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.


acetylcholinesterase inhibitor
ADLARITY (SYSTEM) (TRANSDERMAL) DONEPEZIL HYDROCHLORIDE
Drug Classes: acetylcholinesterase inhibitor
NDA Applicant: CORIUM      NDA No.:
212304  Prod. No.: 001 RX (5MG/DAY); 002 RX (10MG/DAY)
PatentsExpirationPatented Use
Pat. No. 9993466 DP* Donepezil transdermal delivery system
Claim Types: Device
Pat. Sub. Date(s): All strengths: Apr 6, 2022
Jul 26, 2037 
Pat. No. 10016372 Transdermal delivery systems with pharmacokinetics bioequivalent to oral delivery
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Apr 6, 2022
Jul 26, 2037U-3334: A method of transdermal delivery of donepezil for treating mild, moderate and severe dementia of the Alzheimer's type
Pat. No. 10300025 DP* Donepezil transdermal delivery system
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Apr 6, 2022
Jul 26, 2037 
Pat. No. 10307379 DP* Donepezil transdermal delivery system
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Apr 6, 2022
Jul 26, 2037 
Pat. No. 10835499 DP* Systems and methods for long term transdermal administration
Claim Types: Device; Method of administration
Pat. Sub. Date(s): All strengths: Apr 6, 2022
May 20, 2038U-3334: A method of transdermal delivery of donepezil for treating mild, moderate and severe dementia of the Alzheimer's type
Pat. No. 10966936 DP* Systems comprising a composite backing and methods for long term transdermal administration
Claim Types: Device; Method of administration
Pat. Sub. Date(s): All strengths: Apr 6, 2022
Aug 11, 2038U-3334: A method of transdermal delivery of donepezil for treating mild, moderate and severe dementia of the Alzheimer's type
Pat. No. 11103463 Methods for treating Alzheimer's disease with donepezil transdermal system
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 6, 2022
Jul 26, 2037U-3334: A method of transdermal delivery of donepezil for treating mild, moderate and severe dementia of the Alzheimer's type
Pat. No. 11648214 DP* Systems and methods for long term transdermal administration
Claim Types: Device; Method of administration
Pat. Sub. Date(s): All strengths: Jun 2, 2023
Sep 23, 2037U-3334: A method of transdermal delivery of donepezil for treating mild, moderate and severe dementia of the Alzheimer's type
Pat. No. 11679086 Systems comprising a composite backing and methods for long term transdermal administration
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 3, 2023
May 26, 2037U-3334: A method of transdermal delivery of donepezil for treating mild, moderate and severe dementia of the Alzheimer's type
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productMar 11, 2025 

acetylcholinesterase inhibitor
ARICEPT (TABLET) (ORAL) DONEPEZIL HYDROCHLORIDE [GENERIC AB]
Drug Classes: acetylcholinesterase inhibitor
NDA Applicant: EISAI INC      NDA No.:
022568  Prod. No.: 001 RX (23MG)
PatentsExpirationPatented Use
Pat. No. 8481565 DP* Method for stabilizing anti-dementia drug
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 9, 2013
Oct 4, 2026 

acetylcholinesterase inhibitor
NAMZARIC (CAPSULE, EXTENDED RELEASE) (ORAL) DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: acetylcholinesterase inhibitor == N-methyl-D-aspartate (NMDA) receptor antagonist
NDA Applicant: ABBVIE      NDA No.:
206439  Prod. No.: 001 RX (10MG;14MG); 002 RX (10MG;28MG); 003 RX (10MG;7MG); 004 RX (10MG;21MG)
PatentsExpirationPatented Use
Pat. No. 8039009 Modified release formulations of memantine oral dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): 001: None; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016
Sep 24, 2029 *PEDU-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type
Pat. No. 8058291 Methods and compositions for the treatment of CNS-related conditions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 22, 2015; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016
Dec 5, 2029U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type
Pat. No. 8168209 DP* Method and composition for administering an NMDA receptor antagonist to a subject
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 22, 2015; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016
May 22, 2026 *PED 
Pat. No. 8173708 Method and composition for administering an NMDA receptor antagonist to a subject
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jan 22, 2015; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016
May 22, 2026 *PEDU-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type
Pat. No. 8283379 Methods and compositions for the treatment of CNS-related conditions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 22, 2015; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016
May 22, 2026 *PEDU-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type
Pat. No. 8293794 DP* Methods and compositions for the treatment of CNS-related conditions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 22, 2015; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016
Nov 22, 2025 
Pat. No. 8329752 DP* Composition for administering an NMDA receptor antagonist to a subject
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 16, 2016; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016
May 22, 2026 *PED 
Pat. No. 8338485 DP* Compositions for the treatment of CNS-related conditions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 16, 2016; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016
Nov 22, 2025 
Pat. No. 8338486 Methods for the treatment of CNS-related conditions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 16, 2016; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016
Nov 22, 2025U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type
Pat. No. 8362085 Method for administering an NMDA receptor antagonist to a subject
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 16, 2016; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016
May 22, 2026 *PEDU-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type
Pat. No. 8580858 Compositions for the treatment of CNS-related conditions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 16, 2016; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016
Nov 22, 2025U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type
Pat. No. 8598233 DP* Method for administering an NMDA receptor antagonist to a subject
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 16, 2016; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016
May 22, 2026 *PED 

adenosine receptor agonist
LEXISCAN (SOLUTION) (INTRAVENOUS) REGADENOSON [GENERIC AP]
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. RE47301 DP* Process for preparing an A2A-adenosine receptor agonist and its polymorphs
Claim Types: Product-by-process; Formulation; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Apr 2, 2019
Feb 2, 2027 
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
Pat. Sub. Date(s): 001: Mar 8, 2012
Feb 2, 2027 

adrenergic agonist
ADZENYS ER (SUSPENSION, EXTENDED RELEASE) (ORAL) AMPHETAMINE
Drug Classes: adrenergic agonist == amphetamine anorectic == central nervous system (CNS) stimulant == central nervous system stimulant
NDA Applicant: NEOS THERAPS INC      NDA No.:
204325  Prod. No.: 001 DISC (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
Pat. Sub. Date(s): 001: Sep 21, 2017
Jun 28, 2032 
Pat. No. 9017731 DP* Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 21, 2017
Jun 28, 2032 
Pat. No. 9265737 DP* Pharmaceutical composition comprising amphetamines complexed with ion-exchange resin particles
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 21, 2017
Jun 28, 2032 

adrenergic agonist
ADZENYS XR-ODT (TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE) (ORAL) AMPHETAMINE
Drug Classes: adrenergic agonist == amphetamine anorectic == central nervous system (CNS) stimulant == central nervous system stimulant
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
Pat. Sub. Date(s): 001: Feb 26, 2016; 002: None; 003: None; 004: None; 005: None; 006: None
Jun 28, 2032 
Pat. No. 8840924 DP* Compositions and methods of making rapidly dissolving ionically masked formulations
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 26, 2016
Apr 9, 2026 
Pat. No. 9017731 DP* Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 26, 2016; 002: None; 003: None; 004: None; 005: None; 006: None
Jun 28, 2032 
Pat. No. 9265737 DP* Pharmaceutical composition comprising amphetamines complexed with ion-exchange resin particles
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 26, 2016; 002: None; 003: None; 004: None; 005: None; 006: None
Jun 28, 2032 

adrenergic agonist
DYANAVEL XR (SUSPENSION, EXTENDED RELEASE) (ORAL) AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE
Drug Classes: adrenergic agonist == amphetamine anorectic == central nervous system (CNS) stimulant == central nervous system stimulant
NDA Applicant: TRIS PHARMA INC      NDA No.:
208147  Prod. No.: 001 RX (2MG/ML;EQ 0.5MG BASE/ML)
PatentsExpirationPatented Use
Pat. No. 8062667 DP* Modified release formulations containing drug-ion exchange resin complexes
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 27, 2015
Mar 29, 2029 
Pat. No. 8597684 DP* Modified release formulations containing drug-ion exchange resin complexes
Claim Types: Formulation; Product-by-process
Pat. Sub. Date(s): 001: Oct 27, 2015
Mar 15, 2027 
Pat. No. 8747902 DP* Modified release formulations containing drug-ion exchange resin complexes
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 27, 2015
Mar 15, 2027 
Pat. No. 8883217 DP* Modified release formulations containing drug-ion exchange resin complexes
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 27, 2015
Mar 15, 2027 
Pat. No. 9675703 DP* Modified release formulations containing drug - ion exchange resin complexes
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 28, 2017
Mar 15, 2027 
Pat. No. 10086087 DP* Modified release formulations containing drug-ion exchange resin complexes
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 3, 2018
Mar 15, 2027 
Pat. No. 11590228 DP* Extended Release amphetamine Compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 8, 2023
Sep 7, 2036U-3538: Method of treating attention deficit hyperactivity disorder

adrenergic agonist
DYANAVEL XR 5; DYANAVEL XR 10; DYANAVEL XR 15; DYANAVEL XR 20 (TABLET, EXTENDED RELEASE) (ORAL) AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE
Drug Classes: adrenergic agonist == amphetamine anorectic == central nervous system (CNS) stimulant == central nervous system stimulant
NDA Applicant: TRIS PHARMA INC      NDA No.:
210526  Prod. No.: 001 RX (4MG;EQ 1MG BASE); 002 RX (8MG;EQ 2MG BASE); 003 RX (12MG;EQ 3MG BASE); 004 RX (16MG;EQ 4MG BASE)
PatentsExpirationPatented Use
Pat. No. 8337890 DP* Modified release formulations containing drug-ion exchange resin complexes
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 22, 2021
Mar 15, 2027 
Pat. No. 8747902 DP* Modified release formulations containing drug-ion exchange resin complexes
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 22, 2021
Mar 15, 2027 
Pat. No. 9675704 DP* Modified release formulations containing drug-ion exchange resin complexes
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 22, 2021
Mar 15, 2027 
Pat. No. 11590081 DP* Extended Release amphetamine Tablets
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): All strengths: Mar 8, 2023
Sep 24, 2038U-3538: Method of treating attention deficit hyperactivity disorder

adrenergic agonist
EVEKEO ODT (TABLET, ORALLY DISINTEGRATING) (ORAL) AMPHETAMINE SULFATE
Drug Classes: adrenergic agonist == amphetamine anorectic == central nervous system (CNS) stimulant == central nervous system stimulant
NDA Applicant: AZURITY      NDA No.:
209905  Prod. No.: 001 RX (5MG); 002 RX (10MG); 003 RX (15MG); 004 RX (20MG) NDA No.: 209905  Prod. No.: 005 DISC (2.5MG**)
PatentsExpirationPatented Use
Pat. No. 10130580 DP* Taste-masked pharmaceutical compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 31, 2019; 002: Jan 31, 2019; 003: Jan 31, 2019; 004: Jan 31, 2019; 005: Jul 7, 2021
Apr 19, 2024 
Pat. No. 10441554 DP* Oral amphetamine composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 15, 2019; 002: Oct 15, 2019; 003: Oct 15, 2019; 004: Oct 15, 2019; 005: Jul 7, 2021
Mar 10, 2037 
Pat. No. 11160772 DP* Oral amphetamine composition
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Dec 9, 2021
Mar 10, 2037 

adrenergic agonist
MYDAYIS (CAPSULE, EXTENDED RELEASE) (ORAL) AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE [GENERIC AB2]
Drug Classes: adrenergic agonist == amphetamine anorectic == central nervous system (CNS) stimulant == central nervous system stimulant
NDA Applicant: TAKEDA PHARMS USA      NDA No.:
022063  Prod. No.: 001 RX (3.125MG;3.125MG;3.125MG;3.125MG); 002 RX (6.25MG;6.25MG;6.25MG;6.25MG); 003 RX (9.375MG;9.375MG;9.375MG;9.375MG); 004 RX (12.5MG;12.5MG;12.5MG;12.5MG)
PatentsExpirationPatented Use
Pat. No. 8846100 DP* Controlled dose drug delivery system
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 7, 2017
Aug 24, 2029 
Pat. No. 9173857 Controlled dose drug delivery system
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 7, 2017
May 12, 2026U-2025: Treatment of attention deficit hyperactivity disorder

adrenocorticotropic hormone
ACTHAR GEL (INJECTABLE) (INJECTION) CORTICOTROPIN
Drug Classes: adrenocorticotropic hormone
NDA Applicant: MALLINCKRODT ARD      NDA No.:
008372  Prod. No.: 008 RX (80 UNITS/ML)
PatentsExpirationPatented Use
Pat. No. 11752199 Methods of modulating pericytes
Claim Types: Method of use
Pat. Sub. Date(s): 008: Sep 21, 2023
Feb 25, 2041U-3686: Treatment of exacerbations of multiple sclerosis in adults with corticotropin by promoting new vessel formation wherein VCAM-1 expression and angiopoetin-2 expression is increased after the administering
U-3687: Treatment of infantile spasms with corticotropin by promoting new vessel formation wherein VCAM-1 expression and angiopoetin-2 expression is increased after the administering
U-3688: Treatment of ophthalmic diseases with corticotropin by promoting new vessel formation wherein VCAM-1 expression and angiopoetin-2 expression is increased after the administering

aldosterone antagonist
CAROSPIR (SUSPENSION) (ORAL) SPIRONOLACTONE [GENERIC AB]
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
Pat. Sub. Date(s): 001: Sep 21, 2017
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
Pat. No. 10493083 DP* Spironolactone aqueous compositions
Claim Types: Formulation; Drug in a container
Pat. Sub. Date(s): 001: Jan 2, 2020
Oct 28, 2036 
Pat. No. 10624906 DP* Spironolactone aqueous compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 27, 2020
Oct 28, 2036 
Pat. No. 10660907 DP* Spironolactone aqueous compositions
Claim Types: Formulation; Drug in a container
Pat. Sub. Date(s): 001: Jun 15, 2020
Oct 28, 2036 
Pat. No. 10888570 DP* Spironolactone aqueous compositions
Claim Types: Formulation; Drug in a container
Pat. Sub. Date(s): 001: Jan 15, 2021
Oct 28, 2036 
Pat. No. 11389461 DP* Spironolactone aqueous compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 22, 2022
Oct 28, 2036 
Pat. No. 11395828 Spironolactone aqueous compositions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 2, 2022
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
U-3401: CAROSPIR is indicated as an add-on therapy for the treatment of hypertension, to lower blood pressure in adult patients who are not adequately controlled on other agents
U-3402: CAROSPIR is indicated for the management of edema in adult cirrhotic patients when edema is not responsive to fluid and sodium restriction
Pat. No. 11491166 DP* Spironolactone aqueous compositions
Claim Types: Formulation; Drug in a container
Pat. Sub. Date(s): 001: Nov 18, 2022
Oct 28, 2036 

alkaloid
COLCHICINE (CAPSULE) (ORAL) COLCHICINE [GENERIC AB]
Drug Classes: alkaloid
NDA Applicant: PAR PHARM INC      NDA No.:
208678  Prod. No.: 001 RX (0.6MG)
ExclusivityExpirationExclusivity Description
Exclusivity Code: PC - Patent challengeApr 29, 2024 

alkaloid
COLCRYS (TABLET) (ORAL) COLCHICINE [GENERIC AB]
Drug Classes: alkaloid
NDA Applicant: TAKEDA PHARMS USA      NDA No.:
022352  Prod. No.: 001 RX (0.6MG)
PatentsExpirationPatented Use
Pat. No. 7601758 Methods for concomitant administration of colchicine and macrolide antibiotics in the treatment of gout flares
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Feb 10, 2029U-1007: Method of treating gout flares
Pat. No. 7619004 Methods for concomitant administration of colchicine and macrolide antibiotics
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
Dec 3, 2028U-1020: Method of using colchicine for the prophylaxis of gout flares
Pat. No. 7820681 Methods for concomitant administration of colchicine and a second active agent
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Feb 17, 2029U-1020: Method of using colchicine for the prophylaxis of gout flares
Pat. No. 7906519 Methods for concomitant administration of colchicine and a second active agent
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Feb 17, 2029U-1116: Method of administering colchicine to familial mediterranean fever patients
Pat. No. 7915269 Methods for concomitant administration of colchicine and a second active agent
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
Feb 17, 2029U-1007: Method of treating gout flares
Pat. No. 7935731 Methods for concomitant administration of colchicine and macrolide antibiotics
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jun 24, 2011
Dec 3, 2028U-1116: Method of administering colchicine to familial mediterranean fever patients
Pat. No. 7964647 Colchicine compositions and methods
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jun 24, 2011
Oct 6, 2028U-1007: Method of treating gout flares
Pat. No. 7964648 Methods for concomitant administration of colchicine and a second active agent
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jun 24, 2011
Oct 6, 2028U-1161: For the treatment and prophylaxis of gout flares & the treatment of familial Mediterranean fever
Pat. No. 7981938 Colchicine compositions and methods
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jul 22, 2011
Oct 6, 2028U-1166: A method for treatment of gout flares during prophylaxis
Pat. No. 8093296 Methods for concomitant administration of colchicine and macrolide antibiotics
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jan 13, 2012
Oct 6, 2028U-1007: Method of treating gout flares
Pat. No. 8093297 Methods for concomitant administration of colchicine and a second active agent
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jan 13, 2012
Oct 6, 2028U-1161: For the treatment and prophylaxis of gout flares & the treatment of familial Mediterranean fever
Pat. No. 8093298 Methods for concomitant administration of colchicine and macrolide antibiotics
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jan 13, 2012
Oct 6, 2028U-1116: Method of administering colchicine to familial mediterranean fever patients
Pat. No. 8097655 Methods for concomitant administration of colchicine and macrolide antibiotics
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jan 27, 2012
Oct 6, 2028U-1020: Method of using colchicine for the prophylaxis of gout flares
Pat. No. 8415395 Colchicine compositions and methods
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 8, 2013
Oct 6, 2028U-1007: Method of treating gout flares
Pat. No. 8415396 Colchine compositions and methods
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 8, 2013
Oct 6, 2028U-1007: Method of treating gout flares
Pat. No. 8440721 Methods for concomitant administration of colchicine and a second active agent
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jun 10, 2013
Feb 17, 2029U-1007: Method of treating gout flares
Pat. No. 8440722 Methods for concomitant administration of colchicine and a second active agent
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jun 10, 2013
Feb 17, 2029U-1020: Method of using colchicine for the prophylaxis of gout flares

alkaloid
GLOPERBA (SOLUTION) (ORAL) COLCHICINE
Drug Classes: alkaloid
NDA Applicant: SCILEX PHARMS      NDA No.:
210942  Prod. No.: 001 RX (0.6MG/5ML)
PatentsExpirationPatented Use
Pat. No. 9907751 DP* Composition and method of use of colchicine oral liquid
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 26, 2019
Nov 22, 2036 
Pat. No. 10226423 DP* Colchicine drug-to-drug interactions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 27, 2019
Dec 20, 2037 
Pat. No. 10383820 DP* Colchicine drug-to-drug interactions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 28, 2019
Nov 22, 2036U-2814: A method of prophylactic treatment of gout flares in adults comprises administering to a patient a liquid colchicine oral solution
Pat. No. 10383821 DP* Colchicine drug-to-drug interactions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 28, 2019
Nov 22, 2036 

alkaloid
LODOCO (TABLET) (ORAL) COLCHICINE
Drug Classes: alkaloid
NDA Applicant: AGEPHA PHARMA FZ      NDA No.:
215727  Prod. No.: 001 RX (0.5MG)
PatentsExpirationPatented Use
Pat. No. 9744144 Method of treating cardiovascular events using colchicine concurrently with an antiplatelet agent
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 29, 2023
Jan 22, 2035U-3643: Method of treating and/or reducing the risk of a cardiovascular event
Pat. No. 10130585 Methods of treating and/or preventing cardiovascular disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 29, 2023
Dec 31, 2034U-3642: A method of treating cardiovascular disease
Pat. No. 10206891 Method of treating cardiovascular events using colchicine concurrently with an antiplatelet agent
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 29, 2023
Jan 22, 2035U-3641: A method of treating and/or reducing the risk of a cardiovascular event; acute coronary syndrome, out-of-hospital cardiac arrest, and/or noncardioembolic ischemic stroke
Pat. No. 10265281 Treatment or prevention of cardiovascular events via the administration of a colchicine derivative
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 29, 2023
Jan 22, 2035U-3639: A method for treating and/or reducing the risk of a cardiovascular event
Pat. No. 10842762 Method of treating cardiovascular events using colchicine concurrently with an antiplatelet agent
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 29, 2023
Jan 22, 2035U-3640: A method of treating and/or reducing the risk of inflammation, atherosclerotic vascular disease, and cholesterol crystal induced inflammation within atherosclerotic plaques
Pat. No. 11026899 Treatment or prevention of cardiovascular events via the administration of a colchicine derivative
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 29, 2023
Jan 22, 2035U-3639: A method for treating and/or reducing the risk of a cardiovascular event
Pat. No. 11026900 Treatment or prevention of cardiovascular events via the administration of a colchicine derivative
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 29, 2023
Jan 22, 2035U-3639: A method for treating and/or reducing the risk of a cardiovascular event
Pat. No. 11026901 Treatment or prevention of cardiovascular events via the administration of a colchicine derivative
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 29, 2023
Jan 22, 2035U-3638: A method for treating and/or reducing the risk of acute myocardial infarction

alkaloid
MITIGARE (CAPSULE) (ORAL) COLCHICINE [GENERIC AB]
Drug Classes: alkaloid
NDA Applicant: HIKMA INTL PHARMS      NDA No.:
204820  Prod. No.: 001 RX (0.6MG)
PatentsExpirationPatented Use
Pat. No. 8927607 Methods of colchicine administration
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jan 20, 2015
Aug 22, 2033U-1020: Method of using colchicine for the prophylaxis of gout flares
Pat. No. 9399036 Methods of colchicine administration
Claim Types: Method of administration; Method of use
Pat. Sub. Date(s): 001: Aug 23, 2016
Aug 22, 2033U-1020: Method of using colchicine for the prophylaxis of gout flares
Pat. No. 9555029 Methods of colchicine administration
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Feb 14, 2017
Aug 22, 2033U-1020: Method of using colchicine for the prophylaxis of gout flares
Pat. No. 9675613 Methods of colchicine administration
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jun 20, 2017
Aug 22, 2033U-1020: Method of using colchicine for the prophylaxis of gout flares
Pat. No. 9789108 Methods of colchicine administration
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Nov 13, 2017
Aug 22, 2033U-1020: Method of using colchicine for the prophylaxis of gout flares

alkylating drug
BELRAPZO (SOLUTION) (INTRAVENOUS) BENDAMUSTINE HYDROCHLORIDE
Drug Classes: alkylating drug
NDA Applicant: EAGLE PHARMS      NDA No.:
205580  Prod. No.: 001 RX (100MG/4ML (25MG/ML))
PatentsExpirationPatented Use
Pat. No. 8609707 DP* Formulations of bendamustine
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 1, 2018
Aug 11, 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. 8791270 DP* Bendamustine pharmaceutical compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 1, 2018
Jan 12, 2026U-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. 9265831 DP* Formulations of bendamustine
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 1, 2018
Jan 28, 2031 
Pat. No. 9572796 DP* Formulations of bendamustine
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 1, 2018
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
Pat. Sub. Date(s): 001: Aug 1, 2018
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. 10010533 DP* Formulations of bendamustine
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 3, 2018
Jan 28, 2031 
Pat. No. 11103483 DP* Formulations of bendamustine
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 31, 2021
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. 11844783 Formulations of bendamustine
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 19, 2023
Jan 28, 2031U-1542: For use in the treatment of patients with chronic lymphocytic leukemia and/or non-hodgkins lymphoma
U-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. 11872214 DP* Formulations of Bendamustine
Claim Types: Drug in a container; Formulation
Pat. Sub. Date(s): 001: Jan 16, 2024
Jan 28, 2031 

alkylating drug
BENDEKA (SOLUTION) (IV (INFUSION)) 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
Pat. Sub. Date(s): 001: Dec 11, 2015
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
Pat. Sub. Date(s): 001: Jan 7, 2016
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
Pat. Sub. Date(s): 001: Dec 11, 2015
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
Pat. Sub. Date(s): 001: Dec 11, 2015
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
Pat. Sub. Date(s): 001: Dec 11, 2015
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
Pat. Sub. Date(s): 001: Mar 1, 2016
Jan 28, 2031 
Pat. No. 9572796 DP* Formulations of bendamustine
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Feb 21, 2017
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
Pat. Sub. Date(s): 001: Feb 21, 2017
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
Pat. Sub. Date(s): 001: Feb 21, 2017
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
Pat. Sub. Date(s): 001: Feb 28, 2017
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
Pat. Sub. Date(s): 001: Mar 21, 2017
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
Pat. Sub. Date(s): 001: Mar 21, 2017
Mar 15, 2033U-1971: For the treatment of patients with chronic lymphocytic leukemia
Pat. No. 9597399 Formulations of bendamustine
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 21, 2017
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. 10010533 DP* Formulations of bendamustine
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 3, 2018
Jan 28, 2031 
Pat. No. 10052385 Formulations of bendamustine
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 22, 2018
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. 11103483 DP* Formulations of bendamustine
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 31, 2021
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. 11844783 Formulations of bendamustine
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 19, 2023
Jan 28, 2031U-1542: For use in the treatment of patients with chronic lymphocytic leukemia and/or non-hodgkins lymphoma
U-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. 11872214 DP* Formulations of Bendamustine
Claim Types: Drug in a container; Formulation
Pat. Sub. Date(s): 001: Jan 16, 2024
Jan 28, 2031 

alkylating drug
CYCLOPHOSPHAMIDE (SOLUTION) (INTRAVENOUS) CYCLOPHOSPHAMIDE
Drug Classes: alkylating drug
NDA Applicant: EUGIA PHARMA SPECLTS      NDA No.:
210735  Prod. No.: 001 RX (500MG/2.5ML (200MG/ML)); 002 RX (1GM/5ML (200MG/ML)); 003 RX (2GM/10ML (200MG/ML))
PatentsExpirationPatented Use
Pat. No. 9662342 DP* Formulations of cyclophosphamide liquid concentrate
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 3, 2021; 002: Sep 3, 2021; 003: Nov 29, 2023
Jun 26, 2035 

alkylating drug
CYCLOPHOSPHAMIDE (SOLUTION) (INTRAVENOUS) CYCLOPHOSPHAMIDE
Drug Classes: alkylating drug
NDA Applicant: DR REDDYS      NDA No.:
210852  Prod. No.: 001 RX (500MG/ML (500MG/ML)); 002 RX (1GM/2ML (500MG/ML)); 003 RX (2GM/4ML (500MG/ML))
PatentsExpirationPatented Use
Pat. No. 10849916 DP* Stable liquid formulations of cyclophosphamide and its impurities
Claim Types: Compound; Formulation
Pat. Sub. Date(s): All strengths: Jun 27, 2023
Jul 13, 2035 
Pat. No. 11382923 DP* Stable liquid formulations of cyclophosphamide and processes to prepare the same
Claim Types: Composition
Pat. Sub. Date(s): All strengths: Jun 27, 2023
Dec 1, 2035 

alkylating drug
CYCLOPHOSPHAMIDE (SOLUTION) (INTRAVENOUS) CYCLOPHOSPHAMIDE
Drug Classes: alkylating drug
NDA Applicant: INGENUS PHARMS LLC      NDA No.:
212501  Prod. No.: 001 RX (500MG/2.5ML (200MG/ML)); 002 RX (1GM/5ML (200MG/ML)); 003 RX (2GM/10ML (200MG/ML))
PatentsExpirationPatented Use
Pat. No. 10993952 DP* Stable ready to use cyclophosphamide liquid formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: May 4, 2021; 002: May 4, 2021; 003: Mar 28, 2022
Feb 15, 2036 

alkylating drug
EVOMELA (POWDER) (INTRAVENOUS) MELPHALAN HYDROCHLORIDE
Drug Classes: alkylating drug
NDA Applicant: ACROTECH BIOPHARMA      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
Pat. Sub. Date(s): 001: Apr 5, 2016
Mar 13, 2029 
Pat. No. 9200088 DP* Sulfoalkyl ether cyclodextrin compositions
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Apr 5, 2016
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
Pat. Sub. Date(s): 001: Mar 14, 2017
Feb 27, 2033 
Pat. No. 10040872 DP* Alkylated cyclodextrin compositions and processes for preparing and using the same
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Sep 6, 2018
Jan 30, 2034 
Pat. No. 10864183 DP* Injectable nitrogen mustard compositions comprising a cyclodextrin derivative and methods of making and using the same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 15, 2020
May 28, 2030 
Pat. No. 10940128 DP* Injectable melphalan compositions comprising a cyclodextrin derivative and methods of making and using the same
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Mar 19, 2021
Jun 14, 2030U-3086: For high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma
Pat. No. 11020363 DP* Injectable nitrogen mustard compositions comprising a cyclodextrin derivative and methods of making and using the same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 10, 2021
May 28, 2030 

alkylating drug
HEPZATO (POWDER) (INTRA-ARTERIAL) MELPHALAN HYDROCHLORIDE
Drug Classes: alkylating drug
NDA Applicant: DELCATH SYSTEMS INC      NDA No.:
201848  Prod. No.: 001 RX (EQ 50MG BASE/VIAL)
PatentsExpirationPatented Use
Pat. No. 9314561 DP* Filter and frame apparatus and method of use
Claim Types: Device
Pat. Sub. Date(s): 001: Sep 6, 2023
Feb 7, 2034 
Pat. No. 9707331 DP* Apparatus for removing chemotherapy compounds from blood
Claim Types: Device
Pat. Sub. Date(s): 001: Sep 6, 2023
Sep 17, 2034 
Pat. No. 10098997 DP* Apparatus for removing chemotherapy compounds from blood
Claim Types: Device
Pat. Sub. Date(s): 001: Sep 6, 2023
Nov 7, 2032 
Pat. No. 10195334 DP* Filter and frame apparatus and method of use
Claim Types: Process
Pat. Sub. Date(s): 001: Sep 6, 2023
Jan 16, 2033 
Pat. No. 10369264 DP* Apparatus for removing chemotherapy compounds from blood
Claim Types: Kit; Device
Pat. Sub. Date(s): 001: Sep 6, 2023
Nov 7, 2032 
Pat. No. 10569004 Apparatus for removing chemotherapy compounds from blood
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 6, 2023
Nov 7, 2032U-3680: A method for treating a subject with uveal melanoma with unresectable hepatic metastases
U-3683: A method of treating a patient with uveal melanoma with unresectable hepatic metastases
Pat. No. 11083831 DP* Filter and frame apparatus and method of use
Claim Types: Device
Pat. Sub. Date(s): 001: Sep 6, 2023
Dec 30, 2032 
Pat. No. 11241522 DP* Apparatus for removing chemotherapy compounds from blood
Claim Types: Device
Pat. Sub. Date(s): 001: Sep 6, 2023
Nov 7, 2032 
Pat. No. 11633528 Apparatus for removing chemotherapy compounds from blood
Claim Types: Method of use; Device
Pat. Sub. Date(s): 001: Sep 6, 2023
Nov 7, 2032U-3675: A percutaneous hepatic perfusion procedure for treating a patient with uveal melanoma with unresectable hepatic metastases
Pat. No. 11833286 DP* Filter and frame apparatus and method of use
Claim Types: Kit
Pat. Sub. Date(s): 001: Dec 27, 2023
Dec 30, 2032 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productAug 14, 2026 
Exclusivity Code: ODE - Orphan drug exclusivityAug 14, 2030ODE-438: As a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation

alkylating drug
JELMYTO (POWDER) (PYELOCALYCEAL) MITOMYCIN
Drug Classes: alkylating drug
NDA Applicant: UROGEN PHARMA      NDA No.:
211728  Prod. No.: 001 RX (40MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 9040074 DP* Material and method for treating internal cavities
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): 001: Apr 29, 2020
Jan 20, 2031 
Pat. No. 9950069 DP* Material and method for treating internal cavities
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): 001: Apr 29, 2020
Jan 20, 2031 
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityApr 15, 2027ODE-289: Indicated for the treatment of adult patients with low-grade upper tract urothelial cancer (LG-UTUC)

alkylating drug
MELPHALAN HYDROCHLORIDE (SOLUTION) (INTRAVENOUS) MELPHALAN HYDROCHLORIDE
Drug Classes: alkylating drug
NDA Applicant: APOTEX      NDA No.:
217110  Prod. No.: 001 RX (EQ 90MG BASE/ML (EQ 90MG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 10537520 DP* Stable liquid formulations of melphalan
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 1, 2023
Jun 29, 2036 

alkylating drug
MITOSOL (FOR SOLUTION) (TOPICAL) 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
Pat. Sub. Date(s): 001: Mar 22, 2012
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
Pat. Sub. Date(s): 001: Jun 25, 2012
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
Pat. Sub. Date(s): 001: Jan 6, 2016
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
Pat. Sub. Date(s): 001: Feb 10, 2017
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
Pat. Sub. Date(s): 001: Jun 9, 2017
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

alkylating drug
PEPAXTO (POWDER) (INTRAVENOUS) MELPHALAN FLUFENAMIDE HYDROCHLORIDE
Drug Classes: alkylating drug
NDA Applicant: ONCOPEPTIDES AB      NDA No.:
214383  Prod. No.: 001 DISC (EQ 20MG BASE/VIAL)
PatentsExpirationPatented Use
Pat. No. 6992207 DS* DP* Melphalan derivatives and their use as cancer chemotherapeutic drugs
Claim Types: Compound; Process; Composition; Method of use
Pat. Sub. Date(s): 001: Mar 24, 2021
Jun 25, 2024U-3093: In combination with dexamethasone to treat relapsed or refractory multiple myeloma (refactory to at least 1 proteasome inhibitor, 1 immunomodulatory agent, and 1 anti-cd38 mab) in adults who received at least 4 prior lines of therapy
Pat. No. 10285946 DP* Lyophilized preparations of melphalan flufenamide
Claim Types: Formulation; Kit
Pat. Sub. Date(s): 001: Mar 24, 2021
Apr 25, 2032 
Pat. No. 10322182 DP* Lyophilized preparation of cytotoxic dipeptides
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 24, 2021
Apr 25, 2032 
Pat. No. 10543274 Lyophilized preparation of cytotoxic dipeptides
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 24, 2021
Apr 25, 2032U-3093: In combination with dexamethasone to treat relapsed or refractory multiple myeloma (refactory to at least 1 proteasome inhibitor, 1 immunomodulatory agent, and 1 anti-cd38 mab) in adults who received at least 4 prior lines of therapy
Pat. No. 10869928 DP* Lyophilized preparation of cytotoxic dipeptides
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 24, 2021
Apr 25, 2032 
Pat. No. 11344622 Lyophilized preparation of cytotoxic dipeptides
Claim Types: Method of using a product-by-process
Pat. Sub. Date(s): 001: Jun 17, 2022
Apr 25, 2032U-3093: In combination with dexamethasone to treat relapsed or refractory multiple myeloma (refactory to at least 1 proteasome inhibitor, 1 immunomodulatory agent, and 1 anti-cd38 mab) in adults who received at least 4 prior lines of therapy
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityFeb 26, 2026 
Exclusivity Code: ODE - Orphan drug exclusivityFeb 26, 2028ODE-348: Treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD-38 directed monoclonal antibody

alkylating drug
TEPADINA (POWDER) (INTRACAVITARY, INTRAVENOUS, INTRAVESICAL) THIOTEPA [GENERIC AP]
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: 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) (IV (INFUSION)) 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
Pat. Sub. Date(s): All strengths: Jun 4, 2013
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
Pat. Sub. Date(s): All strengths: Jun 4, 2013
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
Pat. Sub. Date(s): All strengths: Jan 16, 2014
Jul 12, 2026 *PED 
Pat. No. 8669279 DP* Solid forms of bendamustine hydrochloride
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Pat. Sub. Date(s): All strengths: Oct 30, 2014
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
Pat. Sub. Date(s): All strengths: Jul 29, 2014
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
Pat. Sub. Date(s): All strengths: Nov 13, 2014
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
Pat. Sub. Date(s): All strengths: Nov 26, 2014
Jul 12, 2026 *PED 
Pat. No. 9533955 DP* Solid forms of bendamustine hydrochloride
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: None; 002: Jan 13, 2017
Sep 26, 2029 *PEDU-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) (IV (INFUSION)) 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
Pat. Sub. Date(s): All strengths: None
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
Pat. Sub. Date(s): All strengths: Sep 17, 2013
Sep 26, 2029 *PED 
Pat. No. 8791270 DP* Bendamustine pharmaceutical compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Dec 9, 2014
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) (TOPICAL) MECHLORETHAMINE HYDROCHLORIDE
Drug Classes: alkylating drug
NDA Applicant: HELSINN      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
Pat. Sub. Date(s): 001: Sep 13, 2013
Mar 7, 2026 
Pat. No. 7872050 Stabilized compositions of volatile alkylating agents and methods of using thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 13, 2013
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
Pat. Sub. Date(s): 001: Sep 13, 2013
Mar 7, 2026 
Pat. No. 8501818 DP* Stabilized compositions of alkylating agents and methods of using same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 13, 2013
Mar 7, 2026 
Pat. No. 8501819 Stabilized compositions of volatile alkylating agents and methods of using thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 13, 2013
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
Pat. Sub. Date(s): 001: Jul 26, 2016
Mar 7, 2026 

alkylating drug
VIVIMUSTA (SOLUTION) (INTRAVENOUS) BENDAMUSTINE HYDROCHLORIDE
Drug Classes: alkylating drug
NDA Applicant: SLAYBACK PHARMA LLC      NDA No.:
212209  Prod. No.: 001 RX (100MG/4ML (25MG/ML))
PatentsExpirationPatented Use
Pat. No. 11844784 DP* Stable pharmaceutical compositions of bendamustine
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 19, 2023
Jul 29, 2042 

alkylating drug
YONDELIS (POWDER) (INTRAVENOUS) 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
Pat. Sub. Date(s): 001: Nov 20, 2015
Jul 7, 2028 *PED 

alkylating drug
ZEPZELCA (POWDER) (INTRAVENOUS) LURBINECTEDIN
Drug Classes: alkylating drug
NDA Applicant: JAZZ      NDA No.:
213702  Prod. No.: 001 RX (4MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 7763615 DS* DP* Ecteinascidin analogs for use as antitumour agents
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Jun 23, 2020
Dec 13, 2029U-2836: Treatment of adult patients with small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJun 15, 2025 
Exclusivity Code: ODE - Orphan drug exclusivityJun 15, 2027ODE-304: Indicated for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy

allylamine antifungal
NAFTIN (GEL) (TOPICAL) NAFTIFINE HYDROCHLORIDE [GENERIC AB]
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
Pat. Sub. Date(s): 001: Jul 22, 2014
Jan 31, 2033 
Pat. No. 9161914 Topical compositions and methods for making and using same
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Nov 3, 2015
Jan 31, 2033U-540: Treatment of fungal infections
Pat. No. 10166205 DP* Topical compositions and methods for making and using same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 19, 2019
Jan 31, 2033 
Pat. No. 10166206 DP* Topical compositions and methods for making and using same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 19, 2019
Jan 31, 2033 
Pat. No. 10695303 DP* Topical compositions and methods for making and using same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 27, 2020
Jan 31, 2033 
Pat. No. 10729667 DP* Topical compositions and methods for making and using same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 31, 2020
Jan 31, 2033 

alpha adrenergic agonist
ADRENALIN (SOLUTION) (INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == catecholamine
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
Pat. Sub. Date(s): 001: Jan 14, 2016
Mar 13, 2035 
Pat. No. 9295657 Epinephrine formulations
Claim Types: Method
Pat. Sub. Date(s): 001: Apr 12, 2016
Mar 13, 2035U-1829: Emergency treatment of allergic reactions (Type I), including anaphylaxis

alpha adrenergic agonist
ADRENALIN (SOLUTION) (INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS) EPINEPHRINE [GENERIC AP]
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == catecholamine
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
Pat. Sub. Date(s): 001: Sep 1, 2015
Mar 13, 2035 
Pat. No. 9295657 Epinephrine formulations
Claim Types: Method
Pat. Sub. Date(s): 001: Apr 12, 2016
Mar 13, 2035U-1829: Emergency treatment of allergic reactions (Type I), including anaphylaxis
Pat. No. 10130592 DP* Epinephrine formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 26, 2018
Mar 13, 2035 

alpha adrenergic agonist
ADRENALIN (SOLUTION) (INTRAVENOUS) EPINEPHRINE
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: PAR STERILE PRODUCTS      NDA No.:
215875  Prod. No.: 001 RX (2MG/250ML (8MCG/ML)); 002 RX (4MG/250ML (16MCG/ML)); 003 RX (5MG/250ML (20MCG/ML)); 004 RX (8MG/250ML (32MCG/ML)); 005 RX (10MG/250ML (40MCG/ML))
PatentsExpirationPatented Use
Pat. No. 10653646 DP* Epinephrine compositions and containers
Claim Types: Formulation; Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): All strengths: May 10, 2023
Mar 21, 2039 
Pat. No. 11083698 Epinephrine compositions and containers
Claim Types: Method of administration; Method of use
Pat. Sub. Date(s): All strengths: May 10, 2023
Mar 21, 2039U-3567: To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock
Pat. No. 11207280 DP* Epinephrine compositions and containers
Claim Types: Process; Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): All strengths: May 10, 2023
Mar 21, 2039 

alpha adrenergic agonist
ADVIL ALLERGY SINUS (TABLET) (ORAL) CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Drug Classes: histamine-1 (H1) receptor antagonist == nonsteroidal anti-inflammatory drug == alpha adrenergic agonist
NDA Applicant: HALEON US HOLDINGS      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
Pat. Sub. Date(s): 001: May 6, 2011
Feb 28, 2027 

alpha adrenergic agonist
ADVIL ALLERGY SINUS, CHILDREN'S (SUSPENSION) (ORAL) CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Drug Classes: histamine-1 (H1) receptor antagonist == nonsteroidal anti-inflammatory drug == alpha adrenergic agonist
NDA Applicant: HALEON US HOLDINGS      NDA No.:
021587  Prod. No.: 001 OTC (1MG/5ML;100MG/5ML;15MG/5ML)
PatentsExpirationPatented Use
Pat. No. 10238640 DP* Pharmaceutical suspension composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 24, 2019
May 25, 2024 

alpha adrenergic agonist
AUVI-Q (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: KALEO INC      NDA No.:
201739  Prod. No.: 001 RX (EQ 0.3MG/DELIVERY)
PatentsExpirationPatented Use
Pat. No. 7947017 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 22, 2013
Mar 12, 2028 
Pat. No. 8021344 DP* Medicament delivery device configured to produce an audible output
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 26, 2013
Nov 2, 2029 
Pat. No. 8206360 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 21, 2013
Feb 27, 2027 
Pat. No. 8226610 DP* Medical injector with compliance tracking and monitoring
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Aug 21, 2012
Apr 10, 2029 
Pat. No. 8231573 DP* Medicament delivery device having an electronic circuit system
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 21, 2012
Nov 25, 2028 
Pat. No. 8313466 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Dec 20, 2012
Nov 23, 2024 
Pat. No. 8361029 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 22, 2013
Nov 23, 2024 
Pat. No. 8425462 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: May 23, 2013
Nov 23, 2024 
Pat. No. 8608698 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 15, 2014
Nov 23, 2024 
Pat. No. 9149579 Devices, systems and methods for medicament delivery
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Nov 6, 2015
Jul 19, 2025U-1758: Method of treating allergic reaction via injection
Pat. No. 9724471 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Aug 23, 2017
May 23, 2027U-2092: Method for confirming dose delivery
Pat. No. 9737669 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 30, 2017
Nov 23, 2024 
Pat. No. 10314977 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Jun 11, 2019
Nov 23, 2024 
Pat. No. 10335549 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 2, 2019
Apr 30, 2025 
Pat. No. 10737028 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 25, 2020
Nov 23, 2024 
Pat. No. 11590286 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 29, 2023
Dec 12, 2026 

alpha adrenergic agonist
AUVI-Q (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: KALEO INC      NDA No.:
201739  Prod. No.: 002 RX (EQ 0.15MG/DELIVERY)
PatentsExpirationPatented Use
Pat. No. 7947017 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: None
Mar 12, 2028 
Pat. No. 8021344 DP* Medicament delivery device configured to produce an audible output
Claim Types: Device
Pat. Sub. Date(s): 002: Jul 26, 2013
Nov 2, 2029 
Pat. No. 8206360 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: None
Feb 27, 2027 
Pat. No. 8226610 DP* Medical injector with compliance tracking and monitoring
Claim Types: Device; Method of use
Pat. Sub. Date(s): 002: None
Apr 10, 2029 
Pat. No. 8231573 DP* Medicament delivery device having an electronic circuit system
Claim Types: Device
Pat. Sub. Date(s): 002: None
Nov 25, 2028 
Pat. No. 8313466 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: None
Nov 23, 2024 
Pat. No. 8361029 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: None
Nov 23, 2024 
Pat. No. 8425462 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device; Method of use
Pat. Sub. Date(s): 002: None
Nov 23, 2024 
Pat. No. 8608698 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Jan 15, 2014
Nov 23, 2024 
Pat. No. 9149579 Devices, systems and methods for medicament delivery
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Nov 6, 2015
Jul 19, 2025U-1758: Method of treating allergic reaction via injection
Pat. No. 9724471 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 002: Aug 23, 2017
May 23, 2027U-2092: Method for confirming dose delivery
Pat. No. 9737669 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Aug 30, 2017
Nov 23, 2024 
Pat. No. 10314977 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Jun 11, 2019
Nov 23, 2024 
Pat. No. 10335549 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Jul 2, 2019
Apr 30, 2025 
Pat. No. 10688244 DP* Medicament delivery device and methods for delivering drugs to infants and children
Claim Types: Method of administration; Device
Pat. Sub. Date(s): 002: Nov 4, 2020
Dec 21, 2037U-2980: Method of treating an allergic reaction using an auto-injector
Pat. No. 10737028 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Aug 25, 2020
Nov 23, 2024 
Pat. No. 10842938 DP* Medicament delivery device and methods for delivering drugs to infants and children
Claim Types: Method of administration; Device
Pat. Sub. Date(s): 002: Dec 10, 2020
Dec 21, 2037U-2980: Method of treating an allergic reaction using an auto-injector
Pat. No. 11590286 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 29, 2023
Dec 12, 2026 
Pat. No. 11771830 DP* Medicament delivery device and methods for delivering drugs to infants and children
Claim Types: Method of administration; Device
Pat. Sub. Date(s): 002: Dec 20, 2023
Dec 21, 2037U-2980: Method of treating an allergic reaction using an auto-injector

alpha adrenergic agonist
AUVI-Q (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: KALEO INC      NDA No.:
201739  Prod. No.: 003 RX (EQ 0.1MG/DELIVERY)
PatentsExpirationPatented Use
Pat. No. 7947017 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Mar 12, 2028 
Pat. No. 8021344 DP* Medicament delivery device configured to produce an audible output
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 2, 2029 
Pat. No. 8206360 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Feb 27, 2027 
Pat. No. 8226610 DP* Medical injector with compliance tracking and monitoring
Claim Types: Device; Method of use
Pat. Sub. Date(s): 003: Dec 15, 2017
Apr 10, 2029 
Pat. No. 8231573 DP* Medicament delivery device having an electronic circuit system
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 25, 2028 
Pat. No. 8313466 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 8361029 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 8425462 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device; Method of use
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 8608698 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 9149579 Devices, systems and methods for medicament delivery
Claim Types: Method of administration
Pat. Sub. Date(s): 003: Dec 15, 2017
Jul 19, 2025U-1758: Method of treating allergic reaction via injection
Pat. No. 9724471 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 003: Dec 15, 2017
May 23, 2027U-2092: Method for confirming dose delivery
Pat. No. 9737669 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 9833573 Devices, systems and methods for medicament delivery
Claim Types: Method of administration
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024U-2172: Method to treat severe allergic emergencies in patients weighing 7.5 to 15 kg (16.5 to 33 lbs)
Pat. No. 10314977 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Jun 11, 2019
Nov 23, 2024 
Pat. No. 10335549 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Jul 2, 2019
Apr 30, 2025 
Pat. No. 10688244 DP* Medicament delivery device and methods for delivering drugs to infants and children
Claim Types: Method of administration; Device
Pat. Sub. Date(s): 003: Nov 4, 2020
Dec 21, 2037U-2980: Method of treating an allergic reaction using an auto-injector
Pat. No. 10737028 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Aug 25, 2020
Nov 23, 2024 
Pat. No. 10842938 DP* Medicament delivery device and methods for delivering drugs to infants and children
Claim Types: Method of administration; Device
Pat. Sub. Date(s): 003: Dec 10, 2020
Dec 21, 2037U-2980: Method of treating an allergic reaction using an auto-injector
Pat. No. 11590286 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Mar 29, 2023
Dec 12, 2026 
Pat. No. 11771830 DP* Medicament delivery device and methods for delivering drugs to infants and children
Claim Types: Method of administration; Device
Pat. Sub. Date(s): 003: Dec 20, 2023
Dec 21, 2037U-2980: Method of treating an allergic reaction using an auto-injector

alpha adrenergic agonist
EMERPHED (SOLUTION) (INTRAVENOUS) EPHEDRINE SULFATE
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == norepinephrine-releasing agent
NDA Applicant: NEXUS      NDA No.:
213407  Prod. No.: 001 RX (50MG/10ML (5MG/ML))
PatentsExpirationPatented Use
Pat. No. 11090278 Compositions comprising ephedrine or an ephedrine salt and methods of making and using same
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Aug 13, 2021
May 16, 2040U-3183: Use of ephedrine sulfate for treating hypotension
Pat. No. 11241400 Compositions comprising ephedrine or an ephedrine salt and methods of making and using same
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Feb 22, 2022
May 16, 2040U-3183: Use of ephedrine sulfate for treating hypotension
Pat. No. 11464752 DP* Compositions comprising ephedrine or an ephedrine salt and methods of making and using same
Claim Types: Formulation claimed by its inherent performace characteristics; Product-by-process
Pat. Sub. Date(s): 001: Oct 17, 2022
May 16, 2040 
Pat. No. 11478436 Compositions comprising ephedrine or an ephedrine salt and methods of making and using same
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Nov 18, 2022
May 16, 2040U-3183: Use of ephedrine sulfate for treating hypotension
Pat. No. 11571398 Compositions comprising ephedrine or an ephedrine salt and methods of making and using same
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Mar 2, 2023
May 16, 2040U-3183: Use of ephedrine sulfate for treating hypotension

alpha adrenergic agonist
EMERPHED (SOLUTION) (INTRAVENOUS) EPHEDRINE SULFATE
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == norepinephrine-releasing agent
NDA Applicant: NEXUS      NDA No.:
213407  Prod. No.: 002 RX (25MG/5ML (5MG/ML))
PatentsExpirationPatented Use
Pat. No. 11464752 DP* Compositions comprising ephedrine or an ephedrine salt and methods of making and using same
Claim Types: Formulation claimed by its inherent performace characteristics; Product-by-process
Pat. Sub. Date(s): 002: Mar 2, 2023
May 16, 2040 
Pat. No. 11571398 Compositions comprising ephedrine or an ephedrine salt and methods of making and using same
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Mar 2, 2023
May 16, 2040U-3183: Use of ephedrine sulfate for treating hypotension

alpha adrenergic agonist
EPHEDRINE SULFATE (SOLUTION) (INTRAVENOUS) EPHEDRINE SULFATE
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == norepinephrine-releasing agent
NDA Applicant: OPERAND PHARMS      NDA No.:
213994  Prod. No.: 001 RX (50MG/10ML (5MG/ML)); 002 RX (25MG/5ML (5MG/ML))
PatentsExpirationPatented Use
Pat. No. 10869845 DP* Ephedrine compositions and methods
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 22, 2020; 002: May 19, 2022
Jan 22, 2040 

alpha adrenergic agonist
EPINEPHRINE (SOLUTION) (INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: BPI LABS      NDA No.:
205029  Prod. No.: 001 RX (1MG/ML (1MG/ML))
PatentsExpirationPatented Use
Pat. No. 9283197 DP* DLR* More potent and less toxic formulations of epinephrine and methods of medical use
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 7, 2016
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
Pat. No. 10004700 DP* DLR* More potent and less toxic formulations of epinephrine and methods of medical use
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Jun 29, 2018
Aug 14, 2034U-2325: Emergency treatment of allergic reactions (Type 1), including anaphylaxis; a method of treating allergic reaction, anaphylaxis, anaphylactic shock, or combination thereof by an injection of at least one dosage of the injectable liquid pharmaceutical
Pat. No. 10039728 DLR* More potent and less toxic formulations of epinephrine and methods of medical use
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 7, 2018
Aug 14, 2034U-1828: Increasing mean arterial blood pressure in adult patients with hypotension associated with septic shock

alpha adrenergic agonist
EPIPEN; EPIPEN JR. (INJECTABLE) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE [GENERIC AB]
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == catecholamine
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
Pat. Sub. Date(s): All strengths: None
Sep 11, 2025 
Pat. No. 7794432 DP* Automatic injector with kickback attenuation
Claim Types: Device; Process
Pat. Sub. Date(s): All strengths: None
Sep 11, 2025 
Pat. No. 8048035 DP* Automatic injector with needle cover
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 25, 2011; 002: None
Sep 11, 2025 
Pat. No. 8870827 DP* Automatic injector
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 30, 2014
Sep 11, 2025 
Pat. No. 9586010 DP* Automatic injector with needle cover
Claim Types: Device
Pat. Sub. Date(s): All strengths: May 12, 2017
Sep 11, 2025 

alpha adrenergic agonist
NEXICLON XR (TABLET, EXTENDED RELEASE) (ORAL) CLONIDINE
Drug Classes: alpha adrenergic agonist == central alpha-2 adrenergic agonist
NDA Applicant: ATHENA      NDA No.:
022500  Prod. No.: 001 RX (EQ 0.17MG BASE) NDA No.: 022500  Prod. No.: 002 DISC (EQ 0.26MG BASE)
PatentsExpirationPatented Use
Pat. No. 8337890 DP* Modified release formulations containing drug-ion exchange resin complexes
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 1, 2020
Apr 17, 2027 
Pat. No. 8623409 DP* Clonidine formulation
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): All strengths: Jul 1, 2020
Sep 8, 2031 

alpha adrenergic agonist
PRIMATENE MIST (AEROSOL, METERED) (INHALATION) EPINEPHRINE
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: ARMSTRONG PHARMS      NDA No.:
205920  Prod. No.: 001 OTC (0.125MG/INH)
PatentsExpirationPatented Use
Pat. No. 8367734 DP* Stable epinephrine suspension formulation with high inhalation delivery efficiency
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 17, 2018
Jan 26, 2026 

alpha adrenergic agonist
SYMJEPI (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: ADAMIS PHARMS CORP      NDA No.:
207534  Prod. No.: 001 RX (0.3MG/0.3ML (0.3MG/0.3ML)) NDA No.: 207534  Prod. No.: 002 DISC (0.15MG/0.3ML (0.15MG/0.3ML))
PatentsExpirationPatented Use
Pat. No. 11141540 DP* Syringe devices
Claim Types: Device; Method of administration
Pat. Sub. Date(s): All strengths: Jun 16, 2022
Oct 20, 2036U-3379: A method for administering a therapeutic dose of epinephrine

alpha adrenergic blocker
COREG CR (CAPSULE, EXTENDED RELEASE) (ORAL) CARVEDILOL PHOSPHATE [GENERIC AB]
Drug Classes: alpha adrenergic blocker == beta-adrenergic receptor inhibitor
NDA Applicant: WOODWARD      NDA No.:
022012  Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (40MG); 004 RX (80MG)
PatentsExpirationPatented Use
Pat. No. 8101209 DP* Microparticulate oral galenical form for the delayed and controlled release of pharmaceutical active principles
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 21, 2012; 002: None; 003: None; 004: None
Mar 11, 2026 *PED 

alpha adrenergic blocker
RYZUMVI (SOLUTION) (OPHTHALMIC) PHENTOLAMINE MESYLATE
Drug Classes: alpha adrenergic blocker
NDA Applicant: FAMYGEN LIFE SCI      NDA No.:
217064  Prod. No.: 001 RX (EQ 0.75% BASE)
PatentsExpirationPatented Use
Pat. No. 9795560 DP* Aqueous ophthalmic solutions of phentolamine and medical uses thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 1, 2024
Jan 31, 2034 
Pat. No. 10278918 DP* Aqueous ophthalmic solutions of phentolamine and medical uses thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 1, 2024
Jan 31, 2034 
Pat. No. 10772829 DP* Aqueous ophthalmic solutions of phentolamine and medical uses thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 1, 2024
Jan 31, 2034 
Pat. No. 11090261 DP* Aqueous ophthalmic solutions of phentolamine and medical uses thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 1, 2024
Jan 31, 2034 
Pat. No. 11844858 DP* Aqueous ophthalmic solutions of phentolamine and medical uses thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 18, 2024
Jan 31, 2034 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productSep 25, 2026 

alpha-1 adrenergic receptor agonist
IMMPHENTIV (SOLUTION) (INTRAVENOUS) PHENYLEPHRINE HYDROCHLORIDE
Drug Classes: alpha-1 adrenergic receptor agonist
NDA Applicant: HIKMA      NDA No.:
203826  Prod. No.: 004 RX (0.5MG/5ML (0.1MG/ML)); 005 RX (1MG/10ML (0.1MG/ML))
PatentsExpirationPatented Use
Pat. No. 11213480 DP* Phenylephrine hydrochloride ready-to-use solution
Claim Types: Formulation; Process; Drug in a container
Pat. Sub. Date(s): All strengths: Mar 22, 2023
Sep 26, 2036 
Pat. No. 11471400 DP* Phenylephrine hydrochloride ready-to-use solution
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Mar 22, 2023
Aug 5, 2036 

alpha-1 adrenergic receptor agonist
MYDCOMBI (SPRAY, METERED) (OPHTHALMIC) PHENYLEPHRINE HYDROCHLORIDE; TROPICAMIDE
Drug Classes: alpha-1 adrenergic receptor agonist == anticholinergic
NDA Applicant: EYENOVIA      NDA No.:
215352  Prod. No.: 001 RX (2.5%;1%)
PatentsExpirationPatented Use
Pat. No. 10839960 Ophthalmic drug delivery
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Sep 20, 2023
Jul 15, 2031U-3685: Method of administering an effective dose of tropicamide and phenylephrine hydrochloride to an eye
Pat. No. 11398306 Ophthalmic drug delivery
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Sep 20, 2023
Jul 15, 2031U-3685: Method of administering an effective dose of tropicamide and phenylephrine hydrochloride to an eye
Pat. No. 11839487 Ophthalmic drug delivery
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jan 12, 2024
Jul 15, 2031U-3685: Method of administering an effective dose of tropicamide and phenylephrine hydrochloride to an eye
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productMay 5, 2026 

alpha-1 adrenergic receptor agonist
OMIDRIA (SOLUTION) (IRRIGATION) KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE [GENERIC AT]
Drug Classes: cyclooxygenase inhibitor == nonsteroidal anti-inflammatory drug == alpha-1 adrenergic receptor agonist
NDA Applicant: RAYNER SURGICAL      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
Pat. Sub. Date(s): 001: Jun 13, 2014
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
Pat. Sub. Date(s): 001: Jun 13, 2014
Jan 30, 2024 *PED 
Pat. No. 9066856 DP* Stable preservative-free mydriatic and anti-inflammatory solutions for injection
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 13, 2015
Apr 23, 2034 *PED 
Pat. No. 9278101 Ophthalmologic irrigation solutions and method
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Mar 9, 2016
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
Pat. Sub. Date(s): 001: Jul 28, 2016
Jan 30, 2024 *PED 
Pat. No. 9486406 DP* Stable preservative-free mydriatic and anti-inflammatory solutions for injection
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 9, 2016
Apr 23, 2034 *PED 
Pat. No. 9855246 DP* Stable preservative-free mydriatic and anti-inflammatory solutions for injection
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 5, 2018
Oct 23, 2033 

alpha-1 adrenergic receptor agonist
PHENYLEPHRINE HYDROCHLORIDE (SOLUTION/DROPS) (OPHTHALMIC) PHENYLEPHRINE HYDROCHLORIDE [GENERIC AT]
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
Pat. Sub. Date(s): All strengths: Oct 17, 2014
Nov 14, 2033U-1594: Dilation of the pupil

alpha-1 adrenergic receptor agonist
PHENYLEPHRINE HYDROCHLORIDE (SOLUTION/DROPS) (OPHTHALMIC) PHENYLEPHRINE HYDROCHLORIDE [GENERIC AT]
Drug Classes: alpha-1 adrenergic receptor agonist
NDA Applicant: MANKIND PHARMA      NDA No.:
216496  Prod. No.: 001 RX (10%)
ExclusivityExpirationExclusivity Description
Exclusivity Code: CGT - Competitive generic therapyJul 17, 2023 

alpha-adrenergic receptor agonist
ALPHAGAN P (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE [GENERIC AB]
Drug Classes: alpha-adrenergic receptor agonist
NDA Applicant: ABBVIE      NDA No.:
021770  Prod. No.: 001 RX (0.1%)
PatentsExpirationPatented Use
Pat. No. 8858961 DP* Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 13, 2014
Mar 2, 2024 *PED 

alpha-adrenergic receptor agonist
LUMIFY (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE
Drug Classes: alpha-adrenergic receptor 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
Pat. Sub. Date(s): 001: Jan 26, 2018
Jul 14, 2030U-2222: Relieves redness of the eye due to minor eye irritations
Pat. No. 9259425 Compositions and methods for eye whitening
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 27, 2021
Jul 14, 2030U-2222: Relieves redness of the eye due to minor eye irritations
Pat. No. 11596600 Vasoconstriction compositions and methods of use
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 27, 2023
Jul 27, 2029U-2222: Relieves redness of the eye due to minor eye irritations
Pat. No. 11833245 Vasoconstriction compositions and methods of use
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 12, 2023
Jul 27, 2029U-2222: Relieves redness of the eye due to minor eye irritations

alpha-adrenergic receptor agonist
MIRVASO (GEL) (TOPICAL) BRIMONIDINE TARTRATE [GENERIC AB]
Drug Classes: alpha-adrenergic receptor 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
Pat. Sub. Date(s): 001: Sep 13, 2013
Aug 25, 2025U-1428: Topical treatment of facial erythema of rosacea
Pat. No. 8053427 DP* Brimonidine gel composition
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 13, 2013
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
Pat. Sub. Date(s): 001: Sep 13, 2013
Jun 13, 2031 
Pat. No. 8231885 DP* Compounds, formulations, and methods for ameliorating telangiectasis
Claim Types: Formulation; Device
Pat. Sub. Date(s): 001: Sep 13, 2013
May 24, 2025 
Pat. No. 8410102 Methods and compositions for treating or preventing erythema
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 13, 2013
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
Pat. Sub. Date(s): 001: Sep 13, 2013
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
Pat. Sub. Date(s): 001: Sep 13, 2013
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
Pat. Sub. Date(s): 001: Sep 13, 2013
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
Pat. Sub. Date(s): 001: Oct 27, 2014
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
Pat. Sub. Date(s): 001: Jan 25, 2018
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
Pat. Sub. Date(s): 001: Jan 25, 2018
Mar 25, 2031U-1428: Topical treatment of facial erythema of rosacea
Pat. No. 10201517 DP* Brimonidine gel compositions and methods of use
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 13, 2019
Jun 13, 2031 

alpha-adrenergic receptor agonist
QOLIANA (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE [GENERIC AT]
Drug Classes: alpha-adrenergic receptor agonist
NDA Applicant: SANDOZ      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
Pat. Sub. Date(s): 001: None
Aug 19, 2025 

alpha-adrenergic receptor agonist
SIMBRINZA (SUSPENSION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE; BRINZOLAMIDE
Drug Classes: alpha-adrenergic receptor agonist == carbonic anhydrase inhibitor
NDA Applicant: ALCON LABS INC      NDA No.:
204251  Prod. No.: 001 RX (0.2%;1%)
PatentsExpirationPatented Use
Pat. No. 9044484 DP* Aqueous pharmaceutical compositions containing borate-polyol complexes
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 9, 2015
Oct 30, 2030 
Pat. No. 9421265 DP* Aqueous pharmaceutical compositions containing borate-polyol complexes
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 24, 2016
Jun 17, 2030 

amide local anesthetic
AKTEN (GEL) (OPHTHALMIC) LIDOCAINE HYDROCHLORIDE
Drug Classes: amide local anesthetic == antiarrhythmic
NDA Applicant: THEA PHARMA      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
Pat. Sub. Date(s): 001: Jun 30, 2014
Jul 24, 2026U-1523: Method of inducing topical anesthesia in the eye

amide local anesthetic
EXPAREL (INJECTABLE, LIPOSOMAL) (INJECTION) BUPIVACAINE
Drug Classes: amide local anesthetic
NDA Applicant: PACIRA PHARMS INC      NDA No.:
022496  Prod. No.: 001 RX (133MG/10ML (13.3MG/ML)); 002 RX (266MG/20ML (13.3MG/ML))
PatentsExpirationPatented Use
Pat. No. 11033495 DP* Manufacturing of bupivacaine multivesicular liposomes
Claim Types: Product-by-process; Method of use
Pat. Sub. Date(s): All strengths: Jul 30, 2021
Jan 22, 2041U-3182: Method of providing postsurgical pain management, for example, via infiltration for local analgesia or via interscalene brachial plexus nerve block for regional analgesia
Pat. No. 11179336 DP* Manufacturing of bupivacaine multivesicular liposomes
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Nov 30, 2021
Jan 22, 2041U-3250: Method of treating pain, for example, treating postsurgical pain via infiltration for local analgesia or via interscalene brachial plexus nerve block for regional analgesia
Pat. No. 11278494 DP* Manufacturing of bupivacaine multivesicular liposomes
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Apr 4, 2022
Jan 22, 2041U-3250: Method of treating pain, for example, treating postsurgical pain via infiltration for local analgesia or via interscalene brachial plexus nerve block for regional analgesia
Pat. No. 11304904 DP* Manufacturing of bupivacaine multivesicular liposomes
Claim Types: Product-by-process; Method of use
Pat. Sub. Date(s): All strengths: Apr 21, 2022
Jan 22, 2041U-3346: Method of providing local or regional analgesia via infiltration for local analgesia or via interscalene brachial plexus nerve block or femoral nerve block for regional analgesia
Pat. No. 11311486 DP* Manufacturing of bupivacaine multivesicular liposomes
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Apr 27, 2022
Jan 22, 2041U-3250: Method of treating pain, for example, treating postsurgical pain via infiltration for local analgesia or via interscalene brachial plexus nerve block for regional analgesia
Pat. No. 11357727 DP* Manufacturing of bupivacaine multivesicular liposomes
Claim Types: Product-by-process; Method of using a product-by-process
Pat. Sub. Date(s): All strengths: Jun 16, 2022
Jan 22, 2041U-3380: Method of treating pain, for example, via infiltration for local analgesia or via interscalene brachial plexus nerve block for regional analgesia
Pat. No. 11426348 DP* Compositions of bupivacaine multivesicular liposomes
Claim Types: Formulation claimed by its inherent performace characteristics; Method of use
Pat. Sub. Date(s): All strengths: Sep 2, 2022
Jan 22, 2041U-3380: Method of treating pain, for example, via infiltration for local analgesia or via interscalene brachial plexus nerve block for regional analgesia
Pat. No. 11452691 DP* Compositions of bupivacaine multivesicular liposomes
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Oct 4, 2022
Jan 22, 2041U-3439: Method of treating pain, for example, via infiltration for local analgesia or via nerve block, for example, nterscalene brachial plexus for regional analgesia
Pat. No. 11819574 DP* Manufacturing of bupivacaine multivesicular liposomes
Claim Types: Product-by-process; Method of use
Pat. Sub. Date(s): All strengths: Dec 6, 2023
Jan 22, 2041U-3250: Method of treating pain, for example, treating postsurgical pain via infiltration for local analgesia or via interscalene brachial plexus nerve block for regional analgesia
Pat. No. 11819575 DP* Manufacturing of bupivacaine multivesicular liposomes
Claim Types: Formulation; Formulation claimed by its inherent performace characteristics; Method of use
Pat. Sub. Date(s): All strengths: Dec 6, 2023
Jan 22, 2041U-3250: Method of treating pain, for example, treating postsurgical pain via infiltration for local analgesia or via interscalene brachial plexus nerve block for regional analgesia
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationNov 9, 2026I-929: Indicated to produce postsurgical regional analgesia in adults via asciatic nerve block in the popliteal fossa and via an adductor canal block
Exclusivity Code: NPP - New patient populationMar 22, 2024 

amide local anesthetic
NAROPIN (SOLUTION) (INJECTION) 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
Pat. Sub. Date(s): All strengths: Nov 6, 2014
Oct 18, 2025 
Pat. No. 7857802 DP* Connector for medical liquid-containing packages and medical liquid-containing packages
Claim Types: Device
Pat. Sub. Date(s): All strengths: Nov 6, 2014
Nov 28, 2026 
Pat. No. 8162915 DP* Connector for packings containing medical liquids, and corresponding packing for medical liquids
Claim Types: Device
Pat. Sub. Date(s): All strengths: Nov 6, 2014
May 23, 2024 

amide local anesthetic
PLIAGLIS (CREAM) (TOPICAL) LIDOCAINE; TETRACAINE
Drug Classes: amide local anesthetic == antiarrhythmic == ester local anesthetic
NDA Applicant: TARO      NDA No.:
021717  Prod. No.: 001 DISC (7%;7%)
PatentsExpirationPatented Use
Pat. No. 10350180 DP* Solid-forming local anesthetic formulations for pain control
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 4, 2019
Jan 14, 2031 
Pat. No. 10603293 DP* Solid-forming local anesthetic formulations for pain control
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 14, 2020
Jan 14, 2031 
Pat. No. 10751305 DP* Solid-forming topical formulations for pain control
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 21, 2020
Jan 14, 2031 

amide local anesthetic
POSIMIR (SOLUTION, EXTENDED RELEASE) (INFILTRATION) BUPIVACAINE
Drug Classes: amide local anesthetic
NDA Applicant: INNOCOLL      NDA No.:
204803  Prod. No.: 001 RX (660MG/5ML (132MG/ML))
PatentsExpirationPatented Use
Pat. No. 8153149 DP* Controlled delivery system
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 2, 2021
Sep 15, 2025 
Pat. No. 8153661 Controlled delivery system
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 2, 2021
Sep 15, 2025U-3074: Method for providing sustained local anesthesia for at least 24 hours
Pat. No. 8753665 DP* Controlled delivery system
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Mar 2, 2021
Sep 15, 2025U-3074: Method for providing sustained local anesthesia for at least 24 hours
Pat. No. 8846072 DP* Controlled delivery system
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Mar 2, 2021
Sep 15, 2025U-3074: Method for providing sustained local anesthesia for at least 24 hours
Pat. No. 11400019 DP* Sustained release drug delivery systems with reduced impurities and related methods
Claim Types: Formulation; Drug in a container
Pat. Sub. Date(s): 001: Sep 1, 2022
Jan 12, 2041 
Pat. No. 11771624 Sustained release drug delivery systems with reduced impurities and related methods
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 2, 2023
Jan 12, 2041U-3724: To produce post-surgical analgesia
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productFeb 1, 2024 

amide local anesthetic
XARACOLL (IMPLANT) (IMPLANTATION) BUPIVACAINE HYDROCHLORIDE
Drug Classes: amide local anesthetic
NDA Applicant: INNOCOLL PHARMS      NDA No.:
209511  Prod. No.: 001 RX (100MG)
PatentsExpirationPatented Use
Pat. No. RE47826 Drug delivery device for providing local analgesia, local anesthesia or nerve blockage
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 28, 2020
May 20, 2029U-2949: A method for inducing a post-surgical analgesia sparing effect by implanting at the surgical site a collagen sponge containing bupivacaine HCl which provides local anesthesia for up to 24 hours following implantation
Pat. No. 11746141 DP* Modified collagen
Claim Types: Product-by-process; Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): 001: Sep 27, 2023
Jan 9, 2033 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productAug 28, 2023 

amide local anesthetic
ZINGO (SYSTEM) (INTRADERMAL) 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
Pat. Sub. Date(s): 001: Oct 9, 2013
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
Pat. Sub. Date(s): 001: Jul 6, 2016
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
Pat. Sub. Date(s): 001: Jul 6, 2016
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) (TOPICAL) LIDOCAINE
Drug Classes: amide local anesthetic == antiarrhythmic
NDA Applicant: SCILEX PHARMS      NDA No.:
207962  Prod. No.: 001 RX (1.8%)
PatentsExpirationPatented Use
Pat. No. 9283174 DP* Non-aqueous patch
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 12, 2018
May 10, 2031 
Pat. No. 9925264 DP* Non-aqueous patch
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 25, 2018
May 10, 2031U-2267: Method for relieving the pain associated with post-herpetic neuralgia
Pat. No. 9931403 DP* Non-aqueous patch
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 25, 2018
May 10, 2031 
Pat. No. 10765640 DP* Non-aqueous patch
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 6, 2020
May 10, 2031 
Pat. No. 10765749 DP* Non-aqueous patch
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 6, 2020
May 10, 2031 
Pat. No. 11278623 DP* Non-aqueous patch
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 1, 2022
May 10, 2031 
Pat. No. 11786455 DP* Non-aqueous patch
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 23, 2023
May 10, 2031U-2267: Method for relieving the pain associated with post-herpetic neuralgia
Pat. No. 11793766 Non-aqueous patch for the relief of pain
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 6, 2023
May 10, 2031U-2267: Method for relieving the pain associated with post-herpetic neuralgia

amide local anesthetic
ZYNRELEF KIT (SOLUTION, EXTENDED RELEASE) (PERIARTICULAR) BUPIVACAINE; MELOXICAM
Drug Classes: amide local anesthetic == nonsteroidal anti-inflammatory drug
NDA Applicant: HERON THERAPS INC      NDA No.:
211988  Prod. No.: 002 RX (200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)); 004 RX (400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)) NDA No.: 211988  Prod. No.: 001 DISC (60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)); 003 DISC (300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML))
PatentsExpirationPatented Use
Pat. No. 9592227 DP* Compositions of a polyorthoester and an aprotic solvent
Claim Types: Formulation; Method of administration; Method of use
Pat. Sub. Date(s): All strengths: May 26, 2021
Mar 13, 2034U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation
Pat. No. 9694079 DP* Long-acting polymeric delivery systems
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: May 26, 2021
Apr 20, 2035U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation
Pat. No. 9744163 DP* Compositions of a polyorthoester and an aprotic solvent
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 26, 2021
Mar 13, 2034 
Pat. No. 9801945 DP* Long-acting polymeric delivery systems
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: May 26, 2021
Apr 20, 2035U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation
Pat. No. 9913909 Compositions of a polyorthoester and an aprotic solvent
Claim Types: Method of administration; Method of use
Pat. Sub. Date(s): All strengths: May 26, 2021
Mar 13, 2034U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation
Pat. No. 10098957 Long-acting polymeric delivery systems
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: May 26, 2021
Apr 20, 2035U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation
Pat. No. 10213510 DP* Long-acting polymeric delivery systems
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: May 26, 2021
Apr 20, 2035U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation
Pat. No. 10398686 DP* Compositions of a polyorthoester and an aprotic solvent
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 26, 2021
Mar 13, 2034 
Pat. No. 10632199 DP* Long-acting polymeric delivery systems
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: May 26, 2021
Apr 20, 2035U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation
Pat. No. 10898575 DP* Long-acting polymeric delivery systems
Claim Types: Formulation; Method of use; Method of Use claimed by its inherent performace characteristics
Pat. Sub. Date(s): All strengths: May 26, 2021
Apr 20, 2035U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation
Pat. No. 10980886 DP* Compositions of a polyorthoester and an organic acid excipient
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 26, 2021
Apr 20, 2035 
Pat. No. 11083730 DP* Long-acting polymeric delivery systems
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Aug 25, 2021
Apr 20, 2035U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation
Pat. No. 11083797 DP* Long-acting polymeric delivery systems
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Aug 25, 2021
Apr 20, 2035U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation
Pat. No. 11253504 Compositions of a polyorthoester and an aprotic solvent
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 2, 2022
Mar 13, 2034U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation
Pat. No. 11413350 Long-acting polymeric delivery systems
Claim Types: Method of use; Method of improving a treatment
Pat. Sub. Date(s): All strengths: Sep 15, 2022
Apr 20, 2035U-3417: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures via instillation
Pat. No. 11844837 Compositions of a polyorthoester and an organic acid excipient
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 3, 2024
Apr 21, 2036U-3417: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures via instillation
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productMay 12, 2024 

aminoglycoside antibacterial
ARIKAYCE KIT (SUSPENSION, LIPOSOMAL) (INHALATION) AMIKACIN SULFATE
Drug Classes: aminoglycoside antibacterial
NDA Applicant: INSMED INC      NDA No.:
207356  Prod. No.: 001 RX (EQ 590MG BASE/8.4ML)
PatentsExpirationPatented Use
Pat. No. 7718189 DP* Sustained release of antiinfectives
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Jun 6, 2025U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen
Pat. No. 8226975 DP* Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof
Claim Types: Kit; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Aug 15, 2028 
Pat. No. 8632804 Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Dec 5, 2026U-2416: Treating mycobacterium avium complex (MAC) lung disease in adults with cystic fibrosis as part of a combination drug regimen
Pat. No. 8642075 DP* Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 24, 2018
Dec 5, 2026 
Pat. No. 8679532 Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Dec 5, 2026U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen
Pat. No. 8802137 DP* Sustained release of antiinfectives
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Apr 8, 2024U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen
Pat. No. 9566234 DP* Systems for treating pulmonary infections
Claim Types: Kit; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Jan 18, 2034U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen
Pat. No. 9827317 DP* Sustained release of antiinfectives
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Apr 8, 2024U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen
Pat. No. 9895385 Methods for treating pulmonary non-tuberculous mycobacterial infections
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
May 15, 2035U-2417: Treating mycobacterium avium complex (MAC) lung disease in non-cystic fibrosis adults as part of a combination antibacterial drug regimen
Pat. No. 10251900 Methods for treating pulmonary non-tuberculous mycobacterial infections
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 2, 2019
May 15, 2035U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen
Pat. No. 10751355 Methods for treating pulmonary non-tuberculous mycobacterial infections
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 24, 2020
May 15, 2035U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen
Pat. No. 11446318 Methods for treating pulmonary non-tuberculous mycobacterial infections
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 14, 2022
May 15, 2035U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivitySep 28, 2030 GAINODE-214: Tx of MAC lung disease in adults with limited or no alternative tx options as part of a combo antibacterial drug regimen who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy

aminoglycoside antibacterial
TOBI PODHALER (POWDER) (INHALATION) TOBRAMYCIN
Drug Classes: aminoglycoside antibacterial
NDA Applicant: MYLAN SPECIALITY LP      NDA No.:
201688  Prod. No.: 001 RX (28MG)
PatentsExpirationPatented Use
Pat. No. RE47526 DP* Aerosolization apparatus with air inlet shield
Claim Types: Device
Pat. Sub. Date(s): 001: Jun 1, 2020
Apr 9, 2024 
Pat. No. 7516741 DP* Aerosolization apparatus with feedback mechanism
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Apr 19, 2013
Jan 11, 2024 
Pat. No. 7559325 DP* Aerosolization apparatus with air inlet shield
Claim Types: Device
Pat. Sub. Date(s): 001: Apr 19, 2013
Oct 27, 2025 
Pat. No. 8069851 DP* Aeorosolization apparatus with air inlet shield
Claim Types: Device
Pat. Sub. Date(s): 001: Apr 19, 2013
Sep 24, 2024 
Pat. No. 8664187 Methods of treatment of endobronchial infections
Claim Types: Method of improving a treatment; Method of use
Pat. Sub. Date(s): 001: Jun 17, 2019
Jun 20, 2025U-909: Treatment of cystic fibrosis patients with pseudomonas aeruginosa
Pat. No. 8869794 DP* Aerosolization apparatus with capsule puncturing member
Claim Types: Device; Process; Part of a dosage form; Method of administration
Pat. Sub. Date(s): 001: Jun 17, 2019
Sep 12, 2028U-909: Treatment of cystic fibrosis patients with pseudomonas aeruginosa
Pat. No. 10207066 DP* Aerosolization apparatus with capsule puncture alignment guide
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Jun 17, 2019
Nov 4, 2030U-909: Treatment of cystic fibrosis patients with pseudomonas aeruginosa
Pat. No. 11484671 DP* Aerosolization apparatus with capsule puncture alignment guide
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Nov 18, 2022
Nov 7, 2024U-909: Treatment of cystic fibrosis patients with pseudomonas aeruginosa

aminoglycoside antibacterial
TOBRADEX ST (SUSPENSION/DROPS) (OPHTHALMIC) DEXAMETHASONE; TOBRAMYCIN
Drug Classes: corticosteroid == aminoglycoside antibacterial
NDA Applicant: HARROW EYE      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
Pat. Sub. Date(s): 001: Sep 30, 2010
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
Pat. Sub. Date(s): 001: Sep 27, 2012
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
Pat. Sub. Date(s): 001: Feb 16, 2016
Dec 19, 2027 

aminoketone
APLENZIN (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROBROMIDE
Drug Classes: aminoketone
NDA Applicant: BAUSCH      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
Pat. Sub. Date(s): All strengths: None
Jun 27, 2026 
Pat. No. 7569610 Modified release formulations of a bupropion salt
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
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
Pat. Sub. Date(s): All strengths: None
Jun 27, 2026 
Pat. No. 7585897 DP* Modified release formulations of a bupropion salt
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Jun 27, 2026 
Pat. No. 7645802 DP* Bupropion hydrobromide and therapeutic applications
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Jun 27, 2026 
Pat. No. 7649019 DP* Modified release formulations of a bupropion salt
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Jun 27, 2026 
Pat. No. 7662407 DP* Modified release formulations of a bupropion salt
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Jun 27, 2026 
Pat. No. 7671094 DP* Bupropion hydrobromide and therapeutic applications
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Jun 27, 2026 

aminoketone
AUVELITY (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Drug Classes: aminoketone == sigma-1 agonist == uncompetitive NMDA receptor antagonist
NDA Applicant: AXSOME      NDA No.:
215430  Prod. No.: 001 RX (105MG;45MG)
PatentsExpirationPatented Use
Pat. No. 8569328 DP* Compositions and methods comprising tilidine or related compounds and dextromethorphan
Claim Types: Composition; Method of use; Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Oct 29, 2033U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9168234 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9198905 Compositions and methods for reducing dextrorphan plasma levels and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9205083 Compositions and methods comprising erythrohydroxybupropion and related compounds for improving the efficacy of dextromethorphan
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9238032 Compositions and methods comprising bupropion or related compounds for sustained delivery of dextromethorphan
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9278095 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9314462 Compositions and methods for increasing dextromethorphan plasma levels and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9370513 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9375429 Compositions and methods comprising erythrohydroxybupropion and related compounds for improving the efficacy of dextromethorphan
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9408815 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9421176 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9457023 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9457025 Compositions and methods comprising bupropion or related compounds for sustained delivery of dextromethorphan
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9474731 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9486450 Hydroxybupropion and related compounds as modulators of drug plasma levels
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9700528 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9700553 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9707191 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9763932 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9861595 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9867819 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9968568 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10058518 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10064857 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment; Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10080727 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10092560 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10092561 Compositions and methods comprising bupropion or related compounds for sustained delivery of dextromethorphan
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10105327 Compositions and methods for increasing the metabolic lifetime of dextromethorphane and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10105361 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10251879 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment; Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10463634 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10512643 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10548857 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10596167 Compositions and methods comprising bupropion or related compounds for sustained delivery of dextromethorphan
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10772850 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment; Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10780064 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Jan 7, 2040U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10780066 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 9, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10786469 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10786496 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10799497 Combination of dextromethorphan and bupropion for treating depression
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10806710 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10864209 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10874663 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10874664 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10874665 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10881624 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment; Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10881657 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10894046 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10894047 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10898453 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10925842 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Jan 7, 2040U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10933034 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10940124 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Jan 7, 2040U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10945973 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10966941 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10966942 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Jan 7, 2040U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10966974 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11020389 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11058648 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11090300 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11096937 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11123343 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11129826 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11141388 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11141416 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11147808 Method of decreasing the fluctuation index of dextromethorphan
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11185515 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11191739 DP* Bupropion as a modulator of drug activity
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11197839 DP* Bupropion as a modulator of drug activity
Claim Types: Composition
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11207281 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11213521 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11229640 Combination of dextromethorphan and bupropion for treating depression
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11234946 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11253491 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11253492 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11273133 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11273134 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11285118 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11285146 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11291638 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11291665 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11298351 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11298352 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11311534 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11344544 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11357744 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11364233 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11382874 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11419867 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11426370 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11426401 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11433067 DP* Bupropion as a modulator of drug activity
Claim Types: Composition; Method of administration; Formulation
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11439636 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11478468 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 10, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11497721 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 2, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11510918 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 7, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11517542 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 21, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11517543 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 21, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11524007 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 21, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11524008 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 21, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11534414 DP* Bupropion as a modulator of drug activity
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): 001: Jan 23, 2023
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11541021 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 23, 2023
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11541048 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 23, 2023
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11596627 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 4, 2023
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11617728 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 3, 2023
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11617747 Bupropion as a modulator of drug activity
Claim Types: Method of use; Method of improving a treatment
Pat. Sub. Date(s): 001: May 3, 2023
Nov 5, 2034U-3563: Dextromethorphan and bupropion in combination to increase dextromethorphan plasma levels
Pat. No. 11717518 Bupropion Dosage Forms With Reduced Food And Alcohol Dosing Effects
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 15, 2023
Jan 20, 2043U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11730706 Treatment of depression in certain patient populations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 28, 2023
Jan 23, 2043U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11752144 Compounds and combinations thereof for treating neurological and psychiatric conditions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 14, 2023
Feb 23, 2043U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11779579 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 12, 2023
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11839612 Compounds and combinations thereof for treating neurological and psychiatric conditions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 5, 2024
Mar 2, 2043U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11844797 Combination of dextromethorphan and bupropion for treating depression
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 5, 2024
Apr 20, 2043U-3778: Treatment of major depressive disorder by administering dextromethorphan and bupropion to a subject having moderate hepatic impairment
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productAug 18, 2025 

aminoketone
CONTRAVE (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE
Drug Classes: aminoketone == opioid antagonist
NDA Applicant: NALPROPION      NDA No.:
200063  Prod. No.: 001 RX (90MG;8MG)
PatentsExpirationPatented Use
Pat. No. 7375111 DP* Compositions for affecting weight loss
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 6, 2014
Mar 26, 2025 
Pat. No. 7462626 Compositions for affecting weight loss
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 6, 2014
Jul 20, 2024U-1583: For chronic weight management for treating overweight or obesity
Pat. No. 8088786 DP* Layered pharmaceutical formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 6, 2014
Feb 3, 2029 
Pat. No. 8318788 Layered pharmaceutical formulations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 6, 2014
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
Pat. Sub. Date(s): 001: Oct 6, 2014
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
Pat. Sub. Date(s): 001: Oct 6, 2014
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
Pat. Sub. Date(s): 001: Jan 20, 2015
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
Pat. Sub. Date(s): 001: Sep 3, 2015
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
Pat. Sub. Date(s): 001: Oct 15, 2015
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
Pat. Sub. Date(s): 001: Feb 17, 2016
Jan 13, 2032U-1808: Use of naltrexone and bupropion for chronic weight management for treating overweight or obesity in patients with major depressive disorder
Pat. No. 9633575 Methods of treating overweight and obesity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 29, 2021
Jun 25, 2033U-1583: For chronic weight management for treating overweight or obesity
Pat. No. 10231964 Compositions and methods for weight loss in at risk patient populations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 17, 2019
Jul 2, 2034U-1583: For chronic weight management for treating overweight or obesity
Pat. No. 10307376 Methods for administering weight loss medications
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 17, 2019
Nov 8, 2027U-1585: Use of naltrexone and bupropion based on an escalating dose schedule
Pat. No. 10403170 Methods of treating overweight and obesity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 29, 2021
Jun 5, 2033U-1583: For chronic weight management for treating overweight or obesity
Pat. No. 10828294 Compositions and methods for weight loss in at risk patient populations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 14, 2020
Jul 2, 2034U-1583: For chronic weight management for treating overweight or obesity
Pat. No. 10835527 Compositions and methods for reducing major adverse cardiovascular events
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 14, 2020
Jul 2, 2034U-1583: For chronic weight management for treating overweight or obesity
Pat. No. 11033543 Methods of providing weight loss therapy in patients with major depression
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 22, 2021
Jan 10, 2031U-1583: For chronic weight management for treating overweight or obesity
Pat. No. 11139056 Methods of treating overweight and obesity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 29, 2021
Jun 5, 2033U-1583: For chronic weight management for treating overweight or obesity
Pat. No. 11278544 Compositions for affecting weight loss
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 24, 2022
Apr 21, 2024U-1583: For chronic weight management for treating overweight or obesity
Pat. No. 11324741 Methods for treating visceral fat conditions
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 19, 2022
May 29, 2029U-1583: For chronic weight management for treating overweight or obesity

aminoketone
FORFIVO XL (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROCHLORIDE
Drug Classes: aminoketone
NDA Applicant: TWI PHARMS      NDA No.:
022497  Prod. No.: 001 RX (450MG)
PatentsExpirationPatented Use
Pat. No. 7674479 DP* Sustained-release bupropion and bupropion/mecamylamine tablets
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 28, 2011
Jun 25, 2027 

aminolevulinate synthase 1-directed small interfering RNA
GIVLAARI (SOLUTION) (SUBCUTANEOUS) GIVOSIRAN SODIUM
Drug Classes: aminolevulinate synthase 1-directed small interfering RNA
NDA Applicant: ALNYLAM PHARMS INC      NDA No.:
212194  Prod. No.: 001 RX (EQ 189MG BASE/ML (EQ 189MG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 8106022 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Dec 12, 2019
Dec 12, 2029U-2672: Treatment of acute hepatic porphyria
Pat. No. 8828956 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Dec 12, 2019
Dec 4, 2028U-2672: Treatment of acute hepatic porphyria
Pat. No. 9133461 DS* DP* [Extended 190 days (0.5 years)]
Compositions and methods for inhibiting expression of the ALAS1 gene
Claim Types: Compound; Composition; Isolated cell containing the compound;; Method of use
Pat. Sub. Date(s): 001: Dec 12, 2019
Nov 30, 2033U-2672: Treatment of acute hepatic porphyria
Pat. No. 9150605 DS* DP* Compositions comprising alternating 2'-modified nucleosides for use in gene modulation
Claim Types: Composition
Pat. Sub. Date(s): 001: Dec 12, 2019
Aug 28, 2025 
Pat. No. 9631193 Compositions and methods for inhibiting expression of the ALAS1 gene
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 12, 2019
Mar 15, 2033U-2672: Treatment of acute hepatic porphyria
Pat. No. 9708615 DS* Therapeutic compositions
Claim Types: Compound
Pat. Sub. Date(s): 001: Dec 12, 2019
Mar 8, 2024 
Pat. No. 10119143 DS* DP* Compositions and methods for inhibiting expression of the ALAS1 gene
Claim Types: Compound; Isolated cell contaiing the compound; Composition; Method of use; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Dec 12, 2019
Oct 3, 2034U-2672: Treatment of acute hepatic porphyria
Pat. No. 10125364 DS* DP* Compositions and methods for inhibiting expression of the ALAS1 gene
Claim Types: Compound; Isolated cell containing the compound; Composition; Method of use; Intermediate
Pat. Sub. Date(s): 001: Dec 12, 2019
Mar 15, 2033U-2672: Treatment of acute hepatic porphyria
Pat. No. 10131907 DS* DP* Glycoconjugates of RNA interference agents
Claim Types: Composition; Process; Method of use
Pat. Sub. Date(s): 001: Dec 12, 2019
Aug 24, 2028U-2672: Treatment of acute hepatic porphyria
Pat. No. 10273477 DS* Therapeutic compositions
Claim Types: Compound
Pat. Sub. Date(s): 001: Dec 12, 2019
Mar 8, 2024 
Pat. No. 11028392 DS* DP* Compositions and methods for inhibiting expression of the ALAS1 gene
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Feb 16, 2022
Oct 3, 2034U-2672: Treatment of acute hepatic porphyria
Pat. No. 11530408 DS* DP* Therapeutic compositions
Claim Types: Composition
Pat. Sub. Date(s): 001: Jan 6, 2023
May 18, 2024 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityNov 20, 2024 
Exclusivity Code: ODE - Orphan drug exclusivityNov 20, 2026ODE-273: Indicated for the treatment of adults with acute hepatic porphyria (AHP)

aminosalicylate
APRISO (CAPSULE, EXTENDED RELEASE) (ORAL) MESALAMINE [GENERIC AB]
Drug Classes: aminosalicylate
NDA Applicant: SALIX      NDA No.:
022301  Prod. No.: 001 RX (375MG)
PatentsExpirationPatented Use
Pat. No. 8865688 Compositions and methods for treatment of bowel diseases with granulated mesalamine
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 22, 2014
May 1, 2030U-1310: For the maintenance of remission of ulcerative colitis

aminosalicylate
CANASA (SUPPOSITORY) (RECTAL) MESALAMINE [GENERIC AB]
Drug Classes: aminosalicylate
NDA Applicant: ABBVIE      NDA No.:
021252  Prod. No.: 002 RX (1GM)
PatentsExpirationPatented Use
Pat. No. 8217083 DP* Mesalamine suppository
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: May 24, 2013
Jun 6, 2028 
Pat. No. 8436051 DP* Mesalamine suppository
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: May 24, 2013
Jun 6, 2028 

aminosalicylate
COLAZAL (CAPSULE) (ORAL) 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
Pat. Sub. Date(s): 001: None
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
Pat. Sub. Date(s): 001: None
Feb 24, 2027 *PEDU-141: Treatment of ulcerative colitis

aminosalicylate
GIAZO (TABLET) (ORAL) BALSALAZIDE DISODIUM
Drug Classes: aminosalicylate
NDA Applicant: VALEANT PHARMS INTL      NDA No.:
022205  Prod. No.: 001 DISC (1.1GM**)
PatentsExpirationPatented Use
Pat. No. 7452872 Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Mar 2, 2012
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
Pat. Sub. Date(s): 001: Mar 2, 2012
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
Pat. Sub. Date(s): 001: Aug 23, 2013
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
Pat. Sub. Date(s): 001: Jan 19, 2016
Aug 2, 2026U-1229: Treatment of mildly to moderately active ulcerative colitis in male patients

aminosalicylate
SFROWASA (ENEMA) (RECTAL) 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
Pat. Sub. Date(s): 002: None
Jul 24, 2027 

amphetamine anorectic
ADZENYS ER (SUSPENSION, EXTENDED RELEASE) (ORAL) AMPHETAMINE
Drug Classes: adrenergic agonist == amphetamine anorectic == central nervous system (CNS) stimulant == central nervous system stimulant
NDA Applicant: NEOS THERAPS INC      NDA No.:
204325  Prod. No.: 001 DISC (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
Pat. Sub. Date(s): 001: Sep 21, 2017
Jun 28, 2032 
Pat. No. 9017731 DP* Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 21, 2017
Jun 28, 2032 
Pat. No. 9265737 DP* Pharmaceutical composition comprising amphetamines complexed with ion-exchange resin particles
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 21, 2017
Jun 28, 2032 

amphetamine anorectic
ADZENYS XR-ODT (TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE) (ORAL) AMPHETAMINE
Drug Classes: adrenergic agonist == amphetamine anorectic == central nervous system (CNS) stimulant == central nervous system stimulant
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
Pat. Sub. Date(s): 001: Feb 26, 2016; 002: None; 003: None; 004: None; 005: None; 006: None
Jun 28, 2032 
Pat. No. 8840924 DP* Compositions and methods of making rapidly dissolving ionically masked formulations
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 26, 2016
Apr 9, 2026 
Pat. No. 9017731 DP* Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 26, 2016; 002: None; 003: None; 004: None; 005: None; 006: None
Jun 28, 2032 
Pat. No. 9265737 DP* Pharmaceutical composition comprising amphetamines complexed with ion-exchange resin particles
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 26, 2016; 002: None; 003: None; 004: None; 005: None; 006: None
Jun 28, 2032 

amphetamine anorectic
DYANAVEL XR (SUSPENSION, EXTENDED RELEASE) (ORAL) AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE
Drug Classes: adrenergic agonist == amphetamine anorectic == central nervous system (CNS) stimulant == central nervous system stimulant
NDA Applicant: TRIS PHARMA INC      NDA No.:
208147  Prod. No.: 001 RX (2MG/ML;EQ 0.5MG BASE/ML)
PatentsExpirationPatented Use
Pat. No. 8062667 DP* Modified release formulations containing drug-ion exchange resin complexes
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 27, 2015
Mar 29, 2029 
Pat. No. 8597684 DP* Modified release formulations containing drug-ion exchange resin complexes
Claim Types: Formulation; Product-by-process
Pat. Sub. Date(s): 001: Oct 27, 2015
Mar 15, 2027 
Pat. No. 8747902 DP* Modified release formulations containing drug-ion exchange resin complexes
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 27, 2015
Mar 15, 2027 
Pat. No. 8883217 DP* Modified release formulations containing drug-ion exchange resin complexes
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 27, 2015
Mar 15, 2027 
Pat. No. 9675703 DP* Modified release formulations containing drug - ion exchange resin complexes
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 28, 2017
Mar 15, 2027 
Pat. No. 10086087 DP* Modified release formulations containing drug-ion exchange resin complexes
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 3, 2018
Mar 15, 2027 
Pat. No. 11590228 DP* Extended Release amphetamine Compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 8, 2023
Sep 7, 2036U-3538: Method of treating attention deficit hyperactivity disorder

amphetamine anorectic
DYANAVEL XR 5; DYANAVEL XR 10; DYANAVEL XR 15; DYANAVEL XR 20 (TABLET, EXTENDED RELEASE) (ORAL) AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE
Drug Classes: adrenergic agonist == amphetamine anorectic == central nervous system (CNS) stimulant == central nervous system stimulant
NDA Applicant: TRIS PHARMA INC      NDA No.:
210526  Prod. No.: 001 RX (4MG;EQ 1MG BASE); 002 RX (8MG;EQ 2MG BASE); 003 RX (12MG;EQ 3MG BASE); 004 RX (16MG;EQ 4MG BASE)
PatentsExpirationPatented Use
Pat. No. 8337890 DP* Modified release formulations containing drug-ion exchange resin complexes
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 22, 2021
Mar 15, 2027 
Pat. No. 8747902 DP* Modified release formulations containing drug-ion exchange resin complexes
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 22, 2021
Mar 15, 2027 
Pat. No. 9675704 DP* Modified release formulations containing drug-ion exchange resin complexes
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 22, 2021
Mar 15, 2027 
Pat. No. 11590081 DP* Extended Release amphetamine Tablets
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): All strengths: Mar 8, 2023
Sep 24, 2038U-3538: Method of treating attention deficit hyperactivity disorder

amphetamine anorectic
EVEKEO ODT (TABLET, ORALLY DISINTEGRATING) (ORAL) AMPHETAMINE SULFATE
Drug Classes: adrenergic agonist == amphetamine anorectic == central nervous system (CNS) stimulant == central nervous system stimulant
NDA Applicant: AZURITY      NDA No.:
209905  Prod. No.: 001 RX (5MG); 002 RX (10MG); 003 RX (15MG); 004 RX (20MG) NDA No.: 209905  Prod. No.: 005 DISC (2.5MG**)
PatentsExpirationPatented Use
Pat. No. 10130580 DP* Taste-masked pharmaceutical compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 31, 2019; 002: Jan 31, 2019; 003: Jan 31, 2019; 004: Jan 31, 2019; 005: Jul 7, 2021
Apr 19, 2024 
Pat. No. 10441554 DP* Oral amphetamine composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 15, 2019; 002: Oct 15, 2019; 003: Oct 15, 2019; 004: Oct 15, 2019; 005: Jul 7, 2021
Mar 10, 2037 
Pat. No. 11160772 DP* Oral amphetamine composition
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Dec 9, 2021
Mar 10, 2037 

amphetamine anorectic
MYDAYIS (CAPSULE, EXTENDED RELEASE) (ORAL) AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE [GENERIC AB2]
Drug Classes: adrenergic agonist == amphetamine anorectic == central nervous system (CNS) stimulant == central nervous system stimulant
NDA Applicant: TAKEDA PHARMS USA      NDA No.:
022063  Prod. No.: 001 RX (3.125MG;3.125MG;3.125MG;3.125MG); 002 RX (6.25MG;6.25MG;6.25MG;6.25MG); 003 RX (9.375MG;9.375MG;9.375MG;9.375MG); 004 RX (12.5MG;12.5MG;12.5MG;12.5MG)
PatentsExpirationPatented Use
Pat. No. 8846100 DP* Controlled dose drug delivery system
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 7, 2017
Aug 24, 2029 
Pat. No. 9173857 Controlled dose drug delivery system
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 7, 2017
May 12, 2026U-2025: Treatment of attention deficit hyperactivity disorder

androgen
ANDROGEL (GEL, METERED) (TRANSDERMAL) TESTOSTERONE [GENERIC AB]
Drug Classes: androgen
NDA Applicant: BESINS HLTHCARE      NDA No.:
022309  Prod. No.: 001 RX (1.62% (20.25MG/1.25GM ACTUATION)) NDA No.: 022309  Prod. No.: 002 DISC (1.62% (20.25MG/1.25GM PACKET)**); 003 DISC (1.62% (40.5MG/2.5GM PACKET)**)
PatentsExpirationPatented Use
Pat. No. 8466136 DP* Testosterone gel and method of use
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jun 24, 2013
Oct 12, 2026 
Pat. No. 8466137 Testosterone gel and method of use
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 24, 2013
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
Pat. Sub. Date(s): All strengths: Jun 24, 2013
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
Pat. Sub. Date(s): All strengths: Jul 19, 2013
Oct 12, 2026 
Pat. No. 8729057 DP* Testosterone gel and method of use
Claim Types: Composition
Pat. Sub. Date(s): 001: None; 002: Jun 13, 2014; 003: Jun 13, 2014
Oct 12, 2026 
Pat. No. 8741881 Testosterone gel and method of use
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 25, 2014
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
Pat. Sub. Date(s): All strengths: Jul 16, 2014
Oct 12, 2026 
Pat. No. 8759329 DP* Testosterone gel and method of use
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 9, 2014
Oct 12, 2026 

androgen
AVEED (INJECTABLE) (INTRAMUSCULAR) 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
Pat. Sub. Date(s): 001: None
Mar 14, 2027 
Pat. No. 8338395 [Extended 435 days (1.2 years)]
Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: None
May 8, 2027U-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) (TRANSDERMAL) TESTOSTERONE
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
Pat. Sub. Date(s): 001: Apr 30, 2013
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
Pat. Sub. Date(s): 001: None
Sep 27, 2027U-1390: A method of increasing the testosterone blood level of an adult male subject in need thereof
Pat. No. 8807861 DP* Spreading implement
Claim Types: Device; Drug in a container; Method of use
Pat. Sub. Date(s): 001: Sep 10, 2014
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
Pat. Sub. Date(s): 001: Apr 9, 2015
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
Pat. Sub. Date(s): 001: Dec 3, 2015
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
Pat. Sub. Date(s): 001: Apr 19, 2016
Feb 26, 2027U-1390: A method of increasing the testosterone blood level of an adult male subject in need thereof

androgen
JATENZO (CAPSULE) (ORAL) TESTOSTERONE UNDECANOATE
Drug Classes: androgen
NDA Applicant: TOLMAR      NDA No.:
206089  Prod. No.: 001 RX (158MG); 002 RX (198MG); 003 RX (237MG)
PatentsExpirationPatented Use
Pat. No. 8241664 DP* Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Apr 8, 2019
Mar 29, 2029U-2506: Method of treating testosterone deficiency
Pat. No. 8492369 DP* Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Apr 8, 2019
Dec 20, 2030U-2506: Method of treating testosterone deficiency
Pat. No. 8778916 DP* Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Apr 8, 2019
Apr 12, 2030 
Pat. No. 10543219 Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 18, 2020
Apr 12, 2030U-2506: Method of treating testosterone deficiency
Pat. No. 10617696 DS* DP* Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 5, 2020
Apr 12, 2030 
Pat. No. 11179402 DS* DP* Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Dec 21, 2021
Apr 14, 2026 
Pat. No. 11179403 Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 21, 2021
Apr 12, 2030U-2506: Method of treating testosterone deficiency
Pat. No. 11331325 Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 2, 2022
Jan 6, 2027U-2506: Method of treating testosterone deficiency
Pat. No. 11426416 Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 12, 2022
Apr 12, 2030U-3420: A method of treating testosterone deficiency in men
Pat. No. 11564933 Methods of treating testosterone deficiency
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 10, 2023
Apr 12, 2039U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone

androgen
KYZATREX (CAPSULE) (ORAL) TESTOSTERONE UNDECANOATE
Drug Classes: androgen
NDA Applicant: MARIUS PHARMS LLC      NDA No.:
213953  Prod. No.: 001 RX (100MG); 002 RX (150MG); 003 RX (200MG)
PatentsExpirationPatented Use
Pat. No. 10576089 DP* Modulation of solubility, stability, absorption, metabolism, and pharmacokinetic profile of lipophilic drugs by sterols
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 26, 2022
Dec 31, 2030U-2506: Method of treating testosterone deficiency
Pat. No. 10576090 DP* Modulation of solubility, stability, absorption, metabolism, and pharmacokinetic profile of lipophilic drugs by sterols
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Aug 26, 2022
Dec 31, 2030 
Pat. No. 11590146 DP* Modulation of solubility, stability, absorption, metabolism, and pharmacokinetic profile of lipophilic drugs by sterols
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 31, 2023
Dec 31, 2030 
Pat. No. 11617758 DP* Emulsion formulations
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: May 31, 2023
Mar 15, 2033U-2506: Method of treating testosterone deficiency
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productJul 27, 2025 

androgen
NATESTO (GEL, METERED) (NASAL) TESTOSTERONE
Drug Classes: androgen
NDA Applicant: ACERUS      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
Pat. Sub. Date(s): 001: Jun 26, 2014
Feb 4, 2024 
Pat. No. 8784869 DP* Controlled release delivery system for nasal applications and methods of treatment
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 20, 2014
Feb 4, 2024 
Pat. No. 8784882 DP* Controlled release delivery system for nasal applications and method of treatment
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 20, 2014
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
Pat. Sub. Date(s): 001: Dec 3, 2014
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
Pat. No. 11090312 Methods of treating hypogonadism with transnasal testerosterone bio-adhesive gel formulations in male with allergic rhinitis, and methods for preventing an allergic rhinitis event
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Sep 10, 2021
Mar 17, 2034U-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
TESTIM (GEL) (TRANSDERMAL) 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
Pat. Sub. Date(s): 001: None
Jan 18, 2025U-843: Method for administration of testosterone

androgen
TESTOSTERONE CYPIONATE (SOLUTION) (INTRAMUSCULAR) TESTOSTERONE CYPIONATE
Drug Classes: androgen
NDA Applicant: SLAYBACK PHARMA LLC      NDA No.:
216318  Prod. No.: 001 DISC (200MG/ML (200MG/ML))
PatentsExpirationPatented Use
Pat. No. 11311554 DP* Pharmaceutical compositions of testosterone
Claim Types: Formulation; Process; Method of use
Pat. Sub. Date(s): 001: Jun 3, 2022
Mar 25, 2039 
Pat. No. 11642355 DP* Pharmaceutical compositions of testosterone
Claim Types: Formulation; Device
Pat. Sub. Date(s): 001: May 12, 2023
Mar 25, 2039 

androgen
TLANDO (CAPSULE) (ORAL) TESTOSTERONE UNDECANOATE
Drug Classes: androgen
NDA Applicant: VERITY      NDA No.:
208088  Prod. No.: 001 RX (112.5MG)
PatentsExpirationPatented Use
Pat. No. 8778922 DP* Steroidal compositions
Claim Types: Formulation; Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): 001: Apr 27, 2022
Jan 8, 2029U-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).
Pat. No. 8865695 Steroidal compositions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 27, 2022
Jan 8, 2029U-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).
Pat. No. 9943527 High-strength testosterone undecanoate compositions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 27, 2022
Nov 30, 2030U-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).
Pat. No. 9949985 High-strength testosterone undecanoate compositions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 27, 2022
Nov 30, 2030U-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).
Pat. No. 10226473 High-strength testosterone undecanoate compositions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 27, 2022
Nov 30, 2030U-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).
Pat. No. 10716794 High-strength testosterone undecanoate compositions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 27, 2022
Nov 30, 2030U-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).
Pat. No. 11304960 DP* Steroidal compositions
Claim Types: Formulation; Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): 001: Apr 27, 2022
Jan 8, 2029U-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).
Pat. No. 11311555 High-strength testosterone undecanoate compositions
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 26, 2022
Nov 30, 2030U-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).
Pat. No. 11364249 High-strength testosterone undecanoate compositions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 19, 2022
Nov 30, 2030U-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).
Pat. No. 11433083 High-strength testosterone undecanoate compositions
Claim Types: Dosaage regimen
Pat. Sub. Date(s): 001: Oct 6, 2022
Nov 30, 2030U-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).
Pat. No. 11464735 DP* Fixed dose oral testosterone undecanoate compositions and use thereof
Claim Types: Dosaage regimen
Pat. Sub. Date(s): 001: Nov 10, 2022
Apr 28, 2041U-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).
Pat. No. 11559530 Oral testosterone undecanoate therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 14, 2023
Nov 28, 2037U-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).
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productMar 28, 2025 

androgen
VOGELXO (GEL; GEL, METERED) (TRANSDERMAL) 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
Pat. Sub. Date(s): All strengths: Jul 22, 2014
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
Pat. Sub. Date(s): All strengths: Mar 30, 2016
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
Pat. Sub. Date(s): All strengths: Jun 21, 2017
Feb 11, 2034U-1531: Method for transdermal delivery of testosterone

androgen
XYOSTED (AUTOINJECTOR) (SOLUTION) (SUBCUTANEOUS) TESTOSTERONE ENANTHATE
Drug Classes: androgen
NDA Applicant: ANTARES PHARMA INC      NDA No.:
209863  Prod. No.: 001 RX (50MG/0.5ML (50MG/0.5ML)); 002 RX (75MG/0.5ML (75MG/0.5ML)); 003 RX (100MG/0.5ML (100MG/0.5ML))
PatentsExpirationPatented Use
Pat. No. 8021335 DP* Prefilled syringe jet injector
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 24, 2018
Oct 4, 2026 
Pat. No. 8562564 DP* Prefilled syringe jet injector
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 24, 2018
Jan 24, 2026 
Pat. No. 9180259 DP* Prefilled syringe jet injector
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 24, 2018
Jan 24, 2026 
Pat. No. 9533102 DP* Prefilled syringe jet injector
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 24, 2018
Jan 24, 2026 
Pat. No. 9629959 DP* Prefilled syringe jet injector
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 24, 2018
Jan 24, 2026 
Pat. No. 9744302 DP* Needle assisted jet injection device having reduced trigger force
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 24, 2018
Nov 19, 2035 
Pat. No. 9950125 DP* Needle assisted jet injection administration of testosterone compositions
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Oct 24, 2018
Sep 4, 2036U-2418: Method of administering testosterone enanthate subcutaneously
Pat. No. 10238662 DP* Needle assisted jet injection administration of testosterone compositions
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Jun 11, 2020
Feb 19, 2035U-2418: Method of administering testosterone enanthate subcutaneously
Pat. No. 10279131 DP* Injection device with cammed RAM assembly
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jun 11, 2020
Jul 31, 2031 
Pat. No. 10357609 DP* Needle assisted jet injection device having reduced trigger force
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jun 11, 2020
Aug 21, 2031 
Pat. No. 10478560 DP* Prefilled syringe injector
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jun 11, 2020
Jan 24, 2026 
Pat. No. 10646495 DP* Testosterone ester triglyceride formulations
Claim Types: Compound; Formulation
Pat. Sub. Date(s): All strengths: Jun 11, 2020
Aug 30, 2038 
Pat. No. 10821072 DP* Needle assisted jet injection administration of testosterone compositions
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Nov 23, 2020
Jun 4, 2033U-2418: Method of administering testosterone enanthate subcutaneously
Pat. No. 10881798 DP* Needle assisted injection device having reduced trigger force
Claim Types: Device
Pat. Sub. Date(s): All strengths: Feb 4, 2021
Feb 11, 2034 
Pat. No. 10905827 DP* Injection device with cammed ram assembly
Claim Types: Device
Pat. Sub. Date(s): All strengths: Mar 2, 2021
Aug 21, 2031 
Pat. No. 10912782 DP* Needle assisted injection administration of testosterone compositions
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Mar 2, 2021
Feb 19, 2035U-2418: Method of administering testosterone enanthate subcutaneously
Pat. No. 11160751 DP* Hematocrit modulation through needle assisted jet injection of testosterone
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 6, 2022
Oct 7, 2034U-2418: Method of administering testosterone enanthate subcutaneously
Pat. No. 11191908 DP* Syringe shock absorber for use in an injection device
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 6, 2022
Oct 18, 2035 
Pat. No. 11446440 DP* Needle assisted injection device having reduced trigger force
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 7, 2022
Aug 21, 2031 
Pat. No. 11446441 DP* Prefilled syringe injector
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 7, 2022
Jan 24, 2026 
Pat. No. 11497753 DP* Hazardous agent injection system
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 14, 2022
Mar 19, 2030 
Pat. No. 11813435 DP* Needle assisted injection device having reduced trigger force
Claim Types: Device
Pat. Sub. Date(s): All strengths: Nov 22, 2023
Feb 25, 2035 
Pat. No. 11844804 Administration of testosterone compositions
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Jan 18, 2024
Jun 4, 2033U-2418: Method of administering testosterone enanthate subcutaneously

androgen receptor inhibitor
WINLEVI (CREAM) (TOPICAL) CLASCOTERONE
Drug Classes: androgen receptor inhibitor
NDA Applicant: SUN PHARM      NDA No.:
213433  Prod. No.: 001 RX (1%)
PatentsExpirationPatented Use
Pat. No. 8143240 17.alpha., 21-dihydroxypregnene esters as antiandrogenic agents
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 4, 2020
Jan 12, 2025U-2942: Method of treating acne vulgaris with topically applied cortexolone 17a-propionate
Pat. No. 8785427 DP* Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives
Claim Types: New polymorph, salt or hydrate; Process; Composition
Pat. Sub. Date(s): 001: Sep 4, 2020
Jul 25, 2030 
Pat. No. 8865690 17alfa, 21-dihydroxypregnene esters as antiandrogenic agents
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 4, 2020
Jul 24, 2024U-2942: Method of treating acne vulgaris with topically applied cortexolone 17a-propionate
Pat. No. 9211295 DP* 17 alpha, 21-dihydroxypregnene esters as antiandrogenic agents
Claim Types: Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 4, 2020
Jul 24, 2024 
Pat. No. 9433628 DP* Enzymatic process for obtaining 17.alpha.-monoesters of cortexolone and/or its 9,11-dehydroderivatives
Claim Types: New polymorph, salt or hydrate; Process; Product-by-process; Composition
Pat. Sub. Date(s): 001: Sep 4, 2020
Feb 28, 2029 
Pat. No. 9486458 Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 4, 2020
Jul 24, 2028U-2942: Method of treating acne vulgaris with topically applied cortexolone 17a-propionate
Pat. No. 10159682 Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 4, 2020
Aug 14, 2028U-2942: Method of treating acne vulgaris with topically applied cortexolone 17a-propionate
Pat. No. 11207332 DP* Enzymatic process for obtaining 17 .alpha.-monoesters of cortexolone and/or its 9,11-dehydroderivatives
Claim Types: Composition; Method of use
Pat. Sub. Date(s): 001: Jan 24, 2022
Nov 20, 2028U-3280: Method of treating acne vulgaris with topically applied cortexolone 17alpha-propionate
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityAug 26, 2025 

androgen receptor inhibitor
XTANDI (CAPSULE) (ORAL) 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
Pat. Sub. Date(s): 001: Sep 27, 2012
Aug 13, 2027 
Pat. No. 8183274 [Extended 101 days (0.3 years)]
Treatment of hyperproliferative disorders with diarylhydantoin compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 27, 2012
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).
U-2345: Treatment of patients with castration-resistant prostate cancer (CRPC)
U-2708: The treatment of patients with metastatic castration-sensitive prostate cancer
U-3763: Treatment of patients with non-metastatic castration-sensitive prostate cancer (NMCSPC) with biochemical recurrence (BCR) at high risk for metastasis
Pat. No. 9126941 Treatment of hyperproliferative disorders with diarylhydantoin compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 7, 2015
May 15, 2026U-1588: The treatment of patients with metastatic castration-resistant prostate cancer (CRPC).
U-2345: Treatment of patients with castration-resistant prostate cancer (CRPC)
U-2708: The treatment of patients with metastatic castration-sensitive prostate cancer
U-3763: Treatment of patients with non-metastatic castration-sensitive prostate cancer (NMCSPC) with biochemical recurrence (BCR) at high risk for metastasis
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationNov 17, 2026I-926: Treatment of patients with non-metastatic castration-sensitive prostate cancer (nmcspc) with biochemical recurrence at high risk for metastasis

androgen receptor inhibitor
XTANDI (TABLET) (ORAL) ENZALUTAMIDE
Drug Classes: androgen receptor inhibitor
NDA Applicant: ASTELLAS      NDA No.:
213674  Prod. No.: 001 RX (40MG); 002 RX (80MG)
PatentsExpirationPatented Use
Pat. No. 7709517 DS* DP* Diarylhydantoin compounds
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Sep 3, 2020
Aug 13, 2027 
Pat. No. 8183274 [Extended 101 days (0.3 years)]
Treatment of hyperproliferative disorders with diarylhydantoin compounds
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 3, 2020
Aug 24, 2026U-2345: Treatment of patients with castration-resistant prostate cancer (CRPC)
U-2708: The treatment of patients with metastatic castration-sensitive prostate cancer
U-3763: Treatment of patients with non-metastatic castration-sensitive prostate cancer (NMCSPC) with biochemical recurrence (BCR) at high risk for metastasis
Pat. No. 9126941 Treatment of hyperproliferative disorders with diarylhydantoin compounds
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 3, 2020
May 15, 2026U-2345: Treatment of patients with castration-resistant prostate cancer (CRPC)
U-2708: The treatment of patients with metastatic castration-sensitive prostate cancer
U-3763: Treatment of patients with non-metastatic castration-sensitive prostate cancer (NMCSPC) with biochemical recurrence (BCR) at high risk for metastasis
Pat. No. 11839689 DP* Formulations of enzalutamide
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Dec 19, 2023
Sep 11, 2033 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationNov 17, 2026I-926: Treatment of patients with non-metastatic castration-sensitive prostate cancer (nmcspc) with biochemical recurrence at high risk for metastasis

angiotensin converting enzyme (ACE) inhibitor
QBRELIS (SOLUTION) (ORAL) LISINOPRIL
Drug Classes: angiotensin converting enzyme (ACE) inhibitor
NDA Applicant: AZURITY      NDA No.:
208401  Prod. No.: 001 RX (1MG/ML)
PatentsExpirationPatented Use
Pat. No. 9463183 DP* Lisinopril formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 13, 2016
Nov 6, 2035 
Pat. No. 9616096 Lisinopril formulations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 14, 2017
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 myocardial 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
Pat. Sub. Date(s): 001: Nov 21, 2017
Nov 6, 2035 
Pat. No. 10039800 Lisinopril formulations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 23, 2018
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 myocardial infarction
U-3: Treatment of hypertension
U-71: Method of treatment of heart failure
U-8: Acute myocardial infarction
Pat. No. 10265370 DP* Lisinopril formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 29, 2019
Nov 6, 2035 
Pat. No. 10406199 Lisinopril formulations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 20, 2019
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 myocardial infarction
U-3: Treatment of hypertension
U-71: Method of treatment of heart failure
U-8: Acute myocardial infarction
Pat. No. 10940177 DP* Lisinopril formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 15, 2021
Nov 6, 2035 
Pat. No. 11179434 DP* Lisinopril formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 23, 2021
Nov 6, 2035 
Pat. No. 11771733 DP* Lisinopril formulations
Claim Types: Formulation; Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): 001: Oct 4, 2023
Nov 6, 2035 

angiotensin II receptor blocker
BYVALSON (TABLET) (ORAL) NEBIVOLOL HYDROCHLORIDE; VALSARTAN [Has competitive generic]
Drug Classes: beta-adrenergic receptor inhibitor == angiotensin II receptor blocker
NDA Applicant: ABBVIE      NDA No.:
206302  Prod. No.: 001 DISC (EQ 5MG BASE;80MG)
PatentsExpirationPatented Use
Pat. No. 7803838 DP* Compositions comprising nebivolol
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 5, 2016
Aug 29, 2026 
Pat. No. 7838552 Compositions comprising nebivolol
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 5, 2016
Oct 4, 2027U-185: Method of treating hypertension

angiotensin II receptor blocker
DIOVAN (TABLET) (ORAL) VALSARTAN [GENERIC AB]
Drug Classes: angiotensin II receptor blocker
NDA Applicant: NOVARTIS      NDA No.:
021283  Prod. No.: 001 RX (80MG); 002 RX (160MG); 004 RX (40MG)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationApr 19, 2024 

angiotensin II receptor blocker
EDARBI (TABLET) (ORAL) AZILSARTAN KAMEDOXOMIL
Drug Classes: angiotensin II receptor blocker
NDA Applicant: AZURITY      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
Pat. Sub. Date(s): All strengths: None
May 22, 2025 
Pat. No. 7572920 DP* Benzimidazole derivative and use as a II receptor antagonist
Claim Types: Composition; Method of use; Formulation; Process
Pat. Sub. Date(s): All strengths: None
Jan 7, 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
Pat. Sub. Date(s): All strengths: Jul 30, 2015
Mar 26, 2028 

angiotensin II receptor blocker
EDARBYCLOR (TABLET) (ORAL) AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE
Drug Classes: angiotensin II receptor blocker == thiazide-like diuretic
NDA Applicant: AZURITY      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
Pat. Sub. Date(s): 001: Jan 17, 2012; 002: None
May 22, 2025 
Pat. No. 7572920 DP* Benzimidazole derivative and use as a II receptor antagonist
Claim Types: Composition; Method of use; Formulation; Process
Pat. Sub. Date(s): 001: Jan 17, 2012; 002: None
Jan 7, 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
Pat. Sub. Date(s): All strengths: Jul 30, 2015
Mar 26, 2028 
Pat. No. 9169238 DP* Solid pharmaceutical composition
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Nov 19, 2015
Feb 4, 2030 
Pat. No. 9387249 Methods of treating hypertension with at least one angiotensin II receptor blocker and chlorthalidone
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 15, 2019
Jul 1, 2031U-3: Treatment of hypertension

angiotensin II receptor blocker
ENTRESTO (TABLET) (ORAL) SACUBITRIL; VALSARTAN
Drug Classes: 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
Pat. Sub. Date(s): All strengths: Aug 6, 2015
May 27, 2024 *PED 
Pat. No. 8101659 DP* [Extended 732 days (2 years)]
Methods of treatment and pharmaceutical composition
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Aug 6, 2015
Jul 15, 2025 *PED 
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
Pat. Sub. Date(s): All strengths: Aug 6, 2015
Nov 27, 2027 *PED 
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
Pat. Sub. Date(s): All strengths: Sep 7, 2016
May 8, 2027 *PEDU-1723: Treatment of heart failure
Pat. No. 9517226 Inhibitors for treating diseases characterized by atrial enlargement or remodeling
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 16, 2021
Aug 22, 2033U-3084: Treatment of heart failure with preserved ejection fraction
Pat. No. 9937143 Inhibitors for treating diseases characterized by atrial enlargement or remodeling
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 16, 2021
Aug 22, 2033U-3084: Treatment of heart failure with preserved ejection fraction
Pat. No. 11058667 Sacubitril-valsartan dosage regimen for treating heart failure
Claim Types: Dosaage regimen
Pat. Sub. Date(s): All strengths: Jul 13, 2021
May 9, 2036U-3170: Treating chronic heart failure with reduced ejection fraction in patients not taking an ACE inhibitor or an ARB or previously taking low doses of these agents, by titrating up from half the usually recommended starting dose
Pat. No. 11135192 Inhibitors for treating diseases characterized by atrial enlargement or remodeling
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 18, 2021
Aug 22, 2033U-3084: Treatment of heart failure with preserved ejection fraction
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousFeb 16, 2024M-82: Labeling revisions related to clinical studies

angiotensin II receptor blocker
VALTURNA (TABLET) (ORAL) 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. 8168616 DP* Combination comprising a renin inhibitor and an angiotensin receptor inhibitor for hypertension
Claim Types: Composition
Pat. Sub. Date(s): All strengths: Jun 6, 2012
Jul 3, 2026 

anthelmintic
EGATEN (TABLET) (ORAL) TRICLABENDAZOLE
Drug Classes: anthelmintic
NDA Applicant: NOVARTIS      NDA No.:
208711  Prod. No.: 001 RX (250MG)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityFeb 13, 2024 
Exclusivity Code: ODE - Orphan drug exclusivityFeb 13, 2026ODE-228: Indicated for the treatment of fascioliasis in patients 6 years of age and older


DS*=Drug Substance and DP*=Drug Product: patent submitted for the product after Aug. 18, 2003.
** Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
DLR* NDA holder has requested delisting of the patent. However, FDA will not delist if doing so would adversely affect an ANDA applicant's eligibility for 180-day generic exclusivity. ANDA applicants must provide a patent certification for the patent, but 505(b)(2) applicants do not need to do so.
Last edited: 13 February 2024
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