Drug Classes 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.


adenosine receptor agonist
LEXISCAN (SOLUTION) REGADENOSON
Drug Classes: adenosine receptor agonist
NDA Applicant: ASTELLAS      NDA No.:
022161  Prod. No.: 001 RX (0.4MG/5ML (0.08MG/ML))
PatentsExpirationPatented Use
Pat. No. 6403567 DS* DP* N-pyrazole A2A adenosine receptor agonists
Claim Types: Compound; Composition; Method of use
Apr 10, 2022U-869: Method for stimulating coronoary vasodilation for purposes of imaging the heart
Pat. No. 6642210 DS* DP* 2-(N-pyrazolo)adenosines with application as adenosine A2A receptor agonists
Claim Types: Compound; Method of use; Composition
Jun 22, 2019U-869: Method for stimulating coronoary vasodilation for purposes of imaging the heart
Pat. No. 7144872 DS* DP* N-pyrazole A.sub.2A receptor agonists
Claim Types: Compound; Method of use
Jun 22, 2019U-116: Method of myocardial imaging
U-869: Method for stimulating coronoary vasodilation for purposes of imaging the heart
U-870: Method of producing coronary vasodilation without peripheral vasodilation
Pat. No. 7183264 DP* N-pyrazole A2A receptor agonists
Claim Types: Method of use; Composition
Jun 22, 2019U-116: Method of myocardial imaging
U-869: Method for stimulating coronoary vasodilation for purposes of imaging the heart
U-870: Method of producing coronary vasodilation without peripheral vasodilation
Pat. No. 7582617 Myocardial perfusion imaging method
Claim Types: Method of use
Jun 22, 2019U-1003: A method of myocardial perfusion imaging and increasing coronary blood flow
Pat. No. 7655636 Use of A2A adenosine receptor agonists
Claim Types: Method of use; Method of administration
Jun 22, 2019U-869: Method for stimulating coronoary vasodilation for purposes of imaging the heart
Pat. No. 7655637 DS* DP* N-pyrazole A.sub.2A receptor agonists
Claim Types: Compound; Method of use; Composition
Jun 22, 2019U-869: Method for stimulating coronoary vasodilation for purposes of imaging the heart
Pat. No. 7683037 Myocardial perfusion imaging method
Claim Types: Method of use
Jun 22, 2019U-1042: Method for stimulating coronary vasodilation for purposes of imaging the heart
Pat. No. 8106029 Use of A.sub.2A adenosine receptor agonists
Claim Types: Method of use
Jun 22, 2019U-1042: Method for stimulating coronary vasodilation for purposes of imaging the heart
Pat. No. 8106183 DS* Process for preparing an A.sub.2A-adenosine receptor agonist and its polymorphs
Claim Types: New polymorph, salt or hydrate; Process
Feb 2, 2027 
Pat. No. 8133879 DP* Myocardial perfusion imaging methods and compositions
Claim Types: Formulation
Jun 22, 2019 
Pat. No. 8183226 Myocardial perfusion imaging method
Claim Types: Method of administration
Jun 22, 2019U-116: Method of myocardial imaging
Pat. No. 8470801 Myocardial perfusion imaging methods and compositions
Claim Types: Method of use
Jun 22, 2019U-116: Method of myocardial imaging
Pat. No. 8536150 Methods of myocardial perfusion imaging
Claim Types: Diagnostic or surgical method
Jun 22, 2019U-116: Method of myocardial imaging
Pat. No. 9045519 DP* N-pyrazole A.sub.2A receptor agonists
Claim Types: Composition; Formulation
Jun 22, 2019 
Pat. No. 9085601 DP* Process for preparing an A2A-adenosine receptor agonist and its polymorphs
Claim Types: Composition
Feb 2, 2027 
Pat. No. 9289446 DP* Myocardial perfusion imaging methods and compositions
Claim Types: Formulation; Kit; Drug in a container; Method of use
Jun 22, 2019U-116: Method of myocardial imaging
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousJan 17, 2020M-194: Information added to the labeling regarding use of regadenoson administration following an inadequate exercise stress test as compared to regadenoson alone

adrenergic agonist
ADDERALL 10; ADDERALL 20; ADDERALL 5; ADDERALL 30; ADDERALL 7.5; ADDERALL 12.5; ADDERALL 15 (TABLET) AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
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 **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**); 008 DISC (5MG;5MG;5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**); 009 DISC (1.25MG;1.25MG;1.25MG;1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**); 010 DISC (7.5MG;7.5MG;7.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**); 011 DISC (1.875MG;1.875MG;1.875MG;1.875MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**); 012 DISC (3.125MG;3.125MG;3.125MG;3.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**); 013 DISC (3.75MG;3.75MG;3.75MG;3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**)
PatentsExpirationPatented Use
Pat. No. 6384020 Rapid immediate release oral dosage form
Claim Types: Formulation
Jan 6, 2021 *PED 

adrenergic agonist
ADDERALL XR 10; ADDERALL XR 20; ADDERALL XR 30; ADDERALL XR 25; ADDERALL XR 5; ADDERALL XR 15 (CAPSULE, EXTENDED RELEASE) AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE [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. 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 
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 

adrenergic agonist
ADZENYS ER (SUSPENSION, EXTENDED RELEASE) AMPHETAMINE
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 

adrenergic agonist
ADZENYS XR-ODT (TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE) AMPHETAMINE
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 

adrenergic agonist
DYANAVEL XR (SUSPENSION, EXTENDED RELEASE) AMPHETAMINE
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 

adrenergic agonist
MYDAYIS (CAPSULE, EXTENDED RELEASE) AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE [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. 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
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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productJun 20, 2020 

aldehyde dehydrogenase inhibitor
ESKATA (SOLUTION) HYDROGEN PEROXIDE
Drug Classes: aldehyde dehydrogenase inhibitor
NDA Applicant: ACLARIS THERAPS INC      NDA No.:
209305  Prod. No.: 001 RX (40%)
PatentsExpirationPatented Use
Pat. No. 7381427 Seborrheic keratosis treatment
Claim Types: Method of use
Jun 8, 2022U-2205: Treatment of seborrheic keratoses that are raised
Pat. No. 9675639 DP* Peroxide formulations and methods and applicators for using the same
Claim Types: Formulation; Method of use; Method of administration
Jul 4, 2035U-2205: Treatment of seborrheic keratoses that are raised
Pat. No. 9980983 Peroxide formulations and methods and applicators for using the same
Claim Types: Method of use
Apr 21, 2035U-2205: Treatment of seborrheic keratoses that are raised
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productDec 14, 2020 

aldosterone antagonist
CAROSPIR (SUSPENSION) SPIRONOLACTONE
Drug Classes: aldosterone antagonist
NDA Applicant: CMP DEV LLC      NDA No.:
209478  Prod. No.: 001 RX (25MG/5ML)
PatentsExpirationPatented Use
Pat. No. 9757394 DP* Spironolactone aqueous formulations
Claim Types: Method of use
Oct 28, 2036U-2109: CAROSPIR is indicated for treatment of NYHA class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure

aldosterone antagonist
INSPRA (TABLET) EPLERENONE [GENERIC AB]
Drug Classes: aldosterone antagonist
NDA Applicant: SEARLE, GD LLC      NDA No.:
021437  Prod. No.: 001 RX (25MG); 002 RX (50MG) NDA No.: 021437  Prod. No.: 003 DISC (100MG)
PatentsExpirationPatented Use
Pat. No. 6410054 Immediate release eplerenone compositions
Claim Types: Formulation; Method of use
Jun 8, 2020 *PEDU-3: Treatment of hypertension
U-537: Treatment of conditions related to hyperaldosteronism such as hypertension and cardiac insufficiency, with eplerenone
Pat. No. 6410524 Combination therapy of angiotensin converting enzyme inhibitor and aldosterone antagonist for reducing morbidity and mortality from cardiovascular disease
Claim Types: Composition; Method of use
May 5, 2020 *PEDU-467: Use of eplerenone in combination with an angiotensin converting enzyme (ACE) inhibitor for treating hypertension
Pat. No. 6495165 Eplerenone compositions having improved bioavailability
Claim Types: Formulation; Method of use
Jun 8, 2020 *PEDU-3: Treatment of hypertension
U-537: Treatment of conditions related to hyperaldosteronism such as hypertension and cardiac insufficiency, with eplerenone
Pat. No. 6534093 Immediate release eplerenone compositions
Claim Types: Formulation; Method of use
Jun 8, 2020 *PEDU-3: Treatment of hypertension
U-537: Treatment of conditions related to hyperaldosteronism such as hypertension and cardiac insufficiency, with eplerenone
Pat. No. 6558707 DP* Immediate release eplerenone compositions
Claim Types: Formulation; Method of use
Jun 8, 2020 *PEDU-537: Treatment of conditions related to hyperaldosteronism such as hypertension and cardiac insufficiency, with eplerenone
Pat. No. 6747020 Methods of treating heart failure and hypertension using combinations of eplerenone and an angiotensin converting enzyme inhibitor
Claim Types: Method of use
May 5, 2020 *PEDU-587: Use of eplerenone in combination with an angiotensin converting enzyme (ACE) inhibitor (and optionally a diuretic) for treating congestive heart failure and hypertension
Pat. No. 7157101 DP* Micronized eplerenone compositions
Claim Types: Formulation
Jun 8, 2020 *PEDU-664: Treatment of conditions for which an aldosterone receptor blocker is indicated, such as hypertension, heart failure, and post-myocardial infarction

alkylating drug
BENDEKA (SOLUTION) BENDAMUSTINE HYDROCHLORIDE
Drug Classes: alkylating drug
NDA Applicant: EAGLE PHARMS      NDA No.:
208194  Prod. No.: 001 RX (100MG/4ML (25MG/ML))
PatentsExpirationPatented Use
Pat. No. 8609707 DP* Formulations of bendamustine
Claim Types: Formulation; Method of use
Aug 11, 2031U-1542: For use in the treatment of patients with chronic lymphocytic leukemia and/or non-hodgkins lymphoma
Pat. No. 8791270 DP* Bendamustine pharmaceutical compositions
Claim Types: Formulation; Method of use
Jan 12, 2026U-1790: For use in treatment of patients with chronic lymphocytic leukemia (CLL) and/or non-hodgkin's lymphoma
Pat. No. 9000021 Method of treating bendamustine-responsive conditions in patients requiring reduced volumes for administration
Claim Types: Method of use
Mar 15, 2033U-1542: For use in the treatment of patients with chronic lymphocytic leukemia and/or non-hodgkins lymphoma
Pat. No. 9034908 Formulations of bendamustine
Claim Types: Method of use
Mar 15, 2033U-1542: For use in the treatment of patients with chronic lymphocytic leukemia and/or non-hodgkins lymphoma
Pat. No. 9144568 Formulations of bendamustine
Claim Types: Method of use
Mar 15, 2033U-1542: For use in the treatment of patients with chronic lymphocytic leukemia and/or non-hodgkins lymphoma
Pat. No. 9265831 DP* Formulations of bendamustine
Claim Types: Formulation
Jan 28, 2031 
Pat. No. 9572796 DP* Formulations of bendamustine
Claim Types: Formulation; Method of use
Jan 28, 2031U-1971: For the treatment of patients with chronic lymphocytic leukemia
U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma
Pat. No. 9572797 Formulations of bendamustine
Claim Types: Method of use
Jan 28, 2031U-1971: For the treatment of patients with chronic lymphocytic leukemia
U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma
Pat. No. 9572887 Formulations of bendamustine
Claim Types: Method of use
Mar 15, 2033U-1971: For the treatment of patients with chronic lymphocytic leukemia
U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma
Pat. No. 9579384 Method of treating bendamustine-responsive conditions in patients requiring reduced volumes for administration
Claim Types: Method of use
Mar 15, 2033U-1971: For the treatment of patients with chronic lymphocytic leukemia
U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma
Pat. No. 9597397 Formulations of bendamustine
Claim Types: Method of use
Mar 15, 2033U-1971: For the treatment of patients with chronic lymphocytic leukemia
U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma
Pat. No. 9597398 Formulations of bendamustine
Claim Types: Method of use
Mar 15, 2033U-1971: For the treatment of patients with chronic lymphocytic leukemia
Pat. No. 9597399 Formulations of bendamustine
Claim Types: Method of use
Mar 15, 2033U-1971: For the treatment of patients with chronic lymphocytic leukemia
U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityDec 7, 2022ODE-179: Treatment of patients with CLL and treatment of patients with indolent B-cell NHL that has progressed during or within six months of treatment with rituximab or a rituximab containing regimen

alkylating drug
EVOMELA (POWDER) MELPHALAN HYDROCHLORIDE
Drug Classes: alkylating drug
NDA Applicant: SPECTRUM PHARMS      NDA No.:
207155  Prod. No.: 001 RX (EQ 50MG BASE/VIAL)
PatentsExpirationPatented Use
Pat. No. 8410077 DP* Sulfoalkyl ether cyclodextrin compositions
Claim Types: Composition; Compound; Product-by-process; Formulation
Mar 13, 2029 
Pat. No. 9200088 DP* Sulfoalkyl ether cyclodextrin compositions
Claim Types: Composition; Formulation
Mar 13, 2029 
Pat. No. 9493582 DP* Alkylated cyclodextrin compositions and processes for preparing and using the same
Claim Types: Formulation; Product-by-process; Process
Feb 27, 2033 
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityMar 10, 2023ODE-110: For high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma

alkylating drug
MITOSOL (FOR SOLUTION) MITOMYCIN
Drug Classes: alkylating drug
NDA Applicant: MOBIUS THERAP      NDA No.:
022572  Prod. No.: 001 RX (0.2MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 7806265 DP* Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application
Claim Types: Drug in a container; Kit
Feb 1, 2029 
Pat. No. 8186511 DP* Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application
Claim Types: Drug in a container
Jul 19, 2026 
Pat. No. 9205075 DP* Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application
Claim Types: Kit
Jul 19, 2026 
Pat. No. 9539241 DS* DP* Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application
Claim Types: Method of use
Jan 2, 2028U-2095: MITOSOL is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery. It is intended for topical application to the site of glaucoma filtration surgery
Pat. No. 9649428 Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application
Claim Types: Kit
May 21, 2029U-2095: MITOSOL is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery. It is intended for topical application to the site of glaucoma filtration surgery
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityFeb 7, 2019ODE-21: An adjunct to ab externo glaucoma surgery

alkylating drug
TEMODAR (POWDER) TEMOZOLOMIDE
Drug Classes: alkylating drug
NDA Applicant: MERCK SHARP DOHME      NDA No.:
022277  Prod. No.: 001 RX (100MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 6987108 DP* Pharmaceutical formulations of antineoplastic agents and processes of making and using the same
Claim Types: Formulation
Sep 8, 2023 
Pat. No. 7786118 DP* Pharmaceutical formulations of antineoplastic agents
Claim Types: Formulation
Feb 21, 2023 
Pat. No. 8623868 DP* Processes of making and using pharmaceutical formulations of antineoplastic agents
Claim Types: Composition; Formulation
Feb 21, 2023 

alkylating drug
TEPADINA (POWDER) THIOTEPA
Drug Classes: alkylating drug
NDA Applicant: ADIENNE SA      NDA No.:
208264  Prod. No.: 001 RX (15MG/VIAL); 002 RX (100MG/VIAL)
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJan 26, 2020I-747: For reducing the risk of graft rejection when used with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor (stem) cell transplantation for pediatric patients with class 3 beta-thalassemia
Exclusivity Code: ODE - Orphan drug exclusivityJan 26, 2024ODE-129: Indicated for reducing the risk of graft rejection when used in conjunction with high-dose busulfan & cyclophosphamide as a preparative regimen for allogenic hematopoietic progenitor cell transplantation for peds. patients with class 3 beta-thalassemia

alkylating drug
TREANDA (POWDER) BENDAMUSTINE HYDROCHLORIDE [GENERIC AP]
Drug Classes: alkylating drug
NDA Applicant: CEPHALON      NDA No.:
022249  Prod. No.: 001 RX (100MG/VIAL); 002 RX (25MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 8436190 DP* Bendamustine pharmaceutical compositions
Claim Types: Formulation
Apr 26, 2031 *PED 
Pat. No. 8445524 DS* DP* Solid forms of bendamustine hydrochloride
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use; Process
Sep 26, 2029 *PEDU-1402: For use in the treatment of patients with chronic lymphocytic leukemia (CLL) and/or indolent B-cell non-Hodgkin lymphoma (NHL)
Pat. No. 8609863 DP* Bendamustine pharmaceutical compositions
Claim Types: Formulation; Product-by-process
Jul 12, 2026 *PED 
Pat. No. 8669279 DP* Solid forms of bendamustine hydrochloride
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Sep 26, 2029 *PEDU-1402: For use in the treatment of patients with chronic lymphocytic leukemia (CLL) and/or indolent B-cell non-Hodgkin lymphoma (NHL)
Pat. No. 8791270 DP* Bendamustine pharmaceutical compositions
Claim Types: Formulation; Method of use
Jul 12, 2026 *PEDU-1542: For use in the treatment of patients with chronic lymphocytic leukemia and/or non-hodgkins lymphoma
Pat. No. 8883836 DP* Solid forms of bendamustine hydrochloride
Claim Types: Method of use; Product-by-process; Process
Sep 26, 2029 *PEDU-1402: For use in the treatment of patients with chronic lymphocytic leukemia (CLL) and/or indolent B-cell non-Hodgkin lymphoma (NHL)
Pat. No. 8895756 DP* Bendamustine pharmaceutical compositions
Claim Types: Drug in a container
Jul 12, 2026 *PED 
Pat. No. 9533955 DP* Solid forms of bendamustine hydrochloride
Claim Types: New polymorph, salt or hydrate; Composition; Formulation
Mar 26, 2029U-1949: For use in the treatment of patients with chronic lymphocytic leukemia (CLL)
U-1952: For use in the treatment of patients with indolent B-cell non-Hodgkin lymphoma

alkylating drug
TREANDA (SOLUTION) BENDAMUSTINE HYDROCHLORIDE
Drug Classes: alkylating drug
NDA Applicant: CEPHALON      NDA No.:
022249  Prod. No.: 003 DISC (45MG/0.5ML (90MG/ML)); 004 DISC (180MG/2ML (90MG/ML))
PatentsExpirationPatented Use
Pat. No. 8344006 DP* Liquid formulations of bendamustine
Claim Types: Formulation; Method of use
Mar 23, 2030 *PEDU-1402: For use in the treatment of patients with chronic lymphocytic leukemia (CLL) and/or indolent B-cell non-Hodgkin lymphoma (NHL)
Pat. No. 8445524 DS* Solid forms of bendamustine hydrochloride
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use; Process
Sep 26, 2029 *PED 
Pat. No. 8791270 DP* Bendamustine pharmaceutical compositions
Claim Types: Formulation; Method of use
Jul 12, 2026 *PEDU-1542: For use in the treatment of patients with chronic lymphocytic leukemia and/or non-hodgkins lymphoma

alkylating drug
VALCHLOR (GEL) MECHLORETHAMINE HYDROCHLORIDE
Drug Classes: alkylating drug
NDA Applicant: ACTELION PHARMS LTD      NDA No.:
202317  Prod. No.: 001 RX (EQ 0.016% BASE)
PatentsExpirationPatented Use
Pat. No. 7838564 DP* Stabilized compositions of volatile alkylating agents and methods of using thereof
Claim Types: Formulation
Mar 7, 2026 
Pat. No. 7872050 Stabilized compositions of volatile alkylating agents and methods of using thereof
Claim Types: Method of use
Jul 8, 2029U-1427: Alkylating drug indicated for the topical treatment of stage ia and ib mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin directed therapy
Pat. No. 8450375 DP* Stabilized compositions of volatile alkylating agents and methods of using thereof
Claim Types: Formulation
Mar 7, 2026 
Pat. No. 8501818 DP* Stabilized compositions of alkylating agents and methods of using same
Claim Types: Formulation
Mar 7, 2026 
Pat. No. 8501819 Stabilized compositions of volatile alkylating agents and methods of using thereof
Claim Types: Method of use
Mar 7, 2026U-1427: Alkylating drug indicated for the topical treatment of stage ia and ib mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin directed therapy
Pat. No. 9382191 DP* Stabilized compositions of volatile alkylating agents and methods of using thereof
Claim Types: Composition
Mar 7, 2026 
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityAug 23, 2020ODE-51: Topical treatment of stage 1a and 1b mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy

alkylating drug
YONDELIS (POWDER) TRABECTEDIN
Drug Classes: alkylating drug
NDA Applicant: JANSSEN PRODS      NDA No.:
207953  Prod. No.: 001 RX (1MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 8895557 DP* Pharmaceutical formulations of ecteinascidin compounds
Claim Types: Formulation; Process
Jul 7, 2028 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityApr 23, 2021 PED 
Exclusivity Code: ODE - Orphan drug exclusivityApr 23, 2023 PEDODE-100: For the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen

allylamine antifungal
NAFTIN (CREAM) NAFTIFINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: allylamine antifungal
NDA Applicant: SEBELA IRELAND LTD      NDA No.:
019599  Prod. No.: 002 RX (2%)
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousNov 10, 2019M-191: Addition of data based on pediatric studies to fulfill the postmarketing requirement 1857-2

allylamine antifungal
NAFTIN (GEL) NAFTIFINE HYDROCHLORIDE
Drug Classes: allylamine antifungal
NDA Applicant: SEBELA IRELAND LTD      NDA No.:
204286  Prod. No.: 001 RX (2%)
PatentsExpirationPatented Use
Pat. No. 8778365 DP* Topical compositions and methods for making and using same
Claim Types: Formulation
Jan 31, 2033 
Pat. No. 9161914 Topical compositions and methods for making and using same
Claim Types: Method of use; Formulation
Jan 31, 2033U-540: Treatment of fungal infections

alpha adrenergic agonist
ADRENACLICK (INJECTABLE) EPINEPHRINE
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI); norepinephrine-releasing agent; alpha adrenergic agonist; beta adrenergic agonist; catecholamine; "norepinephrine, serotonin, and dopamine reuptake inhibitor anorectic"
NDA Applicant: IMPAX LABS INC      NDA No.:
020800  Prod. No.: 003 RX (EQ 0.15MG/DELIVERY); 004 RX (EQ 0.3MG/DELIVERY)
PatentsExpirationPatented Use
Pat. No. 7905352 DP* Kits containing medicine injection devices and containers
Claim Types: Kit; Device
Apr 12, 2027 

alpha adrenergic agonist
ADRENALIN (SOLUTION) EPINEPHRINE [GENERIC AP]
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI); norepinephrine-releasing agent; alpha adrenergic agonist; beta adrenergic agonist; catecholamine; "norepinephrine, serotonin, and dopamine reuptake inhibitor anorectic"
NDA Applicant: PAR STERILE PRODUCTS      NDA No.:
204200  Prod. No.: 001 RX (EQ 1MG BASE/ML (EQ 1MG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 9119876 DP* Epinephrine formulations
Claim Types: Formulation
Mar 13, 2035 
Pat. No. 9295657 Epinephrine formulations
Claim Types: Method
Mar 13, 2035U-1829: Emergency treatment of allergic reactions (type I), including anaphylaxis

alpha adrenergic agonist
ADRENALIN (SOLUTION) EPINEPHRINE
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI); norepinephrine-releasing agent; alpha adrenergic agonist; beta adrenergic agonist; catecholamine; "norepinephrine, serotonin, and dopamine reuptake inhibitor anorectic"
NDA Applicant: PAR STERILE PRODUCTS      NDA No.:
204640  Prod. No.: 001 RX (EQ 30MG BASE/30ML (EQ 1MG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 9119876 DP* Epinephrine formulations
Claim Types: Formulation
Mar 13, 2035 
Pat. No. 9295657 Epinephrine formulations
Claim Types: Method
Mar 13, 2035U-1829: Emergency treatment of allergic reactions (type I), including anaphylaxis

alpha adrenergic agonist
ADVIL ALLERGY SINUS (TABLET) CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Drug Classes: histamine-1 (H1) receptor antagonist; nonsteroidal anti-inflammatory drug; alpha adrenergic agonist
NDA Applicant: PFIZER      NDA No.:
021441  Prod. No.: 001 OTC (2MG;200MG;30MG)
PatentsExpirationPatented Use
Pat. No. 7863287 DP* Compositions of non-steroidal anti-inflammatory drugs, decongestants and anti-histamines
Claim Types: Formulation
Feb 28, 2027 

alpha adrenergic agonist
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION (TABLET, EXTENDED RELEASE) FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE [GENERIC OTC]
Drug Classes: histamine-1 (H1) receptor antagonist; alpha adrenergic agonist
NDA Applicant: SANOFI AVENTIS US      NDA No.:
020786  Prod. No.: 002 OTC (60MG;120MG)
PatentsExpirationPatented Use
Pat. No. 6039974 DP* Pharmaceutical composition for combination of piperidinoalkanol-decongestant
Claim Types: Formulation
Jul 31, 2018 

alpha adrenergic agonist
ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION (TABLET, EXTENDED RELEASE) FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE [GENERIC OTC]
Drug Classes: histamine-1 (H1) receptor antagonist; alpha adrenergic agonist
NDA Applicant: SANOFI AVENTIS US      NDA No.:
021704  Prod. No.: 002 OTC (180MG;240MG)
PatentsExpirationPatented Use
Pat. No. 6613357 DP* Osmotic device containing pseudoephedrine and an H1 antagonist
Claim Types: Device; Method of use
Dec 25, 2020U-1159: Relief of symptoms associated with respiratory allergies, swelling of the nasal passages and sinus congestion and pressure in adults and children 12 years of age and older
Pat. No. RE39069 DP* Multi-layered osmotic device
Claim Types: Device
May 29, 2018 

alpha adrenergic agonist
ALPHAGAN P (SOLUTION/DROPS) BRIMONIDINE TARTRATE
Drug Classes: alpha adrenergic agonist
NDA Applicant: ALLERGAN      NDA No.:
021262  Prod. No.: 001 RX (0.15%)
PatentsExpirationPatented Use
Pat. No. 6562873 Compositions containing therapeutically active components having enhanced solubility
Claim Types: Formulation
Jan 10, 2022 *PED 
Pat. No. 6627210 DP* Compositions containing .alpha.-2-adrenergic agonist components
Claim Types: Formulation
Jan 18, 2022 *PED 
Pat. No. 6641834 DP* Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Jan 28, 2022 *PED 
Pat. No. 6673337 DP* Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Jan 26, 2022 *PED 
Pat. No. 9295641 Compositions containing alpha-2-adrenergic agonist components
Claim Types: Method of use
Jan 10, 2022 *PEDU-1833: Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension

alpha adrenergic agonist
ALPHAGAN P (SOLUTION/DROPS) BRIMONIDINE TARTRATE
Drug Classes: alpha adrenergic agonist
NDA Applicant: ALLERGAN      NDA No.:
021770  Prod. No.: 001 RX (0.1%)
PatentsExpirationPatented Use
Pat. No. 6562873 DP* Compositions containing therapeutically active components having enhanced solubility
Claim Types: Formulation
Jan 10, 2022 *PED 
Pat. No. 6627210 DP* Compositions containing .alpha.-2-adrenergic agonist components
Claim Types: Formulation
Jan 18, 2022 *PED 
Pat. No. 6641834 DP* Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Jan 28, 2022 *PED 
Pat. No. 6673337 DP* Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Jan 26, 2022 *PED 
Pat. No. 8858961 DP* Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Mar 2, 2024 *PED 
Pat. No. 9295641 Compositions containing alpha-2-adrenergic agonist components
Claim Types: Method of use
Jan 10, 2022 *PEDU-1833: Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension
Pat. No. 9687443 DP* Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Jan 10, 2022 *PED 

alpha adrenergic agonist
AUVI-Q (SOLUTION) EPINEPHRINE
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI); norepinephrine-releasing agent; alpha adrenergic agonist; beta adrenergic agonist; catecholamine; "norepinephrine, serotonin, and dopamine reuptake inhibitor anorectic"
NDA Applicant: KALEO INC      NDA No.:
201739  Prod. No.: 001 RX (EQ 0.3MG/DELIVERY); 002 RX (EQ 0.15MG/DELIVERY)
PatentsExpirationPatented Use
Pat. No. 7731686 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Jun 1, 2026 
Pat. No. 7731690 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Jan 15, 2025 
Pat. No. 7749194 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device
Oct 30, 2028 
Pat. No. 7918823 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Nov 23, 2024 
Pat. No. 7947017 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Mar 12, 2028 
Pat. No. 8016788 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Mar 21, 2025 
Pat. No. 8021344 DP* Medicament delivery device configured to produce an audible output
Claim Types: Device
Nov 2, 2029 
Pat. No. 8206360 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Feb 27, 2027 
Pat. No. 8226610 DP* Medical injector with compliance tracking and monitoring
Claim Types: Device; Method of use
Apr 10, 2029 
Pat. No. 8231573 DP* Medicament delivery device having an electronic circuit system
Claim Types: Device
Nov 25, 2028 
Pat. No. 8313466 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Nov 23, 2024 
Pat. No. 8361029 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Nov 23, 2024 
Pat. No. 8425462 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device; Method of use
Nov 23, 2024 
Pat. No. 8608698 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Nov 23, 2024 
Pat. No. 8920377 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Nov 23, 2024 
Pat. No. 8926594 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Mar 31, 2026 
Pat. No. 9056170 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Nov 23, 2024 
Pat. No. 9149579 Devices, systems and methods for medicament delivery
Claim Types: Method of administration
Jul 19, 2025U-1758: Method of treating allergic reaction via injection
Pat. No. 9238108 DP* Medicament delivery device having an electronic circuit system
Claim Types: Device
Feb 20, 2027 
Pat. No. 9259539 DP* Devices, systems and methods for medicament delivery
Claim Types: Method of administration
Feb 1, 2026 
Pat. No. 9278182 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Feb 1, 2026 
Pat. No. 9724471 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device; Method of administration
May 23, 2027U-2092: Method for confirming dose delivery
Pat. No. 9737669 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Nov 23, 2024 

alpha adrenergic agonist
AUVI-Q (SOLUTION) EPINEPHRINE
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI); norepinephrine-releasing agent; alpha adrenergic agonist; beta adrenergic agonist; catecholamine; "norepinephrine, serotonin, and dopamine reuptake inhibitor anorectic"
NDA Applicant: KALEO INC      NDA No.:
201739  Prod. No.: 003 RX (EQ 0.1MG/DELIVERY)
PatentsExpirationPatented Use
Pat. No. 7731686 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Jun 1, 2026 
Pat. No. 7731690 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Jan 15, 2025 
Pat. No. 7749194 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device
Oct 30, 2028 
Pat. No. 7918823 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Nov 23, 2024 
Pat. No. 7947017 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Mar 12, 2028 
Pat. No. 8016788 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Mar 21, 2025 
Pat. No. 8021344 DP* Medicament delivery device configured to produce an audible output
Claim Types: Device
Nov 2, 2029 
Pat. No. 8206360 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Feb 27, 2027 
Pat. No. 8226610 DP* Medical injector with compliance tracking and monitoring
Claim Types: Device; Method of use
Apr 10, 2029 
Pat. No. 8231573 DP* Medicament delivery device having an electronic circuit system
Claim Types: Device
Nov 25, 2028 
Pat. No. 8313466 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Nov 23, 2024 
Pat. No. 8361029 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Nov 23, 2024 
Pat. No. 8425462 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device; Method of use
Nov 23, 2024 
Pat. No. 8608698 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Nov 23, 2024 
Pat. No. 8920377 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Nov 23, 2024 
Pat. No. 8926594 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Mar 31, 2026 
Pat. No. 9056170 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Nov 23, 2024 
Pat. No. 9149579 Devices, systems and methods for medicament delivery
Claim Types: Method of administration
Jul 19, 2025U-1758: Method of treating allergic reaction via injection
Pat. No. 9238108 DP* Medicament delivery device having an electronic circuit system
Claim Types: Device
Feb 20, 2027 
Pat. No. 9259539 DP* Devices, systems and methods for medicament delivery
Claim Types: Method of administration
Feb 1, 2026 
Pat. No. 9278182 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Feb 1, 2026 
Pat. No. 9724471 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device; Method of administration
May 23, 2027U-2092: Method for confirming dose delivery
Pat. No. 9737669 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Nov 23, 2024 
Pat. No. 9833573 Devices, systems and methods for medicament delivery
Claim Types: Method of administration
Nov 23, 2024U-2172: Method to treat severe allergic emergencies in patients weighing 7.5 to 15 kg (16.5 to 33 lbs)

alpha adrenergic agonist
CLARINEX D 24 HOUR (TABLET, EXTENDED RELEASE) DESLORATADINE; PSEUDOEPHEDRINE SULFATE [GENERIC AB]
Drug Classes: histamine-1 (H1) receptor antagonist; alpha adrenergic agonist
NDA Applicant: MERCK SHARP DOHME      NDA No.:
021605  Prod. No.: 001 RX (5MG;240MG)
PatentsExpirationPatented Use
Pat. No. 6100274 DP* 8-chloro-6,11-dihydro-11-](4-piperidylidine)-5H-benzo [5,6]cyclohepta[1,2-bpyridine oral compositions
Claim Types: Formulation
Jan 7, 2020 *PED 
Pat. No. 6979463 DP* Stable extended release oral dosage composition
Claim Types: Formulation; Method of use
Mar 28, 2022 
Pat. No. 7618649 DP* Extended release oral dosage composition
Claim Types: Formulation; Method of use
Jun 19, 2021 *PEDU-1017: A method of treating nasal and non-nasal symptoms of seasonal allergic rhinitis
Pat. No. 7820199 DP* Stable extended release oral dosage composition
Claim Types: Formulation
Sep 28, 2022 *PED 

alpha adrenergic agonist
CLARINEX-D 12 HOUR (TABLET, EXTENDED RELEASE) DESLORATADINE; PSEUDOEPHEDRINE SULFATE
Drug Classes: histamine-1 (H1) receptor antagonist; alpha adrenergic agonist
NDA Applicant: MERCK SHARP DOHME      NDA No.:
021313  Prod. No.: 001 RX (2.5MG;120MG)
PatentsExpirationPatented Use
Pat. No. 6100274 DP* 8-chloro-6,11-dihydro-11-](4-piperidylidine)-5H-benzo [5,6]cyclohepta[1,2-bpyridine oral compositions
Claim Types: Formulation
Jan 7, 2020 *PED 
Pat. No. 6709676 DP* Extended release oral dosage composition
Claim Types: Formulation; Method of use
Feb 18, 2021U-707: Allergic rhinitis
Pat. No. 7618649 DP* Extended release oral dosage composition
Claim Types: Formulation; Method of use
Jun 19, 2021 *PEDU-1017: A method of treating nasal and non-nasal symptoms of seasonal allergic rhinitis
Pat. No. 8187630 DP* Extended release oral dosage composition
Claim Types: Formulation; Method of administration
Dec 19, 2020U-1017: A method of treating nasal and non-nasal symptoms of seasonal allergic rhinitis

alpha adrenergic agonist
COMBIGAN (SOLUTION/DROPS) BRIMONIDINE TARTRATE; TIMOLOL MALEATE
Drug Classes: alpha adrenergic agonist; beta adrenergic blocker
NDA Applicant: ALLERGAN      NDA No.:
021398  Prod. No.: 001 RX (0.2%;EQ 0.5% BASE)
PatentsExpirationPatented Use
Pat. No. 7030149 Combination of brimonidine timolol for topical ophthalmic use
Claim Types: Method of use
Apr 19, 2022U-849: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. dose is one drop of COMBIGAN in the affected eye twice daily
Pat. No. 7320976 Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Method of use
Apr 19, 2022U-849: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. dose is one drop of COMBIGAN in the affected eye twice daily
Pat. No. 7323463 DP* Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Formulation; Drug in a container
Jan 19, 2023 
Pat. No. 7642258 DS* DP* Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Formulation; Kit
Apr 19, 2022U-1024: Reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP
Pat. No. 8133890 Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Method of use
Apr 19, 2022U-1235: Reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension
Pat. No. 8354409 DP* Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Formulation; Method of administration; Method of use
Apr 19, 2022U-1371: Reduction of intraocular pressure in patients with elevated intraocular pressure or glaucoma
Pat. No. 8748425 DP* Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Method of use
Apr 19, 2022U-1524: Reduction of elevated intraocular pressure
Pat. No. 9474751 DP* Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Method of use
Apr 19, 2022U-1524: Reduction of elevated intraocular pressure
Pat. No. 9770453 DP* Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Method of use
Apr 19, 2022U-2131: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, with comparable efficacy, and a reduction in specified adverse events, compared to brimonidine 0.2% tid
Pat. No. 9907801 DP* Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Method of use
Apr 19, 2022U-2239: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, with a reduction in specified adverse events, compared to brimonidine 0.2% tid
Pat. No. 9907802 DP* Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Method of use
Apr 19, 2022U-2240: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, with comparable efficacy to brimonidine 0.2% tid

alpha adrenergic agonist
EPINEPHRINE (SOLUTION) EPINEPHRINE
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI); norepinephrine-releasing agent; alpha adrenergic agonist; beta adrenergic agonist; catecholamine; "norepinephrine, serotonin, and dopamine reuptake inhibitor anorectic"
NDA Applicant: BELCHER PHARMS LLC      NDA No.:
205029  Prod. No.: 001 RX (EQ 1MG BASE/ML (EQ 1MG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 9283197 DP* More potent and less toxic formulations of epinephrine and methods of medical use
Claim Types: Formulation
Aug 15, 2034U-1828: Increasing mean arterial blood pressure in adult patients with hypotension associated with septic shock
U-1829: Emergency treatment of allergic reactions (type I), including anaphylaxis
U-1830: Induction and maintenance of mydriasis during intraocular surgery

alpha adrenergic agonist
EPIPEN; EPIPEN JR. (INJECTABLE) EPINEPHRINE
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI); norepinephrine-releasing agent; alpha adrenergic agonist; beta adrenergic agonist; catecholamine; "norepinephrine, serotonin, and dopamine reuptake inhibitor anorectic"
NDA Applicant: MYLAN SPECIALITY LP      NDA No.:
019430  Prod. No.: 001 RX (0.3MG/DELIVERY); 002 RX (0.15MG/DELIVERY)
PatentsExpirationPatented Use
Pat. No. 7449012 DP* Automatic injector
Claim Types: Device
Sep 11, 2025 
Pat. No. 7794432 DP* Automatic injector with kickback attenuation
Claim Types: Device; Process
Sep 11, 2025 
Pat. No. 8048035 DP* Automatic injector with needle cover
Claim Types: Device
Sep 11, 2025 
Pat. No. 8870827 DP* Automatic injector
Claim Types: Device
Sep 11, 2025 
Pat. No. 9586010 DP* Automatic injector with needle cover
Claim Types: Device
Sep 11, 2025 

alpha adrenergic agonist
LIDOSITE TOPICAL SYSTEM KIT (PATCH) EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI); norepinephrine-releasing agent; alpha adrenergic agonist; beta adrenergic agonist; catecholamine; "norepinephrine, serotonin, and dopamine reuptake inhibitor anorectic"; amide local anesthetic; antiarrhythmic
NDA Applicant: VYTERIS      NDA No.:
021504  Prod. No.: 001 DISC (1.05MG/PATCH;100MG/PATCH)
PatentsExpirationPatented Use
Pat. No. 6629968 DS* DP* Shelf storage stable iontophoresis reservoir-electrode and iontophoretic system incorporating the reservoir-electrode
Claim Types: Process; Product-by-process
Jun 30, 2020 
Pat. No. 6635045 DS* DP* Electrodes and method for manufacturing electrodes for electrically assisted drug delivery
Claim Types: Product-by-process; Process
Jun 29, 2021 

alpha adrenergic agonist
LUMIFY (SOLUTION/DROPS) BRIMONIDINE TARTRATE
Drug Classes: alpha adrenergic agonist
NDA Applicant: BAUSCH AND LOMB INC      NDA No.:
208144  Prod. No.: 001 OTC (0.025%)
PatentsExpirationPatented Use
Pat. No. 8293742 Preferential vasoconstriction compositions and methods of use
Claim Types: Method of use
Jul 14, 2030U-2222: Relieves redness of the eye due to minor eye irritations
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productDec 22, 2020 

alpha adrenergic agonist
MIRVASO (GEL) BRIMONIDINE TARTRATE
Drug Classes: alpha adrenergic agonist
NDA Applicant: GALDERMA LABS LP      NDA No.:
204708  Prod. No.: 001 RX (EQ 0.33% BASE)
PatentsExpirationPatented Use
Pat. No. 7439241 Compounds, formulations, and methods for treating or preventing rosacea
Claim Types: Method of use
Aug 25, 2025U-1428: Topical treatment of facial erythema of rosacea
Pat. No. 8053427 DP* Brimonidine gel composition
Claim Types: Formulation; Method of use
Jun 13, 2031U-1428: Topical treatment of facial erythema of rosacea
Pat. No. 8163725 DP* Gel compositions and methods of use
Claim Types: Formulation; Method of use
Jun 13, 2031 
Pat. No. 8231885 DP* Compounds, formulations, and methods for ameliorating telangiectasis
Claim Types: Formulation; Device
May 24, 2025 
Pat. No. 8410102 Methods and compositions for treating or preventing erythema
Claim Types: Method of use
May 24, 2025U-1428: Topical treatment of facial erythema of rosacea
Pat. No. 8426410 Compounds, formulations, and methods for treating or preventing inflammatory skin disorders
Claim Types: Method of use
May 24, 2025U-1428: Topical treatment of facial erythema of rosacea
Pat. No. 8513247 DP* Methods and compositions for safe and effective treatment of erythema
Claim Types: Method of use
Mar 25, 2031U-1428: Topical treatment of facial erythema of rosacea
Pat. No. 8513249 DP* Methods and compositions for safe and effective treatment of erythema
Claim Types: Method of use; Formulation
Mar 25, 2031U-1428: Topical treatment of facial erythema of rosacea
Pat. No. 8859551 Compounds, formulations, and methods for treating or preventing inflammatory skin disorders
Claim Types: Method of use
May 25, 2024U-1428: Topical treatment of facial erythema of rosacea
Pat. No. 9861631 Methods and compositions for safe and effective treatment of erythema
Claim Types: Method of use
Mar 25, 2031U-1428: Topical treatment of facial erythema of rosacea
Pat. No. 9861632 Methods and compositions for safe and effective treatment of erythema
Claim Types: Method of use
Mar 25, 2031U-1428: Topical treatment of facial erythema of rosacea

alpha adrenergic agonist
MOTRIN, CHILDREN'S COLD (SUSPENSION) IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE [GENERIC OTC]
Drug Classes: nonsteroidal anti-inflammatory drug; alpha adrenergic agonist
NDA Applicant: J AND J CONSUMER INC      NDA No.:
021128  Prod. No.: 001 OTC (100MG/5ML;15MG/5ML)
PatentsExpirationPatented Use
Pat. No. 6211246 Rapidly absorbed liquid compositions
Claim Types: Method of improving a formulation; Formulation
Jun 10, 2019 

alpha adrenergic agonist
MUCINEX D (TABLET, EXTENDED RELEASE) GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE [GENERIC OTC]
Drug Classes: alpha adrenergic agonist
NDA Applicant: RECKITT BENCKISER      NDA No.:
021585  Prod. No.: 001 OTC (600MG;60MG); 002 OTC (1.2GM;120MG)
PatentsExpirationPatented Use
Pat. No. 6372252 DP* Guaifenesin sustained release formulation and tablets
Claim Types: Formulation
Apr 28, 2020 
Pat. No. 6955821 DP* Sustained release formulations of guaifenesin and additional drug ingredients
Claim Types: Formulation; Method of use
Apr 28, 2020U-686: Expectorant and nasal decongestant
Pat. No. 7838032 DP* Sustained release of guaifenesin
Claim Types: Formulation
Apr 28, 2020 

alpha adrenergic agonist
QOLIANA (SOLUTION/DROPS) BRIMONIDINE TARTRATE
Drug Classes: alpha adrenergic agonist
NDA Applicant: SANDOZ INC      NDA No.:
021764  Prod. No.: 001 RX (0.15%)
PatentsExpirationPatented Use
Pat. No. 7265117 DP* Topical brimonidine tartrate formulations that lack chlorine dioxide
Claim Types: Formulation
Aug 19, 2025 

alpha adrenergic agonist
SIMBRINZA (SUSPENSION/DROPS) BRIMONIDINE TARTRATE; BRINZOLAMIDE
Drug Classes: alpha adrenergic agonist; carbonic anhydrase inhibitor
NDA Applicant: NOVARTIS PHARMS CORP      NDA No.:
204251  Prod. No.: 001 RX (0.2%;1%)
PatentsExpirationPatented Use
Pat. No. 6316441 Brinzolamide and brimonidine for treating glaucoma
Claim Types: Method of use
Dec 7, 2019U-778: Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension
Pat. No. 9044484 DP* Aqueous pharmaceutical compositions containing borate-polyol complexes
Claim Types: Formulation
Oct 30, 2030 
Pat. No. 9421265 DP* Aqueous pharmaceutical compositions containing borate-polyol complexes
Claim Types: Formulation
Jun 17, 2030 

alpha adrenergic agonist
TWINJECT 0.3; TWINJECT 0.15 (INJECTABLE) EPINEPHRINE
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI); norepinephrine-releasing agent; alpha adrenergic agonist; beta adrenergic agonist; catecholamine; "norepinephrine, serotonin, and dopamine reuptake inhibitor anorectic"
NDA Applicant: IMPAX LABS INC      NDA No.:
020800  Prod. No.: 001 DISC (EQ 0.3MG/DELIVERY); 002 DISC (EQ 0.15MG/DELIVERY)
PatentsExpirationPatented Use
Pat. No. 7297136 DP* Medicine injection devices and methods
Claim Types: Device
Jan 18, 2025 
Pat. No. 7621891 DP* Method and apparatus for delivering epinephrine
Claim Types: Device
Feb 4, 2025 

alpha adrenergic agonist
ZYRTEC-D 12 HOUR (TABLET, EXTENDED RELEASE) CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE [GENERIC OTC]
Drug Classes: histamine-1 (H1) receptor antagonist; alpha adrenergic agonist
NDA Applicant: J AND J CONSUMER INC      NDA No.:
021150  Prod. No.: 002 OTC (5MG;120MG)
PatentsExpirationPatented Use
Pat. No. 6469009 DP* Pharmaceutical compositions for the treatment of rhinitis
Claim Types: Composition; Method of use
Jul 13, 2019U-295: Treatment of seasonal and perennial allergic rhinitis symptoms
Pat. No. 7014867 DP* Tablet comprising cetirizine and pseudoephedrine
Claim Types: Formulation
Jun 10, 2022 
Pat. No. 7226614 Tablet comprising cetirizine and pseudoephedrine
Claim Types: Method of use
Jun 10, 2022U-295: Treatment of seasonal and perennial allergic rhinitis symptoms

alpha adrenergic blocker
CARVEDILOL PHOSPHATE (CAPSULE, EXTENDED RELEASE) CARVEDILOL PHOSPHATE [GENERIC AB]
Drug Classes: alpha adrenergic blocker; beta adrenergic blocker
NDA Applicant: SUN PHARM INDUSTRIES      NDA No.:
090132  Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (40MG); 004 RX (80MG)
ExclusivityExpirationExclusivity Description
Exclusivity Code: PC - Patent challengeMay 7, 2018 

alpha adrenergic blocker
COREG CR (CAPSULE, EXTENDED RELEASE) CARVEDILOL PHOSPHATE [GENERIC AB]
Drug Classes: alpha adrenergic blocker; beta adrenergic blocker
NDA Applicant: SMITHKLINE BEECHAM      NDA No.:
022012  Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (40MG); 004 RX (80MG)
PatentsExpirationPatented Use
Pat. No. 7268156 DS* DP* Carvedilol phosphate salts and/or solvates thereof, corresponding compositions and/or methods of treatment
Claim Types: New polymorph, salt or hydrate; Method of use; Composition
Dec 27, 2023 *PEDU-313: Treatment of congestive heart failure
U-3: Treatment of hypertension
Pat. No. 8101209 DP* Microparticulate oral galenical form for the delayed and controlled release of pharmaceutical active principles
Claim Types: Formulation
Mar 11, 2026 *PED 

alpha adrenergic blocker
ORAVERSE (INJECTABLE) PHENTOLAMINE MESYLATE
Drug Classes: alpha adrenergic blocker
NDA Applicant: SEPTODONT HOLDING      NDA No.:
022159  Prod. No.: 001 RX (0.4MG/1.7ML)
PatentsExpirationPatented Use
Pat. No. 6764678 Local anesthetic methods and kits
Claim Types: Method of administration
May 11, 2021U-967: A method of reversing soft-tissue anesthesia i.e. anesthesia of the lip and tongue, and the associated functional deficits resulting from an intraoral submucosal injection of a local anesthetic
Pat. No. 6872390 DP* Local anesthetic methods and kits
Claim Types: Formulation
May 11, 2021 
Pat. No. 7229630 DP* Stabilized formulations of alpha adrenergic receptor antagonists and the uses thereof
Claim Types: Formulation; Kit; Drug in a container
Jun 20, 2023 
Pat. No. 7569230 Stabilized formulations of alpha adrenergic receptor antagonists and the uses thereof
Claim Types: Method of use
Oct 17, 2023U-967: A method of reversing soft-tissue anesthesia i.e. anesthesia of the lip and tongue, and the associated functional deficits resulting from an intraoral submucosal injection of a local anesthetic
Pat. No. 7575757 DP* Stabilized formulations of alpha adrenergic receptor antagonists and the uses thereof
Claim Types: Formulation; Drug in a container
Apr 21, 2025 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationMar 18, 2019 

alpha adrenergic blocker
RAPAFLO (CAPSULE) SILODOSIN [GENERIC AB]
Drug Classes: alpha adrenergic blocker
NDA Applicant: ALLERGAN SALES LLC      NDA No.:
022206  Prod. No.: 001 RX (4MG); 002 RX (8MG)
PatentsExpirationPatented Use
Pat. No. 5387603 DS* DP* [Extended 5 years]
1,5,7-trisubstituted indoline compounds and salts thereof
Claim Types: Compound; Composition; Method of use
Dec 1, 2018 

alpha adrenergic blocker
UROXATRAL (TABLET, EXTENDED RELEASE) ALFUZOSIN HYDROCHLORIDE [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 

alpha particle-emitting radioactive therapeutic agent
XOFIGO (SOLUTION) RADIUM RA-223 DICHLORIDE
Drug Classes: alpha particle-emitting radioactive therapeutic agent
NDA Applicant: BAYER HLTHCARE      NDA No.:
203971  Prod. No.: 001 RX (162mCi/6ML (27mCi/ML))
PatentsExpirationPatented Use
Pat. No. 6635234 Preparation and use of radium-223 to target calcified tissues for pain palliation, bone cancer therapy, and bone surface conditioning
Claim Types: Method of use; Method of administration
Nov 17, 2022U-2271: Therapeutic treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMay 15, 2018 

alpha-1 adrenergic receptor agonist
OMIDRIA (SOLUTION) KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE
Drug Classes: cyclooxygenase inhibitor; nonsteroidal anti-inflammatory drug; alpha-1 adrenergic receptor agonist
NDA Applicant: OMEROS      NDA No.:
205388  Prod. No.: 001 RX (EQ 0.3% BASE;EQ 1% BASE)
PatentsExpirationPatented Use
Pat. No. 8173707 Ophthalmologic irrigation solutions and method
Claim Types: Method of use
Jan 30, 2024 *PEDU-1518: Maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain
Pat. No. 8586633 DP* Ophthalmologic irrigation solutions and method
Claim Types: Formulation
Jan 30, 2024 *PED 
Pat. No. 9066856 DP* Stable preservative-free mydriatic and anti-inflammatory solutions for injection
Claim Types: Formulation
Apr 23, 2034 *PED 
Pat. No. 9278101 Ophthalmologic irrigation solutions and method
Claim Types: Method of administration
Jan 30, 2024 *PEDU-1518: Maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain
Pat. No. 9399040 DP* Ophthalmologic irrigation solutions and method
Claim Types: Formulation
Jan 30, 2024 *PED 
Pat. No. 9486406 DP* Stable preservative-free mydriatic and anti-inflammatory solutions for injection
Claim Types: Formulation
Apr 23, 2034 *PED 
Pat. No. 9855246 DP* Stable preservative-free mydriatic and anti-inflammatory solutions for injection
Claim Types: Formulation
Oct 23, 2033 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationJun 8, 2021 PED 

alpha-1 adrenergic receptor agonist
PHENYLEPHRINE HYDROCHLORIDE (SOLUTION/DROPS) PHENYLEPHRINE HYDROCHLORIDE
Drug Classes: alpha-1 adrenergic receptor agonist
NDA Applicant: PARAGON BIOTECK      NDA No.:
203510  Prod. No.: 001 RX (2.5%); 002 RX (10%)
PatentsExpirationPatented Use
Pat. No. 8859623 Methods and compositions of stable phenylephrine formulations
Claim Types: Method of use
Nov 14, 2033U-1594: Dilation of the pupil

amide local anesthetic
AKTEN (GEL) LIDOCAINE HYDROCHLORIDE
Drug Classes: amide local anesthetic; antiarrhythmic
NDA Applicant: AKORN      NDA No.:
022221  Prod. No.: 001 RX (3.5%)
PatentsExpirationPatented Use
Pat. No. 8759401 DP* Aqueous gel formulation and method for inducing topical anesthesia
Claim Types: Formulation; Method of use
Jul 24, 2026U-1523: Method of inducing topical anesthesia in the eye

amide local anesthetic
EXPAREL (INJECTABLE, LIPOSOMAL) BUPIVACAINE
Drug Classes: amide local anesthetic
NDA Applicant: PACIRA PHARMS INC      NDA No.:
022496  Prod. No.: 001 RX (133MG/10ML (13.3MG/ML))
PatentsExpirationPatented Use
Pat. No. 8182835 DP* Sustained-release liposomal anesthetic compositions
Claim Types: Product-by-process; Method of administration; Method of use
Sep 18, 2018U-1246: Single dose administration into the surgical site to produce postsurgical analgesia
Pat. No. 8834921 DP* Sustained-release liposomal anesthetic compositions
Claim Types: Process; Formulation; Method of use
Sep 18, 2018U-1587: Single-dose infiltration into the surgical site to produce postsurgical analgesia.
Pat. No. 9585838 DP* Production of multivesicular liposomes
Claim Types: Process; Product-by-process
Dec 24, 2021 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationApr 6, 2021I-771: Revision of the indication section of the package insert regarding an interscalene brachial plexus nerve block to produce postsurgical regional analgesia

amide local anesthetic
EXPAREL (INJECTABLE, LIPOSOMAL) BUPIVACAINE
Drug Classes: amide local anesthetic
NDA Applicant: PACIRA PHARMS INC      NDA No.:
022496  Prod. No.: 002 RX (266MG/20ML (13.3MG/ML))
PatentsExpirationPatented Use
Pat. No. 8182835 DP* Sustained-release liposomal anesthetic compositions
Claim Types: Product-by-process; Method of administration; Method of use
Sep 18, 2018U-1246: Single dose administration into the surgical site to produce postsurgical analgesia
Pat. No. 8834921 DP* Sustained-release liposomal anesthetic compositions
Claim Types: Process; Formulation; Method of use
Sep 18, 2018U-1587: Single-dose infiltration into the surgical site to produce postsurgical analgesia.
Pat. No. 9205052 Sustained-release liposomal anesthetic compositions
Claim Types: Method of use; Method of administration
Sep 18, 2018U-1246: Single dose administration into the surgical site to produce postsurgical analgesia
Pat. No. 9585838 DP* Production of multivesicular liposomes
Claim Types: Process; Product-by-process
Dec 24, 2021 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationApr 6, 2021I-771: Revision of the indication section of the package insert regarding an interscalene brachial plexus nerve block to produce postsurgical regional analgesia

amide local anesthetic
LIDOSITE TOPICAL SYSTEM KIT (PATCH) EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI); norepinephrine-releasing agent; alpha adrenergic agonist; beta adrenergic agonist; catecholamine; "norepinephrine, serotonin, and dopamine reuptake inhibitor anorectic"; amide local anesthetic; antiarrhythmic
NDA Applicant: VYTERIS      NDA No.:
021504  Prod. No.: 001 DISC (1.05MG/PATCH;100MG/PATCH)
PatentsExpirationPatented Use
Pat. No. 6629968 DS* DP* Shelf storage stable iontophoresis reservoir-electrode and iontophoretic system incorporating the reservoir-electrode
Claim Types: Process; Product-by-process
Jun 30, 2020 
Pat. No. 6635045 DS* DP* Electrodes and method for manufacturing electrodes for electrically assisted drug delivery
Claim Types: Product-by-process; Process
Jun 29, 2021 

amide local anesthetic
NAROPIN (SOLUTION) ROPIVACAINE HYDROCHLORIDE [GENERIC AP]
Drug Classes: amide local anesthetic
NDA Applicant: FRESENIUS KABI USA      NDA No.:
020533  Prod. No.: 006 RX (200MG/100ML (2MG/ML)); 007 RX (400MG/200ML (2MG/ML))
PatentsExpirationPatented Use
Pat. No. 7828787 DP* Connector for packaging containing medical fluids and packaging for medical fluids
Claim Types: Device
Oct 18, 2025 
Pat. No. 7857802 DP* Connector for medical liquid-containing packages and medical liquid-containing packages
Claim Types: Device
Nov 28, 2026 
Pat. No. 8118802 DP* Connector for packaging containing medical fluids and packaging for medical fluids
Claim Types: Device
May 18, 2023 
Pat. No. 8162915 DP* Connector for packings containing medical liquids, and corresponding packing for medical liquids
Claim Types: Device
May 23, 2024 

amide local anesthetic
PLIAGLIS (CREAM) LIDOCAINE; TETRACAINE
Drug Classes: amide local anesthetic; antiarrhythmic; ester local anesthetic
NDA Applicant: TARO PHARMS      NDA No.:
021717  Prod. No.: 001 RX (7%;7%)
PatentsExpirationPatented Use
Pat. No. 6528086 DP* Methods and apparatus for drug delivery involving phase changing formulations
Claim Types: Method of use; Formulation
Sep 28, 2019 

amide local anesthetic
SYNERA (PATCH) LIDOCAINE; TETRACAINE
Drug Classes: amide local anesthetic; antiarrhythmic; ester local anesthetic
NDA Applicant: GALEN SPECIALTY      NDA No.:
021623  Prod. No.: 001 RX (70MG;70MG)
PatentsExpirationPatented Use
Pat. No. 6465709 DP* Exothermic bandage
Claim Types: Device; Method of use
Jul 7, 2020 

amide local anesthetic
TRILIPIX (CAPSULE, DELAYED RELEASE) CHOLINE FENOFIBRATE [GENERIC AB]
Drug Classes: amide local anesthetic; antiarrhythmic
NDA Applicant: ABBVIE      NDA No.:
022224  Prod. No.: 001 RX (EQ 45MG FENOFIBRIC ACID); 002 RX (EQ 135MG FENOFIBRIC ACID)
PatentsExpirationPatented Use
Pat. No. 7259186 DS* Salts of fenofibric acid and pharmaceutical formulations thereof
Claim Types: Formulation; New polymorph, salt or hydrate
Jan 7, 2025 

amide local anesthetic
ZINGO (SYSTEM) LIDOCAINE HYDROCHLORIDE
Drug Classes: amide local anesthetic; antiarrhythmic
NDA Applicant: POWDER PHARMS      NDA No.:
022114  Prod. No.: 001 RX (0.5MG)
PatentsExpirationPatented Use
Pat. No. 8540665 Particle cassettes and processes therefor
Claim Types: Device; Process
Oct 22, 2029U-1438: Zingo intradermal injection system is a drug delivery system that is capable of delivering fine dry powdered lidocaine hydrochloride monohydrate for local anesthetic action
Pat. No. 9358338 Particle cassettes and processes therefor
Claim Types: Device; Process
Apr 27, 2035U-1870: ZINGO is a powder intradermal system that is capable of delivering fine dry powdered lidocaine hydrochloride monohydrate for local anesthetic action
Pat. No. 9370622 Devices and methods for delivering particles
Claim Types: Method of use
Sep 28, 2035U-1870: ZINGO is a powder intradermal system that is capable of delivering fine dry powdered lidocaine hydrochloride monohydrate for local anesthetic action

amide local anesthetic
ZTLIDO (PATCH) LIDOCAINE
Drug Classes: amide local anesthetic; antiarrhythmic
NDA Applicant: SCILEX PHARMS INC      NDA No.:
207962  Prod. No.: 001 RX (1.8%)
PatentsExpirationPatented Use
Pat. No. 9283174 DP* Non-aqueous patch
Claim Types: Formulation
May 10, 2031 
Pat. No. 9925264 DP* Non-aqueous patch
Claim Types: Method of use
May 10, 2031U-2267: Method for relieving the pain associated with post-herpetic neuralgia
Pat. No. 9931403 DP* Non-aqueous patch
Claim Types: Formulation
May 10, 2031 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productFeb 28, 2021 

aminoglycoside antibacterial
BETHKIS (SOLUTION) TOBRAMYCIN
Drug Classes: aminoglycoside antibacterial
NDA Applicant: CHIESI USA INC      NDA No.:
201820  Prod. No.: 001 RX (300MG/4ML)
PatentsExpirationPatented Use
Pat. No. 6987094 DP* Optimized formulation of tobramycin for aerosolization
Claim Types: Formulation; Process
Sep 22, 2022 
Pat. No. 7696178 DP* Optimised formulation of tobramycin for aerosolization
Claim Types: Formulation; Process
Sep 22, 2022 
Pat. No. 7939502 Optimised formulation of tobramycin for aerosolization
Claim Types: Method of use
Jun 14, 2022U-1324: Management of cystic fibrosis patients

aminoglycoside antibacterial
TOBI PODHALER (POWDER) TOBRAMYCIN
Drug Classes: aminoglycoside antibacterial
NDA Applicant: NOVARTIS      NDA No.:
201688  Prod. No.: 001 RX (28MG)
PatentsExpirationPatented Use
Pat. No. 7368102 DP* Pulmonary delivery of aminoglycosides
Claim Types: Formulation; Method of administration
Dec 19, 2022U-909: Treatment of cystic fibrosis patients with pseudomonas aeruginosa
Pat. No. 7442388 DP* Phospholipid-based powders for drug delivery
Claim Types: Formulation; Method of administration; Process
May 10, 2020 
Pat. No. 7516741 DP* Aerosolization apparatus with feedback mechanism
Claim Types: Device; Method of administration
Jan 11, 2024 
Pat. No. 7559325 DP* Aerosolization apparatus with air inlet shield
Claim Types: Device
Oct 27, 2025 
Pat. No. 8069851 DP* Aeorosolization apparatus with air inlet shield
Claim Types: Device
Sep 24, 2024 
Pat. No. 8349294 DP* Stable metal ion-lipid powdered pharmaceutical compositions for drug delivery and methods of use
Claim Types: Formulation
May 10, 2020 
Pat. No. 8715623 DP* Pulmonary delivery of aminoglycoside
Claim Types: Formulation; Method of use; Method of administration
Dec 19, 2022U-909: Treatment of cystic fibrosis patients with pseudomonas aeruginosa

aminoglycoside antibacterial
TOBRADEX ST (SUSPENSION/DROPS) DEXAMETHASONE; TOBRAMYCIN
Drug Classes: corticosteroid; aminoglycoside antibacterial
NDA Applicant: NOVARTIS PHARMS CORP      NDA No.:
050818  Prod. No.: 001 RX (0.05%;0.3%)
PatentsExpirationPatented Use
Pat. No. 7795316 DP* Topical ophthalmic compositions containing tobramycin and dexamethasone
Claim Types: Formulation; Method of use
Aug 3, 2028U-1082: Use of a combination of tobramycin and dexamethasone to treat ocular inflammation where an infection or risk of infection exists
Pat. No. 8101582 DP* Topical ophthalmic compositions containing tobramycin and dexamethasone
Claim Types: Method of use
Dec 19, 2027U-1082: Use of a combination of tobramycin and dexamethasone to treat ocular inflammation where an infection or risk of infection exists
Pat. No. 8450287 DP* Topical ophthalmic compositions containing tobramycin and dexamethasone
Claim Types: Formulation
Dec 19, 2027 

aminoketone
APLENZIN (TABLET, EXTENDED RELEASE) BUPROPION HYDROBROMIDE
Drug Classes: aminoketone
NDA Applicant: VALEANT PHARMS NORTH      NDA No.:
022108  Prod. No.: 001 RX (174MG); 002 RX (348MG); 003 RX (522MG)
PatentsExpirationPatented Use
Pat. No. 7241805 DP* Modified release formulations of a bupropion salt
Claim Types: Formulation; Method of use
Jun 27, 2026 
Pat. No. 7569610 Modified release formulations of a bupropion salt
Claim Types: Method of use
Jun 27, 2026U-997: Treatment of major depressive disorder by dosing at intervals of 24 hours
Pat. No. 7572935 DP* Modified release formulations of a bupropion salt
Claim Types: Formulation
Jun 27, 2026 
Pat. No. 7585897 DP* Modified release formulations of a bupropion salt
Claim Types: Formulation
Jun 27, 2026 
Pat. No. 7645802 DP* Bupropion hydrobromide and therapeutic applications
Claim Types: Formulation; Method of use
Jun 27, 2026 
Pat. No. 7649019 DP* Modified release formulations of a bupropion salt
Claim Types: Formulation
Jun 27, 2026 
Pat. No. 7662407 DP* Modified release formulations of a bupropion salt
Claim Types: Formulation
Jun 27, 2026 
Pat. No. 7671094 DP* Bupropion hydrobromide and therapeutic applications
Claim Types: Formulation; Method of use
Jun 27, 2026 

aminoketone
CONTRAVE (TABLET, EXTENDED RELEASE) BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE
Drug Classes: aminoketone; opioid antagonist
NDA Applicant: OREXIGEN      NDA No.:
200063  Prod. No.: 001 RX (90MG;8MG)
PatentsExpirationPatented Use
Pat. No. 7375111 DP* Compositions for affecting weight loss
Claim Types: Formulation
Mar 26, 2025 
Pat. No. 7462626 Compositions for affecting weight loss
Claim Types: Method of use
Jul 20, 2024U-1583: For chronic weight management for treating overweight or obesity
Pat. No. 8088786 DP* Layered pharmaceutical formulations
Claim Types: Formulation
Feb 3, 2029 
Pat. No. 8318788 Layered pharmaceutical formulations
Claim Types: Method of use
Nov 8, 2027U-1584: Use of naltrexone and bupropion in a layered formulation for chronic weight management for affecting weight loss
Pat. No. 8722085 Methods for administering weight loss medications
Claim Types: Method of administration; Method of use
Nov 8, 2027U-1585: Use of naltrexone and bupropion based on an escalating dose schedule
Pat. No. 8815889 Compositions and methods for increasing insulin sensitivity
Claim Types: Method of use
Jul 20, 2024U-1586: For effect on blood glucose parameters in patients with insulin resistance
Pat. No. 8916195 Sustained release formulation of naltrexone
Claim Types: Method of use; Method of administration
Feb 2, 2030U-1639: Use of naltrexone and bupropion in extended-release form for chronic weight management for treating overweight or obesity
Pat. No. 9107837 Sustained release formulation of naltrexone
Claim Types: Method of use
Jun 4, 2027U-1639: Use of naltrexone and bupropion in extended-release form for chronic weight management for treating overweight or obesity
Pat. No. 9125868 Methods for administering weight loss medications
Claim Types: Method of administration
Nov 8, 2027U-1585: Use of naltrexone and bupropion based on an escalating dose schedule
Pat. No. 9248123 Methods of providing weight loss therapy in patients with major depression
Claim Types: Method of administration
Jan 13, 2032U-1808: Use of naltrexone and bupropion for chronic weight management for treating overweight or obesity in patients with major depressive disorder

aminoketone
FORFIVO XL (TABLET, EXTENDED RELEASE) BUPROPION HYDROCHLORIDE
Drug Classes: aminoketone
NDA Applicant: ALVOGEN      NDA No.:
022497  Prod. No.: 001 RX (450MG)
PatentsExpirationPatented Use
Pat. No. 7674479 DP* Sustained-release bupropion and bupropion/mecamylamine tablets
Claim Types: Formulation
Jun 25, 2027 

aminoketone
WELLBUTRIN XL (TABLET, EXTENDED RELEASE) BUPROPION HYDROCHLORIDE [GENERIC AB3]
Drug Classes: aminoketone
NDA Applicant: VALEANT INTL      NDA No.:
021515  Prod. No.: 001 RX (150MG); 002 RX (300MG)
PatentsExpirationPatented Use
Pat. No. 6096341 Delayed release tablet of bupropion hydrochloride
Claim Types: Formulation
Oct 30, 2018 

aminosalicylate
APRISO (CAPSULE, EXTENDED RELEASE) MESALAMINE
Drug Classes: aminosalicylate
NDA Applicant: VALEANT PHARMS INTL      NDA No.:
022301  Prod. No.: 001 RX (375MG)
PatentsExpirationPatented Use
Pat. No. 6551620 DS* DP* Pellet formulation for the treatment of the intestinal tract
Claim Types: Formulation; Method of use
Apr 20, 2018U-907: For the maintenance of remission of ulcerative colitis in subjects 18 years of age and older
Pat. No. 8337886 DP* Pellet formulation for the treatment of the intestinal tract
Claim Types: Formulation; Method of use
Apr 20, 2018U-1310: For the maintenance of remission of ulcerative colitis
Pat. No. 8496965 DP* Pellet formulation for the treatment of the intenstinal tract
Claim Types: Formulation
Apr 20, 2018 
Pat. No. 8865688 Compositions and methods for treatment of bowel diseases with granulated mesalamine
Claim Types: Method of use
May 1, 2030U-1310: For the maintenance of remission of ulcerative colitis
Pat. No. 8911778 DP* Pellet formulation for the treatment of the intestinal tract
Claim Types: Formulation
Apr 20, 2018U-1310: For the maintenance of remission of ulcerative colitis
Pat. No. 8940328 DP* Pellet formulation for the treatment of the intestinal tract
Claim Types: Formulation
Apr 20, 2018 
Pat. No. 8956647 DP* Pellet formulation for the treatment of the intestinal tract
Claim Types: Formulation
Apr 20, 2018 

aminosalicylate
ASACOL HD (TABLET, DELAYED RELEASE) MESALAMINE [GENERIC AB]
Drug Classes: aminosalicylate
NDA Applicant: APIL      NDA No.:
021830  Prod. No.: 001 RX (800MG)
PatentsExpirationPatented Use
Pat. No. 6893662 DP* Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures
Claim Types: Formulation
Nov 15, 2021U-141: Treatment of ulcerative colitis
Pat. No. 8580302 DP* Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures
Claim Types: Formulation; Method of use
Nov 15, 2021 
Pat. No. 9089492 DP* Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures
Claim Types: Formulation
Nov 15, 2021 

aminosalicylate
CANASA (SUPPOSITORY) MESALAMINE
Drug Classes: aminosalicylate
NDA Applicant: ALLERGAN SALES LLC      NDA No.:
021252  Prod. No.: 001 DISC (500MG)
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousSep 2, 2019M-187: Addition of clinical information obtained from a pediatric trial to section 8.4 of the labeling

aminosalicylate
CANASA (SUPPOSITORY) MESALAMINE [GENERIC AB]
Drug Classes: aminosalicylate
NDA Applicant: ALLERGAN SALES LLC      NDA No.:
021252  Prod. No.: 002 RX (1GM)
PatentsExpirationPatented Use
Pat. No. 8217083 DP* Mesalamine suppository
Claim Types: Formulation; Method of use
Jun 6, 2028 
Pat. No. 8436051 DP* Mesalamine suppository
Claim Types: Formulation
Comments: Method of use
Jun 6, 2028 

aminosalicylate
COLAZAL (CAPSULE) BALSALAZIDE DISODIUM [GENERIC AB]
Drug Classes: aminosalicylate
NDA Applicant: VALEANT PHARMS INTL      NDA No.:
020610  Prod. No.: 001 RX (750MG)
PatentsExpirationPatented Use
Pat. No. 7452872 Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives
Claim Types: Method of administration
Feb 24, 2027 *PEDU-141: Treatment of ulcerative colitis
Pat. No. 7625884 Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives
Claim Types: Method of administration
Feb 24, 2027 *PEDU-141: Treatment of ulcerative colitis

aminosalicylate
DELZICOL (CAPSULE, DELAYED RELEASE) MESALAMINE
Drug Classes: aminosalicylate
NDA Applicant: APIL      NDA No.:
204412  Prod. No.: 001 RX (400MG)
PatentsExpirationPatented Use
Pat. No. 6649180 DP* Hard capsule formed of cellulose ether film with a specific content of methoxyl and hydroxypropoxyl groups
Claim Types: Formulation
Apr 13, 2020 

aminosalicylate
GIAZO (TABLET) BALSALAZIDE DISODIUM [GENERIC AB]
Drug Classes: aminosalicylate
NDA Applicant: VALEANT PHARMS INTL      NDA No.:
022205  Prod. No.: 001 RX (1.1GM)
PatentsExpirationPatented Use
Pat. No. 6197341 DP* Formulations of balsalazide and its derivatives
Claim Types: Composition; Process; Method of use
Mar 13, 2018U-1229: Treatment of mildly to moderately active ulcerative colitis in male patients
Pat. No. 7452872 Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives
Claim Types: Method of administration
Aug 24, 2026U-1229: Treatment of mildly to moderately active ulcerative colitis in male patients
Pat. No. 7625884 Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives
Claim Types: Method of administration
Aug 24, 2026U-1229: Treatment of mildly to moderately active ulcerative colitis in male patients
Pat. No. 8497256 Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives for the treatment of males
Claim Types: Method of use; Method of administration
Jun 23, 2031U-1229: Treatment of mildly to moderately active ulcerative colitis in male patients
Pat. No. 9192616 Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives
Claim Types: Method of use
Aug 2, 2026U-1229: Treatment of mildly to moderately active ulcerative colitis in male patients

aminosalicylate
LIALDA (TABLET, DELAYED RELEASE) MESALAMINE [GENERIC AB]
Drug Classes: aminosalicylate
NDA Applicant: SHIRE      NDA No.:
022000  Prod. No.: 001 RX (1.2GM)
PatentsExpirationPatented Use
Pat. No. 6773720 DP* Mesalazine controlled release oral pharmaceutical compositions
Claim Types: Formulation; Process
Jun 8, 2020 

aminosalicylate
MESALAMINE (TABLET, DELAYED RELEASE) MESALAMINE [GENERIC AB]
Drug Classes: aminosalicylate
NDA Applicant: ZYDUS PHARMS USA INC      NDA No.:
091640  Prod. No.: 001 RX (1.2GM)
ExclusivityExpirationExclusivity Description
Exclusivity Code: PC - Patent challengeJan 14, 2018 

aminosalicylate
SFROWASA (ENEMA) MESALAMINE [GENERIC AB]
Drug Classes: aminosalicylate
NDA Applicant: MYLAN SPECIALITY LP      NDA No.:
019618  Prod. No.: 002 RX (4GM/60ML)
PatentsExpirationPatented Use
Pat. No. 7645801 DS* DP* Reduced irritant enema for treatment of inflammatory bowel disease (IBD)
Claim Types: Drug in a container
Jul 24, 2027 

amphetamine anorectic
ADDERALL 10; ADDERALL 20; ADDERALL 5; ADDERALL 30; ADDERALL 7.5; ADDERALL 12.5; ADDERALL 15 (TABLET) AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
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 **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**); 008 DISC (5MG;5MG;5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**); 009 DISC (1.25MG;1.25MG;1.25MG;1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**); 010 DISC (7.5MG;7.5MG;7.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**); 011 DISC (1.875MG;1.875MG;1.875MG;1.875MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**); 012 DISC (3.125MG;3.125MG;3.125MG;3.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**); 013 DISC (3.75MG;3.75MG;3.75MG;3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**)
PatentsExpirationPatented Use
Pat. No. 6384020 Rapid immediate release oral dosage form
Claim Types: Formulation
Jan 6, 2021 *PED 

amphetamine anorectic
ADDERALL XR 10; ADDERALL XR 20; ADDERALL XR 30; ADDERALL XR 25; ADDERALL XR 5; ADDERALL XR 15 (CAPSULE, EXTENDED RELEASE) AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE [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. 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 
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 

amphetamine anorectic
ADZENYS ER (SUSPENSION, EXTENDED RELEASE) AMPHETAMINE
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 anorectic
ADZENYS XR-ODT (TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE) AMPHETAMINE
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 anorectic
DYANAVEL XR (SUSPENSION, EXTENDED RELEASE) AMPHETAMINE
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 anorectic
MYDAYIS (CAPSULE, EXTENDED RELEASE) AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE [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. 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
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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productJun 20, 2020 

amylin analog
SYMLIN (INJECTABLE) PRAMLINTIDE ACETATE
Drug Classes: amylin analog
NDA Applicant: ASTRAZENECA AB      NDA No.:
021332  Prod. No.: 002 RX (EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)); 003 RX (EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)) NDA No.: 021332  Prod. No.: 001 DISC (EQ 3MG BASE/5ML (EQ 600MCG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 5686411 DS* DP* [Extended 1586 days* (4.3 years)]
Amylin agonist peptides and uses therefor
Claim Types: Compound; Method of use; Composition
Mar 16, 2019U-638: Treatment of diabetes with an amylin agonist, including with insulin

androgen
ANDROGEL (GEL; GEL, METERED) TESTOSTERONE [GENERIC AB1]
Drug Classes: androgen
NDA Applicant: ABBVIE      NDA No.:
021015  Prod. No.: 001 RX (25MG/2.5GM PACKET); 002 RX (50MG/5GM PACKET); 003 RX (12.5MG/1.25GM ACTUATION)
PatentsExpirationPatented Use
Pat. No. 6503894 Pharmaceutical composition and method for treating hypogonadism
Claim Types: Formulation; Device; Method of administration
Mar 1, 2021 *PEDU-490: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
Pat. No. 9125816 Pharmaceutical composition and method for treating hypogonadism
Claim Types: Method of use
Mar 2, 2021 *PEDU-490: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
Pat. No. 9132089 Pharmaceutical composition and method for treating hypogonadism
Claim Types: Method of use
Mar 2, 2021 *PEDU-490: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone

androgen
ANDROGEL (GEL, METERED) TESTOSTERONE [GENERIC AB]
Drug Classes: androgen
NDA Applicant: ABBVIE      NDA No.:
022309  Prod. No.: 001 RX (1.62% (20.25MG/1.25GM ACTUATION)); 002 RX (1.62% (20.25MG/1.25GM PACKET)); 003 RX (1.62% (40.5MG/2.5GM PACKET))
PatentsExpirationPatented Use
Pat. No. 6503894 Pharmaceutical composition and method for treating hypogonadism
Claim Types: Formulation; Device; Method of administration
Mar 2, 2021 *PEDU-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
Pat. No. 8466136 DP* Testosterone gel and method of use
Claim Types: Formulation
Oct 12, 2026 
Pat. No. 8466137 Testosterone gel and method of use
Claim Types: Method of use
Oct 12, 2026U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
Pat. No. 8466138 Testosterone gel and method of use
Claim Types: Method of use
Oct 12, 2026U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
Pat. No. 8486925 DP* Testosterone gel and method of use
Claim Types: Formulation
Oct 12, 2026 
Pat. No. 8729057 DP* Testosterone gel and method of use
Claim Types: Composition
Oct 12, 2026 
Pat. No. 8741881 Testosterone gel and method of use
Claim Types: Method of use
Oct 12, 2026U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
Pat. No. 8754070 DP* Testosterone gel and method of use
Claim Types: Formulation
Oct 12, 2026 
Pat. No. 8759329 DP* Testosterone gel and method of use
Claim Types: Formulation
Oct 12, 2026 
Pat. No. 9125816 Pharmaceutical composition and method for treating hypogonadism
Claim Types: Method of use
Mar 2, 2021 *PEDU-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
Pat. No. 9132089 Pharmaceutical composition and method for treating hypogonadism
Claim Types: Method of use
Mar 2, 2021 *PEDU-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone

androgen
AVEED (INJECTABLE) TESTOSTERONE UNDECANOATE
Drug Classes: androgen
NDA Applicant: ENDO PHARMS INC      NDA No.:
022219  Prod. No.: 001 RX (750MG/3ML (250MG/ML))
PatentsExpirationPatented Use
Pat. No. 7718640 DP* Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels
Claim Types: Formulation
Mar 14, 2027 
Pat. No. 8338395 Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels
Claim Types: Method of use; Method of administration
Feb 27, 2026U-1500: Testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone; primary hypogonadism (congenital or acquired); hypogonadotropic hypogonadism (congenital or acquired).

androgen
AXIRON (SOLUTION, METERED) TESTOSTERONE [Has competitive generic]
Drug Classes: androgen
NDA Applicant: ELI LILLY AND CO      NDA No.:
022504  Prod. No.: 001 DISC (30MG/1.5ML ACTUATION)
PatentsExpirationPatented Use
Pat. No. 8419307 Spreading implement
Claim Types: Method of use
Feb 26, 2027U-1386: A method of increasing the testosterone blood level of a person in need thereof
Pat. No. 8435944 Method and composition for transdermal drug delivery
Claim Types: Method of use
Sep 27, 2027U-1390: A method of increasing the testosterone blood level of an adult male subject in need thereof
Pat. No. 8784878 DP* Transdermal delivery rate control using amorphous pharmaceutical compositions
Claim Types: Formulation
Jul 13, 2023U-1545: A method of transdermally delivering testosterone
Pat. No. 8807861 DP* Spreading implement
Claim Types: Device; Drug in a container; Method of use
Feb 26, 2027U-1563: A method of transdermal administration of a physiologically active agent to a subject.
Pat. No. 8993520 Method and composition for transdermal drug delivery
Claim Types: Method of use
Jun 2, 2026U-1390: A method of increasing the testosterone blood level of an adult male subject in need thereof
Pat. No. 9180194 Method and composition for transdermal drug delivery
Claim Types: Method of use
Jun 2, 2026U-1390: A method of increasing the testosterone blood level of an adult male subject in need thereof
Pat. No. 9289586 Spreading implement
Claim Types: Method of administration
Feb 26, 2027U-1390: A method of increasing the testosterone blood level of an adult male subject in need thereof

androgen
FORTESTA (GEL, METERED) TESTOSTERONE [GENERIC AB]
Drug Classes: androgen
NDA Applicant: ENDO PHARMS      NDA No.:
021463  Prod. No.: 001 RX (10MG/0.5GM ACTUATION)
PatentsExpirationPatented Use
Pat. No. 6319913 Penetration enhancing and irritation reducing systems
Claim Types: Method of administration; Method of use
Nov 9, 2018U-490: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
Pat. No. 6579865 DP* Penetration enhancing and irritation reducing systems
Claim Types: Formulation
Nov 9, 2018 

androgen
NATESTO (GEL, METERED) TESTOSTERONE
Drug Classes: androgen
NDA Applicant: AYTU BIOSCIENCE INC      NDA No.:
205488  Prod. No.: 001 RX (5.5MG/0.122GM ACTUATION)
PatentsExpirationPatented Use
Pat. No. 8574622 DP* Controlled release delivery system for nasal applications
Claim Types: Formulation
Feb 4, 2024 
Pat. No. 8784869 DP* Controlled release delivery system for nasal applications and methods of treatment
Claim Types: Formulation; Method of use
Feb 4, 2024 
Pat. No. 8784882 DP* Controlled release delivery system for nasal applications and method of treatment
Claim Types: Method of use
Feb 4, 2024U-1557: A method of testosterone replacement therapy comprising the step of nasally administering to a patient in need of such treatment an effective amount of testosterone gel formulation.
Pat. No. 8877230 Controlled release delivery system for nasal applications
Claim Types: Method of use
Feb 4, 2024U-1616: Nasal administration of a testosterone gel to a patient to treat the patient for a condition associated with a deficiency or absence of endogenous testosterone

androgen
STRIANT (TABLET, EXTENDED RELEASE) TESTOSTERONE
Drug Classes: androgen
NDA Applicant: AUXILIUM PHARMS LLC      NDA No.:
021543  Prod. No.: 001 RX (30MG)
PatentsExpirationPatented Use
Pat. No. 6248358 Bioadhesive progressive hydration tablets and methods of making and using the same
Claim Types: Formulation; Method of administration; Method of use; Process
Aug 23, 2019U-527: Method of delivering an active ingredient using a progressive hydration bioadhesive

androgen
TESTIM (GEL) TESTOSTERONE [GENERIC AB2]
Drug Classes: androgen
NDA Applicant: AUXILIUM PHARMS LLC      NDA No.:
021454  Prod. No.: 001 RX (50MG/5GM PACKET)
PatentsExpirationPatented Use
Pat. No. 7320968 Pharmaceutical composition
Claim Types: Method of use
Jan 18, 2025U-843: Method for administration of testosterone
Pat. No. 7608605 Pharmaceutical composition
Claim Types: Method of administration
Apr 21, 2023U-1009: Method for administration of testosterone
Pat. No. 7608606 Pharmaceutical composition
Claim Types: Method of adminstration
Apr 21, 2023U-1009: Method for administration of testosterone
Pat. No. 7608607 Pharmaceutical composition
Claim Types: Method of administration
Apr 21, 2023U-1009: Method for administration of testosterone
Pat. No. 7608608 Pharmaceutical composition
Claim Types: Method of administration
Apr 21, 2023U-1009: Method for administration of testosterone
Pat. No. 7608609 Pharmaceutical composition
Claim Types: Method of administration
Apr 21, 2023U-1009: Method for administration of testosterone
Pat. No. 7608610 Pharmaceutical composition
Claim Types: Method of administration
Apr 21, 2023U-1009: Method for administration of testosterone
Pat. No. 7935690 Pharmaceutical composition
Claim Types: Method of use
Apr 21, 2023U-1009: Method for administration of testosterone
Pat. No. 8063029 Pharmaceutical composition
Claim Types: Method of use
Apr 21, 2023U-843: Method for administration of testosterone
Pat. No. 8178518 DP* Pharmaceutical composition
Claim Types: Formulation
Apr 21, 2023 

androgen
TESTODERM TTS (FILM, EXTENDED RELEASE) TESTOSTERONE
Drug Classes: androgen
NDA Applicant: ALZA      NDA No.:
020791  Prod. No.: 001 DISC (5MG/24HR)
PatentsExpirationPatented Use
Pat. No. 6348210 Methods for transdermal drug administration
Claim Types: Method of administration
Nov 10, 2019U-440: Method for transdermal administration of a drug through non-scrotal skin using a transdermal drug delivery device containing the drug and having an adhesive surface

androgen
VOGELXO (GEL; GEL, METERED) TESTOSTERONE [GENERIC AB2]
Drug Classes: androgen
NDA Applicant: UPSHER-SMITH LABS      NDA No.:
204399  Prod. No.: 002 RX (50MG/5GM PACKET); 003 RX (12.5MG/1.25GM ACTUATION)
PatentsExpirationPatented Use
Pat. No. 8785426 DP* Testosterone gel compositions and related methods
Claim Types: Formulation; Method of use; Drug in a container; Device
Feb 11, 2034U-1531: Method for transdermal delivery of testosterone
Pat. No. 9295675 DP* Testosterone gel compositions and related methods
Claim Types: Formulation; Drug in a container; Method of administration
Feb 11, 2034U-1531: Method for transdermal delivery of testosterone
Pat. No. 9662340 DP* Testosterone gel compositions and related methods
Claim Types: Method of use; Formulation; Method of administration
Feb 11, 2034U-1531: Method for transdermal delivery of testosterone

androgen receptor inhibitor
XTANDI (CAPSULE) ENZALUTAMIDE
Drug Classes: androgen receptor inhibitor
NDA Applicant: ASTELLAS      NDA No.:
203415  Prod. No.: 001 RX (40MG)
PatentsExpirationPatented Use
Pat. No. 7709517 DS* DP* Diarylhydantoin compounds
Claim Types: Compound; Composition
Aug 13, 2027 
Pat. No. 8183274 Treatment of hyperproliferative disorders with diarylhydantoin compounds
Claim Types: Method of use
Aug 24, 2026U-1281: The treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel
U-1588: The treatment of patients with metastatic castration-resistant prostate cancer (CRPC).
Pat. No. 9126941 Treatment of hyperproliferative disorders with diarylhydantoin compounds
Claim Types: Method of use
May 15, 2026U-1588: The treatment of patients with metastatic castration-resistant prostate cancer (CRPC).

angiotensin converting enzyme inhibitor
ALTACE (CAPSULE) RAMIPRIL [GENERIC AB]
Drug Classes: angiotensin converting enzyme inhibitor
NDA Applicant: KING PHARMS LLC      NDA No.:
019901  Prod. No.: 001 RX (1.25MG); 002 RX (2.5MG); 003 RX (5MG); 004 RX (10MG)
PatentsExpirationPatented Use
Pat. No. 7368469 Use of inhibitors of the renin-angiotensin system in the prevention of cardiovascular events
Claim Types: Method of use
Aug 30, 2020U-871: Method of reducing risk of myocardial infarction, stroke and death

angiotensin converting enzyme inhibitor
ALTACE (TABLET) RAMIPRIL
Drug Classes: angiotensin converting enzyme inhibitor
NDA Applicant: KING PFIZER      NDA No.:
022021  Prod. No.: 001 DISC (1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**); 002 DISC (2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**); 003 DISC (5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**); 004 DISC (10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**)
PatentsExpirationPatented Use
Pat. No. 7368469 Use of inhibitors of the renin-angiotensin system in the prevention of cardiovascular events
Claim Types: Method of use
Aug 30, 2020U-871: Method of reducing risk of myocardial infarction, stroke and death

angiotensin converting enzyme inhibitor
CARDIOTEC (INJECTABLE) TECHNETIUM TC-99M TEBOROXIME KIT
Drug Classes: angiotensin converting enzyme inhibitor
NDA Applicant: BRACCO      NDA No.:
019928  Prod. No.: 001 DISC (N/A)
PatentsExpirationPatented Use
Pat. No. 6056941 DP* Kit for the preparation of technetium TC 99m teboroxime myocardial perfusion agent
Claim Types: Kit
Jul 28, 2019 

angiotensin converting enzyme inhibitor
EPANED KIT (FOR SOLUTION) ENALAPRIL MALEATE
Drug Classes: angiotensin converting enzyme inhibitor
NDA Applicant: SILVERGATE PHARMS      NDA No.:
204308  Prod. No.: 001 RX (1MG/ML)
PatentsExpirationPatented Use
Pat. No. 8568747 DP* Enalapril compositions
Claim Types: Formulation
Nov 6, 2032 
Pat. No. 8778366 Enalapril compositions
Claim Types: Method of use
Nov 6, 2032U-1723: Treatment of heart failure
U-185: Method of treating hypertension
U-1892: Method of treating left ventricular dysfunction
U-3: Treatment of hypertension
U-71: Method of treatment of heart failure
Pat. No. 9855214 DP* Enalapril compositions
Claim Types: Formulation
Nov 6, 2032 
Pat. No. 9968553 Enalapril compositions
Claim Types: Method of use
Nov 6, 2032U-1723: Treatment of heart failure
U-185: Method of treating hypertension
U-1892: Method of treating left ventricular dysfunction
U-3: Treatment of hypertension
U-71: Method of treatment of heart failure

angiotensin converting enzyme inhibitor
EPANED (SOLUTION) ENALAPRIL MALEATE
Drug Classes: angiotensin converting enzyme inhibitor
NDA Applicant: SILVERGATE PHARMS      NDA No.:
208686  Prod. No.: 001 RX (1MG/ML)
PatentsExpirationPatented Use
Pat. No. 9669008 DP* Enalapril formulations
Claim Types: Formulation
Mar 25, 2036 
Pat. No. 9808442 Enalapril formulations
Claim Types: Method of use
Mar 25, 2036U-1723: Treatment of heart failure
U-185: Method of treating hypertension
U-1892: Method of treating left ventricular dysfunction
U-3: Treatment of hypertension
U-71: Method of treatment of heart failure

angiotensin converting enzyme inhibitor
GIAPREZA (SOLUTION) ANGIOTENSIN II ACETATE
Drug Classes: 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)); 002 RX (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
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityDec 21, 2022 

angiotensin converting enzyme inhibitor
PRESTALIA (TABLET) AMLODIPINE BESYLATE; PERINDOPRIL ARGININE
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 

angiotensin converting enzyme inhibitor
QBRELIS (SOLUTION) LISINOPRIL
Drug Classes: angiotensin converting enzyme inhibitor
NDA Applicant: SILVERGATE PHARMS      NDA No.:
208401  Prod. No.: 001 RX (1MG/ML)
PatentsExpirationPatented Use
Pat. No. 9463183 DP* Lisinopril formulations
Claim Types: Formulation
Nov 6, 2035 
Pat. No. 9616096 Lisinopril formulations
Claim Types: Method of use
Nov 6, 2035U-1723: Treatment of heart failure
U-185: Method of treating hypertension
U-1864: Treatment of myocardial infarction
U-1991: Reduction of mortality in acute mycardial infarction
U-3: Treatment of hypertension
U-71: Method of treatment of heart failure
U-8: Acute myocardial infarction
Pat. No. 9814751 DP* Lisinopril formulations
Claim Types: Formulation
Nov 6, 2035 

angiotensin II receptor blocker
BYVALSON (TABLET) NEBIVOLOL HYDROCHLORIDE; VALSARTAN
Drug Classes: beta adrenergic blocker; angiotensin II receptor blocker
NDA Applicant: ALLERGAN SALES LLC      NDA No.:
206302  Prod. No.: 001 RX (EQ 5MG BASE;80MG)
PatentsExpirationPatented Use
Pat. No. 7803838 DP* Compositions comprising nebivolol
Claim Types: Formulation
Aug 29, 2026 
Pat. No. 7838552 Compositions comprising nebivolol
Claim Types: Method of use
Oct 4, 2027U-185: Method of treating hypertension
ExclusivityExpirationExclusivity Description
Exclusivity Code: NC - New combinationJun 3, 2019 

angiotensin II receptor blocker
EDARBI (TABLET) AZILSARTAN KAMEDOXOMIL
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: Process; Composition; Method of use; Formulation
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 

angiotensin II receptor blocker
EDARBYCLOR (TABLET) AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE
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: Process; Composition; Method of use; Formulation
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 

angiotensin II receptor blocker
ENTRESTO (TABLET) SACUBITRIL; VALSARTAN
Drug Classes: neprilysin inhibitor; angiotensin II receptor blocker
NDA Applicant: NOVARTIS PHARMS CORP      NDA No.:
207620  Prod. No.: 001 RX (24MG;26MG); 002 RX (49MG;51MG); 003 RX (97MG;103MG)
PatentsExpirationPatented Use
Pat. No. 7468390 DP* Methods of treatment and pharmaceutical composition
Claim Types: Formulation; Kit
Nov 27, 2023 
Pat. No. 8101659 DP* Methods of treatment and pharmaceutical composition
Claim Types: Formulation
Jan 14, 2023 
Pat. No. 8404744 DP* Methods of treatment and pharmaceutical composition
Claim Types: Formulation
Jan 14, 2023 
Pat. No. 8796331 Methods of treatment and pharmaceutical composition
Claim Types: Method of use
Jan 14, 2023U-1723: Treatment of heart failure
Pat. No. 8877938 DS* DP* Compounds containing S-N-valeryl-N-{[2'-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl}-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations
Claim Types: Compound; Composition; Formulation
May 27, 2027 
Pat. No. 9388134 Compounds containing S-N-valeryl-N-{[2'-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl)-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations
Claim Types: Method of use
Nov 8, 2026U-1723: Treatment of heart failure
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJul 7, 2020 

angiotensin II receptor blocker
EXFORGE HCT (TABLET) AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN [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 

angiotensin II receptor blocker
EXFORGE (TABLET) AMLODIPINE BESYLATE; VALSARTAN [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 

angiotensin II receptor blocker
GIAPREZA (SOLUTION) ANGIOTENSIN II ACETATE
Drug Classes: 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)); 002 RX (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
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityDec 21, 2022 

angiotensin II receptor blocker
MICARDIS HCT (TABLET) HYDROCHLOROTHIAZIDE; TELMISARTAN [GENERIC AB]
Drug Classes: thiazide diuretic; angiotensin II receptor blocker
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.:
021162  Prod. No.: 001 RX (12.5MG;40MG); 002 RX (12.5MG;80MG)
PatentsExpirationPatented Use
Pat. No. 6358986 Polymorphs of telmisartan
Claim Types: Formulation
Jan 10, 2020 

angiotensin II receptor blocker
MICARDIS (TABLET) TELMISARTAN [GENERIC AB]
Drug Classes: angiotensin II receptor blocker
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.:
020850  Prod. No.: 001 RX (40MG); 003 RX (20MG)
PatentsExpirationPatented Use
Pat. No. 6358986 Polymorphs of telmisartan
Claim Types: Formulation
Jan 10, 2020 

angiotensin II receptor blocker
MICARDIS (TABLET) TELMISARTAN [GENERIC AB]
Drug Classes: angiotensin II receptor blocker
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.:
020850  Prod. No.: 002 RX (80MG)
PatentsExpirationPatented Use
Pat. No. 6358986 Polymorphs of telmisartan
Claim Types: Formulation
Jan 10, 2020 
Pat. No. 7998953 Use of inhibitors of the renin-angiotensin system
Claim Types: Method of use
Jun 6, 2020U-1177: Reduction of cardiac tissue damage associated with myocardial infarction U-1178 Relief of moderate to severe chronic pain
Pat. No. 8003679 Use of inhibitors of the renin-angiotensin system
Claim Types: Method of use
Oct 6, 2022U-1176: Treatment or prevention of stroke

angiotensin II receptor blocker
VALTURNA (TABLET) ALISKIREN HEMIFUMARATE; VALSARTAN
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 

anthelmintic
VERMOX (TABLET, CHEWABLE) MEBENDAZOLE
Drug Classes: anthelmintic
NDA Applicant: JANSSEN PHARMS      NDA No.:
208398  Prod. No.: 001 DISC (500MG)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NS - New strengthOct 19, 2019 


DS*=Drug Substance; DP*=Drug Product - patent submitted for the product after Aug. 18, 2003.
* Extension limited by the 14-year cap of 35 USC 156(c)(3)
Last edited: 25 July 2018
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