ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE (TABLET, FOR SUSPENSION) (ORAL) TRIUMEQ PD
Drug Classes: Antivirals:Anti-HIV Agents, Nucleoside and Nucleotide Reverse Transcriptase Inhibitors (NRTI) == Antivirals:Anti-HIV Combinations == HIV nucleoside analog reverse transcriptase inhibitor (HIV-1 NRTI) == Antivirals:Anti-HIV Agents, Integrase Inhibitors (INSTI) == HIV integrase strand transfer inhibitor (HIV-1 INSTI) == Antivirals:Anti-hepatitis B (HBV) Agents == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: VIIV HLTHCARE      NDA No.: 215413  Prod. No.: 001 RX (EQ 60MG BASE;EQ 5MG BASE;30MG)

Patents	Expiration	Patented Use
Pat. No. 8129385 DS* DP* Substituted 5-hydroxy-3,4,6,9,9a, 10-hexanhydro-2h-1-oxa04a,8a-diaza-anthracene-6,10-dioness Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Apr 7, 2022	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: Apr 7, 2022	Dec 8, 2029

ABALOPARATIDE (SOLUTION) (SUBCUTANEOUS) TYMLOS
Drug Classes: Metabolic Bone Disease Agents == parathyroid hormone related peptide [PTHrP(1-34)] analog
NDA Applicant: RADIUS HEALTH INC      NDA No.: 208743  Prod. No.: 001 RX (3.12MG/1.56ML (2MG/ML))

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.
Pat. No. 10996208 DP* Abaloparatide formulations and methods of testing, storing, modifying, and using same Claim Types: Formulation; Analytical method Pat. Sub. Date(s): 001: Jun 1, 2021	Apr 30, 2038
Pat. No. 11255842 Methods for detecting neutralizing antibodies to parathyroid hormone (PTH) and parathyroid hormone-related peptide (PTHRP) analog Claim Types: Diagnostic or surgical method; Kit Pat. Sub. Date(s): 001: Mar 14, 2022	Jan 10, 2040	U-3322: Use for detecting neutralizing antibodies
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: M - Miscellaneous	Sep 20, 2024	M-270: Information added to clinical pharmacology section
Exclusivity Code: NCE - New chemical entity	Apr 28, 2022

ABAMETAPIR (LOTION) (TOPICAL) XEGLYZE
Drug Classes: Dermatological Agents:Pediculicides/Scabicides
NDA Applicant: DR REDDYS LABS SA      NDA No.: 206966  Prod. No.: 001 DISC (0.74%)

Patents	Expiration	Patented Use
Pat. No. 7812163 DP* Methods and compositions for controlling ectoparasites Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 31, 2020	Oct 28, 2026	U-2863: Topical treatment of head lice infestation in patients 6 months of age and older
Pat. No. 8212038 DP* Methods and compositions for controlling ectoparasites Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 31, 2020	Jul 16, 2024	U-2863: Topical treatment of head lice infestation in patients 6 months of age and older
Pat. No. 9357783 DP* Methods and compositions for controlling ectoparasites Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 31, 2020	Jul 16, 2024
Pat. No. 9839631 DS* DP* Methods and compositions for controlling ectoparasites Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 31, 2020	Jul 16, 2024	U-2863: Topical treatment of head lice infestation in patients 6 months of age and older
Pat. No. 10292389 DP* Pediculicidal composition Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jul 31, 2020	Dec 17, 2034	U-2863: Topical treatment of head lice infestation in patients 6 months of age and older
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	Jul 24, 2025

ABEMACICLIB (TABLET) (ORAL) VERZENIO
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: ELI LILLY AND CO      NDA No.: 208716  Prod. No.: 001 RX (50MG); 002 RX (100MG); 003 RX (150MG)

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 U-3241: In combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hr-positive, HER2-negative, node-positive, early breast cancer at high risk of recurrence and a KI-67 score >=20% U-3242: In combination with fulvestrant for the treatment of adult patients with hr-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endrocrine therapy U-3243: In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women, and men with HR-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	Oct 12, 2024	I-877: Indication for the use of abemaciclib in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early cancer (EBC) at high risk of recurrence and a KI-67 score>20% as determined by an FDA approved test
Exclusivity Code: NCE - New chemical entity	Sep 28, 2022
Exclusivity Code: NPP - New patient population	Oct 12, 2024

ABEMACICLIB (TABLET) (ORAL) VERZENIO
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: ELI LILLY AND CO      NDA No.: 208716  Prod. No.: 004 RX (200MG)

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	Oct 12, 2024	I-877: Indication for the use of abemaciclib in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early cancer (EBC) at high risk of recurrence and a KI-67 score>20% as determined by an FDA approved test
Exclusivity Code: NCE - New chemical entity	Sep 28, 2022
Exclusivity Code: NPP - New patient population	Oct 12, 2024

ABIRATERONE ACETATE (TABLET) (ORAL) YONSA
Drug Classes: Antineoplastics:Antiandrogens == CYP17 inhibitor
NDA Applicant: SUN PHARM      NDA No.: 210308  Prod. No.: 001 RX (125MG)

Patents	Expiration	Patented Use
Pat. No. 9889144 DP* Abiraterone acetate formulation and methods of use Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 19, 2018	Mar 17, 2034
Pat. No. 10292990 Abiraterone steroid formulation Claim Types: Method of use Pat. Sub. Date(s): 001: May 31, 2019	May 20, 2034	U-2535: Use in combination with methylprednisolone for the treatment of patients with prostate cancer

ABROCITINIB (TABLET) (ORAL) CIBINQO
NDA Applicant: PFIZER      NDA No.: 213871  Prod. No.: 001 RX (50MG); 002 RX (100MG); 003 RX (200MG)

Patents	Expiration	Patented Use
Pat. No. 9035074 DS* DP* Pyrrolo[2,3-D]pyrimidine derivatives Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Feb 11, 2022	Feb 19, 2034
Pat. No. 9545405 DS* DP* Pyrrolo[2,3-D]pyrimidine derivatives Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Feb 11, 2022	Feb 19, 2034
Pat. No. 9549929 Pyrrolo[2,3-D]pyrimidine derivatives Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 11, 2022	Feb 19, 2034	U-3195: Treatment of adults with refractory, moderate-to-severe atopic dermatitis not adequately controlled with other systemic drug products or when use of those therapies is inadvisable
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	Jan 14, 2027

ACALABRUTINIB (CAPSULE) (ORAL) CALQUENCE
Drug Classes: Antineoplastics:Molecular Target Inhibitors == 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 [Has competitive generic]
NDA Applicant: MALLINCKRODT HOSP      NDA No.: 022450  Prod. No.: 001 DISC (1GM/100ML (10MG/ML))

Patents	Expiration	Patented Use
Pat. No. 9399012 Reduced dose intravenous acetaminophen Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 8, 2016	Mar 11, 2032 *PED	U-2261: Modified dosing regimen for the management of mild to moderate pain or management of moderate to severe pain as an adjunct to opioid analgesics U-2262: Modified dosing regimen for the reduction of fever
Pat. No. 9610265 Reduced dose intravenous acetaminophen Claim Types: Method of administration Pat. Sub. Date(s): 001: May 4, 2017	May 13, 2029 *PED	U-2263: Modified dosing regimen for the management of moderate to severe pain with adjunctive opioid analgesics
Pat. No. 9987238 Reduced dose intravenous acetaminophen Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 13, 2018	May 13, 2029 *PED	U-2261: Modified dosing regimen for the management of mild to moderate pain or management of moderate to severe pain as an adjunct to opioid analgesics
Pat. No. 10383834 Reduced dose intravenous acetaminophen Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 18, 2019	Nov 13, 2028	U-2262: Modified dosing regimen for the reduction of fever U-2621: Modified dosing regimen for the management of mild to moderate pain

ACETAMINOPHEN (SOLUTION) (INTRAVENOUS) ACETAMINOPHEN [Has competitive generic]
NDA Applicant: FRESENIUS KABI USA      NDA No.: 204767  Prod. No.: 001 RX (1GM/100ML (10MG/ML))

Patents	Expiration	Patented Use
Pat. No. 8741959 DP* Paracetamol for parenteral administration Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 24, 2019	Apr 19, 2030

ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE (TABLET) (ORAL) APADAZ
NDA Applicant: 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; IBUPROFEN (TABLET) (ORAL) ADVIL DUAL ACTION WITH ACETAMINOPHEN
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 211733  Prod. No.: 001 OTC (250MG;125MG)

Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NP - New product	Feb 28, 2023

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE (TABLET, EXTENDED RELEASE) (ORAL) XARTEMIS XR
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: MALLINCKRODT INC      NDA No.: 204031  Prod. No.: 001 DISC (325MG;7.5MG)

Patents	Expiration	Patented Use
Pat. No. 7976870 Gastric retentive oral dosage form with restricted drug release in the lower gastrointestinal tract Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Apr 3, 2014	Jun 1, 2027	U-1498: Method of treating patients with gastric retentive dosage form
Pat. No. 8372432 DP* Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Apr 3, 2014	Mar 11, 2029	U-1499: Management of acute pain in patients requiring opioid analgesia
Pat. No. 8377453 DP* Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: Apr 3, 2014	Nov 19, 2029	U-1499: Management of acute pain in patients requiring opioid analgesia
Pat. No. 8394408 DP* Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 3, 2014	Mar 11, 2029
Pat. No. 8597681 DP* Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans Claim Types: Formulation; Product-by-process Pat. Sub. Date(s): 001: Apr 3, 2014	Dec 21, 2030
Pat. No. 8658631 DP* Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 3, 2014	May 16, 2032
Pat. No. 8668929 Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 3, 2014	Mar 11, 2029	U-1499: Management of acute pain in patients requiring opioid analgesia
Pat. No. 8741885 DP* Gastric retentive extended release pharmaceutical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jun 17, 2014	May 16, 2032	U-1499: Management of acute pain in patients requiring opioid analgesia
Pat. No. 8980319 DP* Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 3, 2015	Dec 21, 2030
Pat. No. 8992975 DP* Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 3, 2015	May 16, 2032
Pat. No. 9050335 DP* Pharmaceutical compositions for extended release of oxycodone and acetaminophen resulting in a quick onset and prolonged period of analgesia Claim Types: Formuation Pat. Sub. Date(s): 001: Jun 25, 2015	May 16, 2032
Pat. No. 9468636 Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 16, 2016	May 16, 2032	U-1499: Management of acute pain in patients requiring opioid analgesia

ACETYLCYSTEINE (INJECTABLE) (INTRAVENOUS) ACETADOTE [GENERIC AP]
Drug Classes: Respiratory Tract/ Pulmonary Agents:Respiratory Tract Agents, Other == antidote == antidote for acetaminophen overdose == mucolytic
NDA Applicant: CUMBERLAND PHARMS      NDA No.: 021539  Prod. No.: 001 RX (6GM/30ML (200MG/ML))

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: Respiratory Tract/ Pulmonary Agents:Respiratory Tract Agents, Other == antidote == antidote for acetaminophen overdose == mucolytic
NDA Applicant: ARBOR PHARMS LLC      NDA No.: 207916  Prod. No.: 001 DISC (500MG); 002 DISC (2.5GM)

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: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Anticholinergic == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant: COVIS      NDA No.: 202450  Prod. No.: 001 RX (0.4MG/INH)

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. 8051851 DP* Inhaler for the administration of powdered pharmaceuticals, and a powder cartridge system for use with this inhaler Claim Types: Device Pat. Sub. Date(s): 001: Aug 17, 2012	Apr 22, 2027
Pat. No. 10085974 DP* Dosage and formulation Claim Types: Formulation; Method of use; Device Pat. Sub. Date(s): 001: Oct 26, 2018	Mar 13, 2029	U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD)
Pat. No. 11000517 DP* Dosage and formulation Claim Types: Composition; Formulation; Method of use; Device Pat. Sub. Date(s): 001: Jun 10, 2021	Mar 13, 2029	U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD)
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: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Anticholinergic == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations == Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == beta-2 adrenergic agonist
NDA Applicant: COVIS      NDA No.: 210595  Prod. No.: 001 RX (0.4MG/INH;0.012MG/INH)

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. 8051851 DP* Inhaler for the administration of powdered pharmaceuticals, and a powder cartridge system for use with this inhaler Claim Types: Device Pat. Sub. Date(s): 001: Apr 24, 2019	Apr 22, 2027
Pat. No. 10085974 DP* Dosage and formulation Claim Types: Formulation; Method of use; Device Pat. Sub. Date(s): 001: Apr 24, 2019	Mar 13, 2029	U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD)
Pat. No. 11000517 DP* Dosage and formulation Claim Types: Composition; Formulation; Method of use; Device Pat. Sub. Date(s): 001: Jun 10, 2021	Mar 13, 2029	U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD)
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NC - New combination	Mar 29, 2022

ACYCLOVIR (OINTMENT) (OPHTHALMIC) AVACLYR
Drug Classes: Antivirals:Antiherpetic Agents == Dermatological Agents:Topical Anti-infectives == Dermatological Agents:Dermatological Agents, Other == nucleoside analog HSV DNA polymerase inhibitor / VZV DNA polymerase inhibitor
NDA Applicant: FERA PHARMS LLC      NDA No.: 202408  Prod. No.: 001 DISC (3%)

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: Antivirals:Antiherpetic Agents == Dermatological Agents:Topical Anti-infectives == Dermatological Agents:Dermatological Agents, Other == nucleoside analog HSV DNA polymerase inhibitor / VZV DNA polymerase inhibitor
NDA Applicant: EPI HLTH      NDA No.: 203791  Prod. No.: 001 RX (50MG)

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: Antivirals:Antiherpetic Agents == Dermatological Agents:Topical Anti-infectives == Dermatological Agents:Dermatological Agents, Other == nucleoside analog HSV DNA polymerase inhibitor / VZV DNA polymerase inhibitor
NDA Applicant: BAUSCH      NDA No.: 022436  Prod. No.: 001 RX (5%;1%)

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: Dermatological Agents:Acne and Rosacea Agents == 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: Dermatological Agents:Acne and Rosacea Agents == 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: Dermatological Agents:Acne and Rosacea Agents == retinoid == Dermatological Agents:Topical Anti-infectives
NDA Applicant: GALDERMA LABS LP      NDA No.: 022320  Prod. No.: 001 RX (0.1%;2.5%)

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 [GENERIC AB]
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == retinoid == Dermatological Agents:Topical Anti-infectives
NDA Applicant: GALDERMA LABS      NDA No.: 207917  Prod. No.: 001 RX (0.3%;2.5%)

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

ADAPALENE; BENZOYL PEROXIDE (GEL) (TOPICAL) ADAPALENE AND BENZOYL PEROXIDE [GENERIC AB]
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == retinoid == Dermatological Agents:Topical Anti-infectives
NDA Applicant: TARO      NDA No.: 209148  Prod. No.: 001 RX (0.3%;2.5%)

Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: PC - Patent challenge	May 30, 2022

AFAMELANOTIDE (IMPLANT) (SUBCUTANEOUS) SCENESSE
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment
NDA Applicant: CLIVUNEL INC      NDA No.: 210797  Prod. No.: 001 RX (16MG)

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: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 201292  Prod. No.: 001 RX (EQ 20MG BASE); 002 RX (EQ 30MG BASE); 003 RX (EQ 40MG BASE)

Patents	Expiration	Patented Use
Pat. No. RE43431 DS* Quinazoline derivatives and pharmaceutical compositions containing them Claim Types: Compound Pat. Sub. Date(s): All strengths: Aug 1, 2013	Jul 13, 2026 *PED
Pat. No. 8426586 DS* Process for preparing amino crotonyl compounds Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): All strengths: Aug 1, 2013	Apr 10, 2030 *PED
Pat. No. 8545884 DP* Solid pharmaceutical formulations comprising BIBW 2992 Claim Types: Intermediate; Formulation; Process; Product-by-process Pat. Sub. Date(s): All strengths: Oct 28, 2013	Jun 19, 2030 *PED
Pat. No. 9539258 Quinazoline derivatives for the treatment of cancer diseases Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 2, 2017	May 9, 2027 *PED	U-1950: Treatment of patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy
Pat. No. 10004743 DP* Process for drying of BIBW2992, of its salts and of solid pharmaceutical formulations comprising this active ingredient Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 2, 2018	Jan 5, 2031 *PED
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivity	Oct 15, 2023 PED	ODE-115: Treatment of patients with metastatic, squamous, non-small cell lung cancer progressing after platinum-based chemotherapy
Exclusivity Code: ODE - Orphan drug exclusivity	Jul 12, 2025 PED	ODE-230: First-line treatment of metastatic non-small cell lung cancer whose tumors have non-resistant epidermal growth factor (EGFR) mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test

AIR POLYMER-TYPE A (FOAM) (INTRAUTERINE) EXEM FOAM KIT
NDA Applicant: GISKIT      NDA No.: 212279  Prod. No.: 001 RX (10ML)

Patents	Expiration	Patented Use
Pat. No. 9034300 DP* Composition and method for medical imaging of body cavities Claim Types: Diagnostic or surgical method Pat. Sub. Date(s): 001: Dec 10, 2019	Oct 15, 2030	U-2663: Use in sonohysterosalpinography to assess fallopian tube patency
Pat. No. 9259494 DP* Composition and method for medical imaging of body cavities Claim Types: Formulation; Kit; Process; Diagnostic or surgical method Pat. Sub. Date(s): 001: Dec 10, 2019	May 4, 2035	U-2663: Use in sonohysterosalpinography to assess fallopian tube patency
Pat. No. 9849199 DP* Composition and method for medical imaging of body cavities Claim Types: Formulation; Kit Pat. Sub. Date(s): 001: Dec 10, 2019	Feb 11, 2036
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	Nov 7, 2024

ALBUTEROL SULFATE (AEROSOL, METERED) (INHALATION) VENTOLIN HFA [Has competitive generic]
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == beta-2 adrenergic agonist
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 020983  Prod. No.: 001 RX (EQ 0.09MG BASE/INH)

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

ALBUTEROL SULFATE (AEROSOL, METERED) (INHALATION) PROAIR HFA [GENERIC AB2]
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == beta-2 adrenergic agonist
NDA Applicant: TEVA BRANDED PHARM      NDA No.: 021457  Prod. No.: 001 RX (EQ 0.09MG BASE/INH)

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: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == beta-2 adrenergic agonist
NDA Applicant: TEVA BRANDED PHARM      NDA No.: 205636  Prod. No.: 001 RX (EQ 0.09MG BASE/INH)

Patents	Expiration	Patented Use
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. 8651103 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 001: Apr 28, 2015	Mar 26, 2028
Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 001: Jan 21, 2016	Jan 13, 2032
Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 001: Jan 21, 2016	Jun 28, 2031
Pat. No. 9463288 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 001: Nov 8, 2016	May 19, 2025
Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement Claim Types: Device Pat. Sub. Date(s): 001: Aug 31, 2017	May 18, 2031
Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 001: Aug 14, 2018	May 18, 2031
Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 001: Dec 12, 2018	May 18, 2031
Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): 001: Mar 19, 2020	Jan 1, 2032
Pat. No. 10765820 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 001: Oct 6, 2020	May 19, 2025

ALBUTEROL SULFATE (POWDER, METERED) (INHALATION) PROAIR DIGIHALER
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == beta-2 adrenergic agonist
NDA Applicant: TEVA BRANDED PHARM      NDA No.: 205636  Prod. No.: 002 RX (EQ 0.09MG BASE/INH)

Patents	Expiration	Patented Use
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. 8651103 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 002: Jan 9, 2019	Mar 26, 2028
Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 002: Jan 9, 2019	Jan 13, 2032
Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 002: Jan 9, 2019	Jun 28, 2031
Pat. No. 9463288 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 002: Jan 9, 2019	May 19, 2025
Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement Claim Types: Device Pat. Sub. Date(s): 002: Jan 9, 2019	May 18, 2031
Pat. No. 9782550 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 002: Jan 9, 2019	Aug 28, 2035
Pat. No. 9782551 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device Pat. Sub. Date(s): 002: Jan 9, 2019	Aug 28, 2035
Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 002: Jan 9, 2019	May 18, 2031
Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 002: Jan 9, 2019	May 18, 2031
Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): 002: Mar 19, 2020	Jan 1, 2032
Pat. No. 10569034 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 002: Mar 12, 2020	Aug 16, 2036
Pat. No. 10765820 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 002: Oct 6, 2020	May 19, 2025
Pat. No. 10918816 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 002: Mar 18, 2021	Dec 14, 2035
Pat. No. 11000653 DP* Inhaler Claim Types: Part of a dosage form; Device; Method of use Pat. Sub. Date(s): 002: Jun 10, 2021	Dec 18, 2038
Pat. No. 11173259 DP* Drug delivery device with electronics and power management Claim Types: Device Pat. Sub. Date(s): 002: Dec 8, 2021	Jul 6, 2040
Pat. No. 11266796 DP* Inhalation device with integrated electronics Claim Types: Device; Method of administration Pat. Sub. Date(s): 002: Apr 7, 2022	Feb 22, 2041

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE (SPRAY, METERED) (INHALATION) COMBIVENT RESPIMAT
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == beta-2 adrenergic agonist == Respiratory Tract/ Pulmonary Agents:Bronchodilators, Anticholinergic == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 021747  Prod. No.: 001 RX (EQ 0.1MG BASE/INH;0.02MG/INH)

Patents	Expiration	Patented Use
Pat. No. 7284474 DP* Piston-pumping system having o-ring seal properties Claim Types: Device Pat. Sub. Date(s): 001: Nov 2, 2011	Aug 26, 2024
Pat. No. 7396341 DP* Blocking device for a locking stressing mechanism having a spring-actuated output drive device Claim Types: Device; Method of use; Method of administration Pat. Sub. Date(s): 001: Nov 2, 2011	Oct 10, 2026
Pat. No. 7837235 DP* Device for clamping a fluidic component Claim Types: Device Pat. Sub. Date(s): 001: Nov 2, 2011	Mar 13, 2028
Pat. No. 7896264 DP* Microstructured high pressure nozzle with built-in filter function Claim Types: Device; Process Pat. Sub. Date(s): 001: Nov 2, 2011	May 26, 2025
Pat. No. 8733341 DP* Atomizer and method of atomizing fluid with a nozzle rinsing mechanism Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Sep 4, 2015	Oct 16, 2030
Pat. No. 9027967 DP* Device for clamping a fluidic component Claim Types: Device; Process Pat. Sub. Date(s): 001: Sep 4, 2015	Mar 31, 2027

ALCAFTADINE (SOLUTION/DROPS) (OPHTHALMIC) LASTACAFT
Drug Classes: Ophthalmic Agents:Ophthalmic Anti-allergy Agents == histamine-1 (H1) receptor antagonist
NDA Applicant: ALLERGAN      NDA No.: 022134  Prod. No.: 001 OTC (0.25%)

Patents	Expiration	Patented Use
Pat. No. 8664215 Ocular allergy treatments with alcaftadine Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 21, 2014	Dec 23, 2027	U-3267: Use of LASTACAFT to temporary relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander
Pat. No. 10617695 DP* Ophthalmic compositions containing alcaftadine Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: May 12, 2020	Mar 19, 2027	U-3267: Use of LASTACAFT to temporary relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander

ALCOHOL (SOLUTION) (INTRA-ARTERIAL) ABLYSINOL
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Alcohol Deterrents/Anti-craving
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: Antineoplastics:Molecular Target Inhibitors == 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: 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
Drug Classes: Metabolic Bone Disease Agents
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
Pat. No. 9592195 DP* Stable effervescent bisphosphonate formulations with rapid solubilization characteristics Claim Types: Formulation Pat. Sub. Date(s): 001: May 12, 2021	Dec 5, 2031

ALISKIREN HEMIFUMARATE (TABLET) (ORAL) TEKTURNA [GENERIC AB]
Drug Classes: Cardiovascular Agents:Cardiovascular Agents, Other == Cardiovascular Agents:Cardiovascular Combinations == renin inhibitor
NDA Applicant: NODEN PHARMA      NDA No.: 021985  Prod. No.: 001 RX (EQ 150MG BASE); 002 RX (EQ 300MG BASE)

Patents	Expiration	Patented Use
Pat. No. 8617595 DP* Galenic formulations of organic compounds Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): All strengths: None	Aug 19, 2026 *PED

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE (TABLET) (ORAL) TEKAMLO
Drug Classes: Cardiovascular Agents:Cardiovascular Agents, Other == Cardiovascular Agents:Cardiovascular Combinations == renin inhibitor == Cardiovascular Agents:Calcium Channel Blocking Agents, Dihydropyridines == 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: Cardiovascular Agents:Cardiovascular Agents, Other == Cardiovascular Agents:Cardiovascular Combinations == renin inhibitor == Cardiovascular Agents:Calcium Channel Blocking Agents, Dihydropyridines == dihydropyridine calcium channel blocker == Cardiovascular Agents:Diuretics, Thiazide == 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

ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE (TABLET) (ORAL) TEKTURNA HCT
Drug Classes: Cardiovascular Agents:Cardiovascular Agents, Other == Cardiovascular Agents:Cardiovascular Combinations == renin inhibitor == Cardiovascular Agents:Diuretics, Thiazide == thiazide diuretic
NDA Applicant: NODEN PHARMA      NDA No.: 022107  Prod. No.: 003 RX (EQ 300MG BASE;12.5MG); 004 RX (EQ 300MG BASE;25MG) NDA No.: 022107  Prod. No.: 001 DISC (EQ 150MG BASE;12.5MG); 002 DISC (EQ 150MG 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: Cardiovascular Agents:Cardiovascular Agents, Other == Cardiovascular Agents:Cardiovascular Combinations == renin inhibitor == Cardiovascular Agents:Angiotensin II Receptor Antagonists == angiotensin II receptor blocker
NDA Applicant: NOVARTIS      NDA No.: 022217  Prod. No.: 001 DISC (EQ 150MG BASE;160MG); 002 DISC (EQ 300MG BASE;320MG)

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: Antigout Agents == Antineoplastics:Treatment Adjuncts == 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: Blood Glucose Regulators:Antidiabetic Agents == Blood Glucose Regulators:Antidiabetic Combinations == dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 022271  Prod. No.: 001 RX (EQ 6.25MG BASE); 002 RX (EQ 12.5MG BASE); 003 RX (EQ 25MG BASE)

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: Blood Glucose Regulators:Antidiabetic Agents == Blood Glucose Regulators:Antidiabetic Combinations == dipeptidyl peptidase-4 (DPP-4) inhibitor == biguanide
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 203414  Prod. No.: 001 RX (EQ 12.5MG BASE;500MG); 002 RX (EQ 12.5MG BASE;1GM)

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: Blood Glucose Regulators:Antidiabetic Agents == Blood Glucose Regulators:Antidiabetic Combinations == dipeptidyl peptidase-4 (DPP-4) inhibitor == peroxisome proliferator-activated receptor (PPAR) alpha agonist == peroxisome proliferator-activated receptor (PPAR) gamma agonist == thiazolidinedione
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 022426  Prod. No.: 001 RX (EQ 25MG BASE;EQ 15MG BASE); 002 RX (EQ 25MG BASE;EQ 30MG BASE); 003 RX (EQ 25MG BASE;EQ 45MG BASE); 005 RX (EQ 12.5MG BASE;EQ 30MG BASE) NDA No.: 022426  Prod. No.: 004 DISC (EQ 12.5MG BASE;EQ 15MG BASE); 006 DISC (EQ 12.5MG BASE;EQ 45MG BASE)

Patents	Expiration	Patented Use
Pat. No. 7807689 DS* DP* Dipeptidyl peptidase inhibitors Claim Types: Compound; Composition; Drug in a container; Method of use Pat. Sub. Date(s): All strengths: None	Jun 27, 2028	U-1337: Method of treating diabetes comprising administering alogliptin
Pat. No. 8173663 [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
Drug Classes: Antineoplastics:Molecular Target Inhibitors
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

ALPELISIB (TABLET) (ORAL) VIJOICE
Drug Classes: Antineoplastics:Molecular Target Inhibitors
NDA Applicant: NOVARTIS      NDA No.: 215039  Prod. No.: 001 RX (50MG); 002 RX (125MG); 003 RX (200MG)

Patents	Expiration	Patented Use
Pat. No. 8227462 DS* DP* Pyrrolidine-1,2-dicarboxamide derivatives Claim Types: Compound; Method of use; Composition; Formulation Pat. Sub. Date(s): All strengths: May 3, 2022	Sep 28, 2030
Pat. No. 8476268 DS* DP* Pyrrolidine-1,2-dicarboxamide derivatives Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): All strengths: May 3, 2022	Sep 10, 2029

ALVIMOPAN (CAPSULE) (ORAL) ENTEREG [GENERIC AB]
Drug Classes: Gastrointestinal Agents:Gastrointestinal Agents, Other == opioid antagonist
NDA Applicant: CUBIST PHARMS      NDA No.: 021775  Prod. No.: 001 RX (12MG)

Patents	Expiration	Patented Use
Pat. No. 8946262 Methods of preventing and treating gastrointestinal dysfunction Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Feb 19, 2015	Feb 12, 2030	U-1655: A method to accelerate the time to gastrointestinal recovery by administering about 12 mg of alvimopan to the patient from about 30 to 60 minutes prior to surgery

AMANTADINE HYDROCHLORIDE (CAPSULE, EXTENDED RELEASE) (ORAL) GOCOVRI
Drug Classes: Antiparkinson Agents:Antiparkinson Agents, Other == Antivirals:Anti-influenza Agents == 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
Pat. No. 11065213 DP* Amantadine compositions and preparations thereof Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): All strengths: Jul 20, 2021	Aug 23, 2038
Pat. No. 11077073 Methods of using amantadine compositions Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 4, 2021	Aug 23, 2038	U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications U-2224: Treatment of dyskinesia and increasing on time without troublesome dyskinesia in patients with Parkinson's Disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications U-3180: Decreasing off time in patients with parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 11197835 Method of administering amantadine prior to a sleep period Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 12, 2022	Dec 2, 2030	U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivity	Aug 24, 2024	ODE-153: Treatment of dyskinesia in patients with parkinson's disease receiving levodopa-based therapy with or without concomitant dopaminergic medications