Orange Book Companion®
Generic names starting with "A"

Patents whose numbers are in italics have been extended under 35 USC 156. Unless otherwise noted, all expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
Products tagged as [GENERIC] have had a generic equivalent approved for at least one strength of the product.


ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE (TABLET) (ORAL) TRIUMEQ
Drug Classes: Antivirals:Anti-HIV Agents, Nucleoside and Nucleotide Reverse Transcriptase Inhibitors (NRTI) == Antivirals:Anti-HIV Combinations == HIV nucleoside analog reverse transcriptase inhibitor (HIV-1 NRTI) == Antivirals:Anti-HIV Agents, Integrase Inhibitors (INSTI) == HIV integrase strand transfer inhibitor (HIV-1 INSTI) == Antivirals:Anti-hepatitis B (HBV) Agents == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: VIIV HLTHCARE      NDA No.: 205551  Prod. No.: 001 RX (EQ 600MG BASE;EQ 50MG BASE;300MG)
2 Patents--2 FamiliesExpirationPatented Use
Pat. No. 8129385 DS* DP* (Family Id: 37215098) Substituted 5-hydroxy-3,4,6,9,9a, 10-hexanhydro-2h-1-oxa04a,8a-diaza-anthracene-6,10-dioness
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Sep 16, 2014
Oct 5, 2027 
Pat. No. 9242986 DS* DP* (Family Id: 42242992) Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Mar 10, 2016
Dec 8, 2029 

ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE (TABLET, FOR SUSPENSION) (ORAL) TRIUMEQ PD
Drug Classes: Antivirals:Anti-HIV Agents, Nucleoside and Nucleotide Reverse Transcriptase Inhibitors (NRTI) == Antivirals:Anti-HIV Combinations == HIV nucleoside analog reverse transcriptase inhibitor (HIV-1 NRTI) == Antivirals:Anti-HIV Agents, Integrase Inhibitors (INSTI) == HIV integrase strand transfer inhibitor (HIV-1 INSTI) == Antivirals:Anti-hepatitis B (HBV) Agents == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: VIIV HLTHCARE      NDA No.: 215413  Prod. No.: 001 RX (EQ 60MG BASE;EQ 5MG BASE;30MG)
2 Patents--2 FamiliesExpirationPatented Use
Pat. No. 8129385 DS* DP* (Family Id: 37215098) Substituted 5-hydroxy-3,4,6,9,9a, 10-hexanhydro-2h-1-oxa04a,8a-diaza-anthracene-6,10-dioness
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Apr 7, 2022
Oct 5, 2027 
Pat. No. 9242986 DS* DP* (Family Id: 42242992) Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Apr 7, 2022
Dec 8, 2029 

ABALOPARATIDE (SOLUTION) (SUBCUTANEOUS) TYMLOS
Drug Classes: Metabolic Bone Disease Agents == parathyroid hormone related peptide [PTHrP(1-34)] analog
NDA Applicant: RADIUS HEALTH INC      NDA No.: 208743  Prod. No.: 001 RX (3.12MG/1.56ML (2MG/ML))
5 Patents--4 FamiliesExpirationPatented Use
Pat. No. 8148333 DP* (Family Id: 39430237) Stable composition comprising a PTHrP analogue
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: May 25, 2017
Nov 8, 2027 
Pat. No. 7803770 [Extended 1303 days (3.6 years)]
(Family Id: 40873336) Method of treating osteoporosis comprising administration of PTHrP analog
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 25, 2017
Apr 28, 2031U-2009: Method of treating postmenopausal women with osteoporosis at high risk for fracture.
Pat. No. 8748382 (Family Id: 40873336) Method of drug delivery for bone anabolic protein
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 25, 2017
Oct 3, 2027U-2009: Method of treating postmenopausal women with osteoporosis at high risk for fracture.
Pat. No. 11255842 (Family Id: 69326581) Methods for detecting neutralizing antibodies to parathyroid hormone (PTH) and parathyroid hormone-related peptide (PTHRP) analog
Claim Types: Diagnostic or surgical method; Kit
Pat. Sub. Date(s): 001: Mar 14, 2022
Jan 10, 2040U-3322: Use for detecting neutralizing antibodies
Pat. No. 10996208 DP* (Family Id: 69523931) Abaloparatide formulations and methods of testing, storing, modifying, and using same
Claim Types: Formulation; Analytical method
Pat. Sub. Date(s): 001: Jun 1, 2021
Apr 30, 2038 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousSep 20, 2024M-270: Information added to clinical pharmacology section
Exclusivity Code: NCE - New chemical entityApr 28, 2022 

ABAMETAPIR (LOTION) (TOPICAL) XEGLYZE
Drug Classes: Dermatological Agents:Pediculicides/Scabicides
NDA Applicant: HATCHTECH      NDA No.: 206966  Prod. No.: 001 DISC (0.74%)
5 Patents--2 FamiliesExpirationPatented Use
Pat. No. 7812163 DP* (Family Id: 36780733) Methods and compositions for controlling ectoparasites
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 31, 2020
Oct 28, 2026U-2863: Topical treatment of head lice infestation in patients 6 months of age and older
Pat. No. 8212038 DP* (Family Id: 36780733) Methods and compositions for controlling ectoparasites
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 31, 2020
Jul 16, 2024U-2863: Topical treatment of head lice infestation in patients 6 months of age and older
Pat. No. 9357783 DP* (Family Id: 36780733) Methods and compositions for controlling ectoparasites
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 31, 2020
Jul 16, 2024 
Pat. No. 9839631 DS* DP* (Family Id: 36780733) Methods and compositions for controlling ectoparasites
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 31, 2020
Jul 16, 2024U-2863: Topical treatment of head lice infestation in patients 6 months of age and older
Pat. No. 10292389 DP* (Family Id: 53366861) Pediculicidal composition
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jul 31, 2020
Dec 17, 2034U-2863: Topical treatment of head lice infestation in patients 6 months of age and older
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJul 24, 2025 

ABEMACICLIB (TABLET) (ORAL) VERZENIO
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: ELI LILLY AND CO      NDA No.: 208716  Prod. No.: 001 RX (50MG); 002 RX (100MG); 003 RX (150MG)
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 7855211 DS* DP* (Family Id: 42267022) Protein kinase inhibitors
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Oct 16, 2017
Dec 15, 2029U-2132: In combination with fulvestrant for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy
U-2135: As monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting
U-2251: In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
U-3241: In combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hr-positive, HER2-negative, node-positive, early breast cancer at high risk of recurrence and a KI-67 score >=20%
U-3242: In combination with fulvestrant for the treatment of adult patients with hr-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endrocrine therapy
U-3243: In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women, and men with HR-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationOct 12, 2024I-877: Indication for the use of abemaciclib in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early cancer (EBC) at high risk of recurrence and a KI-67 score>20% as determined by an FDA approved test
Exclusivity Code: NCE - New chemical entitySep 28, 2022 
Exclusivity Code: NPP - New patient populationOct 12, 2024 

ABEMACICLIB (TABLET) (ORAL) VERZENIO
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: ELI LILLY AND CO      NDA No.: 208716  Prod. No.: 004 RX (200MG)
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 7855211 DS* DP* (Family Id: 42267022) Protein kinase inhibitors
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 004: Oct 16, 2017
Dec 15, 2029U-1981: In combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER-2)-negative advanced or metastatic breast cancer
U-2132: In combination with fulvestrant for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy
U-2135: As monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting
U-2251: In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationOct 12, 2024I-877: Indication for the use of abemaciclib in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early cancer (EBC) at high risk of recurrence and a KI-67 score>20% as determined by an FDA approved test
Exclusivity Code: NCE - New chemical entitySep 28, 2022 
Exclusivity Code: NPP - New patient populationOct 12, 2024 

ABIRATERONE ACETATE (TABLET) (ORAL) YONSA [GENERIC AB]
Drug Classes: Antineoplastics:Antiandrogens == CYP17 inhibitor
NDA Applicant: SUN PHARM      NDA No.: 210308  Prod. No.: 001 RX (125MG)
2 Patents--2 FamiliesExpirationPatented Use
Pat. No. 10292990 (Family Id: 53270047) Abiraterone steroid formulation
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 31, 2019
May 20, 2034U-2535: Use in combination with methylprednisolone for the treatment of patients with prostate cancer
Pat. No. 9889144 DP* (Family Id: 54006256) Abiraterone acetate formulation and methods of use
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 19, 2018
Mar 17, 2034 

ABROCITINIB (TABLET) (ORAL) CIBINQO
Drug Classes: Janus kinase (JAK) inhibitor
NDA Applicant: PFIZER      NDA No.: 213871  Prod. No.: 001 RX (50MG); 002 RX (100MG); 003 RX (200MG)
3 Patents--1 FamilyExpirationPatented Use
Pat. No. 9035074 DS* DP* (Family Id: 50151346) Pyrrolo[2,3-D]pyrimidine derivatives
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Feb 11, 2022
Feb 19, 2034 
Pat. No. 9545405 DS* DP* (Family Id: 50151346) Pyrrolo[2,3-D]pyrimidine derivatives
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Feb 11, 2022
Feb 19, 2034 
Pat. No. 9549929 (Family Id: 50151346) Pyrrolo[2,3-D]pyrimidine derivatives
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 11, 2022
Feb 19, 2034U-3195: Treatment of adults with refractory, moderate-to-severe atopic dermatitis not adequately controlled with other systemic drug products or when use of those therapies is inadvisable
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJan 14, 2027 

ACALABRUTINIB (CAPSULE) (ORAL) CALQUENCE
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: ASTRAZENECA      NDA No.: 210259  Prod. No.: 001 RX (100MG)
7 Patents--4 FamiliesExpirationPatented Use
Pat. No. 7459554 DS* (Family Id: 34465267) Imidazopyrazine tyrosine kinase inhibitors
Claim Types: Compound
Pat. Sub. Date(s): 001: Apr 13, 2018
Nov 24, 2026 
Pat. No. 9290504 DS* DP* (Family Id: 47557677) 4-imidazopyridazin-1-yl-benzamides and 4-imidazotriazin-1-yl-benzamides as BTK inhibitors
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Nov 28, 2017
Jul 11, 2032 
Pat. No. 9758524 (Family Id: 47557677) 4-imidazopyridazin-1-yl-benzamides as BTK inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 28, 2017
Jul 11, 2032U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy
Pat. No. 10239883 (Family Id: 47557677) 4-imidazopyridazin-1-yl-benzamides as BTK inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 12, 2019
Jul 11, 2032U-2666: Treatment of adult patients with chronic lymphocytic leukemia
U-2668: Treatment of adult patients with previously untreated chronic lymphocytic leukemia in combination with obinutuzumab
Pat. No. 9796721 DS* DP* (Family Id: 56363881) Crystal forms of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1- yl)-N-(pyridin-2-yl)benzamide
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 28, 2017
Jul 1, 2036U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy
U-2666: Treatment of adult patients with chronic lymphocytic leukemia
U-2667: Treatment of adult patients with small lymphocytic leukemia
U-2668: Treatment of adult patients with previously untreated chronic lymphocytic leukemia in combination with obinutuzumab
U-2669: Treatment of adult patients with previously untreated small lymphocytic leukemia in combination with obinutuzumab
U-2670: Treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic leukemia
U-2671: Treatment of adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic leukemia in combination with obinutuzumab
Pat. No. 10167291 DP* (Family Id: 56363881) Pharmaceutical composition comprising a crystal form of (S)-4-(8-amino-3-(1-(but-2-ynoyl) pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide
Claim Types: Composition; Method of use
Pat. Sub. Date(s): 001: Jan 24, 2019
Jul 1, 2036U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy
U-2666: Treatment of adult patients with chronic lymphocytic leukemia
U-2667: Treatment of adult patients with small lymphocytic leukemia
U-2668: Treatment of adult patients with previously untreated chronic lymphocytic leukemia in combination with obinutuzumab
U-2669: Treatment of adult patients with previously untreated small lymphocytic leukemia in combination with obinutuzumab
U-2670: Treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic leukemia
U-2671: Treatment of adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic leukemia in combination with obinutuzumab
Pat. No. 10272083 (Family Id: 58446476) Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 22, 2019
Jan 21, 2035U-2519: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy by administering 100 mg of acalabrutinib twice daily
U-2682: Treatment of adult patients with chronic lymphocytic leukemia by administering 100mg of acalabrutinib twice daily
U-2683: Treatment of adult patients with small lymphocytic leukemia by administering 100mg of acalabrutinib twice daily
U-2684: Treatment of adult patients with previously untreated chronic lymphocytic leukemia by administering 100 mg of acalabrutinib twice daily in combination with obinutuzumab
U-2685: Treatment of adult patients with previously untreated small lymphocytic leukemia by administering 100 mg of acalabrutinib twice daily in combination with obinutuzumab
U-2686: Treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic leukemia by administering 100 mg of acalabrutinib twice daily
U-2687: Treatment of adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic leukemia in combination with obinutuzumab by administering 100 mg of acalabrutinib twice daily
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationNov 21, 2022I-817: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
Exclusivity Code: NCE - New chemical entityOct 31, 2022 
Exclusivity Code: ODE - Orphan drug exclusivityOct 31, 2024ODE-175: Treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy
Exclusivity Code: ODE - Orphan drug exclusivityNov 21, 2026ODE-274: Indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

ACALABRUTINIB MALEATE (TABLET) (ORAL) CALQUENCE
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: ASTRAZENECA      NDA No.: 216387  Prod. No.: 001 RX (EQ 100MG BASE)
6 Patents--4 FamiliesExpirationPatented Use
Pat. No. 7459554 DS* (Family Id: 34465267) Imidazopyrazine tyrosine kinase inhibitors
Claim Types: Compound
Pat. Sub. Date(s): 001: Sep 1, 2022
Nov 24, 2026 
Pat. No. 9290504 DS* DP* (Family Id: 47557677) 4-imidazopyridazin-1-yl-benzamides and 4-imidazotriazin-1-yl-benzamides as BTK inhibitors
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Sep 1, 2022
Jul 11, 2032 
Pat. No. 9758524 (Family Id: 47557677) 4-imidazopyridazin-1-yl-benzamides as BTK inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 1, 2022
Jul 11, 2032U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy
Pat. No. 10239883 (Family Id: 47557677) 4-imidazopyridazin-1-yl-benzamides as BTK inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 1, 2022
Jul 11, 2032U-2666: Treatment of adult patients with chronic lymphocytic leukemia
U-2668: Treatment of adult patients with previously untreated chronic lymphocytic leukemia in combination with obinutuzumab
Pat. No. 11059829 DS* DP* (Family Id: 56363881) Crystal forms of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-- yl)-N-(pyridin-2-yl)benzamide maleate
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Pat. Sub. Date(s): 001: Sep 1, 2022
Jul 1, 2036U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy
U-2666: Treatment of adult patients with chronic lymphocytic leukemia
U-2667: Treatment of adult patients with small lymphocytic leukemia
U-2668: Treatment of adult patients with previously untreated chronic lymphocytic leukemia in combination with obinutuzumab
U-2669: Treatment of adult patients with previously untreated small lymphocytic leukemia in combination with obinutuzumab
U-2670: Treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic leukemia
U-2671: Treatment of adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic leukemia in combination with obinutuzumab
Pat. No. 10272083 (Family Id: 58446476) Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 1, 2022
Jan 21, 2035U-2519: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy by administering 100 mg of acalabrutinib twice daily
U-2682: Treatment of adult patients with chronic lymphocytic leukemia by administering 100mg of acalabrutinib twice daily
U-2683: Treatment of adult patients with small lymphocytic leukemia by administering 100mg of acalabrutinib twice daily
U-2684: Treatment of adult patients with previously untreated chronic lymphocytic leukemia by administering 100 mg of acalabrutinib twice daily in combination with obinutuzumab
U-2685: Treatment of adult patients with previously untreated small lymphocytic leukemia by administering 100 mg of acalabrutinib twice daily in combination with obinutuzumab
U-2686: Treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic leukemia by administering 100 mg of acalabrutinib twice daily
U-2687: Treatment of adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic leukemia in combination with obinutuzumab by administering 100 mg of acalabrutinib twice daily

ACETAMINOPHEN (SOLUTION) (INTRAVENOUS) OFIRMEV [Has competitive generic]
NDA Applicant: MALLINCKRODT HOSP      NDA No.: 022450  Prod. No.: 001 DISC (1GM/100ML (10MG/ML))
4 Patents--1 FamilyExpirationPatented Use
Pat. No. 9399012 (Family Id: 40639132) Reduced dose intravenous acetaminophen
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 8, 2016
Mar 11, 2032 *PEDU-2261: Modified dosing regimen for the management of mild to moderate pain or management of moderate to severe pain as an adjunct to opioid analgesics
U-2262: Modified dosing regimen for the reduction of fever
Pat. No. 9610265 (Family Id: 40639132) Reduced dose intravenous acetaminophen
Claim Types: Method of administration
Pat. Sub. Date(s): 001: May 4, 2017
May 13, 2029 *PEDU-2263: Modified dosing regimen for the management of moderate to severe pain with adjunctive opioid analgesics
Pat. No. 9987238 (Family Id: 40639132) Reduced dose intravenous acetaminophen
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 13, 2018
May 13, 2029 *PEDU-2261: Modified dosing regimen for the management of mild to moderate pain or management of moderate to severe pain as an adjunct to opioid analgesics
Pat. No. 10383834 (Family Id: 40639132) Reduced dose intravenous acetaminophen
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 18, 2019
Nov 13, 2028U-2262: Modified dosing regimen for the reduction of fever
U-2621: Modified dosing regimen for the management of mild to moderate pain

ACETAMINOPHEN (SOLUTION) (INTRAVENOUS) ACETAMINOPHEN [Has competitive generic]
NDA Applicant: FRESENIUS KABI USA      NDA No.: 204767  Prod. No.: 001 RX (1GM/100ML (10MG/ML))
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 8741959 DP* (Family Id: 41066778) Paracetamol for parenteral administration
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 24, 2019
Apr 19, 2030 

ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE (TABLET) (ORAL) APADAZ
NDA Applicant: KVK TECH INC      NDA No.: 208653  Prod. No.: 001 RX (325MG;EQ 6.12MG BASE)
5 Patents--1 FamilyExpirationPatented Use
Pat. No. 8461137 DS* DP* (Family Id: 43411452) Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
Claim Types: Composition
Pat. Sub. Date(s): 001: Mar 22, 2018
Feb 22, 2031 
Pat. No. 8748413 DS* DP* (Family Id: 43411452) Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Mar 22, 2018
Jul 1, 2030 
Pat. No. 8828978 DP* (Family Id: 43411452) Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Mar 22, 2018
Jul 1, 2030 
Pat. No. 9132125 DS* DP* (Family Id: 43411452) Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
Claim Types: Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Mar 22, 2018
Jul 1, 2030U-2249: Management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate
Pat. No. 9549923 DS* DP* (Family Id: 43411452) Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and uses thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 22, 2018
Jul 1, 2030 

ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE (TABLET) (ORAL) APADAZ
NDA Applicant: KVK TECH INC      NDA No.: 208653  Prod. No.: 002 RX (325MG;EQ 4.08MG BASE); 003 RX (325MG;EQ 8.16MG BASE)
5 Patents--1 FamilyExpirationPatented Use
Pat. No. 8461137 DS* DP* (Family Id: 43411452) Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
Claim Types: Composition
Pat. Sub. Date(s): All strengths: Jan 25, 2019
Feb 22, 2031 
Pat. No. 8748413 DS* DP* (Family Id: 43411452) Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
Claim Types: Composition; Formulation
Pat. Sub. Date(s): All strengths: Jan 25, 2019
Jul 10, 2030 
Pat. No. 8828978 DP* (Family Id: 43411452) Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
Claim Types: Composition; Formulation
Pat. Sub. Date(s): All strengths: Jan 25, 2019
Jul 1, 2030 
Pat. No. 9132125 DS* DP* (Family Id: 43411452) Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
Claim Types: Composition; Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jan 25, 2019
Jul 1, 2030U-2249: Management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate
Pat. No. 9549923 DS* DP* (Family Id: 43411452) Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and uses thereof
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jan 25, 2019
Jul 1, 2030 

ACETAMINOPHEN; IBUPROFEN (TABLET) (ORAL) ADVIL DUAL ACTION WITH ACETAMINOPHEN
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 211733  Prod. No.: 001 OTC (250MG;125MG)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productFeb 28, 2023 

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE (TABLET, EXTENDED RELEASE) (ORAL) XARTEMIS XR
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: MALLINCKRODT INC      NDA No.: 204031  Prod. No.: 001 DISC (325MG;7.5MG)
12 Patents--6 FamiliesExpirationPatented Use
Pat. No. 7976870 (Family Id: 26699053) 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. 8377453 DP* (Family Id: 40943673) Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic
Claim Types: Formulation; Process; Method of use
Pat. Sub. Date(s): 001: Apr 3, 2014
Nov 19, 2029U-1499: Management of acute pain in patients requiring opioid analgesia
Pat. No. 8372432 DP* (Family Id: 42397922) 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* (Family Id: 42397922) 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 (Family Id: 42397922) 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. 8597681 DP* (Family Id: 44972667) 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* (Family Id: 44972667) 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* (Family Id: 50115055) 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. 8992975 DP* (Family Id: 50115055) 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* (Family Id: 50115055) 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 (Family Id: 50115055) 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
Pat. No. 8741885 DP* (Family Id: 50475521) 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

ACETYLCYSTEINE (INJECTABLE) (INTRAVENOUS) ACETADOTE [GENERIC AP]
Drug Classes: Respiratory Tract/ Pulmonary Agents:Respiratory Tract Agents, Other == antidote == antidote for acetaminophen overdose == mucolytic
NDA Applicant: CUMBERLAND PHARMS      NDA No.: 021539  Prod. No.: 001 RX (6GM/30ML (200MG/ML))
5 Patents--2 FamiliesExpirationPatented Use
Pat. No. 8148356 DP* (Family Id: 36933421) Acetylcysteine composition and uses therefor
Claim Types: Formulation; Drug in a container
Pat. Sub. Date(s): 001: Apr 4, 2012
May 21, 2026 
Pat. No. 8399445 (Family Id: 36933421) Acetylcysteine composition and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 28, 2013
Aug 24, 2025U-1373: Method of treating acetaminophen overdose with acetylcysteine solutions
Pat. No. 8653061 (Family Id: 36933421) Acetylcysteine composition and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 24, 2014
Aug 24, 2025U-1373: Method of treating acetaminophen overdose with acetylcysteine solutions
Pat. No. 8722738 (Family Id: 45494138) Acetycysteine compositions and methods of use thereof
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: May 27, 2014
Apr 6, 2032U-1373: Method of treating acetaminophen overdose with acetylcysteine solutions
Pat. No. 9327028 (Family Id: 45494138) Acetylcysteine compositions and methods of use thereof
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: May 18, 2016
Jul 21, 2031U-1839: Composition and method for providing a reduction in side effects for human patients in need of acetylcysteine therapy

ACETYLCYSTEINE (TABLET, EFFERVESCENT) (ORAL) CETYLEV
Drug Classes: Respiratory Tract/ Pulmonary Agents:Respiratory Tract Agents, Other == antidote == antidote for acetaminophen overdose == mucolytic
NDA Applicant: ARBOR PHARMS LLC      NDA No.: 207916  Prod. No.: 001 DISC (500MG); 002 DISC (2.5GM)
3 Patents--1 FamilyExpirationPatented Use
Pat. No. 8747894 DP* (Family Id: 48190334) Effervescent compositions containing N-acetylcysteine
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Feb 8, 2016
May 8, 2032U-1373: Method of treating acetaminophen overdose with acetylcysteine solutions
Pat. No. 9427421 DP* (Family Id: 48190334) Effervescent compositions containing N-acetylcysteine
Claim Types: Formulation; Product-by-process
Pat. Sub. Date(s): All strengths: Sep 23, 2016
May 8, 2032 
Pat. No. 9561204 (Family Id: 48190334) Effervescent compositions containing N-acetylcysteine
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 9, 2017
May 8, 2032U-1373: Method of treating acetaminophen overdose with acetylcysteine solutions

ACLIDINIUM BROMIDE (POWDER, METERED) (INHALATION) TUDORZA PRESSAIR
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Anticholinergic == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant: COVIS      NDA No.: 202450  Prod. No.: 001 RX (0.4MG/INH)
5 Patents--4 FamiliesExpirationPatented Use
Pat. No. RE46417 DS* DP* [Extended 1679 days (4.6 years)]
(Family Id: 1000002449991) 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-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD)
Pat. No. 6681768 DP* (Family Id: 26873285) 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. 8051851 DP* (Family Id: 34982073) 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* (Family Id: 39645012) Dosage and formulation
Claim Types: Formulation; Method of use; Device
Pat. Sub. Date(s): 001: Oct 26, 2018
Mar 13, 2029U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD)
Pat. No. 11000517 DP* (Family Id: 39645012) Dosage and formulation
Claim Types: Composition; Formulation; Method of use; Device
Pat. Sub. Date(s): 001: Jun 10, 2021
Mar 13, 2029U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD)
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousMar 29, 2022M-256: Information added to the clinical studies section to fulfill a post-marketing requirement

ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE (POWDER, METERED) (INHALATION) DUAKLIR PRESSAIR
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Anticholinergic == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations == Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == beta-2 adrenergic agonist
NDA Applicant: COVIS      NDA No.: 210595  Prod. No.: 001 RX (0.4MG/INH;0.012MG/INH)
5 Patents--4 FamiliesExpirationPatented Use
Pat. No. RE46417 DS* DP* [Extended 1679 days (4.6 years)]
(Family Id: 1000002449991) Quinuclidine derivatives and their use as muscarinic M3 receptor ligands
Claim Types: Compound; Process; Method of use
Pat. Sub. Date(s): 001: Apr 24, 2019
Feb 10, 2025U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD)
Pat. No. 6681768 DP* (Family Id: 26873285) Powder formulation disintegrating system and method for dry powder inhalers
Claim Types: Device
Pat. Sub. Date(s): 001: Apr 24, 2019
Aug 7, 2022 
Pat. No. 8051851 DP* (Family Id: 34982073) 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: Apr 24, 2019
Apr 22, 2027 
Pat. No. 10085974 DP* (Family Id: 39645012) Dosage and formulation
Claim Types: Formulation; Method of use; Device
Pat. Sub. Date(s): 001: Apr 24, 2019
Mar 13, 2029U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD)
Pat. No. 11000517 DP* (Family Id: 39645012) Dosage and formulation
Claim Types: Composition; Formulation; Method of use; Device
Pat. Sub. Date(s): 001: Jun 10, 2021
Mar 13, 2029U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NC - New combinationMar 29, 2022 

ACYCLOVIR (OINTMENT) (OPHTHALMIC) AVACLYR
Drug Classes: Antivirals:Antiherpetic Agents == Dermatological Agents:Topical Anti-infectives == Dermatological Agents:Dermatological Agents, Other == nucleoside analog HSV DNA polymerase inhibitor / VZV DNA polymerase inhibitor
NDA Applicant: FERA PHARMS LLC      NDA No.: 202408  Prod. No.: 001 DISC (3%**)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityMar 29, 2026ODE-235: Indicated for the treatment of acute herpetic keratitis (dendritic ulcers) in patients with herpes simplex (HSV-1 and HSV-2) virus

ACYCLOVIR (TABLET) (BUCCAL) SITAVIG
Drug Classes: Antivirals:Antiherpetic Agents == Dermatological Agents:Topical Anti-infectives == Dermatological Agents:Dermatological Agents, Other == nucleoside analog HSV DNA polymerase inhibitor / VZV DNA polymerase inhibitor
NDA Applicant: EPI HLTH      NDA No.: 203791  Prod. No.: 001 RX (50MG)
3 Patents--2 FamiliesExpirationPatented Use
Pat. No. 8747896 DP* (Family Id: 36889131) Mucosal bioadhesive slow release carrier for delivering active principles
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jul 3, 2014
Jun 3, 2027U-1460: Treatment of herpes labialis
Pat. No. 8791127 DP* (Family Id: 36889131) Mucosal bioadhesive slow release carrier for delivering active principles
Claim Types: Formulation; Process; Method of use
Pat. Sub. Date(s): 001: Aug 6, 2014
Mar 23, 2027U-1460: Treatment of herpes labialis
Pat. No. 8592434 DP* (Family Id: 44082627) Mucoadhesive buccal tablets for the treatment of orofacial herpes
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 12, 2013
Jun 16, 2030U-1460: Treatment of herpes labialis

ACYCLOVIR; HYDROCORTISONE (CREAM) (TOPICAL) XERESE
Drug Classes: Antivirals:Antiherpetic Agents == Dermatological Agents:Topical Anti-infectives == Dermatological Agents:Dermatological Agents, Other == nucleoside analog HSV DNA polymerase inhibitor / VZV DNA polymerase inhibitor
NDA Applicant: BAUSCH      NDA No.: 022436  Prod. No.: 001 RX (5%;1%)
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 7223387 DP* (Family Id: 29552456) Antiviral formulations comprising propylene glycol and an isopropyl alkanoic acid ester
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Nov 13, 2022U-1006: New combination product for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in adults and adolescents (12 years of age and older)
U-1484: Combination product for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in adults and children (6 years of age and older)

ADAPALENE (GEL) (TOPICAL) DIFFERIN [GENERIC AB]
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == retinoid
NDA Applicant: GALDERMA LABS LP      NDA No.: 021753  Prod. No.: 001 RX (0.3%)
6 Patents--1 FamilyExpirationPatented Use
Pat. No. 7579377 (Family Id: 27806678) Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Feb 23, 2025U-818: Topical treatment of acne vulgaris
Pat. No. 7737181 DP* (Family Id: 27806678) Pharmaceutical compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Aug 29, 2024 
Pat. No. 7834060 (Family Id: 27806678) Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphtoic acid for the treatment of dermatological disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 19, 2010
Mar 12, 2023U-1078: Treatment of acne
Pat. No. 7838558 DP* (Family Id: 27806678) Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 30, 2010
Mar 12, 2023 
Pat. No. 7868044 (Family Id: 27806678) Method for the treatment of acne using compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 12, 2011
Mar 12, 2023U-1078: Treatment of acne
Pat. No. 8703820 (Family Id: 27806678) Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 21, 2014
Mar 12, 2023U-1078: Treatment of acne

ADAPALENE (LOTION) (TOPICAL) DIFFERIN
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == retinoid
NDA Applicant: GALDERMA LABS LP      NDA No.: 022502  Prod. No.: 001 RX (0.1%)
3 Patents--1 FamilyExpirationPatented Use
Pat. No. 7998467 DP* (Family Id: 36337580) Cosmetic/dermatological compositions comprising naphthoic acid compounds and polyurethane polymers
Claim Types: Formulation; Process; Method of use
Pat. Sub. Date(s): 001: Aug 19, 2011
May 31, 2028U-1078: Treatment of acne
Pat. No. 8435502 DP* (Family Id: 36337580) Cosmetic/dermatological compositions comprising naphtholic acid compounds and polyurethane polymers
Claim Types: Formulation; Process; Method of use
Pat. Sub. Date(s): 001: May 22, 2013
Sep 15, 2026U-1078: Treatment of acne
Pat. No. 8709392 DP* (Family Id: 36337580) Cosmetic/dermatological compositions comprising naphthoic acid compounds and polyurethane polymers
Claim Types: Formulation; Process; Method of use; Product-by-process
Pat. Sub. Date(s): 001: May 16, 2014
Sep 15, 2026U-1078: Treatment of acne

ADAPALENE; BENZOYL PEROXIDE (GEL) (TOPICAL) EPIDUO [GENERIC AB]
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == retinoid == Dermatological Agents:Topical Anti-infectives
NDA Applicant: GALDERMA LABS LP      NDA No.: 022320  Prod. No.: 001 RX (0.1%;2.5%)
10 Patents--4 FamiliesExpirationPatented Use
Pat. No. 7820186 DP* (Family Id: 27791899) Gel composition for once-daily treatment of common acne comprising a combination of benzoyl peroxide and adapalene and/or adapalene salt
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 2, 2010
Nov 23, 2025 
Pat. No. 7964202 DP* (Family Id: 27791899) Method for treatment of common acne
Claim Types: Method of use; Drug in a container
Pat. Sub. Date(s): 001: Jun 23, 2011
Sep 1, 2024U-1078: Treatment of acne
Pat. No. 8105618 (Family Id: 27791899) Dermatological/cosmetic gels comprising at least one retinoid and/or retinoid salt and benzoyl peroxide
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 29, 2012
Dec 23, 2022U-1078: Treatment of acne
Pat. No. 8241649 DP* (Family Id: 27791899) Dermatological/cosmetic gels comprising at least one retinoid and/or retinoid salt and benzoyl peroxide
Claim Types: Formulation; Drug in a container
Pat. Sub. Date(s): 001: Aug 14, 2012
Dec 23, 2022 
Pat. No. 8936800 DP* (Family Id: 27791899) Gel composition for treatment of common acne comprising a combination of benzoyl peroxide and adapalene and/or adapalene salt
Claim Types: Formulation; Method of use; Drug in a container
Pat. Sub. Date(s): 001: Mar 19, 2015
Dec 23, 2022U-1078: Treatment of acne
Pat. No. 8071644 DP* (Family Id: 37763873) Combinations of adapalene and benzoyl peroxide for treating acne lesions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 7, 2011
Jul 18, 2027U-1078: Treatment of acne
Pat. No. 8129362 (Family Id: 37763873) Combination/association of adapalene and benzoyl peroxide for treating acne lesions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 4, 2012
Jul 18, 2027U-1078: Treatment of acne
Pat. No. 8809305 (Family Id: 39473958) Administration of adapalene and benzoyl peroxide for the long-term treatment of acne vulgaris
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Sep 19, 2014
Dec 23, 2022U-1078: Treatment of acne
Pat. No. 8080537 (Family Id: 41380579) Combinations of adapalene and benzoyl peroxide for treating acne lesions
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Dec 21, 2011
Jul 18, 2027U-1078: Treatment of acne
Pat. No. 8445543 (Family Id: 41380579) Combinations of adapalene and benzoyl peroxide for treating acne lesions
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jun 19, 2013
Jul 12, 2027U-1078: Treatment of acne

ADAPALENE; BENZOYL PEROXIDE (GEL) (TOPICAL) EPIDUO FORTE [GENERIC AB]
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == retinoid == Dermatological Agents:Topical Anti-infectives
NDA Applicant: GALDERMA LABS      NDA No.: 207917  Prod. No.: 001 RX (0.3%;2.5%)
9 Patents--5 FamiliesExpirationPatented Use
Pat. No. 8936800 DP* (Family Id: 27791899) Gel composition for treatment of common acne comprising a combination of benzoyl peroxide and adapalene and/or adapalene salt
Claim Types: Formulation; Method of use; Drug in a container
Pat. Sub. Date(s): 001: Jul 24, 2015
Dec 23, 2022U-1078: Treatment of acne
Pat. No. 9814690 DP* (Family Id: 27791899) Gel composition for treatment of common acne comprising a combination of benzoyl peroxide and adapalene and/or adapalene salt
Claim Types: Formulation; Method of use; Drug in a container
Pat. Sub. Date(s): 001: Dec 12, 2017
Dec 23, 2022U-1078: Treatment of acne
Pat. No. 8703820 (Family Id: 27806678) Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 24, 2015
Mar 12, 2023U-1078: Treatment of acne
Pat. No. 8729127 (Family Id: 27806678) Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 24, 2015
Mar 12, 2023U-1078: Treatment of acne
Pat. No. 9381179 (Family Id: 27806678) Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 4, 2016
Mar 12, 2023U-1078: Treatment of acne
Pat. No. 9387187 (Family Id: 27806678) Administration of 6[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 5, 2016
Mar 12, 2023U-1078: Treatment of acne
Pat. No. 8785420 (Family Id: 37763873) Combination/association of adapalene and benzoyl peroxide for treating acne lesions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 24, 2015
Dec 23, 2022U-1078: Treatment of acne
Pat. No. 8809305 (Family Id: 39473958) Administration of adapalene and benzoyl peroxide for the long-term treatment of acne vulgaris
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jan 29, 2016
Dec 23, 2022U-1078: Treatment of acne
Pat. No. 8445543 (Family Id: 41380579) Combinations of adapalene and benzoyl peroxide for treating acne lesions
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jul 24, 2015
Dec 23, 2022U-1078: Treatment of acne

ADAPALENE; BENZOYL PEROXIDE (GEL) (TOPICAL) ADAPALENE AND BENZOYL PEROXIDE [GENERIC AB]
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == retinoid == Dermatological Agents:Topical Anti-infectives
NDA Applicant: TARO      NDA No.: 209148  Prod. No.: 001 RX (0.3%;2.5%)
ExclusivityExpirationExclusivity Description
Exclusivity Code: PC - Patent challengeMay 30, 2022 

AFAMELANOTIDE (IMPLANT) (SUBCUTANEOUS) SCENESSE
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment
NDA Applicant: CLIVUNEL INC      NDA No.: 210797  Prod. No.: 001 RX (16MG)
2 Patents--2 FamiliesExpirationPatented Use
Pat. No. 10076555 (Family Id: 35786800) Methods of inducing melanogenesis in a subject
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 6, 2019
Feb 11, 2025U-2638: Increase pain-free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP)
Pat. No. 8334265 (Family Id: 39135428) Method of treatment of photodermatoses
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 6, 2019
Mar 11, 2029U-2638: Increase pain-free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityOct 8, 2024 
Exclusivity Code: ODE - Orphan drug exclusivityOct 8, 2026ODE-270: Indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP)

AFATINIB DIMALEATE (TABLET) (ORAL) GILOTRIF
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 201292  Prod. No.: 001 RX (EQ 20MG BASE); 002 RX (EQ 30MG BASE); 003 RX (EQ 40MG BASE)
5 Patents--5 FamiliesExpirationPatented Use
Pat. No. RE43431 DS* [Extended 1452 days (4 years)]
(Family Id: 27214210) Quinazoline derivatives and pharmaceutical compositions containing them
Claim Types: Compound
Pat. Sub. Date(s): All strengths: Aug 1, 2013
Jul 13, 2026 *PED 
Pat. No. 8426586 DS* (Family Id: 34428508) Process for preparing amino crotonyl compounds
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): All strengths: Aug 1, 2013
Apr 10, 2030 *PED 
Pat. No. 9539258 (Family Id: 37700909) Quinazoline derivatives for the treatment of cancer diseases
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 2, 2017
May 9, 2027 *PEDU-1950: Treatment of patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy
Pat. No. 8545884 DP* (Family Id: 40941955) Solid pharmaceutical formulations comprising BIBW 2992
Claim Types: Intermediate; Formulation; Process; Product-by-process
Pat. Sub. Date(s): All strengths: Oct 28, 2013
Jun 19, 2030 *PED 
Pat. No. 10004743 DP* (Family Id: 42813202) Process for drying of BIBW2992, of its salts and of solid pharmaceutical formulations comprising this active ingredient
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Aug 2, 2018
Jan 5, 2031 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousOct 7, 2025 PEDM-276: Revisions to the pediatric use subsection of labeling to include the resultsfrom clinical study 1200.120, conducted to fulfill a pediatric written request
Exclusivity Code: ODE - Orphan drug exclusivityOct 15, 2023 PEDODE-115: Treatment of patients with metastatic, squamous, non-small cell lung cancer progressing after platinum-based chemotherapy
Exclusivity Code: ODE - Orphan drug exclusivityJul 12, 2025 PEDODE-230: First-line treatment of metastatic non-small cell lung cancer whose tumors have non-resistant epidermal growth factor (EGFR) mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test

AIR POLYMER-TYPE A (FOAM) (INTRAUTERINE) EXEM FOAM KIT
NDA Applicant: GISKIT      NDA No.: 212279  Prod. No.: 001 RX (10ML)
3 Patents--1 FamilyExpirationPatented Use
Pat. No. 9034300 DP* (Family Id: 43499949) Composition and method for medical imaging of body cavities
Claim Types: Diagnostic or surgical method
Pat. Sub. Date(s): 001: Dec 10, 2019
Oct 15, 2030U-2663: Use in sonohysterosalpinography to assess fallopian tube patency
Pat. No. 9259494 DP* (Family Id: 43499949) Composition and method for medical imaging of body cavities
Claim Types: Formulation; Kit; Process; Diagnostic or surgical method
Pat. Sub. Date(s): 001: Dec 10, 2019
May 4, 2035U-2663: Use in sonohysterosalpinography to assess fallopian tube patency
Pat. No. 9849199 DP* (Family Id: 43499949) Composition and method for medical imaging of body cavities
Claim Types: Formulation; Kit
Pat. Sub. Date(s): 001: Dec 10, 2019
Feb 11, 2036 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityNov 7, 2024 

ALBUTEROL SULFATE (AEROSOL, METERED) (INHALATION) VENTOLIN HFA [Has competitive generic]
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == beta-2 adrenergic agonist
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 020983  Prod. No.: 001 RX (EQ 0.09MG BASE/INH)
2 Patents--1 FamilyExpirationPatented Use
Pat. No. 7500444 DP* (Family Id: 30001969) Actuation indicator for a dispensing device
Claim Types: Device
Pat. Sub. Date(s): 001: None
Aug 26, 2026 *PED 
Pat. No. 7832351 DP* (Family Id: 30001969) Actuation indicator for a dispensing device
Claim Types: Device
Pat. Sub. Date(s): 001: Sep 7, 2012
Dec 19, 2023 *PED 

ALBUTEROL SULFATE (AEROSOL, METERED) (INHALATION) PROAIR HFA [GENERIC AB2]
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == beta-2 adrenergic agonist
NDA Applicant: TEVA BRANDED PHARM      NDA No.: 021457  Prod. No.: 001 RX (EQ 0.09MG BASE/INH)
10 Patents--3 FamiliesExpirationPatented Use
Pat. No. 7105152 DP* (Family Id: 36951729) Suspension aerosol formulations
Claim Types: Formulation; Device
Pat. Sub. Date(s): 001: None
Sep 12, 2023 
Pat. No. 8132712 DP* (Family Id: 38091187) Metered-dose inhaler
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Mar 27, 2012
Sep 7, 2028 
Pat. No. 9463289 DP* (Family Id: 44971401) Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 8, 2016
May 18, 2031 
Pat. No. 9808587 DP* (Family Id: 44971401) Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 16, 2017
May 18, 2031 
Pat. No. 10022509 DP* (Family Id: 44971401) Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Part of a dosage form
Pat. Sub. Date(s): 001: Aug 14, 2018
May 18, 2031 
Pat. No. 10022510 DP* (Family Id: 44971401) Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 14, 2018
May 18, 2031 
Pat. No. 10086156 DP* (Family Id: 44971401) Dose counter for inhaler and method for counting doses
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): 001: Oct 17, 2018
May 18, 2031 
Pat. No. 10561808 DP* (Family Id: 44971401) Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form
Pat. Sub. Date(s): 001: Mar 19, 2020
Jan 1, 2032 
Pat. No. 10695512 DP* (Family Id: 44971401) Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 30, 2020
May 18, 2031 
Pat. No. 11395889 DP* (Family Id: 44971401) Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form
Pat. Sub. Date(s): 001: Aug 19, 2022
May 18, 2031 

ALBUTEROL SULFATE (POWDER, METERED) (INHALATION) PROAIR RESPICLICK
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == beta-2 adrenergic agonist
NDA Applicant: TEVA BRANDED PHARM      NDA No.: 205636  Prod. No.: 001 RX (EQ 0.09MG BASE/INH)
10 Patents--3 FamiliesExpirationPatented Use
Pat. No. 7540282 DP* (Family Id: 26908022) Reservoir pressure system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): 001: Apr 28, 2015
May 6, 2023 
Pat. No. 8651103 DP* (Family Id: 29415374) Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 001: Apr 28, 2015
Mar 26, 2028 
Pat. No. 9463288 DP* (Family Id: 29415374) Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 8, 2016
May 19, 2025 
Pat. No. 10765820 DP* (Family Id: 29415374) Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 6, 2020
May 19, 2025 
Pat. No. 8978966 DP* (Family Id: 44971401) Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 21, 2016
Jan 13, 2032 
Pat. No. 9216260 DP* (Family Id: 44971401) Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 21, 2016
Jun 28, 2031 
Pat. No. 9731087 DP* (Family Id: 44971401) Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 31, 2017
May 18, 2031 
Pat. No. 10022510 DP* (Family Id: 44971401) Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 14, 2018
May 18, 2031 
Pat. No. 10124131 DP* (Family Id: 44971401) Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): 001: Dec 12, 2018
May 18, 2031 
Pat. No. 10561808 DP* (Family Id: 44971401) Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form
Pat. Sub. Date(s): 001: Mar 19, 2020
Jan 1, 2032 

ALBUTEROL SULFATE (POWDER, METERED) (INHALATION) PROAIR DIGIHALER
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == beta-2 adrenergic agonist
NDA Applicant: TEVA BRANDED PHARM      NDA No.: 205636  Prod. No.: 002 RX (EQ 0.09MG BASE/INH)
20 Patents--8 FamiliesExpirationPatented Use
Pat. No. 7540282 DP* (Family Id: 26908022) Reservoir pressure system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): 002: Jan 9, 2019
May 6, 2023 
Pat. No. 8651103 DP* (Family Id: 29415374) Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 002: Jan 9, 2019
Mar 26, 2028 
Pat. No. 9463288 DP* (Family Id: 29415374) Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 002: Jan 9, 2019
May 19, 2025 
Pat. No. 10765820 DP* (Family Id: 29415374) Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 002: Oct 6, 2020
May 19, 2025 
Pat. No. 8978966 DP* (Family Id: 44971401) Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 002: Jan 9, 2019
Jan 13, 2032 
Pat. No. 9216260 DP* (Family Id: 44971401) Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 002: Jan 9, 2019
Jun 28, 2031 
Pat. No. 9731087 DP* (Family Id: 44971401) Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Device
Pat. Sub. Date(s): 002: Jan 9, 2019
May 18, 2031 
Pat. No. 10022510 DP* (Family Id: 44971401) Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 002: Jan 9, 2019
May 18, 2031 
Pat. No. 10124131 DP* (Family Id: 44971401) Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): 002: Jan 9, 2019
May 18, 2031 
Pat. No. 10561808 DP* (Family Id: 44971401) Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form
Pat. Sub. Date(s): 002: Mar 19, 2020
Jan 1, 2032 
Pat. No. 9782550 DP* (Family Id: 54072809) Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 002: Jan 9, 2019
Aug 28, 2035 
Pat. No. 9782551 DP* (Family Id: 54072809) Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device
Pat. Sub. Date(s): 002: Jan 9, 2019
Aug 28, 2035 
Pat. No. 10569034 DP* (Family Id: 54072809) Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 002: Mar 12, 2020
Aug 16, 2036 
Pat. No. 10918816 DP* (Family Id: 54072809) Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 002: Mar 18, 2021
Dec 14, 2035 
Pat. No. 11344685 DP* (Family Id: 60388067) Drug delivery device with electronics
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 002: Jun 29, 2022
Sep 26, 2039 
Pat. No. 11351317 DP* (Family Id: 60388067) Drug delivery device with electronics
Claim Types: Device; Method of detecting usage condition of a device; Part of a dosage form
Pat. Sub. Date(s): 002: Jun 29, 2022
Feb 10, 2038 
Pat. No. 11357935 DP* (Family Id: 60388067) Drug delivery device with electronics
Claim Types: Device
Pat. Sub. Date(s): 002: Jul 13, 2022
Sep 24, 2038 
Pat. No. 11000653 DP* (Family Id: 60452683) Inhaler
Claim Types: Part of a dosage form; Device; Method of use
Pat. Sub. Date(s): 002: Jun 10, 2021
Dec 18, 2038 
Pat. No. 11266796 DP* (Family Id: 60627623) Inhalation device with integrated electronics
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 002: Apr 7, 2022
Feb 22, 2041 
Pat. No. 11173259 DP* (Family Id: 71522990) Drug delivery device with electronics and power management
Claim Types: Device
Pat. Sub. Date(s): 002: Dec 8, 2021
Jul 6, 2040 

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE (SPRAY, METERED) (INHALATION) COMBIVENT RESPIMAT
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == beta-2 adrenergic agonist == Respiratory Tract/ Pulmonary Agents:Bronchodilators, Anticholinergic == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 021747  Prod. No.: 001 RX (EQ 0.1MG BASE/INH;0.02MG/INH)
6 Patents--5 FamiliesExpirationPatented Use
Pat. No. 7396341 DP* (Family Id: 32302879) Blocking device for a locking stressing mechanism having a spring-actuated output drive device
Claim Types: Device; Method of use; Method of administration
Pat. Sub. Date(s): 001: Nov 2, 2011
Oct 10, 2026 
Pat. No. 7284474 DP* (Family Id: 32309388) Piston-pumping system having o-ring seal properties
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 2, 2011
Aug 26, 2024 
Pat. No. 7896264 DP* (Family Id: 33556479) Microstructured high pressure nozzle with built-in filter function
Claim Types: Device; Process
Pat. Sub. Date(s): 001: Nov 2, 2011
May 26, 2025 
Pat. No. 7837235 DP* (Family Id: 34744648) Device for clamping a fluidic component
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 2, 2011
Mar 13, 2028 
Pat. No. 9027967 DP* (Family Id: 34744648) Device for clamping a fluidic component
Claim Types: Device; Process
Pat. Sub. Date(s): 001: Sep 4, 2015
Mar 31, 2027 
Pat. No. 8733341 DP* (Family Id: 38293956) Atomizer and method of atomizing fluid with a nozzle rinsing mechanism
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Sep 4, 2015
Oct 16, 2030 

ALCAFTADINE (SOLUTION/DROPS) (OPHTHALMIC) LASTACAFT
Drug Classes: Ophthalmic Agents:Ophthalmic Anti-allergy Agents == histamine-1 (H1) receptor antagonist
NDA Applicant: ALLERGAN      NDA No.: 022134  Prod. No.: 001 OTC (0.25%)
2 Patents--1 FamilyExpirationPatented Use
Pat. No. 8664215 (Family Id: 38468943) Ocular allergy treatments with alcaftadine
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 21, 2014
Dec 23, 2027U-3267: Use of LASTACAFT to temporary relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander
Pat. No. 10617695 DP* (Family Id: 38468943) Ophthalmic compositions containing alcaftadine
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: May 12, 2020
Mar 19, 2027U-3267: Use of LASTACAFT to temporary relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander

ALCOHOL (SOLUTION) (INTRA-ARTERIAL) ABLYSINOL
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Alcohol Deterrents/Anti-craving
NDA Applicant: BPI LABS      NDA No.: 207987  Prod. No.: 001 RX (99% (1ML)); 002 RX (99% (5ML))
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityJun 21, 2025ODE-192: Indicated to induce controlled cardiac septal infraction [sic, "infarction"] to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy

ALECTINIB HYDROCHLORIDE (CAPSULE) (ORAL) ALECENSA
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: HOFFMANN-LA ROCHE      NDA No.: 208434  Prod. No.: 001 RX (EQ 150MG BASE)
4 Patents--3 FamiliesExpirationPatented Use
Pat. No. 9126931 DS* (Family Id: 43308919) Tetracyclic compound
Claim Types: Compound
Pat. Sub. Date(s): 001: Dec 22, 2015
May 29, 2031 
Pat. No. 9440922 DP* (Family Id: 43308919) Tetracyclic compound
Claim Types: Composition
Pat. Sub. Date(s): 001: Oct 12, 2016
Jun 9, 2030 
Pat. No. 9365514 DP* (Family Id: 45605249) Composition comprising tetracyclic compound
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 11, 2016
Mar 4, 2032 
Pat. No. 10350214 DP* (Family Id: 54332608) Preparation containing tetracyclic compound at high dose
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Mar 9, 2020
Apr 24, 2035 
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityDec 11, 2022ODE-105: Treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), who have progressed on or are intolerant to crizotinib
Exclusivity Code: ODE - Orphan drug exclusivityNov 6, 2024ODE-159: For treatment of patients with anaplastic lymphoma kinase (ALK) positive, metastatic non-small-cell lung cancer (NSCLC) as detected by an FDA approved test, excluding patients who have progressed on or are intolerant to crizotinib

ALENDRONATE SODIUM (TABLET, EFFERVESCENT) (ORAL) BINOSTO
Drug Classes: Metabolic Bone Disease Agents
NDA Applicant: ASCEND THERAPS US      NDA No.: 202344  Prod. No.: 001 RX (EQ 70MG BASE)
3 Patents--2 FamiliesExpirationPatented Use
Pat. No. 7488496 DS* DP* (Family Id: 32106450) Effervescent compositions comprising bisphosphonates and methods related thereto
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 13, 2012
Aug 11, 2023 
Pat. No. 7964212 DS* DP* (Family Id: 32106450) Effervescent compositions comprising phosphonates and methods related thereto
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 13, 2012
Mar 6, 2023 
Pat. No. 9592195 DP* (Family Id: 46207670) Stable effervescent bisphosphonate formulations with rapid solubilization characteristics
Claim Types: Formulation
Pat. Sub. Date(s): 001: May 12, 2021
Dec 5, 2031 

ALISKIREN HEMIFUMARATE (TABLET) (ORAL) TEKTURNA [GENERIC AB]
Drug Classes: Cardiovascular Agents:Cardiovascular Agents, Other == Cardiovascular Agents:Cardiovascular Combinations == renin inhibitor
NDA Applicant: NODEN PHARMA      NDA No.: 021985  Prod. No.: 001 RX (EQ 150MG BASE); 002 RX (EQ 300MG BASE)
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 8617595 DP* (Family Id: 34994415) Galenic formulations of organic compounds
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): All strengths: None
Aug 19, 2026 *PED 

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE (TABLET) (ORAL) TEKAMLO
Drug Classes: Cardiovascular Agents:Cardiovascular Agents, Other == Cardiovascular Agents:Cardiovascular Combinations == renin inhibitor == Cardiovascular Agents:Calcium Channel Blocking Agents, Dihydropyridines == calcium channel blocker == dihydropyridine calcium channel blocker
NDA Applicant: NOVARTIS      NDA No.: 022545  Prod. No.: 001 DISC (EQ 150MG BASE;EQ 5MG BASE); 002 DISC (EQ 150MG BASE;EQ 10MG BASE); 003 DISC (EQ 300MG BASE;EQ 5MG BASE); 004 DISC (EQ 300MG BASE;EQ 10MG BASE)
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 8613949 DP* (Family Id: 42040192) Galenical formulations of organic compounds
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: None
Dec 21, 2029 

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE (TABLET) (ORAL) AMTURNIDE
Drug Classes: Cardiovascular Agents:Cardiovascular Agents, Other == Cardiovascular Agents:Cardiovascular Combinations == renin inhibitor == Cardiovascular Agents:Calcium Channel Blocking Agents, Dihydropyridines == calcium channel blocker == dihydropyridine calcium channel blocker == Cardiovascular Agents:Diuretics, Thiazide
NDA Applicant: NOVARTIS      NDA No.: 200045  Prod. No.: 001 DISC (EQ 150MG BASE;EQ 5MG BASE;12.5MG); 002 DISC (EQ 300MG BASE;EQ 5MG BASE;12.5MG); 003 DISC (EQ 300MG BASE;EQ 5MG BASE;25MG); 004 DISC (EQ 300MG BASE;EQ 10MG BASE;12.5MG); 005 DISC (EQ 300MG BASE;EQ 10MG BASE;25MG)
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 8183295 DP* (Family Id: 29550141) Pharmaceutical composition comprising a renin inhibitor, a calcium channel blocker and a diuretic
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 3, 2013; 002: None; 003: None; 004: None; 005: None
May 16, 2023 

ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE (TABLET) (ORAL) TEKTURNA HCT
Drug Classes: Cardiovascular Agents:Cardiovascular Agents, Other == Cardiovascular Agents:Cardiovascular Combinations == renin inhibitor == Cardiovascular Agents:Diuretics, Thiazide
NDA Applicant: NODEN PHARMA      NDA No.: 022107  Prod. No.: 001 DISC (EQ 150MG BASE;12.5MG); 002 DISC (EQ 150MG BASE;25MG); 003 DISC (EQ 300MG BASE;12.5MG); 004 DISC (EQ 300MG BASE;25MG)
2 Patents--2 FamiliesExpirationPatented Use
Pat. No. 8618172 DP* (Family Id: 36803824) Galenical formulations of organic compounds
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Jul 13, 2028 
Pat. No. 9023893 DP* (Family Id: 9903412) Synergistic combinations comprising a renin inhibitor for cardiovascular diseases
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 15, 2017
Mar 3, 2022 

ALISKIREN HEMIFUMARATE; VALSARTAN (TABLET) (ORAL) VALTURNA
Drug Classes: Cardiovascular Agents:Cardiovascular Agents, Other == Cardiovascular Agents:Cardiovascular Combinations == renin inhibitor == Cardiovascular Agents:Angiotensin II Receptor Antagonists == angiotensin II receptor blocker
NDA Applicant: NOVARTIS      NDA No.: 022217  Prod. No.: 001 DISC (EQ 150MG BASE;160MG); 002 DISC (EQ 300MG BASE;320MG)
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 8168616 DP* (Family Id: 9903412) Combination comprising a renin inhibitor and an angiotensin receptor inhibitor for hypertension
Claim Types: Composition
Pat. Sub. Date(s): All strengths: Jun 6, 2012
Jul 3, 2026 

ALLOPURINOL; LESINURAD (TABLET) (ORAL) DUZALLO
Drug Classes: Antigout Agents == Antineoplastics:Treatment Adjuncts
NDA Applicant: IRONWOOD PHARMS INC      NDA No.: 209203  Prod. No.: 001 DISC (200MG;200MG); 002 DISC (300MG;200MG)
9 Patents--4 FamiliesExpirationPatented Use
Pat. No. 8003681 DS* (Family Id: 36000576) 2-(5-bromo-4-(4-cyclopropylnaphthalen-1-yl)-4H-1,2,4-triazol-3-ylthio)acet- ic acid and methyl ester<
Claim Types: Compound
Pat. Sub. Date(s): All strengths: Sep 15, 2017
Aug 25, 2025 
Pat. No. 8084483 (Family Id: 40679222) Compounds and compositions and methods of use
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 15, 2017
Aug 17, 2029U-2104: Treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a medically appropriate daily dose of allopurinol alone
Pat. No. 8283369 (Family Id: 40679222) Compounds and compositions and methods of use
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 15, 2017
Nov 26, 2028U-2104: Treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a medically appropriate daily dose of allopurinol alone
Pat. No. 8357713 DP* [Extended 391 days (1.1 years)]
(Family Id: 40679222) Compounds and compositions and methods of use
Claim Types: Composition; Formulation; Method of use
Pat. Sub. Date(s): All strengths: Sep 15, 2017
Dec 22, 2029U-2104: Treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a medically appropriate daily dose of allopurinol alone
Pat. No. 8546437 (Family Id: 40679222) Compounds and compositions and methods of use
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 15, 2017
Apr 29, 2029U-2104: Treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a medically appropriate daily dose of allopurinol alone
Pat. No. 10183012 (Family Id: 40679222) Compounds and compositions and methods of use
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 21, 2019
Nov 26, 2028U-2104: Treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a medically appropriate daily dose of allopurinol alone
Pat. No. 9216179 (Family Id: 45348529) Treatment of gout and hyperuricemia
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 15, 2017
Aug 1, 2031U-2104: Treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a medically appropriate daily dose of allopurinol alone
Pat. No. 8546436 DS* (Family Id: 46381300) Polymorphic forms of 2-(5-bromo-4-(4-cyclopropylnaphthalen-1-yl)-4H-1,2,4-triazol-3-ylthio)ace- ti
Claim Types: New polymorph, salt or hydrate; Composition; Process
Pat. Sub. Date(s): All strengths: Sep 15, 2017
Feb 29, 2032 
Pat. No. 9956205 (Family Id: 46381300) Polymorphic forms of 2-(5-bromo-4-(4-cyclopropylnaphthalen-1-yl)-4H-1,2,4-triazol-3-ylthio)ace- tic acid and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: May 30, 2018
Dec 28, 2031U-2104: Treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a medically appropriate daily dose of allopurinol alone

ALOGLIPTIN BENZOATE (TABLET) (ORAL) NESINA
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == Blood Glucose Regulators:Antidiabetic Combinations == dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 022271  Prod. No.: 001 RX (EQ 6.25MG BASE); 002 RX (EQ 12.5MG BASE); 003 RX (EQ 25MG BASE)
4 Patents--2 FamiliesExpirationPatented Use
Pat. No. 7807689 DS* DP* (Family Id: 34930979) Dipeptidyl peptidase inhibitors
Claim Types: Compound; Composition; Drug in a container; Method of use
Pat. Sub. Date(s): All strengths: None
Jun 27, 2028U-1337: Method of treating diabetes comprising administering alogliptin
Pat. No. 8173663 [Extended 262 days (0.7 years)]
(Family Id: 34930979) Dipeptidyl peptidase inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 19, 2017
Dec 2, 2025U-1338: Method of treating diabetes comprising administering a compound such as alogliptin
Pat. No. 8288539 DS* [Extended 101 days (0.3 years)]
(Family Id: 34930979) Dipeptidyl peptidase inhibitors
Claim Types: Compound
Pat. Sub. Date(s): All strengths: None
Mar 15, 2025 
Pat. No. 8697125 DP* (Family Id: 39156227) Tablet preparation without causing a tableting trouble
Claim Types: Formulation; Process; Product-by-process
Pat. Sub. Date(s): All strengths: May 27, 2014
Jun 16, 2029 

ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE (TABLET) (ORAL) KAZANO
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == Blood Glucose Regulators:Antidiabetic Combinations == dipeptidyl peptidase-4 (DPP-4) inhibitor == biguanide
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 203414  Prod. No.: 001 RX (EQ 12.5MG BASE;500MG); 002 RX (EQ 12.5MG BASE;1GM)
4 Patents--2 FamiliesExpirationPatented Use
Pat. No. 7807689 DS* DP* (Family Id: 34930979) Dipeptidyl peptidase inhibitors
Claim Types: Compound; Composition; Drug in a container; Method of use
Pat. Sub. Date(s): All strengths: None
Jun 27, 2028U-1337: Method of treating diabetes comprising administering alogliptin
Pat. No. 8173663 [Extended 262 days (0.7 years)]
(Family Id: 34930979) Dipeptidyl peptidase inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Mar 15, 2025U-1338: Method of treating diabetes comprising administering a compound such as alogliptin
Pat. No. 8288539 DS* [Extended 101 days (0.3 years)]
(Family Id: 34930979) Dipeptidyl peptidase inhibitors
Claim Types: Compound
Pat. Sub. Date(s): All strengths: None
Jun 24, 2025 
Pat. No. 8900638 DP* (Family Id: 39930391) Solid preparation comprising alogliptin and metformin hydrochloride
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Dec 18, 2014
May 24, 2029 

ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE (TABLET) (ORAL) OSENI
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == Blood Glucose Regulators:Antidiabetic Combinations == dipeptidyl peptidase-4 (DPP-4) inhibitor == peroxisome proliferator-activated receptor (PPAR) alpha agonist == peroxisome proliferator-activated receptor (PPAR) gamma agonist
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 022426  Prod. No.: 001 RX (EQ 25MG BASE;EQ 15MG BASE); 002 RX (EQ 25MG BASE;EQ 30MG BASE); 003 RX (EQ 25MG BASE;EQ 45MG BASE); 005 RX (EQ 12.5MG BASE;EQ 30MG BASE) NDA No.: 022426  Prod. No.: 004 DISC (EQ 12.5MG BASE;EQ 15MG BASE); 006 DISC (EQ 12.5MG BASE;EQ 45MG BASE)
4 Patents--2 FamiliesExpirationPatented Use
Pat. No. 7807689 DS* DP* (Family Id: 34930979) Dipeptidyl peptidase inhibitors
Claim Types: Compound; Composition; Drug in a container; Method of use
Pat. Sub. Date(s): All strengths: None
Jun 27, 2028U-1337: Method of treating diabetes comprising administering alogliptin
Pat. No. 8173663 [Extended 262 days (0.7 years)]
(Family Id: 34930979) Dipeptidyl peptidase inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Mar 15, 2025U-1338: Method of treating diabetes comprising administering a compound such as alogliptin
Pat. No. 8288539 DS* [Extended 101 days (0.3 years)]
(Family Id: 34930979) Dipeptidyl peptidase inhibitors
Claim Types: Compound
Pat. Sub. Date(s): All strengths: None
Mar 15, 2025 
Pat. No. 8637079 DP* (Family Id: 39240362) Solid preparation comprising alogliptin and pioglitazone
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 13, 2014
Jun 4, 2029 

ALPELISIB (TABLET) (ORAL) PIQRAY
Drug Classes: Antineoplastics:Molecular Target Inhibitors
NDA Applicant: NOVARTIS      NDA No.: 212526  Prod. No.: 001 RX (50MG); 002 RX (150MG); 003 RX (200MG)
2 Patents--1 FamilyExpirationPatented Use
Pat. No. 8227462 DS* DP* (Family Id: 40350060) Pyrrolidine-1,2-dicarboxamide derivatives
Claim Types: Compound; Method of use; Composition; Formulation
Pat. Sub. Date(s): All strengths: Jun 17, 2019
Sep 28, 2030U-2539: In combination with fulvestrant for treatment of postmenopausal women, and men, with HR-positive, HER-2-negative, PIK3CA-mutated, advanced or metastatic breast cancer
Pat. No. 8476268 DS* DP* (Family Id: 40350060) Pyrrolidine-1,2-dicarboxamide derivatives
Claim Types: Compound; Method of use; Composition
Pat. Sub. Date(s): All strengths: Jun 17, 2019
Sep 10, 2029 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMay 24, 2024 

ALPELISIB (TABLET) (ORAL) VIJOICE
Drug Classes: Antineoplastics:Molecular Target Inhibitors
NDA Applicant: NOVARTIS      NDA No.: 215039  Prod. No.: 001 RX (50MG); 002 RX (125MG); 003 RX (200MG)
2 Patents--1 FamilyExpirationPatented Use
Pat. No. 8227462 DS* DP* (Family Id: 40350060) Pyrrolidine-1,2-dicarboxamide derivatives
Claim Types: Compound; Method of use; Composition; Formulation
Pat. Sub. Date(s): All strengths: May 3, 2022
Sep 28, 2030 
Pat. No. 8476268 DS* DP* (Family Id: 40350060) Pyrrolidine-1,2-dicarboxamide derivatives
Claim Types: Compound; Method of use; Composition
Pat. Sub. Date(s): All strengths: May 3, 2022
Sep 10, 2029 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMay 24, 2024 

ALVIMOPAN (CAPSULE) (ORAL) ENTEREG [GENERIC AB]
Drug Classes: Gastrointestinal Agents:Gastrointestinal Agents, Other == opioid antagonist
NDA Applicant: CUBIST PHARMS      NDA No.: 021775  Prod. No.: 001 RX (12MG)
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 8946262 (Family Id: 34636584) Methods of preventing and treating gastrointestinal dysfunction
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Feb 19, 2015
Feb 12, 2030U-1655: A method to accelerate the time to gastrointestinal recovery by administering about 12 mg of alvimopan to the patient from about 30 to 60 minutes prior to surgery

AMANTADINE HYDROCHLORIDE (CAPSULE, EXTENDED RELEASE) (ORAL) GOCOVRI
Drug Classes: Antiparkinson Agents:Antiparkinson Agents, Other == Antivirals:Anti-influenza Agents == influenza A M2 protein inhibitor
NDA Applicant: ADAMAS OPERATIONS      NDA No.: 208944  Prod. No.: 001 RX (EQ 68.5MG BASE); 002 RX (EQ 137MG BASE)
18 Patents--4 FamiliesExpirationPatented Use
Pat. No. 8389578 (Family Id: 36498566) Composition and method for treating neurological disease
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Sep 21, 2017
Jan 22, 2028U-2105: Treatment of dyskinesia in patients with Parkinson's disease receiving immediate release levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 8796337 (Family Id: 36498566) Composition and method for treating neurological disease
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Sep 21, 2017
Nov 23, 2025U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 8889740 DP* (Family Id: 36498566) Composition and method for treating neurological disease
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 21, 2017
Nov 23, 2025 
Pat. No. 8895614 DP* (Family Id: 36498566) Composition and method for treating neurological disease
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 21, 2017
Nov 23, 2025 
Pat. No. 8895615 (Family Id: 36498566) Composition and method for treating neurological disease
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Sep 21, 2017
Nov 23, 2025U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 8895616 (Family Id: 36498566) Composition and method for treating neurological disease
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Sep 21, 2017
Nov 23, 2025U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 8895617 (Family Id: 36498566) Composition and method for treating neurological disease
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Sep 21, 2017
Nov 23, 2025U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 8895618 DP* (Family Id: 36498566) Composition and method for treating neurological disease
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 21, 2017
Nov 23, 2025 
Pat. No. 8741343 (Family Id: 44115504) Method of administering amantadine prior to a sleep period
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Sep 21, 2017
Dec 2, 2030U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 9867791 (Family Id: 44115504) Method of administering amantadine prior to a sleep period
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Jan 16, 2018
Dec 2, 2030U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 9867792 (Family Id: 44115504) Method of administering amantadine prior to a sleep period
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Jan 16, 2018
Dec 2, 2030U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 9867793 (Family Id: 44115504) Method of administering amantadine prior to a sleep period
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Jan 16, 2018
Dec 2, 2030U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 9877933 (Family Id: 44115504) Method of administering amantadine prior to a sleep period
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Jan 30, 2018
Dec 2, 2030U-2224: Treatment of dyskinesia and increasing on time without troublesome dyskinesia in patients with Parkinson's Disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 11197835 (Family Id: 44115504) Method of administering amantadine prior to a sleep period
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 12, 2022
Dec 2, 2030U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 10154971 (Family Id: 52105179) Methods of administering amantadine
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): All strengths: Dec 18, 2018
Dec 4, 2034U-2459: Treatment of dyskinesia and decreasing off time in patients with Parkinson's Disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 10646456 (Family Id: 52105179) Methods of administering amantadine
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): All strengths: Jul 14, 2020
Jun 17, 2034U-2808: Treatment of dyskinesia, decreasing off time, and increasing on time without troublesome dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 11065213 DP* (Family Id: 65439620) Amantadine compositions and preparations thereof
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): All strengths: Jul 20, 2021
Aug 23, 2038 
Pat. No. 11077073 (Family Id: 65439620) Methods of using amantadine compositions
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 4, 2021
Aug 23, 2038U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
U-2224: Treatment of dyskinesia and increasing on time without troublesome dyskinesia in patients with Parkinson's Disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
U-3180: Decreasing off time in patients with parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityAug 24, 2024ODE-153: Treatment of dyskinesia in patients with parkinson's disease receiving levodopa-based therapy with or without concomitant dopaminergic medications

AMANTADINE HYDROCHLORIDE (TABLET, EXTENDED RELEASE) (ORAL) OSMOLEX ER
Drug Classes: Antiparkinson Agents:Antiparkinson Agents, Other == Antivirals:Anti-influenza Agents == influenza A M2 protein inhibitor
NDA Applicant: ADAMAS OPERATIONS      NDA No.: 209410  Prod. No.: 001 RX (EQ 129MG BASE); 002 RX (EQ 193MG BASE) NDA No.: 209410  Prod. No.: 003 DISC (EQ 258MG BASE); 004 DISC (EQ 161MG BASE)
18 Patents--5 FamiliesExpirationPatented Use
Pat. No. 8389578 (Family Id: 36498566) Composition and method for treating neurological disease
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Feb 10, 2021
Jan 22, 2028U-219: Treatment of Parkinson's disease
U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease
Pat. No. 8796337 (Family Id: 36498566) Composition and method for treating neurological disease
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Feb 10, 2021
Nov 23, 2025U-219: Treatment of Parkinson's disease
U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients
U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease
Pat. No. 8889740 DP* (Family Id: 36498566) Composition and method for treating neurological disease
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 10, 2021
Nov 23, 2025 
Pat. No. 8895614 DP* (Family Id: 36498566) Composition and method for treating neurological disease
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 10, 2021
Nov 23, 2025 
Pat. No. 8895615 (Family Id: 36498566) Composition and method for treating neurological disease
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Feb 10, 2021
Nov 23, 2025U-219: Treatment of Parkinson's disease
U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease
Pat. No. 8895616 (Family Id: 36498566) Composition and method for treating neurological disease
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Feb 10, 2021
Nov 23, 2025U-219: Treatment of Parkinson's disease
U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease
Pat. No. 8895617 (Family Id: 36498566) Composition and method for treating neurological disease
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Feb 10, 2021
Nov 23, 2025U-219: Treatment of Parkinson's disease
U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease
Pat. No. 8895618 DP* (Family Id: 36498566) Composition and method for treating neurological disease
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 10, 2021
Nov 23, 2025 
Pat. No. 8987333 DP* (Family Id: 36498566) Composition and method for treating neurological disease
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 10, 2021
Nov 23, 2025 
Pat. No. 9072697 (Family Id: 36498566) Composition and method for treating neurological disease
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 10, 2021
Nov 23, 2025U-219: Treatment of Parkinson's disease
U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease
Pat. No. 8252331 DP* (Family Id: 36684171) Osmotic device containing amantadine and an osmotic salt
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 1, 2018; 002: Mar 1, 2018; 003: Mar 1, 2018; 004: Oct 29, 2020
Mar 13, 2030 
Pat. No. 8574626 DP* (Family Id: 48223835) Osmotic device containing amantadine and an osmotic salt
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Mar 1, 2018; 002: Mar 1, 2018; 003: Mar 1, 2018; 004: Oct 29, 2020
Nov 28, 2025U-20: A process for treating a patient suffering from parkinson's syndrome and in need of treatment
Pat. No. 10213394 (Family Id: 65410681) Composition and method for treating neurological disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 13, 2019; 002: Mar 13, 2019; 003: Mar 13, 2019; 004: Oct 29, 2020
Feb 15, 2038U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients
Pat. No. 10500171 (Family Id: 65410681) Composition and method for treating neurological disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 17, 2019; 002: Dec 17, 2019; 003: Dec 17, 2019; 004: Oct 29, 2020
Feb 15, 2038U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients
Pat. No. 10500172 (Family Id: 65410681) Composition and method for treating neurological disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 17, 2019; 002: Dec 17, 2019; 003: Dec 17, 2019; 004: Oct 29, 2020
Feb 15, 2038U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients
Pat. No. 10213393 (Family Id: 65410876) Composition and method for treating neurological disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 13, 2019; 002: Mar 13, 2019; 003: Mar 13, 2019; 004: Oct 29, 2020
Feb 15, 2038U-20: A process for treating a patient suffering from parkinson's syndrome and in need of treatment
Pat. No. 10500170 (Family Id: 65410876) Composition and method for treating neurological disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 17, 2019; 002: Dec 17, 2019; 003: Dec 17, 2019; 004: Oct 29, 2020
Feb 15, 2038U-20: A process for treating a patient suffering from parkinson's syndrome and in need of treatment
Pat. No. 10512617 (Family Id: 65410876) Composition and method for treating neurological disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 2, 2020; 002: Jan 2, 2020; 003: Jan 2, 2020; 004: Oct 29, 2020
Feb 15, 2038U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients

AMBRISENTAN (TABLET) (ORAL) LETAIRIS [GENERIC AB]
Drug Classes: Respiratory Tract/ Pulmonary Agents:Pulmonary Antihypertensives == endothelin receptor antagonist
NDA Applicant: GILEAD      NDA No.: 022081  Prod. No.: 001 RX (5MG); 002 RX (10MG)
3 Patents--2 FamiliesExpirationPatented Use
Pat. No. 8377933 (Family Id: 39092031) Method for treating a pulmonary hypertension condition
Claim Types: Method of administration; Method of use
Pat. Sub. Date(s): All strengths: Oct 23, 2015
Dec 11, 2027U-1754: For the treatment of pulmonary hypertension (PAH) in combination with tadalafil
Pat. No. 9474752 (Family Id: 39092031) Method for treating a pulmonary hypertension condition
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 23, 2016
Dec 11, 2027U-1754: For the treatment of pulmonary hypertension (PAH) in combination with tadalafil
Pat. No. 9549926 (Family Id: 45939010) Compositions and methods of treating pulmonary hypertension
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 16, 2017
Oct 14, 2031U-1965: For the treatment of pulmonary arterial hypertension (PAH) in combination with tadalafil, wherein the weight ratio of ambrisentan to tadalafil is about 1:2 to about 1:3

AMIFAMPRIDINE PHOSPHATE (TABLET) (ORAL) FIRDAPSE
Drug Classes: Central Nervous System Agents:Central Nervous System, Other == potassium channel blocker
NDA Applicant: CATALYST PHARMS      NDA No.: 208078  Prod. No.: 001 RX (EQ 10MG BASE)
6 Patents--2 FamiliesExpirationPatented Use
Pat. No. 10793893 (Family Id: 46579320) Methods of administering 3,4-diaminopyridine
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 7, 2020
Apr 7, 2034U-2956: Method of treating Lambert-Eaton myasthenic syndrome with amifampridine
Pat. No. 11060128 (Family Id: 46579320) Methods of administering 3,4-diaminopyridine
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 19, 2021
Jun 29, 2032U-2956: Method of treating Lambert-Eaton myasthenic syndrome with amifampridine
Pat. No. 11268128 (Family Id: 46579320) Methods of administering 3,4-diaminopyridine
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 10, 2022
Jun 29, 2032U-2956: Method of treating Lambert-Eaton myasthenic syndrome with amifampridine
Pat. No. 11274331 (Family Id: 46579320) Methods of administering 3,4-diaminopyridine
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 30, 2022
Jun 29, 2032U-2956: Method of treating Lambert-Eaton myasthenic syndrome with amifampridine
Pat. No. 11274332 (Family Id: 46579320) Methods of administering 3,4-diaminopyridine
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 30, 2022
Jun 29, 2032U-2956: Method of treating Lambert-Eaton myasthenic syndrome with amifampridine
Pat. No. 10626088 DP* (Family Id: 59981985) Determining degradation of 3,4-diaminopyridine
Claim Types: Compound; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Aug 9, 2022
Feb 25, 2037 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityNov 28, 2023 
Exclusivity Code: ODE - Orphan drug exclusivityNov 28, 2025ODE-223: Indicated for the treatment of lambert-eaton myasthenic syndrome (LEMS) in adults

AMIKACIN SULFATE (SUSPENSION, LIPOSOMAL) (INHALATION) ARIKAYCE KIT
Drug Classes: Antibacterials:Aminoglycosides == aminoglycoside antibacterial
NDA Applicant: INSMED INC      NDA No.: 207356  Prod. No.: 001 RX (EQ 590MG BASE/8.4ML)
11 Patents--4 FamiliesExpirationPatented Use
Pat. No. 7718189 DP* (Family Id: 37669512) Sustained release of antiinfectives
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Jun 6, 2025U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen
Pat. No. 8802137 DP* (Family Id: 37669512) Sustained release of antiinfectives
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Apr 8, 2024U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen
Pat. No. 9827317 DP* (Family Id: 37669512) Sustained release of antiinfectives
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Apr 8, 2024U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen
Pat. No. 8226975 DP* (Family Id: 38123420) Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof
Claim Types: Kit; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Aug 15, 2028 
Pat. No. 8632804 (Family Id: 38123420) Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Dec 5, 2026U-2416: Treating mycobacterium avium complex (MAC) lung disease in adults with cystic fibrosis as part of a combination drug regimen
Pat. No. 8642075 DP* (Family Id: 38123420) Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 24, 2018
Dec 5, 2026 
Pat. No. 8679532 (Family Id: 38123420) Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Dec 5, 2026U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen
Pat. No. 9566234 DP* (Family Id: 49624305) Systems for treating pulmonary infections
Claim Types: Kit; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Jan 18, 2034U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen
Pat. No. 9895385 (Family Id: 54480776) Methods for treating pulmonary non-tuberculous mycobacterial infections
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
May 15, 2035U-2417: Treating mycobacterium avium complex (MAC) lung disease in non-cystic fibrosis adults as part of a combination antibacterial drug regimen
Pat. No. 10251900 (Family Id: 54480776) Methods for treating pulmonary non-tuberculous mycobacterial infections
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 2, 2019
May 15, 2035U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen
Pat. No. 10751355 (Family Id: 54480776) Methods for treating pulmonary non-tuberculous mycobacterial infections
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 24, 2020
May 15, 2035U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivitySep 28, 2030 GAINODE-214: Tx of MAC lung disease in adults with limited or no alternative tx options as part of a combo antibacterial drug regimen who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy

AMINOLEVULINIC ACID HYDROCHLORIDE (SOLUTION) (TOPICAL) LEVULAN
Drug Classes: optical imaging agent == porphyrin precursor
NDA Applicant: DUSA      NDA No.: 020965  Prod. No.: 001 RX (20%)
3 Patents--1 FamilyExpirationPatented Use
Pat. No. 10357567 (Family Id: 67212422) Methods for photodynamic therapy
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Aug 2, 2019
Jan 12, 2038U-3163: Treatment of actinic keratoses of upper extremities by photodynamic therapy
Pat. No. 11077192 (Family Id: 67212422) Methods for photodynamic therapy
Claim Types: Method of administration; Method of use
Pat. Sub. Date(s): 001: Aug 11, 2021
Jan 12, 2038U-3163: Treatment of actinic keratoses of upper extremities by photodynamic therapy
Pat. No. 11135293 (Family Id: 67212422) Methods for photodynamic therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 19, 2021
Jan 12, 2038U-3163: Treatment of actinic keratoses of upper extremities by photodynamic therapy

AMINOLEVULINIC ACID HYDROCHLORIDE (GEL) (TOPICAL) AMELUZ
Drug Classes: optical imaging agent == porphyrin precursor
NDA Applicant: BIOFRONTERA      NDA No.: 208081  Prod. No.: 001 RX (10%)
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 11235169 (Family Id: 78087370) Illumination device for photodynamic therapy, method for treating a skin disease and method for operating an illumination device
Claim Types: Device; Method of use; Method of administration
Pat. Sub. Date(s): 001: Feb 23, 2022
Oct 15, 2040U-3303: Topical lesion-directed and field-directed treatment of actinic keratosis of the face and scalp with photodynamic therapy by positioning an illumination device in an appropriate distance and illuminating the treatment area with narrowband red light

AMINOLEVULINIC ACID HYDROCHLORIDE (FOR SOLUTION) (ORAL) GLEOLAN
Drug Classes: optical imaging agent == porphyrin precursor
NDA Applicant: NXDC      NDA No.: 208630  Prod. No.: 001 RX (1.5GM/VIAL)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityJun 6, 2024ODE-146: Optical imaging agent indicated in patients with glioma (suspected World Health Organization grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery

AMIODARONE HYDROCHLORIDE (INJECTABLE) (INJECTION) NEXTERONE
Drug Classes: Cardiovascular Agents:Antiarrhythmics
NDA Applicant: BAXTER HLTHCARE      NDA No.: 022325  Prod. No.: 002 RX (150MG/100ML (1.5MG/ML)); 003 RX (360MG/200ML (1.8MG/ML)) NDA No.: 022325  Prod. No.: 001 DISC (50MG/ML**)
2 Patents--2 FamiliesExpirationPatented Use
Pat. No. 6869939 DP* (Family Id: 29399340) Formulations containing amiodarone and sulfoalkyl ether cyclodextrin
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: None
May 4, 2022 
Pat. No. 7635773 DP* (Family Id: 41215591) Sulfoalkyl ether cyclodextrin compositions
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: None
Mar 13, 2029 

AMISULPRIDE (SOLUTION) (INTRAVENOUS) BARHEMSYS
Drug Classes: Antiemetics:Antiemetics, Other == dopamine-2 (D2) antagonist
NDA Applicant: ACACIA      NDA No.: 209510  Prod. No.: 001 RX (5MG/2ML (2.5MG/ML)); 002 RX (10MG/4ML (2.5MG/ML))
5 Patents--2 FamiliesExpirationPatented Use
Pat. No. 9084765 (Family Id: 42136792) Use of amisulpride as an anti-emetic
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 16, 2020; 002: Feb 9, 2022
Mar 10, 2031U-1744: Prevention of post-operative nausea and vomiting
U-2754: Treatment of post-operative nausea and vomiting
Pat. No. 9545426 (Family Id: 42136792) Use of amisulpride as an anti-emetic
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 16, 2020; 002: Feb 9, 2022
Mar 10, 2031U-1744: Prevention of post-operative nausea and vomiting
U-2754: Treatment of post-operative nausea and vomiting
Pat. No. 9889118 (Family Id: 42136792) Use of amisulpride as an anti-emetic
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 16, 2020; 002: Feb 9, 2022
Mar 10, 2031U-1744: Prevention of post-operative nausea and vomiting
U-2754: Treatment of post-operative nausea and vomiting
Pat. No. 10525033 DP* (Family Id: 42136792) Use of amisulpride as an anti-emetic
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Mar 16, 2020; 002: Feb 9, 2022
Mar 10, 2031 
Pat. No. 11357753 (Family Id: 58462198) Rescue treatment of post operative nausea and vomiting
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 8, 2022
Feb 9, 2038U-2754: Treatment of post-operative nausea and vomiting
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityFeb 26, 2025 

AMLODIPINE BENZOATE (SUSPENSION) (ORAL) KATERZIA
Drug Classes: Cardiovascular Agents:Calcium Channel Blocking Agents, Dihydropyridines == Cardiovascular Agents:Cardiovascular Combinations == calcium channel blocker == dihydropyridine calcium channel blocker
NDA Applicant: AZURITY      NDA No.: 211340  Prod. No.: 001 RX (EQ 1MG BASE/ML)
6 Patents--2 FamiliesExpirationPatented Use
Pat. No. 10695329 DP* (Family Id: 61829917) Amlodipine formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 22, 2020
Oct 16, 2037 
Pat. No. 10894039 (Family Id: 61829917) Amlodipine formulations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 16, 2021
Oct 6, 2037U-185: Method of treating hypertension
U-3: Treatment of hypertension
Pat. No. 10952998 DP* (Family Id: 61829917) Amlodipine formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 29, 2021
Oct 6, 2037 
Pat. No. 10959991 (Family Id: 61829917) Amlodipine formulations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 15, 2021
Oct 6, 2037U-158: Angina
U-39: Angina pectoris
Pat. No. 11364230 DP* (Family Id: 61829917) Amlodipine formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 24, 2022
Oct 6, 2037 
Pat. No. 10799453 DP* (Family Id: 68161047) Amlodipine formulations
Claim Types: Product-by-process
Pat. Sub. Date(s): 001: Nov 2, 2020
Apr 11, 2039 

AMLODIPINE BESYLATE (TABLET, ORALLY DISINTEGRATING) (ORAL) AMLODIPINE BESYLATE
Drug Classes: Cardiovascular Agents:Calcium Channel Blocking Agents, Dihydropyridines == Cardiovascular Agents:Cardiovascular Combinations == calcium channel blocker == dihydropyridine calcium channel blocker
NDA Applicant: SYNTHON PHARMS      NDA No.: 022026  Prod. No.: 001 DISC (EQ 2.5MG BASE); 002 DISC (EQ 5MG BASE); 003 DISC (EQ 10MG BASE)
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 6828339 DS* (Family Id: 23295188) Amlodipine salt forms and processes for preparing them
Claim Types: New polymorph, salt or hydrate; Formulation
Pat. Sub. Date(s): All strengths: None
Nov 20, 2022 

AMLODIPINE BESYLATE (SOLUTION) (ORAL) NORLIQVA
Drug Classes: Cardiovascular Agents:Calcium Channel Blocking Agents, Dihydropyridines == Cardiovascular Agents:Cardiovascular Combinations == calcium channel blocker == dihydropyridine calcium channel blocker
NDA Applicant: CMP DEV LLC      NDA No.: 214439  Prod. No.: 001 RX (EQ 1MG BASE/ML)
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 11253474 DP* (Family Id: 1000005449905) Pharmaceutical solution of amlodipine
Claim Types: Formulation; Drug in a container; Method of use
Pat. Sub. Date(s): 001: Feb 28, 2022
Feb 24, 2041U-3309: NORLIQVA is indicated for the treatment of hypertension, to lower blood pressure in adults and children 6 years of age and older
U-3310: NORLIQVA is indicated for the symptomatic treatment of chronic stable angina
U-3311: NORLIQVA is indicated for the treatment of confirmed or suspected vasospastic angina

AMLODIPINE BESYLATE; CELECOXIB (TABLET) (ORAL) CONSENSI
Drug Classes: Cardiovascular Agents:Calcium Channel Blocking Agents, Dihydropyridines == Cardiovascular Agents:Cardiovascular Combinations == calcium channel blocker == dihydropyridine calcium channel blocker == Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: PURPLE BIOTECH      NDA No.: 210045  Prod. No.: 001 DISC (EQ 2.5MG BASE;200MG); 002 DISC (EQ 5MG BASE;200MG); 003 DISC (EQ 10MG BASE;200MG)
5 Patents--2 FamiliesExpirationPatented Use
Pat. No. 9408837 (Family Id: 44368489) Ameliorating drug-induced elevations in blood pressure by adjunctive use of antihypertensive drugs
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 11, 2020
Feb 28, 2030U-2410: Treatment of adult patients for whom treatment with both amlodipine for hypertension and celecoxib for osteoarthritis are appropriate
Pat. No. 9662315 DP* (Family Id: 44368489) Ameliorating drug-induced elevations in blood pressure by adjunctive use of antihypertensive drugs
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Oct 16, 2018
May 22, 2029U-2410: Treatment of adult patients for whom treatment with both amlodipine for hypertension and celecoxib for osteoarthritis are appropriate
Pat. No. 10350171 DP* (Family Id: 64904380) Celecoxib and amlodipine formulation and method of making the same
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): All strengths: Sep 6, 2019
Jun 14, 2038 
Pat. No. 10925835 (Family Id: 64904380) Celecoxib and amlodipine formulation and method of making the same
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 22, 2021
Jun 14, 2038U-2410: Treatment of adult patients for whom treatment with both amlodipine for hypertension and celecoxib for osteoarthritis are appropriate
Pat. No. 10945960 DP* (Family Id: 64904380) Celecoxib and amlodipine formulation and method of making the same
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Mar 22, 2021
Jun 14, 2038 

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN (TABLET) (ORAL) EXFORGE HCT [GENERIC AB]
Drug Classes: Cardiovascular Agents:Calcium Channel Blocking Agents, Dihydropyridines == Cardiovascular Agents:Cardiovascular Combinations == calcium channel blocker == dihydropyridine calcium channel blocker == Cardiovascular Agents:Diuretics, Thiazide == Cardiovascular Agents:Angiotensin II Receptor Antagonists == angiotensin II receptor blocker
NDA Applicant: NOVARTIS      NDA No.: 022314  Prod. No.: 001 RX (EQ 5MG BASE;12.5MG;160MG); 002 RX (EQ 5MG BASE;25MG;160MG); 003 RX (EQ 10MG BASE;12.5MG;160MG); 004 RX (EQ 10MG BASE;25MG;160MG); 005 RX (EQ 10MG BASE;25MG;320MG)
2 Patents--2 FamiliesExpirationPatented Use
Pat. No. 8101599 DP* (Family Id: 29550142) Pharmaceutical composition containing anti-hypertensive agents
Claim Types: Formulation; Kit
Pat. Sub. Date(s): 001: Jan 30, 2012; 002: None; 003: None; 004: None; 005: None
May 16, 2023 
Pat. No. 8475839 DP* (Family Id: 38662673) Formulation
Claim Types:
Pat. Sub. Date(s): All strengths: Aug 1, 2013
Nov 16, 2023 *PED 

AMLODIPINE BESYLATE; PERINDOPRIL ARGININE (TABLET) (ORAL) PRESTALIA
Drug Classes: Cardiovascular Agents:Calcium Channel Blocking Agents, Dihydropyridines == Cardiovascular Agents:Cardiovascular Combinations == calcium channel blocker == dihydropyridine calcium channel blocker == Cardiovascular Agents:Angiotensin-converting Enzyme (ACE) Inhibitors == angiotensin converting enzyme inhibitor
NDA Applicant: ADHERA      NDA No.: 205003  Prod. No.: 001 RX (EQ 2.5MG BASE;3.5MG ); 002 RX (EQ 5MG BASE;7MG); 003 RX (EQ 10MG BASE;14MG)
2 Patents--2 FamiliesExpirationPatented Use
Pat. No. 7846961 DS* DP* (Family Id: 37022969) .alpha. crystalline form of the arginine salt of perindopril, a process for its preparation and pharm
Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use
Pat. Sub. Date(s): All strengths: Dec 29, 2015
Oct 5, 2029U-3: Treatment of hypertension
Pat. No. 6696481 DS* DP* (Family Id: 8871521) Salt of perindopril and pharmaceutical compositions containing it
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Pat. Sub. Date(s): All strengths: Dec 29, 2015
Apr 15, 2023U-3: Treatment of hypertension

AMOXICILLIN (TABLET, EXTENDED RELEASE) (ORAL) MOXATAG
Drug Classes: Antibacterials:Beta-lactam, Penicillins == penicillin class antibacterial
NDA Applicant: PRAGMA      NDA No.: 050813  Prod. No.: 001 DISC (775MG)
3 Patents--3 FamiliesExpirationPatented Use
Pat. No. 8357394 DP* (Family Id: 38139672) 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. 8299052 (Family Id: 39113740) 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
Pat. No. 8778924 DS* DP* (Family Id: 39476534) 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

AMOXICILLIN; CLARITHROMYCIN; VONOPRAZAN FUMARATE (CAPSULE, TABLET, TABLET) (ORAL) VOQUEZNA TRIPLE PAK
Drug Classes: Antibacterials:Beta-lactam, Penicillins == penicillin class antibacterial == Antibacterials:Macrolides == macrolide antimicrobial
NDA Applicant: PHATHOM      NDA No.: 215152  Prod. No.: 001 RX (500MG;500MG;EQ 20MG BASE)
2 Patents--2 FamiliesExpirationPatented Use
Pat. No. 7977488 DS* (Family Id: 37517870) 1-heterocyclylsulfonyl, 2-aminomethyl, 5-(hetero-) aryl substituted 1-H-pyrrole derivatives as acid secretion inhibitors
Claim Types: Compound
Pat. Sub. Date(s): 001: Jul 27, 2022
Aug 11, 2028 
Pat. No. 9186411 DP* (Family Id: 41327301) Pharmaceutical composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 27, 2022
Aug 11, 2030 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMay 3, 2032 GAIN 

AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN (CAPSULE, DELAYED RELEASE) (ORAL) TALICIA
Drug Classes: Antibacterials:Beta-lactam, Penicillins == penicillin class antibacterial == Gastrointestinal Agents:Proton Pump Inhibitors == Gastrointestinal Agents:Gastrointestinal Agents, Other == Antimycobacterials:Antimycobacterials, Other == rifamycin antimycobacterial
NDA Applicant: REDHILL      NDA No.: 213004  Prod. No.: 001 RX (250MG;EQ 10MG BASE;12.5MG)
5 Patents--1 FamilyExpirationPatented Use
Pat. No. 9050263 DP* (Family Id: 51297592) Pharmaceutical compositions for the treatment of Helicobacter pylori
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 25, 2019
Feb 12, 2034U-2660: Treatment of H. pylori infection in adults
Pat. No. 9498445 DP* (Family Id: 51297592) Pharmaceutical compositions for the treatment of Helicobacter pylori
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 25, 2019
Feb 12, 2034U-2660: Treatment of H. pylori infection in adults
Pat. No. 9603806 DP* (Family Id: 51297592) Pharmaceutical compositions for the treatment of Helicobacter pylori
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 25, 2019
Feb 12, 2034U-2660: Treatment of H. pylori infection in adults
Pat. No. 10238606 DP* (Family Id: 51297592) Pharmaceutical compositions for the treatment of Helicobacter pylori
Claim Types: Kit
Pat. Sub. Date(s): 001: Nov 25, 2019
Feb 12, 2034 
Pat. No. 11135172 DP* (Family Id: 51297592) Rifabutin-based compositions and methods for treating Helicobacter pylori infection
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 7, 2021
Feb 12, 2034U-2660: Treatment of H. pylori infection in adults

AMOXICILLIN; VONOPRAZAN FUMARATE (CAPSULE, TABLET) (ORAL) VOQUEZNA DUAL PAK
Drug Classes: Antibacterials:Beta-lactam, Penicillins == penicillin class antibacterial
NDA Applicant: PHATHOM      NDA No.: 215153  Prod. No.: 001 RX (500MG;EQ 20MG BASE)
2 Patents--2 FamiliesExpirationPatented Use
Pat. No. 7977488 DS* (Family Id: 37517870) 1-heterocyclylsulfonyl, 2-aminomethyl, 5-(hetero-) aryl substituted 1-H-pyrrole derivatives as acid secretion inhibitors
Claim Types: Compound
Pat. Sub. Date(s): 001: Jul 27, 2022
Aug 11, 2028 
Pat. No. 9186411 DP* (Family Id: 41327301) Pharmaceutical composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 27, 2022
Aug 11, 2030 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMay 3, 2032 GAIN 

AMPHETAMINE (SUSPENSION, EXTENDED RELEASE) (ORAL) ADZENYS ER
Drug Classes: Central Nervous System Agents:Attention Deficit Hyperactivity Disorder Agents, Amphetamines == central nervous system stimulant
NDA Applicant: NEOS THERAPS INC      NDA No.: 204325  Prod. No.: 001 DISC (EQ 1.25MG BASE/ML)
3 Patents--1 FamilyExpirationPatented Use
Pat. No. 8709491 DP* (Family Id: 47424553) Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 21, 2017
Jun 28, 2032 
Pat. No. 9017731 DP* (Family Id: 47424553) Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 21, 2017
Jun 28, 2032 
Pat. No. 9265737 DP* (Family Id: 47424553) Pharmaceutical composition comprising amphetamines complexed with ion-exchange resin particles
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 21, 2017
Jun 28, 2032 

AMPHETAMINE (TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE) (ORAL) ADZENYS XR-ODT
Drug Classes: Central Nervous System Agents:Attention Deficit Hyperactivity Disorder Agents, Amphetamines == central nervous system stimulant
NDA Applicant: NEOS THERAPS      NDA No.: 204326  Prod. No.: 001 RX (EQ 3.1MG BASE); 002 RX (EQ 6.3MG BASE); 003 RX (EQ 9.4MG BASE); 004 RX (EQ 12.5MG BASE); 005 RX (EQ 15.7MG BASE); 006 RX (EQ 18.8MG BASE)
4 Patents--2 FamiliesExpirationPatented Use
Pat. No. 8840924 DP* (Family Id: 37985648) Compositions and methods of making rapidly dissolving ionically masked formulations
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 26, 2016
Apr 9, 2026 
Pat. No. 8709491 DP* (Family Id: 47424553) Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 26, 2016; 002: None; 003: None; 004: None; 005: None; 006: None
Jun 28, 2032 
Pat. No. 9017731 DP* (Family Id: 47424553) Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 26, 2016; 002: None; 003: None; 004: None; 005: None; 006: None
Jun 28, 2032 
Pat. No. 9265737 DP* (Family Id: 47424553) Pharmaceutical composition comprising amphetamines complexed with ion-exchange resin particles
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 26, 2016; 002: None; 003: None; 004: None; 005: None; 006: None
Jun 28, 2032 

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE (CAPSULE, EXTENDED RELEASE) (ORAL) MYDAYIS [Has competitive generic]
Drug Classes: Central Nervous System Agents:Attention Deficit Hyperactivity Disorder Agents, Amphetamines == central nervous system stimulant == central nervous system (CNS) stimulant
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 022063  Prod. No.: 001 RX (3.125MG;3.125MG;3.125MG;3.125MG); 002 RX (6.25MG;6.25MG;6.25MG;6.25MG); 003 RX (9.375MG;9.375MG;9.375MG;9.375MG); 004 RX (12.5MG;12.5MG;12.5MG;12.5MG)
3 Patents--2 FamiliesExpirationPatented Use
Pat. No. 6913768 DP* (Family Id: 31996998) Sustained release delivery of amphetamine salts
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jul 7, 2017
May 24, 2023U-2025: Treatment of attention deficit hyperactivity disorder
Pat. No. 8846100 DP* (Family Id: 38685424) Controlled dose drug delivery system
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 7, 2017
Aug 24, 2029 
Pat. No. 9173857 (Family Id: 38685424) Controlled dose drug delivery system
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 7, 2017
May 12, 2026U-2025: Treatment of attention deficit hyperactivity disorder
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousMar 13, 2023 PEDM-248: Information added to the labeling to describe a trial evaluating a lower dose than those approved for pediatric patients 13 to 17 years of age

AMPHETAMINE SULFATE (TABLET, ORALLY DISINTEGRATING) (ORAL) EVEKEO ODT
Drug Classes: Central Nervous System Agents:Attention Deficit Hyperactivity Disorder Agents, Amphetamines == central nervous system stimulant
NDA Applicant: AZURITY      NDA No.: 209905  Prod. No.: 001 RX (5MG); 002 RX (10MG); 003 RX (15MG); 004 RX (20MG) NDA No.: 209905  Prod. No.: 005 DISC (2.5MG)
3 Patents--2 FamiliesExpirationPatented Use
Pat. No. 10130580 DP* (Family Id: 36145643) Taste-masked pharmaceutical compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 31, 2019; 002: Jan 31, 2019; 003: Jan 31, 2019; 004: Jan 31, 2019; 005: Jul 7, 2021
Apr 19, 2024 
Pat. No. 10441554 DP* (Family Id: 63446790) Oral amphetamine composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 15, 2019; 002: Oct 15, 2019; 003: Oct 15, 2019; 004: Oct 15, 2019; 005: Jul 7, 2021
Mar 10, 2037 
Pat. No. 11160772 DP* (Family Id: 63446790) Oral amphetamine composition
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Dec 9, 2021
Mar 10, 2037 

AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE (SUSPENSION, EXTENDED RELEASE) (ORAL) DYANAVEL XR
Drug Classes: Central Nervous System Agents:Attention Deficit Hyperactivity Disorder Agents, Amphetamines == central nervous system stimulant
NDA Applicant: TRIS PHARMA INC      NDA No.: 208147  Prod. No.: 001 RX (2MG/ML;EQ 0.5MG BASE/ML)
6 Patents--1 FamilyExpirationPatented Use
Pat. No. 8062667 DP* (Family Id: 38512117) Modified release formulations containing drug-ion exchange resin complexes
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 27, 2015
Mar 29, 2029 
Pat. No. 8597684 DP* (Family Id: 38512117) Modified release formulations containing drug-ion exchange resin complexes
Claim Types: Formulation; Product-by-process
Pat. Sub. Date(s): 001: Oct 27, 2015
Mar 15, 2027 
Pat. No. 8747902 DP* (Family Id: 38512117) Modified release formulations containing drug-ion exchange resin complexes
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 27, 2015
Mar 15, 2027 
Pat. No. 8883217 DP* (Family Id: 38512117) Modified release formulations containing drug-ion exchange resin complexes
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 27, 2015
Mar 15, 2027 
Pat. No. 9675703 DP* (Family Id: 38512117) Modified release formulations containing drug - ion exchange resin complexes
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 28, 2017
Mar 15, 2027 
Pat. No. 10086087 DP* (Family Id: 38512117) Modified release formulations containing drug-ion exchange resin complexes
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 3, 2018
Mar 15, 2027 

AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE (TABLET, EXTENDED RELEASE) (ORAL) DYANAVEL XR 5; DYANAVEL XR 10; DYANAVEL XR 15; DYANAVEL XR 20
Drug Classes: Central Nervous System Agents:Attention Deficit Hyperactivity Disorder Agents, Amphetamines == central nervous system stimulant
NDA Applicant: TRIS PHARMA INC      NDA No.: 210526  Prod. No.: 001 RX (4MG;EQ 1MG BASE); 002 RX (8MG;EQ 2MG BASE); 003 RX (12MG;EQ 3MG BASE); 004 RX (16MG;EQ 4MG BASE)
3 Patents--1 FamilyExpirationPatented Use
Pat. No. 8337890 DP* (Family Id: 38512117) Modified release formulations containing drug-ion exchange resin complexes
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 22, 2021
Mar 15, 2027 
Pat. No. 8747902 DP* (Family Id: 38512117) Modified release formulations containing drug-ion exchange resin complexes
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 22, 2021
Mar 15, 2027 
Pat. No. 9675704 DP* (Family Id: 38512117) Modified release formulations containing drug-ion exchange resin complexes
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 22, 2021
Mar 15, 2027 

AMPHOTERICIN B (INJECTABLE, LIPOSOMAL) (INJECTION) AMPHOTERICIN B [GENERIC AB]
Drug Classes: Antifungals == lipid-based polyene antifungal
NDA Applicant: SPIL      NDA No.: 212514  Prod. No.: 001 RX (50MG/VIAL)
ExclusivityExpirationExclusivity Description
Exclusivity Code: CGT - Competitive generic therapyAug 14, 2022 

ANGIOTENSIN II ACETATE (SOLUTION) (INTRAVENOUS) GIAPREZA
Drug Classes: Cardiovascular Agents:Angiotensin-converting Enzyme (ACE) Inhibitors == Cardiovascular Agents:Angiotensin II Receptor Antagonists
NDA Applicant: LA JOLLA PHARMA      NDA No.: 209360  Prod. No.: 001 RX (EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)); 003 RX (EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML))
10 Patents--3 FamiliesExpirationPatented Use
Pat. No. 9572856 [Extended 240 days (0.7 years)]
(Family Id: 44143626) Method of treating low blood pressure
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 22, 2018; 003: Jan 21, 2022
Jul 18, 2031U-2221: Treating refractory hypotension with about 20 ng/kg/min angiotensin II in a patient receiving vasopressor
Pat. No. 9867863 (Family Id: 44143626) Method of treating low blood pressure
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 14, 2018; 003: Jan 21, 2022
Dec 16, 2029U-2231: Treating refractory hypotension with about 5 ng/kg/min to about 20 ng/kg/min angiotensin II in a patient receiving vasopressor
Pat. No. 10335451 (Family Id: 44143626) Method of treating low blood pressure
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 26, 2019; 003: Jan 21, 2022
Dec 16, 2029U-2581: Treating hypotension with about 20 ng/kg/min to about 40 ng/kg/min angiotensin II in a human subject having septic shock
Pat. No. 10500247 (Family Id: 44143626) Method of treating low blood pressure
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 20, 2019; 003: Jan 21, 2022
Dec 16, 2029U-2680: Treating low blood pressure with angiotensin II with an initial rate of about 5 ng/kg/min to about 20 ng/kg/min in a subject having refractory hypotension or severe hypotension
U-2681: Treating low blood pressure with angiotensin II with an initial rate of about 5 ng/kg/min to about 20 ng/kg/min in a subject having refractory hypotension or severe hypotension, and titrating the rate up
Pat. No. 10548943 (Family Id: 44143626) Method of treating low blood pressure
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 20, 2020; 003: Jan 21, 2022
Dec 16, 2029U-2739: Increasing blood pressure with an initial rate of about 20 ng/kg/min angiotensin II in a human subject having septic shock, and titrating the rate up.
U-2740: Increasing blood pressure with a rate of about 20 ng/kg/min to about 40 ng/kg/min angiotensin II in a human subject having septic shock
Pat. No. 9220745 (Family Id: 53367119) Angiotensin II alone or in combination for the treatment of hypotension
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 22, 2018; 003: Jan 21, 2022
Dec 18, 2034U-2217: Treating high output shock with angiotensin II by increasing mean arterial pressure in patients treated with catecholamines and reducing catecholamine use
U-2218: Maintaining mean arterial pressure of about 65 mmHg or higher with angiotensin II in shock patients treated with catecholamines and reducing catecholamine use
Pat. No. 10028995 (Family Id: 53367119) Angiotensin II alone or in combination for the treatment of hypotension
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Aug 2, 2018; 003: Jan 21, 2022
Dec 18, 2034U-2338: Maintaining mean arterial pressure of about 65 mmHg or above with about 1 ng/kg/min to about 40 ng/kg/min angiotensin II in hypotensive patients treated with vasopressin or a vasopressin analogue and reducing vasopressin or vasopressin analogue use
Pat. No. 10493124 (Family Id: 53367119) Angiotensin II alone or in combination for the treatment of hypotension
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 20, 2019; 003: Jan 21, 2022
Dec 18, 2034U-2679: Treating low blood pressure with angiotensin II at an initial rate of about 20 ng/kg/min and titrating down to achieve and/or maintain a map of about 65 mm Hg or above
Pat. No. 11096983 (Family Id: 53367119) Angiotensin II alone or in combination for the treatment of hypotension
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 23, 2021; 003: Jan 21, 2022
Dec 18, 2034U-3211: Treating distributive shock with angiotensin II
U-3212: Treating septic shock with angiotensin II
Pat. No. 11219662 (Family Id: 59273945) Methods for treating hypotension in a patient that has received an ACE inhibitor by administering angiotensin II
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 11, 2022
Jan 6, 2037U-3262: Treating hypotension with angiotensin II in a patient receiving an angiotensin converting enzyme inhibitor
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityDec 21, 2022 

ANGIOTENSIN II ACETATE (SOLUTION) (INTRAVENOUS) GIAPREZA
Drug Classes: Cardiovascular Agents:Angiotensin-converting Enzyme (ACE) Inhibitors == Cardiovascular Agents:Angiotensin II Receptor Antagonists
NDA Applicant: LA JOLLA PHARMA      NDA No.: 209360  Prod. No.: 002 DISC (EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML))
10 Patents--3 FamiliesExpirationPatented Use
Pat. No. 9572856 [Extended 240 days (0.7 years)]
(Family Id: 44143626) Method of treating low blood pressure
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 22, 2018
Nov 20, 2030U-2221: Treating refractory hypotension with about 20 ng/kg/min angiotensin II in a patient receiving vasopressor
Pat. No. 9867863 (Family Id: 44143626) Method of treating low blood pressure
Claim Types: Method of use
Pat. Sub. Date(s): 002: Feb 14, 2018
Dec 16, 2029U-2231: Treating refractory hypotension with about 5 ng/kg/min to about 20 ng/kg/min angiotensin II in a patient receiving vasopressor
Pat. No. 10335451 (Family Id: 44143626) Method of treating low blood pressure
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jul 26, 2019
Dec 16, 2029U-2581: Treating hypotension with about 20 ng/kg/min to about 40 ng/kg/min angiotensin II in a human subject having septic shock
Pat. No. 10500247 (Family Id: 44143626) Method of treating low blood pressure
Claim Types: Method of use
Pat. Sub. Date(s): 002: Dec 20, 2019
Dec 16, 2029U-2680: Treating low blood pressure with angiotensin II with an initial rate of about 5 ng/kg/min to about 20 ng/kg/min in a subject having refractory hypotension or severe hypotension
U-2681: Treating low blood pressure with angiotensin II with an initial rate of about 5 ng/kg/min to about 20 ng/kg/min in a subject having refractory hypotension or severe hypotension, and titrating the rate up
Pat. No. 10548943 (Family Id: 44143626) Method of treating low blood pressure
Claim Types: Method of use
Pat. Sub. Date(s): 002: Feb 20, 2020
Dec 16, 2029U-2739: Increasing blood pressure with an initial rate of about 20 ng/kg/min angiotensin II in a human subject having septic shock, and titrating the rate up.
U-2740: Increasing blood pressure with a rate of about 20 ng/kg/min to about 40 ng/kg/min angiotensin II in a human subject having septic shock
Pat. No. 9220745 (Family Id: 53367119) Angiotensin II alone or in combination for the treatment of hypotension
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 22, 2018
Dec 18, 2034U-2217: Treating high output shock with angiotensin II by increasing mean arterial pressure in patients treated with catecholamines and reducing catecholamine use
U-2218: Maintaining mean arterial pressure of about 65 mmHg or higher with angiotensin II in shock patients treated with catecholamines and reducing catecholamine use
Pat. No. 10028995 (Family Id: 53367119) Angiotensin II alone or in combination for the treatment of hypotension
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 002: Aug 2, 2018
Dec 18, 2034U-2338: Maintaining mean arterial pressure of about 65 mmHg or above with about 1 ng/kg/min to about 40 ng/kg/min angiotensin II in hypotensive patients treated with vasopressin or a vasopressin analogue and reducing vasopressin or vasopressin analogue use
Pat. No. 10493124 (Family Id: 53367119) Angiotensin II alone or in combination for the treatment of hypotension
Claim Types: Method of use
Pat. Sub. Date(s): 002: Dec 20, 2019
Dec 18, 2034U-2679: Treating low blood pressure with angiotensin II at an initial rate of about 20 ng/kg/min and titrating down to achieve and/or maintain a map of about 65 mm Hg or above
Pat. No. 11096983 (Family Id: 53367119) Angiotensin II alone or in combination for the treatment of hypotension
Claim Types: Method of use
Pat. Sub. Date(s): 002: Sep 23, 2021
Dec 18, 2034U-3211: Treating distributive shock with angiotensin II
U-3212: Treating septic shock with angiotensin II
Pat. No. 11219662 (Family Id: 59273945) Methods for treating hypotension in a patient that has received an ACE inhibitor by administering angiotensin II
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 11, 2022
Jan 6, 2037U-3262: Treating hypotension with angiotensin II in a patient receiving an angiotensin converting enzyme inhibitor
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityDec 21, 2022 

ANIDULAFUNGIN (POWDER) (INTRAVENOUS) ERAXIS
Drug Classes: Antifungals == echinocandin antifungal
NDA Applicant: VICURON HOLDINGS      NDA No.: 021632  Prod. No.: 001 RX (50MG/VIAL); 002 RX (100MG/VIAL)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationSep 22, 2023 

APALUTAMIDE (TABLET) (ORAL) ERLEADA
Drug Classes: Antineoplastics:Antiandrogens
NDA Applicant: JANSSEN BIOTECH      NDA No.: 210951  Prod. No.: 001 RX (60MG)
9 Patents--4 FamiliesExpirationPatented Use
Pat. No. 8445507 DS* DP* (Family Id: 38656005) Androgen receptor modulator for the treatment of prostate
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Mar 5, 2018
Sep 15, 2030U-2237: Treatment of non-metastatic, castration-resistant prostate cancer (NM-CRPC)
U-2624: Treatment of metastatic castration-sensitive prostate cancer (MCSPC)
Pat. No. 8802689 (Family Id: 38656005) Androgen receptor modulator for the treatment of prostate cancer and androgen receptor-associated diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 5, 2018
Mar 27, 2027U-2237: Treatment of non-metastatic, castration-resistant prostate cancer (NM-CRPC)
U-2624: Treatment of metastatic castration-sensitive prostate cancer (MCSPC)
Pat. No. 9388159 DS* DP* (Family Id: 38656005) Substituted diazaspiroalkanes as androgen receptor modulators
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Mar 5, 2018
Mar 27, 2027 
Pat. No. 9987261 DP* (Family Id: 38656005) Substituted diazaspiroalkanes as androgen receptor modulators
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 18, 2018
Mar 27, 2027 
Pat. No. 9884054 (Family Id: 49293921) Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 5, 2018
Sep 23, 2033U-2237: Treatment of non-metastatic, castration-resistant prostate cancer (NM-CRPC)
Pat. No. 10052314 (Family Id: 49293921) Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 13, 2018
Sep 23, 2033U-2381: Treatment in combination with a GNRH agonist of non-metastatic, castration-resistant prostate cancer (NM-CRPC)
U-2382: Treatment in combination with a GNRH agonist of high risk non-metastatic, castration-resistant prostate cancer (NM-CRPC)
Pat. No. 10849888 (Family Id: 49293921) Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 5, 2021
Sep 23, 2033U-3013: Treatment in combination with orchiectomy of non-metastatic, castration-resistant prostate cancer (NMCRPC)
Pat. No. 9481663 DS* (Family Id: 49712550) Crystalline forms of an androgen receptor modulator
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Pat. Sub. Date(s): 001: Mar 5, 2018
Jun 4, 2033 
Pat. No. 10702508 (Family Id: 62165723) Anti-androgens for the treatment of non-metastatic castration-resistant prostate cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 5, 2021
Apr 30, 2038U-3012: Treatment in combination with androgen deprivation therapy of non-metastatic, castration-resistant prostate cancer (NMCRPC) that improves metastasis free survival
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationSep 17, 2022I-808: Treatment of patients with metastatic castration-sensitive prostate cancer (MCSPC)
Exclusivity Code: NCE - New chemical entityFeb 14, 2023 

APIXABAN (TABLET) (ORAL) ELIQUIS [GENERIC AB]
Drug Classes: Blood Products and Modifiers:Anticoagulants == factor Xa inhibitor
NDA Applicant: BRISTOL MYERS SQUIBB      NDA No.: 202155  Prod. No.: 001 RX (2.5MG)
2 Patents--2 FamiliesExpirationPatented Use
Pat. No. 9326945 DP* (Family Id: 43901603) Apixaban formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: May 26, 2016
Feb 24, 2031 
Pat. No. 6967208 DS* DP* [Extended 1526 days (4.2 years)]
(Family Id: 44726602) Lactam-containing compounds and derivatives thereof as factor Xa inhibitors
Claim Types: Composition; Method of use; Compound
Pat. Sub. Date(s): 001: Jan 25, 2013
Nov 21, 2026U-1167: Prophylaxis of deep vein thrombosis (DVT)
U-1200: Reducing the risk of stroke and systemic embolism
U-1301: Treatment of deep vein thrombosis (DVT)
U-1302: Treatment of pulmonary embolism (PE)
U-1323: Reducing the risk of stroke
U-1501: Prophylaxis of deep vein thrombosis and pulmonary embolism
U-1502: Prophylaxis of pulmonary embolism
U-1729: Reduce the risk of recurrent deep vein thrombosis (DVT)
U-1730: Reduce the risk of recurrent pulmonary embolism

APIXABAN (TABLET) (ORAL) ELIQUIS [GENERIC AB]
Drug Classes: Blood Products and Modifiers:Anticoagulants == factor Xa inhibitor
NDA Applicant: BRISTOL MYERS SQUIBB      NDA No.: 202155  Prod. No.: 002 RX (5MG)
2 Patents--2 FamiliesExpirationPatented Use
Pat. No. 9326945 DP* (Family Id: 43901603) Apixaban formulations
Claim Types: Formulation
Pat. Sub. Date(s): 002: May 26, 2016
Feb 24, 2031 
Pat. No. 6967208 DS* DP* [Extended 1526 days (4.2 years)]
(Family Id: 44726602) Lactam-containing compounds and derivatives thereof as factor Xa inhibitors
Claim Types: Composition; Method of use; Compound
Pat. Sub. Date(s): 002: Jan 25, 2013
Nov 21, 2026U-1200: Reducing the risk of stroke and systemic embolism
U-1301: Treatment of deep vein thrombosis (DVT)
U-1302: Treatment of pulmonary embolism (PE)
U-1323: Reducing the risk of stroke

APOMORPHINE HYDROCHLORIDE (FILM) (SUBLINGUAL) KYNMOBI
Drug Classes: Antiparkinson Agents:Dopamine Agonists == dopaminergic agonist
NDA Applicant: SUNOVION PHARMS INC      NDA No.: 210875  Prod. No.: 001 RX (10MG); 002 RX (15MG); 003 RX (20MG); 004 RX (25MG); 005 RX (30MG)
19 Patents--9 FamiliesExpirationPatented Use
Pat. No. 8765167 DP* (Family Id: 38087822) Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Feb 20, 2024 
Pat. No. 9855221 DP* (Family Id: 38087822) Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Feb 14, 2022 
Pat. No. 8603514 DP* (Family Id: 39101644) Uniform films for rapid dissolve dosage form incorporating taste-masking compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Apr 3, 2024 
Pat. No. 9931305 DP* (Family Id: 39101644) Uniform films for rapid dissolve dosage form incorporating taste-masking compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Feb 14, 2022 
Pat. No. 10888499 DP* (Family Id: 39872428) Thin film with non-self-aggregating uniform heterogeneity and drug delivery systems made therefrom
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Jan 14, 2021
Feb 14, 2022 
Pat. No. 9044475 DP* (Family Id: 43309244) Sublingual apomorphine
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Jun 11, 2030 
Pat. No. 9326981 (Family Id: 43309244) Sublingual apomorphine
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Jun 11, 2030U-2825: Treatment of 'off' episodes in patients with Parkinson's disease
Pat. No. 9669019 DP* (Family Id: 43309244) Sublingual apomorphine
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Jun 11, 2030U-2825: Treatment of 'off' episodes in patients with Parkinson's disease
Pat. No. 9669021 (Family Id: 43309244) Sublingual apomorphine
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Jun 11, 2030U-2825: Treatment of 'off' episodes in patients with Parkinson's disease
Pat. No. 10420763 DP* (Family Id: 43309244) Sublingual apomorphine
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Jun 11, 2030U-2825: Treatment of 'off' episodes in patients with Parkinson's disease
Pat. No. 10821074 DP* (Family Id: 43431171) Sublingual and buccal film compositions
Claim Types: Device
Pat. Sub. Date(s): All strengths: Nov 12, 2020
Aug 7, 2029 
Pat. No. 8663687 DP* (Family Id: 44914708) Film compositions for delivery of actives
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Feb 2, 2023 
Pat. No. 8414922 DP* (Family Id: 46245147) Sublingual films
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Dec 16, 2031U-2825: Treatment of 'off' episodes in patients with Parkinson's disease
Pat. No. 8846074 DP* (Family Id: 46245147) Sublingual films
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Dec 16, 2031U-2825: Treatment of 'off' episodes in patients with Parkinson's disease
Pat. No. 9283219 DP* (Family Id: 46245147) Sublingual films
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Jun 11, 2030U-2825: Treatment of 'off' episodes in patients with Parkinson's disease
Pat. No. 11419769 DP* (Family Id: 46245147) Sublingual films
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Sep 6, 2022
Dec 16, 2031U-2825: Treatment of 'off' episodes in patients with Parkinson's disease
Pat. No. 10449146 (Family Id: 57143420) Methods of treating Parkinson's Disease by administration of apomorphine to an oral mucosa
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Apr 19, 2036U-2825: Treatment of 'off' episodes in patients with Parkinson's disease
Pat. No. 10959943 (Family Id: 57143420) Methods of treating Parkinson's disease by administration of apomorphine to an oral mucosa
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 2, 2021
Apr 19, 2036U-2825: Treatment of 'off' episodes in patients with Parkinson's disease
Pat. No. 11077068 DP* (Family Id: 68291968) Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions
Claim Types: Product-by-process; Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): All strengths: Aug 5, 2021
Feb 14, 2022 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productMay 21, 2023 

APOMORPHINE HYDROCHLORIDE (INJECTABLE) (SUBCUTANEOUS) APOMORPHINE HYDROCHLORIDE [GENERIC AP]
Drug Classes: Antiparkinson Agents:Dopamine Agonists == dopaminergic agonist
NDA Applicant: SAGE CHEMS      NDA No.: 212025  Prod. No.: 001 RX (30MG/3ML (10MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Code: CGT - Competitive generic therapyAug 24, 2022 

APREMILAST (TABLET) (ORAL) OTEZLA [GENERIC AB]
Drug Classes: Dermatological Agents:Dermatological Agents, Other == phosphodiesterase 4 inhibitor
NDA Applicant: AMGEN INC      NDA No.: 205437  Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (30MG)
11 Patents--5 FamiliesExpirationPatented Use
Pat. No. 6962940 (Family Id: 28457137) (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoiso indoline-1,3-dione: methods of using and compositions thereof
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 15, 2014
Mar 19, 2023U-1504: Use of OTEZLA (apremilast) for inhibiting PDE4
U-2656: Treatment of adult patients with active psoriatic arthritis
U-2658: Treatment of adult patients with oral ulcers associated with Behcet's disease
U-3276: Treatment of patients with plaque psoriasis who are candidates for phototherapy or systemic therapy
Pat. No. 7427638 DS* DP* [Extended 1186 days (3.2 years)]
(Family Id: 28457137) (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminois- oindoline-1,3-dione:, and methods of synthesis and compositions thereof
Claim Types: Composition; Formulation
Pat. Sub. Date(s): All strengths: Apr 15, 2014
Feb 16, 2028 
Pat. No. 7659302 (Family Id: 28457137) Methods of using (+)-2-[1-(3-ethoxy-4 methoxyphenyl)-2-methylsulfonylethyl]-4 acetylaminoisoindoline 1,3-dione
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 15, 2014
Mar 19, 2023U-1505: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis
U-1595: Use of OTEZLA (apremilast) for the treatment of psoriasis
U-2658: Treatment of adult patients with oral ulcers associated with Behcet's disease
U-3276: Treatment of patients with plaque psoriasis who are candidates for phototherapy or systemic therapy
Pat. No. 8455536 (Family Id: 28457137) Methods of using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi-soindoline 1,3-dione
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 15, 2014
Mar 19, 2023U-1505: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis
U-1595: Use of OTEZLA (apremilast) for the treatment of psoriasis
U-2658: Treatment of adult patients with oral ulcers associated with Behcet's disease
U-3276: Treatment of patients with plaque psoriasis who are candidates for phototherapy or systemic therapy
Pat. No. 8802717 (Family Id: 28457137) Methods of treating arthritic conditions using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline 1,3-dione
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 29, 2014
Mar 19, 2023U-1561: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis
Pat. No. 9724330 (Family Id: 28457137) Methods of using (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 19, 2018
Mar 19, 2023U-1561: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis
U-1595: Use of OTEZLA (apremilast) for the treatment of psoriasis
U-2656: Treatment of adult patients with active psoriatic arthritis
U-2658: Treatment of adult patients with oral ulcers associated with Behcet's disease
U-3276: Treatment of patients with plaque psoriasis who are candidates for phototherapy or systemic therapy
Pat. No. 7208516 (Family Id: 36816455) Methods of the treatment of psoriatic arthritis using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 15, 2014
Mar 19, 2023U-1505: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis
Pat. No. 7893101 DS* DP* (Family Id: 46330226) Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione, compositions thereof, and uses thereof
Claim Types: New polymorph, salt or hydrate; Composition
Pat. Sub. Date(s): All strengths: Apr 15, 2014
Dec 9, 2023 
Pat. No. 9018243 (Family Id: 46330226) Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione, compositions thereof, and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: May 18, 2015
Mar 19, 2023U-1505: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis
U-1595: Use of OTEZLA (apremilast) for the treatment of psoriasis
U-2656: Treatment of adult patients with active psoriatic arthritis
U-2658: Treatment of adult patients with oral ulcers associated with Behcet's disease
U-3276: Treatment of patients with plaque psoriasis who are candidates for phototherapy or systemic therapy
Pat. No. 9872854 (Family Id: 50549444) Methods for the treatment of psoriatic arthritis using apremilast
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 21, 2018
May 29, 2034U-2232: Treatment of psoriatic arthritis using a dosage titration schedule
U-2233: Treatment of psoriatic arthritis with apremilast using a dosage titration schedule and a second active agent
Pat. No. 10092541 (Family Id: 53938438) Methods for the treatment of diseases ameliorated by PDE4 inhibition using dosage titration of apremilast
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 9, 2018
May 29, 2034U-2403: Treatment of psoriasis using a dosage titration schedule
U-2659: Treatment of adult patients with oral ulcers associated with Behcet's disease using a dosage titration schedule
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJul 19, 2022I-803: Treatment of adult patients with oral ulcers associated with Behcets disease
Exclusivity Code: I - New IndicationDec 20, 2024I-884: Revisions to the labeling to include data for subjects with mild to moderate plaque psoriasis, and to allow for an expansion of the indication
Exclusivity Code: M - MiscellaneousApr 10, 2023M-257: Information added to the clinical studies section of the labeling regarding the use of plaque psoriasis of the scalp
Exclusivity Code: ODE - Orphan drug exclusivityJul 19, 2026ODE-248: Treatment of adult patients with oral ulcers associated with Behcets disease

APREPITANT (CAPSULE) (ORAL) EMEND [GENERIC AB]
Drug Classes: Antiemetics:Emetogenic Therapy Adjuncts
NDA Applicant: MERCK      NDA No.: 021549  Prod. No.: 001 RX (80MG); 002 RX (125MG) NDA No.: 021549  Prod. No.: 003 DISC (40MG**)
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 8258132 DP* (Family Id: 23331619) Pharmaceutical composition of a tachykinin receptor antagonist
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 27, 2012; 002: None; 003: None
Sep 26, 2027U-1743: For the prevention of nausea and vomiting associated with chemotherapy
U-901: Prevention of postoperative nausea and vomiting

APREPITANT (FOR SUSPENSION) (ORAL) EMEND
Drug Classes: Antiemetics:Emetogenic Therapy Adjuncts
NDA Applicant: MSD MERCK CO      NDA No.: 207865  Prod. No.: 001 RX (125MG/KIT)
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 8258132 DP* (Family Id: 23331619) Pharmaceutical composition of a tachykinin receptor antagonist
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 18, 2016
Sep 26, 2027U-1916: Prevention of nausea and vomiting associated with chemotherapy (CINV)

APREPITANT (EMULSION) (INTRAVENOUS) CINVANTI
Drug Classes: Antiemetics:Emetogenic Therapy Adjuncts
NDA Applicant: HERON THERAPS INC      NDA No.: 209296  Prod. No.: 001 RX (130MG/18ML (7.2MG/ML))
9 Patents--2 FamiliesExpirationPatented Use
Pat. No. 9561229 DP* (Family Id: 54238618) Emulsion formulations of aprepitant
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Dec 5, 2017
Sep 18, 2035U-2161: Treatment of nausea and vomiting, including the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly or moderately emetogenic cancer chemotherapy
Pat. No. 9808465 (Family Id: 54238618) Emulsion formulations of aprepitant
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 5, 2017
Sep 18, 2035U-2161: Treatment of nausea and vomiting, including the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly or moderately emetogenic cancer chemotherapy
Pat. No. 9974793 DP* (Family Id: 54238618) Emulsion formulations of aprepitant
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 19, 2018
Sep 18, 2035 
Pat. No. 9974794 DP* (Family Id: 54238618) Emulsion formulations of aprepitant
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jun 19, 2018
Sep 18, 2035U-2161: Treatment of nausea and vomiting, including the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly or moderately emetogenic cancer chemotherapy
Pat. No. 10500208 DP* (Family Id: 54238618) Emulsion formulations of aprepitant
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Dec 23, 2019
Sep 18, 2035 
Pat. No. 10953018 (Family Id: 54238618) Emulsion formulations of aprepitant
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 8, 2021
Sep 18, 2035U-2161: Treatment of nausea and vomiting, including the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly or moderately emetogenic cancer chemotherapy
Pat. No. 9974742 DP* (Family Id: 59385894) Emulsion formulations of an NK-1 receptor antagonist and uses thereof
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Jun 19, 2018
Sep 18, 2035 
Pat. No. 10624850 (Family Id: 59385894) Emulsion formulations of an NK-1 receptor antagonist and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 30, 2020
Sep 18, 2035U-2161: Treatment of nausea and vomiting, including the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly or moderately emetogenic cancer chemotherapy
Pat. No. 11173118 DP* (Family Id: 59385894) Emulsion formulations of an NK-1 receptor antagonist and uses thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 13, 2021
Sep 18, 2035 

ARGATROBAN (INJECTABLE) (INTRAVENOUS) ARGATROBAN IN SODIUM CHLORIDE
Drug Classes: anticoagulant == direct thrombin inhibitor
NDA Applicant: CIPLA      NDA No.: 022434  Prod. No.: 001 DISC (50MG/50ML (1MG/ML))
2 Patents--2 FamiliesExpirationPatented Use
Pat. No. 7589106 DP* (Family Id: 39230808) Alcohol free formulation of argatroban
Claim Types: Formulation; Drug in a container; Method of use
Pat. Sub. Date(s): 001: Jul 20, 2011
Sep 26, 2027U-1163: Method of treating thrombosis
Pat. No. 7687516 DP* (Family Id: 46329449) Alcohol free formulation of argatroban
Claim Types: Formulation; Drug in a container; Method of administration; Method of use
Pat. Sub. Date(s): 001: Jul 20, 2011
Sep 26, 2027U-1164: Method of treating an argatroban treatable condition

ARIPIPRAZOLE (TABLET) (ORAL) ABILIFY [GENERIC AB]
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 021436  Prod. No.: 001 RX (10MG); 002 RX (15MG); 003 RX (20MG); 004 RX (30MG); 005 RX (5MG); 006 RX (2MG)
10 Patents--5 FamiliesExpirationPatented Use
Pat. No. 7053092 (Family Id: 26734754) 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 (Family Id: 26734754) 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. 9089567 (Family Id: 26734754) 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. 8017615 DP* (Family Id: 27171631) 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. 8580796 DS* (Family Id: 27171631) 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* (Family Id: 27171631) 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. 9359302 DS* DP* (Family Id: 27171631) 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. 9387182 (Family Id: 32716306) 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. 9125939 (Family Id: 33490596) 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 (Family Id: 41212155) 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

ARIPIPRAZOLE (SOLUTION) (ORAL) ABILIFY
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 021713  Prod. No.: 001 DISC (1MG/ML**)
5 Patents--4 FamiliesExpirationPatented Use
Pat. No. 6977257 DP* (Family Id: 23099862) Aripiprazole oral solution
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Oct 24, 2022 *PED 
Pat. No. 7053092 (Family Id: 26734754) 5-HT1a receptor subtype agonist
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Jan 28, 2022U-839: Treatment of major depressive disorder (MDD)
Pat. No. 8642600 (Family Id: 26734754) Method of treating autism
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 5, 2014
Jul 28, 2022 *PEDU-1492: Treatment of irritability associated with autistic disorder
Pat. No. 9387182 (Family Id: 32716306) Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 2, 2016
Dec 25, 2023U-1529: Adjunctive treatment of major depressive disorder (MDD)
Pat. No. 8759350 (Family Id: 41212155) Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: 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

ARIPIPRAZOLE (TABLET, ORALLY DISINTEGRATING) (ORAL) ABILIFY
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 021729  Prod. No.: 002 DISC (10MG**); 003 DISC (15MG**)
10 Patents--5 FamiliesExpirationPatented Use
Pat. No. 7053092 (Family Id: 26734754) 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 (Family Id: 26734754) 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. 9089567 (Family Id: 26734754) 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. 8017615 DP* (Family Id: 27171631) 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. 8580796 DS* (Family Id: 27171631) 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* (Family Id: 27171631) 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. 9359302 DS* DP* (Family Id: 27171631) 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. 9387182 (Family Id: 32716306) 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. 9125939 (Family Id: 33490596) 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 (Family Id: 41212155) 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

ARIPIPRAZOLE (TABLET, ORALLY DISINTEGRATING) (ORAL) ABILIFY
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 021729  Prod. No.: 004 DISC (20MG**); 005 DISC (30MG**)
7 Patents--3 FamiliesExpirationPatented Use
Pat. No. 7053092 (Family Id: 26734754) 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 (Family Id: 26734754) 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. 8017615 DP* (Family Id: 27171631) 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. 8580796 DS* (Family Id: 27171631) 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* (Family Id: 27171631) 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. 9359302 DS* DP* (Family Id: 27171631) 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. 9387182 (Family Id: 32716306) 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)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityDec 12, 2021ODE-80: Treatment of pediatric patients with Tourette's

ARIPIPRAZOLE (INJECTABLE) (INTRAMUSCULAR) ABILIFY
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 021866  Prod. No.: 001 DISC (9.75MG/1.3ML (7.5MG/ML))
2 Patents--1 FamilyExpirationPatented Use
Pat. No. 7115587 DP* (Family Id: 31946748) Aripiprazole complex formulation and method
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Jan 21, 2025 *PEDU-764: Treatment of schizophrenia
Pat. No. 7550445 DP* (Family Id: 31946748) Aripiprazole complex formulation and method
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 21, 2025 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityDec 12, 2021ODE-80: Treatment of pediatric patients with Tourette's

ARIPIPRAZOLE (FOR SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ABILIFY MAINTENA KIT
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: OTSUKA PHARM CO LTD      NDA No.: 202971  Prod. No.: 001 RX (300MG/VIAL); 002 RX (400MG/VIAL); 003 RX (300MG); 004 RX (400MG)
14 Patents--5 FamiliesExpirationPatented Use
Pat. No. 9089567 (Family Id: 26734754) 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. 8399469 DS* (Family Id: 27171631) Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: Apr 15, 2013; 002: None; 003: None; 004: Oct 29, 2014
Jun 29, 2025 
Pat. No. 8993761 DS* (Family Id: 27171631) Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): All strengths: Apr 28, 2015
Sep 25, 2022 
Pat. No. 8338427 DP* (Family Id: 34116189) Methods for administering aripiprazole
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): All strengths: None
Mar 15, 2025U-1633: Use of aripiprazole in extended release injectable suspension in treating acute episodes of schizophrenia
U-543: Treatment of schizophrenia
Pat. No. 8338428 DP* (Family Id: 34116189) Methods for administering aripiprazole
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): All strengths: None
Aug 6, 2023U-1633: Use of aripiprazole in extended release injectable suspension in treating acute episodes of schizophrenia
U-543: Treatment of schizophrenia
Pat. No. 8759351 DP* (Family Id: 34116189) Methods for administering aripiprazole
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jul 22, 2014
Aug 6, 2023U-1530: Use of aripiprazole in extended release injectable suspension
U-1633: Use of aripiprazole in extended release injectable suspension in treating acute episodes of schizophrenia
Pat. No. 7807680 DP* (Family Id: 34549292) Controlled release sterile injectable aripiprazole formulation and method
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: None; 002: None; 003: None; 004: Oct 29, 2014
Oct 19, 2024 
Pat. No. 8030313 (Family Id: 34549292) Controlled release sterile injectable aripiprazole formulation and method
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Oct 19, 2024U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia
U-543: Treatment of schizophrenia
Pat. No. 8722679 DP* (Family Id: 34549292) Controlled release sterile injectable aripiprazole formulation and method
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 9, 2014; 002: Jun 9, 2014; 003: None; 004: Oct 29, 2014
Oct 19, 2024 
Pat. No. 10525057 (Family Id: 52691475) Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): All strengths: Jan 31, 2020
Mar 8, 2034U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia
U-2723: Maintenance monotherapy treatment of Bipolar 1 disorder
U-543: Treatment of schizophrenia
Pat. No. 10980803 (Family Id: 52691475) Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: May 19, 2021
Sep 24, 2033U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia
U-543: Treatment of schizophrenia
Pat. No. 11154553 (Family Id: 52691475) Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 17, 2021
Sep 24, 2033U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia
U-3245: Maintenance monotherapy treatment of bipolar I disorder
U-814: Treatment of schizophrenia
Pat. No. 11344547 (Family Id: 52691475) Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 24, 2022
Sep 24, 2033U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia
U-3245: Maintenance monotherapy treatment of bipolar I disorder
U-814: Treatment of schizophrenia
Pat. No. 11400087 (Family Id: 52691475) Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 29, 2022
Sep 24, 2033U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia
U-3245: Maintenance monotherapy treatment of bipolar I disorder
U-814: Treatment of schizophrenia

ARIPIPRAZOLE (TABLET) (ORAL) ABILIFY MYCITE KIT [Has competitive generic]
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 207202  Prod. No.: 001 RX (2MG); 002 RX (5MG); 003 RX (10MG); 004 RX (15MG); 005 RX (20MG); 006 RX (30MG)
32 Patents--18 FamiliesExpirationPatented Use
Pat. No. 7053092 (Family Id: 26734754) 5-HT1a receptor subtype agonist
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Jan 28, 2022U-1529: Adjunctive treatment of major depressive disorder (MDD)
Pat. No. 9089567 (Family Id: 26734754) Method of treating cognitive impairments and schizophrenias
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Jan 28, 2022U-543: Treatment of schizophrenia
Pat. No. 8017615 DP* (Family Id: 27171631) Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: Composition; Product-by-process; Process
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Jun 16, 2024 
Pat. No. 8114021 DP* (Family Id: 27171631) Body-associated receiver and method
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Jun 21, 2030 
Pat. No. 8580796 DS* (Family Id: 27171631) Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Sep 25, 2022 
Pat. No. 8642760 DS* (Family Id: 27171631) Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: Compound
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Sep 25, 2022 
Pat. No. 9359302 DS* DP* (Family Id: 27171631) 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: Dec 12, 2017
Sep 25, 2022U-1529: Adjunctive treatment of major depressive disorder (MDD)
U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder
U-543: Treatment of schizophrenia
Pat. No. 9387182 (Family Id: 32716306) Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Dec 25, 2023U-1529: Adjunctive treatment of major depressive disorder (MDD)
Pat. No. 9125939 (Family Id: 33490596) Carbostyril derivatives and mood stabilizers for treating mood disorders
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Jul 28, 2026U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder
Pat. No. 7978064 DP* (Family Id: 37215570) Communication system with partial power source
Claim Types: Device; Process
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Sep 14, 2026 
Pat. No. 8674825 DP* (Family Id: 37215570) Pharma-informatics system
Claim Types: Device; Method of use
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Apr 9, 2029U-2170: Method of using a receiver to receive a signal from a tablet embedded with a sensor that communicates information through the body of a patient
Pat. No. 8847766 DP* (Family Id: 37215570) Pharma-informatics system
Claim Types: Device; Method of use
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Mar 29, 2030U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver
Pat. No. 9119554 DP* (Family Id: 37215570) Pharma-informatics system
Claim Types: Device; Process
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Dec 16, 2028 
Pat. No. 8547248 DP* (Family Id: 37809585) Implantable zero-wire communications system
Claim Types: Device; Method of use; Kit
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Dec 18, 2030U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver
Pat. No. 8945005 DP* (Family Id: 39325440) Controlled activation ingestible identifier
Claim Types: Device; Method of use
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Aug 19, 2029U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver
Pat. No. 8718193 DP* (Family Id: 39430365) Active signal processing personal health signal receivers
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Dec 5, 2029 
Pat. No. 9444503 DP* (Family Id: 39430365) Active signal processing personal health signal receivers
Claim Types: Device; Method of use
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Nov 19, 2027U-2169: Method of using a receiver to identify a signal from a tablet embedded with a sensor that communicates information through the body of a patient
Pat. No. 10441194 DP* (Family Id: 39674818) Ingestible event marker systems
Claim Types: Device
Pat. Sub. Date(s): All strengths: Nov 1, 2019
Jul 26, 2029 
Pat. No. 8956288 DP* (Family Id: 39690523) In-body power source having high surface area electrode
Claim Types: Device; Method-of-use; Process
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Jul 6, 2029U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver
Pat. No. 8961412 DP* (Family Id: 40472459) In-body device with virtual dipole signal amplification
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Nov 17, 2030 
Pat. No. 9433371 DP* (Family Id: 40472459) In-body device with virtual dipole signal amplification
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Sep 15, 2029 
Pat. No. 8258962 DP* (Family Id: 41056656) Multi-mode communication ingestible event markers and systems, and methods of using the same
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Nov 25, 2030 
Pat. No. 9060708 DP* (Family Id: 41056656) Multi-mode communication ingestible event markers and systems, and methods of using the same
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Mar 5, 2029 
Pat. No. 9258035 DP* (Family Id: 41056656) Multi-mode communication ingestible event markers and systems, and methods of using the same
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Mar 5, 2029 
Pat. No. 8759350 (Family Id: 41212155) Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Mar 2, 2027U-1529: Adjunctive treatment of major depressive disorder (MDD)
Pat. No. 9149577 DP* (Family Id: 42288378) Body-associated receiver and method
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Dec 15, 2029 
Pat. No. 8545402 DP* (Family Id: 43050733) Highly reliable ingestible event markers and methods for using the same
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Apr 27, 2030 
Pat. No. 9320455 DP* (Family Id: 43050733) Highly reliable ingestible event markers and methods for using the same
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Dec 15, 2031 
Pat. No. 9941931 DP* (Family Id: 43970768) System for supply chain management
Claim Types: Device
Pat. Sub. Date(s): All strengths: May 7, 2018
Nov 4, 2030 
Pat. No. 10517507 DP* (Family Id: 47506868) Communication system with enhanced partial power source and method of manufacturing same
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 23, 2020
Jun 13, 2032 
Pat. No. 11229378 DP* (Family Id: 47506868) Communication system with enhanced partial power source and method of manufacturing same
Claim Types: Device; Process
Pat. Sub. Date(s): All strengths: Feb 18, 2022
Jul 11, 2031 
Pat. No. 9268909 DP* (Family Id: 50488695) Apparatus, system, and method to adaptively optimize power dissipation and broadcast power in a power source for a communication device
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Oct 15, 2033U-2168: Method of using a logic circuit to stabilize battery voltage supplied to a sensor embedded with a tablet and that communicates information via a signal through the body of a patient to a receiver

ARIPIPRAZOLE LAUROXIL (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARISTADA
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: ALKERMES INC      NDA No.: 207533  Prod. No.: 001 RX (441MG/1.6ML (275.63MG/ML)); 004 RX (1064MG/3.9ML (272.82MG/ML))
12 Patents--5 FamiliesExpirationPatented Use
Pat. No. 8431576 DS* (Family Id: 43386893) Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound
Pat. Sub. Date(s): 001: Oct 14, 2015; 004: Jun 27, 2017
Oct 26, 2030 
Pat. No. 8796276 (Family Id: 43386893) Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 14, 2015; 004: Jun 27, 2017
Jun 24, 2030U-543: Treatment of schizophrenia
Pat. No. 10112903 DS* (Family Id: 43386893) Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Nov 20, 2018
Jun 24, 2030U-543: Treatment of schizophrenia
Pat. No. 9034867 DP* (Family Id: 45929620) Pharmaceutical compositions comprising sorbitan esters
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 14, 2015; 004: Jun 27, 2017
Nov 7, 2032U-543: Treatment of schizophrenia
Pat. No. 10226458 (Family Id: 45929620) Pharmaceutical compositions comprising sorbitan esters
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 8, 2019
Mar 19, 2032U-543: Treatment of schizophrenia
Pat. No. 9193685 DP* (Family Id: 50339464) Pharmaceutical compositions having improved storage stability
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Dec 9, 2015; 004: Jun 27, 2017
Oct 24, 2033U-543: Treatment of schizophrenia
Pat. No. 11097006 DP* (Family Id: 50339464) Pharmaceutical compositions having improved storage stability
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Oct 21, 2021
Oct 24, 2033U-764: Treatment of schizophrenia
Pat. No. 9452131 (Family Id: 54141031) Aripiprazole formulations having increased injection speeds
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Oct 5, 2016; 004: Jun 27, 2017
Mar 19, 2035U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection
Pat. No. 10238651 (Family Id: 54141031) Aripiprazole formulations having increased injection speeds
Claim Types: Method of use; Kit
Pat. Sub. Date(s): All strengths: Apr 8, 2019
Mar 19, 2035U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection
Pat. No. 10813928 (Family Id: 54141031) Aripiprazole formulations having increased injection speeds
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 10, 2020
Mar 19, 2035U-2983: Treatment of schizophrenia by rapid and continuous injection
Pat. No. 11406632 (Family Id: 54141031) Aripiprazole formulations having increased injection speeds
Claim Types: Method of use; Kit
Pat. Sub. Date(s): All strengths: Aug 19, 2022
Mar 19, 2035U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection
Pat. No. 11273158 (Family Id: 65818625) Aripiprazole dosing strategy
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 13, 2022
Apr 6, 2039U-543: Treatment of schizophrenia

ARIPIPRAZOLE LAUROXIL (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARISTADA
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: ALKERMES INC      NDA No.: 207533  Prod. No.: 002 RX (662MG/2.4ML (275.83MG/ML))
13 Patents--5 FamiliesExpirationPatented Use
Pat. No. 8431576 DS* (Family Id: 43386893) Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound
Pat. Sub. Date(s): 002: Oct 14, 2015
Oct 26, 2030 
Pat. No. 8796276 (Family Id: 43386893) Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Method of use
Pat. Sub. Date(s): 002: Oct 14, 2015
Jun 24, 2030U-543: Treatment of schizophrenia
Pat. No. 10112903 DS* (Family Id: 43386893) Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 002: Nov 20, 2018
Jun 24, 2030U-543: Treatment of schizophrenia
Pat. No. 9034867 DP* (Family Id: 45929620) Pharmaceutical compositions comprising sorbitan esters
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Oct 14, 2015
Nov 7, 2032U-543: Treatment of schizophrenia
Pat. No. 10226458 (Family Id: 45929620) Pharmaceutical compositions comprising sorbitan esters
Claim Types: Method of use
Pat. Sub. Date(s): 002: Apr 8, 2019
Mar 19, 2032U-543: Treatment of schizophrenia
Pat. No. 9193685 DP* (Family Id: 50339464) Pharmaceutical compositions having improved storage stability
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Dec 9, 2015
Oct 24, 2033U-543: Treatment of schizophrenia
Pat. No. 11097006 DP* (Family Id: 50339464) Pharmaceutical compositions having improved storage stability
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Oct 21, 2021
Oct 24, 2033U-764: Treatment of schizophrenia
Pat. No. 9452131 (Family Id: 54141031) Aripiprazole formulations having increased injection speeds
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Oct 5, 2016
Mar 19, 2035U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection
Pat. No. 9526726 DP* (Family Id: 54141031) Aripiprazole formulations having increased injection speeds
Claim Types: Kit
Pat. Sub. Date(s): 002: Jan 19, 2017
Mar 19, 2035 
Pat. No. 10238651 (Family Id: 54141031) Aripiprazole formulations having increased injection speeds
Claim Types: Method of use; Kit
Pat. Sub. Date(s): 002: Apr 8, 2019
Mar 19, 2035U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection
Pat. No. 10813928 (Family Id: 54141031) Aripiprazole formulations having increased injection speeds
Claim Types: Method of use
Pat. Sub. Date(s): 002: Nov 10, 2020
Mar 19, 2035U-2983: Treatment of schizophrenia by rapid and continuous injection
Pat. No. 11406632 (Family Id: 54141031) Aripiprazole formulations having increased injection speeds
Claim Types: Method of use; Kit
Pat. Sub. Date(s): 002: Aug 19, 2022
Mar 19, 2035U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection
Pat. No. 11273158 (Family Id: 65818625) Aripiprazole dosing strategy
Claim Types: Method of use
Pat. Sub. Date(s): 002: Apr 13, 2022
Apr 6, 2039U-543: Treatment of schizophrenia

ARIPIPRAZOLE LAUROXIL (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARISTADA
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: ALKERMES INC      NDA No.: 207533  Prod. No.: 003 RX (882MG/3.2ML (275.63MG/ML))
13 Patents--5 FamiliesExpirationPatented Use
Pat. No. 8431576 DS* (Family Id: 43386893) Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound
Pat. Sub. Date(s): 003: Oct 14, 2015
Oct 26, 2030 
Pat. No. 8796276 (Family Id: 43386893) Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Method of use
Pat. Sub. Date(s): 003: Oct 14, 2015
Jun 24, 2030U-543: Treatment of schizophrenia
Pat. No. 10112903 DS* (Family Id: 43386893) Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 003: Nov 20, 2018
Jun 24, 2030U-543: Treatment of schizophrenia
Pat. No. 9034867 DP* (Family Id: 45929620) Pharmaceutical compositions comprising sorbitan esters
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: Oct 14, 2015
Nov 7, 2032U-543: Treatment of schizophrenia
Pat. No. 10226458 (Family Id: 45929620) Pharmaceutical compositions comprising sorbitan esters
Claim Types: Method of use
Pat. Sub. Date(s): 003: Apr 8, 2019
Mar 19, 2032U-543: Treatment of schizophrenia
Pat. No. 9193685 DP* (Family Id: 50339464) Pharmaceutical compositions having improved storage stability
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: Dec 9, 2015
Oct 24, 2033U-543: Treatment of schizophrenia
Pat. No. 11097006 DP* (Family Id: 50339464) Pharmaceutical compositions having improved storage stability
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: Oct 21, 2021
Oct 24, 2033U-764: Treatment of schizophrenia
Pat. No. 9452131 (Family Id: 54141031) Aripiprazole formulations having increased injection speeds
Claim Types: Method of administration
Pat. Sub. Date(s): 003: Oct 5, 2016
Mar 19, 2035U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection
Pat. No. 9526726 DP* (Family Id: 54141031) Aripiprazole formulations having increased injection speeds
Claim Types: Kit
Pat. Sub. Date(s): 003: Jan 19, 2017
Mar 19, 2035 
Pat. No. 10238651 (Family Id: 54141031) Aripiprazole formulations having increased injection speeds
Claim Types: Method of use; Kit
Pat. Sub. Date(s): 003: Apr 8, 2019
Mar 19, 2035U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection
Pat. No. 10813928 (Family Id: 54141031) Aripiprazole formulations having increased injection speeds
Claim Types: Method of use
Pat. Sub. Date(s): 003: Nov 10, 2020
Mar 19, 2035U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection
Pat. No. 11406632 (Family Id: 54141031) Aripiprazole formulations having increased injection speeds
Claim Types: Method of use; Kit
Pat. Sub. Date(s): 003: Aug 19, 2022
Mar 19, 2035U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection
Pat. No. 11273158 (Family Id: 65818625) Aripiprazole dosing strategy
Claim Types: Method of use
Pat. Sub. Date(s): 003: Apr 13, 2022
Apr 6, 2039U-543: Treatment of schizophrenia

ARIPIPRAZOLE LAUROXIL (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARISTADA INITIO KIT
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: ALKERMES INC      NDA No.: 209830  Prod. No.: 001 RX (675MG/2.4ML)
8 Patents--3 FamiliesExpirationPatented Use
Pat. No. 8431576 DS* (Family Id: 43386893) Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound
Pat. Sub. Date(s): 001: Jul 18, 2018
Oct 26, 2030 
Pat. No. 8796276 (Family Id: 43386893) Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 18, 2018
Jun 24, 2030U-543: Treatment of schizophrenia
Pat. No. 10112903 DS* (Family Id: 43386893) Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Nov 20, 2018
Jun 24, 2030U-543: Treatment of schizophrenia
Pat. No. 10016415 DP* (Family Id: 55301322) Aripiprazole prodrug compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 18, 2018
Sep 8, 2035 
Pat. No. 10688091 DP* (Family Id: 55301322) Aripiprazole prodrug composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 8, 2020
Aug 17, 2035 
Pat. No. 10849894 (Family Id: 55301322) Aripiprazole prodrug composition
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 9, 2020
Aug 17, 2035U-543: Treatment of schizophrenia
Pat. No. 11154552 DP* (Family Id: 55301322) Aripiprazole prodrug composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 10, 2021
Aug 17, 2035 
Pat. No. 11273158 (Family Id: 65818625) Aripiprazole dosing strategy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 13, 2022
Apr 6, 2039U-543: Treatment of schizophrenia

ARMODAFINIL (TABLET) (ORAL) NUVIGIL [GENERIC AB]
Drug Classes: Sleep Disorder Agents:Wakefulness Promoting Agents
NDA Applicant: CEPHALON      NDA No.: 021875  Prod. No.: 001 RX (50MG); 003 RX (150MG); 004 RX (250MG); 005 RX (200MG) NDA No.: 021875  Prod. No.: 002 DISC (100MG**)
2 Patents--2 FamiliesExpirationPatented Use
Pat. No. 7297346 DP* (Family Id: 26852708) Pharmaceutical formulations of modafinil
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
May 29, 2024 *PED 
Pat. No. 7132570 DS* DP* (Family Id: 32406320) Method for the production of crystalline forms and crystalline forms of optical enantiomers of modafinil
Claim Types: New polymorph, salt or hydrate; Composition; Process
Pat. Sub. Date(s): All strengths: None
Jun 18, 2024 *PED 

ARSENIC TRIOXIDE (INJECTABLE) (INJECTION) TRISENOX [GENERIC AP]
NDA Applicant: CEPHALON      NDA No.: 021248  Prod. No.: 002 RX (2MG/ML) NDA No.: 021248  Prod. No.: 001 DISC (1MG/ML**)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityJan 12, 2025ODE-167: Arsenic trioxide for use in combination with tretinoin for treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression

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

ASCIMINIB HYDROCHLORIDE (TABLET) (ORAL) SCEMBLIX
NDA Applicant: NOVARTIS      NDA No.: 215358  Prod. No.: 001 RX (EQ 20MG BASE); 002 RX (EQ 40MG BASE)
2 Patents--2 FamiliesExpirationPatented Use
Pat. No. 8829195 DS* (Family Id: 48670630) Compounds and compositions for inhibiting the activity of ABL1, ABL2 and BCR-ABL1
Claim Types: Compound; Method of use
Pat. Sub. Date(s): All strengths: Nov 19, 2021
May 13, 2033U-1374: Treatment of Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML)
Pat. No. 11407735 DS* (Family Id: 70775449) Crystalline forms of N-[4-(Chlorodifluoromethoxy)phenyl]-6-[(3R)-3-hydroxypyrrolidin-1-yl]-5-(- 1H-pyrazol-5-yl)pyridine-3-carboxamide
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: Aug 23, 2022
May 14, 2040 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityOct 29, 2026 
Exclusivity Code: ODE - Orphan drug exclusivityOct 29, 2028ODE-381: Treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (PH+ CML) in chronic phase (cp) with the t315i mutation
Exclusivity Code: ODE - Orphan drug exclusivityOct 29, 2028ODE-382: Treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (PH+ CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKIS)

ASCORBIC ACID (SOLUTION) (INTRAVENOUS) ASCOR
NDA Applicant: MCGUFF      NDA No.: 209112  Prod. No.: 001 RX (25,000MG/50ML (500MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityOct 2, 2024ODE-160: For treatment of scurvy in adult and pediatric patients age 5 months and older for whom oral administration is not possible, insufficient or contraindicated

ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE (FOR SOLUTION) (ORAL) MOVIPREP [GENERIC AA]
Drug Classes: Gastrointestinal Agents:Anti-Constipation Agents == Gastrointestinal Agents:Gastrointestinal Agents, Other == osmotic laxative
NDA Applicant: SALIX PHARMS      NDA No.: 021881  Prod. No.: 001 RX (4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM)
2 Patents--1 FamilyExpirationPatented Use
Pat. No. 7169381 DS* DP* (Family Id: 9946609) Colon cleansing compositions and methods
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Sep 1, 2024 
Pat. No. 7658914 DS* DP* (Family Id: 9946609) Colon cleansing compositions
Claim Types: Kit; Formulation
Pat. Sub. Date(s): 001: None
Sep 1, 2024 

ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE (FOR SOLUTION) (ORAL) PLENVU
Drug Classes: Gastrointestinal Agents:Anti-Constipation Agents == Gastrointestinal Agents:Gastrointestinal Agents, Other == osmotic laxative
NDA Applicant: SALIX      NDA No.: 209381  Prod. No.: 001 RX (7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM)
9 Patents--2 FamiliesExpirationPatented Use
Pat. No. 9592252 DP* (Family Id: 45888431) Colonoscopy--preparation
Claim Types: Formulation; Kit; Method of use
Pat. Sub. Date(s): 001: May 24, 2018
Aug 11, 2032U-2310: For cleansing of the colon in preparation for colonoscopy in adults
Pat. No. 10646512 DP* (Family Id: 45888431) Colonoscopy - preparation
Claim Types: Formulation; Kit
Pat. Sub. Date(s): 001: May 15, 2020
Mar 25, 2032 
Pat. No. 10780112 DP* (Family Id: 45888431) Colonoscopy-preparation
Claim Types: Kit
Pat. Sub. Date(s): 001: Sep 25, 2020
Mar 9, 2032 
Pat. No. 10792306 DP* (Family Id: 45888431) Colonoscopy--preparation
Claim Types: Kit; Method of use
Pat. Sub. Date(s): 001: Oct 13, 2020
Mar 9, 2032U-2310: For cleansing of the colon in preparation for colonoscopy in adults
Pat. No. 8999313 DP* (Family Id: 49165735) Compositions
Claim Types: Formulation; Kit
Pat. Sub. Date(s): 001: May 24, 2018
Sep 10, 2033 
Pat. No. 9326969 (Family Id: 49165735) Compositions
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 24, 2018
Sep 10, 2033U-2310: For cleansing of the colon in preparation for colonoscopy in adults
Pat. No. 9707297 DP* (Family Id: 49165735) Compositions
Claim Types: Kit
Pat. Sub. Date(s): 001: May 24, 2018
Sep 10, 2033 
Pat. No. 10016504 DP* (Family Id: 49165735) Compositions
Claim Types: Formulation; Process; Product-by-process
Pat. Sub. Date(s): 001: Jul 24, 2018
Sep 10, 2033 
Pat. No. 10918723 (Family Id: 49165735) Colon cleansing compositions and methods of use
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 3, 2021
Sep 10, 2033U-2310: For cleansing of the colon in preparation for colonoscopy in adults

ASENAPINE (SYSTEM) (TRANSDERMAL) SECUADO
Drug Classes: Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: HISAMITSU      NDA No.: 212268  Prod. No.: 001 RX (3.8MG/24HR); 002 RX (5.7MG/24HR); 003 RX (7.6MG/24HR)
5 Patents--3 FamiliesExpirationPatented Use
Pat. No. 9687474 DP* (Family Id: 49997402) Patch
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 18, 2019
Jul 25, 2033 
Pat. No. 10022445 DP* (Family Id: 49997402) Patch
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 18, 2019
Jul 25, 2033 
Pat. No. 10583121 DP* (Family Id: 49997402) Patch
Claim Types: Device; Method of use
Pat. Sub. Date(s): All strengths: Mar 27, 2020
Jul 25, 2033U-2763: Method of treating adults with schizophrenia comprising administering asenapine via a transdermal patch
Pat. No. 11123305 DP* (Family Id: 63709819) Patch
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Oct 21, 2021
Jul 25, 2033 
Pat. No. 10814002 DP* (Family Id: 64400874) Patch and method for producing the same
Claim Types: Device; Method of use
Pat. Sub. Date(s): All strengths: Nov 13, 2020
Jul 25, 2033U-2763: Method of treating adults with schizophrenia comprising administering asenapine via a transdermal patch
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productOct 11, 2022 

ASENAPINE MALEATE (TABLET) (SUBLINGUAL) SAPHRIS [GENERIC AB]
Drug Classes: Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: ALLERGAN      NDA No.: 022117  Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 10MG BASE)
2 Patents--1 FamilyExpirationPatented Use
Pat. No. 7741358 DS* DP* (Family Id: 37695178) Crystal form of asenapine maleate
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Pat. Sub. Date(s): All strengths: Feb 10, 2017
Oct 6, 2026 *PEDU-1064: Treatment of bipolar disorder and schizophrenia
U-1960: Use of the atypical antipsychotic asenapine for treatment of schizophrenia in adults
U-1961: Use of the atypical antipsychotic asenapine for treatment of manic or mixed episodes of bipolar i disorder: acute monotherapy of manic or mixed episodes (ages 10 to adult)
U-1962: Use of the atypical antipsychotic asenapine for treatment of manic or mixed episodes of bipolar i disorder: maintenance monotherapy in adults
U-1963: Use of the atypical antipsychotic asenapine for treatment of manic or mixed episodes of bipolar i disorder: as adjunctive treatment to lithium or valproate in adults
Pat. No. 8022228 DS* DP* (Family Id: 37695178) Crystal form of asenapine maleate
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): All strengths: Jul 29, 2014
Oct 6, 2026 *PED 

ASENAPINE MALEATE (TABLET) (SUBLINGUAL) SAPHRIS [GENERIC AB]
Drug Classes: Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: ALLERGAN      NDA No.: 022117  Prod. No.: 003 RX (EQ 2.5MG BASE)
2 Patents--1 FamilyExpirationPatented Use
Pat. No. 7741358 DS* DP* (Family Id: 37695178) Crystal form of asenapine maleate
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Pat. Sub. Date(s): 003: Sep 12, 2016
Oct 6, 2026 *PEDU-1893: Method of treating manic or mixed episodes associated with bipolar disorder in pediatric patients
U-1966: Use of the atypical antipsychotic asenapine for treatment of manic or mixed episodes of bipolar i disorder: acute monotherapy of manic or mixed episodes in pediatric patients age 10-17
Pat. No. 8022228 DS* DP* (Family Id: 37695178) Crystal form of asenapine maleate
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 003: Sep 12, 2016
Oct 6, 2026 *PED 

ASPIRIN (CAPSULE) (ORAL) VAZALORE
Drug Classes: Blood Products and Modifiers:Platelet Modifying Agents == anti-platelet agent == nonsteroidal anti-inflammatory drug
NDA Applicant: PLX PHARMA      NDA No.: 203697  Prod. No.: 001 OTC (325MG)
4 Patents--2 FamiliesExpirationPatented Use
Pat. No. 8865187 DP* (Family Id: 32094194) Compositions comprising lecithin oils and NSAIDS for protecting the gastrointestinal tract and providing enhanced therapeutic activity
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 10, 2014
Mar 23, 2022 
Pat. No. 9101637 (Family Id: 32094194) Methods of treating inflammation with compositions comprising lecithin oils and NSAIDS for protecting the gastrointestinal tract and providing enhanced therapeutic activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 9, 2015
Mar 23, 2022U-1731: Temporary relief of minor aches and pains
U-1732: Temporary reduction of fever
U-1733: Treatment/prevention of cardiovascular disease
Pat. No. 9216150 DP* (Family Id: 47996780) pH dependent carriers for targeted release of pharmaceuticals along the gastrointestinal tract, compositions therefrom, and making and using same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 14, 2016
Sep 29, 2032 
Pat. No. 9226892 (Family Id: 47996780) pH dependent carriers for targeted release of pharmaceuticals along the gastrointestinal tract, compositions therefrom, and making and using same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 14, 2016
Sep 29, 2032U-1731: Temporary relief of minor aches and pains
U-1732: Temporary reduction of fever
U-1733: Treatment/prevention of cardiovascular disease

ASPIRIN; OMEPRAZOLE (TABLET, DELAYED RELEASE) (ORAL) YOSPRALA
Drug Classes: Blood Products and Modifiers:Platelet Modifying Agents == anti-platelet agent == nonsteroidal anti-inflammatory drug == Gastrointestinal Agents:Proton Pump Inhibitors == Gastrointestinal Agents:Gastrointestinal Agents, Other
NDA Applicant: GENUS LIFESCIENCES      NDA No.: 205103  Prod. No.: 001 DISC (81MG;40MG); 002 DISC (325MG;40MG)
5 Patents--3 FamiliesExpirationPatented Use
Pat. No. 6926907 DP* (Family Id: 23134063) Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Oct 14, 2016
Feb 28, 2023U-1902: Treatment or secondary prevention of cardiovascular disease, cardiovascular events, or cerebrovascular events and risk-reduction of aspirin-associated gastric ulcers
Pat. No. 8206741 DP* (Family Id: 26854841) Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Oct 14, 2016
Feb 28, 2023U-1902: Treatment or secondary prevention of cardiovascular disease, cardiovascular events, or cerebrovascular events and risk-reduction of aspirin-associated gastric ulcers
Pat. No. 9364439 DP* (Family Id: 26854841) Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Oct 14, 2016
May 31, 2022U-1902: Treatment or secondary prevention of cardiovascular disease, cardiovascular events, or cerebrovascular events and risk-reduction of aspirin-associated gastric ulcers
Pat. No. 9539214 (Family Id: 48698802) Compositions and methods for delivery of omeprazole plus acetylsalicylic acid
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 27, 2017
Mar 13, 2033U-1902: Treatment or secondary prevention of cardiovascular disease, cardiovascular events, or cerebrovascular events and risk-reduction of aspirin-associated gastric ulcers
Pat. No. 9987231 (Family Id: 48698802) Compositions and methods for delivery of omeprazole plus acetylsalicylic acid
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Jul 3, 2018
Jan 2, 2033U-2324: For secondary prevention of cardiovascular and cerebrovascular events in patients at risk of developing aspirin-associated gastric ulcers

ATAZANAVIR SULFATE; COBICISTAT (TABLET) (ORAL) EVOTAZ
Drug Classes: Antivirals:Anti-HIV Agents, Protease Inhibitors (PI) == Antivirals:Anti-HIV Combinations == HIV protease inhibitor == Antivirals:Anti-HIV Agents, Other == CYP3A inhibitor
NDA Applicant: BRISTOL-MYERS SQUIBB      NDA No.: 206353  Prod. No.: 001 RX (EQ 300MG BASE;150MG)
2 Patents--2 FamiliesExpirationPatented Use
Pat. No. 8148374 DS* DP* (Family Id: 39522375) Modulators of pharmacokinetic properties of therapeutics
Claim Types: Composition; Compound; Method of use
Pat. Sub. Date(s): 001: Feb 25, 2015
Sep 3, 2029U-1279: Treatment of HIV infection using a composition containing a pharmacokinetic enhancer that inhibits cytochrome p450 monooxygenase
Pat. No. 10039718 DP* (Family Id: 40809930) Use of solid carrier particles to improve the processability of a pharmaceutical agent
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Sep 5, 2018
Oct 6, 2032 

ATOGEPANT (TABLET) (ORAL) QULIPTA
Drug Classes: calcitonin gene-related peptide receptor antagonist
NDA Applicant: ABBVIE INC      NDA No.: 215206  Prod. No.: 001 RX (10MG); 002 RX (30MG); 003 RX (60MG)
4 Patents--3 FamiliesExpirationPatented Use
Pat. No. 8754096 DS* DP* (Family Id: 45034191) Piperidinone carboxamide azaindane CGRP receptor antagonists
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Oct 26, 2021
Jul 19, 2032U-3142: Preventive treatment of episodic migraine in adults
Pat. No. 9499545 DS* DP* (Family Id: 45034191) Piperidinone carboxamide azaindane CGRP receptor antagonists
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Oct 26, 2021
Nov 10, 2031U-3142: Preventive treatment of episodic migraine in adults
Pat. No. 9850246 DS* (Family Id: 49551123) Process for making CGRP receptor antagonists
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: Oct 26, 2021
Mar 13, 2033 
Pat. No. 10117836 DP* (Family Id: 53778348) Tablet formulation for CGRP active compounds
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Oct 26, 2021
Jan 30, 2035 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entitySep 28, 2026 

ATROPINE SULFATE (SOLUTION) (INTRAVENOUS) ATROPINE SULFATE [GENERIC AP]
Drug Classes: anticholinergic == muscarinic antagonist
NDA Applicant: ACCORD HLTHCARE      NDA No.: 212868  Prod. No.: 001 RX (0.25MG/5ML (0.05MG/ML)); 002 RX (0.5MG/5ML (0.1MG/ML)); 003 RX (1MG/10ML (0.1MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Code: CGT - Competitive generic therapyJan 26, 2022 

ATROPINE SULFATE (SOLUTION) (INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL) ATROPINE SULFATE [GENERIC AP]
Drug Classes: anticholinergic == muscarinic antagonist
NDA Applicant: ACCORD HLTHCARE      NDA No.: 213424  Prod. No.: 001 RX (8MG/20ML (0.4MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Code: CGT - Competitive generic therapySep 21, 2021 

ATROPINE SULFATE (SOLUTION/DROPS) (OPHTHALMIC) ATROPINE SULFATE [GENERIC AT]
Drug Classes: anticholinergic == muscarinic antagonist
NDA Applicant: APOTEX INC      NDA No.: 215624  Prod. No.: 001 RX (1%)
ExclusivityExpirationExclusivity Description
Exclusivity Code: CGT - Competitive generic therapyMay 25, 2022 

ATROPINE SULFATE (SOLUTION) (INTRAVENOUS) ATROPINE SULFATE [GENERIC AP]
Drug Classes: anticholinergic == muscarinic antagonist
NDA Applicant: AM REGENT      NDA No.: 216120  Prod. No.: 001 RX (0.4MG/ML (0.4MG/ML)); 002 RX (1MG/ML (1MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Code: CGT - Competitive generic therapyJan 29, 2023 

AVACOPAN (CAPSULE) (ORAL) TAVNEOS
Drug Classes: complement 5a receptor (C5aR) antagonist
NDA Applicant: CHEMOCENTRYX      NDA No.: 214487  Prod. No.: 001 RX (10MG)
2 Patents--1 FamilyExpirationPatented Use
Pat. No. 8445515 DS* DP* (Family Id: 42267017) C5aR antagonists
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Nov 3, 2021
Feb 3, 2031 
Pat. No. 8906938 DS* DP* (Family Id: 42267017) C5aR antagonists
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Nov 3, 2021
Dec 21, 2029 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityOct 7, 2026 
Exclusivity Code: ODE - Orphan drug exclusivityOct 7, 2028ODE-377: As an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA])

AVANAFIL (TABLET) (ORAL) STENDRA
Drug Classes: Sexual Disorder Agents:Sexual Disorder Agents (Male) == phosphodiesterase-5 (PDE-5) inhibitor
NDA Applicant: METUCHEN PHARMS      NDA No.: 202276  Prod. No.: 001 RX (50MG); 002 RX (100MG); 003 RX (200MG)
2 Patents--2 FamiliesExpirationPatented Use
Pat. No. 6656935 DS* DP* [Extended 1687 days (4.6 years)]
(Family Id: 26545273) Aromatic nitrogen-containing 6-membered cyclic compounds
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: May 29, 2012
Apr 27, 2025U-155: Treatment of erectile dysfunction
Pat. No. 7501409 DP* (Family Id: 26599342) Preparations for oral administration
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
May 5, 2023 

AVAPRITINIB (TABLET) (ORAL) AYVAKIT
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: BLUEPRINT MEDICINES      NDA No.: 212608  Prod. No.: 001 RX (100MG); 002 RX (200MG)
3 Patents--1 FamilyExpirationPatented Use
Pat. No. 9200002 DS* DP* (Family Id: 51904226) Compositions useful for treating disorders related to KIT
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Feb 5, 2020
Oct 15, 2034U-2726: Treatment of unresectable or metastatic gastrointestinal stromal tumor (gist) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation
U-3168: Treatment of advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL)
Pat. No. 9944651 DS* DP* (Family Id: 51904226) Compositions useful for treating disorders related to kit
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Feb 5, 2020
Oct 15, 2034U-2726: Treatment of unresectable or metastatic gastrointestinal stromal tumor (gist) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation
U-3168: Treatment of advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL)
Pat. No. 9994575 DS* DP* (Family Id: 51904226) Compositions useful for treating disorders related to kit
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Feb 5, 2020
Oct 15, 2034U-2726: Treatment of unresectable or metastatic gastrointestinal stromal tumor (gist) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation
U-3168: Treatment of advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL)
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJun 16, 2024I-863: Treatment of adult patients with advanced systemic mastocytosis (ADVSM), including patients with aggressive systemic mastocytosis (ASM) and systemic mastocytosis with an associated hematological neoplasm (SM-AHN)
Exclusivity Code: I - New IndicationJun 16, 2024I-864: Treatment of adult patients with mast cell leukemia (MCL)
Exclusivity Code: NCE - New chemical entityJan 9, 2025 
Exclusivity Code: ODE - Orphan drug exclusivityJun 16, 2028ODE-356: For the treatment of adult patients with advanced systemic mastocytosis (ADVSM). ADVSM includes patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL)
Exclusivity Code: ODE - Orphan drug exclusivityJan 9, 2027ODE-366: Indicated for the treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations

AVAPRITINIB (TABLET) (ORAL) AYVAKIT
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: BLUEPRINT MEDICINES      NDA No.: 212608  Prod. No.: 003 RX (300MG)
3 Patents--1 FamilyExpirationPatented Use
Pat. No. 9200002 DS* DP* (Family Id: 51904226) Compositions useful for treating disorders related to KIT
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 003: Feb 5, 2020
Oct 15, 2034U-2726: Treatment of unresectable or metastatic gastrointestinal stromal tumor (gist) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation
Pat. No. 9944651 DS* DP* (Family Id: 51904226) Compositions useful for treating disorders related to kit
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 003: Feb 5, 2020
Oct 15, 2034U-2726: Treatment of unresectable or metastatic gastrointestinal stromal tumor (gist) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation
Pat. No. 9994575 DS* DP* (Family Id: 51904226) Compositions useful for treating disorders related to kit
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 003: Feb 5, 2020
Oct 15, 2034U-2726: Treatment of unresectable or metastatic gastrointestinal stromal tumor (gist) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJan 9, 2025 
Exclusivity Code: ODE - Orphan drug exclusivityJun 16, 2028ODE-356: For the treatment of adult patients with advanced systemic mastocytosis (ADVSM). ADVSM includes patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL)
Exclusivity Code: ODE - Orphan drug exclusivityJan 9, 2027ODE-366: Indicated for the treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations

AVAPRITINIB (TABLET) (ORAL) AYVAKIT
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: BLUEPRINT MEDICINES      NDA No.: 212608  Prod. No.: 004 RX (25MG); 005 RX (50MG)
3 Patents--1 FamilyExpirationPatented Use
Pat. No. 9200002 DS* DP* (Family Id: 51904226) Compositions useful for treating disorders related to KIT
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Jul 13, 2021
Oct 15, 2034U-3168: Treatment of advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL)
Pat. No. 9944651 DS* DP* (Family Id: 51904226) Compositions useful for treating disorders related to kit
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Jul 13, 2021
Oct 15, 2034U-3168: Treatment of advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL)
Pat. No. 9994575 DS* DP* (Family Id: 51904226) Compositions useful for treating disorders related to kit
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Jul 13, 2021
Oct 15, 2034U-3168: Treatment of advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL)
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJun 16, 2024I-863: Treatment of adult patients with advanced systemic mastocytosis (ADVSM), including patients with aggressive systemic mastocytosis (ASM) and systemic mastocytosis with an associated hematological neoplasm (SM-AHN)
Exclusivity Code: I - New IndicationJun 16, 2024I-864: Treatment of adult patients with mast cell leukemia (MCL)
Exclusivity Code: NCE - New chemical entityJan 9, 2025 
Exclusivity Code: ODE - Orphan drug exclusivityJun 16, 2028ODE-356: For the treatment of adult patients with advanced systemic mastocytosis (ADVSM). ADVSM includes patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL)
Exclusivity Code: ODE - Orphan drug exclusivityJan 9, 2027ODE-366: Indicated for the treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations

AVATROMBOPAG MALEATE (TABLET) (ORAL) DOPTELET
Drug Classes: Blood Products and Modifiers:Platelet Modifying Agents
NDA Applicant: AKARX INC      NDA No.: 210238  Prod. No.: 001 RX (EQ 20MG BASE)
3 Patents--1 FamilyExpirationPatented Use
Pat. No. 7638536 DS* DP* (Family Id: 27615666) 2-Acylaminothiazole derivative or salt thereof
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jun 15, 2018
May 5, 2025 
Pat. No. 8338429 (Family Id: 27615666) 2-acylaminothiazole derivative or salt thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2019
Jun 30, 2023U-2577: Treatment of thrombocytopenia in an adult patient with chronic immune thrombocytopenia who has had an insufficient response to a previous treatment
Pat. No. 8765764 (Family Id: 27615666) 2-acylaminothiazole derivative or salt thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 15, 2018
Jan 15, 2023U-2314: Treatment of thrombocytopenia in an adult patient with chronic liver disease who is scheduled to undergo a procedure using DOPTELET
U-2578: Treatment of thrombocytopenia in an adult patient with chronic liver disease who is scheduled to undergo a procedure
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJun 26, 2022I-802: Treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment
Exclusivity Code: NCE - New chemical entityMay 21, 2023 
Exclusivity Code: ODE - Orphan drug exclusivityJun 26, 2026ODE-246: Treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment

AVIBACTAM SODIUM; CEFTAZIDIME (POWDER) (INTRAVENOUS) AVYCAZ
Drug Classes: beta lactamase inhibitor == Antibacterials:Beta-lactam, Cephalosporins == cephalosporin antibacterial
NDA Applicant: ALLERGAN      NDA No.: 206494  Prod. No.: 001 RX (EQ 0.5GM BASE;2GM/VIAL)
7 Patents--4 FamiliesExpirationPatented Use
Pat. No. 7612087 DP* (Family Id: 27619669) Heterocyclic compounds as inhibitors of beta-lactamases
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 17, 2015
Nov 12, 2026 
Pat. No. 8471025 DS* (Family Id: 42154208) Crystalline forms of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide sodium salt
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Mar 17, 2015
Aug 12, 2031 
Pat. No. 8835455 DP* (Family Id: 42154208) Crystalline forms of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide sodium salt
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 17, 2015
Oct 8, 2030 
Pat. No. 8969566 DS* (Family Id: 46317443) Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Mar 17, 2015
Jun 15, 2032 
Pat. No. 9284314 DS* (Family Id: 46317443) Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Feb 24, 2017
Jun 15, 2032 
Pat. No. 9695122 DS* (Family Id: 46317443) Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof
Claim Types: Formulation; Compound; Composition
Pat. Sub. Date(s): 001: Aug 8, 2017
Jun 15, 2032 
Pat. No. 7112592 DS* DP* [Extended 1413 days (3.9 years)]
(Family Id: 8853181) Azabicyclic compounds, preparation thereof and use as medicines, in particular as antibacterial agents
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Mar 17, 2015
Jan 7, 2026U-2244: A method of treating bacterial infections in hospital-acquired bacterial pneumonia and ventilator-associated bacterial pnenumonia (HABP/VABP) patients comprising administering a bactericidally effective amount of avibactam sodium
U-2508: A method of treating bacterial infections in complicated intra-abdominal infection and complicated urinary tract infection, including pyelonephritis, patients comprising administering a bactericidally effective amount of avibactam sodium
U-282: Method of treating bacterial infections
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityFeb 25, 2025 GAIN 

AXITINIB (TABLET) (ORAL) INLYTA
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: PF PRISM CV      NDA No.: 202324  Prod. No.: 001 RX (1MG); 002 RX (5MG)
4 Patents--4 FamiliesExpirationPatented Use
Pat. No. 6534524 DS* DP* [Extended 1764 days (4.8 years)]
(Family Id: 26839785) 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* (Family Id: 39831473) 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 
Pat. No. 10570202 (Family Id: 52463238) Combination of a PD-1 antagonist and a VEGFR inhibitor for treating cancer
Claim Types: Method of use; Kit
Pat. Sub. Date(s): All strengths: Jun 30, 2020
Feb 3, 2035U-2844: In combination with pembrolizumab for the first-line treatment of patients with advanced renal cell carcinoma
Pat. No. 10869924 (Family Id: 56236125) PD-L1 antagonist combination treatments
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 21, 2021
Jan 12, 2037U-3044: Axitinib in combination with avelumab for the first-line treatment of patients with advanced renal cell carcinoma

AZACITIDINE (POWDER) (INTRAVENOUS, SUBCUTANEOUS) VIDAZA [GENERIC AP]
Drug Classes: Antineoplastics:Antimetabolites == nucleoside metabolic inhibitor
NDA Applicant: CELGENE      NDA No.: 050794  Prod. No.: 001 RX (100MG/VIAL)
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMay 20, 2025I-889: Treatment of pediatric patients aged one month and older with newly diagnosed juvenile myelomonocytic leukemia (JMML)

AZACITIDINE (TABLET) (ORAL) ONUREG
Drug Classes: Antineoplastics:Antimetabolites == nucleoside metabolic inhibitor
NDA Applicant: CELGENE CORP      NDA No.: 214120  Prod. No.: 001 RX (200MG); 002 RX (300MG)
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 8846628 DP* (Family Id: 40941609) Oral formulations of cytidine analogs and methods of use thereof
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Sep 29, 2020
Jun 3, 2030U-2950: Continued treatment of adults with acute myeloid leukemia who achieved first complete remission (CR) or CR with incomplete blood count recovery following intensive induction chemotherapy and are not able to complete intensive curative therapy
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productSep 1, 2023 
Exclusivity Code: ODE - Orphan drug exclusivitySep 1, 2027ODE-320: Indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRI) following intensive induction chemotherapy and are not able to complete intensive curative therapy

AZELAIC ACID (AEROSOL, FOAM) (TOPICAL) FINACEA
Drug Classes: Dermatological Agents:Acne and Rosacea Agents
NDA Applicant: LEO PHARMA AS      NDA No.: 207071  Prod. No.: 001 RX (15%)
8 Patents--6 FamiliesExpirationPatented Use
Pat. No. 8722021 DP* (Family Id: 32178937) Foamable carriers
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 26, 2015
Oct 24, 2023 
Pat. No. 9211259 (Family Id: 37463626) Antibiotic kit and composition and uses thereof
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jan 14, 2016
Feb 28, 2029U-1796: Topical treatment of inflammatory papules and pustules of mild to moderate rosacea
Pat. No. 9265725 DP* (Family Id: 39101639) Dicarboxylic acid foamable vehicle and pharmaceutical compositions thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 23, 2016
Dec 8, 2027 
Pat. No. 10322085 DP* (Family Id: 39101639) Dicarboxylic acid foamable vehicle and pharmaceutical compositions thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 21, 2019
Oct 24, 2023 
Pat. No. 8900554 DP* (Family Id: 46199601) Foamable composition and uses thereof
Claim Types: Composition
Pat. Sub. Date(s): 001: Aug 26, 2015
Oct 24, 2023 
Pat. No. 7700076 DP* (Family Id: 46302609) Penetrating pharmaceutical foam
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 26, 2015
Sep 18, 2027 
Pat. No. 8435498 (Family Id: 46302609) Penetrating pharmaceutical foam
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Aug 26, 2015
Mar 1, 2024U-1727: Topical treatment of inflammatory papules and pustules of mild to moderate rosacea
Pat. No. 10117812 DP* (Family Id: 46325768) Foamable composition combining a polar solvent and a hydrophobic carrier
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 15, 2018
Oct 18, 2027U-1796: Topical treatment of inflammatory papules and pustules of mild to moderate rosacea

AZELASTINE HYDROCHLORIDE (SPRAY, METERED) (NASAL) ASTEPRO [Has competitive generic]
Drug Classes: Ophthalmic Agents:Ophthalmic Anti-allergy Agents == Respiratory Tract/ Pulmonary Agents:Antihistamines == histamine-1 (H1) receptor antagonist
NDA Applicant: MYLAN SPECIALITY LP      NDA No.: 022203  Prod. No.: 001 DISC (0.137MG/SPRAY)
2 Patents--1 FamilyExpirationPatented Use
Pat. No. 8071073 DP* (Family Id: 36498307) Compositions comprising azelastine and methods of use thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 15, 2011
Jun 4, 2028 
Pat. No. 8518919 (Family Id: 36498307) Compositions comprising azelastine and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 18, 2013
Nov 22, 2025U-1430: Treatment of allergic rhinitis, including seasonal and perennial allergic rhinitis

AZELASTINE HYDROCHLORIDE (SPRAY, METERED) (NASAL) ASTEPRO [Has competitive generic]
Drug Classes: Ophthalmic Agents:Ophthalmic Anti-allergy Agents == Respiratory Tract/ Pulmonary Agents:Antihistamines == histamine-1 (H1) receptor antagonist
NDA Applicant: MYLAN SPECIALITY LP      NDA No.: 022203  Prod. No.: 002 DISC (0.2055MG/SPRAY)
3 Patents--1 FamilyExpirationPatented Use
Pat. No. 8071073 DP* (Family Id: 36498307) Compositions comprising azelastine and methods of use thereof
Claim Types: Formulation
Pat. Sub. Date(s): 002: Dec 15, 2011
Jun 4, 2028 
Pat. No. 8518919 (Family Id: 36498307) Compositions comprising azelastine and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 002: Sep 18, 2013
Nov 22, 2025U-1430: Treatment of allergic rhinitis, including seasonal and perennial allergic rhinitis
Pat. No. 9919050 DP* (Family Id: 36498307) Compositions comprising azelastine
Claim Types: Formulation
Pat. Sub. Date(s): 002: Mar 29, 2018
Nov 22, 2025 

AZELASTINE HYDROCHLORIDE (SPRAY, METERED) (NASAL) ASTEPRO ALLERGY; ASTEPRO ALLERGY, CHILDREN'S [Has competitive generic]
Drug Classes: Ophthalmic Agents:Ophthalmic Anti-allergy Agents == Respiratory Tract/ Pulmonary Agents:Antihistamines == histamine-1 (H1) receptor antagonist
NDA Applicant: BAYER HLTHCARE      NDA No.: 213872  Prod. No.: 001 OTC (0.2055MG/SPRAY); 002 OTC (0.2055MG/SPRAY)
3 Patents--1 FamilyExpirationPatented Use
Pat. No. 8071073 DP* (Family Id: 36498307) Compositions comprising azelastine and methods of use thereof
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 8, 2021
Jun 4, 2028 
Pat. No. 8518919 (Family Id: 36498307) Compositions comprising azelastine and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 8, 2021
Nov 22, 2025U-3166: OTC use: allergy symptom reliever; temporary relief of these symptoms due to hay fever or other upper respiratory allergies: nasal congestion, runny nose, sneezing and itchy nose
Pat. No. 9919050 DP* (Family Id: 36498307) Compositions comprising azelastine
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 8, 2021
Nov 22, 2025 

AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE (SPRAY, METERED) (NASAL) DYMISTA [GENERIC AB]
Drug Classes: Ophthalmic Agents:Ophthalmic Anti-allergy Agents == Respiratory Tract/ Pulmonary Agents:Antihistamines == histamine-1 (H1) receptor antagonist == Dermatological Agents:Dermatitis and Pruritus Agents == Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant: MYLAN SPECIALITY LP      NDA No.: 202236  Prod. No.: 001 RX (0.137MG/SPRAY;0.05MG/SPRAY)
4 Patents--1 FamilyExpirationPatented Use
Pat. No. 8163723 (Family Id: 9938620) Combination of azelastine and steroids
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 11, 2012
Feb 29, 2024 *PEDU-1667: Treatment of allergic rhinitis, including seasonal allergic rhinitis
U-644: Treatment of seasonal allergic rhinitis
U-707: Allergic rhinitis
U-77: Treatment of symptoms of seasonal allergic rhinitis
U-81: Relief of symptoms associated with seasonal allergic rhinitis
Pat. No. 8168620 DP* (Family Id: 9938620) Combination of azelastine and steroids
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: May 11, 2012
Aug 24, 2026 *PED 
Pat. No. 9259428 (Family Id: 9938620) Combination of azelastine and fluticasone for nasal administration
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 9, 2016
Dec 13, 2023 *PEDU-644: Treatment of seasonal allergic rhinitis
Pat. No. 9901585 DP* (Family Id: 9938620) Combination of azelastine and fluticasone for nasal administration
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 27, 2018
Jun 13, 2023 

AZILSARTAN KAMEDOXOMIL (TABLET) (ORAL) EDARBI
Drug Classes: Cardiovascular Agents:Angiotensin II Receptor Antagonists == Cardiovascular Agents:Cardiovascular Combinations == angiotensin II receptor blocker
NDA Applicant: AZURITY      NDA No.: 200796  Prod. No.: 001 RX (EQ 40MG MEDOXOMIL); 002 RX (EQ 80MG MEDOXOMIL)
3 Patents--2 FamiliesExpirationPatented Use
Pat. No. 7157584 DS* (Family Id: 34858222) Benzimidazole derivative and use thereof
Claim Types: Compound
Pat. Sub. Date(s): All strengths: None
May 22, 2025 
Pat. No. 7572920 DP* (Family Id: 34858222) Benzimidazole derivative and use as a II receptor antagonist
Claim Types: Composition; Method of use; Formulation; Process
Pat. Sub. Date(s): All strengths: None
Jan 7, 2025U-3: Treatment of hypertension
Pat. No. 9066936 DP* (Family Id: 39590787) Solid pharmaceutical composition comprising a benzimidazole-7-carboxylate derivative and a pH control agent
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Jul 30, 2015
Mar 26, 2028 

AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE (TABLET) (ORAL) EDARBYCLOR
Drug Classes: Cardiovascular Agents:Angiotensin II Receptor Antagonists == Cardiovascular Agents:Cardiovascular Combinations == angiotensin II receptor blocker == Cardiovascular Agents:Diuretics, Thiazide
NDA Applicant: AZURITY      NDA No.: 202331  Prod. No.: 001 RX (EQ 40MG MEDOXOMIL;12.5MG); 002 RX (EQ 40MG MEDOXOMIL;25MG)
5 Patents--4 FamiliesExpirationPatented Use
Pat. No. 7157584 DS* (Family Id: 34858222) Benzimidazole derivative and use thereof
Claim Types: Compound
Pat. Sub. Date(s): 001: Jan 17, 2012; 002: None
May 22, 2025 
Pat. No. 7572920 DP* (Family Id: 34858222) Benzimidazole derivative and use as a II receptor antagonist
Claim Types: Composition; Method of use; Formulation; Process
Pat. Sub. Date(s): 001: Jan 17, 2012; 002: None
Jan 7, 2025U-3: Treatment of hypertension
Pat. No. 9066936 DP* (Family Id: 39590787) Solid pharmaceutical composition comprising a benzimidazole-7-carboxylate derivative and a pH control agent
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Jul 30, 2015
Mar 26, 2028 
Pat. No. 9169238 DP* (Family Id: 41610805) Solid pharmaceutical composition
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Nov 19, 2015
Feb 4, 2030 
Pat. No. 9387249 (Family Id: 41822462) Methods of treating hypertension with at least one angiotensin II receptor blocker and chlorthalidone
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 15, 2019
Jul 1, 2031U-3: Treatment of hypertension

AZITHROMYCIN (FOR SUSPENSION, EXTENDED RELEASE) (ORAL) ZMAX
Drug Classes: Antibacterials:Macrolides == Ophthalmic Agents:Ophthalmic Anti-Infectives == macrolide antimicrobial
NDA Applicant: PF PRISM CV      NDA No.: 050797  Prod. No.: 001 DISC (EQ 2GM BASE/BOT)
2 Patents--2 FamiliesExpirationPatented Use
Pat. No. 6984403 DP* (Family Id: 34468055) Azithromycin dosage forms with reduced side effects
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Feb 14, 2024U-282: Method of treating bacterial infections
Pat. No. 7887844 DP* (Family Id: 34652493) Multiparticulate crystalline drug compositions having controlled release profiles
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Mar 15, 2011
Feb 14, 2024 


DS*=Drug Substance and DP*=Drug Product: patent submitted for the product after Aug. 18, 2003.
** Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Last edited: 16 September 2022
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