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 24, 2025

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

Patents	Expiration	Patented Use
Pat. No. 7855211 DS* DP* Protein kinase inhibitors Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Oct 16, 2017	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 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

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
Pat. No. 10765820 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 001: Oct 6, 2020	May 19, 2025

ALBUTEROL SULFATE (POWDER, METERED) (INHALATION) PROAIR DIGIHALER
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: TEVA BRANDED PHARM      NDA No.: 205636  Prod. No.: 002 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
Pat. No. 10765820 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 002: Oct 6, 2020	May 19, 2025

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