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.
| Patents | Expiration | Patented 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, 2037 | U-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, 2038 | U-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, 2038 | U-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, 2037 | U-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, 2037 | U-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, 2037 | U-3334: A method of transdermal delivery of donepezil for treating mild, moderate and severe dementia of the Alzheimer's type |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Mar 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)
| Patents | Expiration | Patented 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
Drug Classes: acetylcholinesterase inhibitor == N-methyl-D-aspartate (NMDA) receptor antagonist
NDA Applicant: ABBVIE NDA No.: 206439 Prod. No.: 001 RX (10MG;14MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8039009 Modified release formulations of memantine oral dosage forms Claim Types: Method of use Pat. Sub. Date(s): 001: None | Sep 24, 2029 *PED | U-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 | Dec 5, 2029 | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8168209 DP* DLR* Method and composition for administering an NMDA receptor antagonist to a subject Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 22, 2015 | May 22, 2026 *PED | |
| Pat. No. 8173708 DLR* 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 | May 22, 2026 *PED | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8283379 DLR* Methods and compositions for the treatment of CNS-related conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 22, 2015 | May 22, 2026 *PED | U-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 | Nov 22, 2025 | |
| Pat. No. 8338485 DP* Compositions for the treatment of CNS-related conditions Claim Types: Formulation Pat. Sub. Date(s): 001: 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 | Nov 22, 2025 | U-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 | Nov 22, 2025 | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
acetylcholinesterase inhibitor
NAMZARIC (CAPSULE, EXTENDED RELEASE) (ORAL) DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Drug Classes: acetylcholinesterase inhibitor == N-methyl-D-aspartate (NMDA) receptor antagonist
NDA Applicant: ABBVIE NDA No.: 206439 Prod. No.: 002 RX (10MG;28MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8039009 Modified release formulations of memantine oral dosage forms Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 22, 2015 | Sep 24, 2029 *PED | U-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): 002: Jan 22, 2015 | Dec 5, 2029 | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8168209 DP* DLR* Method and composition for administering an NMDA receptor antagonist to a subject Claim Types: Formulation Pat. Sub. Date(s): 002: Jan 22, 2015 | May 22, 2026 *PED | |
| Pat. No. 8173708 DLR* Method and composition for administering an NMDA receptor antagonist to a subject Claim Types: Method of administration Pat. Sub. Date(s): 002: Jan 22, 2015 | May 22, 2026 *PED | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8283379 DLR* Methods and compositions for the treatment of CNS-related conditions Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 22, 2015 | May 22, 2026 *PED | U-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): 002: Jan 22, 2015 | Nov 22, 2025 | |
| Pat. No. 8329752 DP* DLR* Composition for administering an NMDA receptor antagonist to a subject Claim Types: Formulation Pat. Sub. Date(s): 002: Jan 22, 2015 | May 22, 2026 *PED | |
| Pat. No. 8338485 DP* Compositions for the treatment of CNS-related conditions Claim Types: Formulation Pat. Sub. Date(s): 002: Jan 22, 2015 | Nov 22, 2025 | |
| Pat. No. 8338486 Methods for the treatment of CNS-related conditions Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 22, 2015 | Nov 22, 2025 | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8362085 DLR* Method for administering an NMDA receptor antagonist to a subject Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 22, 2015 | May 22, 2026 *PED | U-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): 002: Jan 22, 2015 | Nov 22, 2025 | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8598233 DP* DLR* Method for administering an NMDA receptor antagonist to a subject Claim Types: Formulation Pat. Sub. Date(s): 002: Jan 22, 2015 | May 22, 2026 *PED |
acetylcholinesterase inhibitor
NAMZARIC (CAPSULE, EXTENDED RELEASE) (ORAL) DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Drug Classes: acetylcholinesterase inhibitor == N-methyl-D-aspartate (NMDA) receptor antagonist
NDA Applicant: ABBVIE NDA No.: 206439 Prod. No.: 003 RX (10MG;7MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8039009 Modified release formulations of memantine oral dosage forms Claim Types: Method of use Pat. Sub. Date(s): 003: Aug 16, 2016 | Sep 24, 2029 *PED | U-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): 003: Aug 16, 2016 | Dec 5, 2029 | U-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): 003: Aug 16, 2016 | Nov 22, 2025 | |
| Pat. No. 8338485 DP* Compositions for the treatment of CNS-related conditions Claim Types: Formulation Pat. Sub. Date(s): 003: 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): 003: Aug 16, 2016 | Nov 22, 2025 | U-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): 003: Aug 16, 2016 | Nov 22, 2025 | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
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.: 004 RX (10MG;21MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8039009 Modified release formulations of memantine oral dosage forms Claim Types: Method of use Pat. Sub. Date(s): 004: Aug 16, 2016 | Sep 24, 2029 *PED | U-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): 004: Aug 16, 2016 | Dec 5, 2029 | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8168209 DP* DLR* Method and composition for administering an NMDA receptor antagonist to a subject Claim Types: Formulation Pat. Sub. Date(s): 004: Aug 16, 2016 | May 22, 2026 *PED | |
| Pat. No. 8173708 DLR* Method and composition for administering an NMDA receptor antagonist to a subject Claim Types: Method of administration Pat. Sub. Date(s): 004: Aug 16, 2016 | May 22, 2026 *PED | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8283379 DLR* Methods and compositions for the treatment of CNS-related conditions Claim Types: Method of use Pat. Sub. Date(s): 004: Aug 16, 2016 | May 22, 2026 *PED | U-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): 004: Aug 16, 2016 | Nov 22, 2025 | |
| Pat. No. 8329752 DP* DLR* Composition for administering an NMDA receptor antagonist to a subject Claim Types: Formulation Pat. Sub. Date(s): 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): 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): 004: Aug 16, 2016 | Nov 22, 2025 | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8362085 DLR* Method for administering an NMDA receptor antagonist to a subject Claim Types: Method of use Pat. Sub. Date(s): 004: Aug 16, 2016 | May 22, 2026 *PED | U-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): 004: Aug 16, 2016 | Nov 22, 2025 | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8598233 DP* DLR* Method for administering an NMDA receptor antagonist to a subject Claim Types: Formulation Pat. Sub. Date(s): 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))
| Patents | Expiration | Patented 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)
| Patents | Expiration | Patented 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)
| Patents | Expiration | Patented 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 | |
| Pat. No. 9839619 DP* Method for treating ADD or ADHD comprising administering amphetamine complexed with ion-exchange resin particles Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 22, 2024 | 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)
| Patents | Expiration | Patented 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, 2036 | U-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)
| Patents | Expiration | Patented 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, 2038 | U-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 DISC (5MG); 002 DISC (10MG); 003 DISC (15MG); 004 DISC (20MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10130580 DP* Taste-masked pharmaceutical compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jan 31, 2019 | Apr 19, 2024 | |
| Pat. No. 10441554 DP* Oral amphetamine composition Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 15, 2019 | 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 | |
| Pat. No. 11896562 Oral amphetamine composition Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 16, 2024 | Mar 10, 2037 | U-3299: Treatment of attention deficit hyperactivity disorder (ADHD) in pediatric patients |
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.: 005 DISC (2.5MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10130580 DP* Taste-masked pharmaceutical compositions Claim Types: Formulation Pat. Sub. Date(s): 005: Jul 7, 2021 | Apr 19, 2024 | |
| Pat. No. 10441554 DP* Oral amphetamine composition Claim Types: Formulation Pat. Sub. Date(s): 005: Jul 7, 2021 | Mar 10, 2037 | |
| Pat. No. 11160772 DP* Oral amphetamine composition Claim Types: Formulation Pat. Sub. Date(s): 005: 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)
| Patents | Expiration | Patented 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, 2026 | U-2025: Treatment of attention deficit hyperactivity disorder |
adrenocorticotropic hormone
ACTHAR GEL (AUTOINJECTOR) (INJECTABLE) (INJECTION) CORTICOTROPIN
Drug Classes: adrenocorticotropic hormone
NDA Applicant: MALLINCKRODT ARD NDA No.: 008372 Prod. No.: 003 RX (40 UNITS/0.5ML); 004 RX (80 UNITS/ML); 008 RX (80 UNITS/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11752199 Methods of modulating pericytes Claim Types: Method of use Pat. Sub. Date(s): 003: Jul 31, 2024; 004: Jul 31, 2024; 008: Sep 21, 2023 | Feb 25, 2041 | U-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 |
adrenocorticotropic hormone
PURIFIED CORTROPHIN GEL (INJECTABLE) (INJECTION) CORTICOTROPIN
Drug Classes: adrenocorticotropic hormone
NDA Applicant: ANI PHARMS NDA No.: 008975 Prod. No.: 001 DISC (40 UNITS/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 12102662 Methods For Storing And Warming Purified Corticotropin Compositions Claim Types: Process Pat. Sub. Date(s): 001: Oct 4, 2024 | Oct 27, 2043 | U-3904: Acute exacerbations of multiple sclerosis U-3905: Allergic conjunctivitis U-3906: Anterior segment inflammation U-3907: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: acute gouty arthritis U-3908: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: ankylosing spondylitis U-3909: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: juvenile rheumatoid arthritis U-3910: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis U-3911: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: rheumatoid arthritis U-3912: Atopic dermatitis U-3913: Chorioretinitis U-3914: Diffuse posterior uveitis and choroiditis U-3915: During an exacerbation or as maintenance therapy in selected cases of: systemic dermatomyositis (polymyositis) U-3916: During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus U-3917: Iridocyclitis U-3918: Iritis U-3919: Keratitis U-3920: Optic neuritis U-3921: Serum sickness U-3922: Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa U-3923: Severe erythema multiforme (stevens-johnson syndrome) U-3924: Severe psoriasis U-3925: Symptomatic sarcoidosis U-3926: To induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus |
adrenocorticotropic hormone
PURIFIED CORTROPHIN GEL (INJECTABLE) (INJECTION) CORTICOTROPIN
Drug Classes: adrenocorticotropic hormone
NDA Applicant: ANI PHARMS NDA No.: 008975 Prod. No.: 002 RX (80 UNITS/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11975047 Methods for storing and warming purified corticotropin compositions Claim Types: Process Pat. Sub. Date(s): 002: May 17, 2024 | Oct 27, 2043 | U-3904: Acute exacerbations of multiple sclerosis U-3905: Allergic conjunctivitis U-3906: Anterior segment inflammation U-3907: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: acute gouty arthritis U-3908: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: ankylosing spondylitis U-3909: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: juvenile rheumatoid arthritis U-3910: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis U-3911: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: rheumatoid arthritis U-3912: Atopic dermatitis U-3913: Chorioretinitis U-3914: Diffuse posterior uveitis and choroiditis U-3915: During an exacerbation or as maintenance therapy in selected cases of: systemic dermatomyositis (polymyositis) U-3916: During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus U-3917: Iridocyclitis U-3918: Iritis U-3919: Keratitis U-3920: Optic neuritis U-3921: Serum sickness U-3922: Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa U-3923: Severe erythema multiforme (stevens-johnson syndrome) U-3924: Severe psoriasis U-3925: Symptomatic sarcoidosis U-3926: To induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus |
| Pat. No. 12102662 Methods For Storing And Warming Purified Corticotropin Compositions Claim Types: Process Pat. Sub. Date(s): 002: Oct 4, 2024 | Oct 27, 2043 | U-3904: Acute exacerbations of multiple sclerosis U-3905: Allergic conjunctivitis U-3906: Anterior segment inflammation U-3907: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: acute gouty arthritis U-3908: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: ankylosing spondylitis U-3909: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: juvenile rheumatoid arthritis U-3910: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis U-3911: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: rheumatoid arthritis U-3912: Atopic dermatitis U-3913: Chorioretinitis U-3914: Diffuse posterior uveitis and choroiditis U-3915: During an exacerbation or as maintenance therapy in selected cases of: systemic dermatomyositis (polymyositis) U-3916: During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus U-3917: Iridocyclitis U-3918: Iritis U-3919: Keratitis U-3920: Optic neuritis U-3921: Serum sickness U-3922: Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa U-3923: Severe erythema multiforme (stevens-johnson syndrome) U-3924: Severe psoriasis U-3925: Symptomatic sarcoidosis U-3926: To induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus |
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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9757394 DP* Spironolactone aqueous formulations Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 21, 2017 | Oct 28, 2036 | U-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, 2036 | U-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: ENDO OPERATIONS NDA No.: 208678 Prod. No.: 001 RX (0.6MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: PC - Patent challenge | Apr 29, 2024 |
alkaloid
COLCRYS (TABLET) (ORAL) COLCHICINE [Has competitive generic]
Drug Classes: alkaloid
NDA Applicant: TAKEDA PHARMS USA NDA No.: 022352 Prod. No.: 001 DISC (0.6MG)
| Patents | Expiration | Patented 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, 2029 | U-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, 2028 | U-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, 2029 | U-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, 2029 | U-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, 2029 | U-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, 2028 | U-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, 2028 | U-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, 2028 | U-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, 2028 | U-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, 2028 | U-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, 2028 | U-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, 2028 | U-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, 2028 | U-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, 2028 | U-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, 2028 | U-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, 2029 | U-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, 2029 | U-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)
| Patents | Expiration | Patented 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, 2036 | U-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)
| Patents | Expiration | Patented 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 | Nov 1, 2033 | U-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 | May 9, 2034 | U-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 | Nov 1, 2033 | U-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 | Nov 1, 2033 | U-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 | Nov 1, 2033 | U-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 | Nov 1, 2033 | U-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 | Nov 1, 2033 | U-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 | Nov 1, 2033 | U-3638: A method for treating and/or reducing the risk of acute myocardial infarction |
| Pat. No. 11944594 Treatment or prevention of cardiovascular events via the administration of a colchicine derivative Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Apr 3, 2024 | Nov 1, 2033 | U-3864: Method for reducing a risk of at least one cardiovascular event |
| Pat. No. 11944595 Treatment or prevention of cardiovascular events via the administration of a colchicine derivative Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Apr 5, 2024 | Nov 1, 2033 | U-3867: Method for reducing a composite endpoint risk of myocardial infarction (MI), stroke, coronary revascularization, unstable angina requiring hospitalization, cardiac arrest, and cardiovascular death U-3868: Method for reducing acute myocardial infarction risk |
alkaloid
MITIGARE (CAPSULE) (ORAL) COLCHICINE [GENERIC AB]
Drug Classes: alkaloid
NDA Applicant: HIKMA INTL PHARMS NDA No.: 204820 Prod. No.: 001 RX (0.6MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8927607 Methods of colchicine administration Claim Types: Method of administration Pat. Sub. Date(s): 001: Jan 20, 2015 | Aug 22, 2033 | U-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, 2033 | U-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, 2033 | U-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, 2033 | U-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, 2033 | U-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))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8609707 DP* Formulations of bendamustine Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 1, 2018 | Aug 11, 2031 | 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. 8791270 DP* Bendamustine pharmaceutical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 1, 2018 | Jan 12, 2026 | 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. 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, 2031 | 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. 9572797 Formulations of bendamustine Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 1, 2018 | Jan 28, 2031 | 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. 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, 2031 | 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. 11844783 Formulations of bendamustine Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 19, 2023 | Jan 28, 2031 | U-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) (INTRAVENOUS) BENDAMUSTINE HYDROCHLORIDE
Drug Classes: alkylating drug
NDA Applicant: EAGLE PHARMS NDA No.: 208194 Prod. No.: 001 RX (100MG/4ML (25MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8609707 DP* Formulations of bendamustine Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Dec 11, 2015 | Aug 11, 2031 | U-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, 2026 | U-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, 2033 | U-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, 2033 | U-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, 2033 | U-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, 2031 | 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. 9572797 Formulations of bendamustine Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 21, 2017 | Jan 28, 2031 | 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. 9572887 Formulations of bendamustine Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 21, 2017 | Mar 15, 2033 | 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. 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, 2033 | 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. 9597397 Formulations of bendamustine Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 21, 2017 | Mar 15, 2033 | 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. 9597398 Formulations of bendamustine Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 21, 2017 | Mar 15, 2033 | U-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, 2033 | 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. 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, 2033 | 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. 11103483 DP* Formulations of bendamustine Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 31, 2021 | Jan 28, 2031 | 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. 11844783 Formulations of bendamustine Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 19, 2023 | Jan 28, 2031 | U-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 [Has competitive generic]
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))
| Patents | Expiration | Patented 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: AVYXA HOLDINGS NDA No.: 210852 Prod. No.: 001 RX (500MG/ML (500MG/ML)); 002 RX (1GM/2ML (500MG/ML)); 003 RX (2GM/4ML (500MG/ML))
| Patents | Expiration | Patented 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 [GENERIC AP]
Drug Classes: alkylating drug
NDA Applicant: DR REDDYS NDA No.: 212501 Prod. No.: 001 RX (500MG/2.5ML (200MG/ML)); 002 RX (1GM/5ML (200MG/ML)); 003 RX (2GM/10ML (200MG/ML))
| Patents | Expiration | Patented 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)
| Patents | Expiration | Patented 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, 2030 | U-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)
| Patents | Expiration | Patented 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, 2032 | U-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, 2032 | U-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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Aug 14, 2026 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Aug 14, 2030 | ODE-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
IVRA (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))
| Patents | Expiration | Patented 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
JELMYTO (POWDER) (PYELOCALYCEAL) MITOMYCIN
Drug Classes: alkylating drug
NDA Applicant: UROGEN PHARMA NDA No.: 211728 Prod. No.: 001 RX (40MG/VIAL)
| Patents | Expiration | Patented 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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 15, 2027 | ODE-289: Indicated for the treatment of adult patients with low-grade upper tract urothelial cancer (LG-UTUC) |
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)
| Patents | Expiration | Patented 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, 2028 | U-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, 2029 | U-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
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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity | Jan 26, 2024 | ODE-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
TEPYLUTE (SOLUTION) (INTRAVENOUS) THIOTEPA
Drug Classes: alkylating drug
NDA Applicant: SHORLA NDA No.: 216984 Prod. No.: 001 RX (15MG/1.5ML (10MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11975013 DP* Stable formulations comprising thiotepa Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 25, 2024 | Aug 16, 2041 |
alkylating drug
TREANDA (POWDER) (INTRAVENOUS) BENDAMUSTINE HYDROCHLORIDE [GENERIC AP]
Drug Classes: alkylating drug
NDA Applicant: CEPHALON NDA No.: 022249 Prod. No.: 001 RX (100MG/VIAL); 002 RX (25MG/VIAL)
| Patents | Expiration | Patented 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 *PED | U-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 *PED | U-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 *PED | U-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 *PED | U-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 *PED | U-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) (INTRAVENOUS) 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))
| Patents | Expiration | Patented 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 *PED | U-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 *PED | U-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)
| Patents | Expiration | Patented 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, 2029 | U-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, 2026 | U-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: AZURITY NDA No.: 212209 Prod. No.: 001 RX (100MG/4ML (25MG/ML))
| Patents | Expiration | Patented 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)
| Patents | Expiration | Patented 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)
| Patents | Expiration | Patented 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, 2029 | U-2836: Treatment of adult patients with small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jun 15, 2025 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 15, 2027 | ODE-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%)
| Patents | Expiration | Patented 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, 2033 | U-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: ENDO OPERATIONS NDA No.: 204200 Prod. No.: 001 RX (EQ 1MG BASE/ML (EQ 1MG BASE/ML))
| Patents | Expiration | Patented 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, 2035 | U-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: ENDO OPERATIONS NDA No.: 204640 Prod. No.: 001 RX (EQ 30MG BASE/30ML (EQ 1MG BASE/ML))
| Patents | Expiration | Patented 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, 2035 | U-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: ENDO OPERATIONS 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))
| Patents | Expiration | Patented 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, 2039 | U-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 | |
| Pat. No. 12133837 DP* Epinephrine Compositions And Containers Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Nov 6, 2024 | 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)
| Patents | Expiration | Patented 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)
| Patents | Expiration | Patented 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)
| Patents | Expiration | Patented 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. 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)
| Patents | Expiration | Patented 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. 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, 2037 | U-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, 2037 | U-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, 2037 | U-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)
| Patents | Expiration | Patented 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. 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, 2024 | U-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, 2037 | U-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, 2037 | U-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, 2037 | U-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))
| Patents | Expiration | Patented 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, 2040 | U-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, 2040 | U-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, 2040 | U-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, 2040 | U-3183: Use of ephedrine sulfate for treating hypotension |
alpha adrenergic agonist
EMERPHED (SOLUTION) (INTRAVENOUS) EPHEDRINE SULFATE [Has competitive generic]
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))
| Patents | Expiration | Patented 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, 2040 | U-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: ENDO OPERATIONS NDA No.: 213994 Prod. No.: 001 RX (50MG/10ML (5MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10869845 DP* Ephedrine compositions and methods Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 22, 2020 | Jan 22, 2040 |
alpha adrenergic agonist
EPHEDRINE SULFATE (SOLUTION) (INTRAVENOUS) EPHEDRINE SULFATE [Has competitive generic]
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == norepinephrine-releasing agent
NDA Applicant: ENDO OPERATIONS NDA No.: 213994 Prod. No.: 002 RX (25MG/5ML (5MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10869845 DP* Ephedrine compositions and methods Claim Types: Formulation Pat. Sub. Date(s): 002: May 19, 2022 | Jan 22, 2040 | |
| Pat. No. 12029710 Ephedrine compositions and methods Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 16, 2024 | Jan 22, 2040 | U-3963: Treatment of clinically important hypotension occurring in the setting of anesthesia |
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))
| Patents | Expiration | Patented 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, 2034 | U-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, 2034 | U-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, 2034 | U-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)
| Patents | Expiration | Patented 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
NEFFY (SPRAY) (NASAL) EPINEPHRINE
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: ARS PHARMS OPERATION NDA No.: 214697 Prod. No.: 001 RX (2MG/SPRAY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10576156 DP* Compositions for drug administration Claim Types: Formulation; Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Aug 28, 2024 | Feb 6, 2038 | |
| Pat. No. 10682414 Intranasal epinephrine formulations and methods for the treatment of disease Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 28, 2024 | Feb 6, 2039 | U-3979: Nasal administration of epinephrine for the treatment of allergic reactions (type I), including anaphylaxis |
| Pat. No. 11173209 Compositions for drug administration Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 28, 2024 | Feb 6, 2038 | U-3979: Nasal administration of epinephrine for the treatment of allergic reactions (type I), including anaphylaxis |
| Pat. No. 11191838 DP* Intranasal epinephrine formulations and methods for the treatment of disease Claim Types: Method of use; Formulation Pat. Sub. Date(s): 001: Aug 28, 2024 | Feb 6, 2039 | U-3979: Nasal administration of epinephrine for the treatment of allergic reactions (type I), including anaphylaxis |
| Pat. No. 11717571 Intranasal epinephrine formulations and methods for the treatment of disease Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 28, 2024 | Feb 6, 2039 | U-3979: Nasal administration of epinephrine for the treatment of allergic reactions (type I), including anaphylaxis |
| Pat. No. 11744895 Intranasal epinephrine formulations and methods for the treatment of disease Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 28, 2024 | Feb 6, 2039 | U-3979: Nasal administration of epinephrine for the treatment of allergic reactions (type I), including anaphylaxis |
| Pat. No. 11918655 DP* Intranasal epinephrine formulations and methods for the treatment of disease Claim Types: Method of use; Formulation Pat. Sub. Date(s): 001: Aug 28, 2024 | Feb 6, 2039 | U-3979: Nasal administration of epinephrine for the treatment of allergic reactions (type I), including anaphylaxis |
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)
| Patents | Expiration | Patented 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
ONYDA XR (SUSPENSION, EXTENDED RELEASE) (ORAL) CLONIDINE HYDROCHLORIDE
Drug Classes: alpha adrenergic agonist == central alpha-2 adrenergic agonist
NDA Applicant: TRIS PHARMA INC NDA No.: 217645 Prod. No.: 001 RX (0.1MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8062667 DP* Modified release formulations containing drug-ion exchange resin complexes Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 12, 2024 | Mar 29, 2029 | |
| Pat. No. 11918689 DP* Liquid clonidine extended release composition Claim Types: Formulation; ; Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Jun 12, 2024 | Jul 28, 2041 | U-3944: Method for delivering an effective amount of clonidine for a 24-hour period using a single oral clonidine composition according to claim 1 prior to bed time |
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)
| Patents | Expiration | Patented 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))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11141540 DP* Syringe devices Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Jun 16, 2022 | Oct 20, 2036 | U-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: WAYLIS THERAP NDA No.: 022012 Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (40MG); 004 RX (80MG)
| Patents | Expiration | Patented 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)
| Patents | Expiration | Patented 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. 11400077 Methods and compositions for treatment of presbyopia, mydriasis, and other ocular disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 1, 2024 | Oct 25, 2039 | U-3804: Treatment of pharmacologically-induced mydriasis |
| 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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Sep 25, 2026 |
alpha adrenergic blocker
TEZRULY (SOLUTION) (ORAL) TERAZOSIN HYDROCHLORIDE
Drug Classes: alpha adrenergic blocker
NDA Applicant: NOVITIUM PHARMA NDA No.: 218139 Prod. No.: 001 RX (EQ 1MG BASE/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11224572 DP* Stable oral liquid composition of terazosin Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 24, 2024 | Jan 18, 2042 | U-3990: Treatment of hypertension in patients who are in need of a liquid composition of terazosin U-3991: Treatment of symptomatic benign prostatic hyperplasia (BPH) in patients who are in need of a liquid composition of terazosin |
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))
| Patents | Expiration | Patented 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%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10839960 Ophthalmic drug delivery Claim Types: Method of administration Pat. Sub. Date(s): 001: Sep 20, 2023 | Jul 15, 2031 | U-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, 2031 | U-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, 2031 | U-3685: Method of administering an effective dose of tropicamide and phenylephrine hydrochloride to an eye |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | May 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)
| Patents | Expiration | Patented 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 *PED | U-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 *PED | U-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%)
| Patents | Expiration | Patented 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, 2033 | U-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%)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Jul 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%)
| Patents | Expiration | Patented 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 [GENERIC OTC]
Drug Classes: alpha-adrenergic receptor agonist
NDA Applicant: BAUSCH AND LOMB INC NDA No.: 208144 Prod. No.: 001 OTC (0.025%)
| Patents | Expiration | Patented 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, 2030 | U-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, 2030 | U-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, 2029 | U-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, 2029 | U-2222: Relieves redness of the eye due to minor eye irritations |
alpha-adrenergic receptor agonist
LUMIFY PRESERVATIVE FREE (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE [GENERIC OTC]
Drug Classes: alpha-adrenergic receptor agonist
NDA Applicant: BAUSCH AND LOMB INC NDA No.: 218424 Prod. No.: 001 OTC (0.025%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8293742 Preferential vasoconstriction compositions and methods of use Claim Types: Method of use Pat. Sub. Date(s): 001: May 17, 2024 | Jul 14, 2030 | U-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: May 17, 2024 | Jul 14, 2030 | U-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: May 17, 2024 | Jul 27, 2029 | U-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)
| Patents | Expiration | Patented 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, 2025 | U-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, 2031 | U-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, 2025 | U-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, 2025 | U-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, 2031 | U-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, 2031 | U-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, 2024 | U-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, 2031 | U-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, 2031 | U-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%)
| Patents | Expiration | Patented 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%)
| Patents | Expiration | Patented 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%)
| Patents | Expiration | Patented 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, 2026 | U-1523: Method of inducing topical anesthesia in the eye |
amide local anesthetic
EXPAREL (INJECTABLE, LIPOSOMAL) (INJECTION) BUPIVACAINE [GENERIC AP]
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))
| Patents | Expiration | Patented 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, 2041 | U-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, 2041 | U-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, 2041 | U-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, 2041 | U-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, 2041 | U-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, 2041 | U-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, 2041 | U-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, 2041 | U-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, 2041 | U-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, 2041 | U-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. 11918565 Treatment of post-operative pain via sciatic nerve block with sustained-release liposomal anesthetic compositions Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Mar 20, 2024 | Feb 2, 2043 | U-3841: A method of administering bupivacaine to produce regional analgesia via sciatic nerve block in the popliteal fossa in adults |
| Pat. No. 11925706 DP* Manufacturing of bupivacaine multivesicular liposomes Claim Types: Formulation Pat. Sub. Date(s): All strengths: Mar 15, 2024 | Jan 22, 2041 | U-3380: Method of treating pain, for example, via infiltration for local analgesia or via interscalene brachial plexus nerve block for regional analgesia |
| Pat. No. 11931459 Treatment of pain in pediatric patients by administration of sustained-release liposomal anesthetic compositions Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 20, 2024 | Mar 17, 2042 | U-3839: A method of treating pain by administering bupivacaine via local infiltration in pediatric patients aged 6 to less than 12 years old undergoing cardiac surgery U-3840: A method of treating pain by administering bupivacaine via local infiltration in pediatric patients aged 6 to less than 17 years old undergoing spine surgery |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Nov 9, 2026 | I-929: Indicated to produce postsurgical regional analgesia in adults via a sciatic nerve block in the popliteal fossa and via an adductor canal block |
| Exclusivity Code: NPP - New patient population | Mar 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))
| Patents | Expiration | Patented 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: CRESCITA THERAP NDA No.: 021717 Prod. No.: 001 DISC (7%;7%)
| Patents | Expiration | Patented 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) (INFILTRATION) BUPIVACAINE
Drug Classes: amide local anesthetic
NDA Applicant: INNOCOLL NDA No.: 204803 Prod. No.: 001 RX (660MG/5ML (132MG/ML))
| Patents | Expiration | Patented 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, 2025 | U-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, 2025 | U-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, 2025 | U-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, 2041 | U-3724: To produce post-surgical analgesia |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Feb 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)
| Patents | Expiration | Patented 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, 2029 | U-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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Aug 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8540665 Particle cassettes and processes therefor Claim Types: Device; Process Pat. Sub. Date(s): 001: Oct 9, 2013 | Oct 22, 2029 | U-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, 2035 | U-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, 2035 | U-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%)
| Patents | Expiration | Patented 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, 2031 | U-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, 2031 | U-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, 2031 | U-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))
| Patents | Expiration | Patented 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, 2034 | U-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, 2035 | U-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, 2035 | U-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, 2034 | U-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, 2035 | U-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, 2035 | U-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, 2035 | U-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, 2035 | U-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, 2035 | U-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, 2035 | U-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, 2034 | U-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, 2035 | U-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, 2036 | U-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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jan 23, 2027 | I-933: Revisions to the labeling to expand the use in certain soft tissue and certain orthopedic surgical procedures as well as revising the limitations of use |
| Exclusivity Code: NP - New product | May 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)
| Patents | Expiration | Patented 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, 2025 | U-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, 2026 | U-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, 2026 | U-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, 2024 | U-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, 2034 | U-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, 2024 | U-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, 2035 | U-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, 2035 | U-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, 2035 | U-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, 2035 | U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen |
| Pat. No. 12016873 Methods for treating pulmonary non-tuberculous mycobacterial infections Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 22, 2024 | May 15, 2035 | U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Sep 28, 2030 GAIN | ODE-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)
| Patents | Expiration | Patented 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. 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, 2025 | U-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, 2028 | U-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, 2030 | U-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, 2024 | U-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%)
| Patents | Expiration | Patented 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, 2028 | U-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, 2027 | U-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)
| Patents | Expiration | Patented 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, 2026 | U-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)
| Patents | Expiration | Patented 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, 2033 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2040 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2040 | U-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, 2034 | U-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, 2040 | U-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, 2034 | U-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, 2034 | U-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, 2040 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2034 | U-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, 2043 | U-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, 2043 | U-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, 2043 | U-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, 2034 | U-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, 2043 | U-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, 2043 | U-3778: Treatment of major depressive disorder by administering dextromethorphan and bupropion to a subject having moderate hepatic impairment |
| Pat. No. 11883373 Treatment of depression in certain patient populations Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 8, 2024 | Jan 23, 2043 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11896563 Bupropion and dextromethorphan for reduction of suicide risk in depression patients Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 16, 2024 | Dec 1, 2041 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11925636 Bupropion dosage forms with reduced food and alcohol dosing effects Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 14, 2024 | Jan 20, 2043 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11969421 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: May 7, 2024 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11986444 Treatment of poor metabolizers of dextromethorphan with a combination of bupropion and dextromethorphan Claim Types: Method of use; Method of Use claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: May 31, 2024 | Feb 15, 2043 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 12036191 Treatment of poor metabolizers of dextromethorphan with a combination of bupropion and dextromethorphan Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 5, 2024 | Feb 15, 2043 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 12042473 Compounds and combinations thereof for treating neurological and psychiatric conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 5, 2024 | Feb 23, 2043 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 12109178 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 15, 2024 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Aug 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)
| Patents | Expiration | Patented 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, 2024 | U-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, 2027 | U-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, 2027 | U-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, 2024 | U-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, 2030 | U-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, 2027 | U-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, 2027 | U-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, 2032 | U-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, 2033 | U-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, 2034 | U-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, 2027 | U-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, 2033 | U-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, 2034 | U-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, 2034 | U-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, 2031 | U-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, 2033 | U-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, 2024 | U-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, 2029 | U-1583: For chronic weight management for treating overweight or obesity |
| Pat. No. 11998542 Compositions and methods for reducing major adverse cardiovascular events Claim Types: Method of administration Pat. Sub. Date(s): 001: Jul 5, 2024 | Jul 2, 2034 | U-1583: For chronic weight management for treating overweight or obesity |
| Pat. No. 12048769 Methods for administering weight loss medications Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Aug 19, 2024 | Nov 8, 2027 | U-1585: Use of naltrexone and bupropion based on an escalating dose schedule |
aminoketone
FORFIVO XL (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROCHLORIDE
Drug Classes: aminoketone
NDA Applicant: TWI PHARMS NDA No.: 022497 Prod. No.: 001 RX (450MG)
| Patents | Expiration | Patented 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))
| Patents | Expiration | Patented 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, 2029 | U-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, 2028 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 9133461 DS* DP* 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, 2033 | U-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, 2033 | U-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, 2034 | U-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, 2033 | U-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, 2028 | U-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, 2034 | U-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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Nov 20, 2024 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 20, 2026 | ODE-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)
| Patents | Expiration | Patented 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, 2030 | U-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)
| Patents | Expiration | Patented 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)
| Patents | Expiration | Patented 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 *PED | U-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 *PED | U-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**)
| Patents | Expiration | Patented 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, 2026 | U-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, 2026 | U-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, 2031 | U-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, 2026 | U-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)
| Patents | Expiration | Patented 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)
| Patents | Expiration | Patented 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)
| Patents | Expiration | Patented 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 | |
| Pat. No. 9839619 DP* Method for treating ADD or ADHD comprising administering amphetamine complexed with ion-exchange resin particles Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 22, 2024 | 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)
| Patents | Expiration | Patented 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, 2036 | U-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)
| Patents | Expiration | Patented 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, 2038 | U-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 DISC (5MG); 002 DISC (10MG); 003 DISC (15MG); 004 DISC (20MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10130580 DP* Taste-masked pharmaceutical compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jan 31, 2019 | Apr 19, 2024 | |
| Pat. No. 10441554 DP* Oral amphetamine composition Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 15, 2019 | 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 | |
| Pat. No. 11896562 Oral amphetamine composition Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 16, 2024 | Mar 10, 2037 | U-3299: Treatment of attention deficit hyperactivity disorder (ADHD) in pediatric patients |
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.: 005 DISC (2.5MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10130580 DP* Taste-masked pharmaceutical compositions Claim Types: Formulation Pat. Sub. Date(s): 005: Jul 7, 2021 | Apr 19, 2024 | |
| Pat. No. 10441554 DP* Oral amphetamine composition Claim Types: Formulation Pat. Sub. Date(s): 005: Jul 7, 2021 | Mar 10, 2037 | |
| Pat. No. 11160772 DP* Oral amphetamine composition Claim Types: Formulation Pat. Sub. Date(s): 005: 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)
| Patents | Expiration | Patented 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, 2026 | U-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)); 003 RX (1.62% (40.5MG/2.5GM PACKET)**) NDA No.: 022309 Prod. No.: 002 DISC (1.62% (20.25MG/1.25GM PACKET)**)
| Patents | Expiration | Patented 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, 2026 | U-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, 2026 | U-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, 2026 | U-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 OPERATIONS NDA No.: 022219 Prod. No.: 001 RX (750MG/3ML (250MG/ML))
| Patents | Expiration | Patented 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 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, 2027 | U-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**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8419307 Spreading implement Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 30, 2013 | Feb 26, 2027 | U-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, 2027 | U-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, 2027 | U-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, 2026 | U-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, 2026 | U-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, 2027 | U-1390: A method of increasing the testosterone blood level of an adult male subject in need thereof |
androgen
AZMIRO (SOLUTION) (INTRAMUSCULAR) TESTOSTERONE CYPIONATE
Drug Classes: androgen
NDA Applicant: AZURITY NDA No.: 216318 Prod. No.: 001 RX (200MG/ML (200MG/ML))
| Patents | Expiration | Patented 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
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)
| Patents | Expiration | Patented 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, 2029 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2027 | U-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, 2030 | U-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, 2039 | U-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)
| Patents | Expiration | Patented 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, 2030 | U-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, 2033 | U-2506: Method of treating testosterone deficiency |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Jul 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)
| Patents | Expiration | Patented 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, 2024 | U-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, 2024 | U-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, 2034 | U-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
TLANDO (CAPSULE) (ORAL) TESTOSTERONE UNDECANOATE
Drug Classes: androgen
NDA Applicant: VERITY NDA No.: 208088 Prod. No.: 001 RX (112.5MG)
| Patents | Expiration | Patented 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, 2029 | U-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, 2029 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2029 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2041 | U-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, 2037 | U-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. 12011503 DP* Fixed dose oral testosterone undecanoate compositions and use thereof Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Jul 17, 2024 | Oct 16, 2040 | U-3964: Methods of administering testosterone undecanoate for restoring testosterone concentration in a hypogonadal male subject U-3965: Methods of continuing or discontinuing a dosage regimen of a testosterone undecanoate pharmaceutical composition to a hypogonadal male subject |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Mar 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)
| Patents | Expiration | Patented 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, 2034 | U-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, 2034 | U-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, 2034 | U-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))
| Patents | Expiration | Patented 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, 2036 | U-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, 2035 | U-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, 2033 | U-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, 2035 | U-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, 2034 | U-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, 2033 | U-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%)
| Patents | Expiration | Patented 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, 2025 | U-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, 2025 | U-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 | May 31, 2025 | |
| 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, 2028 | U-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, 2028 | U-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, 2028 | U-3280: Method of treating acne vulgaris with topically applied cortexolone 17alpha-propionate |
| Pat. No. 11938141 DP* Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives Claim Types: Formulation Pat. Sub. Date(s): 001: May 30, 2024 | Jul 24, 2028 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Aug 26, 2025 |
androgen receptor inhibitor
XTANDI (CAPSULE) (ORAL) ENZALUTAMIDE [GENERIC AB]
Drug Classes: androgen receptor inhibitor
NDA Applicant: ASTELLAS NDA No.: 203415 Prod. No.: 001 RX (40MG)
| Patents | Expiration | Patented 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 Treatment of hyperproliferative disorders with diarylhydantoin compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 27, 2012 | Aug 24, 2026 | U-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, 2026 | 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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Nov 17, 2026 | I-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)
| Patents | Expiration | Patented 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 Treatment of hyperproliferative disorders with diarylhydantoin compounds Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 3, 2020 | Aug 24, 2026 | 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): All strengths: Sep 3, 2020 | May 15, 2026 | 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. 11839689 DP* Formulations of enzalutamide Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 19, 2023 | Sep 11, 2033 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Nov 17, 2026 | I-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)
| Patents | Expiration | Patented 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, 2035 | U-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, 2035 | U-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, 2035 | U-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)
| Patents | Expiration | Patented 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, 2027 | U-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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NPP - New patient population | Apr 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)
| Patents | Expiration | Patented 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, 2025 | U-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)
| Patents | Expiration | Patented 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, 2025 | U-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, 2031 | U-3: Treatment of hypertension |
angiotensin II receptor blocker
ENTRESTO (TABLET) (ORAL) SACUBITRIL; VALSARTAN [GENERIC AB]
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)
| Patents | Expiration | Patented 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* 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 *PED | U-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, 2033 | U-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, 2033 | U-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, 2036 | U-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, 2033 | U-3084: Treatment of heart failure with preserved ejection fraction |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Feb 16, 2024 | M-82: Labeling revisions related to clinical studies |
angiotensin II receptor blocker
ENTRESTO SPRINKLE (CAPSULE, PELLETS) (ORAL) SACUBITRIL; VALSARTAN
Drug Classes: angiotensin II receptor blocker
NDA Applicant: NOVARTIS NDA No.: 218591 Prod. No.: 001 RX (6MG;6MG); 002 RX (15MG;16MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8101659 DP* Methods of treatment and pharmaceutical composition Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 8, 2024 | Jan 15, 2025 | |
| 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: May 8, 2024 | May 27, 2027 | |
| Pat. No. 9388134 Compounds containing S-N-valeryl-N-{[2'-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl)-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 8, 2024 | Nov 8, 2026 | U-1723: Treatment of heart failure |
| Pat. No. 10722471 DP* Galenic formulations of organic compounds Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 8, 2024 | Feb 2, 2037 | U-3896: Treatment of heart failure with oral pellets |
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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8168616 DP* Combination comprising a renin inhibitor and an angiotensin receptor inhibitor for hypertension Claim Types: Composition Pat. Sub. Date(s): All strengths: Jun 6, 2012 | Jul 3, 2026 |
anthelmintic
EGATEN (TABLET) (ORAL) TRICLABENDAZOLE
Drug Classes: anthelmintic
NDA Applicant: NOVARTIS NDA No.: 208711 Prod. No.: 001 RX (250MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NCE - New chemical entity | Feb 13, 2024 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Feb 13, 2026 | ODE-228: Indicated for the treatment of fascioliasis in patients 6 years of age and older |