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.
| 2 Patents--2 Families | Expiration | Patented 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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Dec 15, 2026 PED | M-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 Families | Expiration | Patented 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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Dec 15, 2026 PED |
ABALOPARATIDE (SOLUTION) (SUBCUTANEOUS) TYMLOS
NDA Applicant: RADIUS NDA No.: 208743 Prod. No.: 001 RX (3.12MG/1.56ML (2MG/ML))
| 9 Patents--5 Families | Expiration | Patented 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 (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, 2031 | U-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, 2027 | U-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, 2040 | U-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, 2040 | U-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, 2038 | U-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. 11977067 DP* (Family Id: 69523931) Abaloparatide formulations and methods of testing, storing, modifying, and using same Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 001: May 16, 2024 | Apr 30, 2038 | |
| 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, 2031 | U-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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Dec 19, 2025 | I-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 - Miscellaneous | Sep 20, 2024 | M-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 Families | Expiration | Patented 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, 2026 | U-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, 2024 | U-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, 2024 | U-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, 2034 | U-2863: Topical treatment of head lice infestation in patients 6 months of age and older |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jul 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 Family | Expiration | Patented 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 | Sep 28, 2031 | 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-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-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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Oct 12, 2024 | I-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 population | Oct 12, 2024 |
ABEMACICLIB (TABLET) (ORAL) VERZENIO
NDA Applicant: ELI LILLY AND CO NDA No.: 208716 Prod. No.: 004 RX (200MG)
| 1 Patent--1 Family | Expiration | Patented 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 | Sep 28, 2031 | U-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-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-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-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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Oct 12, 2024 | I-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 population | Oct 12, 2024 |
ABIRATERONE ACETATE (TABLET) (ORAL) YONSA
NDA Applicant: SUN PHARM NDA No.: 210308 Prod. No.: 001 RX (125MG)
| 2 Patents--2 Families | Expiration | Patented 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, 2034 | U-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)
| 11 Patents--6 Families | Expiration | Patented 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, 2031 | U-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, 2027 | U-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, 2027 | U-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* (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, 2037 | U-2830: A method for treating metastatic castration-resistant prostate cancer (MCRPC), wherein the cancer is associated with a deleterious BRCA-mutation |
| Pat. No. 11986468 (Family Id: 59649991) Methods of treating prostate cancer Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 2, 2024 | Jul 28, 2037 | U-2830: A method for treating metastatic castration-resistant prostate cancer (MCRPC), wherein the cancer is associated with a deleterious BRCA-mutation |
| Pat. No. 11986469 (Family Id: 59649991) Methods of treating prostate cancer Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 2, 2024 | Jul 28, 2037 | U-2830: A method for treating metastatic castration-resistant prostate cancer (MCRPC), wherein the cancer is associated with a deleterious BRCA-mutation |
| Pat. No. 11992486 (Family Id: 59649991) Methods of treating prostate cancer Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 2, 2024 | Jul 28, 2037 | U-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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Aug 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 Family | Expiration | Patented 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, 2034 | U-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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jan 14, 2027 | |
| Exclusivity Code: NPP - New patient population | Feb 9, 2026 |
ACALABRUTINIB (CAPSULE) (ORAL) CALQUENCE
NDA Applicant: ASTRAZENECA NDA No.: 210259 Prod. No.: 001 RX (100MG)
| 8 Patents--4 Families | Expiration | Patented 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, 2032 | U-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, 2032 | U-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, 2036 | U-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, 2036 | U-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, 2035 | U-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, 2035 | U-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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 31, 2024 | ODE-175: Treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 21, 2026 | ODE-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 Families | Expiration | Patented 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, 2032 | U-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, 2032 | U-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, 2036 | U-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, 2035 | U-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, 2035 | U-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
NDA Applicant: MALLINCKRODT HOSP NDA No.: 022450 Prod. No.: 001 DISC (1GM/100ML (10MG/ML)**)
| 4 Patents--1 Family | Expiration | Patented 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 *PED | U-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 *PED | U-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 *PED | U-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, 2028 | U-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 Family | Expiration | Patented 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 Family | Expiration | Patented 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, 2030 | U-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 Family | Expiration | Patented 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, 2030 | U-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 US NDA No.: 209471 Prod. No.: 001 RX (325MG;97.5MG)
| 3 Patents--2 Families | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10532036 (Family Id: 35783254) Combination composition Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 29, 2023 | Sep 22, 2025 | U-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, 2039 | U-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, 2039 | U-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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Mar 1, 2026 |
ACETAMINOPHEN; IBUPROFEN (TABLET) (ORAL) ADVIL DUAL ACTION WITH ACETAMINOPHEN [GENERIC OTC]
NDA Applicant: HALEON US HOLDINGS NDA No.: 211733 Prod. No.: 001 OTC (250MG;125MG)
| 1 Patent--1 Family | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11918693 DP* (Family Id: 73543315) Ibuprofen and acetaminophen tablet Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: Mar 26, 2024 | Jul 9, 2041 |
ACETAMINOPHEN; IBUPROFEN (TABLET) (ORAL) ACETAMINOPHEN AND IBUPROFEN [GENERIC OTC]
NDA Applicant: GLENMARK PHARMS LTD NDA No.: 218311 Prod. No.: 001 OTC (250MG;125MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: PC - Patent challenge | Nov 3, 2024 |
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))
| 5 Patents--2 Families | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11446266 (Family Id: 46024668) Combination composition Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 16, 2023 | Oct 26, 2031 | U-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. 11896567 (Family Id: 46024668) Combination composition Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 12, 2024 | Oct 26, 2031 | U-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 | |
| Pat. No. 12083087 (Family Id: 51211244) Aqueous formulation comprising paracetamol and ibuprofen Claim Types: Method of use; Formulation Pat. Sub. Date(s): 001: Oct 8, 2024 | Jul 17, 2035 | U-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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Oct 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 Families | Expiration | Patented 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, 2027 | U-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, 2029 | U-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, 2029 | U-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, 2029 | U-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, 2032 | U-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, 2032 | U-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 Families | Expiration | Patented 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, 2025 | U-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, 2025 | U-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, 2032 | U-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, 2031 | U-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 Family | Expiration | Patented 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, 2032 | U-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, 2032 | U-1373: Method of treating acetaminophen overdose with acetylcysteine solutions |
ACETYLCYSTEINE LYSINE (FOR SOLUTION) (ORAL) LEGUBETI
NDA Applicant: GALEPHAR NDA No.: 215040 Prod. No.: 001 DISC (EQ 500MG BASE/PACKET); 002 DISC (EQ 2.5GM BASE/PACKET)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NP - New product | Feb 13, 2027 |
ACLIDINIUM BROMIDE (POWDER, METERED) (INHALATION) TUDORZA PRESSAIR
NDA Applicant: COVIS NDA No.: 202450 Prod. No.: 001 RX (0.4MG/INH)
| 4 Patents--3 Families | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE46417 DS* DP* (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, 2025 | U-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, 2029 | U-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, 2029 | U-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 Families | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE46417 DS* DP* (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, 2025 | U-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, 2029 | U-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, 2029 | U-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%**)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity | Mar 29, 2026 | ODE-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 Families | Expiration | Patented 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, 2027 | U-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, 2027 | U-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, 2030 | U-1460: Treatment of herpes labialis |
ACYCLOVIR (CREAM) (TOPICAL) ACYCLOVIR [GENERIC AB]
NDA Applicant: ALEMBIC NDA No.: 212361 Prod. No.: 001 RX (5%)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Jun 12, 2024 |
ADAGRASIB (TABLET) (ORAL) KRAZATI
NDA Applicant: BRISTOL NDA No.: 216340 Prod. No.: 001 RX (200MG)
| 1 Patent--1 Family | Expiration | Patented 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, 2037 | U-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 U-3953: Treatment, in combination with cetuximab, of adult patients with KRAS G12C-muted locally advanced or metastatic colorectal cancer, per FDA approved test, where prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Dec 12, 2027 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 12, 2029 | ODE-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 Family | Expiration | Patented 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, 2025 | U-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 DISC (0.1%)
| 3 Patents--1 Family | Expiration | Patented 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, 2028 | U-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, 2026 | U-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, 2026 | U-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 Families | Expiration | Patented 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, 2024 | U-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, 2027 | U-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, 2027 | U-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, 2027 | U-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%)
| 8 Patents--2 Families | Expiration | Patented Use |
|---|---|---|
| Pat. No. 12138278 DP* (Family Id: ) Topical compositions Claim Types: Formulation; Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Dec 6, 2024 | Jul 31, 2040 | |
| 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, 2029 | U-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, 2029 | U-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, 2029 | U-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, 2029 | U-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, 2040 | U-3713: Topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older |
| Pat. No. 12128059 DP* (Family Id: 71899773) Topical compositions Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: Nov 8, 2024 | Jul 31, 2040 | U-3713: Topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older |
| Pat. No. 12133859 DP* (Family Id: 71899773) Topical compositions Claim Types: Formulation; Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Nov 22, 2024 | Jul 31, 2040 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Oct 20, 2026 |
AFAMELANOTIDE (IMPLANT) (SUBCUTANEOUS) SCENESSE
NDA Applicant: CLIVUNEL INC NDA No.: 210797 Prod. No.: 001 RX (16MG)
| 2 Patents--2 Families | Expiration | Patented 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, 2025 | U-2638: Increase pain-free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP) |
| Pat. No. 8334265 (Family Id: 39135428) Method of treatment of photodermatoses Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 6, 2019 | Mar 11, 2029 | U-2638: Increase pain-free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Oct 8, 2024 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 8, 2026 | ODE-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 Families | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE43431 DS* (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 *PED | U-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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Oct 7, 2025 PED | M-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 exclusivity | Jul 12, 2025 PED | ODE-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 Family | Expiration | Patented 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, 2030 | U-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, 2035 | U-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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Nov 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 Families | Expiration | Patented 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 Families | Expiration | Patented 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 DISC (EQ 0.09MG BASE/INH)
| 21 Patents--8 Families | Expiration | Patented 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 Family | Expiration | Patented 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, 2030 | U-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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Jan 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 Families | Expiration | Patented 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 Family | Expiration | Patented 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, 2027 | U-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, 2027 | U-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.: 002 RX (99% (5ML)) NDA No.: 207987 Prod. No.: 001 DISC (99% (1ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 21, 2025 | ODE-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 Families | Expiration | Patented 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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Apr 18, 2027 | I-947: For adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors >/= 4 cm or node positive), as detected by an FDA-approved test |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 6, 2024 | ODE-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 |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 18, 2031 | ODE-477: Adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors greater than or equal to 4 cm or node positive), as detected by an FDA-approved test |
ALENDRONATE SODIUM (TABLET, EFFERVESCENT) (ORAL) BINOSTO
NDA Applicant: RADIUS NDA No.: 202344 Prod. No.: 001 RX (EQ 70MG BASE)
| 1 Patent--1 Family | Expiration | Patented 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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Nov 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 Family | Expiration | Patented 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 Family | Expiration | Patented 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 Family | Expiration | Patented 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 Family | Expiration | Patented 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 Families | Expiration | Patented 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, 2029 | U-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, 2028 | U-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* (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, 2029 | U-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, 2029 | U-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, 2028 | U-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, 2031 | U-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, 2031 | U-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 Families | Expiration | Patented 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, 2028 | U-1337: Method of treating diabetes comprising administering alogliptin |
| Pat. No. 8173663 (Family Id: 34930979) Dipeptidyl peptidase inhibitors Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 19, 2017 | Dec 2, 2025 | U-1338: Method of treating diabetes comprising administering a compound such as alogliptin |
| Pat. No. 8288539 DS* (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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Jul 27, 2026 | M-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 Families | Expiration | Patented 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, 2028 | U-1337: Method of treating diabetes comprising administering alogliptin |
| Pat. No. 8173663 (Family Id: 34930979) Dipeptidyl peptidase inhibitors Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Mar 15, 2025 | U-1338: Method of treating diabetes comprising administering a compound such as alogliptin |
| Pat. No. 8288539 DS* (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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Jul 27, 2026 | M-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 Families | Expiration | Patented 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, 2028 | U-1337: Method of treating diabetes comprising administering alogliptin |
| Pat. No. 8173663 (Family Id: 34930979) Dipeptidyl peptidase inhibitors Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Mar 15, 2025 | U-1338: Method of treating diabetes comprising administering a compound such as alogliptin |
| Pat. No. 8288539 DS* (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 Family | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8227462 DS* DP* (Family Id: 40350060) Pyrrolidine-1,2-dicarboxamide derivatives Claim Types: Compound; Method of use; Composition; Formulation Pat. Sub. Date(s): All strengths: Jun 17, 2019 | Apr 29, 2033 | U-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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jan 18, 2027 | I-937: Expansion of the indication to include pre and perimenopausal women |
| Exclusivity Code: NCE - New chemical entity | May 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 Family | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8227462 DS* DP* (Family Id: 40350060) Pyrrolidine-1,2-dicarboxamide derivatives Claim Types: Compound; Method of use; Composition; Formulation Pat. Sub. Date(s): All strengths: May 3, 2022 | 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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | May 24, 2024 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 5, 2029 | ODE-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 |
ALPELISIB (GRANULES) (ORAL) VIJOICE
NDA Applicant: NOVARTIS NDA No.: 218466 Prod. No.: 001 RX (50MG/PACKET)
| 2 Patents--1 Family | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8227462 DS* DP* (Family Id: 40350060) Pyrrolidine-1,2-dicarboxamide derivatives Claim Types: Compound; Method of use; Composition; Formulation Pat. Sub. Date(s): 001: May 15, 2024 | 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): 001: May 15, 2024 | Sep 10, 2029 |
ALVIMOPAN (CAPSULE) (ORAL) ENTEREG
NDA Applicant: CUBIST PHARMS NDA No.: 021775 Prod. No.: 001 DISC (12MG**)
| 1 Patent--1 Family | Expiration | Patented 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, 2030 | U-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 [GENERIC AB]
NDA Applicant: SUPERNUS PHARMS NDA No.: 208944 Prod. No.: 001 RX (EQ 68.5MG BASE); 002 RX (EQ 137MG BASE)
| 19 Patents--4 Families | Expiration | Patented 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, 2028 | U-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, 2025 | U-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, 2025 | U-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, 2025 | U-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, 2025 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | 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 |
| 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, 2030 | U-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, 2034 | U-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, 2034 | U-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. 11903908 (Family Id: 52105179) Methods of administering amantadine Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 8, 2024 | Jun 17, 2034 | U-3822: As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's Disease experiencing 'off' episodes |
| 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, 2038 | U-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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Aug 24, 2024 | ODE-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: SUPERNUS PHARMS NDA No.: 209410 Prod. No.: 001 DISC (EQ 129MG BASE); 002 DISC (EQ 193MG BASE)
| 19 Patents--5 Families | Expiration | Patented 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, 2028 | U-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, 2025 | U-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, 2025 | U-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, 2025 | U-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, 2025 | U-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, 2025 | U-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, 2025 | U-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, 2038 | U-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, 2038 | U-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, 2038 | U-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, 2038 | U-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, 2038 | U-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, 2038 | U-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, 2038 | U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients |
AMANTADINE HYDROCHLORIDE (TABLET, EXTENDED RELEASE) (ORAL) OSMOLEX ER
NDA Applicant: SUPERNUS PHARMS NDA No.: 209410 Prod. No.: 003 DISC (EQ 258MG BASE); 004 DISC (EQ 161MG BASE)
| 18 Patents--5 Families | Expiration | Patented 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, 2028 | U-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, 2025 | U-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, 2025 | U-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, 2025 | U-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, 2025 | U-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, 2025 | U-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, 2025 | U-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, 2038 | U-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, 2038 | U-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, 2038 | U-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, 2038 | U-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, 2038 | U-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, 2038 | U-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 Families | Expiration | Patented 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, 2027 | U-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, 2027 | U-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, 2031 | U-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 Families | Expiration | Patented 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, 2034 | U-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, 2032 | U-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, 2032 | U-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, 2032 | U-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, 2032 | U-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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Nov 28, 2023 | |
| Exclusivity Code: NPP - New patient population | Sep 29, 2025 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 28, 2025 | ODE-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)
| 13 Patents--4 Families | Expiration | Patented 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, 2025 | U-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, 2024 | U-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, 2024 | U-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, 2026 | U-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, 2026 | U-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, 2034 | U-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, 2035 | U-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, 2035 | U-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, 2035 | U-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, 2035 | U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen |
| Pat. No. 12016873 (Family Id: 54480776) Methods for treating pulmonary non-tuberculous mycobacterial infections Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 22, 2024 | May 15, 2035 | U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Sep 28, 2030 GAIN | ODE-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: SUN PHARM INDS INC NDA No.: 020965 Prod. No.: 001 RX (20%)
| 5 Patents--1 Family | Expiration | Patented 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, 2038 | U-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, 2038 | U-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, 2038 | U-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, 2038 | U-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, 2038 | U-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 Families | Expiration | Patented 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, 2040 | U-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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: D - New Dosing Schedule | Oct 4, 2027 | D-194: Increase in the approved dosage regimen to a maximum application area of 60 cm^2 in total (corresponding to three 2 gm tubes) |
AMINOLEVULINIC ACID HYDROCHLORIDE (FOR SOLUTION) (ORAL) GLEOLAN
NDA Applicant: NXDC NDA No.: 208630 Prod. No.: 001 RX (1.5GM/VIAL)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 6, 2024 | ODE-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 Family | Expiration | Patented 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 Families | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9084765 (Family Id: 42136792) Use of amisulpride as an anti-emetic Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 16, 2020; 002: Feb 9, 2022 | Feb 26, 2034 | U-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, 2031 | U-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, 2031 | U-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, 2038 | U-2754: Treatment of post-operative nausea and vomiting |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Feb 26, 2025 |
AMLODIPINE BENZOATE (SUSPENSION) (ORAL) KATERZIA
NDA Applicant: AZURITY NDA No.: 211340 Prod. No.: 001 RX (EQ 1MG BASE/ML)
| 11 Patents--3 Families | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11471409 (Family Id: ) Amlodipine formulations Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 18, 2022 | Oct 6, 2037 | U-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, 2037 | U-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, 2037 | U-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. 12053461 DP* (Family Id: 61829917) Amlodipine formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 15, 2024 | 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 | |
| Pat. No. 11918685 (Family Id: 68161047) Amlodipine formulations Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 14, 2024 | Oct 6, 2037 | U-3447: A method of treating coronary artery disease U-3448: A method of treating hypertension |
AMLODIPINE BESYLATE (SOLUTION) (ORAL) NORLIQVA
NDA Applicant: CMP DEV LLC NDA No.: 214439 Prod. No.: 001 RX (EQ 1MG BASE/ML)
| 4 Patents--3 Families | Expiration | Patented 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, 2041 | U-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, 2041 | U-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, 2041 | U-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. 12005141 DP* (Family Id: 80322116) Pharmaceutical solution of amlodipine Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jun 28, 2024 | Feb 24, 2041 | U-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 |
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 Families | Expiration | Patented 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, 2030 | U-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, 2029 | U-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, 2038 | U-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 DISC (EQ 2.5MG BASE;3.5MG ); 002 DISC (EQ 5MG BASE;7MG); 003 DISC (EQ 10MG BASE;14MG)
| 1 Patent--1 Family | Expiration | Patented 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, 2029 | U-3: Treatment of hypertension |
AMOXICILLIN (TABLET, EXTENDED RELEASE) (ORAL) MOXATAG
NDA Applicant: PRAGMA NDA No.: 050813 Prod. No.: 001 DISC (775MG)
| 3 Patents--3 Families | Expiration | Patented 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, 2027 | U-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, 2026 | U-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 Families | Expiration | Patented 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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | May 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)
| 7 Patents--2 Families | Expiration | Patented 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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-2660: Treatment of H. pylori infection in adults |
| Pat. No. 11931463 DP* (Family Id: 51297592) All-in-one fixed-dose combination for treating Helicobacter pylori infection Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 4, 2024 | Feb 12, 2034 | U-3866: Treatment of helicobacter pylori infection in adults using specified dosage form |
| 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, 2042 | U-3816: Treatment of helicobacter pylori infection using the administered dosage forms in adults with different body mass index determinations |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Nov 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 Families | Expiration | Patented 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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | May 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 Family | Expiration | Patented 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)
| 5 Patents--2 Families | Expiration | Patented 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 | |
| Pat. No. 9839619 DP* (Family Id: 47424553) Method for treating ADD or ADHD comprising administering amphetamine complexed with ion-exchange resin particles Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 22, 2024 | 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 Family | Expiration | Patented 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, 2026 | U-2025: Treatment of attention deficit hyperactivity disorder |
AMPHETAMINE SULFATE (TABLET, ORALLY DISINTEGRATING) (ORAL) EVEKEO ODT
NDA Applicant: AZURITY NDA No.: 209905 Prod. No.: 001 DISC (5MG); 002 DISC (10MG); 003 DISC (15MG); 004 DISC (20MG)
| 4 Patents--2 Families | Expiration | Patented 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, 2037 | U-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 Families | Expiration | Patented 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 Families | Expiration | Patented 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, 2036 | U-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 Families | Expiration | Patented 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, 2038 | U-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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Jun 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 Families | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9572856 (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, 2031 | U-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, 2029 | U-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, 2029 | U-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, 2029 | U-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, 2029 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2037 | U-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 Families | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9572856 (Family Id: 44143626) Method of treating low blood pressure Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 22, 2018 | Nov 20, 2030 | U-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, 2029 | U-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, 2029 | U-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, 2029 | U-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, 2029 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2037 | U-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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NPP - New patient population | Sep 22, 2023 |
APALUTAMIDE (TABLET) (ORAL) ERLEADA
NDA Applicant: JANSSEN BIOTECH NDA No.: 210951 Prod. No.: 001 RX (60MG)
| 11 Patents--5 Families | Expiration | Patented 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, 2030 | U-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, 2027 | U-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, 2033 | U-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, 2033 | U-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, 2033 | U-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, 2033 | U-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, 2033 | U-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, 2038 | U-3012: Treatment in combination with androgen deprivation therapy of non-metastatic, castration-resistant prostate cancer (NMCRPC) that improves metastasis free survival |
| Pat. No. 11963952 (Family Id: 69630665) Anti-androgens for the treatment of metastatic castration-sensitive prostate cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 26, 2024 | Jan 30, 2040 | U-3901: Treatment of metastatic castration sensitive prostate cancer |
APALUTAMIDE (TABLET) (ORAL) ERLEADA
NDA Applicant: JANSSEN BIOTECH NDA No.: 210951 Prod. No.: 002 RX (240MG)
| 10 Patents--5 Families | Expiration | Patented 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, 2030 | U-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, 2027 | U-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, 2033 | U-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, 2033 | U-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, 2033 | U-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, 2033 | U-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, 2038 | U-3012: Treatment in combination with androgen deprivation therapy of non-metastatic, castration-resistant prostate cancer (NMCRPC) that improves metastasis free survival |
| Pat. No. 11963952 (Family Id: 69630665) Anti-androgens for the treatment of metastatic castration-sensitive prostate cancer Claim Types: Method of use Pat. Sub. Date(s): 002: Apr 26, 2024 | Jan 30, 2040 | U-3901: Treatment of metastatic castration sensitive prostate cancer |
APIXABAN (TABLET) (ORAL) ELIQUIS [GENERIC AB]
NDA Applicant: BRISTOL MYERS SQUIBB NDA No.: 202155 Prod. No.: 001 RX (2.5MG)
| 2 Patents--2 Families | Expiration | Patented 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* (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, 2026 | U-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 Families | Expiration | Patented 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* (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, 2026 | 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 |
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 Families | Expiration | Patented 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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2031 | U-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, 2031 | U-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, 2030 | U-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, 2031 | U-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, 2036 | U-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, 2036 | U-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 Families | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7427638 DS* DP* (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 | Aug 16, 2028 *PED | |
| 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 | Nov 29, 2034 *PED | U-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 | Nov 29, 2034 *PED | U-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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Dec 20, 2024 | I-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 - Miscellaneous | Jan 20, 2027 PED | M-299: Clinical study information added to the label about the treatment of moderate to severe genital psoriasis |
| Exclusivity Code: NPP - New patient population | Oct 25, 2027 PED | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jan 19, 2027 PED | ODE-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 Family | Expiration | Patented 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, 2027 | U-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 Family | Expiration | Patented 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, 2027 | U-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))
| 12 Patents--2 Families | Expiration | Patented 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, 2035 | U-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, 2035 | U-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, 2035 | U-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, 2035 | U-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, 2035 | U-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 | |
| Pat. No. 12115254 DP* (Family Id: 59385894) Methods of use of emulsion formulations of an NK-1 receptor antagonist Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 7, 2024 | Sep 18, 2035 | |
| Pat. No. 12115255 DP* (Family Id: 59385894) Methods of use of emulsion formulations of an NK-1 receptor antagonist Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 7, 2024 | 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))
| 13 Patents--2 Families | Expiration | Patented 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, 2035 | U-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, 2035 | U-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, 2035 | U-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, 2035 | U-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, 2035 | U-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, 2035 | U-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, 2035 | U-3690: A method for preventing of post-operative nausea and vomiting |
| Pat. No. 12115254 DP* (Family Id: 59385894) Methods of use of emulsion formulations of an NK-1 receptor antagonist Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 7, 2024 | Sep 18, 2035 | |
| Pat. No. 12115255 DP* (Family Id: 59385894) Methods of use of emulsion formulations of an NK-1 receptor antagonist Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 7, 2024 | Sep 18, 2035 |
APROCITENTAN (TABLET) (ORAL) TRYVIO
NDA Applicant: IDORSIA NDA No.: 217686 Prod. No.: 001 RX (12.5MG)
| 5 Patents--2 Families | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8324232 DS* DP* (Family Id: 40140023) 4-pyrimidinesulfamide derivative Claim Types: Compound; Composition; Method of use; Process Pat. Sub. Date(s): 001: Apr 16, 2024 | Sep 21, 2029 | U-3878: Treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs |
| Pat. No. 10919881 DS* DP* (Family Id: 60268369) Crystalline forms of a 4-pyrimidinesulfamide derivative aprocitentan Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Apr 16, 2024 | Feb 26, 2038 | |
| Pat. No. 11174247 (Family Id: 60268369) Combinations of a 4-pyrimidinesulfamide derivative with active ingredients for the treatment of endothelin related diseases Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Apr 16, 2024 | Nov 6, 2037 | U-3879: Treatment of hypertension in combination with other antihypertensive drugs, including an angiotensin receptor blocker, to lower blood pressure in adult patients who are not adequately controlled on other drugs |
| Pat. No. 11680058 (Family Id: 60268369) Crystalline forms of a 4-pyrimidinesulfamide derivative aprocitentan Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 16, 2024 | Jul 26, 2038 | U-3878: Treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs |
| Pat. No. 11787782 (Family Id: 60268369) Combinations of a 4-pyrimidinesulfamide derivative with active ingredients for the treatment of endothelin related diseases Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Apr 16, 2024 | Mar 2, 2038 | U-3877: Treatment of hypertension in combination with other antihypertensive drugs, including an angiotensin converting enzyme inhibitor, to lower blood pressure in adult patients who are not adequately controlled on other drugs |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Mar 22, 2029 |
ARGATROBAN (INJECTABLE) (INTRAVENOUS) ARGATROBAN IN SODIUM CHLORIDE
NDA Applicant: CIPLA NDA No.: 022434 Prod. No.: 001 DISC (50MG/50ML (1MG/ML)**)
| 2 Patents--2 Families | Expiration | Patented 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, 2027 | U-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, 2027 | U-1164: Method of treating an argatroban treatable condition |
ARIMOCLOMOL CITRATE (CAPSULE) (ORAL) MIPLYFFA
NDA Applicant: ZEVRA DENMARK NDA No.: 214927 Prod. No.: 001 RX (EQ 47MG BASE); 002 RX (EQ 62MG BASE); 003 RX (EQ 93MG BASE); 004 RX (EQ 124MG BASE)
| 3 Patents--1 Family | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9289472 (Family Id: 41124251) Use of HSP70 as a regulator of enzymatic activity Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 21, 2024 | Aug 11, 2029 | U-4021: Use of arimoclomol, in combination with miglustat, for treatment of neurological manifestations of Niemann-Pick disease type C (NPC) |
| Pat. No. 9884058 (Family Id: 41124251) Use of Hsp70 as a regulator of enzymatic activity Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 21, 2024 | Jun 26, 2029 | U-4021: Use of arimoclomol, in combination with miglustat, for treatment of neurological manifestations of Niemann-Pick disease type C (NPC) |
| Pat. No. 11045460 (Family Id: 41124251) Use of Hsp70 as a regulator of enzymatic activity Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 21, 2024 | Aug 19, 2029 | U-4021: Use of arimoclomol, in combination with miglustat, for treatment of neurological manifestations of Niemann-Pick disease type C (NPC) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Sep 20, 2029 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Sep 20, 2031 | ODE-496: Treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adult and pediatric patients 2 years of age and older |
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 Families | Expiration | Patented 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, 2026 | U-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, 2027 | U-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 Family | Expiration | Patented 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, 2027 | U-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 Families | Expiration | Patented 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, 2026 | U-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, 2027 | U-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 Family | Expiration | Patented 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 Family | Expiration | Patented 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 *PED | U-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 [GENERIC AP]
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 Families | Expiration | Patented 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, 2025 | U-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, 2024 | U-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, 2034 | U-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, 2033 | U-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, 2033 | U-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, 2033 | U-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, 2033 | U-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 Families | Expiration | Patented 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, 2026 | U-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, 2029 | U-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, 2030 | U-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, 2030 | U-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, 2029 | U-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, 2027 | U-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, 2029 | U-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, 2027 | U-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, 2033 | U-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 (FILM) (ORAL) OPIPZA
NDA Applicant: XIAMEN LP PHARM CO NDA No.: 216655 Prod. No.: 001 RX (2MG); 002 RX (5MG); 003 RX (10MG)
| 2 Patents--1 Family | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11331315 DP* (Family Id: 73474685) Aripiprazole oral soluble film Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 12, 2024 | Nov 3, 2040 | |
| Pat. No. 11701352 DP* (Family Id: 73474685) Process for preparing aripiprazole oral soluble film Claim Types: Process Pat. Sub. Date(s): All strengths: Nov 12, 2024 | Dec 15, 2041 |
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))
| 6 Patents--3 Families | Expiration | Patented 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, 2025 | U-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, 2033 | U-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, 2033 | U-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, 2033 | U-3245: Maintenance monotherapy treatment of bipolar I disorder U-814: Treatment of schizophrenia |
| Pat. No. 12016927 DP* (Family Id: 48614096) Injectable preparation Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 24, 2024 | Apr 23, 2033 | U-3245: Maintenance monotherapy treatment of bipolar I disorder U-543: 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 Families | Expiration | Patented 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, 2030 | U-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, 2030 | U-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, 2032 | U-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, 2032 | U-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, 2033 | U-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, 2033 | U-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, 2035 | U-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, 2035 | U-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, 2035 | U-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, 2035 | U-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, 2039 | U-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 Families | Expiration | Patented 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, 2030 | U-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, 2030 | U-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, 2032 | U-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, 2032 | U-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, 2033 | U-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, 2033 | U-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, 2035 | U-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, 2035 | U-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, 2035 | U-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, 2035 | U-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, 2039 | U-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 Families | Expiration | Patented 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, 2030 | U-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, 2030 | U-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, 2032 | U-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, 2032 | U-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, 2033 | U-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, 2033 | U-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, 2035 | U-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, 2035 | U-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, 2035 | U-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, 2035 | U-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, 2039 | U-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 Families | Expiration | Patented 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, 2030 | U-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, 2030 | U-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, 2035 | U-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, 2039 | U-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 Families | Expiration | Patented 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**)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity | Jan 12, 2025 | ODE-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)
| 1 Patent--1 Family | Expiration | Patented Use |
|---|---|---|
| Pat. No. 12121506 DP* (Family Id: 93123223) Artesunate powders, pharmaceutical compositions and methods of manufacture Claim Types: Formulation claimed by its inherent performace characteristics; Process Pat. Sub. Date(s): 001: Oct 23, 2024 | Feb 16, 2044 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | May 26, 2025 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | May 26, 2027 | ODE-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 Families | Expiration | Patented 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, 2033 | U-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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Oct 29, 2027 | I-953: Treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronicmyeloid leukemia (PH+ CML) in chronic phase (CP) |
| Exclusivity Code: I - New Indication | Oct 29, 2027 | I-954: Treatment of adult patients with previously treated Philadelphia chromosome-positive chronicmyeloid leukemia (PH+ CML) in chronic phase (CP) |
| Exclusivity Code: NCE - New chemical entity | Oct 29, 2026 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 29, 2028 | ODE-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 exclusivity | Oct 29, 2028 | ODE-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) |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 29, 2031 | ODE-499: Treatment of adult patients with newly diagnosed philadelphia chromosome-positive chronicmyeloid leukemia (PH+ CML) in chronic phase (CP), excluding patients with the t315i mutation |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 29, 2031 | ODE-500: Treatment of adult patients with previously treated philadelphia chromosome-positive chronic myeloid leukemia ((PH+ CML) in chronic phase (CP), excluding patients previously treated with two or more tyrosine kinase inhibitors (TKIS), and excluding patients with the T315I mutation |
ASCIMINIB HYDROCHLORIDE (TABLET) (ORAL) SCEMBLIX
NDA Applicant: NOVARTIS NDA No.: 215358 Prod. No.: 003 RX (EQ 100MG BASE)
| 2 Patents--2 Families | Expiration | Patented 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): 003: May 10, 2024 | May 13, 2033 | U-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): 003: May 10, 2024 | May 14, 2040 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Oct 29, 2026 | |
| Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s) | Oct 29, 2028 |
ASCORBIC ACID (SOLUTION) (INTRAVENOUS) ASCOR
NDA Applicant: MCGUFF NDA No.: 209112 Prod. No.: 001 RX (25,000MG/50ML (500MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 2, 2024 | ODE-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 Family | Expiration | Patented 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)
| 11 Patents--2 Families | Expiration | Patented 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, 2032 | U-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, 2032 | U-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, 2032 | U-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, 2033 | U-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, 2033 | U-2310: For cleansing of the colon in preparation for colonoscopy in adults |
| Pat. No. 12083179 DP* (Family Id: 49165735) Colon cleansing compositions and method of use Claim Types: Formulation; Kit; Method of use Pat. Sub. Date(s): 001: Sep 18, 2024 | Sep 10, 2033 | U-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 Families | Expiration | Patented 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, 2033 | U-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, 2033 | U-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 Family | Expiration | Patented 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 *PED | U-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 Family | Expiration | Patented 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 *PED | U-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 Family | Expiration | Patented 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, 2032 | U-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, 2032 | U-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 Family | Expiration | Patented 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, 2032 | U-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 Family | Expiration | Patented 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, 2033 | U-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, 2033 | U-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 Families | Expiration | Patented 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, 2029 | U-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)
| 4 Patents--3 Families | Expiration | Patented 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, 2032 | U-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, 2031 | U-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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Apr 17, 2026 | I-909: Preventive treatment of migraine in adults |
| Exclusivity Code: NCE - New chemical entity | Sep 28, 2026 |
ATOGEPANT (TABLET) (ORAL) QULIPTA
NDA Applicant: ABBVIE NDA No.: 215206 Prod. No.: 003 RX (60MG)
| 5 Patents--4 Families | Expiration | Patented 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): 003: Oct 26, 2021 | Jul 19, 2032 | U-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): 003: Oct 26, 2021 | Nov 10, 2031 | U-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): 003: 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): 003: Oct 26, 2021 | Jan 30, 2035 | |
| Pat. No. 12090148 (Family Id: 80003948) Treatment of migraine Claim Types: Method of use Pat. Sub. Date(s): 003: Oct 16, 2024 | Jul 29, 2041 | U-3534: Preventive treatment of migraine in adults |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Apr 17, 2026 | I-909: Preventive treatment of migraine in adults |
| Exclusivity Code: NCE - New chemical entity | Sep 28, 2026 |
ATORVASTATIN CALCIUM (SUSPENSION) (ORAL) ATORVALIQ
NDA Applicant: CMP DEV LLC NDA No.: 213260 Prod. No.: 001 RX (20MG/5ML)
| 3 Patents--1 Family | Expiration | Patented 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, 2037 | U-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 |
| Pat. No. 11925704 DP* (Family Id: 59313282) Aqueous suspension suitable for oral administration Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Mar 25, 2024 | Jun 7, 2037 | U-3853: Method for lowering cholesterol level in a human |
ATROPINE SULFATE (SOLUTION/DROPS) (OPHTHALMIC) ATROPINE SULFATE [GENERIC AT2]
NDA Applicant: SOMERSET NDA No.: 217791 Prod. No.: 001 RX (1%)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Dec 4, 2024 |
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))
| 9 Patents--3 Families | Expiration | Patented 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, 2026 | U-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, 2025 | U-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, 2025 | U-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, 2034 | U-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, 2034 | U-3673: Treatment of geographic atrophy secondary to age-related macular degeneration by administerting avacincaptad pegol to the eye |
| Pat. No. 12016875 (Family Id: 52277261) Methods for treating or preventing ophthalmological conditions Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Oct 1, 2024 | Jul 11, 2034 | U-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)
| 4 Patents--3 Families | Expiration | Patented 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. 11951214 DP* (Family Id: 70849818) Capsule formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 26, 2024 | Nov 27, 2039 | |
| 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, 2041 | U-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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Oct 7, 2026 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 7, 2028 | ODE-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 [GENERIC AB]
NDA Applicant: METUCHEN PHARMS NDA No.: 202276 Prod. No.: 001 RX (50MG); 002 RX (100MG); 003 RX (200MG)
| 1 Patent--1 Family | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6656935 DS* DP* (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, 2025 | U-155: Treatment of erectile dysfunction |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Oct 18, 2025 | M-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)
| 6 Patents--2 Families | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11999744 (Family Id: ) Crystalline forms of (S)-1-(4-fluorophenyl)-1-(2-(4-(6-(1-methyl-1H-pyrazol-4-yl)pyrrolo[2,1-f][1,2,4]triazin-4-yl)piperazinyl)-pyrimidin-5-yl)ethan-1-amine and methods of making Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 5, 2024 | Apr 10, 2040 | 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. 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, 2034 | U-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, 2034 | U-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, 2034 | U-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. 11964980 DS* DP* (Family Id: 70476546) Crystalline forms of (S)-1-(4-fluorophenyl)-1-(2-(4-(6-(1-methyl-1H-pyrazol-4-yl)pyrrolo[2,1- f][1,2,4]triazin-4-yl)piperazinyl)-pyrimidin-5-yl)ethan-1-amine and methods of making Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): All strengths: Apr 23, 2024 | Apr 10, 2040 | |
| Pat. No. 12060354 (Family Id: 70476546) Crystalline forms of (S)-1-(4-fluorophenyl)-1-(2-(4-(6-(1-methyl-1H-pyrazol-4-yl)pyrrolo[2,1-f][1,2,4]triazin-4-yl)piperazinyl)-pyrimidin-5-yl)ethan-1-amine and methods of making Claim Types: Method of use; New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: Aug 14, 2024 | Mar 8, 2042 | U-2726: Treatment of unresectable or metastatic gastrointestinal stromal tumor (gist) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jun 16, 2024 | I-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 Indication | Jun 16, 2024 | I-864: Treatment of adult patients with mast cell leukemia (MCL) |
| Exclusivity Code: NCE - New chemical entity | Jan 9, 2025 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 16, 2028 | ODE-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 exclusivity | Jan 9, 2027 | ODE-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 exclusivity | May 22, 2030 | ODE-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)
| 5 Patents--2 Families | Expiration | Patented 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, 2034 | U-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, 2034 | U-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, 2034 | U-2726: Treatment of unresectable or metastatic gastrointestinal stromal tumor (gist) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation |
| Pat. No. 11964980 DS* DP* (Family Id: 70476546) Crystalline forms of (S)-1-(4-fluorophenyl)-1-(2-(4-(6-(1-methyl-1H-pyrazol-4-yl)pyrrolo[2,1- f][1,2,4]triazin-4-yl)piperazinyl)-pyrimidin-5-yl)ethan-1-amine and methods of making Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 003: Apr 23, 2024 | Apr 10, 2040 | |
| Pat. No. 12060354 (Family Id: 70476546) Crystalline forms of (S)-1-(4-fluorophenyl)-1-(2-(4-(6-(1-methyl-1H-pyrazol-4-yl)pyrrolo[2,1-f][1,2,4]triazin-4-yl)piperazinyl)-pyrimidin-5-yl)ethan-1-amine and methods of making Claim Types: Method of use; New polymorph, salt or hydrate Pat. Sub. Date(s): 003: Aug 14, 2024 | Mar 8, 2042 | U-2726: Treatment of unresectable or metastatic gastrointestinal stromal tumor (gist) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jan 9, 2025 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 16, 2028 | ODE-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 exclusivity | Jan 9, 2027 | ODE-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 exclusivity | May 22, 2030 | ODE-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)
| 6 Patents--2 Families | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11999744 (Family Id: ) Crystalline forms of (S)-1-(4-fluorophenyl)-1-(2-(4-(6-(1-methyl-1H-pyrazol-4-yl)pyrrolo[2,1-f][1,2,4]triazin-4-yl)piperazinyl)-pyrimidin-5-yl)ethan-1-amine and methods of making Claim Types: Method of use Pat. Sub. Date(s): 004: Jun 5, 2024 | Apr 10, 2040 | 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) U-3506: Treatment of indolent systemic mastocytosis (ISM) |
| 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, 2034 | 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) 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, 2034 | 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) 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, 2034 | 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) 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, 2034 | U-3506: Treatment of indolent systemic mastocytosis (ISM) |
| Pat. No. 11964980 DS* DP* (Family Id: 70476546) Crystalline forms of (S)-1-(4-fluorophenyl)-1-(2-(4-(6-(1-methyl-1H-pyrazol-4-yl)pyrrolo[2,1- f][1,2,4]triazin-4-yl)piperazinyl)-pyrimidin-5-yl)ethan-1-amine and methods of making Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 004: Apr 23, 2024 | Apr 10, 2040 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jun 16, 2024 | I-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 Indication | Jun 16, 2024 | I-864: Treatment of adult patients with mast cell leukemia (MCL) |
| Exclusivity Code: I - New Indication | May 22, 2026 | I-912: Treatment of adult patients with indolent systemic mastocytosis (ISM) |
| Exclusivity Code: NCE - New chemical entity | Jan 9, 2025 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 16, 2028 | ODE-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 exclusivity | Jan 9, 2027 | ODE-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 exclusivity | May 22, 2030 | ODE-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)
| 5 Patents--2 Families | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11999744 (Family Id: ) Crystalline forms of (S)-1-(4-fluorophenyl)-1-(2-(4-(6-(1-methyl-1H-pyrazol-4-yl)pyrrolo[2,1-f][1,2,4]triazin-4-yl)piperazinyl)-pyrimidin-5-yl)ethan-1-amine and methods of making Claim Types: Method of use Pat. Sub. Date(s): 005: Jun 5, 2024 | Apr 10, 2040 | 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. 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, 2034 | 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): 005: Jul 13, 2021 | Oct 15, 2034 | 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): 005: Jul 13, 2021 | Oct 15, 2034 | 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. 11964980 DS* DP* (Family Id: 70476546) Crystalline forms of (S)-1-(4-fluorophenyl)-1-(2-(4-(6-(1-methyl-1H-pyrazol-4-yl)pyrrolo[2,1- f][1,2,4]triazin-4-yl)piperazinyl)-pyrimidin-5-yl)ethan-1-amine and methods of making Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 005: Apr 23, 2024 | Apr 10, 2040 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jun 16, 2024 | I-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 Indication | Jun 16, 2024 | I-864: Treatment of adult patients with mast cell leukemia (MCL) |
| Exclusivity Code: NCE - New chemical entity | Jan 9, 2025 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 16, 2028 | ODE-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 exclusivity | Jan 9, 2027 | ODE-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 exclusivity | May 22, 2030 | ODE-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 Family | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7638536 DS* DP* (Family Id: 27615666) 2-Acylaminothiazole derivative or salt thereof Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jun 15, 2018 | Jul 28, 2027 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 26, 2026 | ODE-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: ABBVIE NDA No.: 206494 Prod. No.: 001 RX (EQ 0.5GM BASE;2GM/VIAL)
| 7 Patents--4 Families | Expiration | Patented 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* (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, 2026 | U-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) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Feb 25, 2025 GAIN | |
| Exclusivity Code: NPP - New patient population | Dec 20, 2025 | |
| Exclusivity Code: NPP - New patient population | Jan 26, 2027 |
AXITINIB (TABLET) (ORAL) INLYTA
NDA Applicant: PF PRISM CV NDA No.: 202324 Prod. No.: 001 RX (1MG); 002 RX (5MG)
| 4 Patents--4 Families | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6534524 DS* DP* (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 | Oct 29, 2025 *PED | |
| 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 | Jun 14, 2031 *PED | |
| 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 | Aug 3, 2035 *PED | U-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 | Jul 12, 2037 *PED | U-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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: I - New Indication | May 20, 2025 | I-889: Treatment of pediatric patients aged one month and older with newly diagnosed juvenile myelomonocytic leukemia (JMML) |
| Exclusivity Code: ODE - Orphan drug exclusivity | May 20, 2029 | ODE-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)
| 3 Patents--2 Families | Expiration | Patented 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, 2030 | U-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. 12053482 (Family Id: 40941609) Oral formulations of cytidine analogs and methods of use thereof Claim Types: Method of use; Method of Use claimed by its inherent performace characteristics Pat. Sub. Date(s): All strengths: Aug 28, 2024 | May 14, 2029 | U-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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Sep 1, 2023 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Sep 1, 2027 | ODE-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 Families | Expiration | Patented 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, 2029 | U-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, 2024 | U-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, 2027 | U-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 Family | Expiration | Patented 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, 2025 | U-1430: Treatment of allergic rhinitis, including seasonal and perennial allergic rhinitis |
AZELASTINE HYDROCHLORIDE (SPRAY, METERED) (NASAL) ASTEPRO [Has competitive generic]
NDA Applicant: MYLAN SPECIALITY LP NDA No.: 022203 Prod. No.: 002 DISC (0.2055MG/SPRAY)
| 3 Patents--1 Family | Expiration | Patented 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, 2025 | U-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 [GENERIC OTC]
NDA Applicant: BAYER HLTHCARE NDA No.: 213872 Prod. No.: 001 OTC (0.2055MG/SPRAY); 002 OTC (0.2055MG/SPRAY)
| 3 Patents--1 Family | Expiration | Patented 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, 2025 | U-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 Family | Expiration | Patented 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 *PED | U-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 Families | Expiration | Patented 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, 2025 | U-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 Families | Expiration | Patented 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, 2025 | U-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, 2031 | U-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 Families | Expiration | Patented 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, 2024 | U-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 |