Orange Book Companion
Generic names starting with "A"

Patents whose numbers are in italics have been extended under 35 USC 156. Unless otherwise noted, all expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
Products tagged as [GENERIC] have had a generic equivalent approved for at least one strength of the product.


ABACAVIR SULFATE (TABLET) (ORAL) ZIAGEN [GENERIC AB]
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitors (HIV
NDA Applicant: VIIV HLTHCARE      NDA No.: 020977  Prod. No.: 001 RX (EQ 300MG BASE)
PatentsExpirationPatented Use
Pat. No. 6294540 DS* DP* Carbocyclic nucleoside hemisulfate and its use in treating viral infections
Claim Types: Composition; Method of use
Nov 14, 2018 *PEDU-65: Method of treatment of a patient infected with HIV

ABACAVIR SULFATE (SOLUTION) (ORAL) ZIAGEN [GENERIC AA]
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitors (HIV
NDA Applicant: VIIV HLTHCARE      NDA No.: 020978  Prod. No.: 001 RX (EQ 20MG BASE/ML)
PatentsExpirationPatented Use
Pat. No. 6294540 DS* DP* Carbocyclic nucleoside hemisulfate and its use in treating viral infections
Claim Types: Composition; Method of use
Nov 14, 2018 *PEDU-65: Method of treatment of a patient infected with HIV
Pat. No. 6641843 DP* Pharmaceutical compositions
Claim Types: Formulation; Process
Aug 4, 2019 *PED 

ABACAVIR SULFATE (SOLUTION) (ORAL) ABACAVIR SULFATE [GENERIC AA]
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitors (HIV
NDA Applicant: HETERO LABS LTD III      NDA No.: 201107  Prod. No.: 001 RX (EQ 20MG BASE/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Code: PC - Patent challengeMar 14, 2018 

ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE (TABLET) (ORAL) TRIUMEQ
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitors (HIV; human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI); HBV nucleoside analog reverse transcriptase inhibitor (HBV- NRTI); HIV nucleoside analog reverse transcriptase inhibitors (HIV NRTI)
NDA Applicant: VIIV HLTHCARE      NDA No.: 205551  Prod. No.: 001 RX (EQ 600MG BASE;EQ 50MG BASE;300MG)
PatentsExpirationPatented Use
Pat. No. 6294540 DS* DP* Carbocyclic nucleoside hemisulfate and its use in treating viral infections
Claim Types: Composition; Method of use
Nov 14, 2018 *PEDU-1572: Treatment of human immunodeficiency virus (HIV) infection.
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
Oct 5, 2027 
Pat. No. 9242986 DS* DP* Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates
Claim Types: New polymorph, salt or hydrate
Dec 8, 2029 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityAug 12, 2018 

ABACAVIR SULFATE; LAMIVUDINE (TABLET) (ORAL) EPZICOM [GENERIC AB]
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitors (HIV; HBV nucleoside analog reverse transcriptase inhibitor (HBV- NRTI); HIV nucleoside analog reverse transcriptase inhibitors (HIV NRTI)
NDA Applicant: VIIV HLTHCARE      NDA No.: 021652  Prod. No.: 001 RX (EQ 600MG BASE;300MG)
PatentsExpirationPatented Use
Pat. No. 6294540 DS* DP* Carbocyclic nucleoside hemisulfate and its use in treating viral infections
Claim Types: Composition; Method of use
Nov 14, 2018 *PEDU-257: Treatment of HIV infection

ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE (TABLET) (ORAL) TRIZIVIR [GENERIC AB]
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitors (HIV; HBV nucleoside analog reverse transcriptase inhibitor (HBV- NRTI); HIV nucleoside analog reverse transcriptase inhibitors (HIV NRTI)
NDA Applicant: VIIV HLTHCARE      NDA No.: 021205  Prod. No.: 001 RX (EQ 300MG BASE;150MG;300MG)
PatentsExpirationPatented Use
Pat. No. 6294540 DS* DP* Carbocyclic nucleoside hemisulfate and its use in treating viral infections
Claim Types: Composition; Method of use
Nov 14, 2018 *PEDU-65: Method of treatment of a patient infected with HIV

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))
PatentsExpirationPatented Use
Pat. No. 7803770 Method of treating osteoporosis comprising administration of PTHrP analog
Claim Types: Method of use
Mar 26, 2028U-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
Nov 8, 2027 
Pat. No. 8748382 Method of drug delivery for bone anabolic protein
Claim Types: Method of use
Oct 3, 2027U-2009: Method of treating postmenopausal women with osteoporosis at high risk for fracture.
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityApr 28, 2022 

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)
PatentsExpirationPatented Use
Pat. No. 7855211 DS* DP* Protein kinase inhibitors
Claim Types: Compound; Composition; Method of use
Dec 15, 2029U-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 diease 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
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationFeb 26, 2021I-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 entitySep 28, 2022 

ABEMACICLIB (TABLET) (ORAL) VERZENIO
Drug Classes: kinase inhibitor
NDA Applicant: ELI LILLY AND CO      NDA No.: 208716  Prod. No.: 004 RX (200MG)
PatentsExpirationPatented Use
Pat. No. 7855211 DS* DP* Protein kinase inhibitors
Claim Types: Compound; Composition; Method of use
Dec 15, 2029U-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 diease 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
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationFeb 26, 2021I-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 entitySep 28, 2022 

ABIRATERONE ACETATE (TABLET) (ORAL) ZYTIGA
Drug Classes: CYP17 inhibitor
NDA Applicant: JANSSEN BIOTECH      NDA No.: 202379  Prod. No.: 001 RX (250MG); 002 RX (500MG)
PatentsExpirationPatented Use
Pat. No. 8822438 Methods and compositions for treating cancer
Claim Types: Method of use
Aug 24, 2027U-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationFeb 7, 2021I-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)
PatentsExpirationPatented Use
Pat. No. 9889144 DP* Abiraterone acetate formulation and methods of use
Claim Types: Formulation
Mar 17, 2034 

ACALABRUTINIB (CAPSULE) (ORAL) CALQUENCE
Drug Classes: kinase inhibitor
NDA Applicant: ASTRAZENECA      NDA No.: 210259  Prod. No.: 001 RX (100MG)
PatentsExpirationPatented Use
Pat. No. 7459554 DS* Imidazopyrazine tyrosine kinase inhibitors
Claim Types: Compound
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
Jul 11, 2032 
Pat. No. 9758524 4-imidazopyridazin-1-yl-benzamides as BTK inhibitors
Claim Types: Method of use
Jul 11, 2032U-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
Jul 1, 2036U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityOct 31, 2022 
Exclusivity Code: ODE - Orphan drug exclusivityOct 31, 2024ODE-175: Treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy

ACETAMINOPHEN (SOLUTION) (INTRAVENOUS) OFIRMEV [GENERIC AP]
Drug Classes: antidote for acetaminophen overdose; mucolytic antidote for acetaminophen overdose
NDA Applicant: MALLINCKRODT IP      NDA No.: 022450  Prod. No.: 001 RX (1GM/100ML (10MG/ML))
PatentsExpirationPatented Use
Pat. No. 6028222 DP* Stable liquid paracetamol compositions, and method for preparing same
Claim Types: Formulation
Feb 5, 2018 *PED 
Pat. No. 6992218 DP* Method for obtaining aqueous formulations of oxidation-sensitive active principles
Claim Types: Product-by-process; Process
Dec 6, 2021 *PED 
Pat. No. 9399012 Reduced dose intravenous acetaminophen
Claim Types: Method of use
Mar 11, 2032 *PEDU-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
May 13, 2029 *PEDU-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
May 13, 2029 *PEDU-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousJul 27, 2020 PEDM-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; BENZHYDROCODONE HYDROCHLORIDE (TABLET) (ORAL) APADAZ
Drug Classes: antidote for acetaminophen overdose; mucolytic antidote for acetaminophen overdose
NDA Applicant: KEMPHARM      NDA No.: 208653  Prod. No.: 001 RX (325MG;EQ 6.12MG BASE)
PatentsExpirationPatented 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
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
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
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
Jul 1, 2030U-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
Jul 1, 2030 

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE (TABLET, EXTENDED RELEASE) (ORAL) XARTEMIS XR
Drug Classes: antidote for acetaminophen overdose; mucolytic antidote for acetaminophen overdose; opioid agonist
NDA Applicant: MALLINCKRODT INC      NDA No.: 204031  Prod. No.: 001 DISC (325MG;7.5MG)
PatentsExpirationPatented Use
Pat. No. 6488962 DP* Tablet shapes to enhance gastric retention of swellable controlled-release oral dosage forms
Claim Types: Composition
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
Jun 1, 2027U-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
Mar 11, 2029U-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
Nov 19, 2029U-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
Mar 11, 2029 
Pat. No. 8597681 DP* Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans
Claim Types: Formulation; Product-by-process
Dec 21, 2030 
Pat. No. 8658631 DP* Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia
Claim Types: Formulation
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
Mar 11, 2029U-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
May 16, 2032U-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
Dec 21, 2030 
Pat. No. 8992975 DP* Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia
Claim Types: Formulation
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
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
May 16, 2032U-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))
PatentsExpirationPatented Use
Pat. No. 8148356 DP* Acetylcysteine composition and uses therefor
Claim Types: Formulation; Drug in a container
May 21, 2026 
Pat. No. 8399445 Acetylcysteine composition and uses thereof
Claim Types: Method of use
Aug 24, 2025U-1373: Method of treating acetaminophen overdose with acetylcysteine solutions
Pat. No. 8653061 Acetylcysteine composition and uses thereof
Claim Types: Method of use
Aug 24, 2025U-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
Apr 6, 2032U-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
Jul 21, 2031U-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 RX (500MG); 002 RX (2.5GM)
PatentsExpirationPatented Use
Pat. No. 8747894 DP* Effervescent compositions containing N-acetylcysteine
Claim Types: Formulation; Method of use
May 8, 2032U-1373: Method of treating acetaminophen overdose with acetylcysteine solutions
Pat. No. 9427421 DP* Effervescent compositions containing N-acetylcysteine
Claim Types: Formulation; Product-by-process
May 8, 2032 
Pat. No. 9561204 Effervescent compositions containing N-acetylcysteine
Claim Types: Method of use
May 8, 2032U-1373: Method of treating acetaminophen overdose with acetylcysteine solutions

ACLIDINIUM BROMIDE (POWDER, METERED) (INHALATION) TUDORZA PRESSAIR
Drug Classes: anticholinergic
NDA Applicant: ASTRAZENECA PHARMS      NDA No.: 202450  Prod. No.: 001 RX (0.4MG/INH)
PatentsExpirationPatented 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
Feb 10, 2025U-1263: Treatment of chronic obstructive pulmonary disease (COPD) or chronic bronchitis
Pat. No. 6681768 DP* Powder formulation disintegrating system and method for dry powder inhalers
Claim Types: Device
Aug 7, 2022 
Pat. No. 7078412 DS* DP* Quinuclidine derivatives and medicinal compositions containing the same
Claim Types: Compound; Composition; Method of use
Jul 16, 2020U-1263: Treatment of chronic obstructive pulmonary disease (COPD) or chronic bronchitis
Pat. No. 8051851 DP* Inhaler for the administration of powdered pharmaceuticals, and a powder cartridge system for use with this inhaler
Claim Types: Device
Apr 22, 2027 
Pat. No. 9056100 DP* Quinuclidine derivatives and medicinal compositions containing the same
Claim Types: Formulation; Method of use
Jul 7, 2020U-1263: Treatment of chronic obstructive pulmonary disease (COPD) or chronic bronchitis
Pat. No. 9333195 DP* Quinuclidine derivatives and medicinal compositions containing the same
Claim Types: Composition; Formulation; Method of use
Jul 7, 2020U-1263: Treatment of chronic obstructive pulmonary disease (COPD) or chronic bronchitis

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)
PatentsExpirationPatented Use
Pat. No. 8592434 DP* Mucoadhesive buccal tablets for the treatment of orofacial herpes
Claim Types: Method of use
Jun 16, 2030U-1460: Treatment of herpes labialis
Pat. No. 8747896 DP* Mucosal bioadhesive slow release carrier for delivering active principles
Claim Types: Formulation; Method of use
Jun 3, 2027U-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
Mar 23, 2027U-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: VALEANT BERMUDA      NDA No.: 022436  Prod. No.: 001 RX (5%;1%)
PatentsExpirationPatented Use
Pat. No. 6514980 DP* Nucleoside analogs in combination therapy of herpes simplex infections
Claim Types: Formulation; Method of use
Jul 24, 2018U-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)
Pat. No. 7223387 DP* Antiviral formulations comprising propylene glycol and an isopropyl alkanoic acid ester
Claim Types: Formulation; Method of use
Nov 13, 2022U-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 [Has competitive generic]
Drug Classes: retinoid
NDA Applicant: GALDERMA LABS LP      NDA No.: 020380  Prod. No.: 002 OTC (0.1%)
ExclusivityExpirationExclusivity Description
Exclusivity Code: RTO - RX to OTC switch or OTC useJul 8, 2019 

ADAPALENE (GEL) (TOPICAL) DIFFERIN [GENERIC AB]
Drug Classes: retinoid
NDA Applicant: GALDERMA LABS LP      NDA No.: 021753  Prod. No.: 001 RX (0.3%)
PatentsExpirationPatented 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
Feb 23, 2025U-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
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
Mar 12, 2023U-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
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
Mar 12, 2023U-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
Mar 12, 2023U-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%)
PatentsExpirationPatented Use
Pat. No. 7998467 DP* Cosmetic/dermatological compositions comprising naphthoic acid compounds and polyurethane polymers
Claim Types: Formulation; Process; Method of use
May 31, 2028U-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
Sep 15, 2026U-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
Sep 15, 2026U-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%)
PatentsExpirationPatented 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
Nov 23, 2025 
Pat. No. 7964202 DP* Method for treatment of common acne
Claim Types: Method of use; Drug in a container
Sep 1, 2024U-1078: Treatment of acne
Pat. No. 8071644 DP* Combinations of adapalene and benzoyl peroxide for treating acne lesions
Claim Types: Method of use
Jul 18, 2027U-1078: Treatment of acne
Pat. No. 8080537 Combinations of adapalene and benzoyl peroxide for treating acne lesions
Claim Types: Method of administration
Jul 18, 2027U-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
Dec 23, 2022U-1078: Treatment of acne
Pat. No. 8129362 Combination/association of adapalene and benzoyl peroxide for treating acne lesions
Claim Types: Method of use
Jul 18, 2027U-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
Dec 23, 2022 
Pat. No. 8445543 Combinations of adapalene and benzoyl peroxide for treating acne lesions
Claim Types: Method of administration
Jul 12, 2027U-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
Dec 23, 2022U-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
Dec 23, 2022U-1078: Treatment of acne

ADAPALENE; BENZOYL PEROXIDE (GEL) (TOPICAL) ADAPALENE AND BENZOYL PEROXIDE [GENERIC AB]
Drug Classes: retinoid
NDA Applicant: ACTAVIS MID ATLANTIC      NDA No.: 203790  Prod. No.: 001 RX (0.1%;2.5%)
ExclusivityExpirationExclusivity Description
Exclusivity Code: PC - Patent challengeJan 23, 2018 

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%)
PatentsExpirationPatented Use
Pat. No. 8445543 Combinations of adapalene and benzoyl peroxide for treating acne lesions
Claim Types: Method of administration
Dec 23, 2022U-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
Mar 12, 2023U-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
Mar 12, 2023U-1078: Treatment of acne
Pat. No. 8785420 Combination/association of adapalene and benzoyl peroxide for treating acne lesions
Claim Types: Method of use
Dec 23, 2022U-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
Dec 23, 2022U-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
Dec 23, 2022U-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
Mar 12, 2023U-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
Mar 12, 2023U-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
Dec 23, 2022U-1078: Treatment of acne
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productJul 15, 2018 

ADEFOVIR DIPIVOXIL (TABLET) (ORAL) HEPSERA [GENERIC AB]
Drug Classes: HBV nucleoside analog reverse transcriptase inhibitor (HBV- NRTI)
NDA Applicant: GILEAD      NDA No.: 021449  Prod. No.: 001 RX (10MG)
PatentsExpirationPatented Use
Pat. No. 6451340 DS* DP* Nucleotide analog compositions
Claim Types: New polymorph, salt or hydrate; Method of use; Process; Product-by-process; Formulation
Jul 23, 2018U-470: Therapy in chronic hepatitis B virus infection

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)
PatentsExpirationPatented Use
Pat. No. RE43431 DS* Quinazoline derivatives and pharmaceutical compositions containing them
Claim Types: Compound
Jan 22, 2022 
Pat. No. 6251912 DS* DP* Substituted quinazoline derivatives
Claim Types: Compound; Method of use; Composition
Jul 29, 2018U-1067: Treatment of cancer
Pat. No. 8426586 DS* Process for preparing amino crotonyl compounds
Claim Types: New polymorph, salt or hydrate; Process
Oct 10, 2029 
Pat. No. 8545884 DP* Solid pharmaceutical formulations comprising BIBW 2992
Claim Types: Intermediate; Formulation; Process; Product-by-process
Dec 19, 2029 
Pat. No. 9539258 Quinazoline derivatives for the treatment of cancer diseases
Claim Types: Method of use
Nov 9, 2026U-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
Jul 5, 2030 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJan 12, 2021I-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: NCE - New chemical entityJul 12, 2018 
Exclusivity Code: ODE - Orphan drug exclusivityApr 15, 2023ODE-115: Treatment of patients with metastatic, squamous, non-small cell lung cancer progressing after platinum-based chemotherapy
Exclusivity Code: ODE - Orphan drug exclusivityJul 12, 2020ODE-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.

AFATINIB DIMALEATE (TABLET) (ORAL) GILOTRIF
Drug Classes: kinase inhibitor
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 201292  Prod. No.: 003 RX (EQ 40MG BASE)
PatentsExpirationPatented Use
Pat. No. RE43431 DS* Quinazoline derivatives and pharmaceutical compositions containing them
Claim Types: Compound
Jan 22, 2022 
Pat. No. 6251912 DS* DP* Substituted quinazoline derivatives
Claim Types: Compound; Method of use; Composition
Jul 29, 2018U-1067: Treatment of cancer
Pat. No. 8426586 DS* Process for preparing amino crotonyl compounds
Claim Types: New polymorph, salt or hydrate; Process
Oct 10, 2029 
Pat. No. 8545884 DP* Solid pharmaceutical formulations comprising BIBW 2992
Claim Types: Intermediate; Formulation; Process; Product-by-process
Dec 19, 2029 
Pat. No. 9539258 Quinazoline derivatives for the treatment of cancer diseases
Claim Types: Method of use
Nov 9, 2026U-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
Jul 5, 2030 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationApr 15, 2019I-730: New indication for the treatment of patients with metastatic, squamous, non-small cell lung cancer progressing after platinum-based chemotherapy
Exclusivity Code: I - New IndicationJan 12, 2021I-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: NCE - New chemical entityJul 12, 2018 
Exclusivity Code: ODE - Orphan drug exclusivityApr 15, 2023ODE-115: Treatment of patients with metastatic, squamous, non-small cell lung cancer progressing after platinum-based chemotherapy
Exclusivity Code: ODE - Orphan drug exclusivityJul 12, 2020ODE-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.

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)
PatentsExpirationPatented Use
Pat. No. 6723303 DP* Ultrasound contrast agents including protein stabilized microspheres of perfluoropropane, perfluorobutane or perfluoropentane
Claim Types: Composition
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)
PatentsExpirationPatented Use
Pat. No. 6702997 Albuterol inhalation solution, system, kit and method for relieving symptoms of pediatric asthma
Claim Types: Method of use
Dec 28, 2021U-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
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 020983  Prod. No.: 001 RX (EQ 0.09MG BASE/INH)
PatentsExpirationPatented Use
Pat. No. 6161724 DP* Indicating device
Claim Types: Device
Jul 16, 2018 *PED 
Pat. No. 6170717 DP* Valve for aerosol container
Claim Types: Device
Jun 23, 2018 *PED 
Pat. No. 6315173 DP* Valve for aerosol container
Claim Types: Device
Jun 23, 2018 *PED 
Pat. No. 6431168 DP* Dispenser with doses' counter
Claim Types: Device; Method of administration; Drug in a container
Dec 8, 2018 *PED 
Pat. No. 6435372 DP* Delivery system for a medicament and method for the assembly thereof
Claim Types: Device; Process
Jul 16, 2018 *PED 
Pat. No. 6510969 DP* Valve for aerosol container
Claim Types: Device
Jun 23, 2018 *PED 
Pat. No. 6938796 DP* Indicating device
Claim Types: Device; Process; Method of administration
Jul 16, 2018 *PED 
Pat. No. 6966467 DP* Valve for aerosol container
Claim Types: Device
Jun 23, 2018 *PED 
Pat. No. 6997349 DP* Indicating device
Claim Types: Device; Kit; Process
Jul 16, 2018 *PED 
Pat. No. 7107986 DP* Dispenser with doses' counter
Claim Types: Device
Dec 6, 2018 *PED 
Pat. No. 7143908 DP* Indicating device
Claim Types: Device; Process
Jul 16, 2018 *PED 
Pat. No. 7350676 DP* Valve for aerosol container
Claim Types: Device
Feb 24, 2019 *PED 
Pat. No. 7500444 DP* Actuation indicator for a dispensing device
Claim Types: Device
Aug 26, 2026 *PED 
Pat. No. 7832351 DP* Actuation indicator for a dispensing device
Claim Types: Device
Dec 19, 2023 *PED 
Pat. No. 9861771 DP* Device housing for an aerosol container
Claim Types: Device
Oct 11, 2020 

ALBUTEROL SULFATE (AEROSOL, METERED) (INHALATION) PROAIR HFA
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: TEVA BRANDED PHARM      NDA No.: 021457  Prod. No.: 001 RX (EQ 0.09MG BASE/INH)
PatentsExpirationPatented Use
Pat. No. 7105152 DP* Suspension aerosol formulations
Claim Types: Formulation; Device
Sep 12, 2023 
Pat. No. 8132712 DP* Metered-dose inhaler
Claim Types: Device; Method of use
Sep 7, 2028 
Pat. No. 9463289 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
May 18, 2031 
Pat. No. 9808587 DP* Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Device
May 18, 2031 
Pat. No. 10022509 DP* Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Part of a dosage form
May 18, 2031 
Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
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 0.090MG BASE/INH)
PatentsExpirationPatented Use
Pat. No. 6701917 DP* Dose counter for medicament inhaler
Claim Types: Device
Jun 23, 2021 
Pat. No. 6718972 DP* Dose metering system for medicament inhaler
Claim Types: Device; Drug in a container
Jun 23, 2021 
Pat. No. 6748947 DP* De-agglomerator for breath-actuated dry powder inhaler
Claim Types: Device; Drug in a container
Jun 23, 2021 
Pat. No. 6871646 DP* De-agglomerator for breath-actuated dry powder inhaler
Claim Types: Method of improving a treatment
Jun 23, 2021 
Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler
Claim Types: Device
May 6, 2023 
Pat. No. 8006690 DP* Reservoir pressure system for medicament inhaler
Claim Types: Device
Jun 23, 2021 
Pat. No. 8651103 DP* Dry powder inhalation apparatus
Claim Types: Device
Mar 26, 2028 
Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Jan 13, 2032 
Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Jun 28, 2031 
Pat. No. 9463288 DP* Dry powder inhalation apparatus
Claim Types: Device
May 19, 2025 
Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Device
May 18, 2031 
Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
May 18, 2031 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productMar 12, 2018 
Exclusivity Code: NPP - New patient populationApr 28, 2019 

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%**)
PatentsExpirationPatented 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
Dec 28, 2021U-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)
PatentsExpirationPatented Use
Pat. No. 6846413 DP* Microstructured filter
Claim Types: Device
Aug 28, 2018 
Pat. No. 6977042 DP* Microstructured filter
Claim Types: Device
Aug 28, 2018 
Pat. No. 6988496 DP* Cartridge for a liquid
Claim Types: Method of administration; Drug in a container
Feb 23, 2020 
Pat. No. 7284474 DP* Piston-pumping system having o-ring seal properties
Claim Types: Device
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
Oct 10, 2026 
Pat. No. 7802568 DP* Cartridge for a liquid
Claim Types: Device
Feb 26, 2019 
Pat. No. 7837235 DP* Device for clamping a fluidic component
Claim Types: Device
Mar 13, 2028 
Pat. No. 7896264 DP* Microstructured high pressure nozzle with built-in filter function
Claim Types: Device; Process
May 26, 2025 
Pat. No. 7988001 DP* Container provided with a pressure equalization opening
Claim Types: Device
Aug 4, 2021 
Pat. No. 8733341 DP* Atomizer and method of atomizing fluid with a nozzle rinsing mechanism
Claim Types: Device; Method of administration
Oct 16, 2030 
Pat. No. 9027967 DP* Device for clamping a fluidic component
Claim Types: Device; Process
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%)
PatentsExpirationPatented Use
Pat. No. 8664215 Ocular allergy treatments with alcaftadine
Claim Types: Method of use
Dec 23, 2027U-1493: Method for preventing itching associated with allergic conjunctivitis

ALCOHOL (SOLUTION) (INTRA-ARTERIAL) ABLYSINOL
Drug Classes: pediculicide
NDA Applicant: BELCHER PHARMS LLC      NDA No.: 207987  Prod. No.: 001 RX (99% (1ML)); 002 RX (99% (5ML))
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityJun 21, 2025ODE-192: Indicated to induce controlled cardiac septal infraction 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)
PatentsExpirationPatented Use
Pat. No. 9126931 DS* Tetracyclic compound
Claim Types: Compound
May 29, 2031 
Pat. No. 9365514 DP* Composition comprising tetracyclic compound
Claim Types: Formulation
Mar 4, 2032 
Pat. No. 9440922 DP* Tetracyclic compound
Claim Types: Composition
Jun 9, 2030 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationNov 6, 2020I-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 entityDec 11, 2020 
Exclusivity Code: ODE - Orphan drug exclusivityDec 11, 2022ODE-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 exclusivityNov 6, 2024ODE-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 (SOLUTION) (ORAL) FOSAMAX
NDA Applicant: MERCK      NDA No.: 021575  Prod. No.: 001 DISC (EQ 70MG BASE/75ML**)
PatentsExpirationPatented Use
Pat. No. 5994329 Method for inhibiting bone resorption
Claim Types: Method of use; Kit
Jan 17, 2019 *PED 
Pat. No. 6015801 Method for inhibiting bone resorption
Claim Types: Method of use
Jan 17, 2019 *PED 
Pat. No. 6225294 Method for inhibiting bone resorption
Claim Types: Kit
Jan 17, 2019 *PED 

ALENDRONATE SODIUM (TABLET, EFFERVESCENT) (ORAL) BINOSTO
NDA Applicant: MISSION PHARMA      NDA No.: 202344  Prod. No.: 001 RX (EQ 70MG BASE)
PatentsExpirationPatented Use
Pat. No. 7488496 DS* DP* Effervescent compositions comprising bisphosphonates and methods related thereto
Claim Types: Formulation
Aug 11, 2023 
Pat. No. 7964212 DS* DP* Effervescent compositions comprising phosphonates and methods related thereto
Claim Types: Formulation
Mar 6, 2023 

ALENDRONATE SODIUM; CHOLECALCIFEROL (TABLET) (ORAL) FOSAMAX PLUS D
Drug Classes: vitamin D
NDA Applicant: MERCK      NDA No.: 021762  Prod. No.: 001 RX (EQ 70MG BASE;2,800 IU)
PatentsExpirationPatented Use
Pat. No. 5994329 Method for inhibiting bone resorption
Claim Types: Method of use; Kit
Jan 17, 2019 *PEDU-647: Treatment of osteoporosis in post menopausal women and/or the treatment to increase bone mass in men with osteoporosis

ALFUZOSIN HYDROCHLORIDE (TABLET, EXTENDED RELEASE) (ORAL) UROXATRAL [GENERIC AB]
Drug Classes: alpha adrenergic blocker
NDA Applicant: CONCORDIA PHARMS INC      NDA No.: 021287  Prod. No.: 001 RX (10MG)
PatentsExpirationPatented Use
Pat. No. 6149940 Tablet with controlled release of alfuzosine chlorhydrate
Claim Types: Formulation
Feb 22, 2018 *PED 

ALISKIREN HEMIFUMARATE (TABLET) (ORAL) TEKTURNA
Drug Classes: renin inhibitor
NDA Applicant: NODEN PHARMA      NDA No.: 021985  Prod. No.: 001 RX (EQ 150MG BASE); 002 RX (EQ 300MG BASE)
PatentsExpirationPatented Use
Pat. No. 5559111 DS* DP* [Extended 1204 days (3.3 years)]
.delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides
Claim Types: Compound; Composition; Method of use
Jan 21, 2019 *PEDU-3: Treatment of hypertension
Pat. No. 8617595 DP* Galenic formulations of organic compounds
Claim Types: Formulation; Method of use; Process
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)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productMay 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)
PatentsExpirationPatented Use
Pat. No. 5559111 DS* DP* [Extended 1204 days (3.3 years)]
.delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides
Claim Types: Compound; Composition; Method of use
Jul 21, 2018U-3: Treatment of hypertension
Pat. No. 8613949 DP* Galenical formulations of organic compounds
Claim Types: Formulation; Process
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)
PatentsExpirationPatented Use
Pat. No. 5559111 DS* DP* [Extended 1204 days (3.3 years)]
.delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides
Claim Types: Compound; Composition; Method of use
Jul 21, 2018U-3: Treatment of hypertension
Pat. No. 8183295 DP* Pharmaceutical composition comprising a renin inhibitor, a calcium channel blocker and a diuretic
Claim Types: Formulation
May 16, 2023 
Pat. No. 8618174 DP* Synergistic combinations comprising a renin inhibitor for cardiovascular diseases
Claim Types: Composition; Formulation
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)
PatentsExpirationPatented Use
Pat. No. 5559111 DS* DP* [Extended 1204 days (3.3 years)]
.delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides
Claim Types: Compound; Composition; Method of use
Jan 21, 2019 *PEDU-3: Treatment of hypertension
Pat. No. 8618172 DP* Galenical formulations of organic compounds
Claim Types: Formulation
Jul 13, 2028 
Pat. No. 9023893 DP* Synergistic combinations comprising a renin inhibitor for cardiovascular diseases
Claim Types: Formulation
Mar 3, 2022 

ALISKIREN HEMIFUMARATE; VALSARTAN (TABLET) (ORAL) VALTURNA
Drug Classes: renin inhibitor; angiotensin II receptor blocker
NDA Applicant: NOVARTIS      NDA No.: 022217  Prod. No.: 001 DISC (EQ 150MG BASE;160MG); 002 DISC (EQ 300MG BASE;320MG)
PatentsExpirationPatented Use
Pat. No. 5559111 DS* DP* [Extended 1204 days (3.3 years)]
.delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides
Claim Types: Compound; Composition; Method of use
Jul 21, 2018U-3: Treatment of hypertension
Pat. No. 8168616 DP* Combination comprising a renin inhibitor and an angiotensin receptor inhibitor for hypertension
Claim Types: Composition
Jul 3, 2026 

ALLOPURINOL; LESINURAD (TABLET) (ORAL) DUZALLO
Drug Classes: xanthine oxidase inhibitor; URAT1 inhibitor
NDA Applicant: IRONWOOD PHARMS INC      NDA No.: 209203  Prod. No.: 001 RX (200MG;200MG); 002 RX (300MG;200MG)
PatentsExpirationPatented 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
Aug 25, 2025 
Pat. No. 8084483 Compounds and compositions and methods of use
Claim Types: Method of use
Aug 17, 2029U-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
Nov 26, 2028U-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
Nov 26, 2028U-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
Feb 29, 2032 
Pat. No. 8546437 Compounds and compositions and methods of use
Claim Types: Method of use
Apr 29, 2029U-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
Aug 1, 2031U-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
Dec 28, 2031U-2104: Treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a medically appropriate daily dose of allopurinol alone

ALOGLIPTIN BENZOATE (TABLET) (ORAL) NESINA
Drug Classes: dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 022271  Prod. No.: 001 RX (EQ 6.25MG BASE); 002 RX (EQ 12.5MG BASE); 003 RX (EQ 25MG BASE)
PatentsExpirationPatented Use
Pat. No. 6890898 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1335: Methods of modifying glucose metabolism and treating diabetes comprising administering a dipeptidyl peptidase inhibitor and one or more other therapeutic agents such as metformin
Pat. No. 7078381 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1335: Methods of modifying glucose metabolism and treating diabetes comprising administering a dipeptidyl peptidase inhibitor and one or more other therapeutic agents such as metformin
Pat. No. 7459428 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1336: Methods of treating diabetes comprising administering a dipeptidyl peptidase inhibitor and metformin
Pat. No. 7807689 DS* DP* Dipeptidyl peptidase inhibitors
Claim Types: Compound; Composition; Drug in a container; Method of use
Jun 27, 2028U-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
Dec 2, 2025U-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
Mar 15, 2025 
Pat. No. 8697125 DP* Tablet preparation without causing a tableting trouble
Claim Types: Formulation; Process; Product-by-process
Jun 16, 2029 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousApr 5, 2019M-177: Information added to the labeling describing examine, a trial evaluating cardiovascular ischemic risks associated with alogliptin use in patients with Type 2 diabetes at high risk of ischemic cardiovascular disease
Exclusivity Code: NCE - New chemical entityJan 25, 2018 

ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE (TABLET) (ORAL) KAZANO
Drug Classes: dipeptidyl peptidase-4 (DPP-4) inhibitor; biguanide
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 203414  Prod. No.: 001 RX (EQ 12.5MG BASE;500MG); 002 RX (EQ 12.5MG BASE;1GM)
PatentsExpirationPatented Use
Pat. No. 6890898 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1335: Methods of modifying glucose metabolism and treating diabetes comprising administering a dipeptidyl peptidase inhibitor and one or more other therapeutic agents such as metformin
Pat. No. 7078381 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1335: Methods of modifying glucose metabolism and treating diabetes comprising administering a dipeptidyl peptidase inhibitor and one or more other therapeutic agents such as metformin
Pat. No. 7459428 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1336: Methods of treating diabetes comprising administering a dipeptidyl peptidase inhibitor and metformin
Pat. No. 7807689 DS* DP* Dipeptidyl peptidase inhibitors
Claim Types: Compound; Composition; Drug in a container; Method of use
Jun 27, 2028U-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
Mar 15, 2025U-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
Jun 24, 2025 
Pat. No. 8900638 DP* Solid preparation comprising alogliptin and metformin hydrochloride
Claim Types: Formulation; Process
May 24, 2029 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousApr 5, 2019M-177: Information added to the labeling describing examine, a trial evaluating cardiovascular ischemic risks associated with alogliptin use in patients with Type 2 diabetes at high risk of ischemic cardiovascular disease
Exclusivity Code: NCE - New chemical entityJan 25, 2018 

ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE (TABLET) (ORAL) OSENI
Drug Classes: dipeptidyl peptidase-4 (DPP-4) inhibitor; peroxisome proliferator-activated receptor (PPAR) alpha agonist; peroxisome proliferator-activated receptor (PPAR) gamma agonist; thiazolidinedione
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 022426  Prod. No.: 001 RX (EQ 25MG BASE;EQ 15MG BASE); 002 RX (EQ 25MG BASE;EQ 30MG BASE); 003 RX (EQ 25MG BASE;EQ 45MG BASE); 004 RX (EQ 12.5MG BASE;EQ 15MG BASE); 005 RX (EQ 12.5MG BASE;EQ 30MG BASE)
PatentsExpirationPatented Use
Pat. No. 6329404 DP* [Extended 5 years]
Pharmaceutical composition
Claim Types: Composition; Method of use
Jun 19, 2021U-1334: Methods of treating diabetes comprising administering an insulin sensitivity enhancer such as pioglitazone in combination with an insulin secretion enhancer
Pat. No. 6890898 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1335: Methods of modifying glucose metabolism and treating diabetes comprising administering a dipeptidyl peptidase inhibitor and one or more other therapeutic agents such as metformin
Pat. No. 7078381 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1335: Methods of modifying glucose metabolism and treating diabetes comprising administering a dipeptidyl peptidase inhibitor and one or more other therapeutic agents such as metformin
Pat. No. 7459428 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1336: Methods of treating diabetes comprising administering a dipeptidyl peptidase inhibitor and metformin
Pat. No. 7807689 DS* DP* Dipeptidyl peptidase inhibitors
Claim Types: Compound; Composition; Drug in a container; Method of use
Jun 27, 2028U-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
Mar 15, 2025U-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
Mar 15, 2025 
Pat. No. 8637079 DP* Solid preparation comprising alogliptin and pioglitazone
Claim Types: Formulation
Jun 4, 2029 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousApr 5, 2019M-177: Information added to the labeling describing examine, a trial evaluating cardiovascular ischemic risks associated with alogliptin use in patients with Type 2 diabetes at high risk of ischemic cardiovascular disease
Exclusivity Code: NCE - New chemical entityJan 25, 2018 

ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE (TABLET) (ORAL) OSENI
Drug Classes: dipeptidyl peptidase-4 (DPP-4) inhibitor; peroxisome proliferator-activated receptor (PPAR) alpha agonist; peroxisome proliferator-activated receptor (PPAR) gamma agonist; thiazolidinedione
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 022426  Prod. No.: 006 RX (EQ 12.5MG BASE;EQ 45MG BASE)
PatentsExpirationPatented Use
Pat. No. 6890898 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1335: Methods of modifying glucose metabolism and treating diabetes comprising administering a dipeptidyl peptidase inhibitor and one or more other therapeutic agents such as metformin
Pat. No. 7078381 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1335: Methods of modifying glucose metabolism and treating diabetes comprising administering a dipeptidyl peptidase inhibitor and one or more other therapeutic agents such as metformin
Pat. No. 7459428 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1336: Methods of treating diabetes comprising administering a dipeptidyl peptidase inhibitor and metformin
Pat. No. 7807689 DS* DP* Dipeptidyl peptidase inhibitors
Claim Types: Compound; Composition; Drug in a container; Method of use
Jun 27, 2028U-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
Mar 15, 2025U-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
Mar 15, 2025 
Pat. No. 8637079 DP* Solid preparation comprising alogliptin and pioglitazone
Claim Types: Formulation
Jun 4, 2029 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousApr 5, 2019M-177: Information added to the labeling describing examine, a trial evaluating cardiovascular ischemic risks associated with alogliptin use in patients with Type 2 diabetes at high risk of ischemic cardiovascular disease
Exclusivity Code: NCE - New chemical entityJan 25, 2018 

ALPRAZOLAM (TABLET, ORALLY DISINTEGRATING) (ORAL) NIRAVAM
Drug Classes: benzodiazepine
NDA Applicant: UCB INC      NDA No.: 021726  Prod. No.: 001 DISC (0.25MG**); 002 DISC (0.5MG**); 003 DISC (1MG**); 004 DISC (2MG**)
PatentsExpirationPatented Use
Pat. No. 6024981 DP* Rapidly dissolving robust dosage form
Claim Types: Formulation; Process; Drug in a container
Apr 9, 2018 
Pat. No. 6221392 DP* Rapidly dissolving robust dosage form
Claim Types: Formulation
Apr 9, 2018 

ALVIMOPAN (CAPSULE) (ORAL) ENTEREG
Drug Classes: opioid antagonist
NDA Applicant: CUBIST PHARMS      NDA No.: 021775  Prod. No.: 001 RX (12MG)
PatentsExpirationPatented Use
Pat. No. 6469030 Methods for the treatment and prevention of ileus
Claim Types: Method of use
Nov 29, 2020U-879: A method of treating or preventing ileus
Pat. No. 8112290 Methods for delivering a drug to a hospital patient for short-term use while minimizing long-term use of the drug
Claim Types: Method of administration
Jul 31, 2030U-1443: Accelerating the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis
Pat. No. 8645160 Methods for delivering a drug to a hospital patient for short-term use while minimizing long-term use of the drug
Claim Types: Method of administration
Jun 18, 2029U-1485: Treating a subject undergoing abdominal surgery by administering alvimopan to accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis
Pat. No. 8946262 Methods of preventing and treating gastrointestinal dysfunction
Claim Types: Method of use; Method of administration
Feb 12, 2030U-1655: A method to accelerate the time to gastrointestinal recovery by administering about 12 mg of alvimopan to the patient from about 30 to 60 minutes prior to surgery

AMANTADINE HYDROCHLORIDE (CAPSULE, EXTENDED RELEASE) (ORAL) GOCOVRI
Drug Classes: influenza A M2 protein inhibitor
NDA Applicant: ADAMAS PHARMA      NDA No.: 208944  Prod. No.: 001 RX (EQ 68.5MG BASE); 002 RX (EQ 137MG BASE)
PatentsExpirationPatented Use
Pat. No. 8389578 Composition and method for treating neurological disease
Claim Types: Method of administration
Jan 22, 2028U-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
Dec 2, 2030U-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
Nov 23, 2025U-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
Nov 23, 2025 
Pat. No. 8895614 DP* Composition and method for treating neurological disease
Claim Types: Formulation
Nov 23, 2025 
Pat. No. 8895615 Composition and method for treating neurological disease
Claim Types: Method of administration
Nov 23, 2025U-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
Nov 23, 2025U-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
Nov 23, 2025U-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
Nov 23, 2025 
Pat. No. 9867791 Method of administering amantadine prior to a sleep period
Claim Types: Method of administration
Dec 2, 2030U-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
Dec 2, 2030U-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
Dec 2, 2030U-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
Dec 2, 2030U-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationAug 24, 2020I-769: Treatment of dyskinesia in patients with parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Exclusivity Code: ODE - Orphan drug exclusivityAug 24, 2024ODE-153: Treatment of dyskinesia in patients with parkinson's disease receiving levodopa-based therapy with or without concomitant dopaminergic medications

AMANTADINE HYDROCHLORIDE (TABLET, EXTENDED RELEASE) (ORAL) OSMOLEX ER
Drug Classes: influenza A M2 protein inhibitor
NDA Applicant: OSMOTICA PHARM      NDA No.: 209410  Prod. No.: 001 RX (EQ 129MG BASE); 002 RX (EQ 193MG BASE); 003 RX (EQ 258MG BASE)
PatentsExpirationPatented Use
Pat. No. RE39069 DP* Multi-layered osmotic device
Claim Types: Device
May 29, 2018 
Pat. No. 8252331 DP* Osmotic device containing amantadine and an osmotic salt
Claim Types: Formulation
Mar 13, 2030 
Pat. No. 8574626 DP* Osmotic device containing amantadine and an osmotic salt
Claim Types: Formulation; Method of use
Nov 28, 2025U-20: A process for treating a patient suffering from parkinson's syndrome and in need of treatment

AMBRISENTAN (TABLET) (ORAL) LETAIRIS
Drug Classes: endothelin receptor antagonist
NDA Applicant: GILEAD      NDA No.: 022081  Prod. No.: 001 RX (5MG); 002 RX (10MG)
PatentsExpirationPatented Use
Pat. No. RE42462 DS* [Extended 1026 days (2.8 years)]
Carboxylic acid derivatives, their preparation and use
Claim Types: Compound
Jul 29, 2018 
Pat. No. 8377933 Method for treating a pulmonary hypertension condition
Claim Types: Method of administration; Method of use
Dec 11, 2027U-1754: For the treatment of pulmonary hypertension (PAH) in combination with tadalafil
Pat. No. 9474752 Method for treating a pulmonary hypertension condition
Claim Types: Method of use
Dec 11, 2027U-1754: For the treatment of pulmonary hypertension (PAH) in combination with tadalafil
Pat. No. 9549926 Compositions and methods of treating pulmonary hypertension
Claim Types: Method of use
Oct 14, 2031U-1965: For the treatment of pulmonary arterial hypertension (PAH) in combination with tadalafil, wherein the weight ratio of ambrisentan to tadalafil is about 1:2 to about 1:3
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationOct 2, 2018I-716: Revised indication to include language about the benefits of using LETAIRIS in combination with tadalafil to reduce the risk of disease progression and hospitalization for worsening PAH and to improve exercise ability, based on the ambition study

AMINOLEVULINIC ACID HYDROCHLORIDE (SOLUTION) (TOPICAL) LEVULAN
Drug Classes: porphyrin precursor
NDA Applicant: DUSA      NDA No.: 020965  Prod. No.: 001 RX (20%)
PatentsExpirationPatented Use
Pat. No. 6709446 Illuminator for photodynamic therapy and diagnosis which produces substantially uniform intensity visible light
Claim Types: Device; Method of use
May 1, 2018U-289: Treatment of non-hyperkeratotic actinic keratoses of face and scalp
Pat. No. 7723910 Method of photodynamically diagnosing or treating a contoured surface
Claim Types: Method of use
Jun 17, 2019U-289: Treatment of non-hyperkeratotic actinic keratoses of face and scalp
Pat. No. 8216289 Illuminator for photodynamic therapy
Claim Types: Diagnostic or surgical method
May 1, 2018U-289: Treatment of non-hyperkeratotic actinic keratoses of face and scalp
Pat. No. 8758418 Illuminator for photodynamic therapy
Claim Types: Method of use
May 1, 2018U-289: Treatment of non-hyperkeratotic actinic keratoses of face and scalp
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMar 9, 2021I-766: Treatment of minimally to moderately thick actinic keratosis of the upper extremities in conjunction with a blue light photodynamic therapy illuminator

AMINOLEVULINIC ACID HYDROCHLORIDE (GEL) (TOPICAL) AMELUZ
Drug Classes: porphyrin precursor
NDA Applicant: BIOFRONTERA      NDA No.: 208081  Prod. No.: 001 RX (10%)
PatentsExpirationPatented Use
Pat. No. 6559183 DP* Nano-emulsion of 5-aminolevulinic acid
Claim Types: Formulation; Kit; Process; Method of use; Diagnostic or surgical method
Nov 12, 2019U-804: Treatment of actinic keratoses by photodynamic therapy
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productMay 10, 2019 

AMINOLEVULINIC ACID HYDROCHLORIDE (FOR SOLUTION) (ORAL) GLEOLAN
Drug Classes: porphyrin precursor
NDA Applicant: NXDC      NDA No.: 208630  Prod. No.: 001 RX (1.5GM/VIAL)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityJun 6, 2024ODE-146: Optical imaging agent indicated in patients with glioma (suspected World Health Organization grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery

AMIODARONE HYDROCHLORIDE (INJECTABLE) (INJECTION) NEXTERONE [Has competitive generic]
Drug Classes: antiarrhythmic
NDA Applicant: BAXTER HLTHCARE      NDA No.: 022325  Prod. No.: 002 RX (150MG/100ML (1.5MG/ML)); 003 RX (360MG/200ML (1.8MG/ML)) NDA No.: 022325  Prod. No.: 001 DISC (50MG/ML)
PatentsExpirationPatented Use
Pat. No. 6869939 DP* Formulations containing amiodarone and sulfoalkyl ether cyclodextrin
Claim Types: Formulation; Process
May 4, 2022 
Pat. No. 7635773 DP* Sulfoalkyl ether cyclodextrin compositions
Claim Types: Formulation; Process
Mar 13, 2029 

AMLODIPINE BESYLATE (TABLET, ORALLY DISINTEGRATING) (ORAL) AMLODIPINE BESYLATE
Drug Classes: dihydropyridine calcium channel blocker
NDA Applicant: SYNTHON PHARMS      NDA No.: 022026  Prod. No.: 001 DISC (EQ 2.5MG BASE); 002 DISC (EQ 5MG BASE); 003 DISC (EQ 10MG BASE)
PatentsExpirationPatented Use
Pat. No. 6828339 DS* Amlodipine salt forms and processes for preparing them
Claim Types: New polymorph, salt or hydrate; Formulation
Nov 20, 2022 

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM (TABLET) (ORAL) CADUET [GENERIC AB]
Drug Classes: dihydropyridine calcium channel blocker; HMG CoA-reductase inhibitor
NDA Applicant: PFIZER      NDA No.: 021540  Prod. No.: 001 RX (EQ 5MG BASE;EQ 10MG BASE); 002 RX (EQ 5MG BASE;EQ 20MG BASE); 003 RX (EQ 5MG BASE;EQ 40MG BASE); 004 RX (EQ 5MG BASE;EQ 80MG BASE); 005 RX (EQ 10MG BASE;EQ 10MG BASE); 006 RX (EQ 10MG BASE;EQ 20MG BASE); 007 RX (EQ 10MG BASE;EQ 40MG BASE); 008 RX (EQ 10MG BASE;EQ 80MG BASE); 009 RX (EQ 2.5MG BASE;EQ 10MG BASE); 010 RX (EQ 2.5MG BASE;EQ 20MG BASE); 011 RX (EQ 2.5MG BASE;EQ 40MG BASE)
PatentsExpirationPatented Use
Pat. No. 6455574 Therapeutic combination
Claim Types: Method of use
Aug 11, 2018U-552: Treatment of hypertension and hyperlipidemia with a single composition

AMLODIPINE BESYLATE; CELECOXIB (TABLET) (ORAL) CONSENSI
Drug Classes: dihydropyridine calcium channel blocker; nonsteroidal anti-inflammatory drug
NDA Applicant: KITOV PHARMS LTD      NDA No.: 210045  Prod. No.: 001 RX (EQ 2.5MG BASE;200MG); 002 RX (EQ 5MG BASE;200MG); 003 RX (EQ 10MG BASE;200MG)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NC - New combinationMay 31, 2021 

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN (TABLET) (ORAL) EXFORGE HCT [GENERIC AB]
Drug Classes: dihydropyridine calcium channel blocker; thiazide diuretic; angiotensin II receptor blocker
NDA Applicant: NOVARTIS      NDA No.: 022314  Prod. No.: 001 RX (5MG;12.5MG;160MG); 002 RX (5MG;25MG;160MG); 003 RX (10MG;12.5MG;160MG); 004 RX (10MG;25MG;160MG); 005 RX (10MG;25MG;320MG)
PatentsExpirationPatented Use
Pat. No. 8101599 DP* Pharmaceutical composition containing anti-hypertensive agents
Claim Types: Formulation; Kit
May 16, 2023 
Pat. No. 8475839 DP* Formulation
Claim Types:
Nov 16, 2023 *PED 

AMLODIPINE BESYLATE; PERINDOPRIL ARGININE (TABLET) (ORAL) PRESTALIA
Drug Classes: dihydropyridine calcium channel blocker; angiotensin converting enzyme inhibitor
NDA Applicant: MARINA BIOTECH      NDA No.: 205003  Prod. No.: 001 RX (EQ 2.5MG BASE;3.5MG ); 002 RX (EQ 5MG BASE;7MG); 003 RX (EQ 10MG BASE;14MG)
PatentsExpirationPatented Use
Pat. No. 6696481 DS* DP* Salt of perindopril and pharmaceutical compositions containing it
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Apr 15, 2023U-3: Treatment of hypertension
Pat. No. 7846961 DS* DP* .alpha. crystalline form of the arginine salt of perindopril, a process for its preparation and pharm
Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use
Oct 5, 2029U-3: Treatment of hypertension
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productJan 21, 2018 

AMLODIPINE BESYLATE; VALSARTAN (TABLET) (ORAL) EXFORGE [GENERIC AB]
Drug Classes: dihydropyridine calcium channel blocker; angiotensin II receptor blocker
NDA Applicant: NOVARTIS      NDA No.: 021990  Prod. No.: 002 RX (EQ 5MG BASE;160MG); 003 RX (EQ 10MG BASE;160MG); 004 RX (EQ 5MG BASE;320MG); 005 RX (EQ 10MG BASE;320MG)
PatentsExpirationPatented Use
Pat. No. 6395728 DP* Method of treatment and pharmaceutical composition
Claim Types: Method of use; Composition; Formulation
Jul 8, 2019 

AMOXICILLIN (TABLET, EXTENDED RELEASE) (ORAL) MOXATAG
Drug Classes: penicillin class antibacterial
NDA Applicant: VERNALIS R AND D LTD      NDA No.: 050813  Prod. No.: 001 RX (775MG)
PatentsExpirationPatented Use
Pat. No. 6544555 DS* DP* Antibiotic product, use and formulation thereof
Claim Types: Formulation; Method of use
Oct 13, 2020U-897: Method of treating tonsillitis and/or pharyngitis secondary to streptococcus pyogenes in a once-a-day amoxicillin product
Pat. No. 6669948 DS* DP* Antibiotic product, use and formulation thereof
Claim Types: Formulation; Method of use
Oct 13, 2020U-897: Method of treating tonsillitis and/or pharyngitis secondary to streptococcus pyogenes in a once-a-day amoxicillin product
Pat. No. 6723341 DS* DP* Antibiotic product, use and formulation thereof
Claim Types: Formulation; Method of use
Oct 13, 2020U-897: Method of treating tonsillitis and/or pharyngitis secondary to streptococcus pyogenes in a once-a-day amoxicillin product
Pat. No. 8299052 Pharmaceutical compositions and methods for improved bacterial eradication
Claim Types: Method of use
May 7, 2027U-1304: Use of once-a-day amoxicillin product to treat tonsillitis and/or pharyngitis secondary to streptococcus pyogenes
Pat. No. 8357394 DP* Compositions and methods for improved efficacy of penicillin-type antibiotics
Claim Types: Formulation
Dec 8, 2026 
Pat. No. 8778924 DS* DP* Modified release amoxicillin products
Claim Types: Formulation; Method of use
Dec 8, 2026U-897: Method of treating tonsillitis and/or pharyngitis secondary to streptococcus pyogenes in a once-a-day amoxicillin product

AMOXICILLIN; CLAVULANATE POTASSIUM (TABLET, EXTENDED RELEASE) (ORAL) AUGMENTIN XR [GENERIC AB]
Drug Classes: penicillin class antibacterial
NDA Applicant: DR REDDYS LABS INC      NDA No.: 050785  Prod. No.: 001 RX (1GM;EQ 62.5MG BASE)
PatentsExpirationPatented Use
Pat. No. 6746692 DP* Modified release pharmaceutical formulation comprising amoxycillin
Claim Types: Formulation
Apr 4, 2020 
Pat. No. 6783773 DP* Composition comprising amoxicillin and potassium clavulanate
Claim Types: Formulation
Apr 4, 2020 
Pat. No. 6878386 Method of treating a bacterial infection comprising amoxycillin and potassium clavulanate
Claim Types: Method of use
Apr 4, 2020U-926: Mgt specific bacterial infections. treatment pts w/ community acquired pneumonia or bacterial sinusitis due to confirmed, or suspected b-lactamase producing pathogens & S. pneumoniae with reduced susceptibility to penicillin (mic=2mc/ml)
Pat. No. 7217430 DP* Compositions and methods of treatment comprising amoxicillin and potassium clavulanate with xanthan
Claim Types: Formulation; Method of use
Apr 4, 2020U-926: Mgt specific bacterial infections. treatment pts w/ community acquired pneumonia or bacterial sinusitis due to confirmed, or suspected b-lactamase producing pathogens & S. pneumoniae with reduced susceptibility to penicillin (mic=2mc/ml)
Pat. No. 7250176 Method of treating a bacterial infection
Claim Types: Method of use
Apr 4, 2020U-926: Mgt specific bacterial infections. treatment pts w/ community acquired pneumonia or bacterial sinusitis due to confirmed, or suspected b-lactamase producing pathogens & S. pneumoniae with reduced susceptibility to penicillin (mic=2mc/ml)

AMPHETAMINE (SUSPENSION, EXTENDED RELEASE) (ORAL) ADZENYS ER
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: NEOS THERAPS INC      NDA No.: 204325  Prod. No.: 001 RX (EQ 1.25MG BASE/ML)
PatentsExpirationPatented Use
Pat. No. 8709491 DP* Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles
Claim Types: Formulation
Jun 28, 2032 
Pat. No. 9017731 DP* Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles
Claim Types: Formulation
Jun 28, 2032 
Pat. No. 9265737 DP* Pharmaceutical composition comprising amphetamines complexed with ion-exchange resin particles
Claim Types: Formulation
Jun 28, 2032 

AMPHETAMINE (TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE) (ORAL) ADZENYS XR-ODT
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: NEOS THERAPS      NDA No.: 204326  Prod. No.: 001 RX (EQ 3.1MG BASE); 002 RX (EQ 6.3MG BASE); 003 RX (EQ 9.4MG BASE); 004 RX (EQ 12.5MG BASE); 005 RX (EQ 15.7MG BASE); 006 RX (EQ 18.8MG BASE)
PatentsExpirationPatented Use
Pat. No. 8709491 DP* Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles
Claim Types: Formulation
Jun 28, 2032 
Pat. No. 8840924 DP* Compositions and methods of making rapidly dissolving ionically masked formulations
Claim Types: Formulation
Apr 9, 2026 
Pat. No. 9017731 DP* Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles
Claim Types: Formulation
Jun 28, 2032 
Pat. No. 9265737 DP* Pharmaceutical composition comprising amphetamines complexed with ion-exchange resin particles
Claim Types: Formulation
Jun 28, 2032 

AMPHETAMINE (SUSPENSION, EXTENDED RELEASE) (ORAL) DYANAVEL XR
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: TRIS PHARMA INC      NDA No.: 208147  Prod. No.: 001 RX (EQ 2.5MG BASE/ML)
PatentsExpirationPatented Use
Pat. No. 8062667 DP* Modified release formulations containing drug-ion exchange resin complexes
Claim Types: Formulation
Mar 29, 2029 
Pat. No. 8597684 DP* Modified release formulations containing drug-ion exchange resin complexes
Claim Types: Formulation; Product-by-process
Mar 15, 2027 
Pat. No. 8747902 DP* Modified release formulations containing drug-ion exchange resin complexes
Claim Types: Formulation
Mar 15, 2027 
Pat. No. 8883217 DP* Modified release formulations containing drug-ion exchange resin complexes
Claim Types: Formulation
Mar 15, 2027 
Pat. No. 9675703 DP* Modified release formulations containing drug - ion exchange resin complexes
Claim Types: Formulation
Mar 15, 2027 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productOct 19, 2018 

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE (TABLET) (ORAL) ADDERALL 10; ADDERALL 20; ADDERALL 5; ADDERALL 30; ADDERALL 7.5; ADDERALL 12.5; ADDERALL 15
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: TEVA WOMENS      NDA No.: 011522  Prod. No.: 007 DISC (2.5MG;2.5MG;2.5MG;2.5MG**); 008 DISC (5MG;5MG;5MG;5MG**); 009 DISC (1.25MG;1.25MG;1.25MG;1.25MG**); 010 DISC (7.5MG;7.5MG;7.5MG;7.5MG**); 011 DISC (1.875MG;1.875MG;1.875MG;1.875MG**); 012 DISC (3.125MG;3.125MG;3.125MG;3.125MG**); 013 DISC (3.75MG;3.75MG;3.75MG;3.75MG**)
PatentsExpirationPatented Use
Pat. No. 6384020 Rapid immediate release oral dosage form
Claim Types: Formulation
Jan 6, 2021 *PED 

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE (CAPSULE, EXTENDED RELEASE) (ORAL) ADDERALL XR 10; ADDERALL XR 20; ADDERALL XR 30; ADDERALL XR 25; ADDERALL XR 5; ADDERALL XR 15 [GENERIC AB]
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: SHIRE      NDA No.: 021303  Prod. No.: 001 RX (2.5MG;2.5MG;2.5MG;2.5MG); 002 RX (5MG;5MG;5MG;5MG); 003 RX (7.5MG;7.5MG;7.5MG;7.5MG); 004 RX (6.25MG;6.25MG;6.25MG;6.25MG); 005 RX (1.25MG;1.25MG;1.25MG;1.25MG); 006 RX (3.75MG;3.75MG;3.75MG;3.75MG)
PatentsExpirationPatented Use
Pat. No. RE41148 DP* Oral pulsed dose drug delivery system
Claim Types: Formulation
Apr 21, 2019 *PED 
Pat. No. RE42096 DP* Oral pulsed dose drug delivery system
Claim Types: Formulation
Apr 21, 2019 *PED 
Pat. No. 6322819 Oral pulsed dose drug delivery system
Claim Types: Formulation
Apr 21, 2019 *PED 
Pat. No. 6605300 Oral pulsed dose drug delivery system
Claim Types: Formulation
Apr 21, 2019 *PED 

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE (CAPSULE, EXTENDED RELEASE) (ORAL) MYDAYIS [Has competitive generic]
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: SHIRE DEV LLC      NDA No.: 022063  Prod. No.: 001 RX (3.125MG;3.125MG;3.125MG;3.125MG); 002 RX (6.25MG;6.25MG;6.25MG;6.25MG); 003 RX (9.375MG;9.375MG;9.375MG;9.375MG); 004 RX (12.5MG;12.5MG;12.5MG;12.5MG)
PatentsExpirationPatented Use
Pat. No. RE41148 DP* Oral pulsed dose drug delivery system
Claim Types: Formulation
Oct 21, 2018 
Pat. No. RE42096 DP* Oral pulsed dose drug delivery system
Claim Types: Formulation
Oct 21, 2018 
Pat. No. 6913768 DP* Sustained release delivery of amphetamine salts
Claim Types: Formulation; Method of use
May 24, 2023U-2025: Treatment of attention deficit hyperactivity disorder
Pat. No. 8846100 DP* Controlled dose drug delivery system
Claim Types: Formulation
Aug 24, 2029 
Pat. No. 9173857 Controlled dose drug delivery system
Claim Types: Method of use
May 12, 2026U-2025: Treatment of attention deficit hyperactivity disorder
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productJun 20, 2020 

AMPHOTERICIN B (INJECTABLE, LIPID COMPLEX) (INJECTION) ABELCET
Drug Classes: lipid-based polyene antifungal
NDA Applicant: LEADIANT BIOSCI INC      NDA No.: 050724  Prod. No.: 001 RX (5MG/ML)
PatentsExpirationPatented Use
Pat. No. 6406713 DS* Methods of preparing low-toxicity drug-lipid complexes
Claim Types: Process
Jun 18, 2019 

ANGIOTENSIN II ACETATE (SOLUTION) (INTRAVENOUS) GIAPREZA
Drug Classes: vasoconstrictor; angiotensin II receptor blocker; angiotensin converting enzyme inhibitor
NDA Applicant: LA JOLLA PHARMA      NDA No.: 209360  Prod. No.: 001 RX (EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)) NDA No.: 209360  Prod. No.: 002 DISC (EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 9220745 Angiotensin II alone or in combination for the treatment of hypotension
Claim Types: Method of use
Dec 18, 2034U-2217: Treating high output shock with angiotensin II by increasing mean arterial pressure in patients treated with catecholamines and reducing catecholamine use
U-2218: Maintaining mean arterial pressure of about 65 mmHg or higher with angiotensin II in shock patients treated with catecholamines and reducing catecholamine use
Pat. No. 9572856 Method of treating low blood pressure
Claim Types: Method of use
Sep 20, 2030U-2221: Treating refractory hypotension with about 20 ng/kg/min angiotensin II in a patient receiving vasopressor
Pat. No. 9867863 Method of treating low blood pressure
Claim Types: Method of use
Dec 16, 2029U-2231: Treating refractory hypotension with about 5 ng/kg/min to about 20 ng/kg/min angiotensin II in a patient receiving vasopressor
Pat. No. 10028995 Angiotensin II alone or in combination for the treatment of hypotension
Claim Types: Method of improving a treatment
Dec 18, 2034U-2338: Maintaining mean arterial pressure of about 65 mmHg or above with about 1 ng/kg/min to about 40 ng/kg/min angiotensin II in hypotensive patients treated with vasopressin or a vasopressin analogue and reducing vasopressin or vasopressin analogue use
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityDec 21, 2022 

ANIDULAFUNGIN (POWDER) (INTRAVENOUS) ERAXIS
Drug Classes: echinocandin antifungal
NDA Applicant: VICURON      NDA No.: 021632  Prod. No.: 001 RX (50MG/VIAL); 002 RX (100MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 5965525 DS* DP* [Extended 1223 days (3.4 years)]
Cyclic peptide antifungal agents
Claim Types: Compound; Method of use; Composition
Feb 17, 2020U-540: Treatment of fungal infections
Pat. No. 6960564 DP* Echinocandin pharmaceutical formulations containing micelle-forming surfactants
Claim Types: Formulation; Process; Method of use
Apr 12, 2021U-540: Treatment of fungal infections
Pat. No. 7709444 DP* Echinocandin pharmaceutical formulations containing micelle-forming surfactants
Claim Types: Formulation; Process; Method of use
Apr 12, 2021U-540: Treatment of fungal infections

APALUTAMIDE (TABLET) (ORAL) ERLEADA
NDA Applicant: JANSSEN BIOTECH      NDA No.: 210951  Prod. No.: 001 RX (60MG)
PatentsExpirationPatented Use
Pat. No. 8445507 DS* DP* Androgen receptor modulator for the treatment of prostate
Claim Types: Compound; Composition; Method of use
Sep 15, 2030U-2237: Treatment of non-metastatic, castration-resistant prostate cancer (NM-CRPC)
Pat. No. 8802689 Androgen receptor modulator for the treatment of prostate cancer and androgen receptor-associated diseases
Claim Types: Method of use
Mar 27, 2027U-2237: Treatment of non-metastatic, castration-resistant prostate cancer (NM-CRPC)
Pat. No. 9388159 DS* DP* Substituted diazaspiroalkanes as androgen receptor modulators
Claim Types: Compound; Composition
Mar 27, 2027 
Pat. No. 9481663 DS* DP* Crystalline forms of an androgen receptor modulator
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Jun 4, 2033U-2237: Treatment of non-metastatic, castration-resistant prostate cancer (NM-CRPC)
Pat. No. 9884054 Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer
Claim Types: Method of use
Sep 23, 2033U-2237: Treatment of non-metastatic, castration-resistant prostate cancer (NM-CRPC)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityFeb 14, 2023 

APIXABAN (TABLET) (ORAL) ELIQUIS
Drug Classes: factor Xa inhibitor
NDA Applicant: BRISTOL MYERS SQUIBB      NDA No.: 202155  Prod. No.: 001 RX (2.5MG)
PatentsExpirationPatented Use
Pat. No. 6413980 DS* DP* Nitrogen containing heterobicycles as factor Xa inhibitors
Claim Types: Compound; Composition; Method of use
Dec 22, 2019U-1200: Reducing the risk of stroke and systemic embolism
U-1301: Treatment of deep vein thrombosis (DVT)
U-1302: Treatment of pulmonary embolism (PE)
U-1501: Prophylaxis of deep vein thrombosis and pulmonary embolism
Pat. No. 6967208 DS* DP* [Extended 1526 days (4.2 years)]
Lactam-containing compounds and derivatives thereof as factor Xa inhibitors
Claim Types: Composition; Method of use; Compound
Nov 21, 2026U-1167: Prophylaxis of deep vein thrombosis (DVT)
U-1200: Reducing the risk of stroke and systemic embolism
U-1301: Treatment of deep vein thrombosis (DVT)
U-1302: Treatment of pulmonary embolism (PE)
U-1323: Reducing the risk of stroke
U-1501: Prophylaxis of deep vein thrombosis and pulmonary embolism
U-1502: Prophylaxis of pulmonary embolism
U-1729: Reduce the risk of recurrent deep vein thrombosis (DVT)
U-1730: Reduce the risk of recurrent pulmonary embolism
Pat. No. 9326945 DP* Apixaban formulations
Claim Types: Formulation
Feb 24, 2031 

APIXABAN (TABLET) (ORAL) ELIQUIS
Drug Classes: factor Xa inhibitor
NDA Applicant: BRISTOL MYERS SQUIBB      NDA No.: 202155  Prod. No.: 002 RX (5MG)
PatentsExpirationPatented Use
Pat. No. 6413980 DS* DP* Nitrogen containing heterobicycles as factor Xa inhibitors
Claim Types: Compound; Composition; Method of use
Dec 22, 2019U-1200: Reducing the risk of stroke and systemic embolism
U-1301: Treatment of deep vein thrombosis (DVT)
U-1302: Treatment of pulmonary embolism (PE)
Pat. No. 6967208 DS* DP* [Extended 1526 days (4.2 years)]
Lactam-containing compounds and derivatives thereof as factor Xa inhibitors
Claim Types: Composition; Method of use; Compound
Nov 21, 2026U-1200: Reducing the risk of stroke and systemic embolism
U-1301: Treatment of deep vein thrombosis (DVT)
U-1302: Treatment of pulmonary embolism (PE)
U-1323: Reducing the risk of stroke
Pat. No. 9326945 DP* Apixaban formulations
Claim Types: Formulation
Feb 24, 2031 

APREMILAST (TABLET) (ORAL) OTEZLA
Drug Classes: phosphodiesterase 4 inhibitor
NDA Applicant: CELGENE CORP      NDA No.: 205437  Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (30MG)
PatentsExpirationPatented Use
Pat. No. 6020358 DS* DP* Substituted phenethylsulfones and method of reducing TNF.alpha. levels
Claim Types: Compound; Method of use; Composition
Oct 30, 2018U-1504: Use of OTEZLA (apremilast) for inhibiting PDE4
Pat. No. 6962940 (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoiso indoline-1,3-dione: methods of using and compositions thereof
Claim Types: Method of use
Mar 19, 2023U-1504: Use of OTEZLA (apremilast) for inhibiting PDE4
Pat. No. 7208516 Methods of the treatment of psoriatic arthritis using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione
Claim Types: Method of use
Mar 19, 2023U-1505: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis
Pat. No. 7427638 DS* DP* [Extended 1186 days (3.2 years)]
(+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminois- oindoline-1,3-dione:, and methods of synthesis and compositions thereof
Claim Types: Composition; Formulation
Feb 16, 2028 
Pat. No. 7659302 Methods of using (+)-2-[1-(3-ethoxy-4 methoxyphenyl)-2-methylsulfonylethyl]-4 acetylaminoisoindoline 1,3-dione
Claim Types: Method of use
Mar 19, 2023U-1505: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis
U-1595: Use of OTEZLA (apremilast) for the treatment of psoriasis
Pat. No. 7893101 DS* DP* Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione, compositions thereof, and uses thereof
Claim Types: New polymorph, salt or hydrate; Composition
Dec 9, 2023 
Pat. No. 8455536 Methods of using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi-soindoline 1,3-dione
Claim Types: Method of use
Mar 19, 2023U-1505: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis
U-1595: Use of OTEZLA (apremilast) for the treatment of psoriasis
Pat. No. 8802717 Methods of treating arthritic conditions using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline 1,3-dione
Claim Types: Method of use
Mar 19, 2023U-1561: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis
Pat. No. 9018243 Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione, compositions thereof, and uses thereof
Claim Types: Method of use
Mar 19, 2023U-1505: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis
U-1595: Use of OTEZLA (apremilast) for the treatment of psoriasis
Pat. No. 9724330 Methods of using (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione
Claim Types: Method of use
Mar 19, 2023U-1561: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis
U-1595: Use of OTEZLA (apremilast) for the treatment of psoriasis
Pat. No. 9872854 Methods for the treatment of psoriatic arthritis using apremilast
Claim Types: Method of use
May 29, 2034U-2232: Treatment of psoriatic arthritis using a dosage titration schedule
U-2233: Treatment of psoriatic arthritis with apremilast using a dosage titration schedule and a second active agent
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMar 21, 2019 

APREPITANT (CAPSULE) (ORAL) EMEND [GENERIC AB]
Drug Classes: substance P/neurokinin-1 (NK-1) receptor antagonist
NDA Applicant: MERCK      NDA No.: 021549  Prod. No.: 001 RX (80MG); 002 RX (125MG)
PatentsExpirationPatented Use
Pat. No. 6096742 DS* DP* Polymorphic form of a tachykinin receptor antagonist
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Jul 1, 2018U-1743: For the prevention of nausea and vomiting associated with chemotherapy
U-1744: Prevention of post-operative nausea and vomiting
U-745: Treatment or prevention of emesis
U-745: Treatment or prevention of emesis
Pat. No. 6096742 Polymorphic form of a tachykinin receptor antagonist
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Jul 1, 2018 
Pat. No. 8258132 DP* Pharmaceutical composition of a tachykinin receptor antagonist
Claim Types: Formulation; Method of use
Sep 26, 2027U-1743: For the prevention of nausea and vomiting associated with chemotherapy
U-901: Prevention of postoperative nausea and vomiting
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationAug 28, 2018 

APREPITANT (CAPSULE) (ORAL) EMEND [GENERIC AB]
Drug Classes: substance P/neurokinin-1 (NK-1) receptor antagonist
NDA Applicant: MERCK      NDA No.: 021549  Prod. No.: 003 RX (40MG)
PatentsExpirationPatented Use
Pat. No. 6096742 DS* DP* Polymorphic form of a tachykinin receptor antagonist
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Jul 1, 2018U-1743: For the prevention of nausea and vomiting associated with chemotherapy
U-1744: Prevention of post-operative nausea and vomiting
U-745: Treatment or prevention of emesis
Pat. No. 8258132 DP* Pharmaceutical composition of a tachykinin receptor antagonist
Claim Types: Formulation; Method of use
Sep 26, 2027U-1743: For the prevention of nausea and vomiting associated with chemotherapy
U-901: Prevention of postoperative nausea and vomiting
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationAug 28, 2018 

APREPITANT (FOR SUSPENSION) (ORAL) EMEND
Drug Classes: substance P/neurokinin-1 (NK-1) receptor antagonist
NDA Applicant: MSD MERCK CO      NDA No.: 207865  Prod. No.: 001 RX (125MG/KIT)
PatentsExpirationPatented Use
Pat. No. 6096742 DS* DP* Polymorphic form of a tachykinin receptor antagonist
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Jul 1, 2018U-1916: Prevention of nausea and vomiting associated with chemotherapy (CINV)
Pat. No. 8258132 DP* Pharmaceutical composition of a tachykinin receptor antagonist
Claim Types: Formulation; Method of use
Sep 26, 2027U-1916: Prevention of nausea and vomiting associated with chemotherapy (CINV)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationAug 28, 2018 

APREPITANT (EMULSION) (INTRAVENOUS) CINVANTI
Drug Classes: substance P/neurokinin-1 (NK-1) receptor antagonist
NDA Applicant: HERON THERAPS INC      NDA No.: 209296  Prod. No.: 001 RX (130MG/18ML (7.2MG/ML))
PatentsExpirationPatented Use
Pat. No. 9561229 DP* Emulsion formulations of aprepitant
Claim Types: Formulation; Method of use
Sep 18, 2035U-2161: Treatment of nausea and vomiting, including the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly or moderately emetogenic cancer chemotherapy
Pat. No. 9808465 Emulsion formulations of aprepitant
Claim Types: Method of use
Sep 18, 2035U-2161: Treatment of nausea and vomiting, including the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly or moderately emetogenic cancer chemotherapy
Pat. No. 9974742 DP* Emulsion formulations of an NK-1 receptor antagonist and uses thereof
Claim Types: Formulation; Process
Sep 18, 2035 
Pat. No. 9974793 DP* Emulsion formulations of aprepitant
Claim Types: Formulation
Sep 18, 2035 
Pat. No. 9974794 DP* Emulsion formulations of aprepitant
Claim Types: Formulation; Method of use
Sep 18, 2035U-2161: Treatment of nausea and vomiting, including the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly or moderately emetogenic cancer chemotherapy

ARFORMOTEROL TARTRATE (SOLUTION) (INHALATION) BROVANA
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: SUNOVION      NDA No.: 021912  Prod. No.: 001 RX (EQ 0.015MG BASE/2ML)
PatentsExpirationPatented Use
Pat. No. 6472563 DS* Formoterol tartrate process and polymorph
Claim Types: New polymorph, salt or hydrate; Method of use; Composition; Formulation; Process
Nov 9, 2021 
Pat. No. 6667344 DP* Bronchodilating compositions and methods
Claim Types: Formulation; Drug in a container
Jun 22, 2021 
Pat. No. 6720453 DS* Formoterol tartrate polymorph
Claim Types: New polymorph, salt or hydrate; Method of use; Composition; Formulation
Nov 9, 2021 
Pat. No. 6814953 Bronchodilating compositions and methods
Claim Types: Kit; Method of use
Jun 22, 2021U-793: For the long term treatment, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema
Pat. No. 7145036 DS* Formoterol tartrate polymorph
Claim Types: New polymorph, salt or hydrate
Nov 9, 2021 
Pat. No. 7348362 DP* Bronchodilating .beta.-agonist compositions and methods
Claim Types: Drug in a container; Method of administration
Jun 22, 2021U-793: For the long term treatment, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema
Pat. No. 7462645 Bronchodilating beta-agonist compositions and methods
Claim Types: Method of use
Jun 22, 2021U-793: For the long term treatment, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema
Pat. No. 7465756 DP* Bronchodilating beta-agonist compositions and methods
Claim Types: Formulation
Jun 22, 2021 
Pat. No. 7473710 Bronchodilating beta-agonist compositions and methods
Claim Types: Method of administration
Jun 22, 2021U-793: For the long term treatment, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema
Pat. No. 7541385 Bronchodilating .beta.-agonist compositions and methods
Claim Types: Method of administration
Jun 22, 2021U-793: For the long term treatment, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema
Pat. No. 8110706 DP* Formoterol tartrate process and polymorph
Claim Types: Composition; Formulation
Nov 9, 2021 

ARGATROBAN (INJECTABLE) (INTRAVENOUS) ARGATROBAN IN SODIUM CHLORIDE
Drug Classes: anticoagulant; direct thrombin inhibitor
NDA Applicant: EAGLE PHARMS      NDA No.: 022434  Prod. No.: 001 RX (50MG/50ML (1MG/ML))
PatentsExpirationPatented Use
Pat. No. 7589106 DP* Alcohol free formulation of argatroban
Claim Types: Formulation; Drug in a container
Sep 26, 2027U-1163: Method of treating thrombosis
Pat. No. 7687516 DP* Alcohol free formulation of argatroban
Claim Types: Formulation; Drug in a container; Method of administration; Method of use
Sep 26, 2027U-1164: Method of treating an argatroban treatable condition

ARIPIPRAZOLE (TABLET) (ORAL) ABILIFY [GENERIC AB]
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 021436  Prod. No.: 001 RX (10MG); 002 RX (15MG); 003 RX (20MG); 004 RX (30MG); 005 RX (5MG); 006 RX (2MG)
PatentsExpirationPatented Use
Pat. No. 7053092 5-HT1a receptor subtype agonist
Claim Types: Method of use
Jan 28, 2022U-839: Treatment of major depressive disorder (MDD)
Pat. No. 8017615 DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: Composition; Product-by-process; Process
Dec 16, 2024 *PED 
Pat. No. 8580796 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate
Mar 25, 2023 *PED 
Pat. No. 8642600 Method of treating autism
Claim Types: Method of use
Jul 28, 2022 *PEDU-1492: Treatment of irritability associated with autistic disorder
Pat. No. 8642760 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: Compound
Mar 25, 2023 *PED 
Pat. No. 8759350 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Claim Types: Formulation; Method of use
Mar 2, 2027U-1529: Adjunctive treatment of major depressive disorder (MDD)
Pat. No. 9089567 Method of treating cognitive impairments and schizophrenias
Claim Types: Method of use
Jan 28, 2022U-543: Treatment of schizophrenia
Pat. No. 9125939 Carbostyril derivatives and mood stabilizers for treating mood disorders
Claim Types: Method of use
Jul 28, 2026U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder
Pat. No. 9359302 DS* DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate; Process; Product-by-process; Composition; Method of use; Kit; Formulation
Sep 25, 2022U-1859: Treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, adjunctive treatment of major depressive disorder, and treatment of irritability associated with autistic disorder
Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Claim Types: Formulation; Method of use
Dec 25, 2023U-1529: Adjunctive treatment of major depressive disorder (MDD)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityDec 12, 2021ODE-80: Treatment of pediatric patients with Tourette's

ARIPIPRAZOLE (SOLUTION) (ORAL) ABILIFY
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 021713  Prod. No.: 001 DISC (1MG/ML**)
PatentsExpirationPatented Use
Pat. No. 6977257 DP* Aripiprazole oral solution
Claim Types: Formulation
Oct 24, 2022 *PED 
Pat. No. 7053092 5-HT1a receptor subtype agonist
Claim Types: Method of use
Jan 28, 2022U-839: Treatment of major depressive disorder (MDD)
Pat. No. 8642600 Method of treating autism
Claim Types: Method of use
Jul 28, 2022 *PEDU-1492: Treatment of irritability associated with autistic disorder
Pat. No. 8759350 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Claim Types: Formulation; Method of use
Mar 2, 2027U-1529: Adjunctive treatment of major depressive disorder (MDD)
Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Claim Types: Formulation; Method of use
Dec 25, 2023U-1529: Adjunctive treatment of major depressive disorder (MDD)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityDec 12, 2021ODE-80: Treatment of pediatric patients with Tourette's

ARIPIPRAZOLE (TABLET, ORALLY DISINTEGRATING) (ORAL) ABILIFY
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 021729  Prod. No.: 002 DISC (10MG**); 003 DISC (15MG**)
PatentsExpirationPatented Use
Pat. No. 7053092 5-HT1a receptor subtype agonist
Claim Types: Method of use
Jan 28, 2022U-839: Treatment of major depressive disorder (MDD)
Pat. No. 8017615 DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: Composition; Product-by-process; Process
Dec 16, 2024 *PED 
Pat. No. 8518421 DP* Flashmelt oral dosage formulation
Claim Types: Formulation
Jul 24, 2021 *PED 
Pat. No. 8580796 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate
Mar 25, 2023 *PED 
Pat. No. 8642600 Method of treating autism
Claim Types: Method of use
Jul 28, 2022 *PEDU-1492: Treatment of irritability associated with autistic disorder
Pat. No. 8642760 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: Compound
Mar 25, 2023 *PED 
Pat. No. 8759350 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Claim Types: Formulation; Method of use
Mar 2, 2027U-1529: Adjunctive treatment of major depressive disorder (MDD)
Pat. No. 9089567 Method of treating cognitive impairments and schizophrenias
Claim Types: Method of use
Jan 28, 2022U-543: Treatment of schizophrenia
Pat. No. 9125939 Carbostyril derivatives and mood stabilizers for treating mood disorders
Claim Types: Method of use
Jul 28, 2026U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder
Pat. No. 9358207 DP* Flashmelt oral dosage formulation
Claim Types: Formulation
Apr 12, 2020 
Pat. No. 9359302 DS* DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate; Process; Product-by-process; Composition; Method of use; Kit; Formulation
Sep 25, 2022U-1859: Treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, adjunctive treatment of major depressive disorder, and treatment of irritability associated with autistic disorder
Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Claim Types: Formulation; Method of use
Dec 25, 2023U-1529: Adjunctive treatment of major depressive disorder (MDD)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityDec 12, 2021ODE-80: Treatment of pediatric patients with Tourette's

ARIPIPRAZOLE (TABLET, ORALLY DISINTEGRATING) (ORAL) ABILIFY
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 021729  Prod. No.: 004 DISC (20MG**); 005 DISC (30MG**)
PatentsExpirationPatented Use
Pat. No. 7053092 5-HT1a receptor subtype agonist
Claim Types: Method of use
Jan 28, 2022U-839: Treatment of major depressive disorder (MDD)
Pat. No. 8017615 DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: Composition; Product-by-process; Process
Dec 16, 2024 *PED 
Pat. No. 8518421 DP* Flashmelt oral dosage formulation
Claim Types: Formulation
Jul 24, 2021 *PED 
Pat. No. 8580796 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate
Mar 25, 2023 *PED 
Pat. No. 8642600 Method of treating autism
Claim Types: Method of use
Jul 28, 2022 *PEDU-1492: Treatment of irritability associated with autistic disorder
Pat. No. 8642760 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: Compound
Mar 25, 2023 *PED 
Pat. No. 9358207 DP* Flashmelt oral dosage formulation
Claim Types: Formulation
Apr 12, 2020 
Pat. No. 9359302 DS* DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate; Process; Product-by-process; Composition; Method of use; Kit; Formulation
Sep 25, 2022U-1859: Treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, adjunctive treatment of major depressive disorder, and treatment of irritability associated with autistic disorder
Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Claim Types: Formulation; Method of use
Dec 25, 2023U-1529: Adjunctive treatment of major depressive disorder (MDD)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityDec 12, 2021ODE-80: Treatment of pediatric patients with Tourette's

ARIPIPRAZOLE (INJECTABLE) (INTRAMUSCULAR) ABILIFY
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 021866  Prod. No.: 001 DISC (9.75MG/1.3ML (7.5MG/ML))
PatentsExpirationPatented Use
Pat. No. 7115587 DP* Aripiprazole complex formulation and method
Claim Types: Formulation; Method of use
Jan 21, 2025 *PEDU-764: Treatment of schizophrenia
Pat. No. 7550445 DP* Aripiprazole complex formulation and method
Claim Types: Formulation
Jan 21, 2025 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityDec 12, 2021ODE-80: Treatment of pediatric patients with Tourette's

ARIPIPRAZOLE (FOR SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ABILIFY MAINTENA KIT
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA PHARM CO LTD      NDA No.: 202971  Prod. No.: 001 RX (300MG/VIAL); 002 RX (400MG/VIAL); 003 RX (300MG); 004 RX (400MG)
PatentsExpirationPatented Use
Pat. No. 7807680 DP* Controlled release sterile injectable aripiprazole formulation and method
Claim Types: Formulation; Process
Oct 19, 2024 
Pat. No. 8030313 Controlled release sterile injectable aripiprazole formulation and method
Claim Types: Method of use
Oct 19, 2024U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia
U-543: Treatment of schizophrenia
Pat. No. 8338427 DP* Methods for administering aripiprazole
Claim Types: Formulation; Method of administration
Mar 15, 2025U-1633: Use of aripiprazole in extended release injectable suspension in treating acute episodes of schizophrenia
U-543: Treatment of schizophrenia
Pat. No. 8338428 DP* Methods for administering aripiprazole
Claim Types: Formulation; Method of administration
Aug 6, 2023U-1633: Use of aripiprazole in extended release injectable suspension in treating acute episodes of schizophrenia
U-543: Treatment of schizophrenia
Pat. No. 8399469 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate; Process
Jun 29, 2025 
Pat. No. 8722679 DP* Controlled release sterile injectable aripiprazole formulation and method
Claim Types: Formulation
Oct 19, 2024 
Pat. No. 8759351 DP* Methods for administering aripiprazole
Claim Types: Formulation; Method of use
Aug 6, 2023U-1530: Use of aripiprazole in extended release injectable suspension
U-1633: Use of aripiprazole in extended release injectable suspension in treating acute episodes of schizophrenia
Pat. No. 8993761 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate; Process
Sep 25, 2022 
Pat. No. 9089567 Method of treating cognitive impairments and schizophrenias
Claim Types: Method of use
Jan 28, 2022U-543: Treatment of schizophrenia
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJul 27, 2020I-746: New indication of maintenance monotherapy treatment of bipolar I disorder in adults

ARIPIPRAZOLE (TABLET) (ORAL) ABILIFY MYCITE KIT [Has competitive generic]
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA PHARM CO LTD      NDA No.: 207202  Prod. No.: 001 RX (2MG); 002 RX (5MG); 003 RX (10MG); 004 RX (15MG); 005 RX (20MG); 006 RX (30MG)
PatentsExpirationPatented Use
Pat. No. 7053092 5-HT1a receptor subtype agonist
Claim Types: Method of use
Jan 28, 2022U-1529: Adjunctive treatment of major depressive disorder (MDD)
Pat. No. 7978064 DP* Communication system with partial power source
Claim Types: Device; Process
Sep 14, 2026 
Pat. No. 8017615 DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: Composition; Product-by-process; Process
Jun 16, 2024 
Pat. No. 8114021 DP* Body-associated receiver and method
Claim Types: Device
Nov 2, 2026 
Pat. No. 8258962 DP* Multi-mode communication ingestible event markers and systems, and methods of using the same
Claim Types: Device
Nov 25, 2030 
Pat. No. 8545402 DP* Highly reliable ingestible event markers and methods for using the same
Claim Types: Device
Apr 27, 2030 
Pat. No. 8547248 DP* Implantable zero-wire communications system
Claim Types: Device; Method of use; Kit
Dec 18, 2030U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver
Pat. No. 8580796 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate
Sep 25, 2022 
Pat. No. 8642760 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: Compound
Sep 25, 2022 
Pat. No. 8674825 DP* Pharma-informatics system
Claim Types: Device; Method of use
Apr 9, 2029U-2170: Method of using a receiver to receive a signal from a tablet embedded with a sensor that communicates information through the body of a patient
Pat. No. 8718193 DP* Active signal processing personal health signal receivers
Claim Types: Device
Dec 5, 2029 
Pat. No. 8759350 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Claim Types: Formulation; Method of use
Mar 2, 2027U-1529: Adjunctive treatment of major depressive disorder (MDD)
Pat. No. 8847766 DP* Pharma-informatics system
Claim Types: Device; Method of use
Mar 29, 2030U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver
Pat. No. 8945005 DP* Controlled activation ingestible identifier
Claim Types: Device; Method of use
Aug 19, 2029U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver
Pat. No. 8956288 DP* In-body power source having high surface area electrode
Claim Types: Device; Method-of-use; Process
Jul 6, 2029U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver
Pat. No. 8961412 DP* In-body device with virtual dipole signal amplification
Claim Types: Device
Nov 17, 2030 
Pat. No. 9060708 DP* Multi-mode communication ingestible event markers and systems, and methods of using the same
Claim Types: Device
Mar 5, 2029 
Pat. No. 9089567 Method of treating cognitive impairments and schizophrenias
Claim Types: Method of use
Jan 28, 2022U-543: Treatment of schizophrenia
Pat. No. 9119554 DP* Pharma-informatics system
Claim Types: Device; Process
Dec 16, 2028 
Pat. No. 9125939 Carbostyril derivatives and mood stabilizers for treating mood disorders
Claim Types: Method of use
Jul 28, 2026U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder
Pat. No. 9149577 DP* Body-associated receiver and method
Claim Types: Device
Dec 15, 2029 
Pat. No. 9258035 DP* Multi-mode communication ingestible event markers and systems, and methods of using the same
Claim Types: Device
Mar 5, 2029 
Pat. No. 9268909 DP* Apparatus, system, and method to adaptively optimize power dissipation and broadcast power in a power source for a communication device
Claim Types: Method of use
Oct 15, 2033U-2168: Method of using a logic circuit to stabilize battery voltage supplied to a sensor embedded with a tablet and that communicates information via a signal through the body of a patient to a receiver
Pat. No. 9270503 DP* Methods, devices and systems for receiving and decoding a signal in the presence of noise using slices and warping
Claim Types: Method of use
Sep 19, 2034U-2169: Method of using a receiver to identify a signal from a tablet embedded with a sensor that communicates information through the body of a patient
Pat. No. 9320455 DP* Highly reliable ingestible event markers and methods for using the same
Claim Types: Device
Dec 15, 2031 
Pat. No. 9359302 DS* DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate; Process; Product-by-process; Composition; Method of use; Kit; Formulation
Sep 25, 2022U-1529: Adjunctive treatment of major depressive disorder (MDD)
U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder
U-543: Treatment of schizophrenia
Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Claim Types: Formulation; Method of use
Dec 25, 2023U-1529: Adjunctive treatment of major depressive disorder (MDD)
Pat. No. 9433371 DP* In-body device with virtual dipole signal amplification
Claim Types: Device
Sep 15, 2029 
Pat. No. 9444503 DP* Active signal processing personal health signal receivers
Claim Types: Device; Method of use
Nov 19, 2027U-2169: Method of using a receiver to identify a signal from a tablet embedded with a sensor that communicates information through the body of a patient
Pat. No. 9577864 DP* Method and apparatus for use with received electromagnetic signal at a frequency not known exactly in advance
Claim Types: Method of use
Oct 3, 2033U-2169: Method of using a receiver to identify a signal from a tablet embedded with a sensor that communicates information through the body of a patient
Pat. No. 9787511 DP* Methods, devices and systems for receiving and decoding a signal in the presence of noise using slices and warping
Claim Types: Method of use; Device
Sep 19, 2034U-2169: Method of using a receiver to identify a signal from a tablet embedded with a sensor that communicates information through the body of a patient
Pat. No. 9941931 DP* System for supply chain management
Claim Types: Device
Nov 4, 2030 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJul 27, 2020I-746: New indication of maintenance monotherapy treatment of bipolar I disorder in adults

ARIPIPRAZOLE LAUROXIL (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARISTADA
Drug Classes: atypical antipsychotic
NDA Applicant: ALKERMES INC      NDA No.: 207533  Prod. No.: 001 RX (441MG/1.6ML (275.63MG/ML)); 002 RX (662MG/2.4ML (275.83MG/ML)); 003 RX (882MG/3.2ML (275.63MG/ML))
PatentsExpirationPatented Use
Pat. No. 8431576 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound
Oct 26, 2030 
Pat. No. 8796276 Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Method of use
Jun 24, 2030U-543: Treatment of schizophrenia
Pat. No. 9034867 DP* Pharmaceutical compositions comprising sorbitan esters
Claim Types: Formulation; Method of use
Nov 7, 2032U-543: Treatment of schizophrenia
Pat. No. 9193685 DP* Pharmaceutical compositions having improved storage stability
Claim Types: Formulation; Method of use
Oct 24, 2033U-543: Treatment of schizophrenia
Pat. No. 9452131 Aripiprazole formulations having increased injection speeds
Claim Types: Method of administration
Mar 19, 2035U-543: Treatment of schizophrenia
Pat. No. 9526726 DP* Aripiprazole formulations having increased injection speeds
Claim Types: Kit
Mar 19, 2035 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityOct 5, 2020 

ARIPIPRAZOLE LAUROXIL (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARISTADA
Drug Classes: atypical antipsychotic
NDA Applicant: ALKERMES INC      NDA No.: 207533  Prod. No.: 004 RX (1064MG/3.9ML (272.82MG/ML))
PatentsExpirationPatented Use
Pat. No. 8431576 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound
Oct 26, 2030 
Pat. No. 8796276 Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Method of use
Jun 24, 2030U-543: Treatment of schizophrenia
Pat. No. 9034867 DP* Pharmaceutical compositions comprising sorbitan esters
Claim Types: Formulation; Method of use
Nov 7, 2032U-543: Treatment of schizophrenia
Pat. No. 9193685 DP* Pharmaceutical compositions having improved storage stability
Claim Types: Formulation; Method of use
Oct 24, 2033U-543: Treatment of schizophrenia
Pat. No. 9452131 Aripiprazole formulations having increased injection speeds
Claim Types: Method of administration
Mar 19, 2035U-543: Treatment of schizophrenia
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityOct 5, 2020 

ARIPIPRAZOLE LAUROXIL (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARISTADA INITIO KIT
Drug Classes: atypical antipsychotic
NDA Applicant: ALKERMES INC      NDA No.: 209830  Prod. No.: 001 RX (675MG/2.4ML)
PatentsExpirationPatented Use
Pat. No. 8431576 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound
Oct 26, 2030 
Pat. No. 8796276 Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Method of use
Jun 24, 2030U-543: Treatment of schizophrenia
Pat. No. 10016415 DP* Aripiprazole prodrug compositions
Claim Types: Formulation
Sep 8, 2035 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityOct 5, 2020 

ARMODAFINIL (TABLET) (ORAL) NUVIGIL [GENERIC AB]
NDA Applicant: CEPHALON      NDA No.: 021875  Prod. No.: 001 RX (50MG); 003 RX (150MG); 004 RX (250MG); 005 RX (200MG) NDA No.: 021875  Prod. No.: 002 DISC (100MG**)
PatentsExpirationPatented Use
Pat. No. 7132570 DS* DP* Method for the production of crystalline forms and crystalline forms of optical enantiomers of modafinil
Claim Types: New polymorph, salt or hydrate; Composition; Process
Jun 18, 2024 *PED 
Pat. No. 7297346 DP* Pharmaceutical formulations of modafinil
Claim Types: Formulation
May 29, 2024 *PED 

ARSENIC TRIOXIDE (INJECTABLE) (INJECTION) TRISENOX [Has competitive generic]
NDA Applicant: CEPHALON      NDA No.: 021248  Prod. No.: 001 DISC (1MG/ML)
PatentsExpirationPatented Use
Pat. No. 6723351 Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol
Claim Types: Method of use
Nov 10, 2018U-2204: Treating patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression
U-2229: In combination with tretinoin, treating adults and pediatric patients 1 year and older with newly-diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RAR-A gene expression
U-573: Treatment of acute promyelogenous leukemia (APL)
Pat. No. 6855339 Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol
Claim Types: Method of use
Nov 10, 2018U-2204: Treating patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression
U-2229: In combination with tretinoin, treating adults and pediatric patients 1 year and older with newly-diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RAR-A gene expression
U-617: Treatment of acute promyelogenous leukemia (APL)
Pat. No. 6861076 Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol
Claim Types: Method of use
Nov 10, 2018U-2204: Treating patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression
U-2229: In combination with tretinoin, treating adults and pediatric patients 1 year and older with newly-diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RAR-A gene expression
U-617: Treatment of acute promyelogenous leukemia (APL)
Pat. No. 6884439 Process for producing arsenic trioxide formulations and methods for treatingcancer using arsenic trioxide or melarsoprol
Claim Types: Method of use
Nov 10, 2018U-2204: Treating patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression
U-2229: In combination with tretinoin, treating adults and pediatric patients 1 year and older with newly-diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RAR-A gene expression
U-651: Treatment of acute promyelocytic leukemia (APL)
Pat. No. 6982096 Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol
Claim Types: Method of use
Nov 10, 2018U-2204: Treating patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression
U-2229: In combination with tretinoin, treating adults and pediatric patients 1 year and older with newly-diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RAR-A gene expression
U-651: Treatment of acute promyelocytic leukemia (APL)
Pat. No. 8273379 Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol
Claim Types: Method of use
Nov 10, 2018U-1291: Treatment of acute promyelocytic leukemia (APL) in patients whose APL is characterized by the presence of the (15;17) translocation or pml/rar-alpha gene expression
U-2204: Treating patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression
U-2229: In combination with tretinoin, treating adults and pediatric patients 1 year and older with newly-diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RAR-A gene expression
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityJan 12, 2025ODE-167: Arsenic trioxide for use in combination with tretinoin for treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression

ARSENIC TRIOXIDE (INJECTABLE) (INJECTION) TRISENOX
NDA Applicant: CEPHALON      NDA No.: 021248  Prod. No.: 002 RX (2MG/ML)
PatentsExpirationPatented Use
Pat. No. 6723351 Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol
Claim Types: Method of use
Nov 10, 2018U-2204: Treating patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression
U-2229: In combination with tretinoin, treating adults and pediatric patients 1 year and older with newly-diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RAR-A gene expression
Pat. No. 6855339 Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol
Claim Types: Method of use
Nov 10, 2018U-2204: Treating patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression
U-2229: In combination with tretinoin, treating adults and pediatric patients 1 year and older with newly-diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RAR-A gene expression
Pat. No. 6861076 Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol
Claim Types: Method of use
Nov 10, 2018U-2204: Treating patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression
U-2229: In combination with tretinoin, treating adults and pediatric patients 1 year and older with newly-diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RAR-A gene expression
Pat. No. 6884439 Process for producing arsenic trioxide formulations and methods for treatingcancer using arsenic trioxide or melarsoprol
Claim Types: Method of use
Nov 10, 2018U-2204: Treating patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression
U-2229: In combination with tretinoin, treating adults and pediatric patients 1 year and older with newly-diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RAR-A gene expression
Pat. No. 6982096 Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol
Claim Types: Method of use
Nov 10, 2018U-2204: Treating patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression
U-2229: In combination with tretinoin, treating adults and pediatric patients 1 year and older with newly-diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RAR-A gene expression
Pat. No. 8273379 Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol
Claim Types: Method of use
Nov 10, 2018U-2204: Treating patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression
U-2229: In combination with tretinoin, treating adults and pediatric patients 1 year and older with newly-diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RAR-A gene expression
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityJan 12, 2025ODE-167: Arsenic trioxide for use in combination with tretinoin for treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression

ASCORBIC ACID (SOLUTION) (INTRAVENOUS) ASCOR
Drug Classes: vitamin C
NDA Applicant: MCGUFF      NDA No.: 209112  Prod. No.: 001 RX (25,000MG/50ML (500MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityOct 2, 2024ODE-160: For treatment of scurvy in adult and pediatric patients age 5 months and older for whom oral administration is not possible, insufficient or contraindicated

ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE (FOR SOLUTION) (ORAL) MOVIPREP
Drug Classes: vitamin C; osmotic laxative
NDA Applicant: SALIX PHARMS      NDA No.: 021881  Prod. No.: 001 RX (4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM)
PatentsExpirationPatented Use
Pat. No. 7169381 DS* DP* Colon cleansing compositions and methods
Claim Types: Formulation
Sep 1, 2024 
Pat. No. 7658914 DS* DP* Colon cleansing compositions
Claim Types: Kit; Formulation
Sep 1, 2024 

ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE (FOR SOLUTION) (ORAL) PLENVU
Drug Classes: vitamin C; osmotic laxative
NDA Applicant: SALIX PHARMS INC      NDA No.: 209381  Prod. No.: 001 RX (7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM)
PatentsExpirationPatented Use
Pat. No. 8999313 DP* Compositions
Claim Types: Formulation; Kit
Sep 10, 2033 
Pat. No. 9326969 Compositions
Claim Types: Method of use
Sep 10, 2033U-2310: For cleansing of the colon in preparation for colonoscopy in adults
Pat. No. 9592252 DP* Colonoscopy--preparation
Claim Types: Formulation; Kit; Method of use
Aug 11, 2032U-2310: For cleansing of the colon in preparation for colonoscopy in adults
Pat. No. 9707297 DP* Compositions
Claim Types: Kit
Sep 10, 2033 
Pat. No. 10016504 DP* Compositions
Claim Types: Formulation; Process; Product-by-process
Sep 10, 2033 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productMay 4, 2021 

ASENAPINE MALEATE (TABLET) (SUBLINGUAL) SAPHRIS [GENERIC AB]
Drug Classes: atypical antipsychotic
NDA Applicant: FOREST LABS LLC      NDA No.: 022117  Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 10MG BASE)
PatentsExpirationPatented Use
Pat. No. 5763476 DP* [Extended 5 years]
Sublingual or buccal pharmaceutical composition
Claim Types: Formulation; Method of use
Dec 9, 2020 *PEDU-1960: Use of the atypical antipsychotic asenapine for treatment of schizophrenia in adults
U-1961: Use of the atypical antipsychotic asenapine for treatment of manic or mixed episodes of bipolar i disorder: acute monotherapy of manic or mixed episodes (ages 10 to adult)
U-1962: Use of the atypical antipsychotic asenapine for treatment of manic or mixed episodes of bipolar i disorder: maintenance monotherapy in adults
U-1963: Use of the atypical antipsychotic asenapine for treatment of manic or mixed episodes of bipolar i disorder: as adjunctive treatment to lithium or valproate in adults
U-326: Method of treating schizophrenia and bipolar disorder
Pat. No. 7741358 DS* DP* Crystal form of asenapine maleate
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Oct 6, 2026 *PEDU-1064: Treatment of bipolar disorder and schizophrenia
U-1960: Use of the atypical antipsychotic asenapine for treatment of schizophrenia in adults
U-1961: Use of the atypical antipsychotic asenapine for treatment of manic or mixed episodes of bipolar i disorder: acute monotherapy of manic or mixed episodes (ages 10 to adult)
U-1962: Use of the atypical antipsychotic asenapine for treatment of manic or mixed episodes of bipolar i disorder: maintenance monotherapy in adults
U-1963: Use of the atypical antipsychotic asenapine for treatment of manic or mixed episodes of bipolar i disorder: as adjunctive treatment to lithium or valproate in adults
Pat. No. 8022228 DS* DP* Crystal form of asenapine maleate
Claim Types: New polymorph, salt or hydrate; Process
Oct 6, 2026 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: D - New Dosing ScheduleJan 13, 2020D-166: Broaden initial starting dose for bipolar i disorder to 5-10mg twice daily
Exclusivity Code: I - New IndicationJan 13, 2020I-597: Monotherapy for the maintenance treatment of bipolar I disorder
Exclusivity Code: M - MiscellaneousSep 12, 2018 PEDM-158: Updates to the labeling to reflect safety results from clinical trials in schizophrenia adolescent patients aged 12 to 17 years
Exclusivity Code: NPP - New patient populationSep 12, 2018 PED 

ASENAPINE MALEATE (TABLET) (SUBLINGUAL) SAPHRIS
Drug Classes: atypical antipsychotic
NDA Applicant: FOREST LABS LLC      NDA No.: 022117  Prod. No.: 003 RX (EQ 2.5 BASE)
PatentsExpirationPatented Use
Pat. No. 5763476 DP* [Extended 5 years]
Sublingual or buccal pharmaceutical composition
Claim Types: Formulation; Method of use
Dec 9, 2020 *PEDU-1893: Method of treating manic or mixed episodes associated with bipolar disorder in pediatric patients
U-1966: Use of the atypical antipsychotic asenapine for treatment of manic or mixed episodes of bipolar i disorder: acute monotherapy of manic or mixed episodes in pediatric patients age 10-17
Pat. No. 7741358 DS* DP* Crystal form of asenapine maleate
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Oct 6, 2026 *PEDU-1893: Method of treating manic or mixed episodes associated with bipolar disorder in pediatric patients
U-1966: Use of the atypical antipsychotic asenapine for treatment of manic or mixed episodes of bipolar i disorder: acute monotherapy of manic or mixed episodes in pediatric patients age 10-17
Pat. No. 8022228 DS* DP* Crystal form of asenapine maleate
Claim Types: New polymorph, salt or hydrate; Process
Oct 6, 2026 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: D - New Dosing ScheduleJan 13, 2020D-166: Broaden initial starting dose for bipolar i disorder to 5-10mg twice daily
Exclusivity Code: I - New IndicationJan 13, 2020I-597: Monotherapy for the maintenance treatment of bipolar I disorder

ASPIRIN (CAPSULE) (ORAL) VAZALORE
Drug Classes: anti-platelet agent; nonsteroidal anti-inflammatory drug
NDA Applicant: PLX PHARMA      NDA No.: 203697  Prod. No.: 001 OTC (325MG)
PatentsExpirationPatented Use
Pat. No. 8865187 DP* Compositions comprising lecithin oils and NSAIDS for protecting the gastrointestinal tract and providing enhanced therapeutic activity
Claim Types: Formulation
Mar 23, 2022 
Pat. No. 9101637 Methods of treating inflammation with compositions comprising lecithin oils and NSAIDS for protecting the gastrointestinal tract and providing enhanced therapeutic activity
Claim Types: Method of improving a treatment
Mar 23, 2022U-1731: Temporary relief of minor aches and pains
U-1732: Temporary reduction of fever
U-1733: Treatment/prevention of cardiovascular disease
Pat. No. 9216150 DP* pH dependent carriers for targeted release of pharmaceuticals along the gastrointestinal tract, compositions therefrom, and making and using same
Claim Types: Formulation
Sep 29, 2032 
Pat. No. 9226892 pH dependent carriers for targeted release of pharmaceuticals along the gastrointestinal tract, compositions therefrom, and making and using same
Claim Types: Method of use
Sep 29, 2032U-1731: Temporary relief of minor aches and pains
U-1732: Temporary reduction of fever
U-1733: Treatment/prevention of cardiovascular disease
Pat. No. 9351984 DP* Compositions comprising lecithin oils and NSAIDs for protecting the gastrointestinal tract and providing enhanced therapeutic activity
Claim Types: Formulation; Process
Dec 19, 2021 

ASPIRIN; OMEPRAZOLE (TABLET, DELAYED RELEASE) (ORAL) YOSPRALA
Drug Classes: anti-platelet agent; nonsteroidal anti-inflammatory drug; proton pump inhibitor
NDA Applicant: GENUS LIFESCIENCES      NDA No.: 205103  Prod. No.: 001 DISC (81MG;40MG); 002 DISC (325MG;40MG)
PatentsExpirationPatented Use
Pat. No. 6926907 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation; Method of use
Feb 28, 2023U-1902: Treatment or secondary prevention of cardiovascular disease, cardiovascular events, or cerebrovascular events and risk-reduction of aspirin-associated gastric ulcers
Pat. No. 8206741 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation; Method of use
Feb 28, 2023U-1902: Treatment or secondary prevention of cardiovascular disease, cardiovascular events, or cerebrovascular events and risk-reduction of aspirin-associated gastric ulcers
Pat. No. 9364439 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation; Method of use
May 31, 2022U-1902: Treatment or secondary prevention of cardiovascular disease, cardiovascular events, or cerebrovascular events and risk-reduction of aspirin-associated gastric ulcers
Pat. No. 9539214 Compositions and methods for delivery of omeprazole plus acetylsalicylic acid
Claim Types: Method of use
Mar 13, 2033U-1902: Treatment or secondary prevention of cardiovascular disease, cardiovascular events, or cerebrovascular events and risk-reduction of aspirin-associated gastric ulcers
Pat. No. 9987231 Compositions and methods for delivery of omeprazole plus acetylsalicylic acid
Claim Types: Method of administration
Jan 2, 2033U-2324: For secondary prevention of cardiovascular and cerebrovascular events in patients at risk of developing aspirin-associated gastric ulcers
ExclusivityExpirationExclusivity Description
Exclusivity Code: NC - New combinationSep 14, 2019 

ATAZANAVIR SULFATE (CAPSULE) (ORAL) REYATAZ [GENERIC AB]
Drug Classes: HIV protease inhibitor
NDA Applicant: BRISTOL MYERS SQUIBB      NDA No.: 021567  Prod. No.: 002 RX (EQ 150MG BASE); 003 RX (EQ 200MG BASE); 004 RX (EQ 300MG BASE) NDA No.: 021567  Prod. No.: 001 DISC (EQ 100MG BASE**)
PatentsExpirationPatented Use
Pat. No. 6087383 DS* DP* Bisulfate salt of HIV protease inhibitor
Claim Types: Compound; Composition
Jun 21, 2019 *PED 

ATAZANAVIR SULFATE (CAPSULE) (ORAL) ATAZANAVIR SULFATE [GENERIC AB]
Drug Classes: HIV protease inhibitor
NDA Applicant: TEVA PHARMS USA      NDA No.: 091673  Prod. No.: 001 RX (EQ 100MG BASE); 002 RX (EQ 150MG BASE); 003 RX (EQ 200MG BASE); 004 RX (EQ 300MG BASE)
ExclusivityExpirationExclusivity Description
Exclusivity Code: PC - Patent challengeJun 25, 2018 

ATAZANAVIR SULFATE (POWDER) (ORAL) REYATAZ
Drug Classes: HIV protease inhibitor
NDA Applicant: BRISTOL MYERS SQUIBB      NDA No.: 206352  Prod. No.: 001 RX (EQ 50MG BASE/PACKET)
PatentsExpirationPatented Use
Pat. No. 6087383 DS* DP* Bisulfate salt of HIV protease inhibitor
Claim Types: Compound; Composition
Jun 21, 2019 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationMar 24, 2019 PED 

ATAZANAVIR SULFATE; COBICISTAT (TABLET) (ORAL) EVOTAZ
Drug Classes: HIV protease inhibitor; CYP3A inhibitor
NDA Applicant: BRISTOL-MYERS SQUIBB      NDA No.: 206353  Prod. No.: 001 RX (EQ 300MG BASE;150MG)
PatentsExpirationPatented Use
Pat. No. 6087383 DS* DP* Bisulfate salt of HIV protease inhibitor
Claim Types: Compound; Composition
Jun 21, 2019 *PED 
Pat. No. 8148374 DS* DP* Modulators of pharmacokinetic properties of therapeutics
Claim Types: Composition; Compound; Method of use
Sep 3, 2029U-1279: Treatment of HIV infection using a composition containing a pharmacokinetic enhancer that inhibits cytochrome p450 monooxygenase
Pat. No. 10039718 DP* Use of solid carrier particles to improve the processability of a pharmaceutical agent
Claim Types: Formulation; Process
Oct 4, 2032 

ATORVASTATIN CALCIUM (TABLET) (ORAL) LIPITOR [GENERIC AB]
Drug Classes: HMG CoA-reductase inhibitor
NDA Applicant: PFIZER      NDA No.: 020702  Prod. No.: 001 RX (EQ 10MG BASE); 002 RX (EQ 20MG BASE)
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousJun 23, 2020M-204: Clinical information added to the package insert regarding use of atorvastatin in children and adolescents ages 10-17 with heterozygous familial hypercholesterolemia (HEFH)

AVANAFIL (TABLET) (ORAL) STENDRA
Drug Classes: phosphodiesterase 5 (PDE5) inhibitor
NDA Applicant: METUCHEN PHARMS      NDA No.: 202276  Prod. No.: 001 RX (50MG); 002 RX (100MG); 003 RX (200MG)
PatentsExpirationPatented Use
Pat. No. 6656935 DS* DP* [Extended 1687 days (4.6 years)]
Aromatic nitrogen-containing 6-membered cyclic compounds
Claim Types: Compound; Composition; Method of use
Apr 27, 2025U-155: Treatment of erectile dysfunction
Pat. No. 7501409 DP* Preparations for oral administration
Claim Types: Formulation
May 5, 2023 

AVATROMBOPAG MALEATE (TABLET) (ORAL) DOPTELET
NDA Applicant: AKARX INC      NDA No.: 210238  Prod. No.: 001 RX (EQ 20MG BASE)
PatentsExpirationPatented Use
Pat. No. 7638536 DS* DP* 2-Acylaminothiazole derivative or salt thereof
Claim Types: Compound; Composition
May 5, 2025 
Pat. No. 8765764 2-acylaminothiazole derivative or salt thereof
Claim Types: Method of use
Jan 15, 2023U-2314: Treatment of thrombocytopenia in an adult patient with chronic liver disease who is scheduled to undergo a procedure using DOPTELET
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMay 21, 2023 

AVIBACTAM SODIUM; CEFTAZIDIME (POWDER) (IV (INFUSION)) AVYCAZ
Drug Classes: beta lactamase inhibitor; cephalosporin antibacterial
NDA Applicant: ALLERGAN SALES LLC      NDA No.: 206494  Prod. No.: 001 RX (EQ 0.5GM BASE;2GM/VIAL)
PatentsExpirationPatented Use
Pat. No. 7112592 DS* DP* Azabicyclic compounds, preparation thereof and use as medicines, in particular as antibacterial agents
Claim Types: Compound; Composition; Method of use
Feb 24, 2022U-2244: A method of treating bacterial infections in hospital-acquired bacterial pneumonia and ventilator-associated bacterial pnenumonia (HABP/VABP) patients comprising administering a bactericidally effective amount of avibactam sodium
U-282: Method of treating bacterial infections
Pat. No. 7612087 DP* Heterocyclic compounds as inhibitors of beta-lactamases
Claim Types: Formulation
Nov 12, 2026 
Pat. No. 8178554 DS* DP* Heterocyclic compounds, their preparation and their use as medicaments, in particular as anti-bacterial agents
Claim Types: Compound; Composition; Method of use
Jul 24, 2021U-2245: A method of treating a bacterial infection in hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) patients comprising administering an effective amount of avibactam sodium
U-282: Method of treating bacterial infections
Pat. No. 8471025 DS* Crystalline forms of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide sodium salt
Claim Types: New polymorph, salt or hydrate
Aug 12, 2031 
Pat. No. 8835455 DP* Crystalline forms of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide sodium salt
Claim Types: Formulation
Oct 8, 2030 
Pat. No. 8969566 DS* Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof
Claim Types: Product-by-process; Process
Jun 15, 2032 
Pat. No. 9284314 DS* Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof
Claim Types: Product-by-process; Process
Jun 15, 2032 
Pat. No. 9695122 DS* Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof
Claim Types: Formulation; Compound; Composition
Jun 15, 2032 

AXITINIB (TABLET) (ORAL) INLYTA
Drug Classes: kinase inhibitor
NDA Applicant: PF PRISM CV      NDA No.: 202324  Prod. No.: 001 RX (1MG); 002 RX (5MG)
PatentsExpirationPatented Use
Pat. No. 6534524 DS* DP* [Extended 1764 days (4.8 years)]
Indazole compounds and pharmaceutical compositions for inhibiting protein kinases, and methods for their use
Claim Types: Compound; Composition; Method of use
Apr 29, 2025 
Pat. No. 7141581 Indazole compounds and pharmaceutical compositions for inhibiting protein kinases, and methods for their use
Claim Types: Method of use
Jun 30, 2020U-1220: Treatment of renal cell carcinoma
Pat. No. 8791140 DS* Crystalline forms of 6-[2-(methylcarbamoyl)phenylsulfanyl]-3-E-[2-(pyridin-2-yl)ethenyondazole suitable for the treatment of abnormal cell growth in mammals
Claim Types: New polymorph, salt or hydrate
Dec 14, 2030 

AZELAIC ACID (GEL) (TOPICAL) FINACEA
NDA Applicant: BAYER HLTHCARE      NDA No.: 021470  Prod. No.: 001 RX (15%)
PatentsExpirationPatented Use
Pat. No. 6534070 Composition with azelaic acid
Claim Types: Formulation; Method of use
Nov 18, 2018 

AZELAIC ACID (AEROSOL, FOAM) (TOPICAL) FINACEA
NDA Applicant: BAYER HLTHCARE      NDA No.: 207071  Prod. No.: 001 RX (15%)
PatentsExpirationPatented Use
Pat. No. 6730288 DP* Mousse composition
Claim Types: Formulation
Sep 8, 2019 
Pat. No. 7700076 DP* Penetrating pharmaceutical foam
Claim Types: Formulation
Sep 18, 2027 
Pat. No. 8435498 Penetrating pharmaceutical foam
Claim Types: Method of administration
Mar 1, 2024U-1727: Topical treatment of inflammatory papules and pustules of mild to moderate rosacea
Pat. No. 8722021 DP* Foamable carriers
Claim Types: Formulation
Oct 24, 2023 
Pat. No. 8900554 DP* Foamable composition and uses thereof
Claim Types: Composition
Oct 24, 2023 
Pat. No. 9211259 Antibiotic kit and composition and uses thereof
Claim Types: Method of use; Method of administration
Feb 28, 2029U-1796: Topical treatment of inflammatory papules and pustules of mild to moderate rosacea
Pat. No. 9265725 DP* Dicarboxylic acid foamable vehicle and pharmaceutical compositions thereof
Claim Types: Formulation
Dec 8, 2027 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productJul 29, 2018 

AZELASTINE HYDROCHLORIDE (SPRAY, METERED) (NASAL) ASTEPRO [Has competitive generic]
Drug Classes: histamine-1 receptor antagonist
NDA Applicant: MYLAN SPECIALITY LP      NDA No.: 022203  Prod. No.: 001 DISC (EQ 0.125MG BASE/SPRAY)
PatentsExpirationPatented Use
Pat. No. 8071073 DP* Compositions comprising azelastine and methods of use thereof
Claim Types: Formulation
Jun 4, 2028 
Pat. No. 8518919 Compositions comprising azelastine and methods of use thereof
Claim Types: Method of use
Nov 22, 2025U-1430: Treatment of allergic rhinitis, including seasonal and perennial allergic rhinitis
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationFeb 20, 2018 

AZELASTINE HYDROCHLORIDE (SPRAY, METERED) (NASAL) ASTEPRO [GENERIC AB]
Drug Classes: histamine-1 receptor antagonist
NDA Applicant: MYLAN SPECIALITY LP      NDA No.: 022203  Prod. No.: 002 RX (EQ 0.1876MG BASE/SPRAY)
PatentsExpirationPatented Use
Pat. No. 8071073 DP* Compositions comprising azelastine and methods of use thereof
Claim Types: Formulation
Jun 4, 2028 
Pat. No. 8518919 Compositions comprising azelastine and methods of use thereof
Claim Types: Method of use
Nov 22, 2025U-1430: Treatment of allergic rhinitis, including seasonal and perennial allergic rhinitis
Pat. No. 9919050 DP* Compositions comprising azelastine
Claim Types: Formulation
Nov 22, 2025 

AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE (SPRAY, METERED) (NASAL) DYMISTA [GENERIC AB]
Drug Classes: histamine-1 receptor antagonist; corticosteroid
NDA Applicant: MYLAN SPECIALITY LP      NDA No.: 202236  Prod. No.: 001 RX (EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY)
PatentsExpirationPatented Use
Pat. No. 8163723 Combination of azelastine and steroids
Claim Types: Method of use
Feb 29, 2024 *PEDU-1667: Treatment of allergic rhinitis, including seasonal allergic rhinitis
U-644: Treatment of seasonal allergic rhinitis
U-707: Allergic rhinitis
U-77: Treatment of symptoms of seasonal allergic rhinitis
U-81: Relief of symptoms associated with seasonal allergic rhinitis
Pat. No. 8168620 DP* Combination of azelastine and steroids
Claim Types: Formulation; Process
Aug 24, 2026 *PED 
Pat. No. 9259428 Combination of azelastine and fluticasone for nasal administration
Claim Types: Method of use
Dec 13, 2023 *PEDU-644: Treatment of seasonal allergic rhinitis
Pat. No. 9901585 DP* Combination of azelastine and fluticasone for nasal administration
Claim Types: Formulation
Jun 13, 2023 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationAug 20, 2018 PED 

AZILSARTAN KAMEDOXOMIL (TABLET) (ORAL) EDARBI
Drug Classes: angiotensin II receptor blocker
NDA Applicant: ARBOR PHARMS LLC      NDA No.: 200796  Prod. No.: 001 RX (EQ 40MG MEDOXOMIL); 002 RX (EQ 80MG MEDOXOMIL)
PatentsExpirationPatented Use
Pat. No. 7157584 DS* Benzimidazole derivative and use thereof
Claim Types: Compound
May 22, 2025 
Pat. No. 7572920 DP* Benzimidazole derivative and use as a II receptor antagonist
Claim Types: Composition; Method of use; Formulation; Process
Jan 7, 2025U-3: Treatment of hypertension
Pat. No. 9066936 DP* Solid pharmaceutical composition comprising a benzimidazole-7-carboxylate derivative and a pH control agent
Claim Types: Formulation; Process
Mar 26, 2028 

AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE (TABLET) (ORAL) EDARBYCLOR
Drug Classes: angiotensin II receptor blocker; thiazide-like diuretic
NDA Applicant: ARBOR PHARMS LLC      NDA No.: 202331  Prod. No.: 001 RX (EQ 40MG MEDOXOMIL;12.5MG); 002 RX (EQ 40MG MEDOXOMIL;25MG)
PatentsExpirationPatented Use
Pat. No. 7157584 DS* Benzimidazole derivative and use thereof
Claim Types: Compound
May 22, 2025 
Pat. No. 7572920 DP* Benzimidazole derivative and use as a II receptor antagonist
Claim Types: Composition; Method of use; Formulation; Process
Jan 7, 2025U-3: Treatment of hypertension
Pat. No. 9066936 DP* Solid pharmaceutical composition comprising a benzimidazole-7-carboxylate derivative and a pH control agent
Claim Types: Formulation; Process
Mar 26, 2028 
Pat. No. 9169238 DP* Solid pharmaceutical composition
Claim Types: Formulation; Process
Feb 4, 2030 

AZITHROMYCIN (FOR SUSPENSION) (ORAL) ZITHROMAX
Drug Classes: macrolide antimicrobial
NDA Applicant: PFIZER      NDA No.: 050693  Prod. No.: 001 RX (EQ 1GM BASE/PACKET)
PatentsExpirationPatented Use
Pat. No. 6268489 DS* Azithromycin dihydrate
Claim Types: New polymorph, salt or hydrate; Process
Jul 31, 2018 

AZITHROMYCIN (FOR SUSPENSION) (ORAL) ZITHROMAX [GENERIC AB]
Drug Classes: macrolide antimicrobial
NDA Applicant: PFIZER      NDA No.: 050710  Prod. No.: 001 RX (EQ 100MG BASE/5ML); 002 RX (EQ 200MG BASE/5ML)
PatentsExpirationPatented Use
Pat. No. 6268489 DS* Azithromycin dihydrate
Claim Types: New polymorph, salt or hydrate; Process
Jul 31, 2018 

AZITHROMYCIN (TABLET) (ORAL) ZITHROMAX [GENERIC AB]
Drug Classes: macrolide antimicrobial
NDA Applicant: PFIZER      NDA No.: 050711  Prod. No.: 001 RX (EQ 250MG BASE)
PatentsExpirationPatented Use
Pat. No. 6268489 DS* Azithromycin dihydrate
Claim Types: New polymorph, salt or hydrate; Process
Jul 31, 2018 

AZITHROMYCIN (TABLET) (ORAL) ZITHROMAX [GENERIC AB]
Drug Classes: macrolide antimicrobial
NDA Applicant: PFIZER      NDA No.: 050730  Prod. No.: 001 RX (EQ 600MG BASE)
PatentsExpirationPatented Use
Pat. No. 6268489 DS* Azithromycin dihydrate
Claim Types: New polymorph, salt or hydrate; Process
Jul 31, 2018 

AZITHROMYCIN (INJECTABLE) (INJECTION) ZITHROMAX [GENERIC AP]
Drug Classes: macrolide antimicrobial
NDA Applicant: PFIZER      NDA No.: 050733  Prod. No.: 001 RX (EQ 500MG BASE/VIAL)
PatentsExpirationPatented Use
Pat. No. 6268489 DS* Azithromycin dihydrate
Claim Types: New polymorph, salt or hydrate; Process
Jul 31, 2018 

AZITHROMYCIN (TABLET) (ORAL) ZITHROMAX [GENERIC AB]
Drug Classes: macrolide antimicrobial
NDA Applicant: PFIZER      NDA No.: 050784  Prod. No.: 001 RX (EQ 500MG BASE)
PatentsExpirationPatented Use
Pat. No. 6268489 DS* Azithromycin dihydrate
Claim Types: New polymorph, salt or hydrate; Process
Jul 31, 2018 

AZITHROMYCIN (FOR SUSPENSION, EXTENDED RELEASE) (ORAL) ZMAX
Drug Classes: macrolide antimicrobial
NDA Applicant: PF PRISM CV      NDA No.: 050797  Prod. No.: 001 DISC (EQ 2GM BASE/BOT)
PatentsExpirationPatented Use
Pat. No. 6268489 DS* Azithromycin dihydrate
Claim Types: New polymorph, salt or hydrate; Process
Jul 31, 2018 
Pat. No. 6984403 DP* Azithromycin dosage forms with reduced side effects
Claim Types: Formulation; Method of use
Feb 14, 2024U-282: Method of treating bacterial infections
Pat. No. 7887844 DP* Multiparticulate crystalline drug compositions having controlled release profiles
Claim Types: Formulation; Process
Feb 14, 2024 

AZITHROMYCIN (SOLUTION/DROPS) (OPHTHALMIC) AZASITE
Drug Classes: macrolide antimicrobial
NDA Applicant: OAK PHARMS INC      NDA No.: 050810  Prod. No.: 001 RX (1%)
PatentsExpirationPatented Use
Pat. No. 6239113 Topical treatment or prevention of ocular infections
Claim Types: Method of use
Mar 31, 2019U-709: Method of combating bacteria in a patient
Pat. No. 6569443 DP* Topical treatment or prevention of ocular infections
Claim Types: Formulation; Method of use
Mar 31, 2019U-709: Method of combating bacteria in a patient
Pat. No. 6861411 Method of treating eye infections with azithromycin
Claim Types: Method of use
Nov 25, 2018U-709: Method of combating bacteria in a patient
Pat. No. 7056893 DP* Topical treatment for prevention of ocular infections
Claim Types: Formulation; Process; Method of use
Mar 31, 2019U-709: Method of combating bacteria in a patient

AZITHROMYCIN (FOR SUSPENSION) (ORAL) AZITHROMYCIN [GENERIC AB]
Drug Classes: macrolide antimicrobial
NDA Applicant: LUPIN LTD      NDA No.: 065488  Prod. No.: 001 RX (EQ 100MG BASE/5ML); 002 RX (EQ 200MG BASE/5ML)
ExclusivityExpirationExclusivity Description
Exclusivity Code: PC - Patent challengeMar 26, 2018 

AZTREONAM (FOR SOLUTION) (INHALATION) CAYSTON
Drug Classes: monobactam antibacterial
NDA Applicant: GILEAD      NDA No.: 050814  Prod. No.: 001 RX (75MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 7208141 DP* Inhalable aztreonam aerosol for treatment and prevention of pulmonary bacterial infections
Claim Types: Formulation; Method of use; Method of administration
Dec 20, 2021U-1031: Improve respiratory symptoms in cystic fibrosis in patients with pseudomonas aeruginosa
Pat. No. 7214364 DP* Inhalable aztreonam lysinate formulation for treatment and prevention of pulmonary bacterial infections
Claim Types: Formulation
Dec 20, 2021 
Pat. No. 7427633 DP* Inhalable aztreonam lysinate formulation for treatment and prevention of pulmonary bacterial infections
Claim Types: Formulation; Method of use; Method of administration
Dec 20, 2021U-1031: Improve respiratory symptoms in cystic fibrosis in patients with pseudomonas aeruginosa
Pat. No. 8399496 DP* Inhalable aztreonam lysinate formulation for treatment and prevention of pulmonary bacterial infections
Claim Types: Formulation; Method of administration; Method of use
Dec 20, 2021U-1377: Improve respiratory symptoms in cystic fibrosis in patients with pseudomonas aeruginosa


DS*=Drug Substance; DP*=Drug Product - patent submitted for the product after Aug. 18, 2003.
**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons
Last edited: 16 September 2018
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