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.
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8129385 DS* DP* Substituted 5-hydroxy-3,4,6,9,9a, 10-hexanhydro-2h-1-oxa04a,8a-diaza-anthracene-6,10-dioness Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Sep 16, 2014 | Apr 5, 2028 *PED | |
| Pat. No. 9242986 DS* DP* Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: 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
Drug Classes: nucleoside analogue human immunodeficiency virus (HIV-1) reverse == HIV integrase strand transfer inhibitor (HIV-1 INSTI) == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: VIIV HLTHCARE NDA No.: 215413 Prod. No.: 001 RX (EQ 60MG BASE;EQ 5MG BASE;30MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8129385 DS* DP* Substituted 5-hydroxy-3,4,6,9,9a, 10-hexanhydro-2h-1-oxa04a,8a-diaza-anthracene-6,10-dioness Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Apr 7, 2022 | Apr 5, 2028 *PED | |
| Pat. No. 9242986 DS* DP* Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: 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
Drug Classes: parathyroid hormone related peptide [PTHrP(1-34)] analog
NDA Applicant: RADIUS NDA No.: 208743 Prod. No.: 001 RX (3.12MG/1.56ML (2MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE49444 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 |
| Pat. No. 7803770 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. 8148333 DP* Stable composition comprising a PTHrP analogue Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: May 25, 2017 | Nov 8, 2027 | |
| Pat. No. 8748382 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. 10996208 DP* 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. 11255842 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 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. 11782041 DP* 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* 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 | |
| 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%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7812163 DP* 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* 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* 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* 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* 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
Drug Classes: kinase inhibitor
NDA Applicant: ELI LILLY AND CO NDA No.: 208716 Prod. No.: 001 RX (50MG); 002 RX (100MG); 003 RX (150MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7855211 DS* DP* 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
Drug Classes: kinase inhibitor
NDA Applicant: ELI LILLY AND CO NDA No.: 208716 Prod. No.: 004 RX (200MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7855211 DS* DP* 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
Drug Classes: CYP17 inhibitor
NDA Applicant: SUN PHARM NDA No.: 210308 Prod. No.: 001 RX (125MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9889144 DP* Abiraterone acetate formulation and methods of use Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 19, 2018 | Mar 17, 2034 | |
| Pat. No. 10292990 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 |
ABIRATERONE ACETATE; NIRAPARIB TOSYLATE (TABLET) (ORAL) AKEEGA
Drug Classes: CYP17 inhibitor == poly (ADP-ribose) polymerase (PARP) inhibitor
NDA Applicant: JANSSEN BIOTECH NDA No.: 216793 Prod. No.: 001 RX (500MG;EQ 50MG BASE); 002 RX (500MG;EQ 100MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8071579 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. 8071623 DS* DP* 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. 8143241 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. 8436185 DS* DP* 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. 8859562 Use of RNAI inhibiting PARP activity for the manufacture of a medicament for the treatment of cancer Claim Types: Method of use Pat. Sub. Date(s): 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. 11091459 DS* DP* Niraparib compositions Claim Types: Formulation; Process; Composition Pat. Sub. Date(s): All strengths: Sep 6, 2023 | Mar 27, 2038 | |
| Pat. No. 11207311 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. 11673877 DS* DP* Niraparib compositions Claim Types: New polymorph, salt or hydrate; Method of use Pat. Sub. Date(s): All strengths: Sep 6, 2023 | Mar 27, 2038 | |
| Pat. No. 11986468 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 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 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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Aug 11, 2026 |
ABROCITINIB (TABLET) (ORAL) CIBINQO
Drug Classes: Janus kinase (JAK) inhibitor
NDA Applicant: PFIZER NDA No.: 213871 Prod. No.: 001 RX (50MG); 002 RX (100MG); 003 RX (200MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9035074 DS* DP* 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* 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 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
Drug Classes: kinase inhibitor
NDA Applicant: ASTRAZENECA NDA No.: 210259 Prod. No.: 001 RX (100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7459554 DS* Imidazopyrazine tyrosine kinase inhibitors Claim Types: Compound Pat. Sub. Date(s): 001: Apr 13, 2018 | Nov 24, 2026 | |
| Pat. No. 9290504 DS* DP* 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 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. 9796721 DS* DP* 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* 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. 10239883 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. 10272083 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 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
Drug Classes: kinase inhibitor
NDA Applicant: ASTRAZENECA NDA No.: 216387 Prod. No.: 001 RX (EQ 100MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7459554 DS* Imidazopyrazine tyrosine kinase inhibitors Claim Types: Compound Pat. Sub. Date(s): 001: Sep 1, 2022 | Nov 24, 2026 | |
| Pat. No. 9290504 DS* DP* 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 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 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. 10272083 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. 11059829 DS* DP* 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. 11771696 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)**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9399012 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 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 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 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))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8741959 DP* 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8461137 DS* DP* 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* 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* 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* 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* 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8461137 DS* DP* 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* 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* 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* 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* 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
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: AFT PHARMS US NDA No.: 209471 Prod. No.: 001 RX (325MG;97.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10532036 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* 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* 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]
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: HALEON US HOLDINGS NDA No.: 211733 Prod. No.: 001 OTC (250MG;125MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11918693 DP* 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]
Drug Classes: nonsteroidal anti-inflammatory drug
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
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: HIKMA NDA No.: 215320 Prod. No.: 001 RX (1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11213498 DP* 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* 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. 11446266 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 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. 12083087 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
Drug Classes: opioid agonist
NDA Applicant: MALLINCKRODT INC NDA No.: 204031 Prod. No.: 001 DISC (325MG;7.5MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7976870 Gastric retentive oral dosage form with restricted drug release in the lower gastrointestinal tract Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Apr 3, 2014 | Jun 1, 2027 | U-1498: Method of treating patients with gastric retentive dosage form |
| Pat. No. 8372432 DP* Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Apr 3, 2014 | Mar 11, 2029 | U-1499: Management of acute pain in patients requiring opioid analgesia |
| Pat. No. 8377453 DP* Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic Claim Types: Formulation; Process; 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. 8394408 DP* Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 3, 2014 | Mar 11, 2029 | |
| Pat. No. 8597681 DP* Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans Claim Types: Formulation; Product-by-process Pat. Sub. Date(s): 001: Apr 3, 2014 | Dec 21, 2030 | |
| Pat. No. 8658631 DP* Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 3, 2014 | May 16, 2032 | |
| Pat. No. 8668929 Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 3, 2014 | Mar 11, 2029 | U-1499: Management of acute pain in patients requiring opioid analgesia |
| Pat. No. 8741885 DP* Gastric retentive extended release pharmaceutical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jun 17, 2014 | May 16, 2032 | U-1499: Management of acute pain in patients requiring opioid analgesia |
| Pat. No. 8980319 DP* Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 3, 2015 | Dec 21, 2030 | |
| Pat. No. 8992975 DP* Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 3, 2015 | May 16, 2032 | |
| Pat. No. 9050335 DP* Pharmaceutical compositions for extended release of oxycodone and acetaminophen resulting in a quick onset and prolonged period of analgesia Claim Types: Formuation Pat. Sub. Date(s): 001: Jun 25, 2015 | May 16, 2032 | |
| Pat. No. 9468636 Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 16, 2016 | May 16, 2032 | U-1499: Management of acute pain in patients requiring opioid analgesia |
ACETYLCYSTEINE (INJECTABLE) (INTRAVENOUS) ACETADOTE [GENERIC AP]
Drug Classes: antidote == antidote for acetaminophen overdose == mucolytic
NDA Applicant: CUMBERLAND PHARMS NDA No.: 021539 Prod. No.: 001 RX (6GM/30ML (200MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8148356 DP* 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 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 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 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 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
Drug Classes: antidote == antidote for acetaminophen overdose == mucolytic
NDA Applicant: ARBOR PHARMS LLC NDA No.: 207916 Prod. No.: 001 DISC (500MG); 002 DISC (2.5GM)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8747894 DP* 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* 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 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
Drug Classes: antidote == antidote for acetaminophen overdose == mucolytic
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
Drug Classes: anticholinergic
NDA Applicant: COVIS NDA No.: 202450 Prod. No.: 001 RX (0.4MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE46417 DS* DP* 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* Inhaler for the administration of powdered pharmaceuticals, and a powder cartridge system for use with this inhaler Claim Types: Device Pat. Sub. Date(s): 001: Aug 17, 2012 | Apr 22, 2027 | |
| Pat. No. 10085974 DP* Dosage and formulation Claim Types: Formulation; Method of use; Device Pat. Sub. Date(s): 001: Oct 26, 2018 | Mar 13, 2029 | U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD) |
| Pat. No. 11000517 DP* 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
Drug Classes: anticholinergic == beta-2 adrenergic agonist
NDA Applicant: COVIS NDA No.: 210595 Prod. No.: 001 RX (0.4MG/INH;0.012MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE46417 DS* DP* 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* 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* 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* 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
Drug Classes: nucleoside analog HSV DNA polymerase inhibitor / VZV DNA
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
Drug Classes: nucleoside analog HSV DNA polymerase inhibitor / VZV DNA
NDA Applicant: LNHC NDA No.: 203791 Prod. No.: 001 RX (50MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8592434 DP* 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 |
| Pat. No. 8747896 DP* 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* 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 |
ACYCLOVIR (CREAM) (TOPICAL) ACYCLOVIR [GENERIC AB]
Drug Classes: nucleoside analog HSV DNA polymerase inhibitor / VZV DNA
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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10689377 DS* DP* 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]
Drug Classes: retinoid
NDA Applicant: GALDERMA LABS LP NDA No.: 021753 Prod. No.: 001 RX (0.3%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7579377 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* 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
Drug Classes: retinoid
NDA Applicant: GALDERMA LABS LP NDA No.: 022502 Prod. No.: 001 DISC (0.1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7998467 DP* 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* 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* 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]
Drug Classes: retinoid
NDA Applicant: GALDERMA LABS LP NDA No.: 022320 Prod. No.: 001 RX (0.1%;2.5%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7820186 DP* 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* 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* 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. 8080537 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 |
| Pat. No. 8129362 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 |
ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE (GEL) (TOPICAL) CABTREO
Drug Classes: retinoid == lincosamide antibacterial
NDA Applicant: BAUSCH NDA No.: 216632 Prod. No.: 001 RX (0.15%;3.1%;1.2%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8288434 DP* 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* 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* 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 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* 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 |
| 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8334265 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) |
| Pat. No. 10076555 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) |
| 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
Drug Classes: kinase inhibitor
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 201292 Prod. No.: 001 RX (EQ 20MG BASE); 002 RX (EQ 30MG BASE); 003 RX (EQ 40MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE43431 DS* 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* 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. 8545884 DP* 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. 9539258 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. 10004743 DP* 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9034300 DP* 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* 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* 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]
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: TEVA BRANDED PHARM NDA No.: 021457 Prod. No.: 001 RX (EQ 0.09MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8132712 DP* Metered-dose inhaler Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Mar 27, 2012 | Sep 7, 2028 | |
| Pat. No. 9463289 DP* 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* 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* 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* 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* 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* 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* 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* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): 001: Aug 19, 2022 | May 18, 2031 |
ALBUTEROL SULFATE (POWDER, METERED) (INHALATION) PROAIR RESPICLICK
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: TEVA BRANDED PHARM NDA No.: 205636 Prod. No.: 001 RX (EQ 0.09MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8651103 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 001: Apr 28, 2015 | Mar 26, 2028 | |
| Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 001: Jan 21, 2016 | Jan 13, 2032 | |
| Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 001: Jan 21, 2016 | Jun 28, 2031 | |
| Pat. No. 9463288 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 001: Nov 8, 2016 | May 19, 2025 | |
| Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement Claim Types: Device Pat. Sub. Date(s): 001: Aug 31, 2017 | May 18, 2031 | |
| Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 001: Aug 14, 2018 | May 18, 2031 | |
| Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 001: Dec 12, 2018 | May 18, 2031 | |
| Pat. No. 10561808 DP* 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. 10765820 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 001: Oct 6, 2020 | May 19, 2025 |
ALBUTEROL SULFATE (POWDER, METERED) (INHALATION) PROAIR DIGIHALER
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: TEVA BRANDED PHARM NDA No.: 205636 Prod. No.: 002 DISC (EQ 0.09MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8651103 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 002: Jan 9, 2019 | Mar 26, 2028 | |
| Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 002: Jan 9, 2019 | Jan 13, 2032 | |
| Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 002: Jan 9, 2019 | Jun 28, 2031 | |
| Pat. No. 9463288 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 002: Jan 9, 2019 | May 19, 2025 | |
| Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement Claim Types: Device Pat. Sub. Date(s): 002: Jan 9, 2019 | May 18, 2031 | |
| Pat. No. 9782550 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 002: Jan 9, 2019 | Aug 28, 2035 | |
| Pat. No. 9782551 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device Pat. Sub. Date(s): 002: Jan 9, 2019 | Aug 28, 2035 | |
| Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 002: Jan 9, 2019 | May 18, 2031 | |
| Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 002: Jan 9, 2019 | May 18, 2031 | |
| Pat. No. 10561808 DP* 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. 10569034 DP* 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. 10765820 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 002: Oct 6, 2020 | May 19, 2025 | |
| Pat. No. 10918816 DP* 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. 11000653 DP* 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. 11173259 DP* Drug delivery device with electronics and power management Claim Types: Device Pat. Sub. Date(s): 002: Dec 8, 2021 | Jul 6, 2040 | |
| Pat. No. 11266796 DP* Inhalation device with integrated electronics Claim Types: Device; Method of administration Pat. Sub. Date(s): 002: Apr 7, 2022 | Feb 22, 2041 | |
| Pat. No. 11344685 DP* 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* 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* Drug delivery device with electronics Claim Types: Device Pat. Sub. Date(s): 002: Jul 13, 2022 | Sep 24, 2038 | |
| Pat. No. 11439777 DP* Drug delivery device with electronics Claim Types: Device Pat. Sub. Date(s): 002: Oct 6, 2022 | May 24, 2040 | |
| Pat. No. 11464923 DP* 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
Drug Classes: beta-2 adrenergic agonist == corticosteroid
NDA Applicant: ASTRAZENECA NDA No.: 214070 Prod. No.: 001 RX (EQ 0.09MG BASE/INH;0.08MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9415009 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
Drug Classes: beta-2 adrenergic agonist == anticholinergic
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 021747 Prod. No.: 001 RX (EQ 0.1MG BASE/INH;0.02MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7284474 DP* Piston-pumping system having o-ring seal properties Claim Types: Device Pat. Sub. Date(s): 001: Nov 2, 2011 | Aug 26, 2024 | |
| Pat. No. 7396341 DP* 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. 7837235 DP* Device for clamping a fluidic component Claim Types: Device Pat. Sub. Date(s): 001: Nov 2, 2011 | Mar 13, 2028 | |
| Pat. No. 7896264 DP* 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. 8733341 DP* 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 | |
| Pat. No. 9027967 DP* Device for clamping a fluidic component Claim Types: Device; Process Pat. Sub. Date(s): 001: Sep 4, 2015 | Mar 31, 2027 |
ALCAFTADINE (SOLUTION/DROPS) (OPHTHALMIC) LASTACAFT [GENERIC OTC]
Drug Classes: histamine-1 (H1) receptor antagonist
NDA Applicant: ABBVIE NDA No.: 022134 Prod. No.: 001 OTC (0.25%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8664215 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* 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
Drug Classes: pediculicide
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
Drug Classes: kinase inhibitor
NDA Applicant: HOFFMANN-LA ROCHE NDA No.: 208434 Prod. No.: 001 RX (EQ 150MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9126931 DS* Tetracyclic compound Claim Types: Compound Pat. Sub. Date(s): 001: Dec 22, 2015 | May 29, 2031 | |
| Pat. No. 9365514 DP* Composition comprising tetracyclic compound Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 11, 2016 | Mar 4, 2032 | |
| Pat. No. 9440922 DP* Tetracyclic compound Claim Types: Composition Pat. Sub. Date(s): 001: Oct 12, 2016 | Jun 9, 2030 | |
| Pat. No. 10350214 DP* 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* 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9592195 DP* 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]
Drug Classes: renin inhibitor
NDA Applicant: NODEN PHARMA NDA No.: 021985 Prod. No.: 001 RX (EQ 150MG BASE); 002 RX (EQ 300MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8617595 DP* Galenic formulations of organic compounds Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): All strengths: None | Aug 19, 2026 *PED |
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE (TABLET) (ORAL) TEKAMLO
Drug Classes: renin inhibitor == calcium channel blocker == dihydropyridine calcium channel blocker
NDA Applicant: NOVARTIS NDA No.: 022545 Prod. No.: 001 DISC (EQ 150MG BASE;EQ 5MG BASE); 002 DISC (EQ 150MG BASE;EQ 10MG BASE); 003 DISC (EQ 300MG BASE;EQ 5MG BASE); 004 DISC (EQ 300MG BASE;EQ 10MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8613949 DP* 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
Drug Classes: renin inhibitor == thiazide diuretic
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**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8618172 DP* Galenical formulations of organic compounds Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jul 13, 2028 |
ALISKIREN HEMIFUMARATE; VALSARTAN (TABLET) (ORAL) VALTURNA
Drug Classes: renin inhibitor == angiotensin II receptor blocker
NDA Applicant: NOVARTIS NDA No.: 022217 Prod. No.: 001 DISC (EQ 150MG BASE;160MG); 002 DISC (EQ 300MG BASE;320MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8168616 DP* Combination comprising a renin inhibitor and an angiotensin receptor inhibitor for hypertension Claim Types: Composition Pat. Sub. Date(s): All strengths: Jun 6, 2012 | Jul 3, 2026 |
ALLOPURINOL; LESINURAD (TABLET) (ORAL) DUZALLO
Drug Classes: xanthine oxidase inhibitor == URAT1 inhibitor
NDA Applicant: IRONWOOD PHARMS INC NDA No.: 209203 Prod. No.: 001 DISC (200MG;200MG); 002 DISC (300MG;200MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8003681 DS* 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 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 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* 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. 8546436 DS* 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. 8546437 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. 9216179 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. 9956205 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 |
| Pat. No. 10183012 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 |
ALOGLIPTIN BENZOATE (TABLET) (ORAL) NESINA
Drug Classes: dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: TAKEDA PHARMS USA NDA No.: 022271 Prod. No.: 001 RX (EQ 6.25MG BASE); 002 RX (EQ 12.5MG BASE); 003 RX (EQ 25MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7807689 DS* DP* Dipeptidyl peptidase inhibitors Claim Types: Compound; Composition; Drug in a container; Method of use Pat. Sub. Date(s): All strengths: None | Jun 27, 2028 | U-1337: Method of treating diabetes comprising administering alogliptin |
| Pat. No. 8173663 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* Dipeptidyl peptidase inhibitors Claim Types: Compound Pat. Sub. Date(s): All strengths: None | Mar 15, 2025 | |
| Pat. No. 8697125 DP* 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
Drug Classes: dipeptidyl peptidase-4 (DPP-4) inhibitor == biguanide
NDA Applicant: TAKEDA PHARMS USA NDA No.: 203414 Prod. No.: 001 RX (EQ 12.5MG BASE;500MG); 002 RX (EQ 12.5MG BASE;1GM)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7807689 DS* DP* Dipeptidyl peptidase inhibitors Claim Types: Compound; Composition; Drug in a container; Method of use Pat. Sub. Date(s): All strengths: None | Jun 27, 2028 | U-1337: Method of treating diabetes comprising administering alogliptin |
| Pat. No. 8173663 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* Dipeptidyl peptidase inhibitors Claim Types: Compound Pat. Sub. Date(s): All strengths: None | Jun 24, 2025 | |
| Pat. No. 8900638 DP* 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
Drug Classes: dipeptidyl peptidase-4 (DPP-4) inhibitor == peroxisome proliferator-activated receptor (PPAR) alpha agonist == peroxisome proliferator-activated receptor (PPAR) gamma agonist == thiazolidinedione
NDA Applicant: TAKEDA PHARMS USA NDA No.: 022426 Prod. No.: 001 RX (EQ 25MG BASE;EQ 15MG BASE); 002 RX (EQ 25MG BASE;EQ 30MG BASE); 003 RX (EQ 25MG BASE;EQ 45MG BASE); 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**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7807689 DS* DP* Dipeptidyl peptidase inhibitors Claim Types: Compound; Composition; Drug in a container; Method of use Pat. Sub. Date(s): All strengths: None | Jun 27, 2028 | U-1337: Method of treating diabetes comprising administering alogliptin |
| Pat. No. 8173663 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* Dipeptidyl peptidase inhibitors Claim Types: Compound Pat. Sub. Date(s): All strengths: None | Mar 15, 2025 | |
| Pat. No. 8637079 DP* Solid preparation comprising alogliptin and pioglitazone Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 13, 2014 | Jun 4, 2029 |
ALPELISIB (TABLET) (ORAL) PIQRAY
NDA Applicant: NOVARTIS NDA No.: 212526 Prod. No.: 001 RX (50MG); 002 RX (150MG); 003 RX (200MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8227462 DS* DP* 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* 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8227462 DS* DP* 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* 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8227462 DS* DP* 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* 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
Drug Classes: opioid antagonist
NDA Applicant: CUBIST PHARMS NDA No.: 021775 Prod. No.: 001 DISC (12MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8946262 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]
Drug Classes: influenza A M2 protein inhibitor
NDA Applicant: SUPERNUS PHARMS NDA No.: 208944 Prod. No.: 001 RX (EQ 68.5MG BASE); 002 RX (EQ 137MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8389578 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. 8741343 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. 8796337 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* 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* 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 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 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 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* Composition and method for treating neurological disease Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 21, 2017 | Nov 23, 2025 | |
| Pat. No. 9867791 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 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 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 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. 10154971 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 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. 11065213 DP* 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 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 |
| Pat. No. 11197835 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. 11903908 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 |
| 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
Drug Classes: influenza A M2 protein inhibitor
NDA Applicant: SUPERNUS PHARMS NDA No.: 209410 Prod. No.: 001 DISC (EQ 129MG BASE); 002 DISC (EQ 193MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8252331 DP* 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. 8389578 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. 8574626 DP* 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. 8796337 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* 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* 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 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 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 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* 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* 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 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. 10213393 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. 10213394 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. 10500170 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. 10500171 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 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. 10512617 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 |
| Pat. No. 11890261 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 |
AMANTADINE HYDROCHLORIDE (TABLET, EXTENDED RELEASE) (ORAL) OSMOLEX ER
Drug Classes: influenza A M2 protein inhibitor
NDA Applicant: SUPERNUS PHARMS NDA No.: 209410 Prod. No.: 003 DISC (EQ 258MG BASE); 004 DISC (EQ 161MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8252331 DP* 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. 8389578 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. 8574626 DP* 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. 8796337 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* 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* 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 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 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 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* 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* 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 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. 10213393 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. 10213394 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. 10500170 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. 10500171 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 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. 10512617 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]
Drug Classes: endothelin receptor antagonist
NDA Applicant: GILEAD NDA No.: 022081 Prod. No.: 001 RX (5MG); 002 RX (10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8377933 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 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 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
Drug Classes: potassium channel blocker
NDA Applicant: CATALYST PHARMS NDA No.: 208078 Prod. No.: 001 RX (EQ 10MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10626088 DP* 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 | |
| Pat. No. 10793893 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 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 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 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 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 |
| 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
Drug Classes: aminoglycoside antibacterial
NDA Applicant: INSMED INC NDA No.: 207356 Prod. No.: 001 RX (EQ 590MG BASE/8.4ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7718189 DP* 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. 8226975 DP* 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 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* 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 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. 8802137 DP* 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. 9566234 DP* 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. 9827317 DP* 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. 9895385 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 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 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 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 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%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10357567 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 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 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 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 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%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11235169 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 |
| Pat. No. 11540981 DP* Nanoemulsion formulation with improved stability and cell penetration Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 18, 2023 | Feb 7, 2028 |
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
Drug Classes: antiarrhythmic
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**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7635773 DP* Sulfoalkyl ether cyclodextrin compositions Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: None | Mar 13, 2029 |
AMISULPRIDE (SOLUTION) (INTRAVENOUS) BARHEMSYS
Drug Classes: dopamine-2 (D2) antagonist
NDA Applicant: ACACIA NDA No.: 209510 Prod. No.: 001 RX (5MG/2ML (2.5MG/ML)); 002 RX (10MG/4ML (2.5MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9084765 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 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 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* 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 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
Drug Classes: calcium channel blocker == dihydropyridine calcium channel blocker
NDA Applicant: AZURITY NDA No.: 211340 Prod. No.: 001 RX (EQ 1MG BASE/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10695329 DP* Amlodipine formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 22, 2020 | Oct 16, 2037 | |
| Pat. No. 10799453 DP* Amlodipine formulations Claim Types: Product-by-process Pat. Sub. Date(s): 001: Nov 2, 2020 | Apr 11, 2039 | |
| Pat. No. 10894039 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* Amlodipine formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 29, 2021 | Oct 6, 2037 | |
| Pat. No. 10959991 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* Amlodipine formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 24, 2022 | Oct 6, 2037 | |
| Pat. No. 11471409 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* Amlodipine Formulations Claim Types: Product-by-process Pat. Sub. Date(s): 001: Nov 4, 2022 | Oct 6, 2037 | |
| Pat. No. 11701326 DP* Amlodipine formulations Claim Types: Product-by-process Pat. Sub. Date(s): 001: Jul 20, 2023 | Oct 6, 2037 | |
| Pat. No. 11918685 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 |
| Pat. No. 12053461 DP* Amlodipine formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 15, 2024 | Oct 6, 2037 |
AMLODIPINE BESYLATE (SOLUTION) (ORAL) NORLIQVA
Drug Classes: calcium channel blocker == dihydropyridine calcium channel blocker
NDA Applicant: CMP DEV LLC NDA No.: 214439 Prod. No.: 001 RX (EQ 1MG BASE/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11253474 DP* 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* 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* 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* 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
Drug Classes: calcium channel blocker == dihydropyridine calcium channel blocker == nonsteroidal anti-inflammatory drug
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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9408837 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* 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* 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 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* 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
Drug Classes: calcium channel blocker == dihydropyridine calcium channel blocker
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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7846961 DS* DP* .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
Drug Classes: penicillin class antibacterial
NDA Applicant: PRAGMA NDA No.: 050813 Prod. No.: 001 DISC (775MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8299052 Pharmaceutical compositions and methods for improved bacterial eradication Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 3, 2012 | May 7, 2027 | U-1304: Use of once-a-day amoxicillin product to treat tonsillitis and/or pharyngitis secondary to streptococcus pyogenes |
| Pat. No. 8357394 DP* Compositions and methods for improved efficacy of penicillin-type antibiotics Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 30, 2013 | Dec 8, 2026 | |
| Pat. No. 8778924 DS* DP* Modified release amoxicillin products Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jun 17, 2015 | Dec 8, 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
Drug Classes: penicillin class antibacterial == macrolide antimicrobial
NDA Applicant: PHATHOM NDA No.: 215152 Prod. No.: 001 RX (500MG;500MG;EQ 20MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7977488 DS* 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* 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
Drug Classes: penicillin class antibacterial == proton pump inhibitor == rifamycin antimycobacterial
NDA Applicant: REDHILL NDA No.: 213004 Prod. No.: 001 RX (250MG;EQ 10MG BASE;12.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9050263 DP* 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* 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* 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* 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* 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. 11878011 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 |
| Pat. No. 11931463 DP* 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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Nov 1, 2027 GAIN |
AMOXICILLIN; VONOPRAZAN FUMARATE (CAPSULE, TABLET) (ORAL) VOQUEZNA DUAL PAK
Drug Classes: penicillin class antibacterial
NDA Applicant: PHATHOM NDA No.: 215153 Prod. No.: 001 RX (500MG;EQ 20MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7977488 DS* 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* 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
Drug Classes: adrenergic agonist == amphetamine anorectic == central nervous system (CNS) stimulant == central nervous system stimulant
NDA Applicant: NEOS THERAPS INC NDA No.: 204325 Prod. No.: 001 DISC (EQ 1.25MG BASE/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8709491 DP* 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* 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* Pharmaceutical composition comprising amphetamines complexed with ion-exchange resin particles Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 21, 2017 | Jun 28, 2032 |
AMPHETAMINE (TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE) (ORAL) ADZENYS XR-ODT
Drug Classes: adrenergic agonist == amphetamine anorectic == central nervous system (CNS) stimulant == central nervous system stimulant
NDA Applicant: NEOS THERAPS NDA No.: 204326 Prod. No.: 001 RX (EQ 3.1MG BASE); 002 RX (EQ 6.3MG BASE); 003 RX (EQ 9.4MG BASE); 004 RX (EQ 12.5MG BASE); 005 RX (EQ 15.7MG BASE); 006 RX (EQ 18.8MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8709491 DP* 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. 8840924 DP* 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. 9017731 DP* 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* 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* 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]
Drug Classes: adrenergic agonist == amphetamine anorectic == central nervous system (CNS) stimulant == central nervous system stimulant
NDA Applicant: TAKEDA PHARMS USA NDA No.: 022063 Prod. No.: 001 RX (3.125MG;3.125MG;3.125MG;3.125MG); 002 RX (6.25MG;6.25MG;6.25MG;6.25MG); 003 RX (9.375MG;9.375MG;9.375MG;9.375MG); 004 RX (12.5MG;12.5MG;12.5MG;12.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8846100 DP* Controlled dose drug delivery system Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 7, 2017 | Aug 24, 2029 | |
| Pat. No. 9173857 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
Drug Classes: adrenergic agonist == amphetamine anorectic == central nervous system (CNS) stimulant == central nervous system stimulant
NDA Applicant: AZURITY NDA No.: 209905 Prod. No.: 001 DISC (5MG); 002 DISC (10MG); 003 DISC (15MG); 004 DISC (20MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10130580 DP* Taste-masked pharmaceutical compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jan 31, 2019 | Apr 19, 2024 | |
| Pat. No. 10441554 DP* Oral amphetamine composition Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 15, 2019 | Mar 10, 2037 | |
| Pat. No. 11160772 DP* Oral amphetamine composition Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 9, 2021 | Mar 10, 2037 | |
| Pat. No. 11896562 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
Drug Classes: adrenergic agonist == amphetamine anorectic == central nervous system (CNS) stimulant == central nervous system stimulant
NDA Applicant: AZURITY NDA No.: 209905 Prod. No.: 005 DISC (2.5MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10130580 DP* Taste-masked pharmaceutical compositions Claim Types: Formulation Pat. Sub. Date(s): 005: Jul 7, 2021 | Apr 19, 2024 | |
| Pat. No. 10441554 DP* Oral amphetamine composition Claim Types: Formulation Pat. Sub. Date(s): 005: Jul 7, 2021 | Mar 10, 2037 | |
| Pat. No. 11160772 DP* 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
Drug Classes: adrenergic agonist == amphetamine anorectic == central nervous system (CNS) stimulant == central nervous system stimulant
NDA Applicant: TRIS PHARMA INC NDA No.: 208147 Prod. No.: 001 RX (2MG/ML;EQ 0.5MG BASE/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8062667 DP* 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* 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* 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* 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* 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* 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* 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
Drug Classes: adrenergic agonist == amphetamine anorectic == central nervous system (CNS) stimulant == central nervous system stimulant
NDA Applicant: TRIS PHARMA INC NDA No.: 210526 Prod. No.: 001 RX (4MG;EQ 1MG BASE); 002 RX (8MG;EQ 2MG BASE); 003 RX (12MG;EQ 3MG BASE); 004 RX (16MG;EQ 4MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8337890 DP* 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* 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* 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* 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))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9220745 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. 9572856 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 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. 10028995 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. 10335451 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. 10493124 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. 10500247 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 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. 11096983 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. 11219662 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 |
| Pat. No. 11559559 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 |
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))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9220745 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. 9572856 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 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. 10028995 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. 10335451 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. 10493124 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. 10500247 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 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. 11096983 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. 11219662 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 |
| Pat. No. 11559559 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 |
ANIDULAFUNGIN (POWDER) (INTRAVENOUS) ERAXIS
Drug Classes: echinocandin antifungal
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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE49353 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. 8445507 DS* DP* 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 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* Substituted diazaspiroalkanes as androgen receptor modulators Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Mar 5, 2018 | Mar 27, 2027 | |
| Pat. No. 9481663 DS* DP* 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. 9884054 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. 9987261 DP* Substituted diazaspiroalkanes as androgen receptor modulators Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 18, 2018 | Mar 27, 2027 | |
| Pat. No. 10052314 DLR* 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. 10702508 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. 10849888 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. 11963952 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE49353 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. 8445507 DS* DP* 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 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* Substituted diazaspiroalkanes as androgen receptor modulators Claim Types: Compound; Composition Pat. Sub. Date(s): 002: Feb 27, 2023 | Mar 27, 2027 | |
| Pat. No. 9481663 DS* DP* 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. 9884054 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. 9987261 DP* Substituted diazaspiroalkanes as androgen receptor modulators Claim Types: Formulation Pat. Sub. Date(s): 002: Feb 27, 2023 | Mar 27, 2027 | |
| Pat. No. 10702508 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. 10849888 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. 11963952 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]
Drug Classes: factor Xa inhibitor
NDA Applicant: BRISTOL MYERS SQUIBB NDA No.: 202155 Prod. No.: 001 RX (2.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6967208 DS* DP* 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 |
| Pat. No. 9326945 DP* Apixaban formulations Claim Types: Formulation Pat. Sub. Date(s): 001: May 26, 2016 | Feb 24, 2031 |
APIXABAN (TABLET) (ORAL) ELIQUIS [GENERIC AB]
Drug Classes: factor Xa inhibitor
NDA Applicant: BRISTOL MYERS SQUIBB NDA No.: 202155 Prod. No.: 002 RX (5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6967208 DS* DP* 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 |
| Pat. No. 9326945 DP* Apixaban formulations Claim Types: Formulation Pat. Sub. Date(s): 002: May 26, 2016 | Feb 24, 2031 |
APOMORPHINE HYDROCHLORIDE (FILM) (SUBLINGUAL) KYNMOBI
Drug Classes: dopaminergic agonist
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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8414922 DP* 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. 8603514 DP* 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. 8765167 DP* 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. 8846074 DP* 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. 9044475 DP* Sublingual apomorphine Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Jun 11, 2030 | |
| Pat. No. 9283219 DP* 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. 9326981 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* 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 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* 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. 10449146 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. 10821074 DP* Sublingual and buccal film compositions Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 12, 2020 | Aug 7, 2029 | |
| Pat. No. 10959943 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 |
| Pat. No. 11419769 DP* 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 |
APREMILAST (TABLET) (ORAL) OTEZLA [GENERIC AB]
Drug Classes: phosphodiesterase 4 inhibitor
NDA Applicant: AMGEN INC NDA No.: 205437 Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (30MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7427638 DS* DP* (+)-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 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 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]
Drug Classes: substance P/neurokinin-1 (NK-1) receptor antagonist
NDA Applicant: MERCK NDA No.: 021549 Prod. No.: 001 RX (80MG); 002 RX (125MG) NDA No.: 021549 Prod. No.: 003 DISC (40MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8258132 DP* 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
Drug Classes: substance P/neurokinin-1 (NK-1) receptor antagonist
NDA Applicant: MSD MERCK CO NDA No.: 207865 Prod. No.: 001 RX (125MG/KIT)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8258132 DP* 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
Drug Classes: substance P/neurokinin-1 (NK-1) receptor antagonist
NDA Applicant: HERON THERAPS INC NDA No.: 209296 Prod. No.: 001 RX (130MG/18ML (7.2MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9561229 DP* 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 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. 9974742 DP* 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. 9974793 DP* Emulsion formulations of aprepitant Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 19, 2018 | Sep 18, 2035 | |
| Pat. No. 9974794 DP* 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* Emulsion formulations of aprepitant Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Dec 23, 2019 | Sep 18, 2035 | |
| Pat. No. 10624850 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. 10953018 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. 11173118 DP* 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* Methods of use of emulsion formulations of an NK-1 receptor antagonist Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 2, 2023 | Sep 18, 2035 |
APREPITANT (EMULSION) (INTRAVENOUS) APONVIE
Drug Classes: substance P/neurokinin-1 (NK-1) receptor antagonist
NDA Applicant: HERON THERAPS INC NDA No.: 216457 Prod. No.: 001 RX (32MG/4.4ML (7.2MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9561229 DP* 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 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* 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. 9974793 DP* Emulsion formulations of aprepitant Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 5, 2022 | Sep 18, 2035 | |
| Pat. No. 9974794 DP* 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* Emulsion formulations of aprepitant Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Oct 5, 2022 | Sep 18, 2035 | |
| Pat. No. 10624850 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. 10953018 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. 11173118 DP* 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* 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. 11878074 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 |
APROCITENTAN (TABLET) (ORAL) TRYVIO
NDA Applicant: IDORSIA NDA No.: 217686 Prod. No.: 001 RX (12.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8324232 DS* DP* 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* 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 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 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 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)**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7589106 DP* 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* 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9289472 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 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 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]
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA NDA No.: 021436 Prod. No.: 001 RX (10MG); 002 RX (15MG); 003 RX (20MG); 004 RX (30MG); 005 RX (5MG); 006 RX (2MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8017615 DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: Composition; Product-by-process; Process Pat. Sub. Date(s): All strengths: None | Dec 16, 2024 *PED | |
| Pat. No. 8759350 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 22, 2014 | Mar 2, 2027 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
| Pat. No. 9125939 Carbostyril derivatives and mood stabilizers for treating mood disorders Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 7, 2015 | Jul 28, 2026 | U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder |
ARIPIPRAZOLE (SOLUTION) (ORAL) ABILIFY
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA NDA No.: 021713 Prod. No.: 001 DISC (1MG/ML**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8759350 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
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA NDA No.: 021729 Prod. No.: 002 DISC (10MG**); 003 DISC (15MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8017615 DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: Composition; Product-by-process; Process Pat. Sub. Date(s): All strengths: None | Dec 16, 2024 *PED | |
| Pat. No. 8759350 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 22, 2014 | Mar 2, 2027 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
| Pat. No. 9125939 Carbostyril derivatives and mood stabilizers for treating mood disorders Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 7, 2015 | Jul 28, 2026 | U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder |
ARIPIPRAZOLE (TABLET, ORALLY DISINTEGRATING) (ORAL) ABILIFY
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA NDA No.: 021729 Prod. No.: 004 DISC (20MG**); 005 DISC (30MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8017615 DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: Composition; Product-by-process; Process Pat. Sub. Date(s): All strengths: None | Dec 16, 2024 *PED |
ARIPIPRAZOLE (INJECTABLE) (INTRAMUSCULAR) ABILIFY
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA NDA No.: 021866 Prod. No.: 001 DISC (9.75MG/1.3ML (7.5MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7115587 DP* 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* 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
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA PHARM CO LTD NDA No.: 202971 Prod. No.: 001 RX (300MG/VIAL); 002 RX (400MG/VIAL); 003 RX (300MG); 004 RX (400MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7807680 DP* 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 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. 8338427 DP* 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. 8399469 DS* 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. 8722679 DP* Controlled release sterile injectable aripiprazole formulation and method Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 9, 2014; 002: Jun 9, 2014; 003: None; 004: Oct 29, 2014 | Oct 19, 2024 | |
| Pat. No. 10525057 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 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 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 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 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 |
| Pat. No. 11648347 DP* 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 |
ARIPIPRAZOLE (TABLET) (ORAL) ABILIFY MYCITE KIT [Has competitive generic]
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA NDA No.: 207202 Prod. No.: 001 RX (2MG); 002 RX (5MG); 003 RX (10MG); 004 RX (15MG); 005 RX (20MG); 006 RX (30MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7978064 DP* Communication system with partial power source Claim Types: Device; Process Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Sep 14, 2026 | |
| Pat. No. 8017615 DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: Composition; Product-by-process; Process Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Jun 16, 2024 | |
| Pat. No. 8114021 DP* Body-associated receiver and method Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Jun 21, 2030 | |
| Pat. No. 8258962 DP* 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. 8545402 DP* 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. 8547248 DP* 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. 8674825 DP* 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. 8718193 DP* Active signal processing personal health signal receivers Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Dec 5, 2029 | |
| Pat. No. 8759350 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Mar 2, 2027 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
| Pat. No. 8847766 DP* 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. 8945005 DP* 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. 8956288 DP* 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. 8961412 DP* 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. 9060708 DP* 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. 9119554 DP* Pharma-informatics system Claim Types: Device; Process Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Dec 16, 2028 | |
| Pat. No. 9125939 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. 9149577 DP* Body-associated receiver and method Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Dec 15, 2029 | |
| Pat. No. 9258035 DP* 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. 9268909 DP* 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 |
| Pat. No. 9320455 DP* 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. 9433371 DP* 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. 9444503 DP* 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. 9941931 DP* System for supply chain management Claim Types: Device Pat. Sub. Date(s): All strengths: May 7, 2018 | Nov 4, 2030 | |
| Pat. No. 10441194 DP* Ingestible event marker systems Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 1, 2019 | Jul 26, 2029 | |
| Pat. No. 10517507 DP* 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* 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. 11464423 DP* 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. 11476952 DP* Pharma-informatics system Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 9, 2022 | Apr 28, 2026 |
ARIPIPRAZOLE (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ABILIFY ASIMTUFII
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA NDA No.: 217006 Prod. No.: 001 RX (720MG/2.4ML (300MG/ML)); 002 RX (960MG/3.2ML (300MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8338427 DP* 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. 8399469 DS* 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. 10517951 DP* 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* 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* 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* 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
Drug Classes: atypical antipsychotic
NDA Applicant: ALKERMES INC NDA No.: 207533 Prod. No.: 001 RX (441MG/1.6ML (275.63MG/ML)); 004 RX (1064MG/3.9ML (272.82MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8431576 DS* 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 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. 9034867 DP* 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. 9193685 DP* 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. 9452131 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. 10112903 DS* 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. 10226458 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. 10238651 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 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. 11097006 DP* 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. 11273158 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 |
| Pat. No. 11406632 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 |
ARIPIPRAZOLE LAUROXIL (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARISTADA
Drug Classes: atypical antipsychotic
NDA Applicant: ALKERMES INC NDA No.: 207533 Prod. No.: 002 RX (662MG/2.4ML (275.83MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8431576 DS* 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 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. 9034867 DP* 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. 9193685 DP* 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. 9452131 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* Aripiprazole formulations having increased injection speeds Claim Types: Kit Pat. Sub. Date(s): 002: Jan 19, 2017 | Mar 19, 2035 | |
| Pat. No. 10112903 DS* 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. 10226458 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. 10238651 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 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. 11097006 DP* 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. 11273158 Aripiprazole dosing strategy Claim Types: Method of use Pat. Sub. Date(s): 002: Apr 13, 2022 | Apr 6, 2039 | U-543: Treatment of schizophrenia |
| Pat. No. 11406632 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 |
ARIPIPRAZOLE LAUROXIL (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARISTADA
Drug Classes: atypical antipsychotic
NDA Applicant: ALKERMES INC NDA No.: 207533 Prod. No.: 003 RX (882MG/3.2ML (275.63MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8431576 DS* 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 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. 9034867 DP* 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. 9193685 DP* 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. 9452131 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* Aripiprazole formulations having increased injection speeds Claim Types: Kit Pat. Sub. Date(s): 003: Jan 19, 2017 | Mar 19, 2035 | |
| Pat. No. 10112903 DS* 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. 10226458 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. 10238651 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 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. 11097006 DP* 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. 11273158 Aripiprazole dosing strategy Claim Types: Method of use Pat. Sub. Date(s): 003: Apr 13, 2022 | Apr 6, 2039 | U-543: Treatment of schizophrenia |
| Pat. No. 11406632 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 |
ARIPIPRAZOLE LAUROXIL (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARISTADA INITIO KIT
Drug Classes: atypical antipsychotic
NDA Applicant: ALKERMES INC NDA No.: 209830 Prod. No.: 001 RX (675MG/2.4ML (281.25MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8431576 DS* 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 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. 10016415 DP* Aripiprazole prodrug compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 18, 2018 | Sep 8, 2035 | |
| Pat. No. 10112903 DS* 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. 10688091 DP* Aripiprazole prodrug composition Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 8, 2020 | Aug 17, 2035 | |
| Pat. No. 10849894 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* Aripiprazole prodrug composition Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 10, 2021 | Aug 17, 2035 | |
| Pat. No. 11273158 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**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7132570 DS* DP* 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 | |
| Pat. No. 7297346 DP* Pharmaceutical formulations of modafinil Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | May 29, 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 12121506 DP* 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8829195 DS* 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* 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: 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) |
ASCIMINIB HYDROCHLORIDE (TABLET) (ORAL) SCEMBLIX
NDA Applicant: NOVARTIS NDA No.: 215358 Prod. No.: 003 RX (EQ 100MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8829195 DS* 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* 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7169381 DS* DP* Colon cleansing compositions and methods Claim Types: Formulation Pat. Sub. Date(s): 001: None | Sep 1, 2024 | |
| Pat. No. 7658914 DS* DP* 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8999313 DP* Compositions Claim Types: Formulation; Kit Pat. Sub. Date(s): 001: May 24, 2018 | Sep 10, 2033 | |
| Pat. No. 9326969 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. 9592252 DP* 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. 9707297 DP* Compositions Claim Types: Kit Pat. Sub. Date(s): 001: May 24, 2018 | Sep 10, 2033 | |
| Pat. No. 10016504 DP* Compositions Claim Types: Formulation; Process; Product-by-process Pat. Sub. Date(s): 001: Jul 24, 2018 | Sep 10, 2033 | |
| Pat. No. 10646512 DP* Colonoscopy - preparation Claim Types: Formulation; Kit Pat. Sub. Date(s): 001: May 15, 2020 | Mar 25, 2032 | |
| Pat. No. 10780112 DP* Colonoscopy-preparation Claim Types: Kit Pat. Sub. Date(s): 001: Sep 25, 2020 | Mar 9, 2032 | |
| Pat. No. 10792306 DP* 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. 10918723 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. 11529368 DP* 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. 12083179 DP* 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
Drug Classes: atypical antipsychotic
NDA Applicant: HISAMITSU NDA No.: 212268 Prod. No.: 001 RX (3.8MG/24HR); 002 RX (5.7MG/24HR); 003 RX (7.6MG/24HR)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9687474 DP* Patch Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 18, 2019 | Jul 25, 2033 | |
| Pat. No. 10022445 DP* Patch Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 18, 2019 | Jul 25, 2033 | |
| Pat. No. 10583121 DP* 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. 10814002 DP* 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 |
| Pat. No. 11123305 DP* Patch Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 21, 2021 | Jul 25, 2033 | |
| Pat. No. 11813364 DP* Patch Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 11, 2023 | Sep 22, 2033 |
ASENAPINE MALEATE (TABLET) (SUBLINGUAL) SAPHRIS [GENERIC AB]
Drug Classes: atypical antipsychotic
NDA Applicant: ALLERGAN NDA No.: 022117 Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 10MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7741358 DS* DP* 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* Crystal form of asenapine maleate Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): All strengths: Jul 29, 2014 | Oct 6, 2026 *PED |
ASENAPINE MALEATE (TABLET) (SUBLINGUAL) SAPHRIS [GENERIC AB]
Drug Classes: atypical antipsychotic
NDA Applicant: ALLERGAN NDA No.: 022117 Prod. No.: 003 RX (EQ 2.5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7741358 DS* DP* 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* Crystal form of asenapine maleate Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 003: Sep 12, 2016 | Oct 6, 2026 *PED |
ASPIRIN (CAPSULE) (ORAL) VAZALORE
Drug Classes: anti-platelet agent == nonsteroidal anti-inflammatory drug
NDA Applicant: PLX PHARMA NDA No.: 203697 Prod. No.: 001 OTC (325MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9216150 DP* 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 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* 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 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
Drug Classes: anti-platelet agent == nonsteroidal anti-inflammatory drug
NDA Applicant: PLX PHARMA NDA No.: 203697 Prod. No.: 002 OTC (81MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10646431 DP* 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 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
Drug Classes: anti-platelet agent == nonsteroidal anti-inflammatory drug == proton pump inhibitor
NDA Applicant: GENUS LIFESCIENCES NDA No.: 205103 Prod. No.: 001 DISC (81MG;40MG); 002 DISC (325MG;40MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9539214 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 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
Drug Classes: HIV protease inhibitor == CYP3A inhibitor
NDA Applicant: BRISTOL NDA No.: 206353 Prod. No.: 001 RX (EQ 300MG BASE;150MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8148374 DS* DP* 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* Use of solid carrier particles to improve the processability of a pharmaceutical agent Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Sep 5, 2018 | Oct 6, 2032 |
ATOGEPANT (TABLET) (ORAL) QULIPTA
Drug Classes: calcitonin gene-related peptide receptor antagonist
NDA Applicant: ABBVIE NDA No.: 215206 Prod. No.: 001 RX (10MG); 002 RX (30MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8754096 DS* DP* 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* 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* 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* 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
Drug Classes: calcitonin gene-related peptide receptor antagonist
NDA Applicant: ABBVIE NDA No.: 215206 Prod. No.: 003 RX (60MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8754096 DS* DP* 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* 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* 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* Tablet formulation for CGRP active compounds Claim Types: Formulation Pat. Sub. Date(s): 003: Oct 26, 2021 | Jan 30, 2035 | |
| Pat. No. 12090148 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
Drug Classes: HMG-CoA reductase inhibitor
NDA Applicant: CMP DEV LLC NDA No.: 213260 Prod. No.: 001 RX (20MG/5ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11369567 DP* Aqueous suspension suitable for oral administration Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 7, 2023 | Jun 7, 2037 | |
| Pat. No. 11654106 DP* 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* 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]
Drug Classes: anticholinergic == muscarinic antagonist
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))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7538211 DS* 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* 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* 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 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* 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* 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 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 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 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
Drug Classes: complement 5a receptor (C5aR) antagonist
NDA Applicant: CHEMOCENTRYX NDA No.: 214487 Prod. No.: 001 RX (10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8445515 DS* DP* C5aR antagonists Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Nov 3, 2021 | Feb 3, 2031 | |
| Pat. No. 8906938 DS* DP* C5aR antagonists Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Nov 3, 2021 | Dec 21, 2029 | |
| Pat. No. 11603356 DS* DP* 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 |
| Pat. No. 11951214 DP* Capsule formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 26, 2024 | Nov 27, 2039 | |
| 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]
Drug Classes: phosphodiesterase-5 (PDE-5) inhibitor
NDA Applicant: METUCHEN PHARMS NDA No.: 202276 Prod. No.: 001 RX (50MG); 002 RX (100MG); 003 RX (200MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6656935 DS* DP* 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
Drug Classes: kinase inhibitor
NDA Applicant: BLUEPRINT MEDICINES NDA No.: 212608 Prod. No.: 001 RX (100MG); 002 RX (200MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9200002 DS* DP* 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* 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* 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* 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. 11999744 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. 12060354 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
Drug Classes: kinase inhibitor
NDA Applicant: BLUEPRINT MEDICINES NDA No.: 212608 Prod. No.: 003 RX (300MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9200002 DS* DP* 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* 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* 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* 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 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
Drug Classes: kinase inhibitor
NDA Applicant: BLUEPRINT MEDICINES NDA No.: 212608 Prod. No.: 004 RX (25MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9200002 DS* DP* 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* 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* 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* 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* 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 | |
| Pat. No. 11999744 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) |
| 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
Drug Classes: kinase inhibitor
NDA Applicant: BLUEPRINT MEDICINES NDA No.: 212608 Prod. No.: 005 RX (50MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9200002 DS* DP* 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* 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* 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* 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 | |
| Pat. No. 11999744 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) |
| 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7638536 DS* DP* 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
Drug Classes: beta lactamase inhibitor == cephalosporin antibacterial
NDA Applicant: ABBVIE NDA No.: 206494 Prod. No.: 001 RX (EQ 0.5GM BASE;2GM/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7112592 DS* DP* Azabicyclic compounds, preparation thereof and use as medicines, in particular as antibacterial agents Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Mar 17, 2015 | Jan 7, 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) |
| Pat. No. 7612087 DP* Heterocyclic compounds as inhibitors of beta-lactamases Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 17, 2015 | Nov 12, 2026 | |
| Pat. No. 8471025 DS* Crystalline forms of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide sodium salt Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Mar 17, 2015 | Aug 12, 2031 | |
| Pat. No. 8835455 DP* Crystalline forms of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide sodium salt Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 17, 2015 | Oct 8, 2030 | |
| Pat. No. 8969566 DS* Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Mar 17, 2015 | Jun 15, 2032 | |
| Pat. No. 9284314 DS* Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Feb 24, 2017 | Jun 15, 2032 | |
| Pat. No. 9695122 DS* Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof Claim Types: Formulation; Compound; Composition Pat. Sub. Date(s): 001: Aug 8, 2017 | Jun 15, 2032 | |
| 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
Drug Classes: kinase inhibitor
NDA Applicant: PF PRISM CV NDA No.: 202324 Prod. No.: 001 RX (1MG); 002 RX (5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6534524 DS* DP* 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* 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 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 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]
Drug Classes: nucleoside metabolic inhibitor
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
Drug Classes: nucleoside metabolic inhibitor
NDA Applicant: BRISTOL NDA No.: 214120 Prod. No.: 001 RX (200MG); 002 RX (300MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8846628 DP* 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. 11571436 DP* 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 | |
| Pat. No. 12053482 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 |
| 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%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7700076 DP* Penetrating pharmaceutical foam Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 26, 2015 | Sep 18, 2027 | |
| Pat. No. 8435498 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. 9211259 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* Dicarboxylic acid foamable vehicle and pharmaceutical compositions thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 23, 2016 | Dec 8, 2027 | |
| Pat. No. 10117812 DP* 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
Drug Classes: histamine-1 (H1) receptor antagonist
NDA Applicant: MYLAN SPECIALITY LP NDA No.: 022203 Prod. No.: 001 DISC (0.137MG/SPRAY**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8071073 DP* 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 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]
Drug Classes: histamine-1 (H1) receptor antagonist
NDA Applicant: MYLAN SPECIALITY LP NDA No.: 022203 Prod. No.: 002 DISC (0.2055MG/SPRAY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8071073 DP* 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 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* 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]
Drug Classes: histamine-1 (H1) receptor antagonist
NDA Applicant: BAYER HLTHCARE NDA No.: 213872 Prod. No.: 001 OTC (0.2055MG/SPRAY); 002 OTC (0.2055MG/SPRAY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8071073 DP* 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 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* Compositions comprising azelastine Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 8, 2021 | Nov 22, 2025 |
AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE (SPRAY, METERED) (NASAL) DYMISTA [GENERIC AB]
Drug Classes: histamine-1 (H1) receptor antagonist == corticosteroid
NDA Applicant: MYLAN SPECIALITY LP NDA No.: 202236 Prod. No.: 001 RX (0.137MG/SPRAY;0.05MG/SPRAY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8163723 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* 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
Drug Classes: angiotensin II receptor blocker
NDA Applicant: AZURITY NDA No.: 200796 Prod. No.: 001 RX (EQ 40MG MEDOXOMIL); 002 RX (EQ 80MG MEDOXOMIL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7157584 DS* Benzimidazole derivative and use thereof Claim Types: Compound Pat. Sub. Date(s): All strengths: None | May 22, 2025 | |
| Pat. No. 7572920 DP* 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* Solid pharmaceutical composition comprising a benzimidazole-7-carboxylate derivative and a pH control agent Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Jul 30, 2015 | Mar 26, 2028 |
AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE (TABLET) (ORAL) EDARBYCLOR
Drug Classes: angiotensin II receptor blocker == thiazide-like diuretic
NDA Applicant: AZURITY NDA No.: 202331 Prod. No.: 001 RX (EQ 40MG MEDOXOMIL;12.5MG); 002 RX (EQ 40MG MEDOXOMIL;25MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7157584 DS* 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* 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* 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* Solid pharmaceutical composition Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Nov 19, 2015 | Feb 4, 2030 | |
| Pat. No. 9387249 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
Drug Classes: macrolide antimicrobial
NDA Applicant: PF PRISM CV NDA No.: 050797 Prod. No.: 001 DISC (EQ 2GM BASE/BOT)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6984403 DP* 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* Multiparticulate crystalline drug compositions having controlled release profiles Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Mar 15, 2011 | Feb 14, 2024 |