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 | Oct 5, 2027 | |
| 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 | Dec 8, 2029 |
ABALOPARATIDE (SOLUTION) (SUBCUTANEOUS) TYMLOS
Drug Classes: parathyroid hormone related peptide [PTHrP(1-34)] analog
NDA Applicant: RADIUS HEALTH INC NDA No.: 208743 Prod. No.: 001 RX (3.12MG/1.56ML (2MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| 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. |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Apr 28, 2022 |
ABAMETAPIR (LOTION) (TOPICAL) XEGLYZE
NDA Applicant: DR REDDYS LABS SA NDA No.: 206966 Prod. No.: 001 RX (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 31, 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 | Dec 15, 2029 | U-2132: In combination with fulvestrant for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy U-2135: As monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting U-2251: In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Feb 26, 2021 | I-768: In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer |
| Exclusivity Code: NCE - New chemical entity | Sep 28, 2022 |
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 | Dec 15, 2029 | 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-2132: In combination with fulvestrant for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy U-2135: As monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting U-2251: In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Feb 26, 2021 | I-768: In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer |
| Exclusivity Code: NCE - New chemical entity | Sep 28, 2022 |
ABIRATERONE ACETATE (TABLET) (ORAL) ZYTIGA [GENERIC AB]
Drug Classes: CYP17 inhibitor
NDA Applicant: JANSSEN BIOTECH NDA No.: 202379 Prod. No.: 001 RX (250MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: I - New Indication | Feb 7, 2021 | I-765: Abiraterone acetate in combination with prednisone for the treatment of patients with metastatic high-risk castration-sensitive prostate cancer |
ABIRATERONE ACETATE (TABLET) (ORAL) ZYTIGA
Drug Classes: CYP17 inhibitor
NDA Applicant: JANSSEN BIOTECH NDA No.: 202379 Prod. No.: 002 RX (500MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8822438 DLR* Methods and compositions for treating cancer Claim Types: Method of use Pat. Sub. Date(s): 002: Aug 2, 2017 | Aug 24, 2027 | U-1579: Use in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer U-1580: Use in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer who had received prior docetaxel chemotherapy U-2235: Use in combination with prednisone for the treatment of patients with metastatic high-risk castration-sensitive prostate cancer |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Feb 7, 2021 | I-765: Abiraterone acetate in combination with prednisone for the treatment of patients with metastatic high-risk castration-sensitive prostate cancer |
ABIRATERONE ACETATE (TABLET) (ORAL) YONSA
Drug Classes: CYP17 inhibitor
NDA Applicant: SUN PHARMA GLOBAL 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 |
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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Nov 21, 2022 | I-817: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) |
| Exclusivity Code: NCE - New chemical entity | Oct 31, 2022 | |
| 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) |
ACETAMINOPHEN (SOLUTION) (INTRAVENOUS) OFIRMEV [GENERIC AP]
NDA Applicant: MALLINCKRODT HOSP NDA No.: 022450 Prod. No.: 001 RX (1GM/100ML (10MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6992218 DP* Method for obtaining aqueous formulations of oxidation-sensitive active principles Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Nov 12, 2010 | Dec 6, 2021 *PED | |
| 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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Jul 27, 2020 PED | M-196: Revisions to the package insert based on data from a randomized, placebo controlled, multicenter study of intravenous acetaminophen for the treatment of acute pain in pediatric patients to fulfill the post-marketing requirement 1704-1 |
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: KVK TECH INC NDA No.: 208653 Prod. No.: 001 RX (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: KVK TECH INC NDA No.: 208653 Prod. No.: 002 RX (325MG;EQ 4.08MG BASE); 003 RX (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; BUTALBITAL (CAPSULE) (ORAL) BUTALBITAL AND ACETAMINOPHEN [GENERIC AA]
Drug Classes: barbiturate
NDA Applicant: GRANULES PHARMS NDA No.: 213115 Prod. No.: 001 RX (300MG;50MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Jul 28, 2020 |
ACETAMINOPHEN; IBUPROFEN (TABLET) (ORAL) ADVIL DUAL ACTION WITH ACETAMINOPHEN
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: GLAXOSMITHKLINE NDA No.: 211733 Prod. No.: 001 OTC (250MG;125MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NP - New product | Feb 28, 2023 |
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. 6488962 DP* Tablet shapes to enhance gastric retention of swellable controlled-release oral dosage forms Claim Types: Composition Pat. Sub. Date(s): 001: Apr 3, 2014 | Jun 20, 2020 | |
| Pat. No. 7976870 Gastric retentive oral dosage form with restricted drug release in the lower gastrointestinal tract Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Apr 3, 2014 | Jun 1, 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 |
ACLIDINIUM BROMIDE (POWDER, METERED) (INHALATION) TUDORZA PRESSAIR
Drug Classes: anticholinergic
NDA Applicant: CIRCASSIA NDA No.: 202450 Prod. No.: 001 RX (0.4MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE46417 DS* DP* [Extended 1679 days (4.6 years)] Quinuclidine derivatives and their use as muscarinic M3 receptor ligands Claim Types: Compound; Process; Method of use Pat. Sub. Date(s): 001: Jun 28, 2017 | Feb 10, 2025 | U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD) |
| Pat. No. 6681768 DP* Powder formulation disintegrating system and method for dry powder inhalers Claim Types: Device Pat. Sub. Date(s): 001: Aug 17, 2012 | Aug 7, 2022 | |
| Pat. No. 7078412 DS* DP* Quinuclidine derivatives and medicinal compositions containing the same Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Aug 17, 2012 | Jul 7, 2020 | 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. 9056100 DP* Quinuclidine derivatives and medicinal compositions containing the same Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jul 15, 2015 | Jul 7, 2020 | U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD) |
| Pat. No. 9333195 DP* Quinuclidine derivatives and medicinal compositions containing the same Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Jun 8, 2016 | Jul 7, 2020 | U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD) |
| Pat. No. 10034867 DP* Quinuclidine derivatives and medicinal compositions containing the same Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Oct 25, 2018 | Jul 7, 2020 | U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD) U-2514: Maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) |
| 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. 10588895 Quinuclidine derivatives and medicinal compositions containing the same Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 9, 2020 | Jul 7, 2020 | U-2772: Maintenance treatment of chronic pulmonary disease (COPD) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Mar 29, 2022 | M-256: Information added to the clinical studies section to fulfill a post-marketing requirement |
ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE (POWDER, METERED) (INHALATION) DUAKLIR PRESSAIR
Drug Classes: anticholinergic; beta-2 adrenergic agonist
NDA Applicant: CIRCASSIA NDA No.: 210595 Prod. No.: 001 RX (0.4MG/INH;0.012MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE46417 DS* DP* [Extended 1679 days (4.6 years)] Quinuclidine derivatives and their use as muscarinic M3 receptor ligands Claim Types: Compound; Process; Method of use Pat. Sub. Date(s): 001: Apr 24, 2019 | Feb 10, 2025 | U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD) |
| Pat. No. 6681768 DP* Powder formulation disintegrating system and method for dry powder inhalers Claim Types: Device Pat. Sub. Date(s): 001: Apr 24, 2019 | Aug 7, 2022 | |
| Pat. No. 7078412 DS* DP* Quinuclidine derivatives and medicinal compositions containing the same Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Apr 24, 2019 | Jul 7, 2020 | U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD) |
| Pat. No. 7750023 DP* Quinuclidine derivatives and medicinal compositions containing the same Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Apr 24, 2019 | Jul 7, 2020 | 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. 8129405 DP* Quinuclidine derivatives and medicinal compositions containing the same Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Apr 24, 2019 | Jul 7, 2020 | U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD) |
| Pat. No. 9056100 DP* Quinuclidine derivatives and medicinal compositions containing the same Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Apr 24, 2019 | Jul 7, 2020 | U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD) |
| Pat. No. 9333195 DP* Quinuclidine derivatives and medicinal compositions containing the same Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Apr 24, 2019 | Jul 7, 2020 | U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD) |
| Pat. No. 10034867 DP* Quinuclidine derivatives and medicinal compositions containing the same Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Apr 24, 2019 | Jul 7, 2020 | U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD) U-2514: Maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) |
| 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. 10588895 Quinuclidine derivatives and medicinal compositions containing the same Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 9, 2020 | Jul 7, 2020 | U-2772: Maintenance treatment of chronic pulmonary disease (COPD) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NC - New combination | Mar 29, 2022 |
ACYCLOVIR (OINTMENT) (OPHTHALMIC) AVACLYR
Drug Classes: nucleoside analog HSV DNA polymerase inhibitor / VZV DNA polymerase inhibitor
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 polymerase inhibitor
NDA Applicant: EPI HLTH 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; HYDROCORTISONE (CREAM) (TOPICAL) XERESE
Drug Classes: nucleoside analog HSV DNA polymerase inhibitor / VZV DNA polymerase inhibitor; corticosteroid
NDA Applicant: BAUSCH NDA No.: 022436 Prod. No.: 001 RX (5%;1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7223387 DP* Antiviral formulations comprising propylene glycol and an isopropyl alkanoic acid ester Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Nov 13, 2022 | U-1006: New combination product for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in adults and adolescents (12 years of age and older) U-1484: Combination product for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in adults and children (6 years of age and older) |
ADAPALENE (GEL) (TOPICAL) DIFFERIN [GENERIC AB]
Drug Classes: 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 | |
| Pat. No. 7834060 Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphtoic acid for the treatment of dermatological disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 19, 2010 | Mar 12, 2023 | U-1078: Treatment of acne |
| Pat. No. 7838558 DP* Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 30, 2010 | Mar 12, 2023 | |
| Pat. No. 7868044 Method for the treatment of acne using compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 12, 2011 | Mar 12, 2023 | U-1078: Treatment of acne |
| Pat. No. 8703820 Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders Claim Types: Method of use Pat. Sub. Date(s): 001: May 21, 2014 | Mar 12, 2023 | U-1078: Treatment of acne |
ADAPALENE (LOTION) (TOPICAL) DIFFERIN
Drug Classes: retinoid
NDA Applicant: GALDERMA LABS LP NDA No.: 022502 Prod. No.: 001 RX (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. 8105618 Dermatological/cosmetic gels comprising at least one retinoid and/or retinoid salt and benzoyl peroxide Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 29, 2012 | Dec 23, 2022 | 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 |
| Pat. No. 8241649 DP* Dermatological/cosmetic gels comprising at least one retinoid and/or retinoid salt and benzoyl peroxide Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): 001: Aug 14, 2012 | Dec 23, 2022 | |
| Pat. No. 8445543 Combinations of adapalene and benzoyl peroxide for treating acne lesions Claim Types: Method of administration Pat. Sub. Date(s): 001: Jun 19, 2013 | Jul 12, 2027 | U-1078: Treatment of acne |
| Pat. No. 8809305 Administration of adapalene and benzoyl peroxide for the long-term treatment of acne vulgaris Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Sep 19, 2014 | Dec 23, 2022 | U-1078: Treatment of acne |
| Pat. No. 8936800 DP* Gel composition for treatment of common acne comprising a combination of benzoyl peroxide and adapalene and/or adapalene salt Claim Types: Formulation; Method of use; Drug in a container Pat. Sub. Date(s): 001: Mar 19, 2015 | Dec 23, 2022 | U-1078: Treatment of acne |
ADAPALENE; BENZOYL PEROXIDE (GEL) (TOPICAL) EPIDUO FORTE
Drug Classes: retinoid
NDA Applicant: GALDERMA LABS NDA No.: 207917 Prod. No.: 001 RX (0.3%;2.5%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8445543 Combinations of adapalene and benzoyl peroxide for treating acne lesions Claim Types: Method of administration Pat. Sub. Date(s): 001: Jul 24, 2015 | Dec 23, 2022 | U-1078: Treatment of acne |
| Pat. No. 8703820 Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 24, 2015 | Mar 12, 2023 | U-1078: Treatment of acne |
| Pat. No. 8729127 Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 24, 2015 | Mar 12, 2023 | U-1078: Treatment of acne |
| Pat. No. 8785420 Combination/association of adapalene and benzoyl peroxide for treating acne lesions Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 24, 2015 | Dec 23, 2022 | U-1078: Treatment of acne |
| Pat. No. 8809305 Administration of adapalene and benzoyl peroxide for the long-term treatment of acne vulgaris Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 29, 2016 | Dec 23, 2022 | U-1078: Treatment of acne |
| Pat. No. 8936800 DP* Gel composition for treatment of common acne comprising a combination of benzoyl peroxide and adapalene and/or adapalene salt Claim Types: Formulation; Method of use; Drug in a container Pat. Sub. Date(s): 001: Jul 24, 2015 | Dec 23, 2022 | U-1078: Treatment of acne |
| Pat. No. 9381179 Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 4, 2016 | Mar 12, 2023 | U-1078: Treatment of acne |
| Pat. No. 9387187 Administration of 6[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 5, 2016 | Mar 12, 2023 | U-1078: Treatment of acne |
| Pat. No. 9814690 DP* Gel composition for treatment of common acne comprising a combination of benzoyl peroxide and adapalene and/or adapalene salt Claim Types: Formulation; Method of use; Drug in a container Pat. Sub. Date(s): 001: Dec 12, 2017 | Dec 23, 2022 | U-1078: Treatment of acne |
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 | Jan 13, 2026 | |
| 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 | Oct 10, 2029 | |
| 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 | Dec 19, 2029 | |
| 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 | Nov 9, 2026 | 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 | Jul 5, 2030 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jan 12, 2021 | I-763: Treatment of patients with metastatic non-small cell lung cancer whose tumors have non-resistant epidermal growth factor receptor mutations as detected by an FDA-approved test |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 15, 2023 | ODE-115: Treatment of patients with metastatic, squamous, non-small cell lung cancer progressing after platinum-based chemotherapy |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jan 12, 2025 | ODE-230: First-line treatment of metastatic nonsmall cell lung cancer whose tumors have non-resistant epidermal growth factor mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jul 12, 2020 | ODE-50: First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) 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 DISC (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 |
ALBUMIN HUMAN (INJECTABLE) (INJECTION) OPTISON
Drug Classes: human serum albumin; radioactive diagnostic agent; ultrasound contrast agent
NDA Applicant: GE HEALTHCARE NDA No.: 020899 Prod. No.: 001 RX (10MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6723303 DP* Ultrasound contrast agents including protein stabilized microspheres of perfluoropropane, perfluorobutane or perfluoropentane Claim Types: Composition Pat. Sub. Date(s): 001: None | Apr 20, 2021 |
ALBUTEROL SULFATE (SOLUTION) (INHALATION) ACCUNEB [GENERIC AN]
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: MYLAN SPECIALITY LP NDA No.: 020949 Prod. No.: 001 RX (EQ 0.042% BASE); 002 RX (EQ 0.021% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6702997 Albuterol inhalation solution, system, kit and method for relieving symptoms of pediatric asthma Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Dec 28, 2021 | U-558: Indicated for the relief of bronchospasm in patients 2-12 years of age with asthma (reversible obstructive airway disease) |
ALBUTEROL SULFATE (AEROSOL, METERED) (INHALATION) VENTOLIN HFA [Has competitive generic]
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: GLAXOSMITHKLINE NDA No.: 020983 Prod. No.: 001 RX (EQ 0.09MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7500444 DP* Actuation indicator for a dispensing device Claim Types: Device Pat. Sub. Date(s): 001: None | Aug 26, 2026 *PED | |
| Pat. No. 7832351 DP* Actuation indicator for a dispensing device Claim Types: Device Pat. Sub. Date(s): 001: Sep 7, 2012 | Dec 19, 2023 *PED | |
| Pat. No. 9861771 DP* Device housing for an aerosol container Claim Types: Device Pat. Sub. Date(s): 001: Mar 14, 2018 | Oct 11, 2020 |
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. 7105152 DP* Suspension aerosol formulations Claim Types: Formulation; Device Pat. Sub. Date(s): 001: None | Sep 12, 2023 | |
| 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 |
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. 6701917 DP* Dose counter for medicament inhaler Claim Types: Device Pat. Sub. Date(s): 001: Apr 28, 2015 | Jun 23, 2021 | |
| Pat. No. 6718972 DP* Dose metering system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): 001: Apr 28, 2015 | Jun 23, 2021 | |
| Pat. No. 6748947 DP* De-agglomerator for breath-actuated dry powder inhaler Claim Types: Device; Part of a dosage form Pat. Sub. Date(s): 001: Apr 28, 2015 | Jun 23, 2021 | |
| Pat. No. 6871646 DP* De-agglomerator for breath-actuated dry powder inhaler Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Apr 28, 2015 | Jun 23, 2021 | |
| Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): 001: Apr 28, 2015 | May 6, 2023 | |
| Pat. No. 8006690 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): 001: Apr 28, 2015 | Jun 23, 2021 | |
| 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 |
ALBUTEROL SULFATE (POWDER, METERED) (INHALATION) PROAIR DIGIHALER
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: TEVA BRANDED PHARM NDA No.: 205636 Prod. No.: 002 RX (EQ 0.09MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6701917 DP* Dose counter for medicament inhaler Claim Types: Device Pat. Sub. Date(s): 002: Jan 9, 2019 | Jun 23, 2021 | |
| Pat. No. 6718972 DP* Dose metering system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): 002: Jan 9, 2019 | Jun 23, 2021 | |
| Pat. No. 6748947 DP* De-agglomerator for breath-actuated dry powder inhaler Claim Types: Device; Part of a dosage form Pat. Sub. Date(s): 002: Jan 9, 2019 | Jun 23, 2021 | |
| Pat. No. 6871646 DP* De-agglomerator for breath-actuated dry powder inhaler Claim Types: Method of improving a treatment Pat. Sub. Date(s): 002: Jan 9, 2019 | Jun 23, 2021 | |
| Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): 002: Jan 9, 2019 | May 6, 2023 | |
| Pat. No. 8006690 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): 002: Jan 9, 2019 | Jun 23, 2021 | |
| 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 |
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE (SOLUTION) (INHALATION) DUONEB
Drug Classes: beta-2 adrenergic agonist; anticholinergic
NDA Applicant: MYLAN SPECIALITY LP NDA No.: 020950 Prod. No.: 001 DISC (EQ 0.083% BASE;0.017%**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6632842 Albuterol and ipratropium inhalation solution, system, kit and method for relieving symptoms of chronic obstructive pulmonary disease Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: None | Dec 28, 2021 | U-532: Treatment of bronchospasm associated with COPD in patients requiring more than one broncho dilator |
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. 6988496 DP* Cartridge for a liquid Claim Types: Method of administration; Drug in a container Pat. Sub. Date(s): 001: Nov 2, 2011 | Feb 23, 2020 | |
| 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. 7988001 DP* Container provided with a pressure equalization opening Claim Types: Device Pat. Sub. Date(s): 001: Nov 2, 2011 | Aug 4, 2021 | |
| 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
Drug Classes: histamine-1 (H1) receptor antagonist
NDA Applicant: ALLERGAN NDA No.: 022134 Prod. No.: 001 RX (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-1493: Method for preventing itching associated with allergic conjunctivitis |
| 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-1493: Method for preventing itching associated with allergic conjunctivitis |
ALCOHOL (SOLUTION) (INTRA-ARTERIAL) ABLYSINOL
Drug Classes: pediculicide
NDA Applicant: BELCHER NDA No.: 207987 Prod. No.: 001 RX (99% (1ML)); 002 RX (99% (5ML))
| 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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Nov 6, 2020 | I-756: Expanded the approved indication by removing the restriction for use only in patients who have progressed on or are intolerant to crizotinib |
| Exclusivity Code: NCE - New chemical entity | Dec 11, 2020 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 11, 2022 | ODE-105: Treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), who have progressed on or are intolerant to crizotinib |
| Exclusivity Code: ODE - Orphan drug 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 |
ALENDRONATE SODIUM (TABLET, EFFERVESCENT) (ORAL) BINOSTO
NDA Applicant: ASCEND THERAPS US NDA No.: 202344 Prod. No.: 001 RX (EQ 70MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7488496 DS* DP* Effervescent compositions comprising bisphosphonates and methods related thereto Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 13, 2012 | Aug 11, 2023 | |
| Pat. No. 7964212 DS* DP* Effervescent compositions comprising phosphonates and methods related thereto Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 13, 2012 | Mar 6, 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 (CAPSULE, PELLET) (ORAL) TEKTURNA
Drug Classes: renin inhibitor
NDA Applicant: NODEN PHARMA NDA No.: 210709 Prod. No.: 001 DISC (EQ 37.5MG BASE)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NP - New product | May 14, 2021 PED |
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE (TABLET) (ORAL) TEKAMLO
Drug Classes: renin inhibitor; 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; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE (TABLET) (ORAL) AMTURNIDE
Drug Classes: renin inhibitor; dihydropyridine calcium channel blocker; thiazide diuretic
NDA Applicant: NOVARTIS NDA No.: 200045 Prod. No.: 001 DISC (EQ 150MG BASE;EQ 5MG BASE;12.5MG); 002 DISC (EQ 300MG BASE;EQ 5MG BASE;12.5MG); 003 DISC (EQ 300MG BASE;EQ 5MG BASE;25MG); 004 DISC (EQ 300MG BASE;EQ 10MG BASE;12.5MG); 005 DISC (EQ 300MG BASE;EQ 10MG BASE;25MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8183295 DP* Pharmaceutical composition comprising a renin inhibitor, a calcium channel blocker and a diuretic Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 3, 2013; 002: None; 003: None; 004: None; 005: None | May 16, 2023 | |
| Pat. No. 8618174 DP* Synergistic combinations comprising a renin inhibitor for cardiovascular diseases Claim Types: Composition; Formulation Pat. Sub. Date(s): All strengths: None | Nov 15, 2021 |
ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE (TABLET) (ORAL) TEKTURNA HCT
Drug Classes: renin inhibitor; thiazide diuretic
NDA Applicant: NODEN PHARMA NDA No.: 022107 Prod. No.: 001 RX (EQ 150MG BASE;12.5MG); 002 RX (EQ 150MG BASE;25MG); 003 RX (EQ 300MG BASE;12.5MG); 004 RX (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 | |
| Pat. No. 9023893 DP* Synergistic combinations comprising a renin inhibitor for cardiovascular diseases Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 15, 2017 | Mar 3, 2022 |
ALISKIREN HEMIFUMARATE; VALSARTAN (TABLET) (ORAL) VALTURNA
Drug Classes: 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 | 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. 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 [Extended 262 days (0.7 years)] 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* [Extended 101 days (0.3 years)] 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 |
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 [Extended 262 days (0.7 years)] 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* [Extended 101 days (0.3 years)] 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 |
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); 004 RX (EQ 12.5MG BASE;EQ 15MG BASE); 005 RX (EQ 12.5MG BASE;EQ 30MG BASE); 006 RX (EQ 12.5MG BASE;EQ 45MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6329404 DP* [Extended 5 years] Pharmaceutical composition Claim Types: Composition; Method of use Pat. Sub. Date(s): 001: Jan 19, 2017; 002: Jan 19, 2017; 003: Jan 19, 2017; 004: Jan 19, 2017; 005: Jan 19, 2017; 006: Feb 22, 2013 | Jun 19, 2021 | U-1334: Methods of treating diabetes comprising administering an insulin sensitivity enhancer such as pioglitazone in combination with an insulin secretion enhancer |
| 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 [Extended 262 days (0.7 years)] 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* [Extended 101 days (0.3 years)] 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 | Sep 28, 2030 | U-2539: In combination with fulvestrant for treatment of postmenopausal women, and men, with HR-positive, HER-2-negative, PIK3CA-mutated, advanced or metastatic breast cancer |
| Pat. No. 8476268 DS* DP* 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: NCE - New chemical entity | May 24, 2024 |
ALVIMOPAN (CAPSULE) (ORAL) ENTEREG
Drug Classes: opioid antagonist
NDA Applicant: CUBIST PHARMS NDA No.: 021775 Prod. No.: 001 RX (12MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6469030 Methods for the treatment and prevention of ileus Claim Types: Method of use Pat. Sub. Date(s): 001: None | Nov 29, 2020 | U-879: A method of treating or preventing ileus |
| Pat. No. 8112290 DLR* Methods for delivering a drug to a hospital patient for short-term use while minimizing long-term use of the drug Claim Types: Method of administration Pat. Sub. Date(s): 001: Mar 1, 2012 | Jul 31, 2030 | U-1443: Accelerating the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis |
| Pat. No. 8645160 DLR* Methods for delivering a drug to a hospital patient for short-term use while minimizing long-term use of the drug Claim Types: Method of administration Pat. Sub. Date(s): 001: None | Jun 18, 2029 | U-1485: Treating a subject undergoing abdominal surgery by administering alvimopan to accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis |
| 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
Drug Classes: influenza A M2 protein inhibitor
NDA Applicant: ADAMAS PHARMA 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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Aug 24, 2020 | I-769: Treatment of dyskinesia in patients with parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications |
| 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: OSMOTICA PHARM NDA No.: 209410 Prod. No.: 001 RX (EQ 129MG BASE); 002 RX (EQ 193MG BASE); 003 RX (EQ 258MG 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. 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. 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 |
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 (TABLET) (ORAL) RUZURGI
Drug Classes: potassium channel blocker
NDA Applicant: JACOBUS PHARM CO INC NDA No.: 209321 Prod. No.: 001 RX (10MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity | May 6, 2026 | ODE-244: Treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 to less than 17 years of age |
AMIFAMPRIDINE PHOSPHATE (TABLET) (ORAL) FIRDAPSE
Drug Classes: potassium channel blocker
NDA Applicant: CATALYST PHARMS NDA No.: 208078 Prod. No.: 001 RX (EQ 10MG BASE)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NCE - New chemical entity | Nov 28, 2023 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 28, 2025 | ODE-223: Indicated for the treatment of lambert-eaton myasthenic syndrome (LEMS) in adults |
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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: GAIN - Generating Antibiotic Incentives Now | Sep 28, 2030 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Sep 28, 2025 | 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 |
AMINOCAPROIC ACID (TABLET) (ORAL) AMINOCAPROIC ACID [GENERIC AB]
Drug Classes: antifibrinolytic
NDA Applicant: AMNEAL NDA No.: 212492 Prod. No.: 001 RX (500MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | May 30, 2020 |
AMINOCAPROIC ACID (SYRUP) (ORAL) AMINOCAPROIC ACID [GENERIC AA]
Drug Classes: antifibrinolytic
NDA Applicant: AMNEAL NDA No.: 212780 Prod. No.: 001 RX (1.25GM/5ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Feb 26, 2020 |
AMINOLEVULINIC ACID HYDROCHLORIDE (SOLUTION) (TOPICAL) LEVULAN
Drug Classes: porphyrin precursor
NDA Applicant: DUSA 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-804: Treatment of actinic keratoses by photodynamic therapy |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Mar 9, 2021 | I-766: Treatment of minimally to moderately thick actinic keratosis of the upper extremities in conjunction with a blue light photodynamic therapy illuminator |
AMINOLEVULINIC ACID HYDROCHLORIDE (FOR SOLUTION) (ORAL) GLEOLAN
Drug Classes: porphyrin precursor
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. 6869939 DP* Formulations containing amiodarone and sulfoalkyl ether cyclodextrin Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: None | May 4, 2022 | |
| Pat. No. 7635773 DP* Sulfoalkyl ether cyclodextrin compositions Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: None | Mar 13, 2029 |
AMISULPRIDE (SOLUTION) (INTRAVENOUS) BARHEMSYS
NDA Applicant: ACACIA NDA No.: 209510 Prod. No.: 001 RX (5MG/2ML (2.5MG/ML))
| 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 | Mar 10, 2031 | U-1744: Prevention of post-operative nausea and vomiting U-2754: 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 | 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 | 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 | Mar 10, 2031 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Feb 26, 2025 |
AMLODIPINE BENZOATE (SUSPENSION) (ORAL) KATERZIA
Drug Classes: 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 |
AMLODIPINE BESYLATE (TABLET, ORALLY DISINTEGRATING) (ORAL) AMLODIPINE BESYLATE
Drug Classes: dihydropyridine calcium channel blocker
NDA Applicant: SYNTHON PHARMS NDA No.: 022026 Prod. No.: 001 DISC (EQ 2.5MG BASE); 002 DISC (EQ 5MG BASE); 003 DISC (EQ 10MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6828339 DS* Amlodipine salt forms and processes for preparing them Claim Types: New polymorph, salt or hydrate; Formulation Pat. Sub. Date(s): All strengths: None | Nov 20, 2022 |
AMLODIPINE BESYLATE; CELECOXIB (TABLET) (ORAL) CONSENSI
Drug Classes: dihydropyridine calcium channel blocker; nonsteroidal anti-inflammatory drug
NDA Applicant: COEPTIS NDA No.: 210045 Prod. No.: 001 RX (EQ 2.5MG BASE;200MG); 002 RX (EQ 5MG BASE;200MG); 003 RX (EQ 10MG BASE;200MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| 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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NC - New combination | May 31, 2021 |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN (TABLET) (ORAL) EXFORGE HCT [GENERIC AB]
Drug Classes: dihydropyridine calcium channel blocker; thiazide diuretic; angiotensin II receptor blocker
NDA Applicant: NOVARTIS NDA No.: 022314 Prod. No.: 001 RX (EQ 5MG BASE;12.5MG;160MG); 002 RX (EQ 5MG BASE;25MG;160MG); 003 RX (EQ 10MG BASE;12.5MG;160MG); 004 RX (EQ 10MG BASE;25MG;160MG); 005 RX (EQ 10MG BASE;25MG;320MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8101599 DP* Pharmaceutical composition containing anti-hypertensive agents Claim Types: Formulation; Kit Pat. Sub. Date(s): 001: Jan 30, 2012; 002: None; 003: None; 004: None; 005: None | May 16, 2023 | |
| Pat. No. 8475839 DP* Formulation Claim Types: Pat. Sub. Date(s): All strengths: Aug 1, 2013 | Nov 16, 2023 *PED |
AMLODIPINE BESYLATE; PERINDOPRIL ARGININE (TABLET) (ORAL) PRESTALIA
Drug Classes: dihydropyridine calcium channel blocker; angiotensin converting enzyme inhibitor
NDA Applicant: ADHERA NDA No.: 205003 Prod. No.: 001 RX (EQ 2.5MG BASE;3.5MG ); 002 RX (EQ 5MG BASE;7MG); 003 RX (EQ 10MG BASE;14MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6696481 DS* DP* Salt of perindopril and pharmaceutical compositions containing it Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): All strengths: Dec 29, 2015 | Apr 15, 2023 | U-3: Treatment of hypertension |
| 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. 6544555 DS* DP* Antibiotic product, use and formulation thereof Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Oct 13, 2020 | U-897: Method of treating tonsillitis and/or pharyngitis secondary to streptococcus pyogenes in a once-a-day amoxicillin product |
| Pat. No. 6669948 DS* DP* Antibiotic product, use and formulation thereof Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Oct 13, 2020 | U-897: Method of treating tonsillitis and/or pharyngitis secondary to streptococcus pyogenes in a once-a-day amoxicillin product |
| Pat. No. 6723341 DS* DP* Antibiotic product, use and formulation thereof Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Oct 13, 2020 | U-897: Method of treating tonsillitis and/or pharyngitis secondary to streptococcus pyogenes in a once-a-day amoxicillin product |
| Pat. No. 8299052 Pharmaceutical compositions and methods for improved bacterial eradication Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 3, 2012 | May 7, 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; CLAVULANATE POTASSIUM (TABLET, EXTENDED RELEASE) (ORAL) AUGMENTIN XR [GENERIC AB]
Drug Classes: penicillin class antibacterial
NDA Applicant: NEOPHARMA NDA No.: 050785 Prod. No.: 001 RX (1GM;EQ 62.5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6746692 DP* Modified release pharmaceutical formulation comprising amoxycillin Claim Types: Formulation Pat. Sub. Date(s): 001: None | Apr 4, 2020 | |
| Pat. No. 6783773 DP* Composition comprising amoxicillin and potassium clavulanate Claim Types: Formulation Pat. Sub. Date(s): 001: None | Apr 4, 2020 | |
| Pat. No. 6878386 Method of treating a bacterial infection comprising amoxycillin and potassium clavulanate Claim Types: Method of use Pat. Sub. Date(s): 001: None | Apr 4, 2020 | U-926: Mgt specific bacterial infections. treatment pts w/ community acquired pneumonia or bacterial sinusitis due to confirmed, or suspected b-lactamase producing pathogens & S. pneumoniae with reduced susceptibility to penicillin (mic=2mc/ml) |
| Pat. No. 7217430 DP* Compositions and methods of treatment comprising amoxicillin and potassium clavulanate with xanthan Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Apr 4, 2020 | U-926: Mgt specific bacterial infections. treatment pts w/ community acquired pneumonia or bacterial sinusitis due to confirmed, or suspected b-lactamase producing pathogens & S. pneumoniae with reduced susceptibility to penicillin (mic=2mc/ml) |
| Pat. No. 7250176 Method of treating a bacterial infection Claim Types: Method of use Pat. Sub. Date(s): 001: None | Apr 4, 2020 | U-926: Mgt specific bacterial infections. treatment pts w/ community acquired pneumonia or bacterial sinusitis due to confirmed, or suspected b-lactamase producing pathogens & S. pneumoniae with reduced susceptibility to penicillin (mic=2mc/ml) |
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 |
AMPHETAMINE (SUSPENSION, EXTENDED RELEASE) (ORAL) ADZENYS ER
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: NEOS THERAPS INC NDA No.: 204325 Prod. No.: 001 RX (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: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
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 |
AMPHETAMINE (SUSPENSION, EXTENDED RELEASE) (ORAL) DYANAVEL XR
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: TRIS PHARMA INC NDA No.: 208147 Prod. No.: 001 RX (EQ 2.5MG 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 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE (TABLET) (ORAL) ADDERALL 10; ADDERALL 20; ADDERALL 5; ADDERALL 30; ADDERALL 7.5; ADDERALL 12.5; ADDERALL 15
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: TEVA WOMENS NDA No.: 011522 Prod. No.: 007 DISC (2.5MG;2.5MG;2.5MG;2.5MG**); 008 DISC (5MG;5MG;5MG;5MG**); 009 DISC (1.25MG;1.25MG;1.25MG;1.25MG**); 010 DISC (7.5MG;7.5MG;7.5MG;7.5MG**); 011 DISC (1.875MG;1.875MG;1.875MG;1.875MG**); 012 DISC (3.125MG;3.125MG;3.125MG;3.125MG**); 013 DISC (3.75MG;3.75MG;3.75MG;3.75MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6384020 Rapid immediate release oral dosage form Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jan 6, 2021 *PED |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE (CAPSULE, EXTENDED RELEASE) (ORAL) MYDAYIS [Has competitive generic]
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
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. 6913768 DP* Sustained release delivery of amphetamine salts Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 7, 2017 | May 24, 2023 | U-2025: Treatment of attention deficit hyperactivity disorder |
| 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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Mar 13, 2023 PED | M-248: Information added to the labeling to describe a trial evaluating a lower dose than those approved for pediatric patients 13 to 17 years of age |
| Exclusivity Code: NP - New product | Jun 20, 2020 |
AMPHETAMINE SULFATE (TABLET, ORALLY DISINTEGRATING) (ORAL) EVEKEO ODT
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: ARBOR PHARMS LLC NDA No.: 209905 Prod. No.: 001 RX (5MG); 002 RX (10MG); 003 RX (15MG); 004 RX (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 |
ANGIOTENSIN II ACETATE (SOLUTION) (INTRAVENOUS) GIAPREZA
Drug Classes: vasoconstrictor; angiotensin II receptor blocker; angiotensin converting enzyme inhibitor
NDA Applicant: LA JOLLA PHARMA NDA No.: 209360 Prod. No.: 001 RX (EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)) 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): All strengths: 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): All strengths: 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): All strengths: 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): All strengths: 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): All strengths: 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): All strengths: 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): All strengths: 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): All strengths: 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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Dec 21, 2022 |
ANIDULAFUNGIN (POWDER) (INTRAVENOUS) ERAXIS
Drug Classes: echinocandin antifungal
NDA Applicant: VICURON NDA No.: 021632 Prod. No.: 001 RX (50MG/VIAL); 002 RX (100MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5965525 DS* DP* [Extended 1223 days (3.4 years)] Cyclic peptide antifungal agents Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): All strengths: None | Feb 17, 2020 | U-540: Treatment of fungal infections |
| Pat. No. 6960564 DP* Echinocandin pharmaceutical formulations containing micelle-forming surfactants Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): All strengths: None | Apr 12, 2021 | U-540: Treatment of fungal infections |
| Pat. No. 7709444 DP* Echinocandin pharmaceutical formulations containing micelle-forming surfactants Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): All strengths: None | Apr 12, 2021 | U-540: Treatment of fungal infections |
APALUTAMIDE (TABLET) (ORAL) ERLEADA
NDA Applicant: JANSSEN BIOTECH NDA No.: 210951 Prod. No.: 001 RX (60MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| 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 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) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Sep 17, 2022 | I-808: Treatment of patients with metastatic castration-sensitive prostate cancer (MCSPC) |
| Exclusivity Code: NCE - New chemical entity | Feb 14, 2023 |
APIXABAN (TABLET) (ORAL) ELIQUIS [Has competitive generic]
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* [Extended 1526 days (4.2 years)] 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 [Has competitive generic]
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* [Extended 1526 days (4.2 years)] 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: SUNOVION PHARMS INC NDA No.: 210875 Prod. No.: 001 RX (10MG); 002 RX (15MG); 003 RX (20MG); 004 RX (25MG); 005 RX (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. 8663687 DP* Film compositions for delivery of actives Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Feb 2, 2023 | |
| 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. 9855221 DP* Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Feb 14, 2022 | |
| Pat. No. 9931305 DP* Uniform films for rapid dissolve dosage form incorporating taste-masking compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Feb 14, 2022 | |
| Pat. No. 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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | May 21, 2023 |
APREMILAST (TABLET) (ORAL) OTEZLA
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. 6962940 (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoiso indoline-1,3-dione: methods of using and compositions thereof Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 15, 2014 | Mar 19, 2023 | U-1504: Use of OTEZLA (apremilast) for inhibiting PDE4 U-2656: Treatment of adult patients with active psoriatic arthritis U-2657: Treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy U-2658: Treatment of adult patients with oral ulcers associated with Behcet's disease |
| Pat. No. 7208516 Methods of the treatment of psoriatic arthritis using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 15, 2014 | Mar 19, 2023 | U-1505: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis |
| Pat. No. 7427638 DS* DP* [Extended 1186 days (3.2 years)] (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminois- oindoline-1,3-dione:, and methods of synthesis and compositions thereof Claim Types: Composition; Formulation Pat. Sub. Date(s): All strengths: Apr 15, 2014 | Feb 16, 2028 | |
| Pat. No. 7659302 Methods of using (+)-2-[1-(3-ethoxy-4 methoxyphenyl)-2-methylsulfonylethyl]-4 acetylaminoisoindoline 1,3-dione Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 15, 2014 | Mar 19, 2023 | U-1505: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis U-1595: Use of OTEZLA (apremilast) for the treatment of psoriasis U-2657: Treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy U-2658: Treatment of adult patients with oral ulcers associated with Behcet's disease |
| Pat. No. 7893101 DS* DP* Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione, compositions thereof, and uses thereof Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): All strengths: Apr 15, 2014 | Dec 9, 2023 | |
| Pat. No. 8455536 Methods of using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi-soindoline 1,3-dione Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 15, 2014 | Mar 19, 2023 | U-1505: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis U-1595: Use of OTEZLA (apremilast) for the treatment of psoriasis U-2657: Treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy U-2658: Treatment of adult patients with oral ulcers associated with Behcet's disease |
| Pat. No. 8802717 Methods of treating arthritic conditions using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline 1,3-dione Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 29, 2014 | Mar 19, 2023 | U-1561: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis |
| Pat. No. 9018243 Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione, compositions thereof, and uses thereof Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 18, 2015 | Mar 19, 2023 | U-1505: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis U-1595: Use of OTEZLA (apremilast) for the treatment of psoriasis U-2656: Treatment of adult patients with active psoriatic arthritis U-2657: Treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy U-2658: Treatment of adult patients with oral ulcers associated with Behcet's disease |
| Pat. No. 9724330 Methods of using (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 19, 2018 | Mar 19, 2023 | U-1561: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis U-1595: Use of OTEZLA (apremilast) for the treatment of psoriasis U-2656: Treatment of adult patients with active psoriatic arthritis U-2657: Treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy U-2658: Treatment of adult patients with oral ulcers associated with Behcet's disease |
| 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 | May 29, 2034 | 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 | May 29, 2034 | 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 | Jul 19, 2022 | I-803: Treatment of adult patients with oral ulcers associated with Behcets disease |
| Exclusivity Code: M - Miscellaneous | Apr 10, 2023 | M-257: Information added to the clinical studies section of the labeling regarding the use of plaque psoriasis of the scalp |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jul 19, 2026 | 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 |
ARFORMOTEROL TARTRATE (SOLUTION) (INHALATION) BROVANA
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: SUNOVION NDA No.: 021912 Prod. No.: 001 RX (EQ 0.015MG BASE/2ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6472563 DS* Formoterol tartrate process and polymorph Claim Types: New polymorph, salt or hydrate; Method of use; Composition; Formulation; Process Pat. Sub. Date(s): 001: None | Nov 9, 2021 | |
| Pat. No. 6667344 DP* Bronchodilating compositions and methods Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): 001: Jun 1, 2012 | Jun 22, 2021 | |
| Pat. No. 6720453 DS* Formoterol tartrate polymorph Claim Types: New polymorph, salt or hydrate; Method of use; Composition; Formulation Pat. Sub. Date(s): 001: None | Nov 9, 2021 | |
| Pat. No. 6814953 Bronchodilating compositions and methods Claim Types: Kit; Method of use Pat. Sub. Date(s): 001: Jun 1, 2012 | Jun 22, 2021 | U-793: For the long term treatment, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema |
| Pat. No. 7145036 DS* Formoterol tartrate polymorph Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: None | Nov 9, 2021 | |
| Pat. No. 7348362 DP* Bronchodilating .beta.-agonist compositions and methods Claim Types: Drug in a container; Method of administration Pat. Sub. Date(s): 001: Jul 11, 2013 | Jun 22, 2021 | U-793: For the long term treatment, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema |
| Pat. No. 7462645 Bronchodilating beta-agonist compositions and methods Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 11, 2013 | Jun 22, 2021 | U-793: For the long term treatment, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema |
| Pat. No. 7465756 DP* Bronchodilating beta-agonist compositions and methods Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 11, 2013 | Jun 22, 2021 | |
| Pat. No. 7473710 Bronchodilating beta-agonist compositions and methods Claim Types: Method of administration Pat. Sub. Date(s): 001: Jul 11, 2013 | Jun 22, 2021 | U-793: For the long term treatment, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema |
| Pat. No. 7541385 Bronchodilating .beta.-agonist compositions and methods Claim Types: Method of administration Pat. Sub. Date(s): 001: Jul 11, 2013 | Jun 22, 2021 | U-793: For the long term treatment, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema |
| Pat. No. 8110706 DP* Formoterol tartrate process and polymorph Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Feb 9, 2012 | Nov 9, 2021 |
ARGATROBAN (INJECTABLE) (INTRAVENOUS) ARGATROBAN IN SODIUM CHLORIDE
Drug Classes: anticoagulant; direct thrombin inhibitor
NDA Applicant: EAGLE PHARMS NDA No.: 022434 Prod. No.: 001 RX (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 |
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. 7053092 5-HT1a receptor subtype agonist Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Jan 28, 2022 | U-839: Treatment of major depressive disorder (MDD) |
| Pat. No. 8017615 DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: Composition; Product-by-process; Process Pat. Sub. Date(s): All strengths: None | Dec 16, 2024 *PED | |
| Pat. No. 8580796 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: None | Mar 25, 2023 *PED | |
| Pat. No. 8642600 Method of treating autism Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 5, 2014 | Jul 28, 2022 *PED | U-1492: Treatment of irritability associated with autistic disorder |
| Pat. No. 8642760 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: Compound Pat. Sub. Date(s): All strengths: Mar 5, 2014 | Mar 25, 2023 *PED | |
| Pat. No. 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. 9089567 Method of treating cognitive impairments and schizophrenias Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 26, 2015 | Jan 28, 2022 | U-543: Treatment of schizophrenia |
| 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 |
| Pat. No. 9359302 DS* DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate; Process; Product-by-process; Composition; Method of use; Kit; Formulation Pat. Sub. Date(s): All strengths: Jun 30, 2016 | Sep 25, 2022 | U-1859: Treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, adjunctive treatment of major depressive disorder, and treatment of irritability associated with autistic disorder |
| Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Aug 2, 2016 | Dec 25, 2023 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 12, 2021 | ODE-80: Treatment of pediatric patients with Tourette's |
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. 6977257 DP* Aripiprazole oral solution Claim Types: Formulation Pat. Sub. Date(s): 001: None | Oct 24, 2022 *PED | |
| Pat. No. 7053092 5-HT1a receptor subtype agonist Claim Types: Method of use Pat. Sub. Date(s): 001: None | Jan 28, 2022 | U-839: Treatment of major depressive disorder (MDD) |
| Pat. No. 8642600 Method of treating autism Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 5, 2014 | Jul 28, 2022 *PED | U-1492: Treatment of irritability associated with autistic disorder |
| Pat. No. 8759350 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jul 22, 2014 | Mar 2, 2027 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
| Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 2, 2016 | Dec 25, 2023 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 12, 2021 | ODE-80: Treatment of pediatric patients with Tourette's |
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. 7053092 5-HT1a receptor subtype agonist Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Jan 28, 2022 | U-839: Treatment of major depressive disorder (MDD) |
| Pat. No. 8017615 DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: Composition; Product-by-process; Process Pat. Sub. Date(s): All strengths: None | Dec 16, 2024 *PED | |
| Pat. No. 8518421 DP* Flashmelt oral dosage formulation Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 26, 2013 | Jul 24, 2021 *PED | |
| Pat. No. 8580796 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: None | Mar 25, 2023 *PED | |
| Pat. No. 8642600 Method of treating autism Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 5, 2014 | Jul 28, 2022 *PED | U-1492: Treatment of irritability associated with autistic disorder |
| Pat. No. 8642760 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: Compound Pat. Sub. Date(s): All strengths: Mar 5, 2014 | Mar 25, 2023 *PED | |
| Pat. No. 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. 9089567 Method of treating cognitive impairments and schizophrenias Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 26, 2015 | Jan 28, 2022 | U-543: Treatment of schizophrenia |
| 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 |
| Pat. No. 9358207 DP* Flashmelt oral dosage formulation Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 30, 2016 | Apr 12, 2020 | |
| Pat. No. 9359302 DS* DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate; Process; Product-by-process; Composition; Method of use; Kit; Formulation Pat. Sub. Date(s): All strengths: Jun 30, 2016 | Sep 25, 2022 | U-1859: Treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, adjunctive treatment of major depressive disorder, and treatment of irritability associated with autistic disorder |
| Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Aug 2, 2016 | Dec 25, 2023 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 12, 2021 | ODE-80: Treatment of pediatric patients with Tourette's |
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. 7053092 5-HT1a receptor subtype agonist Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Jan 28, 2022 | U-839: Treatment of major depressive disorder (MDD) |
| Pat. No. 8017615 DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: Composition; Product-by-process; Process Pat. Sub. Date(s): All strengths: None | Dec 16, 2024 *PED | |
| Pat. No. 8518421 DP* Flashmelt oral dosage formulation Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 26, 2013 | Jul 24, 2021 *PED | |
| Pat. No. 8580796 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: None | Mar 25, 2023 *PED | |
| Pat. No. 8642600 Method of treating autism Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 5, 2014 | Jul 28, 2022 *PED | U-1492: Treatment of irritability associated with autistic disorder |
| Pat. No. 8642760 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: Compound Pat. Sub. Date(s): All strengths: Mar 5, 2014 | Mar 25, 2023 *PED | |
| Pat. No. 9358207 DP* Flashmelt oral dosage formulation Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 30, 2016 | Apr 12, 2020 | |
| Pat. No. 9359302 DS* DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate; Process; Product-by-process; Composition; Method of use; Kit; Formulation Pat. Sub. Date(s): All strengths: Jun 30, 2016 | Sep 25, 2022 | U-1859: Treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, adjunctive treatment of major depressive disorder, and treatment of irritability associated with autistic disorder |
| Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Aug 2, 2016 | Dec 25, 2023 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 12, 2021 | ODE-80: Treatment of pediatric patients with Tourette's |
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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 12, 2021 | ODE-80: Treatment of pediatric patients with Tourette's |
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. 8338428 DP* Methods for administering aripiprazole Claim Types: Formulation; Method of administration Pat. Sub. Date(s): All strengths: None | Aug 6, 2023 | 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. 8759351 DP* Methods for administering aripiprazole Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 22, 2014 | Aug 6, 2023 | U-1530: Use of aripiprazole in extended release injectable suspension U-1633: Use of aripiprazole in extended release injectable suspension in treating acute episodes of schizophrenia |
| Pat. No. 8993761 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: Apr 28, 2015 | Sep 25, 2022 | |
| Pat. No. 9089567 Method of treating cognitive impairments and schizophrenias Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 26, 2015 | Jan 28, 2022 | U-543: Treatment of schizophrenia |
| 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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jul 27, 2020 | I-746: New indication of maintenance monotherapy treatment of bipolar I disorder in adults |
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. 7053092 5-HT1a receptor subtype agonist Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Jan 28, 2022 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
| 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. 8580796 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Sep 25, 2022 | |
| Pat. No. 8642760 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: Compound Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Sep 25, 2022 | |
| Pat. No. 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. 9089567 Method of treating cognitive impairments and schizophrenias Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Jan 28, 2022 | U-543: Treatment of schizophrenia |
| 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. 9359302 DS* DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate; Process; Product-by-process; Composition; Method of use; Kit; Formulation Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Sep 25, 2022 | U-1529: Adjunctive treatment of major depressive disorder (MDD) U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder U-543: Treatment of schizophrenia |
| Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Dec 25, 2023 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
| 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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jul 27, 2020 | I-746: New indication of maintenance monotherapy treatment of bipolar I disorder in adults |
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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Oct 5, 2020 |
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)); 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): All strengths: 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): All strengths: 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): All strengths: 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): All strengths: 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): All strengths: 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): All strengths: 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): 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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Oct 5, 2020 |
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)
| 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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Oct 5, 2020 |
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)
| 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 |
ASCORBIC ACID (SOLUTION) (INTRAVENOUS) ASCOR
Drug Classes: vitamin C
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]
Drug Classes: vitamin C; osmotic laxative
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) PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID [GENERIC AA]
Drug Classes: vitamin C; osmotic laxative
NDA Applicant: NOVEL LABS INC NDA No.: 090145 Prod. No.: 001 RX (4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: PC - Patent challenge | Feb 27, 2021 |
ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE (FOR SOLUTION) (ORAL) PLENVU
Drug Classes: vitamin C; osmotic laxative
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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | May 4, 2021 |
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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Oct 11, 2022 |
ASENAPINE MALEATE (TABLET) (SUBLINGUAL) SAPHRIS
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. 5763476 DP* [Extended 5 years] Sublingual or buccal pharmaceutical composition Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Feb 10, 2017 | Dec 9, 2020 *PED | 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 U-326: Method of treating schizophrenia and bipolar disorder |
| 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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: D - New Dosing Schedule | Jan 13, 2020 | D-166: Broaden initial starting dose for bipolar i disorder to 5-10mg twice daily |
| Exclusivity Code: I - New Indication | Jan 13, 2020 | I-597: Monotherapy for the maintenance treatment of bipolar I disorder |
ASENAPINE MALEATE (TABLET) (SUBLINGUAL) SAPHRIS
Drug Classes: atypical antipsychotic
NDA Applicant: ALLERGAN NDA No.: 022117 Prod. No.: 003 RX (EQ 2.5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5763476 DP* [Extended 5 years] Sublingual or buccal pharmaceutical composition Claim Types: Formulation; Method of use Pat. Sub. Date(s): 003: Sep 12, 2016 | Dec 9, 2020 *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. 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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: D - New Dosing Schedule | Jan 13, 2020 | D-166: Broaden initial starting dose for bipolar i disorder to 5-10mg twice daily |
| Exclusivity Code: I - New Indication | Jan 13, 2020 | I-597: Monotherapy for the maintenance treatment of bipolar I disorder |
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. 8865187 DP* Compositions comprising lecithin oils and NSAIDS for protecting the gastrointestinal tract and providing enhanced therapeutic activity Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 10, 2014 | Mar 23, 2022 | |
| Pat. No. 9101637 Methods of treating inflammation with compositions comprising lecithin oils and NSAIDS for protecting the gastrointestinal tract and providing enhanced therapeutic activity Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 9, 2015 | Mar 23, 2022 | U-1731: Temporary relief of minor aches and pains U-1732: Temporary reduction of fever U-1733: Treatment/prevention of cardiovascular disease |
| Pat. No. 9216150 DP* 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. 9351984 DP* Compositions comprising lecithin oils and NSAIDs for protecting the gastrointestinal tract and providing enhanced therapeutic activity Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Jul 11, 2016 | Dec 19, 2021 |
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 RX (81MG;40MG); 002 RX (325MG;40MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6926907 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Oct 14, 2016 | Feb 28, 2023 | U-1902: Treatment or secondary prevention of cardiovascular disease, cardiovascular events, or cerebrovascular events and risk-reduction of aspirin-associated gastric ulcers |
| Pat. No. 8206741 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Oct 14, 2016 | Feb 28, 2023 | U-1902: Treatment or secondary prevention of cardiovascular disease, cardiovascular events, or cerebrovascular events and risk-reduction of aspirin-associated gastric ulcers |
| Pat. No. 9364439 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Oct 14, 2016 | May 31, 2022 | U-1902: Treatment or secondary prevention of cardiovascular disease, cardiovascular events, or cerebrovascular events and risk-reduction of aspirin-associated gastric ulcers |
| 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-MYERS SQUIBB 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 4, 2032 |
ATORVASTATIN CALCIUM (TABLET) (ORAL) LIPITOR [GENERIC AB]
Drug Classes: HMG CoA-reductase inhibitor
NDA Applicant: UPJOHN NDA No.: 020702 Prod. No.: 001 RX (EQ 10MG BASE); 002 RX (EQ 20MG BASE)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: M - Miscellaneous | Jun 23, 2020 | M-204: Clinical information added to the package insert regarding use of atorvastatin in children and adolescents ages 10-17 with heterozygous familial hypercholesterolemia (HEFH) |
AVANAFIL (TABLET) (ORAL) STENDRA
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* [Extended 1687 days (4.6 years)] 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 |
| Pat. No. 7501409 DP* Preparations for oral administration Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | May 5, 2023 |
AVAPRITINIB (TABLET) (ORAL) AYVAKIT
NDA Applicant: BLUEPRINT MEDICINES NDA No.: 212608 Prod. No.: 001 RX (100MG); 002 RX (200MG); 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): 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 |
| 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 |
| 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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jan 9, 2025 |
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 | May 5, 2025 | |
| Pat. No. 8338429 2-acylaminothiazole derivative or salt thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2019 | Jun 30, 2023 | U-2577: Treatment of thrombocytopenia in an adult patient with chronic immune thrombocytopenia who has had an insufficient response to a previous treatment |
| Pat. No. 8765764 2-acylaminothiazole derivative or salt thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 15, 2018 | Jan 15, 2023 | U-2314: Treatment of thrombocytopenia in an adult patient with chronic liver disease who is scheduled to undergo a procedure using DOPTELET U-2578: Treatment of thrombocytopenia in an adult patient with chronic liver disease who is scheduled to undergo a procedure |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jun 26, 2022 | I-802: Treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment |
| Exclusivity Code: NCE - New chemical entity | May 21, 2023 | |
| 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) (IV (INFUSION)) AVYCAZ
Drug Classes: beta lactamase inhibitor; cephalosporin antibacterial
NDA Applicant: ALLERGAN 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 pnenumonia (HABP/VABP) patients comprising administering a bactericidally effective amount of avibactam sodium U-2508: A method of treating bacterial infections in complicated intra-abdominal infection and complicated urinary tract infection, including pyelonephritis, patients comprising administering a bactericidally effective amount of avibactam sodium U-282: Method of treating bacterial infections |
| 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. 8178554 DS* DP* Heterocyclic compounds, their preparation and their use as medicaments, in particular as anti-bacterial agents Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Mar 17, 2015 | Jul 24, 2021 | U-2245: A method of treating a bacterial infection in hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) patients comprising administering an effective amount of avibactam sodium U-2509: A method of treating a bacterial infection in complicated intra-abdominal infection (CIAI) and complicated urinary tract infection (CUTI), including pyelonephritis, patients comprising administering an effective amount of avibactam sodium U-282: Method of treating bacterial infections |
| 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 |
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* [Extended 1764 days (4.8 years)] Indazole compounds and pharmaceutical compositions for inhibiting protein kinases, and methods for their use Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Feb 16, 2012; 002: None | Apr 29, 2025 | |
| Pat. No. 7141581 Indazole compounds and pharmaceutical compositions for inhibiting protein kinases, and methods for their use Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 16, 2012; 002: None | Jun 30, 2020 | U-1220: Treatment of renal cell carcinoma |
| Pat. No. 8791140 DS* Crystalline forms of 6-[2-(methylcarbamoyl)phenylsulfanyl]-3-E-[2-(pyridin-2-yl)ethenyondazole suitable for the treatment of abnormal cell growth in mammals Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: None | Dec 14, 2030 | |
| 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 | Feb 3, 2035 | U-2844: In combination with pembrolizumab for the first-line treatment of patients with advanced renal cell carcinoma |
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. 8722021 DP* Foamable carriers Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 26, 2015 | Oct 24, 2023 | |
| Pat. No. 8900554 DP* Foamable composition and uses thereof Claim Types: Composition Pat. Sub. Date(s): 001: Aug 26, 2015 | Oct 24, 2023 | |
| 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 |
| Pat. No. 10322085 DP* Dicarboxylic acid foamable vehicle and pharmaceutical compositions thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 21, 2019 | Oct 24, 2023 |
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.: 001 DISC (EQ 0.125MG BASE/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 [GENERIC AB]
Drug Classes: histamine-1 (H1) receptor antagonist
NDA Applicant: MYLAN SPECIALITY LP NDA No.: 022203 Prod. No.: 002 RX (EQ 0.1876MG BASE/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; 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 (EQ 0.125MG BASE/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 | |
| Pat. No. 9259428 Combination of azelastine and fluticasone for nasal administration Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 9, 2016 | Dec 13, 2023 *PED | U-644: Treatment of seasonal allergic rhinitis |
| Pat. No. 9901585 DP* Combination of azelastine and fluticasone for nasal administration Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 27, 2018 | Jun 13, 2023 |
AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE (SPRAY, METERED) (NASAL) AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE [GENERIC AB]
Drug Classes: histamine-1 (H1) receptor antagonist; corticosteroid
NDA Applicant: APOTEX NDA No.: 207712 Prod. No.: 001 RX (EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: PC - Patent challenge | Aug 29, 2020 |
AZILSARTAN KAMEDOXOMIL (TABLET) (ORAL) EDARBI
Drug Classes: angiotensin II receptor blocker
NDA Applicant: ARBOR PHARMS LLC 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: ARBOR PHARMS LLC 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 |
AZTREONAM (FOR SOLUTION) (INHALATION) CAYSTON
Drug Classes: monobactam antibacterial
NDA Applicant: GILEAD NDA No.: 050814 Prod. No.: 001 RX (75MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7208141 DP* Inhalable aztreonam aerosol for treatment and prevention of pulmonary bacterial infections Claim Types: Formulation; Method of use; Method of administration Pat. Sub. Date(s): 001: None | Dec 20, 2021 | U-1031: Improve respiratory symptoms in cystic fibrosis in patients with pseudomonas aeruginosa |
| Pat. No. 7214364 DP* Inhalable aztreonam lysinate formulation for treatment and prevention of pulmonary bacterial infections Claim Types: Formulation Pat. Sub. Date(s): 001: None | Dec 20, 2021 | |
| Pat. No. 7427633 DP* Inhalable aztreonam lysinate formulation for treatment and prevention of pulmonary bacterial infections Claim Types: Formulation; Method of use; Method of administration Pat. Sub. Date(s): 001: None | Dec 20, 2021 | U-1031: Improve respiratory symptoms in cystic fibrosis in patients with pseudomonas aeruginosa |
| Pat. No. 8399496 DP* Inhalable aztreonam lysinate formulation for treatment and prevention of pulmonary bacterial infections Claim Types: Formulation; Method of administration; Method of use Pat. Sub. Date(s): 001: Apr 19, 2013 | Dec 20, 2021 | U-1377: Improve respiratory symptoms in cystic fibrosis in patients with pseudomonas aeruginosa |