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
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
Apr 5, 2028 *PED 
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
Jun 8, 2030 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousDec 15, 2026 PEDM-294: Information added to the labeling regarding the result of study 205860

ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE (TABLET, FOR SUSPENSION) (ORAL) TRIUMEQ PD
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
Apr 5, 2028 *PED 
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
Jun 8, 2030 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationDec 15, 2026 PED 

ABALOPARATIDE (SOLUTION) (SUBCUTANEOUS) TYMLOS
NDA Applicant: RADIUS      NDA No.:
208743  Prod. No.: 001 RX (3.12MG/1.56ML (2MG/ML))
8 Patents--5 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.
U-3543: Treatment to increase bone density in men 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. 11680942 (Family Id: 69326581) Methods for detecting neutralizing antibodies to parathyroid hormone (PTH) and parathyroid hormone-related peptide (PTHrP) analog
Claim Types: Analytical method; Kit
Pat. Sub. Date(s): 001: Jul 20, 2023
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 
Pat. No. 11782041 DP* (Family Id: 69523931) Abaloparatide formulations and methods of testing, storing, modifying, and using same
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 23, 2023
Apr 30, 2038U-2009: Method of treating postmenopausal women with osteoporosis at high risk for fracture.
U-3543: Treatment to increase bone density in men with osteoporosis at high risk for fracture
Pat. No. RE49444 (Family Id: 85381527) Method of treating osteoporosis comprising administration of PTHrP analog
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 14, 2023
Apr 28, 2031U-2009: Method of treating postmenopausal women with osteoporosis at high risk for fracture.
U-3543: Treatment to increase bone density in men with osteoporosis at high risk for fracture
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationDec 19, 2025I-907: To increase bone density in men with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture), or patients who have failed or are intolerant to other available osteoporosis therapy
Exclusivity Code: M - MiscellaneousSep 20, 2024M-270: Information added to clinical pharmacology section

ABAMETAPIR (LOTION) (TOPICAL) XEGLYZE
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
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 endocrine 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
U-3265: In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
U-3546: 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
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: NPP - New patient populationOct 12, 2024 

ABEMACICLIB (TABLET) (ORAL) VERZENIO
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: NPP - New patient populationOct 12, 2024 

ABIRATERONE ACETATE (TABLET) (ORAL) YONSA
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 

ABIRATERONE ACETATE; NIRAPARIB TOSYLATE (TABLET) (ORAL) AKEEGA
NDA Applicant: JANSSEN BIOTECH      NDA No.:
216793  Prod. No.: 001 RX (500MG;EQ 50MG BASE); 002 RX (500MG;EQ 100MG BASE)
8 Patents--6 FamiliesExpirationPatented Use
Pat. No. 8859562 (Family Id: 27772701) Use of RNAI inhibiting PARP activity for the manufacture of a medicament for the treatment of cancer
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 6, 2023
Aug 4, 2031U-2830: A method for treating metastatic castration-resistant prostate cancer (MCRPC), wherein the cancer is associated with a deleterious BRCA-mutation
Pat. No. 8071579 (Family Id: 34655227) DNA damage repair inhibitors for the treatment of cancer
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 6, 2023
Aug 12, 2027U-2830: A method for treating metastatic castration-resistant prostate cancer (MCRPC), wherein the cancer is associated with a deleterious BRCA-mutation
Pat. No. 8143241 (Family Id: 34655227) DNA damage repair inhibitors for treatment of cancer
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 6, 2023
Aug 12, 2027U-2830: A method for treating metastatic castration-resistant prostate cancer (MCRPC), wherein the cancer is associated with a deleterious BRCA-mutation
Pat. No. 8071623 DS* DP* [Extended 702 days (1.9 years)]
(Family Id: 39246752) Amide substituted indazoles as poly(ADP-ribose)polymerase(PARP) inhibitors
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Sep 6, 2023
Mar 27, 2031 
Pat. No. 8436185 DS* DP* (Family Id: 40404013) Pharmaceutically acceptable salts of 2-{4-[(3S)-piperidin-3-yl]phenyl}-2H-indazole-7-carboxamide
Claim Types: Compound
Pat. Sub. Date(s): All strengths: Sep 6, 2023
Apr 24, 2029 
Pat. No. 11207311 (Family Id: 59649991) Method of treating prostate cancer
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 6, 2023
Jul 28, 2037U-2830: A method for treating metastatic castration-resistant prostate cancer (MCRPC), wherein the cancer is associated with a deleterious BRCA-mutation
Pat. No. 11091459 DS* DP* (Family Id: 63676949) Niraparib compositions
Claim Types: Formulation; Process; Composition
Pat. Sub. Date(s): All strengths: Sep 6, 2023
Mar 27, 2038 
Pat. No. 11673877 DS* DP* (Family Id: 63676949) Niraparib compositions
Claim Types: New polymorph, salt or hydrate; Method of use
Pat. Sub. Date(s): All strengths: Sep 6, 2023
Mar 27, 2038 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productAug 11, 2026 

ABROCITINIB (TABLET) (ORAL) CIBINQO
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 
Exclusivity Code: NPP - New patient populationFeb 9, 2026 

ACALABRUTINIB (CAPSULE) (ORAL) CALQUENCE
NDA Applicant: ASTRAZENECA      NDA No.:
210259  Prod. No.: 001 RX (100MG)
8 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
Pat. No. 11771696 (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: Oct 30, 2023
Jan 21, 2035U-3710: Treatment of adult patients with previously untreated chronic lymphocytic leukemia by orally administering 100 mg of acalabrutinib twice daily in combination with intravenous administration of obinutuzumab
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityOct 31, 2024ODE-175: Treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy
Exclusivity Code: ODE - Orphan drug exclusivityNov 21, 2026ODE-274: Indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

ACALABRUTINIB MALEATE (TABLET) (ORAL) CALQUENCE
NDA Applicant: ASTRAZENECA      NDA No.:
216387  Prod. No.: 001 RX (EQ 100MG BASE)
7 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
Pat. No. 11771696 (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: Oct 30, 2023
Jan 21, 2035U-3710: Treatment of adult patients with previously untreated chronic lymphocytic leukemia by orally administering 100 mg of acalabrutinib twice daily in combination with intravenous administration of obinutuzumab

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: ZEVRA THERAP      NDA No.:
208653  Prod. No.: 001 DISC (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: ZEVRA THERAP      NDA No.:
208653  Prod. No.: 002 DISC (325MG;EQ 4.08MG BASE); 003 DISC (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) COMBOGESIC
NDA Applicant: AFT PHARMS LTD      NDA No.:
209471  Prod. No.: 001 DISC (325MG;97.5MG)
3 Patents--2 FamiliesExpirationPatented Use
Pat. No. 10532036 (Family Id: 35783254) Combination composition
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 29, 2023
Sep 22, 2025U-3553: A method of treating mild to moderate acute pain in adults by administering 975-1000 mg of acetaminophen and 292.5-300 mg of ibuprofen in a single administration
Pat. No. 11197830 DP* (Family Id: 72140141) Pharmaceutical composition containing acetaminophen and ibuprofen
Claim Types: Product-by-process
Pat. Sub. Date(s): 001: Mar 29, 2023
Feb 27, 2039U-3553: A method of treating mild to moderate acute pain in adults by administering 975-1000 mg of acetaminophen and 292.5-300 mg of ibuprofen in a single administration
Pat. No. 11534407 DP* (Family Id: 72140141) Pharmaceutical compostion containing acetominophen and ibuprofen
Claim Types: Product-by-process; Formulation claimed by its inherent performace characteristics; Method of use
Pat. Sub. Date(s): 001: Mar 29, 2023
Feb 27, 2039U-3553: A method of treating mild to moderate acute pain in adults by administering 975-1000 mg of acetaminophen and 292.5-300 mg of ibuprofen in a single administration
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productMar 1, 2026 

ACETAMINOPHEN; IBUPROFEN SODIUM (SOLUTION) (INTRAVENOUS) COMBOGESIC IV
NDA Applicant: HIKMA      NDA No.:
215320  Prod. No.: 001 RX (1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML))
3 Patents--2 FamiliesExpirationPatented Use
Pat. No. 11446266 (Family Id: 46024668) Combination composition
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 16, 2023
Oct 26, 2031U-3744: Method of treating mild to moderate pain in adults
U-3745: Method of treating moderate to severe pain in adults as an adjunct to opioid analgesics
Pat. No. 11213498 DP* (Family Id: 51211244) Aqueous formulation comprising paracetamol and ibuprofen
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): 001: Nov 16, 2023
Jan 14, 2036 
Pat. No. 11389416 DP* (Family Id: 51211244) Aqueous formulation comprising paracetamol and ibuprofen
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): 001: Nov 16, 2023
Jul 17, 2035 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productOct 17, 2026 

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE (TABLET, EXTENDED RELEASE) (ORAL) XARTEMIS XR
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]
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
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
NDA Applicant: COVIS      NDA No.:
202450  Prod. No.: 001 RX (0.4MG/INH)
4 Patents--3 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. 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)

ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE (POWDER, METERED) (INHALATION) DUAKLIR PRESSAIR
NDA Applicant: COVIS      NDA No.:
210595  Prod. No.: 001 RX (0.4MG/INH;0.012MG/INH)
4 Patents--3 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. 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)

ACYCLOVIR (OINTMENT) (OPHTHALMIC) AVACLYR
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
NDA Applicant: LNHC      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 (CREAM) (TOPICAL) ACYCLOVIR [GENERIC AB]
NDA Applicant: ALEMBIC      NDA No.:
212361  Prod. No.: 001 RX (5%)
ExclusivityExpirationExclusivity Description
Exclusivity Code: CGT - Competitive generic therapyJun 12, 2024 

ADAGRASIB (TABLET) (ORAL) KRAZATI
NDA Applicant: MIRATI THERAPS      NDA No.:
216340  Prod. No.: 001 RX (200MG)
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 10689377 DS* DP* (Family Id: 66431793) KRas G12C inhibitors
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Dec 20, 2022
May 17, 2037U-3490: Treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an fda approved test, who have received at least one prior systemic therapy
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityDec 12, 2027 
Exclusivity Code: ODE - Orphan drug exclusivityDec 12, 2029ODE-352: Treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy

ADAPALENE (GEL) (TOPICAL) DIFFERIN [GENERIC AB]
NDA Applicant: GALDERMA LABS LP      NDA No.:
021753  Prod. No.: 001 RX (0.3%)
2 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 

ADAPALENE (LOTION) (TOPICAL) DIFFERIN
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]
NDA Applicant: GALDERMA LABS LP      NDA No.:
022320  Prod. No.: 001 RX (0.1%;2.5%)
5 Patents--3 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. 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. 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

ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE (GEL) (TOPICAL) CABTREO
NDA Applicant: BAUSCH      NDA No.:
216632  Prod. No.: 001 RX (0.15%;3.1%;1.2%)
5 Patents--2 FamiliesExpirationPatented Use
Pat. No. 8288434 DP* (Family Id: 41398394) Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 2, 2023
Aug 5, 2029U-3713: Topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older
Pat. No. 9561208 DP* (Family Id: 41398394) Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 2, 2023
Jun 3, 2029U-3713: Topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older
Pat. No. 10220049 DP* (Family Id: 41398394) Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 2, 2023
Jun 3, 2029U-3713: Topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older
Pat. No. 10624918 (Family Id: 41398394) Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 2, 2023
Jun 3, 2029U-3713: Topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older
Pat. No. 11389467 DP* (Family Id: 71899773) Topical compositions
Claim Types: Formulation; Method of use; Drug in a container; Process
Pat. Sub. Date(s): 001: Nov 2, 2023
Dec 28, 2040U-3713: Topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productOct 20, 2026 

AFAMELANOTIDE (IMPLANT) (SUBCUTANEOUS) SCENESSE
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 [Extended 1411 days (3.9 years)]
(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
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 results from clinical study 1200.120, conducted to fulfill a pediatric written request
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) PROAIR HFA [GENERIC AB2]
NDA Applicant: TEVA BRANDED PHARM      NDA No.:
021457  Prod. No.: 001 RX (EQ 0.09MG BASE/INH)
9 Patents--2 FamiliesExpirationPatented Use
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
NDA Applicant: TEVA BRANDED PHARM      NDA No.:
205636  Prod. No.: 001 RX (EQ 0.09MG BASE/INH)
9 Patents--2 FamiliesExpirationPatented Use
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
NDA Applicant: TEVA BRANDED PHARM      NDA No.:
205636  Prod. No.: 002 RX (EQ 0.09MG BASE/INH)
21 Patents--8 FamiliesExpirationPatented Use
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. 11439777 DP* (Family Id: 60388067) Drug delivery device with electronics
Claim Types: Device
Pat. Sub. Date(s): 002: Oct 6, 2022
May 24, 2040 
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 
Pat. No. 11464923 DP* (Family Id: 76662456) Inhaler system
Claim Types: Device; Method of improving a treatment
Pat. Sub. Date(s): 002: Nov 10, 2022
Jun 19, 2040 

ALBUTEROL SULFATE; BUDESONIDE (AEROSOL, METERED) (INHALATION) AIRSUPRA
NDA Applicant: ASTRAZENECA      NDA No.:
214070  Prod. No.: 001 RX (EQ 0.09MG BASE/INH;0.08MG/INH)
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 9415009 (Family Id: 45564962) Compositions, methods and systems for respiratory delivery of two or more active agents
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jan 24, 2023
May 28, 2030U-3509: As-needed treatment or prevention of bronchoconstriction and reduction of the risk of exacerbations in patients with asthma 18 years of age and older
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productJan 10, 2026 

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE (SPRAY, METERED) (INHALATION) COMBIVENT RESPIMAT
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 [GENERIC OTC]
NDA Applicant: ABBVIE      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
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
NDA Applicant: HOFFMANN-LA ROCHE      NDA No.:
208434  Prod. No.: 001 RX (EQ 150MG BASE)
5 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 
Pat. No. 11433076 DP* (Family Id: 54332608) Preparation containing tetracyclic compound at high dose
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 28, 2022
Apr 24, 2035 
ExclusivityExpirationExclusivity Description
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
NDA Applicant: RADIUS      NDA No.:
202344  Prod. No.: 001 RX (EQ 70MG BASE)
1 Patent--1 FamilyExpirationPatented Use
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 

ALENDRONATE SODIUM (SOLUTION) (ORAL) ALENDRONATE SODIUM [GENERIC AA]
NDA Applicant: NOVITIUM PHARMA      NDA No.:
214512  Prod. No.: 001 RX (EQ 70MG BASE/75ML)
ExclusivityExpirationExclusivity Description
Exclusivity Code: CGT - Competitive generic therapyNov 20, 2023 

ALISKIREN HEMIFUMARATE (TABLET) (ORAL) TEKTURNA [GENERIC AB]
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
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; HYDROCHLOROTHIAZIDE (TABLET) (ORAL) TEKTURNA HCT
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**)
1 Patent--1 FamilyExpirationPatented 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 

ALISKIREN HEMIFUMARATE; VALSARTAN (TABLET) (ORAL) VALTURNA
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
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
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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousJul 27, 2026M-300: Revisions to the pediatric use subsection of labeling to include the results from clinical study SYR-322-309, conducted in response to a pediatric written request

ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE (TABLET) (ORAL) KAZANO
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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousJul 27, 2026M-300: Revisions to the pediatric use subsection of labeling to include the results from clinical study SYR-322-309, conducted in response to a pediatric written request

ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE (TABLET) (ORAL) OSENI
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
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* [Extended 1327 days (3.6 years)]
(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
Apr 29, 2033U-3809: In combination with fulvestrant for treatment of adults 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
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* [Extended 1327 days (3.6 years)]
(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
Apr 29, 2033 
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 
Exclusivity Code: ODE - Orphan drug exclusivityApr 5, 2029ODE-396: Treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-related overgrowth spectrum (PROS) who require systemic therapy

ALVIMOPAN (CAPSULE) (ORAL) ENTEREG [Has competitive generic]
NDA Applicant: CUBIST PHARMS      NDA No.:
021775  Prod. No.: 001 DISC (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
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
NDA Applicant: ADAMAS OPERATIONS      NDA No.:
209410  Prod. No.: 001 RX (EQ 129MG BASE); 002 RX (EQ 193MG BASE)
19 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): All strengths: Mar 1, 2018
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): All strengths: Mar 1, 2018
Nov 28, 2025U-20: A process for treating a patient suffering from parkinson's syndrome and in need of treatment
Pat. No. 10213394 (Family Id: 65410681) Composition and method for treating neurological disease
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 13, 2019
Feb 15, 2038U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients
Pat. No. 10500171 (Family Id: 65410681) Composition and method for treating neurological disease
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 17, 2019
Feb 15, 2038U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients
Pat. No. 10500172 (Family Id: 65410681) Composition and method for treating neurological disease
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 17, 2019
Feb 15, 2038U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients
Pat. No. 11890261 (Family Id: 65410681) Composition and method for treating neurological disease
Claim Types: Method of use; Method of Use claimed by its inherent performace characteristics
Pat. Sub. Date(s): All strengths: Mar 4, 2024
Feb 15, 2038U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients
Pat. No. 10213393 (Family Id: 65410876) Composition and method for treating neurological disease
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 13, 2019
Feb 15, 2038U-20: A process for treating a patient suffering from parkinson's syndrome and in need of treatment
Pat. No. 10500170 (Family Id: 65410876) Composition and method for treating neurological disease
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 17, 2019
Feb 15, 2038U-20: A process for treating a patient suffering from parkinson's syndrome and in need of treatment
Pat. No. 10512617 (Family Id: 65410876) Composition and method for treating neurological disease
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 2, 2020
Feb 15, 2038U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients

AMANTADINE HYDROCHLORIDE (TABLET, EXTENDED RELEASE) (ORAL) OSMOLEX ER
NDA Applicant: ADAMAS OPERATIONS      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): 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): 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): 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): 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): 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): 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): 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): 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]
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
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
May 26, 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: NPP - New patient populationSep 29, 2025 
Exclusivity Code: ODE - Orphan drug exclusivityNov 28, 2025ODE-223: Treatment of Lambert-Eaton myasthenic syndrome (LEMS)

AMIKACIN SULFATE (SUSPENSION, LIPOSOMAL) (INHALATION) ARIKAYCE KIT
NDA Applicant: INSMED INC      NDA No.:
207356  Prod. No.: 001 RX (EQ 590MG BASE/8.4ML)
12 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
Pat. No. 11446318 (Family Id: 54480776) Methods for treating pulmonary non-tuberculous mycobacterial infections
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 14, 2022
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
NDA Applicant: DUSA      NDA No.:
020965  Prod. No.: 001 RX (20%)
5 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
Pat. No. 11571478 (Family Id: 67212422) Methods for photodynamic therapy
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Jun 14, 2023
Jan 12, 2038U-3163: Treatment of actinic keratoses of upper extremities by photodynamic therapy
Pat. No. 11690914 (Family Id: 67212422) Methods for photodynamic therapy
Claim Types: Method of improving a treatment; Method of use
Pat. Sub. Date(s): 001: Jul 14, 2023
Jan 12, 2038U-3163: Treatment of actinic keratoses of upper extremities by photodynamic therapy

AMINOLEVULINIC ACID HYDROCHLORIDE (GEL) (TOPICAL) AMELUZ
NDA Applicant: BIOFRONTERA      NDA No.:
208081  Prod. No.: 001 RX (10%)
2 Patents--2 FamiliesExpirationPatented Use
Pat. No. 11540981 DP* (Family Id: 38042639) Nanoemulsion formulation with improved stability and cell penetration
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 18, 2023
Feb 7, 2028 
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
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
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**)
1 Patent--1 FamilyExpirationPatented Use
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
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 [Extended 1084 days (3 years)]
(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
Feb 26, 2034U-1744: Prevention of post-operative nausea and vomiting
U-2754: Treatment of post-operative nausea and vomiting
U-3467: Prevention and treatment of post-operative nausea and vomiting
Pat. No. 9545426 (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
NDA Applicant: AZURITY      NDA No.:
211340  Prod. No.: 001 RX (EQ 1MG BASE/ML)
9 Patents--3 FamiliesExpirationPatented Use
Pat. No. 11471409 (Family Id: ) Amlodipine formulations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 18, 2022
Oct 6, 2037U-3447: A method of treating coronary artery disease
U-3448: A method of treating hypertension
Pat. No. 11484498 DP* (Family Id: 1000006657143) Amlodipine Formulations
Claim Types: Product-by-process
Pat. Sub. Date(s): 001: Nov 4, 2022
Oct 6, 2037 
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 
Pat. No. 11701326 DP* (Family Id: 68161047) Amlodipine formulations
Claim Types: Product-by-process
Pat. Sub. Date(s): 001: Jul 20, 2023
Oct 6, 2037 

AMLODIPINE BESYLATE (SOLUTION) (ORAL) NORLIQVA
NDA Applicant: CMP DEV LLC      NDA No.:
214439  Prod. No.: 001 RX (EQ 1MG BASE/ML)
3 Patents--3 FamiliesExpirationPatented 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
Pat. No. 11458095 DP* (Family Id: 1000006597675) Pharmaceutical solution of amlodipine
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 5, 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
Pat. No. 11723866 DP* (Family Id: 80322116) Pharmaceutical solution of amlodipine
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 18, 2023
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
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; PERINDOPRIL ARGININE (TABLET) (ORAL) PRESTALIA
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)
1 Patent--1 FamilyExpirationPatented 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

AMOXICILLIN (TABLET, EXTENDED RELEASE) (ORAL) MOXATAG
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
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
NDA Applicant: REDHILL      NDA No.:
213004  Prod. No.: 001 RX (250MG;EQ 10MG BASE;12.5MG)
6 Patents--2 FamiliesExpirationPatented 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
Pat. No. 11878011 (Family Id: 78411885) Method for eradicating Helicobacter pylori infection in patients regardless of body mass index
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 21, 2024
May 27, 2042U-3816: Treatment of helicobacter pylori infection using the administered dosage forms in adults with different body mass index determinations
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productNov 1, 2027 GAIN 

AMOXICILLIN; VONOPRAZAN FUMARATE (CAPSULE, TABLET) (ORAL) VOQUEZNA DUAL PAK
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
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
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 [GENERIC AB2]
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)
2 Patents--1 FamilyExpirationPatented Use
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

AMPHETAMINE SULFATE (TABLET, ORALLY DISINTEGRATING) (ORAL) EVEKEO ODT
NDA Applicant: AZURITY      NDA No.:
209905  Prod. No.: 001 RX (5MG); 002 RX (10MG); 003 RX (15MG); 004 RX (20MG)
4 Patents--2 FamiliesExpirationPatented Use
Pat. No. 10130580 DP* (Family Id: 36145643) Taste-masked pharmaceutical compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jan 31, 2019
Apr 19, 2024 
Pat. No. 10441554 DP* (Family Id: 63446790) Oral amphetamine composition
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Oct 15, 2019
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 
Pat. No. 11896562 (Family Id: 63446790) Oral amphetamine composition
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 16, 2024
Mar 10, 2037U-3299: Treatment of attention deficit hyperactivity disorder (ADHD) in pediatric patients

AMPHETAMINE SULFATE (TABLET, ORALLY DISINTEGRATING) (ORAL) EVEKEO ODT
NDA Applicant: AZURITY      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): 005: Jul 7, 2021
Apr 19, 2024 
Pat. No. 10441554 DP* (Family Id: 63446790) Oral amphetamine composition
Claim Types: Formulation
Pat. Sub. Date(s): 005: Jul 7, 2021
Mar 10, 2037 
Pat. No. 11160772 DP* (Family Id: 63446790) Oral amphetamine composition
Claim Types: Formulation
Pat. Sub. Date(s): 005: Dec 9, 2021
Mar 10, 2037 

AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE (SUSPENSION, EXTENDED RELEASE) (ORAL) DYANAVEL XR
NDA Applicant: TRIS PHARMA INC      NDA No.:
208147  Prod. No.: 001 RX (2MG/ML;EQ 0.5MG BASE/ML)
7 Patents--2 FamiliesExpirationPatented 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 
Pat. No. 11590228 DP* (Family Id: 85289184) Extended Release amphetamine Compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 8, 2023
Sep 7, 2036U-3538: Method of treating attention deficit hyperactivity disorder

AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE (TABLET, EXTENDED RELEASE) (ORAL) DYANAVEL XR 5; DYANAVEL XR 10; DYANAVEL XR 15; DYANAVEL XR 20
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)
4 Patents--2 FamiliesExpirationPatented 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 
Pat. No. 11590081 DP* (Family Id: 85289242) Extended Release amphetamine Tablets
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): All strengths: Mar 8, 2023
Sep 24, 2038U-3538: Method of treating attention deficit hyperactivity disorder

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

ANGIOTENSIN II ACETATE (SOLUTION) (INTRAVENOUS) GIAPREZA
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))
11 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. 11559559 (Family Id: 53367119) Angiotensin II alone or in combination for the treatment of hypotension
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 8, 2023
Dec 18, 2034U-3514: Increasing blood pressure in a patient having distributive shock
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

ANGIOTENSIN II ACETATE (SOLUTION) (INTRAVENOUS) GIAPREZA
NDA Applicant: LA JOLLA PHARMA      NDA No.:
209360  Prod. No.: 002 DISC (EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML))
11 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. 11559559 (Family Id: 53367119) Angiotensin II alone or in combination for the treatment of hypotension
Claim Types: Method of use
Pat. Sub. Date(s): 002: Feb 8, 2023
Dec 18, 2034U-3514: Increasing blood pressure in a patient having distributive shock
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

ANIDULAFUNGIN (POWDER) (INTRAVENOUS) ERAXIS
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
NDA Applicant: JANSSEN BIOTECH      NDA No.:
210951  Prod. No.: 001 RX (60MG)
10 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. RE49353 (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 12, 2023
Sep 23, 2033U-2381: Treatment in combination with a GNRH agonist of non-metastatic, castration-resistant prostate cancer (NM-CRPC)
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 DLR* (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* DP* (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, 2033U-2237: Treatment of non-metastatic, castration-resistant prostate cancer (NM-CRPC)
U-2624: Treatment of metastatic castration-sensitive prostate cancer (MCSPC)
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

APALUTAMIDE (TABLET) (ORAL) ERLEADA
NDA Applicant: JANSSEN BIOTECH      NDA No.:
210951  Prod. No.: 002 RX (240MG)
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): 002: Feb 27, 2023
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): 002: Feb 27, 2023
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): 002: Feb 27, 2023
Mar 27, 2027 
Pat. No. 9987261 DP* (Family Id: 38656005) Substituted diazaspiroalkanes as androgen receptor modulators
Claim Types: Formulation
Pat. Sub. Date(s): 002: Feb 27, 2023
Mar 27, 2027 
Pat. No. RE49353 (Family Id: 49293921) Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer
Claim Types: Method of use
Pat. Sub. Date(s): 002: Feb 27, 2023
Sep 23, 2033U-2381: Treatment in combination with a GNRH agonist of non-metastatic, castration-resistant prostate cancer (NM-CRPC)
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): 002: Feb 27, 2023
Sep 23, 2033U-2237: Treatment of 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): 002: Feb 27, 2023
Sep 23, 2033U-3013: Treatment in combination with orchiectomy of non-metastatic, castration-resistant prostate cancer (NMCRPC)
Pat. No. 9481663 DS* DP* (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): 002: Feb 27, 2023
Jun 4, 2033U-2237: Treatment of non-metastatic, castration-resistant prostate cancer (NM-CRPC)
U-2624: Treatment of metastatic castration-sensitive prostate cancer (MCSPC)
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): 002: Feb 27, 2023
Apr 30, 2038U-3012: Treatment in combination with androgen deprivation therapy of non-metastatic, castration-resistant prostate cancer (NMCRPC) that improves metastasis free survival

APIXABAN (TABLET) (ORAL) ELIQUIS [GENERIC AB]
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]
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
NDA Applicant: SUMITOMO PHARMA AM      NDA No.:
210875  Prod. No.: 001 DISC (10MG); 002 DISC (15MG); 003 DISC (20MG); 004 DISC (25MG); 005 DISC (30MG)
14 Patents--6 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. 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. 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. 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

APREMILAST (TABLET) (ORAL) OTEZLA [GENERIC AB]
NDA Applicant: AMGEN INC      NDA No.:
205437  Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (30MG)
3 Patents--3 FamiliesExpirationPatented Use
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. 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 IndicationDec 20, 2024I-884: Revisions to the labeling to include data for subjects with mild to moderate plaque psoriasis, and to allow for an expansion of the indication
Exclusivity Code: M - MiscellaneousJul 20, 2026M-299: Clinical study information added to the label about the treatment of moderate to severe genital psoriasis
Exclusivity Code: ODE - Orphan drug exclusivityJul 19, 2026ODE-248: Treatment of adult patients with oral ulcers associated with Behcets disease

APREPITANT (CAPSULE) (ORAL) EMEND [GENERIC AB]
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
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
NDA Applicant: HERON THERAPS INC      NDA No.:
209296  Prod. No.: 001 RX (130MG/18ML (7.2MG/ML))
10 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 
Pat. No. 11744800 DP* (Family Id: 59385894) Methods of use of emulsion formulations of an NK-1 receptor antagonist
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 2, 2023
Sep 18, 2035 

APREPITANT (EMULSION) (INTRAVENOUS) APONVIE
NDA Applicant: HERON THERAPS INC      NDA No.:
216457  Prod. No.: 001 RX (32MG/4.4ML (7.2MG/ML))
11 Patents--2 FamiliesExpirationPatented Use
Pat. No. 11878074 (Family Id: ) Methods of use of emulsion formulations of an NK-1 receptor antagonist
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 6, 2024
Sep 18, 2035U-3787: A method for preventing post-operative nausea and vomiting
Pat. No. 9561229 DP* (Family Id: 54238618) Emulsion formulations of aprepitant
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 5, 2022
Sep 18, 2035U-3440: A method of administering aprepitant for prevention of post-operative nausea and vomiting
Pat. No. 9808465 (Family Id: 54238618) Emulsion formulations of aprepitant
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 5, 2022
Sep 18, 2035U-3440: A method of administering aprepitant for prevention of post-operative nausea and vomiting
Pat. No. 9974793 DP* (Family Id: 54238618) Emulsion formulations of aprepitant
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 5, 2022
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: Oct 5, 2022
Sep 18, 2035U-3440: A method of administering aprepitant for prevention of post-operative nausea and vomiting
Pat. No. 10500208 DP* (Family Id: 54238618) Emulsion formulations of aprepitant
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Oct 5, 2022
Sep 18, 2035 
Pat. No. 10953018 (Family Id: 54238618) Emulsion formulations of aprepitant
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 5, 2022
Sep 18, 2035U-3440: A method of administering aprepitant for prevention of post-operative nausea and vomiting
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: Oct 5, 2022
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: Oct 5, 2022
Sep 18, 2035U-3440: A method of administering aprepitant for prevention of post-operative nausea and vomiting
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: Oct 5, 2022
Sep 18, 2035 
Pat. No. 11744800 DP* (Family Id: 59385894) Methods of use of emulsion formulations of an NK-1 receptor antagonist
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 2, 2023
Sep 18, 2035U-3690: A method for preventing of post-operative nausea and vomiting

ARGATROBAN (INJECTABLE) (INTRAVENOUS) ARGATROBAN IN SODIUM CHLORIDE
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]
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)
3 Patents--3 FamiliesExpirationPatented Use
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. 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)

ARIPIPRAZOLE (SOLUTION) (ORAL) ABILIFY
NDA Applicant: OTSUKA      NDA No.:
021713  Prod. No.: 001 DISC (1MG/ML**)
1 Patent--1 FamilyExpirationPatented Use
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)

ARIPIPRAZOLE (TABLET, ORALLY DISINTEGRATING) (ORAL) ABILIFY
NDA Applicant: OTSUKA      NDA No.:
021729  Prod. No.: 002 DISC (10MG**); 003 DISC (15MG**)
3 Patents--3 FamiliesExpirationPatented Use
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. 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)

ARIPIPRAZOLE (TABLET, ORALLY DISINTEGRATING) (ORAL) ABILIFY
NDA Applicant: OTSUKA      NDA No.:
021729  Prod. No.: 004 DISC (20MG**); 005 DISC (30MG**)
1 Patent--1 FamilyExpirationPatented Use
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 

ARIPIPRAZOLE (INJECTABLE) (INTRAMUSCULAR) ABILIFY
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 

ARIPIPRAZOLE (FOR SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ABILIFY MAINTENA KIT
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)
11 Patents--5 FamiliesExpirationPatented Use
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. 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. 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. 11648347 DP* (Family Id: 45592780) Medical device containing a cake composition comprising aripiprazole as an active ingredient, and a cake composition comprising aripiprazole as an active ingredient
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jun 15, 2023
Apr 6, 2034 
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]
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)
28 Patents--16 FamiliesExpirationPatented Use
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. 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. 11476952 DP* (Family Id: 37215570) Pharma-informatics system
Claim Types: Device
Pat. Sub. Date(s): All strengths: Nov 9, 2022
Apr 28, 2026 
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. 11464423 DP* (Family Id: 39690523) In-body power source having high surface area electrode
Claim Types: Device
Pat. Sub. Date(s): All strengths: Nov 9, 2022
Sep 15, 2030 
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 (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ABILIFY ASIMTUFII
NDA Applicant: OTSUKA      NDA No.:
217006  Prod. No.: 001 RX (720MG/2.4ML (300MG/ML)); 002 RX (960MG/3.2ML (300MG/ML))
5 Patents--3 FamiliesExpirationPatented Use
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): All strengths: May 25, 2023
Jun 29, 2025 
Pat. No. 8338427 DP* (Family Id: 34116189) Methods for administering aripiprazole
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): All strengths: May 25, 2023
Mar 15, 2025U-1530: Use of aripiprazole in extended release injectable suspension
Pat. No. 10517951 DP* (Family Id: 48614096) Injectable preparation
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 25, 2023
Apr 23, 2033U-3245: Maintenance monotherapy treatment of bipolar I disorder
U-814: Treatment of schizophrenia
Pat. No. 11097007 DP* (Family Id: 48614096) Injectable preparation
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: May 25, 2023
Apr 23, 2033U-3245: Maintenance monotherapy treatment of bipolar I disorder
U-814: Treatment of schizophrenia
Pat. No. 11638757 DP* (Family Id: 48614096) Injectable preparation
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: May 25, 2023
Apr 23, 2033U-3245: Maintenance monotherapy treatment of bipolar I disorder
U-814: Treatment of schizophrenia

ARIPIPRAZOLE LAUROXIL (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARISTADA
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
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
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
NDA Applicant: ALKERMES INC      NDA No.:
209830  Prod. No.: 001 RX (675MG/2.4ML (281.25MG/ML))
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]
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]
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
NDA Applicant: SALIX      NDA No.:
209381  Prod. No.: 001 RX (7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM)
10 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. 11529368 DP* (Family Id: 45888431) Colonoscopy—preparation
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 11, 2023
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
NDA Applicant: HISAMITSU      NDA No.:
212268  Prod. No.: 001 RX (3.8MG/24HR); 002 RX (5.7MG/24HR); 003 RX (7.6MG/24HR)
6 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. 11813364 DP* (Family Id: 63709819) Patch
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 11, 2023
Sep 22, 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

ASENAPINE MALEATE (TABLET) (SUBLINGUAL) SAPHRIS [GENERIC AB]
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]
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
NDA Applicant: PLX PHARMA      NDA No.:
203697  Prod. No.: 001 OTC (325MG)
4 Patents--1 FamilyExpirationPatented Use
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
Pat. No. 10646431 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 5, 2023
Sep 29, 2032 
Pat. No. 10786444 (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 administration
Pat. Sub. Date(s): 001: Apr 5, 2023
Sep 29, 2032U-3559: A method of targeting release of a non-steroidal anti-inflammatory drug (NSAID) to the small intestine of the subject when administered orally

ASPIRIN (CAPSULE) (ORAL) VAZALORE
NDA Applicant: PLX PHARMA      NDA No.:
203697  Prod. No.: 002 OTC (81MG)
2 Patents--1 FamilyExpirationPatented Use
Pat. No. 10646431 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): 002: Apr 5, 2023
Sep 29, 2032 
Pat. No. 10786444 (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 administration
Pat. Sub. Date(s): 002: Apr 27, 2023
Sep 29, 2032U-3559: A method of targeting release of a non-steroidal anti-inflammatory drug (NSAID) to the small intestine of the subject when administered orally

ASPIRIN; OMEPRAZOLE (TABLET, DELAYED RELEASE) (ORAL) YOSPRALA
NDA Applicant: GENUS LIFESCIENCES      NDA No.:
205103  Prod. No.: 001 DISC (81MG;40MG); 002 DISC (325MG;40MG)
2 Patents--1 FamilyExpirationPatented Use
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
NDA Applicant: BRISTOL      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
NDA Applicant: ABBVIE      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-3534: Preventive treatment of 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-3534: Preventive treatment of 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: I - New IndicationApr 17, 2026I-909: Preventive treatment of migraine in adults
Exclusivity Code: NCE - New chemical entitySep 28, 2026 

ATORVASTATIN CALCIUM (SUSPENSION) (ORAL) ATORVALIQ
NDA Applicant: CMP DEV LLC      NDA No.:
213260  Prod. No.: 001 RX (20MG/5ML)
2 Patents--1 FamilyExpirationPatented Use
Pat. No. 11369567 DP* (Family Id: 59313282) Aqueous suspension suitable for oral administration
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 7, 2023
Jun 7, 2037 
Pat. No. 11654106 DP* (Family Id: 59313282) Aqueous suspension suitable for oral administration
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jun 1, 2023
Jun 7, 2037U-3612: As an adjunct to diet to reduce low-density lipoprotein cholesterol in adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia
U-3613: As an adjunct to other low-density lipoprotein cholesterol (LDL-C) lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia

AVACINCAPTAD PEGOL SODIUM (SOLUTION) (INTRAVITREAL) IZERVAY
NDA Applicant: ASTELLAS      NDA No.:
217225  Prod. No.: 001 RX (EQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML))
8 Patents--3 FamiliesExpirationPatented Use
Pat. No. 7538211 DS* (Family Id: 34891329) Aptamer therapeutics useful in the treatment of complement-related disorders
Claim Types: Compound
Pat. Sub. Date(s): 001: Aug 31, 2023
Feb 14, 2025 
Pat. No. 7579456 DS* (Family Id: 34891329) Aptamer therapeutics useful in the treatment of complement-related disorders
Claim Types: Composition
Pat. Sub. Date(s): 001: Aug 31, 2023
Feb 14, 2025 
Pat. No. 7803931 DS* (Family Id: 36916987) Aptamer therapeutics useful in the treatment of complement-related disorders
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Aug 31, 2023
Feb 14, 2025 
Pat. No. 8236773 (Family Id: 36916987) Aptamer therapeutics useful in the treatment of complement-related disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 31, 2023
Nov 11, 2026U-3673: Treatment of geographic atrophy secondary to age-related macular degeneration by administerting avacincaptad pegol to the eye
Pat. No. 9617546 DS* (Family Id: 36916987) Aptamer therapeutics useful in the treatment of complement-related disorders
Claim Types: Compound; Method of use
Pat. Sub. Date(s): 001: Aug 31, 2023
Feb 14, 2025U-3673: Treatment of geographic atrophy secondary to age-related macular degeneration by administerting avacincaptad pegol to the eye
Pat. No. 10947544 DS* (Family Id: 36916987) Aptamer therapeutics useful in the treatment of complement-related disorders
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Aug 31, 2023
Feb 14, 2025U-3673: Treatment of geographic atrophy secondary to age-related macular degeneration by administerting avacincaptad pegol to the eye
Pat. No. 11273171 (Family Id: 52277261) Methods for treating or preventing ophthalmological conditions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 31, 2023
Jul 11, 2034U-3673: Treatment of geographic atrophy secondary to age-related macular degeneration by administerting avacincaptad pegol to the eye
Pat. No. 11491176 (Family Id: 52277261) Methods for treating or preventing ophthalmological conditions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 31, 2023
Jul 11, 2034U-3673: Treatment of geographic atrophy secondary to age-related macular degeneration by administerting avacincaptad pegol to the eye

AVACOPAN (CAPSULE) (ORAL) TAVNEOS
NDA Applicant: CHEMOCENTRYX      NDA No.:
214487  Prod. No.: 001 RX (10MG)
3 Patents--2 FamiliesExpirationPatented 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 
Pat. No. 11603356 DS* DP* (Family Id: 75846408) Amorphous form of a complement component C5a receptor
Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use
Pat. Sub. Date(s): 001: Apr 14, 2023
May 29, 2041U-3558: An adjunctive treatment of adult patients with TAVNEOS (avacopan) with severe active ANCA-associated vasculitis (GPA and MPA) in combination with standard therapy including glucocorticoids
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
NDA Applicant: METUCHEN PHARMS      NDA No.:
202276  Prod. No.: 001 RX (50MG); 002 RX (100MG); 003 RX (200MG)
1 Patent--1 FamilyExpirationPatented 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
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousOct 18, 2025M-282: Revisions to the labeling to add the results of a clinical study (TA-303) in patients with ED following bilateral nerve-sparing radical prostatectomy

AVAPRITINIB (TABLET) (ORAL) AYVAKIT
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
Exclusivity Code: ODE - Orphan drug exclusivityMay 22, 2030ODE-434: Treatment of adult patients with indolent systemic mastocytosis (ISM)

AVAPRITINIB (TABLET) (ORAL) AYVAKIT
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
Exclusivity Code: ODE - Orphan drug exclusivityMay 22, 2030ODE-434: Treatment of adult patients with indolent systemic mastocytosis (ISM)

AVAPRITINIB (TABLET) (ORAL) AYVAKIT
NDA Applicant: BLUEPRINT MEDICINES      NDA No.:
212608  Prod. No.: 004 RX (25MG)
4 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): 004: 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)
U-3506: Treatment of indolent systemic mastocytosis (ISM)
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): 004: 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)
U-3506: Treatment of indolent systemic mastocytosis (ISM)
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): 004: 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)
U-3506: Treatment of indolent systemic mastocytosis (ISM)
Pat. No. 11827642 DS* DP* (Family Id: 51904226) Compositions useful for treating disorders related to KIT
Claim Types: Method of use
Pat. Sub. Date(s): 004: Dec 21, 2023
Oct 15, 2034U-3506: Treatment of indolent systemic mastocytosis (ISM)
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: I - New IndicationMay 22, 2026I-912: Treatment of adult patients with indolent systemic mastocytosis (ISM)
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
Exclusivity Code: ODE - Orphan drug exclusivityMay 22, 2030ODE-434: Treatment of adult patients with indolent systemic mastocytosis (ISM)

AVAPRITINIB (TABLET) (ORAL) AYVAKIT
NDA Applicant: BLUEPRINT MEDICINES      NDA No.:
212608  Prod. No.: 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): 005: 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): 005: 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): 005: 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
Exclusivity Code: ODE - Orphan drug exclusivityMay 22, 2030ODE-434: Treatment of adult patients with indolent systemic mastocytosis (ISM)

AVATROMBOPAG MALEATE (TABLET) (ORAL) DOPTELET
NDA Applicant: AKARX INC      NDA No.:
210238  Prod. No.: 001 RX (EQ 20MG BASE)
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 7638536 DS* DP* [Extended 1655 days (4.5 years)]
(Family Id: 27615666) 2-Acylaminothiazole derivative or salt thereof
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jun 15, 2018
Jul 28, 2027 
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityJun 26, 2026ODE-246: Treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment

AVIBACTAM SODIUM; CEFTAZIDIME (POWDER) (INTRAVENOUS) AVYCAZ
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 pneumonia (HABP/VABP) patients comprising administering a bactericidally effective amount of avibactam sodium
U-2508: A method of treating bacterial infections in complicated intra-abdominal infection and complicated urinary tract infection, including pyelonephritis, patients comprising administering a bactericidally effective amount of avibactam sodium
U-282: Method of treating bacterial infections
U-3818: Treatment of complicated intra-abdominal infections, complicated urinary tract infections, and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia in adult and pediatric patients (at least 31 weeks gestational age)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityFeb 25, 2025 GAIN 
Exclusivity Code: NPP - New patient populationDec 20, 2025 

AXITINIB (TABLET) (ORAL) INLYTA
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]
NDA Applicant: BRISTOL-MYERS      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)
Exclusivity Code: ODE - Orphan drug exclusivityMay 20, 2029ODE-399: Treatment of pediatric patients aged one month and older with newly diagnosed juvenile myelomonocytic leukemia (JMML)

AZACITIDINE (TABLET) (ORAL) ONUREG
NDA Applicant: BRISTOL      NDA No.:
214120  Prod. No.: 001 RX (200MG); 002 RX (300MG)
2 Patents--2 FamiliesExpirationPatented 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
Pat. No. 11571436 DP* (Family Id: Oral formulations of cytidine analogs and methods of use thereof) Oral formulations of cytidine analogs and methods of use thereof
Claim Types: Composition
Pat. Sub. Date(s): All strengths: Feb 10, 2023
May 14, 2029 
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
NDA Applicant: LEO PHARMA AS      NDA No.:
207071  Prod. No.: 001 RX (15%)
5 Patents--4 FamiliesExpirationPatented Use
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. 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
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
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
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]
NDA Applicant: MYLAN SPECIALITY LP      NDA No.:
202236  Prod. No.: 001 RX (0.137MG/SPRAY;0.05MG/SPRAY)
2 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 

AZILSARTAN KAMEDOXOMIL (TABLET) (ORAL) EDARBI
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
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
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
DLR* NDA holder has requested delisting of the patent. However, FDA will not delist if doing so would adversely affect an ANDA applicant's eligibility for 180-day generic exclusivity. ANDA applicants must provide a patent certification for the patent, but 505(b)(2) applicants do not need to do so.
Last edited: 12 March 2024
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