. No. 7668730 Sensitive drug distribution system and method
Claim Types: Method of distribution
Pat. Sub. Date(s): 001: None
Dec 16, 2024 *PEDU-1110: Method of treating a patient with a prescription drug using a computer database in a computer system for distribution
Pat. No. 7765106 Sensitive drug distribution system and method
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Dec 16, 2024 *PEDU-1069: A method of treating a patient with a prescription drug using an exclusive computer database in a computer system for distribution
Pat. No. 7765107 Sensitive drug distribution system and method
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Dec 16, 2024 *PEDU-1070: A method to control abuse of a sensitive drug by controlling with a computer processor the distribution of the sensitive drug via an exclusivity central pharmacy that maintains a central database
Pat. No. 8772306 Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 9, 2014
Sep 15, 2033 *PEDU-1532: Method of treating excessive daytime sleepiness and/or cataplexy in narcolepsy patients with sodium oxybate when divalproex sodium is concomitantly administered.
Pat. No. 9050302 Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Claim Types: Method of administration; method of improving a treatment
Pat. Sub. Date(s): 001: Jul 8, 2015
Sep 15, 2033 *PEDU-1532: Method of treating excessive daytime sleepiness and/or cataplexy in narcolepsy patients with sodium oxybate when divalproex sodium is concomitantly administered.
Pat. No. 9486426 Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 6, 2016
Sep 15, 2033 *PEDU-1532: Method of treating excessive daytime sleepiness and/or cataplexy in narcolepsy patients with sodium oxybate when divalproex sodium is concomitantly administered.

AFREZZA (POWDER) (INHALATION) INSULIN RECOMBINANT HUMAN
Drug Classes: insulin analog
NDA Applicant: MANNKIND      NDA No.: 022472  Prod. No.: 001 RX (4 UNITS/INH); 002 RX (8 UNITS/INH); 003 RX (12 UNITS/INH)
PatentsExpirationPatented Use
Pat. No. 6444226 DP* Purification and stabilization of peptide and protein pharmaceutical agents
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): All strengths: Jul 24, 2014
Jun 29, 2020U-1534: Administration of a composition comprising insulin complexed with a diketopiperazine.
Pat. No. 6652885 Purification and stabilization of peptide and protein pharmaceutical agents
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 24, 2014
Jun 29, 2020U-1535: Administration of a composition comprising insulin complexed with microparticles of a diketopiperazine.
Pat. No. 7648960 Method for delivery of monomeric or dimeric insulin complexed to diketopiperazine microparticles
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 24, 2014
Jun 29, 2020U-1535: Administration of a composition comprising insulin complexed with microparticles of a diketopiperazine.
Pat. No. 7943178 DP* Methods and compositions for delivering peptides
Claim Types: Method of use; Product-by-process
Pat. Sub. Date(s): All strengths: Jul 24, 2014
Jun 29, 2020U-1535: Administration of a composition comprising insulin complexed with microparticles of a diketopiperazine.
Pat. No. 8389470 DP* Methods and compositions for delivering peptides
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): All strengths: Jul 24, 2014
Jun 29, 2020U-1621: Pulmonary administration of a composition comprising insulin bound to a complexing agent.
Pat. No. 8889099 DP* Methods and compositions for delivering peptides
Claim Types: Method of administration; Formulation
Pat. Sub. Date(s): All strengths: Dec 17, 2014
Jun 29, 2020U-1621: Pulmonary administration of a composition comprising insulin bound to a complexing agent.
Pat. No. 8950397 DP* Unit dose cartridge and dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Apr 25, 2016
Jul 20, 2021 
Pat. No. 8215300 DP* Unit dose cartridge and dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015
Nov 24, 2022 
Pat. No. 7305986 DP* Unit dose capsules for use in a dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015
Jan 16, 2023 
Pat. No. 8156936 DP* Unit dose capsules and dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015
Jan 16, 2023 
Pat. No. 7464706 DP* Unit dose cartridge and dry powder inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015
Mar 2, 2023 
Pat. No. 8146588 DP* Unit dose capsules and dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015
Apr 24, 2023 
Pat. No. 7943572 Superior control of blood glucose in diabetes treatment
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Jul 24, 2014
Aug 10, 2026U-1539: Pulmonary administration of an insulin composition comprising FDKP at the beginning of a meal to a patient also being treated with a long-acting insulin.
Pat. No. 9283193 DP* Method of drug formulation based on increasing the affinity of crystalline microparticle surfaces for active agents
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Apr 12, 2016
Sep 14, 2026 
Pat. No. 9717689 DP* Method of drug formulation based on increasing the affinity of crystalline microparticle surfaces for active agents
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Aug 28, 2017
Sep 14, 2026 
Pat. No. 8729019 DP* Method of drug formulation based on increasing the affinity of crystalline microparticle surfaces for active agents
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 14, 2014; 003: May 15, 2015
Dec 26, 2028 
Pat. No. 8912193 DP* Dry powder inhaler and system for drug delivery
Claim Types: Composition; Method of use; Product-by-process; Method of administration
Pat. Sub. Date(s): All strengths: Aug 18, 2015
Jun 12, 2029U-1538: Administration of FDKP microparticles comprising insulin.
Pat. No. 9192675 DP* Dry powder inhaler and system for drug delivery
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): All strengths: Dec 23, 2015
Jun 12, 2029U-1788: Treatment of patient having diabetes mellitus via oral inhalation of fdkp microparticles comprising insulin
Pat. No. 9446133 DP* Dry powder inhaler and system for drug delivery
Claim Types: Composition; Formulation; Method of use; Method of administration
Pat. Sub. Date(s): All strengths: Oct 19, 2016
Jun 12, 2029U-1861: Use of an inhaler to administer dry powder medicament
Pat. No. 9662461 DP* Dry powder drug delivery system and methods
Claim Types: Device; Method of administration
Pat. Sub. Date(s): All strengths: Jun 26, 2017
Jun 12, 2029U-2019: Method of delivering to a patient with diabetes mellitus in a single inhalation, greater than 75% of a dry powder dose comprising insulin and fumaryl diketopiperazine using a high resistance to flow dry powder inhaler.
Pat. No. 9393372 DP* Dry powder drug delivery system
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 3, 2016
Jul 4, 2029 
Pat. No. 8119593 Method of treating diabetes type 2 by metformin and an ultrarapid acting insulin
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Jul 24, 2014
Aug 11, 2029U-1537: Treatment of a patient having diabetes mellitus with a prandial rapid acting insulin.
Pat. No. 8258095 Method of controlling glycemia by ultrarapid acting insulin without adjusting an insulin dose for meal content
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Jul 24, 2014
Aug 11, 2029U-1537: Treatment of a patient having diabetes mellitus with a prandial rapid acting insulin.
Pat. No. 9943571 Use of ultrarapid acting insulin
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: May 15, 2018
Aug 11, 2029U-1537: Treatment of a patient having diabetes mellitus with a prandial rapid acting insulin.
Pat. No. 10046031 Use of ultrarapid acting insulin
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 12, 2018
Aug 11, 2029U-2383: Method of controlling glycemia in a diabetic patient with delayed or prolonged food absorpbtion by administering 50 to 75% of a predetermined dose of insulin-FDKP at mealtime, and administering remainder of dose 30-120 minutes after beginning of meal
Pat. No. 8623817 Method of treating diabetes type 2 by administering ultrarapid acting insulin
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 24, 2014
Sep 18, 2029U-1537: Treatment of a patient having diabetes mellitus with a prandial rapid acting insulin.
Pat. No. 9339615 DP* Dry powder inhaler and system for drug delivery
Claim Types: Device
Pat. Sub. Date(s): All strengths: May 31, 2016
Oct 20, 2029 
Pat. No. 9511198 Dry powder inhaler and system for drug delivery
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 5, 2017
Feb 16, 2030U-1929: Treatment of diabetes mellitus with an inhaled insulin to improve glycemic control using a dry powder inhalation system comprising an inhaler, a cartridge and a dry powder medicament comprising insulin in a single inhalation
U-1930: Method of aerosolizing/deagglomerating an insulin dry powder for use in treating diabetes mellitus via oral inhalation using an inhaler with a cartridge containing the insulin dry powder.
Pat. No. 8485180 DP* Dry powder drug delivery system
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015
Mar 25, 2030 
Pat. No. 8551528 DP* Diketopiperazine microparticles with defined specific surface areas
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015
Jun 11, 2030 
Pat. No. 8734845 DP* Diketopiperazine microparticles with defined specific surface areas
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015
Jun 11, 2030 
Pat. No. 8778403 DP* Diketopiperazine microparticles with defined specific surface areas
Claim Types: Device; Method of administration
Pat. Sub. Date(s): All strengths: Jul 24, 2014
Jun 11, 2030U-1538: Administration of FDKP microparticles comprising insulin.
Pat. No. 9358352 DP* Dry powder drug delivery system and methods
Claim Types: Device; Drug in a container; Method of administration
Pat. Sub. Date(s): All strengths: Jun 30, 2016
Feb 15, 2031U-1861: Use of an inhaler to administer dry powder medicament
Pat. No. 9597374 Use of ultrarapid acting insulin
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 11, 2017
Oct 8, 2031U-1987: Method of controlling glycemia in diabetics by administering an initial dose of insulin-FDKP with a meal; determining blood glucose level 1-2 hrs after and administering a supplemental dose of insulin-FDKP if postprandial glucose level is >140 mg/dl
Pat. No. 8424518 DP* Dry powder inhaler and system for drug delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015
Oct 17, 2031 
Pat. No. 8499757 DP* Dry powder inhaler and system for drug delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015
Feb 19, 2032 
Pat. No. 8636001 DP* Dry powder inhaler and system for drug delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015
Jul 12, 2032 

OLEPTRO (TABLET, EXTENDED RELEASE) (ORAL) TRAZODONE HYDROCHLORIDE
Drug Classes: selective serotonin reuptake inhibitor (SSRI)
NDA Applicant: ANGELINI PHARMA      NDA No.: 022411  Prod. No.: 001 DISC (150MG**); 002 DISC (300MG**)
PatentsExpirationPatented Use
Pat. No. 6607748 DP* Cross-linked high amylose starch for use in controlled-release pharmaceutical formulations and processes for its manufacture
Claim Types: Formulation; Product-by-process; Process
Pat. Sub. Date(s): All strengths: None
Jun 29, 2020 
Pat. No. 7829120 DP* Trazodone composition for once a day administration
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Dec 6, 2010; 002: None
Mar 27, 2027U-796: Method of treating depression
Pat. No. 8133893 DS* DP* Trazodone and trazodone hydrochloride in purified form
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Mar 16, 2012; 002: None
Mar 13, 2029 

RYZOLT (TABLET, EXTENDED RELEASE) (ORAL) TRAMADOL HYDROCHLORIDE
Drug Classes: opioid agonist
NDA Applicant: PURDUE PHARMA      NDA No.: 021745  Prod. No.: 001 DISC (100MG**); 002 DISC (200MG**); 003 DISC (300MG**)
PatentsExpirationPatented Use
Pat. No. 6607748 DP* Cross-linked high amylose starch for use in controlled-release pharmaceutical formulations and processes for its manufacture
Claim Types: Formulation; Product-by-process; Process
Pat. Sub. Date(s): All strengths: None
Jun 29, 2020 
Pat. No. 7988998 DP* Sustained-release tramadol formulations with 24-hour efficacy
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 1, 2011; 002: None; 003: None
Oct 27, 2023 

STALEVO 50; STALEVO 100; STALEVO 150; STALEVO 200; STALEVO 75; STALEVO 125 (TABLET) (ORAL) CARBIDOPA; ENTACAPONE; LEVODOPA [GENERIC AB]
Drug Classes: aromatic amino acid decarboxylation inhibitor; catechol o-methyl transferase (COMT) inhibitor
NDA Applicant: ORION PHARMA      NDA No.: 021485  Prod. No.: 001 RX (12.5MG;200MG;50MG); 002 RX (25MG;200MG;100MG); 003 RX (37.5MG;200MG;150MG); 004 RX (50MG;200MG;200MG); 005 RX (18.75MG;200MG;75MG); 006 RX (31.25MG;200MG;125MG)
PatentsExpirationPatented Use
Pat. No. 6500867 DP* Pharmaceutical composition comprising entacapone, levodopa, and carbidopa
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Jun 29, 2020U-219: Treatment of Parkinson's disease
Pat. No. 6797732 DP* Pharmaceutical composition comprising entracapone, levodopa, and carbidopa
Claim Types: Composition; Formulation
Pat. Sub. Date(s): All strengths: None
Jun 29, 2020 

INLYTA (TABLET) (ORAL) AXITINIB
Drug Classes: kinase inhibitor
NDA Applicant: PF PRISM CV      NDA No.: 202324  Prod. No.: 001 RX (1MG); 002 RX (5MG)
PatentsExpirationPatented Use
Pat. No. 7141581 Indazole compounds and pharmaceutical compositions for inhibiting protein kinases, and methods for their use
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 16, 2012; 002: None
Jun 30, 2020U-1220: Treatment of renal cell carcinoma
Pat. No. 6534524 DS* DP* [Extended 1764 days (4.8 years)]
Indazole compounds and pharmaceutical compositions for inhibiting protein kinases, and methods for their use
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Feb 16, 2012; 002: None
Apr 29, 2025 
Pat. No. 8791140 DS* Crystalline forms of 6-[2-(methylcarbamoyl)phenylsulfanyl]-3-E-[2-(pyridin-2-yl)ethenyondazole suitable for the treatment of abnormal cell growth in mammals
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: None
Dec 14, 2030 

LIDOSITE TOPICAL SYSTEM KIT (PATCH) (IONTOPHORESIS, TOPICAL) EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI); norepinephrine-releasing agent; alpha adrenergic agonist; beta adrenergic agonist; catecholamine; norepinephrine, serotonin, and dopamine reuptake inhibitor anorectic; amide local anesthetic; antiarrhythmic
NDA Applicant: VYTERIS      NDA No.: 021504  Prod. No.: 001 DISC (1.05MG/PATCH;100MG/PATCH)
PatentsExpirationPatented Use
Pat. No. 6629968 DS* DP* Shelf storage stable iontophoresis reservoir-electrode and iontophoretic system incorporating the reservoir-electrode
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: None
Jun 30, 2020 
Pat. No. 6635045 DS* DP* Electrodes and method for manufacturing electrodes for electrically assisted drug delivery
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: None
Jun 29, 2021 

SYNERA (PATCH) (TOPICAL) LIDOCAINE; TETRACAINE
Drug Classes: amide local anesthetic; antiarrhythmic; ester local anesthetic
NDA Applicant: GALEN SPECIALTY      NDA No.: 021623  Prod. No.: 001 RX (70MG;70MG)
PatentsExpirationPatented Use
Pat. No. 6465709 DP* Exothermic bandage
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Jul 19, 2012
Jul 7, 2020 

TUDORZA PRESSAIR (POWDER, METERED) (INHALATION) ACLIDINIUM BROMIDE
Drug Classes: anticholinergic
NDA Applicant: ASTRAZENECA PHARMS      NDA No.: 202450  Prod. No.: 001 RX (0.4MG/INH)
PatentsExpirationPatented Use
Pat. No. 9056100 DP* Quinuclidine derivatives and medicinal compositions containing the same
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jul 15, 2015
Jul 7, 2020U-1263: Treatment of chronic obstructive pulmonary disease (COPD) or chronic bronchitis
Pat. No. 9333195 DP* Quinuclidine derivatives and medicinal compositions containing the same
Claim Types: Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Jun 8, 2016
Jul 7, 2020U-1263: Treatment of chronic obstructive pulmonary disease (COPD) or chronic bronchitis
Pat. No. 10034867 DP* Quinuclidine derivatives and medicinal compositions containing the same
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Oct 25, 2018
Jul 7, 2020U-2431: Treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis
U-2432: Long-term, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD)
Pat. No. 7078412 DS* DP* Quinuclidine derivatives and medicinal compositions containing the same
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Aug 17, 2012
Jul 16, 2020U-1263: Treatment of chronic obstructive pulmonary disease (COPD) or chronic bronchitis
Pat. No. 6681768 DP* Powder formulation disintegrating system and method for dry powder inhalers
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 17, 2012
Aug 7, 2022 
Pat. No. RE46417 DS* DP* [Extended 1679 days (4.6 years)]
Quinuclidine derivatives and their use as muscarinic M3 receptor ligands
Claim Types: Compound; Process; Method of use
Pat. Sub. Date(s): 001: Jun 28, 2017
Feb 10, 2025U-1263: Treatment of chronic obstructive pulmonary disease (COPD) or chronic bronchitis
Pat. No. 8051851 DP* Inhaler for the administration of powdered pharmaceuticals, and a powder cartridge system for use with this inhaler
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 17, 2012
Apr 22, 2027 
Pat. No. 10085974 DP* Dosage and formulation
Claim Types: Formulation; Method of use; Device
Pat. Sub. Date(s): 001: Oct 26, 2018
Mar 13, 2029U-1263: Treatment of chronic obstructive pulmonary disease (COPD) or chronic bronchitis

ADLYXIN (SOLUTION) (SUBCUTANEOUS) LIXISENATIDE
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: SANOFI-AVENTIS US      NDA No.: 208471  Prod. No.: 001 RX (0.15MG/3ML (0.05MG/ML)); 002 RX (0.3MG/3ML (0.1MG/ML))
PatentsExpirationPatented Use
Pat. No. RE45313 DS* DP* Exendin variant peptides
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Aug 3, 2016
Jul 12, 2020 
Pat. No. 9855388 DP* Dosing and drive mechanism for drug delivery device
Claim Types: Device; Process; Method of administration
Pat. Sub. Date(s): All strengths: Jan 12, 2018
Apr 24, 2029U-1881: Improvement in glycemic control in Type 2 diabetes mellitus patients by use of a pen injector
Pat. No. 8915888 DP* Dosing and drive mechanism for drug delivery device
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 3, 2016
Jun 8, 2030U-1881: Improvement in glycemic control in Type 2 diabetes mellitus patients by use of a pen injector
Pat. No. 9981013 Use of AVE0010 for the treatment of diabetes mellitus type 2
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 8, 2018
Aug 30, 2030U-2297: Improvement of glycemic control in Type 2 diabetes patients by administering a starting dose of 10 mcg for 14 days and increasing to a maintenance dose of 20 mcg on day 15
Pat. No. 9707176 DP* Pharmaceutical composition comprising a GLP-1 agonist and methionine
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Aug 3, 2017
Nov 11, 2030 
Pat. No. 10028910 DP* Pharmaceutical composition comprising a GLP-1-agonist and methionine
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 30, 2018
Nov 11, 2030 
Pat. No. 8475414 DP* Medication delivery device and method for operating a medication delivery device
Claim Types: Device; Method of use
Pat. Sub. Date(s): All strengths: Aug 3, 2016
Dec 28, 2030U-1881: Improvement in glycemic control in Type 2 diabetes mellitus patients by use of a pen injector
Pat. No. 9308329 DP* Medication delivery device and method for operating a medication delivery device
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 3, 2016
Dec 28, 2030U-1881: Improvement in glycemic control in Type 2 diabetes mellitus patients by use of a pen injector
Pat. No. 8882721 DP* Drive assembly suitable for use in a drug delivery device and drug delivery device
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 3, 2016
Jun 28, 2031 
Pat. No. 9084853 DP* Drive mechanism for a drug delivery device and drug delivery device
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 3, 2016
Oct 5, 2031 
Pat. No. 9511193 DP* Assembly and indicator for a drug delivery device
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 29, 2016
Jan 19, 2032 
Pat. No. 9440029 DP* Drive mechanism for a drug delivery device and drug delivery device
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 29, 2016
Jan 30, 2032 
Pat. No. 9072836 DP* Drive mechanism for a drug delivery device and drug delivery device
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 3, 2016
Mar 15, 2032 
Pat. No. 9821032 Pharmaceutical combination for improving glycemic control as add-on therapy to basal insulin
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 19, 2017
May 9, 2032U-2200: Combination treatment with insulin glargine with or without metformin for improvement of glycemic control in Type 2 diabetes mellitus patients
Pat. No. 9408893 Pharmaceutical combination for use in glycemic control in diabetes type 2 patients
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 9, 2016
Aug 27, 2032U-1894: Combination treatment with a glitazone for improvement of glycemic control in Type 2 diabetes mellitus patients
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJul 27, 2021 

SOLIQUA 100/33 (SOLUTION) (SUBCUTANEOUS) INSULIN GLARGINE; LIXISENATIDE
Drug Classes: insulin analog; glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: SANOFI-AVENTIS US      NDA No.: 208673  Prod. No.: 001 RX (300 UNITS/3ML;99MCG/3ML (100 UNITS/ML;33MCG/ML))
PatentsExpirationPatented Use
Pat. No. RE45313 DS* DP* Exendin variant peptides
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Nov 23, 2016
Jul 12, 2020 
Pat. No. 8603044 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 23, 2016
Mar 2, 2024 
Pat. No. 9233211 DP* Relating to a pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 23, 2016
Mar 2, 2024 
Pat. No. 9408979 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 23, 2016
Mar 2, 2024 
Pat. No. 9526844 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 001: Dec 27, 2016
Mar 2, 2024 
Pat. No. 9604008 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 28, 2017
Mar 2, 2024 
Pat. No. 9610409 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Pat. Sub. Date(s): 001: Apr 4, 2017
Mar 2, 2024 
Pat. No. 9775954 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 3, 2017
Mar 2, 2024 
Pat. No. 9827379 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Nov 28, 2017
Mar 2, 2024U-2146: Improvement in glycemic control in diabetes mellitus patients by use of a pen injector with a rotating drive sleeve
Pat. No. 8556864 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 23, 2016
Mar 3, 2024 
Pat. No. 9011391 Pen-type injector
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 23, 2016
Mar 26, 2024U-1923: Improvement in glycemic control in adults with Type 2 diabetes mellitus inadequately controlled by basal insulin or lixisenatide by use of a pen injector with a threaded drive sleeve
Pat. No. 8992486 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 23, 2016
Jun 5, 2024 
Pat. No. 9604009 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 28, 2017
Aug 16, 2024 
Pat. No. 9533105 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 3, 2017
Aug 17, 2024 
Pat. No. 9623189 DP* Relating to drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Pat. Sub. Date(s): 001: Apr 18, 2017
Aug 19, 2024 
Pat. No. 9561331 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 7, 2017
Aug 28, 2024 
Pat. No. 8512297 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 23, 2016
Sep 15, 2024 
Pat. No. 8679069 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 23, 2016
Apr 12, 2025 
Pat. No. 7918833 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 23, 2016
Sep 23, 2027 
Pat. No. 9526764 DP* Combination of an insulin and a GLP-1-agonist
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 5, 2017
Oct 9, 2029 
Pat. No. 9707176 DP* Pharmaceutical composition comprising a GLP-1 agonist and methionine
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 3, 2017
Nov 11, 2030 
Pat. No. 9821032 Pharmaceutical combination for improving glycemic control as add-on therapy to basal insulin
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 19, 2017
May 9, 2032U-2182: Improvement of glycemic control in Type 2 diabetes mellitus patients
Pat. No. 10029011 DP* Pharmaceutical composition comprising a GLP-1 agonist, an insulin and methionine
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 30, 2018
Aug 2, 2032 
Pat. No. 9717852 DP* Cartridge holder and pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 12, 2018
Apr 8, 2033 
Pat. No. 9950039 Insulin glargine/lixisenatide fixed ratio formulation
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 4, 2018
Dec 10, 2035U-2277: Improvement in glycemic control in adults with Type 2 diabetes mellitus inadequately controlled by lixisenatide
U-2278: Improvement in glycemic control in adults with Type 2 diabetes mellitus inadequately controlled by lixisenatide in combination with metformin
U-2279: Improvement in glycemic control in adults with Type 2 diabetes mellitus inadequately controlled by lixisenatide in combination with metformin and a second oral antidiabetic drug
ExclusivityExpirationExclusivity Description
Exclusivity Code: NC - New combinationNov 21, 2019 
Exclusivity Code: NCE - New chemical entityJul 27, 2021 

EGRIFTA (POWDER) (SUBCUTANEOUS) TESAMORELIN ACETATE
Drug Classes: growth hormone releasing factor (GRG) analog
NDA Applicant: THERATECHNOLOGIES      NDA No.: 022505  Prod. No.: 002 DISC (EQ 2MG BASE/VIAL)
PatentsExpirationPatented Use
Pat. No. 7144577 Treatment of HIV-associated dysmorphia/dysmetabolic syndrome (HADDS) with or without lipodystrophy
Claim Types: Method of use
Pat. Sub. Date(s): 002: None
Jul 14, 2020U-1100: Reduction of excess abdominal fat in HIV-infected patients with lipodystrophy
Pat. No. 7316997 GH secretagogues and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): 002: None
Aug 14, 2023U-1100: Reduction of excess abdominal fat in HIV-infected patients with lipodystrophy

CLEOCIN (SUPPOSITORY) (VAGINAL) CLINDAMYCIN PHOSPHATE
Drug Classes: lincosamide antibacterial
NDA Applicant: PHARMACIA AND UPJOHN      NDA No.: 050767  Prod. No.: 001 RX (100MG)
PatentsExpirationPatented Use
Pat. No. 6495157 DP* Intravaginal clindamycin ovule composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jul 20, 2020 

OSPHENA (TABLET) (ORAL) OSPEMIFENE
Drug Classes: estrogen agonist/antagonist
NDA Applicant: DUCHESNAY      NDA No.: 203505  Prod. No.: 001 RX (60MG)
PatentsExpirationPatented Use
Pat. No. 9566252 Method for the alleviation of dyspareunia in women
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 6, 2017
Jul 21, 2020U-1370: Treatment of dyspareunia associated with menopause
Pat. No. 8470890 Method for enhancing the bioavailability of ospemifene
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Feb 13, 2024U-1369: Treatment of vaginal symptoms of urogenital atrophy by orally administering ospemifene with food to enhance bioavailability of ospemifene
U-1370: Treatment of dyspareunia associated with menopause
Pat. No. 8772353 Method for enhancing the bioavalability of ospemifene
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 23, 2014
Feb 13, 2024U-1369: Treatment of vaginal symptoms of urogenital atrophy by orally administering ospemifene with food to enhance bioavailability of ospemifene
U-1370: Treatment of dyspareunia associated with menopause
Pat. No. 9241915 Method for enhancing the bioavailability of ospemifene
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Feb 10, 2016
Feb 13, 2024U-1369: Treatment of vaginal symptoms of urogenital atrophy by orally administering ospemifene with food to enhance bioavailability of ospemifene
U-1370: Treatment of dyspareunia associated with menopause
Pat. No. 9855224 Method for enhancing the bioavailability of ospemifene
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 23, 2018
Feb 13, 2024U-1369: Treatment of vaginal symptoms of urogenital atrophy by orally administering ospemifene with food to enhance bioavailability of ospemifene
U-1370: Treatment of dyspareunia associated with menopause
Pat. No. 6245819 [Extended 5 years]
Method for the treatment of vaginal dryness and sexual dysfunction in women during or after the menopause
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 25, 2013
Jul 21, 2025U-1370: Treatment of dyspareunia associated with menopause
Pat. No. 8236861 Method for enhancing the bioavailablity of ospemifene
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Mar 25, 2013
Aug 11, 2026U-1369: Treatment of vaginal symptoms of urogenital atrophy by orally administering ospemifene with food to enhance bioavailability of ospemifene
U-1370: Treatment of dyspareunia associated with menopause
Pat. No. 8642079 DP* Solid formulations of ospemifene
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 20, 2014
Jul 9, 2028 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityFeb 26, 2018 

AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER (SOLUTION) (INTRAVENOUS) MOXIFLOXACIN HYDROCHLORIDE [Has competitive generic]
Drug Classes: quinolone antimicrobial
NDA Applicant: BAYER HLTHCARE      NDA No.: 021277  Prod. No.: 001 DISC (400MG/250ML (1.6MG/ML))
PatentsExpirationPatented Use
Pat. No. 6548079 DP* Moxifloxacin formulation containing common salt
Claim Types: Formulation; Process; Method of use
Pat. Sub. Date(s): 001: None
Jul 25, 2020U-298: Method of combating bacteria in a patient
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousSep 27, 2019M-185: Updates to the labeling to include results of a trial to evaluate the safety of moxifloxacin in pediatric patients with complicated intra-abdominal infections

MYRBETRIQ (TABLET, EXTENDED RELEASE) (ORAL) MIRABEGRON
Drug Classes: beta-3 adrenergic agonist
NDA Applicant: APGDI      NDA No.: 202611  Prod. No.: 001 RX (25MG); 002 RX (50MG)
PatentsExpirationPatented Use
Pat. No. 6562375 DP* Stable pharmaceutical composition for oral use
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Jul 30, 2012; 002: None
Aug 1, 2020 
Pat. No. 6346532 DS* DP* [Extended 1259 days (3.4 years)]
Amide derivatives or salts thereof
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Jul 30, 2012; 002: None
Mar 27, 2022 
Pat. No. RE44872 Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 16, 2014
Nov 4, 2023U-1527: For the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency
Pat. No. 7342117 DS* .alpha.-form or .beta.-form crystal of acetanilide derivative
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Jul 30, 2012; 002: None
Nov 4, 2023 
Pat. No. 7982049 DP* .alpha.-form or .beta.-form crystal of acetanilide derivative
Claim Types: Composition; Method of use; Formulation
Pat. Sub. Date(s): 001: Jul 30, 2012; 002: None
Nov 4, 2023 
Pat. No. 8835474 Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 14, 2014
Nov 4, 2023U-1527: For the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency
Pat. No. 8772315 Pharmaceutical composition for treating overactive bladder
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: May 17, 2018
Oct 30, 2028U-2300: Use in combination with the muscarinic antagonist solifenacin succinate for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationApr 27, 2021I-777: Co-administration therapy of mirabegron with solifenacin succinate for treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency

CLINDAGEL (GEL) (TOPICAL) CLINDAMYCIN PHOSPHATE [Has competitive generic]
Drug Classes: lincosamide antibacterial
NDA Applicant: PRECISION DERMAT      NDA No.: 050782  Prod. No.: 001 RX (EQ 1% BASE)
PatentsExpirationPatented Use
Pat. No. 6387383 DP* Topical low-viscosity gel composition
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): 001: None
Aug 3, 2020U-818: Topical treatment of acne vulgaris

DESONATE (GEL) (TOPICAL) DESONIDE
Drug Classes: corticosteroid
NDA Applicant: LEO PHARMA AS      NDA No.: 021844  Prod. No.: 001 RX (0.05%)
PatentsExpirationPatented Use
Pat. No. 6387383 DS* DP* Topical low-viscosity gel composition
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): 001: None
Aug 3, 2020U-783: DESONATE gel is indicated for the treatment of mild to moderate atopic dermatitis in patients 3 months of age and older

ZIANA (GEL) (TOPICAL) CLINDAMYCIN PHOSPHATE; TRETINOIN [GENERIC AB]
Drug Classes: lincosamide antibacterial; retinoid
NDA Applicant: MEDICIS      NDA No.: 050802  Prod. No.: 001 RX (1.2%;0.025%)
PatentsExpirationPatented Use
Pat. No. 6387383 DP* Topical low-viscosity gel composition
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): 001: None
Aug 3, 2020U-916: Topical treatment of acne vulgaris in patients 12 years or older

BRIDION (SOLUTION) (INTRAVENOUS) SUGAMMADEX SODIUM
NDA Applicant: ORGANON SUB MERCK      NDA No.: 022225  Prod. No.: 001 RX (EQ 500MG BASE/5ML (EQ 100MG BASE/ML)); 002 RX (EQ 200MG BASE/2ML (EQ 100MG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 7265099 Use of chemical chelators as reversal agents for drug-induced neuromuscular block
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 12, 2016
Aug 7, 2020U-1795: Reversal of neuromuscular blockage induced by rocuronium bromide or vecuronium bromide
Pat. No. RE44733 DS* DP* 6-mercapto-cyclodextrin derivatives:reversal agents for drug-induced neuromuscular block
Claim Types:
Pat. Sub. Date(s): All strengths: Jan 12, 2016
Jan 27, 2021U-1794: Reversal of drug-induced neuromuscular block
Pat. No. 6949527 6-Mercapto-cyclodextrin derivatives: reversal agents for drug-induced neuromuscular block
Claim Types: Kit; Method of use
Pat. Sub. Date(s): All strengths: Jan 12, 2016
Jan 27, 2021U-1795: Reversal of neuromuscular blockage induced by rocuronium bromide or vecuronium bromide
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityDec 15, 2020 

ANTARA (MICRONIZED) (CAPSULE) (ORAL) FENOFIBRATE [GENERIC AB]
Drug Classes: peroxisome proliferator-activated receptor (PPAR) alpha agonist
NDA Applicant: LUPIN ATLANTIS      NDA No.: 021695  Prod. No.: 001 RX (43MG); 003 RX (130MG)
PatentsExpirationPatented Use
Pat. No. 7863331 Pharmaceutical composition containing fenofibrate and method for the preparation thereof
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Aug 8, 2020U-1106: Treating hypertriglyceridemias with reduction of food effect
U-1107: Treating hypercholesterolemias with reduction of food effect
Pat. No. 7101574 DS* DP* Pharmaceutical composition containing fenofibrate and the preparation method
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: None
Aug 20, 2020 

CIPRODEX (SUSPENSION/DROPS) (OTIC) CIPROFLOXACIN; DEXAMETHASONE
Drug Classes: quinolone antimicrobial; corticosteroid
NDA Applicant: NOVARTIS PHARMS CORP      NDA No.: 021537  Prod. No.: 001 RX (0.3%;0.1%)
PatentsExpirationPatented Use
Pat. No. 6284804 Topical suspension formulations containing ciprofloxacin and dexamethasone
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Aug 10, 2020 
Pat. No. 6359016 Topical suspension formulations containing ciprofloxacin and dexamethasone
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Aug 10, 2020 
Pat. No. 9149486 DP* Method of treating middle ear infections
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 2, 2015
Sep 13, 2022U-1578: Treatment of acute otitis media
Pat. No. 9345714 DP* Method of treating middle ear infections
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 6, 2016
Sep 13, 2022U-1578: Treatment of acute otitis media
Pat. No. 9402805 DP* Method of treating middle ear infections
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 2, 2016
Sep 13, 2022U-1578: Treatment of acute otitis media
U-1679: Treatment of acute otitis externa
Pat. No. 8846650 DP* Method of treating middle ear infections
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Oct 3, 2014
Jun 4, 2025U-1578: Treatment of acute otitis media

RAYALDEE (CAPSULE, EXTENDED RELEASE) (ORAL) CALCIFEDIOL
Drug Classes: vitamin D3 analog
NDA Applicant: OPKO IRELAND GLOBAL      NDA No.: 208010  Prod. No.: 001 RX (0.03MG)
PatentsExpirationPatented Use
Pat. No. 6582727 DP* Film forming compositions comprising modified starches and iota-carrageenan and methods for manufacturing soft capsules using same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 6, 2016
Aug 22, 2020 
Pat. No. 8906410 DP* Oral dosage form of 25-hydroxyvitamin D
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 6, 2016
Feb 2, 2027 
Pat. No. 9943530 Treating vitamin D insufficiency and deficiency with 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 1, 2018
Feb 2, 2027U-2274: Maintaining serum 25-hydroxyvitamin D at a level of at least 30 ng/ml with oral, sustained release 25-hydroxyvitamin D
Pat. No. 8207149 Method for treating secondary hyperparathyroidism in CKD
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 6, 2016
Apr 25, 2028U-1871: Treatment of secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease using controlled release, oral 25-hydroxyvitamin D
Pat. No. 8778373 Methods for controlled release oral dosage of a vitamin D compound
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jul 6, 2016
Apr 25, 2028U-1873: Administration of 25-hydroxyvitamin D3 by controlled release
Pat. No. 9408858 Method for treating secondary hyperparathyroidism in CKD
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 16, 2016
Apr 25, 2028U-1888: Use of controlled release 25-hydroxyvitamin D in treating secondary hyperparathyroidism in patients having chronic kidney disease
Pat. No. 9498486 Method for controlled release oral dosage of a vitamin D compound
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 6, 2016
Apr 25, 2028U-1920: Use of extended release oral 25-hydroxyvitamin D3 in treating secondary hyperparathyroidism in adult patients having chronic kidney disease stage 3 or stage 4
Pat. No. 9925147 DP* Method for treating secondary hyperparathyroidism in CKD
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Apr 9, 2018
Apr 25, 2028U-2255: Treating secondary hyperparathyroidism in chronic kidney disease with sustained release 25-hydroxyvitamin D to reduce the patient's serum parathyroid hormone level and the sustained release is over at least 10 hours
U-2256: Treating secondary hyperparathyroidism in chronic kidney disease with sustained release 25-hydroxyvitamin D to reduce the patient's serum parathyroid hormone level and cmax is reduced compared to bolus IV injection and immediate-release, oral dosing
U-2257: Treating SHPT in CKD with sustained release calcifediol to reduce serum parathyroid hormone level and change in serum concentration of calcifediol in dose interval is reduced compared to bolus IV injection and immediate-release, oral dosing
U-2258: Treating secondary hyperparathyroidism in CKD with sustained release calcifediol to reduce the patient's serum parathyroid hormone level and cmax24hr/c24hr is reduced compared to bolus IV injection and immediate-release, oral dosing
U-2259: Treating secondary hyperparathyroidism in CKD with sustained release calcifediol to reduce the patient's serum parathyroid hormone level and Tmax is increased compared to bolus IV injection and immediate-release, oral dosing
Pat. No. 8361488 DP* Methods and compositions for controlled release oral dosage of a vitamin D compound
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 6, 2016
Jul 19, 2028 
Pat. No. 8426391 Treating vitamin D insufficiency and deficiency with 25-hydroxyvitamin D.sub.2 and 25-hydroxyvitamin D.s
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 6, 2016
Aug 27, 2028U-1872: Use of sustained release 25-hydroxyvitamin D in treating patients having 25-hydroxyvitamin D insufficiency or deficiency
Pat. No. 9861644 DP* Stabilized modified release vitamin D formulation and method of administering same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 23, 2018
Mar 14, 2034 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productJun 17, 2019 

SOLAGE (SOLUTION) (TOPICAL) MEQUINOL; TRETINOIN
Drug Classes: skin lightening agent; retinoid
NDA Applicant: AQUA PHARMS      NDA No.: 020922  Prod. No.: 001 DISC (2%;0.01%)
PatentsExpirationPatented Use
Pat. No. 6353029 Storage stable tretinoin and 4-hydroxyanisole containing topical composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Aug 24, 2020 

QVAR REDIHALER (AEROSOL, METERED) (INHALATION) BECLOMETHASONE DIPROPIONATE
Drug Classes: corticosteroid
NDA Applicant: NORTON WATERFORD      NDA No.: 207921  Prod. No.: 001 RX (0.04MG/INH); 002 RX (0.08MG/INH)
PatentsExpirationPatented Use
Pat. No. 7637260 DP* Medicament dispensing device with a multimaterial diaphragm bounding a pneumatic force chamber
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 28, 2017
Aug 25, 2020 
Pat. No. 8132712 DP* Metered-dose inhaler
Claim Types: Device; Method of use
Pat. Sub. Date(s): All strengths: Aug 28, 2017
Sep 7, 2028 
Pat. No. 10022509 DP* Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Part of a dosage form
Pat. Sub. Date(s): All strengths: Aug 13, 2018
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. 10086156 DP* Dose counter for inhaler and method for counting doses
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): All strengths: Oct 16, 2018
May 18, 2031 
Pat. No. 8931476 DP* Inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 28, 2017
Jul 17, 2031 

ALTACE (CAPSULE) (ORAL) RAMIPRIL [GENERIC AB]
Drug Classes: angiotensin converting enzyme inhibitor
NDA Applicant: KING PHARMS LLC      NDA No.: 019901  Prod. No.: 001 RX (1.25MG); 002 RX (2.5MG); 003 RX (5MG); 004 RX (10MG)
PatentsExpirationPatented Use
Pat. No. 7368469 Use of inhibitors of the renin-angiotensin system in the prevention of cardiovascular events
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Aug 30, 2020U-871: Method of reducing risk of myocardial infarction, stroke and death

ALTACE (TABLET) (ORAL) RAMIPRIL
Drug Classes: angiotensin converting enzyme inhibitor
NDA Applicant: KING PFIZER      NDA No.: 022021  Prod. No.: 001 DISC (1.25MG**); 002 DISC (2.5MG**); 003 DISC (5MG**); 004 DISC (10MG**)
PatentsExpirationPatented Use
Pat. No. 7368469 Use of inhibitors of the renin-angiotensin system in the prevention of cardiovascular events
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Aug 30, 2020U-871: Method of reducing risk of myocardial infarction, stroke and death

YASMIN (TABLET) (ORAL-28) DROSPIRENONE; ETHINYL ESTRADIOL [GENERIC AB]
Drug Classes: progestin; estrogen
NDA Applicant: BAYER HLTHCARE      NDA No.: 021098  Prod. No.: 001 RX (3MG;0.03MG)
PatentsExpirationPatented Use
Pat. No. 6787531 DP* Pharmaceutical composition for use as a contraceptive
Claim Types: Formulation; Kit
Pat. Sub. Date(s): 001: None
Aug 31, 2020 

YAZ (TABLET) (ORAL) DROSPIRENONE; ETHINYL ESTRADIOL [GENERIC AB]
Drug Classes: progestin; estrogen
NDA Applicant: BAYER HLTHCARE      NDA No.: 021676  Prod. No.: 001 RX (3MG;0.02MG)
PatentsExpirationPatented Use
Pat. No. 6787531 DP* Pharmaceutical composition for use as a contraceptive
Claim Types: Formulation; Kit
Pat. Sub. Date(s): 001: None
Aug 31, 2020 
Pat. No. 6958326 DP* Cyclodextrin-drospirenone inclusion complexes
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: None
Dec 20, 2021 
Pat. No. 7163931 Compositions of estrogen-cyclodextrin complexes
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Dec 20, 2021U-1: Prevention of pregnancy

AMITIZA (CAPSULE) (ORAL) LUBIPROSTONE
Drug Classes: chloride channel activator
NDA Applicant: SUCAMPO PHARMA LLC      NDA No.: 021908  Prod. No.: 001 RX (24MCG)
PatentsExpirationPatented Use
Pat. No. 6414016 Anti-constipation composition
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Sep 5, 2020U-1392: Method of relieving or preventing constipation in a human patient with opioid-induced constipation
U-717: Method of relieving or preventing constipation in a human constipated patient
Pat. No. 8071613 Anti-constipation composition
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 21, 2011
Sep 5, 2020U-1203: Method for relieving or treating constipation in a human constipated patient
U-1393: Method for relieving or treating constipation in a patient with opioid-induced constipation
Pat. No. 8114890 DP* Anti-constipation composition
Claim Types: Formulation5558083
Pat. Sub. Date(s): 001: Feb 14, 2012
Comments: A
Sep 5, 2020 
Pat. No. 6583174 DP* Composition and method for stabilizing the same
Claim Types: Composition; Formulation; Process
Pat. Sub. Date(s): 001: None
Oct 16, 2020 
Pat. No. 7417067 DP* Composition and method for stabilizing the same
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Oct 16, 2020 
Pat. No. 8097649 DP* Composition and method for stabilizing the same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 18, 2012
Oct 16, 2020 
Pat. No. 8088934 DS* Composition and method for stabilizing the same
Claim Types: Compound
Pat. Sub. Date(s): 001: None
May 18, 2021 
Pat. No. 7064148 Chloride channel opener
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Aug 30, 2022U-1404: Method for treating constipation in a patient with opioid-induced constipation by opening CIC channels
U-739: Method for treating constipation by opening CIC channels in a mammalian subject
Pat. No. 8097653 Dosage unit comprising a prostaglandin analog for treating constipation
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 18, 2012
Nov 14, 2022U-1214: Method for relieving constipation in a human patient that comprises administering to the patient a dosage unit comprising (i) 24mcg+/- 10% of a drug substance and (ii) a pharmaceutically suitable excipient
U-1394: Method for relieving constipation in a patient with opioid-induced constipation that comprises administering to the patient a dosage unit comprising(i)24microg+/- 10% of a drug substance and (ii) a pharmaceutically suitable excipient
Pat. No. 8389542 DP* Dosage unit comprising a prostaglandin analog for treating constipation
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 22, 2013
Nov 14, 2022U-1345: Use in relieving or preventing constipation in a human patient with a dosage unit comprising 24microg+/- 10% of a drug substance and a pharmaceutically suitable excipient
U-1395: Use in relieving or preventing constipation in a patient with opioid-induced constipation with a dosage unit comprising 24microg +/- 10% of a drug substance and a pharmaceutically suitable excipient
Pat. No. 6982283 Method for treating drug-induced constipation
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 9, 2013
Dec 4, 2022U-1391: Method for treating opioid-induced constipation
Pat. No. 8748481 Method for treating gastrointestinal disorder
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 20, 2014
Sep 1, 2025U-1520: Method for the long term treatment of chronic constipation in a human subject
Pat. No. 8338639 DP* Soft-gelatin capsule formulation
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 20, 2012
Jan 23, 2027 
Pat. No. 8779187 DP* Soft-gelatin capsule formulation
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Aug 7, 2014
Jul 23, 2027 
Pat. No. 8026393 DP* Soft-gelatin capsule formulation
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 26, 2011
Oct 25, 2027 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousApr 26, 2021M-225: Revisions to section 8.4 of the prescribing information to include a safety and efficacy study in pediatric patients ages >=6 years to <18 years with chronic idiopathic constipation

AMITIZA (CAPSULE) (ORAL) LUBIPROSTONE
Drug Classes: chloride channel activator
NDA Applicant: SUCAMPO PHARMA LLC      NDA No.: 021908  Prod. No.: 002 RX (8MCG)
PatentsExpirationPatented Use
Pat. No. 6414016 Anti-constipation composition
Claim Types: Method of use
Pat. Sub. Date(s): 002: None
Sep 5, 2020U-874: Method of treating constipation in a patient with irritable bowel syndrome
Pat. No. 8071613 Anti-constipation composition
Claim Types: Method of use
Pat. Sub. Date(s): 002: None
Sep 5, 2020U-1202: Method for relieving or treating constipation in a patient with irritable bowel syndrome
Pat. No. 8114890 DP* Anti-constipation composition
Claim Types: Formulation5558083
Pat. Sub. Date(s): 002: None
Comments: A
Sep 5, 2020 
Pat. No. 6583174 DP* Composition and method for stabilizing the same
Claim Types: Composition; Formulation; Process
Pat. Sub. Date(s): 002: None
Oct 16, 2020 
Pat. No. 7417067 DP* Composition and method for stabilizing the same
Claim Types: Formulation
Pat. Sub. Date(s): 002: None
Oct 16, 2020 
Pat. No. 8097649 DP* Composition and method for stabilizing the same
Claim Types: Formulation
Pat. Sub. Date(s): 002: None
Oct 16, 2020 
Pat. No. 8088934 DS* Composition and method for stabilizing the same
Claim Types: Compound
Pat. Sub. Date(s): 002: None
May 18, 2021 
Pat. No. 7064148 Chloride channel opener
Claim Types: Method of use
Pat. Sub. Date(s): 002: None
Aug 30, 2022U-739: Method for treating constipation by opening CIC channels in a mammalian subject
U-873: Method of treating constipation in a patient with irritable bowel syndrome by opening chloride channels (CIC)
Pat. No. 7795312 Method for treating abdominal discomfort
Claim Types: Method of use
Pat. Sub. Date(s): 002: None
Sep 17, 2024U-1085: Method for treating irritable bowel syndrome and method for treating abdominal discomfort associated with irritable bowel syndrome
Pat. No. 8748481 Method for treating gastrointestinal disorder
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 20, 2014
Sep 1, 2025U-1519: Method for the long term treatment of chronic constipation in a human subject with irritable bowel syndrome
Pat. No. 8338639 DP* Soft-gelatin capsule formulation
Claim Types: Formulation
Pat. Sub. Date(s): 002: None
Jan 23, 2027 
Pat. No. 8779187 DP* Soft-gelatin capsule formulation
Claim Types: Formulation; Process
Pat. Sub. Date(s): 002: Aug 7, 2014
Jan 23, 2027 
Pat. No. 8026393 DP* Soft-gelatin capsule formulation
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: None
Oct 25, 2027 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousApr 26, 2021M-225: Revisions to section 8.4 of the prescribing information to include a safety and efficacy study in pediatric patients ages >=6 years to <18 years with chronic idiopathic constipation

BIDIL (TABLET) (ORAL) HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE
Drug Classes: arteriolar vasodilator; nitrate vasodilator
NDA Applicant: ARBOR PHARMS LLC      NDA No.: 020727  Prod. No.: 001 RX (37.5MG;20MG)
PatentsExpirationPatented Use
Pat. No. 6465463 Methods of treating and preventing congestive heart failure with hydralazine compounds and isosorbide dinitrate or isosorbide mononitrate
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Sep 8, 2020U-71: Method of treatment of heart failure
Pat. No. 6784177 Methods using hydralazine compounds and isosorbide dinitrate or isosorbide mononitrate
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Sep 8, 2020U-71: Method of treatment of heart failure

DEXYCU KIT (SUSPENSION) (INTRAOCULAR) DEXAMETHASONE
Drug Classes: corticosteroid
NDA Applicant: EYEPOINT PHARMS      NDA No.: 208912  Prod. No.: 001 RX (9%)
PatentsExpirationPatented Use
Pat. No. 10022502 Dose guides for injection syringe
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 3, 2018
Sep 12, 2020U-2340: Treatment of postoperative inflammation
Pat. No. 7560120 DP* Vehicles for delivery of biologically active substances
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 5, 2018
Sep 5, 2022 
Pat. No. 6960346 DP* Vehicles for delivery of biologically active substances
Claim Types: Formulation; Kit
Pat. Sub. Date(s): 001: Mar 5, 2018
Jul 3, 2023 
Pat. No. 10028965 Use of sustained release dexamethasone in post-cataract surgery inflammation
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 3, 2018
May 23, 2034U-2340: Treatment of postoperative inflammation
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productFeb 9, 2021 

BEVYXXA (CAPSULE) (ORAL) BETRIXABAN
Drug Classes: factor Xa (FXa) inhibitor
NDA Applicant: PORTOLA PHARMS INC      NDA No.: 208383  Prod. No.: 001 RX (40MG); 002 RX (80MG)
PatentsExpirationPatented Use
Pat. No. 6376515 DS* DP* Benzamides and related inhibitors of factor Xa
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Jul 21, 2017
Sep 15, 2020U-1167: Prophylaxis of deep vein thrombosis (DVT)
U-1502: Prophylaxis of pulmonary embolism
U-2029: Preventing condition characterized by undesired thrombosis
U-2030: Prophylaxis of venous thrombosis
Pat. No. 6835739 DS* DP* Benzamides and related inhibitors of factor Xa
Claim Types: Composition; Compound
Pat. Sub. Date(s): All strengths: Jul 21, 2017
Sep 15, 2020 
Pat. No. 8518977 DS* Benzamides and related inhibitors of factor XA
Claim Types: Compound
Pat. Sub. Date(s): All strengths: Jul 21, 2017
Sep 15, 2020 
Pat. No. 8691847 DS* DP* Benzamides and related inhibitors of factor Xa
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Jul 21, 2017
Sep 15, 2020U-2029: Preventing condition characterized by undesired thrombosis
U-2035: Prophylaxis of venous thromboembolism
Pat. No. 9629831 Benzamides and related inhibitors of factor XA
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 21, 2017
Sep 15, 2020U-1167: Prophylaxis of deep vein thrombosis (DVT)
U-1502: Prophylaxis of pulmonary embolism
U-2030: Prophylaxis of venous thrombosis
U-2035: Prophylaxis of venous thromboembolism
Pat. No. 9555023 Pharmaceutical salts and polymorphs of a factor Xa inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 21, 2017
Nov 7, 2026U-1502: Prophylaxis of pulmonary embolism
Pat. No. 7598276 DS* Pharmaceutical salts and polymorphs of a factor Xa inhibitor
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: Jul 21, 2017
Nov 8, 2026 
Pat. No. 8557852 Methods of using crystalline forms of a salt of a factor Xa inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 21, 2017
Sep 8, 2028U-1167: Prophylaxis of deep vein thrombosis (DVT)
U-2030: Prophylaxis of venous thrombosis
Pat. No. 8987463 DP* Methods of synthesizing factor Xa inhibitors
Claim Types: Composition
Pat. Sub. Date(s): All strengths: Jul 21, 2017
Dec 28, 2030 
Pat. No. 8404724 DP* Unit dose formulations and methods of treating thrombosis with an oral factor Xa inhibitor
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jul 21, 2017
Mar 29, 2031U-2034: Inhibiting coagulation
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJun 23, 2022 

STARLIX (TABLET) (ORAL) NATEGLINIDE [GENERIC AB]
Drug Classes: glinide
NDA Applicant: NOVARTIS      NDA No.: 021204  Prod. No.: 001 RX (60MG); 002 RX (120MG)
PatentsExpirationPatented Use
Pat. No. 6559188 DP* Method of treating metabolic disorders especially diabetes, or a disease or condition associated with diabetes
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Sep 15, 2020U-827: Use for treatment of diabetes, particularly Type 2 diabetes
Pat. No. 6878749 DP* Method of treating metabolic disorders, especially diabetes, or a disease or condition associated with diabetes
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Sep 15, 2020 

MEGACE ES (SUSPENSION) (ORAL) MEGESTROL ACETATE [GENERIC AB]
Drug Classes: progestin
NDA Applicant: ENDO PHARMS INC      NDA No.: 021778  Prod. No.: 001 RX (125MG/ML)
PatentsExpirationPatented Use
Pat. No. 6592903 DP* Nanoparticulate dispersions comprising a synergistic combination of a polymeric surface stabilizer and dioctyl sodium sulfosuccinate
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: None
Sep 21, 2020 
Pat. No. 7101576 Nanoparticulate megestrol formulations
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Apr 22, 2024U-755: Treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (aids)
Pat. No. 9040088 Nanoparticulate megestrol formulations
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jun 11, 2015
Apr 22, 2024U-755: Treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (aids)
Pat. No. 9101540 DP* Nanoparticulate megestrol formulations
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 13, 2015
Apr 22, 2024U-755: Treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (aids)
Pat. No. 9101549 Nanoparticulate megestrol formulations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 13, 2015
Apr 22, 2024U-755: Treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (aids)
Pat. No. 9107827 Nanoparticulate megestrol formulations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 27, 2015
Apr 22, 2024U-755: Treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (aids)

OFEV (CAPSULE) (ORAL) NINTEDANIB ESYLATE
Drug Classes: kinase inhibitor
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 205832  Prod. No.: 001 RX (EQ 100MG BASE); 002 RX (EQ 150MG BASE)
PatentsExpirationPatented Use
Pat. No. 6762180 DS* DP* Substituted indolines which inhibit receptor tyrosine kinases
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Oct 22, 2014
Oct 3, 2020 
Pat. No. 7119093 DS* DP* 3-Z-[1-(4-(N-((4-Methyl-piperazin-1-yl)-methylcarbonyl)-N-methyl-amino)-an-ilino)-1-phenyl-methylene]-6-methoxycarbonyl-2-indolinone-monoethanesulpho- nate and the use thereof as a pharmaceutical composition
Claim Types: New polymorph, salt or hydrate; Composition; Intermediate
Pat. Sub. Date(s): All strengths: Oct 22, 2014
Feb 21, 2024 
Pat. No. 7989474 Use of Lck inhibitors for treatment of immunologic diseases
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 13, 2015
Apr 6, 2024U-1677: Treatment of idiopathic pulmonary fibrosis (IPF)
Pat. No. 10105323 DP* Pharmaceutical dosage form for immediate release of an indolinone derivative
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 6, 2018
Jun 4, 2029 
Pat. No. 9907756 DP* Capsule pharmaceutical dosage form comprising a suspension formulation of an indolinone derivative
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Apr 4, 2018
Jun 7, 2029 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityOct 15, 2019 
Exclusivity Code: ODE - Orphan drug exclusivityOct 15, 2021ODE-77: Treatment of idiopathic pulmonary fibrosis

FARXIGA (TABLET) (ORAL) DAPAGLIFLOZIN
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor
NDA Applicant: ASTRAZENECA AB      NDA No.: 202293  Prod. No.: 001 RX (5MG); 002 RX (10MG)
PatentsExpirationPatented Use
Pat. No. 6414126 DS* DP* C-aryl glucoside SGLT2 inhibitors and method
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): All strengths: Feb 5, 2014
Oct 4, 2020U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 6515117 DS* DP* C-aryl glucoside SGLT2 inhibitors and method
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): All strengths: Feb 5, 2014
Oct 4, 2020U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 6936590 C-aryl glucoside SGLT2 inhibitors and method
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 5, 2014
Oct 4, 2020U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 9198925 Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 18, 2015
Oct 4, 2020U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 9238076 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Nov 15, 2017
Apr 15, 2024U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Pat. No. 8431685 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Nov 15, 2017
Apr 13, 2025U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Pat. No. 8461105 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Nov 15, 2017
Apr 13, 2025U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Pat. No. 7456254 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Nov 15, 2017
Jun 30, 2025U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Pat. No. 8329648 Methods for treating diabetes and reducing body weight
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 15, 2017
Aug 18, 2026U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
U-2212: Reducing fasting plasma glucose in a human in need thereof in combination with a sustained-release composition containing exendin-4
U-2213: Reducing HBA1C in a human in need thereof in combination with a sustained-release composition containing exendin-4
Pat. No. 8906851 Method for treating diabetes
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 15, 2017
Aug 18, 2026U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Pat. Sub. Date(s): All strengths: Feb 5, 2014
Jun 20, 2027U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 8221786 DP* Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 5, 2014
Mar 21, 2028 
Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 5, 2014
Mar 21, 2028U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 8716251 DP* Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jun 2, 2014
Mar 21, 2028 
Pat. No. 7851502 DP* Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 5, 2014
Aug 19, 2028 
Pat. No. 7919598 DS* Crystal structures of SGLT2 inhibitors and processes for preparing same
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): All strengths: Feb 5, 2014
Dec 16, 2029 
Pat. No. 8721615 DP* Ampoule comprising an ampoule holder
Claim Types: Device
Pat. Sub. Date(s): All strengths: Nov 15, 2017
Jan 18, 2030 
Pat. No. 8685934 Methods for treating extreme insulin resistance in patients resistant to previous treatment with other anti-diabetic drugs employing an SGLT2 inhibitor and compositions thereof
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 25, 2014
May 26, 2030U-1522: Treatment of Type 2 diabetes mellitus in a patient, wherein glycemic control (HBA1C < 7.0%) is not achievable using one or more of insulin, metformin, pioglitazone, or rosiglitazone
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousMar 11, 2018M-157: Information added to the labeling regarding the safety and efficacy of dapagliflozin 10mg once daily in patients with Type 2 diabetes who have inadequate glycemic control on a background combination of metformin and sulfonylurea
Exclusivity Code: M - MiscellaneousOct 20, 2020M-212: Information added to the labeling regarding the safety and efficacy of dapagliflozin in patients with Type 2 diabetes who have inadequate glycemic control on a background combination of metformin and exenatide extended release
Exclusivity Code: NCE - New chemical entityJan 8, 2019 

QTERN (TABLET) (ORAL) DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor; dipeptidyl peptidase 4 (DPP-4) inhibitor
NDA Applicant: ASTRAZENECA AB      NDA No.: 209091  Prod. No.: 001 RX (10MG;EQ 5MG BASE)
PatentsExpirationPatented Use
Pat. No. 6414126 DS* DP* C-aryl glucoside SGLT2 inhibitors and method
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Mar 22, 2017
Oct 4, 2020U-1976: Method for treating Type 2 diabetes mellitus (T2DM) in patients who have inadequate control with dapagliflozin
U-1977: Method for treating Type 2 diabetes mellitus (T2DM) in patients who are already treated with dapagliflozin and saxagliptin
Pat. No. 6515117 DS* DP* C-aryl glucoside SGLT2 inhibitors and method
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Mar 22, 2017
Oct 4, 2020U-1976: Method for treating Type 2 diabetes mellitus (T2DM) in patients who have inadequate control with dapagliflozin
U-1977: Method for treating Type 2 diabetes mellitus (T2DM) in patients who are already treated with dapagliflozin and saxagliptin
Pat. No. 6936590 C-aryl glucoside SGLT2 inhibitors and method
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 22, 2017
Oct 4, 2020U-1976: Method for treating Type 2 diabetes mellitus (T2DM) in patients who have inadequate control with dapagliflozin
U-1977: Method for treating Type 2 diabetes mellitus (T2DM) in patients who are already treated with dapagliflozin and saxagliptin
Pat. No. 9198925 Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 22, 2017
Oct 4, 2020U-1976: Method for treating Type 2 diabetes mellitus (T2DM) in patients who have inadequate control with dapagliflozin
U-1977: Method for treating Type 2 diabetes mellitus (T2DM) in patients who are already treated with dapagliflozin and saxagliptin
Pat. No. RE44186 DS* DP* Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Mar 22, 2017
Jul 31, 2023U-1976: Method for treating Type 2 diabetes mellitus (T2DM) in patients who have inadequate control with dapagliflozin
U-1977: Method for treating Type 2 diabetes mellitus (T2DM) in patients who are already treated with dapagliflozin and saxagliptin
Pat. No. 8628799 DP* Coated tablet formulation and method
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 22, 2017
Jul 13, 2025 
Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Mar 22, 2017
Jun 20, 2027U-1976: Method for treating Type 2 diabetes mellitus (T2DM) in patients who have inadequate control with dapagliflozin
U-1977: Method for treating Type 2 diabetes mellitus (T2DM) in patients who are already treated with dapagliflozin and saxagliptin
Pat. No. 8221786 DP* Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 22, 2017
Mar 21, 2028 
Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 22, 2017
Mar 21, 2028U-1976: Method for treating Type 2 diabetes mellitus (T2DM) in patients who have inadequate control with dapagliflozin
U-1977: Method for treating Type 2 diabetes mellitus (T2DM) in patients who are already treated with dapagliflozin and saxagliptin
Pat. No. 8716251 DP* Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 22, 2017
Mar 21, 2028 
Pat. No. 7919598 DS* Crystal structures of SGLT2 inhibitors and processes for preparing same
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: Mar 22, 2017
Dec 16, 2029 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousApr 5, 2019M-175: Information added to the labeling describing savor, a phase IV trial evaluating the effect of saxagliptin on the incidence of cardiovascular death, myocardial infarction or ischaemic stroke in patients with Type 2 diabetes
Exclusivity Code: NC - New combinationFeb 27, 2020 
Exclusivity Code: NCE - New chemical entityJan 8, 2019 

XIGDUO XR (TABLET, EXTENDED RELEASE) (ORAL) DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor; biguanide
NDA Applicant: ASTRAZENECA AB      NDA No.: 205649  Prod. No.: 001 RX (5MG;500MG); 002 RX (5MG;1GM); 003 RX (10MG;500MG); 004 RX (10MG;1GM); 005 RX (2.5MG;1GM)
PatentsExpirationPatented Use
Pat. No. 6414126 DS* DP* C-aryl glucoside SGLT2 inhibitors and method
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 24, 2014; 002: Nov 24, 2014; 003: Nov 24, 2014; 004: Nov 24, 2014; 005: Aug 30, 2017
Oct 4, 2020U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 6515117 DS* DP* C-aryl glucoside SGLT2 inhibitors and method
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 24, 2014; 002: Nov 24, 2014; 003: Nov 24, 2014; 004: Nov 24, 2014; 005: Aug 30, 2017
Oct 4, 2020U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 6936590 C-aryl glucoside SGLT2 inhibitors and method
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 24, 2014; 002: Nov 24, 2014; 003: Nov 24, 2014; 004: Nov 24, 2014; 005: Aug 30, 2017
Oct 4, 2020U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 9198925 Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 18, 2015; 002: Dec 18, 2015; 003: Dec 18, 2015; 004: Dec 18, 2015; 005: Aug 30, 2017
Oct 4, 2020U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 24, 2014; 002: Nov 24, 2014; 003: Nov 24, 2014; 004: Nov 24, 2014; 005: Aug 30, 2017
Jun 20, 2027U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 7919598 DS* Crystal structures of SGLT2 inhibitors and processes for preparing same
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: Nov 24, 2014; 002: Nov 24, 2014; 003: Nov 24, 2014; 004: Nov 24, 2014; 005: Aug 30, 2017
Dec 16, 2029 
Pat. No. 8685934 Methods for treating extreme insulin resistance in patients resistant to previous treatment with other anti-diabetic drugs employing an SGLT2 inhibitor and compositions thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 24, 2014; 002: Nov 24, 2014; 003: Nov 24, 2014; 004: Nov 24, 2014; 005: Aug 30, 2017
May 26, 2030U-1522: Treatment of Type 2 diabetes mellitus in a patient, wherein glycemic control (HBA1C < 7.0%) is not achievable using one or more of insulin, metformin, pioglitazone, or rosiglitazone
Pat. No. 9616028 DP* Bilayer tablet formulations
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Aug 30, 2017
Nov 12, 2030 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJan 8, 2019 

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
Oct 10, 2020U-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
Dec 9, 2023U-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
Dec 9, 2023U-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
Dec 9, 2023U-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
Oct 27, 2024U-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
Feb 21, 2026U-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
Feb 21, 2026U-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
Feb 21, 2026U-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
Aug 13, 2026U-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
Mar 4, 2032U-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
Mar 4, 2032U-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
Jan 12, 2034U-1434: Treatment of pancreatic cancer
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivitySep 6, 2020ODE-52: Treatment of metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine.

MOXATAG (TABLET, EXTENDED RELEASE) (ORAL) AMOXICILLIN
Drug Classes: penicillin class antibacterial
NDA Applicant: VERNALIS R AND D LTD      NDA No.: 050813  Prod. No.: 001 RX (775MG)
PatentsExpirationPatented Use
Pat. No. 6544555 DS* DP* Antibiotic product, use and formulation thereof
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Oct 13, 2020U-897: Method of treating tonsillitis and/or pharyngitis secondary to streptococcus pyogenes in a once-a-day amoxicillin product
Pat. No. 6669948 DS* DP* Antibiotic product, use and formulation thereof
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Oct 13, 2020U-897: Method of treating tonsillitis and/or pharyngitis secondary to streptococcus pyogenes in a once-a-day amoxicillin product
Pat. No. 6723341 DS* DP* Antibiotic product, use and formulation thereof
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Oct 13, 2020U-897: Method of treating tonsillitis and/or pharyngitis secondary to streptococcus pyogenes in a once-a-day amoxicillin product
Pat. No. 8357394 DP* Compositions and methods for improved efficacy of penicillin-type antibiotics
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 30, 2013
Dec 8, 2026 
Pat. No. 8778924 DS* DP* Modified release amoxicillin products
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jun 17, 2015
Dec 8, 2026U-897: Method of treating tonsillitis and/or pharyngitis secondary to streptococcus pyogenes in a once-a-day amoxicillin product
Pat. No. 8299052 Pharmaceutical compositions and methods for improved bacterial eradication
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 3, 2012
May 7, 2027U-1304: Use of once-a-day amoxicillin product to treat tonsillitis and/or pharyngitis secondary to streptococcus pyogenes

LESCOL XL (TABLET, EXTENDED RELEASE) (ORAL) FLUVASTATIN SODIUM [GENERIC AB]
Drug Classes: HMG CoA-reductase inhibitor
NDA Applicant: NOVARTIS      NDA No.: 021192  Prod. No.: 001 RX (EQ 80MG BASE)
PatentsExpirationPatented Use
Pat. No. 6242003 Organic compounds
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: None
Oct 13, 2020 *PED 

SPRYCEL (TABLET) (ORAL) DASATINIB
Drug Classes: kinase inhibitor
NDA Applicant: BRISTOL MYERS SQUIBB      NDA No.: 021986  Prod. No.: 001 RX (20MG); 002 RX (50MG); 003 RX (70MG); 004 RX (100MG); 005 RX (80MG); 006 RX (140MG)
PatentsExpirationPatented Use
Pat. No. 7125875 Cyclic protein tyrosine kinase inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Oct 13, 2020 *PEDU-779: A method for treatment of a cancer, wherein the cancer is chronic myelogenous leukemia
U-780: A method for the treatment of cancer
Pat. No. 7153856 Cyclic protein tyrosine kinase inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Oct 28, 2020 *PEDU-780: A method for the treatment of cancer
Pat. No. 6596746 DS* DP* [Extended 76 days (0.2 years)]
Cyclic protein tyrosine kinase inhibitors
Claim Types: Compound; Method of use; Composition
Pat. Sub. Date(s): All strengths: None
Dec 28, 2020 *PEDU-748: A method for the treatment of a protein tyrosine kinase-associated disorder
U-780: A method for the treatment of cancer
Pat. No. 8680103 DP* Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Apr 14, 2014
Aug 4, 2025 *PED 
Pat. No. 7491725 DS* DP* Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors
Claim Types: New polymorph, salt or hydrate; Composition; Process
Pat. Sub. Date(s): All strengths: None
Sep 28, 2026 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationNov 9, 2020 
Exclusivity Code: ODE - Orphan drug exclusivityNov 9, 2024ODE-164: Treatment of pediatric patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase

RENAGEL (TABLET) (ORAL) SEVELAMER HYDROCHLORIDE
Drug Classes: phosphate binder
NDA Applicant: GENZYME      NDA No.: 021179  Prod. No.: 001 RX (400MG); 002 RX (800MG)
PatentsExpirationPatented Use
Pat. No. 6733780 DP* Direct compression polymer tablet core
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Oct 18, 2020 

AVANDARYL (TABLET) (ORAL) GLIMEPIRIDE; ROSIGLITAZONE MALEATE
Drug Classes: sulfonylurea; peroxisome proliferator-activated receptor (PPAR) gamma agonist; thiazolidinedione
NDA Applicant: SB PHARMCO      NDA No.: 021700  Prod. No.: 001 DISC (1MG;4MG**); 002 DISC (2MG;4MG**); 003 DISC (4MG;4MG**); 004 DISC (2MG;8MG**); 005 DISC (4MG;8MG**)
PatentsExpirationPatented Use
Pat. No. 7358366 DS* Thiazolidinedione derivative and its use as antidiabetic
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: None
Oct 19, 2020 *PED 

AVANDIA (TABLET) (ORAL) ROSIGLITAZONE MALEATE
Drug Classes: peroxisome proliferator-activated receptor (PPAR) gamma agonist; thiazolidinedione
NDA Applicant: SB PHARMCO      NDA No.: 021071  Prod. No.: 002 RX (EQ 2MG BASE); 003 RX (EQ 4MG BASE) NDA No.: 021071  Prod. No.: 004 DISC (EQ 8MG BASE)
PatentsExpirationPatented Use
Pat. No. 7358366 DS* Thiazolidinedione derivative and its use as antidiabetic
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: None
Oct 19, 2020 *PED 

OZURDEX (IMPLANT) (INTRAVITREAL) DEXAMETHASONE
Drug Classes: corticosteroid
NDA Applicant: ALLERGAN      NDA No.: 022315  Prod. No.: 001 RX (0.7MG)
PatentsExpirationPatented Use
Pat. No. 6726918 DP* Methods for treating inflammation-mediated conditions of the eye
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: None
Oct 20, 2020U-1204: Treatment of uveitis
U-1205: Treatment of macular edema
Pat. No. 7033605 DP* Methods for reducing or preventing transplant rejection in the eye and intraocular implants for use therefor
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: None
Oct 20, 2020 
Pat. No. 8043628 Methods for reducing edema
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Oct 20, 2020U-1205: Treatment of macular edema
Pat. No. 8063031 DP* Implants and methods for treating inflammation-mediated conditions of the eye
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 23, 2011
Oct 20, 2020 
Pat. No. 8088407 Method for reducing or preventing transplant rejection in the eye and intraocular implants for use therefor
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Oct 20, 2020U-1205: Treatment of macular edema
Pat. No. 9012437 Implants and methods for treating inflammation-mediated conditions of the eye
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 19, 2015
Oct 20, 2020U-1205: Treatment of macular edema
Pat. No. 9283178 Methods for treating edema in the eye and intraocular implants for use therefor
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 12, 2016
Oct 20, 2020U-1205: Treatment of macular edema
Pat. No. 9592242 Methods for treating edema in the eye and intraocular implants for use therefor
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 13, 2017
Oct 20, 2020U-1989: Intravitreal treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
U-1990: Intravitreal treatment of diabetic macular edema
Pat. No. 9775849 Implants and methods for treating inflammation-mediated conditions of the eye
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 2, 2017
Oct 20, 2020U-1989: Intravitreal treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
U-1990: Intravitreal treatment of diabetic macular edema
Pat. No. 7767223 DP* Methods for reducing or preventing transplant rejection in the eye and intraocular implants for use
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Nov 28, 2021 
Pat. No. 8034366 DP* Ocular implant made by a double extrusion process
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Dec 23, 2011
Jan 9, 2023U-1204: Treatment of uveitis
U-1205: Treatment of macular edema
Pat. No. 8034370 DP* Ocular implant made by a double extrusion process
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 23, 2011
Jan 9, 2023 
Pat. No. 8506987 Ocular implant made by a double extrusion process
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 11, 2013
Jan 9, 2023U-1204: Treatment of uveitis
U-1205: Treatment of macular edema
Pat. No. 9192511 DP* Ocular implant made by a double extrusion process
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 21, 2015
Jan 9, 2023 
Pat. No. 10076526 DP* Ocular implant made by a double extrusion process
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 17, 2018
Jan 9, 2023 
Pat. No. 6899717 Methods and apparatus for delivery of ocular implants
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
Nov 1, 2023U-1206: Delivering an ocular implant as described in the dosage and administration section of the approved labeling of OZURDEX

LONHALA MAGNAIR KIT (SOLUTION) (INHALATION) GLYCOPYRROLATE
Drug Classes: anticholinergic
NDA Applicant: SUNOVION RESP      NDA No.: 208437  Prod. No.: 001 RX (25MCG/ML)
PatentsExpirationPatented Use
Pat. No. 6962151 DP* Inhalation nebulizer
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 2, 2018
Oct 27, 2020 
Pat. No. 7316067 DP* Forming a perforate membrane by laser drilling and a subsequent electro-polishing step
Claim Types: Device; Process
Pat. Sub. Date(s): 001: Jan 2, 2018
Sep 6, 2022 
Pat. No. 8511581 DP* Fluid droplet production apparatus and method
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 2, 2018
Nov 8, 2023 
Pat. No. 7458372 DP* Inhalation therapy device
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 2, 2018
Nov 18, 2024 
Pat. No. 7931212 DP* Fluid droplet production apparatus and method
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 2, 2018
Nov 25, 2025 
Pat. No. 9265900 DP* Disposable ampoule for an aerosol generating device
Claim Types: Drug in a container; Product-by-process; Method of use
Pat. Sub. Date(s): 001: Jan 2, 2018
Dec 7, 2028 
Pat. No. 9789270 DP* Inhalation therapy device comprising an ampoule for storing a medicament to be nebulized
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 2, 2018
Oct 30, 2030 
Pat. No. 9168556 DP* Membrane nebulizer and method for welding a membrane to a carrier during the production of a membrane nebulizer
Claim Types: Device; Process
Pat. Sub. Date(s): 001: Jan 2, 2018
Sep 1, 2032 
Pat. No. 9604018 DP* Aerosol therapy device
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 2, 2018
May 16, 2033 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productDec 5, 2020 

METADATE CD (CAPSULE, EXTENDED RELEASE) (ORAL) METHYLPHENIDATE HYDROCHLORIDE [GENERIC AB2]
Drug Classes: central nervous system stimulant
NDA Applicant: LANNETT CO INC      NDA No.: 021259  Prod. No.: 001 RX (20MG); 002 RX (30MG); 003 RX (10MG); 004 RX (40MG)
PatentsExpirationPatented Use
Pat. No. 6344215 DP* Methylphenidate modified release formulations
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Oct 27, 2020 

CAMPTOSAR (INJECTABLE) (INJECTION) IRINOTECAN HYDROCHLORIDE [GENERIC AP]
Drug Classes: topoisomerase inhibitor
NDA Applicant: PFIZER INC      NDA No.: 020571  Prod. No.: 001 RX (40MG/2ML (20MG/ML)); 002 RX (100MG/5ML (20MG/ML))
PatentsExpirationPatented Use
Pat. No. 6403569 Method for treating cancer using camptothecin derivatives and 5-fluorouracil
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Oct 28, 2020 *PEDU-449: Use in combination with 5-fluorouracil and leucovorin for the treatment of metastatic colorectal cancer where the dose of leucovorin is at least 200mg per square meter
Pat. No. 6794370 Method for treating cancer using camptothecin derivatives and 5-fluorouracil
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Nov 1, 2020 *PEDU-606: Use of irinotecan in combination with 5-fluorouracil and leucovorin for the treatment of metastatic colorectal cancer

HYSINGLA (TABLET, EXTENDED RELEASE) (ORAL) HYDROCODONE BITARTRATE
Drug Classes: opioid agonist
NDA Applicant: PURDUE PHARMA LP      NDA No.: 206627  Prod. No.: 001 RX (20MG); 002 RX (30MG); 003 RX (40MG); 004 RX (60MG)
PatentsExpirationPatented Use
Pat. No. 9023401 DP* Controlled release hydrocodone formulations
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 22, 2015
Oct 30, 2020 
Pat. No. 9056052 DP* Controlled release hydrocodone formulations
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 13, 2015
Oct 30, 2020 
Pat. No. 9060940 Controlled release hydrocodone
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): All strengths: Jul 17, 2015
Oct 30, 2020U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 9198863 DP* Controlled release hydrocodone formulations
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Dec 24, 2015
Oct 30, 2020 
Pat. No. 9205056 DP* Controlled release hydrocodone formulations
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