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. RE47351 DS* DP* 2-(N-pyrazolo)adenosines with application as adenosine A.sub.2A receptor agonists Claim Types: Compound; Diagnostic or surgical method; Method of use Pat. Sub. Date(s): 001: Apr 18, 2019 | Jun 22, 2019 | U-869: Method for stimulating coronary vasodilation for purposes of imaging the heart |
| 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. 6403567 DS* DP* [Extended 1024 days (2.8 years)] N-pyrazole A2A adenosine receptor agonists Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: None | Apr 10, 2022 | U-869: Method for stimulating coronary vasodilation for purposes of imaging the heart |
| Pat. No. 7144872 DS* DP* N-pyrazole A.sub.2A receptor agonists Claim Types: Compound; Method of use Pat. Sub. Date(s): 001: None | Jun 22, 2019 | U-116: Method of myocardial imaging U-869: Method for stimulating coronary vasodilation for purposes of imaging the heart U-870: Method of producing coronary vasodilation without peripheral vasodilation |
| Pat. No. 7183264 DP* N-pyrazole A2A receptor agonists Claim Types: Method of use; Composition Pat. Sub. Date(s): 001: None | Jun 22, 2019 | U-116: Method of myocardial imaging U-869: Method for stimulating coronary vasodilation for purposes of imaging the heart U-870: Method of producing coronary vasodilation without peripheral vasodilation |
| Pat. No. 7582617 Myocardial perfusion imaging method Claim Types: Method of use Pat. Sub. Date(s): 001: None | Jun 22, 2019 | U-1003: A method of myocardial perfusion imaging and increasing coronary blood flow |
| Pat. No. 7655636 Use of A2A adenosine receptor agonists Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: None | Jun 22, 2019 | U-869: Method for stimulating coronary vasodilation for purposes of imaging the heart |
| Pat. No. 7655637 DS* DP* N-pyrazole A.sub.2A receptor agonists Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): 001: None | Jun 22, 2019 | U-869: Method for stimulating coronary vasodilation for purposes of imaging the heart |
| Pat. No. 7683037 Myocardial perfusion imaging method Claim Types: Method of use Pat. Sub. Date(s): 001: None | Jun 22, 2019 | U-1042: Method for stimulating coronary vasodilation for purposes of imaging the heart |
| Pat. No. 8106029 Use of A.sub.2A adenosine receptor agonists Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 8, 2012 | Jun 22, 2019 | U-1042: Method for stimulating coronary vasodilation for purposes of imaging the heart |
| Pat. No. 8106183 DS* Process for preparing an A.sub.2A-adenosine receptor agonist and its polymorphs Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Mar 8, 2012 | Feb 2, 2027 | |
| Pat. No. 8133879 DP* Myocardial perfusion imaging methods and compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 3, 2012 | Jun 22, 2019 | |
| Pat. No. 8183226 Myocardial perfusion imaging method Claim Types: Method of administration Pat. Sub. Date(s): 001: Jun 19, 2012 | Jun 22, 2019 | U-116: Method of myocardial imaging |
| Pat. No. 8470801 Myocardial perfusion imaging methods and compositions Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 23, 2013 | Jun 22, 2019 | U-116: Method of myocardial imaging |
| Pat. No. 8536150 Methods of myocardial perfusion imaging Claim Types: Diagnostic or surgical method Pat. Sub. Date(s): 001: Oct 18, 2013 | Jun 22, 2019 | U-116: Method of myocardial imaging |
| Pat. No. 9045519 DP* N-pyrazole A.sub.2A receptor agonists Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Jun 25, 2015 | Jun 22, 2019 | |
| Pat. No. 9289446 DP* Myocardial perfusion imaging methods and compositions Claim Types: Formulation; Kit; Drug in a container; Method of use Pat. Sub. Date(s): 001: Apr 20, 2016 | Jun 22, 2019 | U-116: Method of myocardial imaging |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Jan 17, 2020 | M-194: Information added to the labeling regarding use of regadenoson administration following an inadequate exercise stress test as compared to regadenoson alone |
adrenergic agonist
ADDERALL 10; ADDERALL 20; ADDERALL 5; ADDERALL 30; ADDERALL 7.5; ADDERALL 12.5; ADDERALL 15 (TABLET) (ORAL) AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: TEVA WOMENS NDA No.: 011522 Prod. No.: 007 DISC (2.5MG;2.5MG;2.5MG;2.5MG**); 008 DISC (5MG;5MG;5MG;5MG**); 009 DISC (1.25MG;1.25MG;1.25MG;1.25MG**); 010 DISC (7.5MG;7.5MG;7.5MG;7.5MG**); 011 DISC (1.875MG;1.875MG;1.875MG;1.875MG**); 012 DISC (3.125MG;3.125MG;3.125MG;3.125MG**); 013 DISC (3.75MG;3.75MG;3.75MG;3.75MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6384020 Rapid immediate release oral dosage form Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jan 6, 2021 *PED |
adrenergic agonist
ADDERALL XR 10; ADDERALL XR 20; ADDERALL XR 30; ADDERALL XR 25; ADDERALL XR 5; ADDERALL XR 15 (CAPSULE, EXTENDED RELEASE) (ORAL) AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE [GENERIC AB]
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: SHIRE NDA No.: 021303 Prod. No.: 001 RX (2.5MG;2.5MG;2.5MG;2.5MG); 002 RX (5MG;5MG;5MG;5MG); 003 RX (7.5MG;7.5MG;7.5MG;7.5MG); 004 RX (6.25MG;6.25MG;6.25MG;6.25MG); 005 RX (1.25MG;1.25MG;1.25MG;1.25MG); 006 RX (3.75MG;3.75MG;3.75MG;3.75MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE41148 DP* Oral pulsed dose drug delivery system Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Apr 21, 2019 *PED | |
| Pat. No. RE42096 DP* Oral pulsed dose drug delivery system Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Apr 21, 2019 *PED | |
| Pat. No. 6322819 Oral pulsed dose drug delivery system Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Apr 21, 2019 *PED | |
| Pat. No. 6605300 Oral pulsed dose drug delivery system Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Apr 21, 2019 *PED |
adrenergic agonist
ADZENYS ER (SUSPENSION, EXTENDED RELEASE) (ORAL) AMPHETAMINE
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: NEOS THERAPS INC NDA No.: 204325 Prod. No.: 001 RX (EQ 1.25MG BASE/ML)
| 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: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: NEOS THERAPS NDA No.: 204326 Prod. No.: 001 RX (EQ 3.1MG BASE); 002 RX (EQ 6.3MG BASE); 003 RX (EQ 9.4MG BASE); 004 RX (EQ 12.5MG BASE); 005 RX (EQ 15.7MG BASE); 006 RX (EQ 18.8MG BASE)
| 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 |
adrenergic agonist
AMPHETAMINE SULFATE (TABLET) (ORAL) AMPHETAMINE SULFATE [GENERIC AA]
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: AMNEAL PHARMS NDA No.: 211139 Prod. No.: 001 RX (5MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Mar 26, 2019 |
adrenergic agonist
AMPHETAMINE SULFATE (TABLET) (ORAL) AMPHETAMINE SULFATE [GENERIC AA]
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: AMNEAL PHARMS NDA No.: 211139 Prod. No.: 002 RX (10MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Mar 30, 2019 |
adrenergic agonist
DYANAVEL XR (SUSPENSION, EXTENDED RELEASE) (ORAL) AMPHETAMINE
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: TRIS PHARMA INC NDA No.: 208147 Prod. No.: 001 RX (EQ 2.5MG BASE/ML)
| 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 |
adrenergic agonist
EVEKEO ODT (TABLET, ORALLY DISINTEGRATING) (ORAL) AMPHETAMINE SULFATE
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: ARBOR PHARMS LLC NDA No.: 209905 Prod. No.: 001 RX (5MG); 002 RX (10MG); 003 RX (15MG); 004 RX (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 |
adrenergic agonist
MYDAYIS (CAPSULE, EXTENDED RELEASE) (ORAL) AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE [Has competitive generic]
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: SHIRE DEV LLC NDA No.: 022063 Prod. No.: 001 RX (3.125MG;3.125MG;3.125MG;3.125MG); 002 RX (6.25MG;6.25MG;6.25MG;6.25MG); 003 RX (9.375MG;9.375MG;9.375MG;9.375MG); 004 RX (12.5MG;12.5MG;12.5MG;12.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6913768 DP* Sustained release delivery of amphetamine salts Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 7, 2017 | May 24, 2023 | U-2025: Treatment of attention deficit hyperactivity disorder |
| 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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Mar 13, 2023 PED | M-248: Information added to the labeling to describe a trial evaluating a lower dose than those approved for pediatric patients 13 to 17 years of age |
| Exclusivity Code: NP - New product | Jun 20, 2020 |
aldehyde dehydrogenase inhibitor
ESKATA (SOLUTION) (TOPICAL) HYDROGEN PEROXIDE
Drug Classes: aldehyde dehydrogenase inhibitor; isocitrate dehydrogenase-2 inhibitor
NDA Applicant: ACLARIS NDA No.: 209305 Prod. No.: 001 DISC (40%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7381427 Seborrheic keratosis treatment Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 3, 2018 | Jun 8, 2022 | U-2205: Treatment of seborrheic keratoses that are raised |
| Pat. No. 9675639 DP* Peroxide formulations and methods and applicators for using the same Claim Types: Formulation; Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 3, 2018 | Jul 4, 2035 | U-2205: Treatment of seborrheic keratoses that are raised |
| Pat. No. 9980983 Peroxide formulations and methods and applicators for using the same Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 18, 2018 | Apr 21, 2035 | U-2205: Treatment of seborrheic keratoses that are raised |
| Pat. No. 10098910 DP* Peroxide formulations and methods and applicators for using the same Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Oct 25, 2018 | Apr 21, 2035 | U-2205: Treatment of seborrheic keratoses that are raised |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Dec 14, 2020 |
aldosterone antagonist
CAROSPIR (SUSPENSION) (ORAL) SPIRONOLACTONE
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 |
aldosterone antagonist
INSPRA (TABLET) (ORAL) EPLERENONE [GENERIC AB]
Drug Classes: aldosterone antagonist
NDA Applicant: SEARLE, GD LLC NDA No.: 021437 Prod. No.: 001 RX (25MG); 002 RX (50MG) NDA No.: 021437 Prod. No.: 003 DISC (100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6410054 Immediate release eplerenone compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Jun 8, 2020 *PED | U-3: Treatment of hypertension U-537: Treatment of conditions related to hyperaldosteronism such as hypertension and cardiac insufficiency, with eplerenone |
| Pat. No. 6410524 Combination therapy of angiotensin converting enzyme inhibitor and aldosterone antagonist for reducing morbidity and mortality from cardiovascular disease Claim Types: Composition; Method of use Pat. Sub. Date(s): All strengths: None | May 5, 2020 *PED | U-467: Use of eplerenone in combination with an angiotensin converting enzyme (ACE) inhibitor for treating hypertension |
| Pat. No. 6495165 Eplerenone compositions having improved bioavailability Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Jun 8, 2020 *PED | U-3: Treatment of hypertension U-537: Treatment of conditions related to hyperaldosteronism such as hypertension and cardiac insufficiency, with eplerenone |
| Pat. No. 6534093 Immediate release eplerenone compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Jun 8, 2020 *PED | U-3: Treatment of hypertension U-537: Treatment of conditions related to hyperaldosteronism such as hypertension and cardiac insufficiency, with eplerenone |
| Pat. No. 6558707 DP* Immediate release eplerenone compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Jun 8, 2020 *PED | U-537: Treatment of conditions related to hyperaldosteronism such as hypertension and cardiac insufficiency, with eplerenone |
| Pat. No. 6747020 Methods of treating heart failure and hypertension using combinations of eplerenone and an angiotensin converting enzyme inhibitor Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | May 5, 2020 *PED | U-587: Use of eplerenone in combination with an angiotensin converting enzyme (ACE) inhibitor (and optionally a diuretic) for treating congestive heart failure and hypertension |
| Pat. No. 7157101 DP* Micronized eplerenone compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jun 8, 2020 *PED | U-664: Treatment of conditions for which an aldosterone receptor blocker is indicated, such as hypertension, heart failure, and post-myocardial infarction |
alkylating drug
BELRAPZO (SOLUTION) (IV (INFUSION)) 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 |
alkylating drug
BENDEKA (SOLUTION) (IV (INFUSION)) BENDAMUSTINE HYDROCHLORIDE
Drug Classes: alkylating drug
NDA Applicant: EAGLE PHARMS NDA No.: 208194 Prod. No.: 001 RX (100MG/4ML (25MG/ML))
| 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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 7, 2022 | ODE-179: Treatment of patients with CLL and treatment of patients with indolent B-cell NHL that has progressed during or within six months of treatment with rituximab or a rituximab containing regimen |
alkylating drug
EVOMELA (POWDER) (INTRAVENOUS) MELPHALAN HYDROCHLORIDE
Drug Classes: alkylating drug
NDA Applicant: ACROTECH 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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Mar 10, 2023 | ODE-110: For high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma |
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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Feb 7, 2019 | ODE-21: An adjunct to ab externo glaucoma surgery |
alkylating drug
TEMODAR (POWDER) (INTRAVENOUS) TEMOZOLOMIDE
Drug Classes: alkylating drug
NDA Applicant: MERCK SHARP DOHME NDA No.: 022277 Prod. No.: 001 RX (100MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6987108 DP* Pharmaceutical formulations of antineoplastic agents and processes of making and using the same Claim Types: Formulation Pat. Sub. Date(s): 001: None | Sep 8, 2023 | |
| Pat. No. 7786118 DP* Pharmaceutical formulations of antineoplastic agents Claim Types: Formulation Pat. Sub. Date(s): 001: None | Feb 21, 2023 | |
| Pat. No. 8623868 DP* Processes of making and using pharmaceutical formulations of antineoplastic agents Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Jan 28, 2014 | Feb 21, 2023 |
alkylating drug
TEPADINA (POWDER) (INTRAVENOUS) THIOTEPA
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: I - New Indication | Jan 26, 2020 | I-747: For reducing the risk of graft rejection when used with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor (stem) cell transplantation for pediatric patients with class 3 beta-thalassemia |
| Exclusivity Code: ODE - Orphan drug 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
TREANDA (POWDER) (IV (INFUSION)) BENDAMUSTINE HYDROCHLORIDE
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 Pat. Sub. Date(s): 001: None; 002: Jan 13, 2017 | Mar 26, 2029 | 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) (IV (INFUSION)) BENDAMUSTINE HYDROCHLORIDE
Drug Classes: alkylating drug
NDA Applicant: CEPHALON NDA No.: 022249 Prod. No.: 003 DISC (45MG/0.5ML (90MG/ML)); 004 DISC (180MG/2ML (90MG/ML))
| 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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Aug 23, 2020 | ODE-51: Topical treatment of stage 1a and 1b mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy |
alkylating drug
YONDELIS (POWDER) (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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Dec 29, 2021 PED | M-232: Information added to section 8.4 of the labeling to describe the results from pediatric studies |
| Exclusivity Code: NCE - New chemical entity | Apr 23, 2021 PED | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 23, 2023 PED | ODE-100: For the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen |
allylamine antifungal
NAFTIN (CREAM) (TOPICAL) NAFTIFINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: allylamine antifungal
NDA Applicant: SEBELA IRELAND LTD NDA No.: 019599 Prod. No.: 002 RX (2%)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: M - Miscellaneous | Nov 10, 2019 | M-191: Addition of data based on pediatric studies to fulfill the postmarketing requirement 1857-2 |
allylamine antifungal
NAFTIN (GEL) (TOPICAL) NAFTIFINE HYDROCHLORIDE
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 |
alpha adrenergic agonist
ADRENACLICK (INJECTABLE) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI); norepinephrine-releasing agent; alpha adrenergic agonist; beta adrenergic agonist; catecholamine; norepinephrine, serotonin, and dopamine reuptake inhibitor anorectic
NDA Applicant: IMPAX NDA No.: 020800 Prod. No.: 003 RX (EQ 0.15MG/DELIVERY); 004 RX (EQ 0.3MG/DELIVERY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7905352 DP* Kits containing medicine injection devices and containers Claim Types: Kit; Device Pat. Sub. Date(s): All strengths: Jun 2, 2017 | Apr 12, 2027 | |
| Pat. No. 10166344 DP* Injection needle assembly Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 15, 2019 | Jan 21, 2025 |
alpha adrenergic agonist
ADRENALIN (SOLUTION) (INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI); norepinephrine-releasing agent; alpha adrenergic agonist; beta adrenergic agonist; catecholamine; norepinephrine, serotonin, and dopamine reuptake inhibitor anorectic
NDA Applicant: PAR STERILE PRODUCTS NDA No.: 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
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI); norepinephrine-releasing agent; alpha adrenergic agonist; beta adrenergic agonist; catecholamine; norepinephrine, serotonin, and dopamine reuptake inhibitor anorectic
NDA Applicant: PAR STERILE PRODUCTS NDA No.: 204640 Prod. No.: 001 RX (EQ 30MG BASE/30ML (EQ 1MG BASE/ML))
| 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
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: GLAXOSMITHKLINE 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: GLAXOSMITHKLINE 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
ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION (TABLET, EXTENDED RELEASE) (ORAL) FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE [GENERIC OTC]
Drug Classes: histamine-1 (H1) receptor antagonist; alpha adrenergic agonist
NDA Applicant: SANOFI AVENTIS US NDA No.: 021704 Prod. No.: 002 OTC (180MG;240MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6613357 DP* Osmotic device containing pseudoephedrine and an H1 antagonist Claim Types: Device; Method of use Pat. Sub. Date(s): 002: Jul 1, 2011 | Dec 25, 2020 | U-1159: Relief of symptoms associated with respiratory allergies, swelling of the nasal passages and sinus congestion and pressure in adults and children 12 years of age and older |
alpha adrenergic agonist
ALPHAGAN P (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE
Drug Classes: alpha adrenergic agonist
NDA Applicant: ALLERGAN NDA No.: 021262 Prod. No.: 001 RX (0.15%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6562873 Compositions containing therapeutically active components having enhanced solubility Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 10, 2022 *PED | |
| Pat. No. 6627210 DP* Compositions containing .alpha.-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 18, 2022 *PED | |
| Pat. No. 6641834 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 28, 2022 *PED | |
| Pat. No. 6673337 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 26, 2022 *PED | |
| Pat. No. 9295641 Compositions containing alpha-2-adrenergic agonist components Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 28, 2016 | Jan 10, 2022 *PED | U-1833: Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension |
alpha adrenergic agonist
ALPHAGAN P (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE
Drug Classes: alpha adrenergic agonist
NDA Applicant: ALLERGAN NDA No.: 021770 Prod. No.: 001 RX (0.1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6562873 DP* Compositions containing therapeutically active components having enhanced solubility Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 10, 2022 *PED | |
| Pat. No. 6627210 DP* Compositions containing .alpha.-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 18, 2022 *PED | |
| Pat. No. 6641834 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 28, 2022 *PED | |
| Pat. No. 6673337 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 26, 2022 *PED | |
| 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 | |
| Pat. No. 9295641 Compositions containing alpha-2-adrenergic agonist components Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 28, 2016 | Jan 10, 2022 *PED | U-1833: Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension |
| Pat. No. 9687443 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 10, 2017 | Jan 10, 2022 *PED | |
| Pat. No. 10307368 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 24, 2019 | Jul 10, 2021 |
alpha adrenergic agonist
AUVI-Q (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI); norepinephrine-releasing agent; alpha adrenergic agonist; beta adrenergic agonist; catecholamine; norepinephrine, serotonin, and dopamine reuptake inhibitor anorectic
NDA Applicant: KALEO INC NDA No.: 201739 Prod. No.: 001 RX (EQ 0.3MG/DELIVERY); 002 RX (EQ 0.15MG/DELIVERY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7731686 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 22, 2013; 002: None | Jun 1, 2026 | |
| Pat. No. 7731690 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 22, 2013; 002: None | Jan 15, 2025 | |
| Pat. No. 7749194 DP* Devices, systems, and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 22, 2013; 002: None | Oct 30, 2028 | |
| Pat. No. 7918823 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 22, 2013; 002: None | Nov 23, 2024 | |
| Pat. No. 7947017 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 22, 2013; 002: None | Mar 12, 2028 | |
| Pat. No. 8016788 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 22, 2013; 002: None | Mar 21, 2025 | |
| Pat. No. 8021344 DP* Medicament delivery device configured to produce an audible output Claim Types: Device Pat. Sub. Date(s): All strengths: 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; 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): 001: Aug 21, 2012; 002: None | 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; 002: None | 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; 002: None | 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; 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): 001: May 23, 2013; 002: None | Nov 23, 2024 | |
| Pat. No. 8608698 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 15, 2014 | Nov 23, 2024 | |
| Pat. No. 8920377 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 29, 2015 | Nov 23, 2024 | |
| Pat. No. 8926594 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): All strengths: Feb 5, 2015 | Mar 31, 2026 | |
| Pat. No. 9056170 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): All strengths: Jul 16, 2015 | Nov 23, 2024 | |
| Pat. No. 9149579 Devices, systems and methods for medicament delivery Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Nov 6, 2015 | Jul 19, 2025 | U-1758: Method of treating allergic reaction via injection |
| Pat. No. 9238108 DP* Medicament delivery device having an electronic circuit system Claim Types: Device Pat. Sub. Date(s): All strengths: Feb 18, 2016 | Feb 20, 2027 | |
| Pat. No. 9259539 DP* Devices, systems and methods for medicament delivery Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Mar 23, 2016 | Feb 1, 2026 | |
| Pat. No. 9278182 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): All strengths: Apr 11, 2016 | Feb 1, 2026 | |
| Pat. No. 9724471 DP* Devices, systems, and methods for medicament delivery Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Aug 23, 2017 | May 23, 2027 | U-2092: Method for confirming dose delivery |
| Pat. No. 9737669 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 30, 2017 | Nov 23, 2024 | |
| Pat. No. 10314977 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): All strengths: Jun 11, 2019 | Nov 23, 2024 | |
| Pat. No. 10335549 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): All strengths: Jul 2, 2019 | Apr 30, 2025 |
alpha adrenergic agonist
AUVI-Q (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI); norepinephrine-releasing agent; alpha adrenergic agonist; beta adrenergic agonist; catecholamine; norepinephrine, serotonin, and dopamine reuptake inhibitor anorectic
NDA Applicant: KALEO INC NDA No.: 201739 Prod. No.: 003 RX (EQ 0.1MG/DELIVERY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7731686 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 | Jun 1, 2026 | |
| Pat. No. 7731690 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 | Jan 15, 2025 | |
| Pat. No. 7749194 DP* Devices, systems, and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 | Oct 30, 2028 | |
| Pat. No. 7918823 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 | Nov 23, 2024 | |
| 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. 8016788 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 | Mar 21, 2025 | |
| 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. 8920377 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 | Nov 23, 2024 | |
| Pat. No. 8926594 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 | Mar 31, 2026 | |
| Pat. No. 9056170 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 | Nov 23, 2024 | |
| Pat. No. 9149579 Devices, systems and methods for medicament delivery Claim Types: Method of administration Pat. Sub. Date(s): 003: Dec 15, 2017 | Jul 19, 2025 | U-1758: Method of treating allergic reaction via injection |
| Pat. No. 9238108 DP* Medicament delivery device having an electronic circuit system Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 | Feb 20, 2027 | |
| Pat. No. 9259539 DP* Devices, systems and methods for medicament delivery Claim Types: Method of administration Pat. Sub. Date(s): 003: Dec 15, 2017 | Feb 1, 2026 | |
| Pat. No. 9278182 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 | Feb 1, 2026 | |
| Pat. No. 9724471 DP* Devices, systems, and methods for medicament delivery Claim Types: Device; Method of administration Pat. Sub. Date(s): 003: Dec 15, 2017 | May 23, 2027 | U-2092: Method for confirming dose delivery |
| Pat. No. 9737669 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 | Nov 23, 2024 | |
| Pat. No. 9833573 Devices, systems and methods for medicament delivery Claim Types: Method of administration Pat. Sub. Date(s): 003: Dec 15, 2017 | Nov 23, 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 |
alpha adrenergic agonist
CLARINEX D 24 HOUR (TABLET, EXTENDED RELEASE) (ORAL) DESLORATADINE; PSEUDOEPHEDRINE SULFATE [GENERIC AB]
Drug Classes: histamine-1 (H1) receptor antagonist; alpha adrenergic agonist
NDA Applicant: MERCK SHARP DOHME NDA No.: 021605 Prod. No.: 001 RX (5MG;240MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6100274 DP* 8-chloro-6,11-dihydro-11-](4-piperidylidine)-5H-benzo [5,6]cyclohepta[1,2-bpyridine oral compositions Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 7, 2020 *PED | |
| Pat. No. 6979463 DP* Stable extended release oral dosage composition Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Mar 28, 2022 | |
| Pat. No. 7618649 DP* Extended release oral dosage composition Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Jun 19, 2021 *PED | U-1017: A method of treating nasal and non-nasal symptoms of seasonal allergic rhinitis |
| Pat. No. 7820199 DP* Stable extended release oral dosage composition Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 23, 2010 | Sep 28, 2022 *PED |
alpha adrenergic agonist
CLARINEX-D 12 HOUR (TABLET, EXTENDED RELEASE) (ORAL) DESLORATADINE; PSEUDOEPHEDRINE SULFATE
Drug Classes: histamine-1 (H1) receptor antagonist; alpha adrenergic agonist
NDA Applicant: MERCK SHARP DOHME NDA No.: 021313 Prod. No.: 001 RX (2.5MG;120MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6100274 DP* 8-chloro-6,11-dihydro-11-](4-piperidylidine)-5H-benzo [5,6]cyclohepta[1,2-bpyridine oral compositions Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 7, 2020 *PED | |
| Pat. No. 6709676 DP* Extended release oral dosage composition Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Feb 18, 2021 | U-707: Allergic rhinitis |
| Pat. No. 7618649 DP* Extended release oral dosage composition Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Jun 19, 2021 *PED | U-1017: A method of treating nasal and non-nasal symptoms of seasonal allergic rhinitis |
| Pat. No. 8187630 DP* Extended release oral dosage composition Claim Types: Formulation; Method of administration Pat. Sub. Date(s): 001: Jun 28, 2012 | Dec 19, 2020 | U-1017: A method of treating nasal and non-nasal symptoms of seasonal allergic rhinitis |
alpha adrenergic agonist
COMBIGAN (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE; TIMOLOL MALEATE
Drug Classes: alpha adrenergic agonist; beta-adrenergic receptor inhibitor
NDA Applicant: ALLERGAN NDA No.: 021398 Prod. No.: 001 RX (0.2%;EQ 0.5% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7030149 Combination of brimonidine timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: None | Apr 19, 2022 | U-849: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. dose is one drop of COMBIGAN in the affected eye twice daily |
| Pat. No. 7320976 Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: None | Apr 19, 2022 | U-849: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. dose is one drop of COMBIGAN in the affected eye twice daily |
| Pat. No. 7323463 DP* DLR* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): 001: None | Jan 19, 2023 | |
| Pat. No. 7642258 DS* DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Formulation; Kit Pat. Sub. Date(s): 001: None | Apr 19, 2022 | U-1024: Reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP |
| Pat. No. 8133890 Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 2, 2012 | Apr 19, 2022 | U-1235: Reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension |
| Pat. No. 8354409 DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Formulation; Method of administration; Method of use Pat. Sub. Date(s): 001: Mar 27, 2013 | Apr 19, 2022 | U-1371: Reduction of intraocular pressure in patients with elevated intraocular pressure or glaucoma |
| Pat. No. 8748425 DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 7, 2014 | Apr 19, 2022 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 9474751 DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 25, 2016 | Apr 19, 2022 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 9770453 DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 12, 2017 | Apr 19, 2022 | U-2131: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, with comparable efficacy, and a reduction in specified adverse events, compared to brimonidine 0.2% tid |
| Pat. No. 9907801 DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 7, 2018 | Apr 19, 2022 | U-2239: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, with a reduction in specified adverse events, compared to brimonidine 0.2% tid |
| Pat. No. 9907802 DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 7, 2018 | Apr 19, 2022 | U-2240: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, with comparable efficacy to brimonidine 0.2% tid |
alpha adrenergic agonist
EPINEPHRINE (SOLUTION) (INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI); norepinephrine-releasing agent; alpha adrenergic agonist; beta adrenergic agonist; catecholamine; norepinephrine, serotonin, and dopamine reuptake inhibitor anorectic
NDA Applicant: BELCHER PHARMS LLC NDA No.: 205029 Prod. No.: 001 RX (EQ 1MG BASE/ML (EQ 1MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9283197 DP* 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* 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 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: serotonin and norepinephrine reuptake inhibitor (SNRI); norepinephrine-releasing agent; alpha adrenergic agonist; beta adrenergic agonist; catecholamine; norepinephrine, serotonin, and dopamine reuptake inhibitor anorectic
NDA Applicant: MYLAN SPECIALITY LP NDA No.: 019430 Prod. No.: 001 RX (0.3MG/DELIVERY); 002 RX (0.15MG/DELIVERY)
| 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
LIDOSITE TOPICAL SYSTEM KIT (PATCH) (IONTOPHORESIS, TOPICAL) EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI); norepinephrine-releasing agent; alpha adrenergic agonist; beta adrenergic agonist; catecholamine; norepinephrine, serotonin, and dopamine reuptake inhibitor anorectic; amide local anesthetic; antiarrhythmic
NDA Applicant: VYTERIS NDA No.: 021504 Prod. No.: 001 DISC (1.05MG/PATCH;100MG/PATCH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6629968 DS* DP* Shelf storage stable iontophoresis reservoir-electrode and iontophoretic system incorporating the reservoir-electrode Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: None | Jun 30, 2020 | |
| Pat. No. 6635045 DS* DP* Electrodes and method for manufacturing electrodes for electrically assisted drug delivery Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: None | Jun 29, 2021 |
alpha adrenergic agonist
LUMIFY (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE
Drug Classes: alpha adrenergic 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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Dec 22, 2020 |
alpha adrenergic agonist
MIRVASO (GEL) (TOPICAL) BRIMONIDINE TARTRATE
Drug Classes: alpha adrenergic 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 agonist
MOTRIN, CHILDREN'S COLD (SUSPENSION) (ORAL) IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE [GENERIC OTC]
Drug Classes: nonsteroidal anti-inflammatory drug; alpha adrenergic agonist
NDA Applicant: J AND J CONSUMER INC NDA No.: 021128 Prod. No.: 001 OTC (100MG/5ML;15MG/5ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6211246 Rapidly absorbed liquid compositions Claim Types: Method of improving a formulation; Formulation Pat. Sub. Date(s): 001: None | Jun 10, 2019 |
alpha adrenergic agonist
MUCINEX D (TABLET, EXTENDED RELEASE) (ORAL) GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE [GENERIC OTC]
Drug Classes: alpha adrenergic agonist
NDA Applicant: RB HLTH NDA No.: 021585 Prod. No.: 001 OTC (600MG;60MG); 002 OTC (1.2GM;120MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6372252 DP* Guaifenesin sustained release formulation and tablets Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Apr 28, 2020 | |
| Pat. No. 6955821 DP* Sustained release formulations of guaifenesin and additional drug ingredients Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Apr 28, 2020 | U-686: Expectorant and nasal decongestant |
| Pat. No. 7838032 DP* Sustained release of guaifenesin Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 21, 2010; 002: None | Apr 28, 2020 |
alpha adrenergic agonist
PRIMATENE MIST (AEROSOL, METERED) (INHALATION) EPINEPHRINE
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI); norepinephrine-releasing agent; alpha adrenergic agonist; beta adrenergic agonist; catecholamine; norepinephrine, serotonin, and dopamine reuptake inhibitor anorectic
NDA Applicant: 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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Nov 7, 2021 |
alpha adrenergic agonist
QOLIANA (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE
Drug Classes: alpha adrenergic agonist
NDA Applicant: SANDOZ INC 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 agonist
SIMBRINZA (SUSPENSION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE; BRINZOLAMIDE
Drug Classes: alpha adrenergic agonist; carbonic anhydrase inhibitor
NDA Applicant: NOVARTIS NDA No.: 204251 Prod. No.: 001 RX (0.2%;1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6316441 Brinzolamide and brimonidine for treating glaucoma Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 13, 2013 | Dec 7, 2019 | U-778: Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension |
| Pat. No. 9044484 DP* Aqueous pharmaceutical compositions containing borate-polyol complexes Claim Types: Formulation 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 |
alpha adrenergic agonist
TWINJECT 0.3; TWINJECT 0.15 (INJECTABLE) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI); norepinephrine-releasing agent; alpha adrenergic agonist; beta adrenergic agonist; catecholamine; norepinephrine, serotonin, and dopamine reuptake inhibitor anorectic
NDA Applicant: IMPAX NDA No.: 020800 Prod. No.: 001 DISC (EQ 0.3MG/DELIVERY); 002 DISC (EQ 0.15MG/DELIVERY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7297136 DP* Medicine injection devices and methods Claim Types: Device Pat. Sub. Date(s): All strengths: None | Jan 18, 2025 | |
| Pat. No. 7621891 DP* Method and apparatus for delivering epinephrine Claim Types: Device Pat. Sub. Date(s): All strengths: None | Feb 4, 2025 |
alpha adrenergic agonist
ZYRTEC-D 12 HOUR (TABLET, EXTENDED RELEASE) (ORAL) CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE [GENERIC OTC]
Drug Classes: histamine-1 (H1) receptor antagonist; alpha adrenergic agonist
NDA Applicant: J AND J CONSUMER INC NDA No.: 021150 Prod. No.: 002 OTC (5MG;120MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6469009 DP* Pharmaceutical compositions for the treatment of rhinitis Claim Types: Composition; Method of use Pat. Sub. Date(s): 002: None | Jul 13, 2019 | U-295: Treatment of seasonal and perennial allergic rhinitis symptoms |
| Pat. No. 7014867 DP* Tablet comprising cetirizine and pseudoephedrine Claim Types: Formulation Pat. Sub. Date(s): 002: None | Jun 10, 2022 | |
| Pat. No. 7226614 Tablet comprising cetirizine and pseudoephedrine Claim Types: Method of use Pat. Sub. Date(s): 002: None | Jun 10, 2022 | U-295: Treatment of seasonal and perennial allergic rhinitis symptoms |
alpha adrenergic blocker
COREG CR (CAPSULE, EXTENDED RELEASE) (ORAL) CARVEDILOL PHOSPHATE [GENERIC AB]
Drug Classes: alpha adrenergic blocker; beta-adrenergic receptor inhibitor
NDA Applicant: SMITHKLINE BEECHAM NDA No.: 022012 Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (40MG); 004 RX (80MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7268156 DS* DP* Carvedilol phosphate salts and/or solvates thereof, corresponding compositions and/or methods of treatment Claim Types: New polymorph, salt or hydrate; Method of use; Composition Pat. Sub. Date(s): All strengths: None | Dec 27, 2023 *PED | U-313: Treatment of congestive heart failure U-3: Treatment of hypertension |
| Pat. No. 8101209 DP* Microparticulate oral galenical form for the delayed and controlled release of pharmaceutical active principles Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 21, 2012; 002: None; 003: None; 004: None | Mar 11, 2026 *PED |
alpha adrenergic blocker
ORAVERSE (INJECTABLE) (INJECTION) PHENTOLAMINE MESYLATE
Drug Classes: alpha adrenergic blocker
NDA Applicant: SEPTODONT HOLDING NDA No.: 022159 Prod. No.: 001 RX (0.4MG/1.7ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6764678 Local anesthetic methods and kits Claim Types: Method of administration Pat. Sub. Date(s): 001: None | May 11, 2021 | U-967: A method of reversing soft-tissue anesthesia i.e. anesthesia of the lip and tongue, and the associated functional deficits resulting from an intraoral submucosal injection of a local anesthetic |
| Pat. No. 6872390 DP* Local anesthetic methods and kits Claim Types: Formulation Pat. Sub. Date(s): 001: None | May 11, 2021 | |
| Pat. No. 7229630 DP* Stabilized formulations of alpha adrenergic receptor antagonists and the uses thereof Claim Types: Formulation; Kit; Drug in a container Pat. Sub. Date(s): 001: None | Jun 20, 2023 | |
| Pat. No. 7569230 Stabilized formulations of alpha adrenergic receptor antagonists and the uses thereof Claim Types: Method of use Pat. Sub. Date(s): 001: None | Oct 17, 2023 | U-967: A method of reversing soft-tissue anesthesia i.e. anesthesia of the lip and tongue, and the associated functional deficits resulting from an intraoral submucosal injection of a local anesthetic |
| Pat. No. 7575757 DP* Stabilized formulations of alpha adrenergic receptor antagonists and the uses thereof Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): 001: None | Apr 21, 2025 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Mar 18, 2019 |
alpha particle-emitting radioactive therapeutic agent
XOFIGO (SOLUTION) (INTRAVENOUS) RADIUM RA-223 DICHLORIDE
Drug Classes: alpha particle-emitting radioactive therapeutic agent
NDA Applicant: BAYER HLTHCARE NDA No.: 203971 Prod. No.: 001 RX (162mCi/6ML (27mCi/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6635234 [Extended 1049 days (2.9 years)] Preparation and use of radium-223 to target calcified tissues for pain palliation, bone cancer therapy, and bone surface conditioning Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jun 11, 2013 | Nov 17, 2022 | U-2271: Therapeutic treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease |
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: OMEROS 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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Jun 8, 2021 PED |
alpha-1 adrenergic receptor agonist
PHENYLEPHRINE HYDROCHLORIDE (SOLUTION/DROPS) (OPHTHALMIC) PHENYLEPHRINE HYDROCHLORIDE
Drug Classes: alpha-1 adrenergic receptor agonist
NDA Applicant: PARAGON BIOTECK NDA No.: 203510 Prod. No.: 001 RX (2.5%); 002 RX (10%)
| 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 |
amide local anesthetic
AKTEN (GEL) (OPHTHALMIC) LIDOCAINE HYDROCHLORIDE
Drug Classes: amide local anesthetic; antiarrhythmic
NDA Applicant: AKORN 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
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. 9585838 DP* Production of multivesicular liposomes Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: Apr 3, 2017 | Dec 24, 2021 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Apr 6, 2021 | I-771: Revision of the indication section of the package insert regarding an interscalene brachial plexus nerve block to produce postsurgical regional analgesia |
amide local anesthetic
LIDOSITE TOPICAL SYSTEM KIT (PATCH) (IONTOPHORESIS, TOPICAL) EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI); norepinephrine-releasing agent; alpha adrenergic agonist; beta adrenergic agonist; catecholamine; norepinephrine, serotonin, and dopamine reuptake inhibitor anorectic; amide local anesthetic; antiarrhythmic
NDA Applicant: VYTERIS NDA No.: 021504 Prod. No.: 001 DISC (1.05MG/PATCH;100MG/PATCH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6629968 DS* DP* Shelf storage stable iontophoresis reservoir-electrode and iontophoretic system incorporating the reservoir-electrode Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: None | Jun 30, 2020 | |
| Pat. No. 6635045 DS* DP* Electrodes and method for manufacturing electrodes for electrically assisted drug delivery Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: None | Jun 29, 2021 |
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. 8118802 DP* Connector for packaging containing medical fluids and packaging for medical fluids Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 6, 2014 | May 18, 2023 | |
| Pat. No. 8162915 DP* Connector for packings containing medical liquids, and corresponding packing for medical liquids Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 6, 2014 | May 23, 2024 |
amide local anesthetic
PLIAGLIS (CREAM) (TOPICAL) LIDOCAINE; TETRACAINE
Drug Classes: amide local anesthetic; antiarrhythmic; ester local anesthetic
NDA Applicant: TARO PHARMS NDA No.: 021717 Prod. No.: 001 RX (7%;7%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6528086 DP* Methods and apparatus for drug delivery involving phase changing formulations Claim Types: Method of use; Formulation Pat. Sub. Date(s): 001: None | Sep 28, 2019 | |
| 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 |
amide local anesthetic
SYNERA (PATCH) (TOPICAL) LIDOCAINE; TETRACAINE
Drug Classes: amide local anesthetic; antiarrhythmic; ester local anesthetic
NDA Applicant: GALEN SPECIALTY NDA No.: 021623 Prod. No.: 001 RX (70MG;70MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6465709 DP* Exothermic bandage Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Jul 19, 2012 | Jul 7, 2020 |
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 INC 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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Feb 28, 2021 |
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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: GAIN - Generating Antibiotic Incentives Now | Sep 28, 2030 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Sep 28, 2025 | 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
BETHKIS (SOLUTION) (INHALATION) TOBRAMYCIN
Drug Classes: aminoglycoside antibacterial
NDA Applicant: CHIESI USA INC NDA No.: 201820 Prod. No.: 001 RX (300MG/4ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6987094 DP* Optimized formulation of tobramycin for aerosolization Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Jan 30, 2013 | Sep 22, 2022 | |
| Pat. No. 7696178 DP* Optimised formulation of tobramycin for aerosolization Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Jan 30, 2013 | Sep 22, 2022 | |
| Pat. No. 7939502 Optimised formulation of tobramycin for aerosolization Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 30, 2013 | Jun 14, 2022 | U-1324: Management of cystic fibrosis patients |
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. 7368102 DP* Pulmonary delivery of aminoglycosides Claim Types: Formulation; Method of administration Pat. Sub. Date(s): 001: Apr 19, 2013 | Dec 19, 2022 | U-909: Treatment of cystic fibrosis patients with pseudomonas aeruginosa |
| Pat. No. 7442388 DP* Phospholipid-based powders for drug delivery Claim Types: Formulation; Method of administration; Process Pat. Sub. Date(s): 001: Apr 19, 2013 | May 10, 2020 | |
| Pat. No. 7516741 DP* Aerosolization apparatus with feedback mechanism Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Apr 19, 2013 | Jan 11, 2024 | |
| Pat. No. 7559325 DP* Aerosolization apparatus with air inlet shield Claim Types: Device Pat. Sub. Date(s): 001: Apr 19, 2013 | Oct 27, 2025 | |
| Pat. No. 8069851 DP* Aeorosolization apparatus with air inlet shield Claim Types: Device Pat. Sub. Date(s): 001: Apr 19, 2013 | Sep 24, 2024 | |
| Pat. No. 8349294 DP* Stable metal ion-lipid powdered pharmaceutical compositions for drug delivery and methods of use Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 19, 2013 | May 10, 2020 | |
| 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. 8715623 DP* Pulmonary delivery of aminoglycoside Claim Types: Formulation; Method of use; Method of administration Pat. Sub. Date(s): 001: Oct 20, 2014 | Dec 19, 2022 | 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 Pat. Sub. Date(s): 001: Jun 17, 2019 | Sep 12, 2028 | U-909: Treatment of cystic fibrosis patients with pseudomonas aeruginosa |
| Pat. No. 9421166 DP* Pulmonary delivery of aminoglycoside Claim Types: Formulation; Method of administration Pat. Sub. Date(s): 001: Jun 17, 2019 | Dec 19, 2022 | 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 |
aminoglycoside antibacterial
TOBRADEX ST (SUSPENSION/DROPS) (OPHTHALMIC) DEXAMETHASONE; TOBRAMYCIN
Drug Classes: corticosteroid; aminoglycoside antibacterial
NDA Applicant: NOVARTIS 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: VALEANT PHARMS NORTH 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
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. 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 |
aminoketone
FORFIVO XL (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROCHLORIDE
Drug Classes: aminoketone
NDA Applicant: ALVOGEN 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 |
aminosalicylate
APRISO (CAPSULE, EXTENDED RELEASE) (ORAL) MESALAMINE [GENERIC AB]
Drug Classes: aminosalicylate
NDA Applicant: VALEANT PHARMS INTL 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
ASACOL HD (TABLET, DELAYED RELEASE) (ORAL) MESALAMINE [GENERIC AB]
Drug Classes: aminosalicylate
NDA Applicant: APIL NDA No.: 021830 Prod. No.: 001 RX (800MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6893662 DP* Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures Claim Types: Formulation Pat. Sub. Date(s): 001: None | Nov 15, 2021 | U-141: Treatment of ulcerative colitis |
| Pat. No. 8580302 DP* Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 13, 2013 | Nov 15, 2021 | |
| Pat. No. 9089492 DP* Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 22, 2015 | Nov 15, 2021 |
aminosalicylate
CANASA (SUPPOSITORY) (RECTAL) MESALAMINE
Drug Classes: aminosalicylate
NDA Applicant: ALLERGAN NDA No.: 021252 Prod. No.: 001 DISC (500MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: M - Miscellaneous | Sep 2, 2019 | M-187: Addition of clinical information obtained from a pediatric trial to section 8.4 of the labeling |
aminosalicylate
CANASA (SUPPOSITORY) (RECTAL) MESALAMINE [GENERIC AB]
Drug Classes: aminosalicylate
NDA Applicant: ALLERGAN 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 Pat. Sub. Date(s): 002: May 24, 2013 Comments: Method of use | 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
DELZICOL (CAPSULE, DELAYED RELEASE) (ORAL) MESALAMINE [GENERIC AB]
Drug Classes: aminosalicylate
NDA Applicant: APIL NDA No.: 204412 Prod. No.: 001 RX (400MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6649180 DP* Hard capsule formed of cellulose ether film with a specific content of methoxyl and hydroxypropoxyl groups Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 12, 2013 | Apr 13, 2020 |
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
LIALDA (TABLET, DELAYED RELEASE) (ORAL) MESALAMINE [GENERIC AB]
Drug Classes: aminosalicylate
NDA Applicant: SHIRE NDA No.: 022000 Prod. No.: 001 RX (1.2GM)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6773720 DP* Mesalazine controlled release oral pharmaceutical compositions Claim Types: Formulation; Process Pat. Sub. Date(s): 001: None | Jun 8, 2020 |
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
ADDERALL 10; ADDERALL 20; ADDERALL 5; ADDERALL 30; ADDERALL 7.5; ADDERALL 12.5; ADDERALL 15 (TABLET) (ORAL) AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: TEVA WOMENS NDA No.: 011522 Prod. No.: 007 DISC (2.5MG;2.5MG;2.5MG;2.5MG**); 008 DISC (5MG;5MG;5MG;5MG**); 009 DISC (1.25MG;1.25MG;1.25MG;1.25MG**); 010 DISC (7.5MG;7.5MG;7.5MG;7.5MG**); 011 DISC (1.875MG;1.875MG;1.875MG;1.875MG**); 012 DISC (3.125MG;3.125MG;3.125MG;3.125MG**); 013 DISC (3.75MG;3.75MG;3.75MG;3.75MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6384020 Rapid immediate release oral dosage form Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jan 6, 2021 *PED |
amphetamine anorectic
ADDERALL XR 10; ADDERALL XR 20; ADDERALL XR 30; ADDERALL XR 25; ADDERALL XR 5; ADDERALL XR 15 (CAPSULE, EXTENDED RELEASE) (ORAL) AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE [GENERIC AB]
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: SHIRE NDA No.: 021303 Prod. No.: 001 RX (2.5MG;2.5MG;2.5MG;2.5MG); 002 RX (5MG;5MG;5MG;5MG); 003 RX (7.5MG;7.5MG;7.5MG;7.5MG); 004 RX (6.25MG;6.25MG;6.25MG;6.25MG); 005 RX (1.25MG;1.25MG;1.25MG;1.25MG); 006 RX (3.75MG;3.75MG;3.75MG;3.75MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE41148 DP* Oral pulsed dose drug delivery system Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Apr 21, 2019 *PED | |
| Pat. No. RE42096 DP* Oral pulsed dose drug delivery system Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Apr 21, 2019 *PED | |
| Pat. No. 6322819 Oral pulsed dose drug delivery system Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Apr 21, 2019 *PED | |
| Pat. No. 6605300 Oral pulsed dose drug delivery system Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Apr 21, 2019 *PED |
amphetamine anorectic
ADZENYS ER (SUSPENSION, EXTENDED RELEASE) (ORAL) AMPHETAMINE
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: NEOS THERAPS INC NDA No.: 204325 Prod. No.: 001 RX (EQ 1.25MG BASE/ML)
| 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: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: NEOS THERAPS NDA No.: 204326 Prod. No.: 001 RX (EQ 3.1MG BASE); 002 RX (EQ 6.3MG BASE); 003 RX (EQ 9.4MG BASE); 004 RX (EQ 12.5MG BASE); 005 RX (EQ 15.7MG BASE); 006 RX (EQ 18.8MG BASE)
| 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 |
amphetamine anorectic
AMPHETAMINE SULFATE (TABLET) (ORAL) AMPHETAMINE SULFATE [GENERIC AA]
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: AMNEAL PHARMS NDA No.: 211139 Prod. No.: 001 RX (5MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Mar 26, 2019 |
amphetamine anorectic
AMPHETAMINE SULFATE (TABLET) (ORAL) AMPHETAMINE SULFATE [GENERIC AA]
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: AMNEAL PHARMS NDA No.: 211139 Prod. No.: 002 RX (10MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Mar 30, 2019 |
amphetamine anorectic
DYANAVEL XR (SUSPENSION, EXTENDED RELEASE) (ORAL) AMPHETAMINE
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: TRIS PHARMA INC NDA No.: 208147 Prod. No.: 001 RX (EQ 2.5MG BASE/ML)
| 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 |
amphetamine anorectic
EVEKEO ODT (TABLET, ORALLY DISINTEGRATING) (ORAL) AMPHETAMINE SULFATE
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: ARBOR PHARMS LLC NDA No.: 209905 Prod. No.: 001 RX (5MG); 002 RX (10MG); 003 RX (15MG); 004 RX (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 |
amphetamine anorectic
MYDAYIS (CAPSULE, EXTENDED RELEASE) (ORAL) AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE [Has competitive generic]
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: SHIRE DEV LLC NDA No.: 022063 Prod. No.: 001 RX (3.125MG;3.125MG;3.125MG;3.125MG); 002 RX (6.25MG;6.25MG;6.25MG;6.25MG); 003 RX (9.375MG;9.375MG;9.375MG;9.375MG); 004 RX (12.5MG;12.5MG;12.5MG;12.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6913768 DP* Sustained release delivery of amphetamine salts Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 7, 2017 | May 24, 2023 | U-2025: Treatment of attention deficit hyperactivity disorder |
| 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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Mar 13, 2023 PED | M-248: Information added to the labeling to describe a trial evaluating a lower dose than those approved for pediatric patients 13 to 17 years of age |
| Exclusivity Code: NP - New product | Jun 20, 2020 |
amylin analog
SYMLIN (INJECTABLE) (SUBCUTANEOUS) PRAMLINTIDE ACETATE
Drug Classes: amylin analog
NDA Applicant: ASTRAZENECA AB NDA No.: 021332 Prod. No.: 002 RX (EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)); 003 RX (EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)) NDA No.: 021332 Prod. No.: 001 DISC (EQ 3MG BASE/5ML (EQ 600MCG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5686411 DS* DP* [Extended 1586 days (4.3 years)] Amylin agonist peptides and uses therefor Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): All strengths: None | Mar 16, 2019 | U-638: Treatment of diabetes with an amylin agonist, including with insulin |
androgen
ANDROGEL (GEL; GEL, METERED) (TRANSDERMAL) TESTOSTERONE [GENERIC AB1]
Drug Classes: androgen
NDA Applicant: ABBVIE NDA No.: 021015 Prod. No.: 001 RX (25MG/2.5GM PACKET); 002 RX (50MG/5GM PACKET); 003 RX (12.5MG/1.25GM ACTUATION)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6503894 Pharmaceutical composition and method for treating hypogonadism Claim Types: Formulation; Device; Method of administration Pat. Sub. Date(s): All strengths: None | Mar 1, 2021 *PED | U-490: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone |
| Pat. No. 9125816 Pharmaceutical composition and method for treating hypogonadism Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 14, 2015 | Mar 2, 2021 *PED | U-490: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone |
| Pat. No. 9132089 Pharmaceutical composition and method for treating hypogonadism Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 28, 2015 | Mar 2, 2021 *PED | U-490: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone |
androgen
ANDROGEL (GEL, METERED) (TRANSDERMAL) TESTOSTERONE [GENERIC AB]
Drug Classes: androgen
NDA Applicant: ABBVIE NDA No.: 022309 Prod. No.: 001 RX (1.62% (20.25MG/1.25GM ACTUATION)); 002 RX (1.62% (20.25MG/1.25GM PACKET)); 003 RX (1.62% (40.5MG/2.5GM PACKET))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6503894 Pharmaceutical composition and method for treating hypogonadism Claim Types: Formulation; Device; Method of administration Pat. Sub. Date(s): 001: None; 002: May 23, 2014; 003: May 23, 2014 | Mar 2, 2021 *PED | U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone |
| Pat. No. 8466136 DP* Testosterone gel and method of use Claim Types: Formulation 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 | |
| Pat. No. 9125816 Pharmaceutical composition and method for treating hypogonadism Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 14, 2015 | Mar 2, 2021 *PED | U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone |
| Pat. No. 9132089 Pharmaceutical composition and method for treating hypogonadism Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 28, 2015 | Mar 2, 2021 *PED | U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone |
androgen
AVEED (INJECTABLE) (INTRAMUSCULAR) TESTOSTERONE UNDECANOATE
Drug Classes: androgen
NDA Applicant: ENDO PHARMS INC NDA No.: 022219 Prod. No.: 001 RX (750MG/3ML (250MG/ML))
| 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 | Feb 27, 2026 | 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. 8784878 DP* Transdermal delivery rate control using amorphous pharmaceutical compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 7, 2014 | Jul 13, 2023 | U-1545: A method of transdermally delivering testosterone |
| 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
JATENZO (CAPSULE) (ORAL) TESTOSTERONE UNDECANOATE
Drug Classes: androgen
NDA Applicant: CLARUS 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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Mar 27, 2022 |
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 |
androgen
STRIANT (TABLET, EXTENDED RELEASE) (BUCCAL) TESTOSTERONE
Drug Classes: androgen
NDA Applicant: AUXILIUM PHARMS LLC NDA No.: 021543 Prod. No.: 001 DISC (30MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6248358 Bioadhesive progressive hydration tablets and methods of making and using the same Claim Types: Formulation; Method of administration; Method of use; Process Pat. Sub. Date(s): 001: None | Aug 23, 2019 | U-527: Method of delivering an active ingredient using a progressive hydration bioadhesive |
androgen
TESTIM (GEL) (TRANSDERMAL) TESTOSTERONE [GENERIC AB2]
Drug Classes: androgen
NDA Applicant: AUXILIUM PHARMS LLC NDA No.: 021454 Prod. No.: 001 RX (50MG/5GM PACKET)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7320968 Pharmaceutical composition Claim Types: Method of use Pat. Sub. Date(s): 001: None | Jan 18, 2025 | U-843: Method for administration of testosterone |
| Pat. No. 7608605 Pharmaceutical composition Claim Types: Method of administration Pat. Sub. Date(s): 001: None | Apr 21, 2023 | U-1009: Method for administration of testosterone |
| Pat. No. 7608606 Pharmaceutical composition Claim Types: Method of adminstration Pat. Sub. Date(s): 001: None | Apr 21, 2023 | U-1009: Method for administration of testosterone |
| Pat. No. 7608607 Pharmaceutical composition Claim Types: Method of administration Pat. Sub. Date(s): 001: None | Apr 21, 2023 | U-1009: Method for administration of testosterone |
| Pat. No. 7608608 Pharmaceutical composition Claim Types: Method of administration Pat. Sub. Date(s): 001: None | Apr 21, 2023 | U-1009: Method for administration of testosterone |
| Pat. No. 7608609 Pharmaceutical composition Claim Types: Method of administration Pat. Sub. Date(s): 001: None | Apr 21, 2023 | U-1009: Method for administration of testosterone |
| Pat. No. 7608610 Pharmaceutical composition Claim Types: Method of administration Pat. Sub. Date(s): 001: None | Apr 21, 2023 | U-1009: Method for administration of testosterone |
| Pat. No. 7935690 Pharmaceutical composition Claim Types: Method of use Pat. Sub. Date(s): 001: May 19, 2011 | Apr 21, 2023 | U-1009: Method for administration of testosterone |
| Pat. No. 8063029 Pharmaceutical composition Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 8, 2011 | Apr 21, 2023 | U-843: Method for administration of testosterone |
| Pat. No. 8178518 DP* Pharmaceutical composition Claim Types: Formulation Pat. Sub. Date(s): 001: May 15, 2012 | Apr 21, 2023 |
androgen
TESTODERM TTS (FILM, EXTENDED RELEASE) (TRANSDERMAL) TESTOSTERONE
Drug Classes: androgen
NDA Applicant: ALZA NDA No.: 020791 Prod. No.: 001 DISC (5MG/24HR)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6348210 Methods for transdermal drug administration Claim Types: Method of administration Pat. Sub. Date(s): 001: None | Nov 10, 2019 | U-440: Method for transdermal administration of a drug through non-scrotal skin using a transdermal drug delivery device containing the drug and having an adhesive surface |
androgen
TESTOSTERONE (GEL, METERED) (TRANSDERMAL) TESTOSTERONE [GENERIC AB]
Drug Classes: androgen
NDA Applicant: PERRIGO ISRAEL NDA No.: 204268 Prod. No.: 001 RX (1.62% (20.25MG/1.25GM ACTUATION))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: PC - Patent challenge | Apr 10, 2019 |
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. RE44847 DP* Needle assisted jet injector Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 24, 2018 | Aug 10, 2019 | U-2419: Method of operating an injection device |
| Pat. No. RE44846 DP* Needle assisted jet injector Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 24, 2018 | Aug 10, 2019 | |
| 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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Sep 28, 2021 |
androgen receptor inhibitor
XTANDI (CAPSULE) (ORAL) ENZALUTAMIDE
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 [Extended 101 days (0.3 years)] Treatment of hyperproliferative disorders with diarylhydantoin compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 27, 2012 | Aug 24, 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) |
| 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) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jul 13, 2021 | I-786: Treatment of patients with non-metastatic castration-resistant prostate cancer |
| Exclusivity Code: I - New Indication | Dec 16, 2022 | I-808: Treatment of patients with metastatic castration-sensitive prostate cancer (MCSPC) |
angiotensin converting enzyme inhibitor
ALTACE (CAPSULE) (ORAL) RAMIPRIL [GENERIC AB]
Drug Classes: angiotensin converting enzyme inhibitor
NDA Applicant: KING PHARMS LLC NDA No.: 019901 Prod. No.: 001 RX (1.25MG); 002 RX (2.5MG); 003 RX (5MG); 004 RX (10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7368469 Use of inhibitors of the renin-angiotensin system in the prevention of cardiovascular events Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Aug 30, 2020 | U-871: Method of reducing risk of myocardial infarction, stroke and death |
angiotensin converting enzyme inhibitor
ALTACE (TABLET) (ORAL) RAMIPRIL
Drug Classes: angiotensin converting enzyme inhibitor
NDA Applicant: KING PFIZER NDA No.: 022021 Prod. No.: 001 DISC (1.25MG**); 002 DISC (2.5MG**); 003 DISC (5MG**); 004 DISC (10MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7368469 Use of inhibitors of the renin-angiotensin system in the prevention of cardiovascular events Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Aug 30, 2020 | U-871: Method of reducing risk of myocardial infarction, stroke and death |
angiotensin converting enzyme inhibitor
EPANED (SOLUTION) (ORAL) ENALAPRIL MALEATE
Drug Classes: angiotensin converting enzyme inhibitor
NDA Applicant: SILVERGATE PHARMS NDA No.: 208686 Prod. No.: 001 RX (1MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9669008 DP* Enalapril formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 9, 2017 | Mar 25, 2036 | |
| Pat. No. 9808442 Enalapril formulations Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 20, 2017 | Mar 25, 2036 | U-1723: Treatment of heart failure U-185: Method of treating hypertension U-1892: Method of treating left ventricular dysfunction U-3: Treatment of hypertension U-71: Method of treatment of heart failure |
| Pat. No. 10039745 DP* Enalapril formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 23, 2018 | Mar 25, 2036 | |
| Pat. No. 10154987 Enalapril formulations Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 4, 2019 | Mar 25, 2036 | U-1723: Treatment of heart failure U-185: Method of treating hypertension U-1892: Method of treating left ventricular dysfunction U-3: Treatment of hypertension U-71: Method of treatment of heart failure |
angiotensin converting enzyme inhibitor
EPANED KIT (FOR SOLUTION) (ORAL) ENALAPRIL MALEATE
Drug Classes: angiotensin converting enzyme inhibitor
NDA Applicant: SILVERGATE PHARMS NDA No.: 204308 Prod. No.: 001 DISC (1MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8568747 DP* Enalapril compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 31, 2013 | Nov 6, 2032 | |
| Pat. No. 8778366 Enalapril compositions Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 16, 2014 | Nov 6, 2032 | U-1723: Treatment of heart failure U-185: Method of treating hypertension U-1892: Method of treating left ventricular dysfunction U-3: Treatment of hypertension U-71: Method of treatment of heart failure |
| Pat. No. 9855214 DP* Enalapril compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 10, 2018 | Nov 6, 2032 | |
| Pat. No. 9968553 Enalapril compositions Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 1, 2018 | Nov 6, 2032 | U-1723: Treatment of heart failure U-185: Method of treating hypertension U-1892: Method of treating left ventricular dysfunction U-3: Treatment of hypertension U-71: Method of treatment of heart failure |
angiotensin converting enzyme inhibitor
GIAPREZA (SOLUTION) (INTRAVENOUS) ANGIOTENSIN II ACETATE
Drug Classes: vasoconstrictor; angiotensin II receptor blocker; angiotensin converting enzyme inhibitor
NDA Applicant: LA JOLLA PHARMA NDA No.: 209360 Prod. No.: 001 RX (EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)) NDA No.: 209360 Prod. No.: 002 DISC (EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9220745 Angiotensin II alone or in combination for the treatment of hypotension Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 22, 2018 | Dec 18, 2034 | U-2217: Treating high output shock with angiotensin II by increasing mean arterial pressure in patients treated with catecholamines and reducing catecholamine use U-2218: Maintaining mean arterial pressure of about 65 mmHg or higher with angiotensin II in shock patients treated with catecholamines and reducing catecholamine use |
| Pat. No. 9572856 Method of treating low blood pressure Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 22, 2018 | Nov 20, 2030 | U-2221: Treating refractory hypotension with about 20 ng/kg/min angiotensin II in a patient receiving vasopressor |
| Pat. No. 9867863 Method of treating low blood pressure Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 14, 2018 | Dec 16, 2029 | U-2231: Treating refractory hypotension with about 5 ng/kg/min to about 20 ng/kg/min angiotensin II in a patient receiving vasopressor |
| Pat. No. 10028995 Angiotensin II alone or in combination for the treatment of hypotension Claim Types: Method of improving a treatment Pat. Sub. Date(s): All strengths: Aug 2, 2018 | Dec 18, 2034 | U-2338: Maintaining mean arterial pressure of about 65 mmHg or above with about 1 ng/kg/min to about 40 ng/kg/min angiotensin II in hypotensive patients treated with vasopressin or a vasopressin analogue and reducing vasopressin or vasopressin analogue use |
| Pat. No. 10335451 Method of treating low blood pressure Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 26, 2019 | Dec 16, 2029 | U-2581: Treating hypotension with about 20 ng/kg/min to about 40 ng/kg/min angiotensin II in a human subject having septic shock |
| Pat. No. 10493124 Angiotensin II alone or in combination for the treatment of hypotension Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 20, 2019 | Dec 18, 2034 | U-2679: Treating low blood pressure with angiotensin II at an initial rate of about 20 ng/kg/min and titrating down to achieve and/or maintain a map of about 65 mm Hg or above |
| Pat. No. 10500247 Method of treating low blood pressure Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 20, 2019 | Dec 16, 2029 | U-2680: Treating low blood pressure with angiotensin II with an initial rate of about 5 ng/kg/min to about 20 ng/kg/min in a subject having refractory hypotension or severe hypotension U-2681: Treating low blood pressure with angiotensin II with an initial rate of about 5 ng/kg/min to about 20 ng/kg/min in a subject having refractory hypotension or severe hypotension, and titrating the rate up |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Dec 21, 2022 |
angiotensin converting enzyme inhibitor
PRESTALIA (TABLET) (ORAL) AMLODIPINE BESYLATE; PERINDOPRIL ARGININE
Drug Classes: dihydropyridine calcium channel blocker; angiotensin converting enzyme inhibitor
NDA Applicant: ADHERA NDA No.: 205003 Prod. No.: 001 RX (EQ 2.5MG BASE;3.5MG ); 002 RX (EQ 5MG BASE;7MG); 003 RX (EQ 10MG BASE;14MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6696481 DS* DP* Salt of perindopril and pharmaceutical compositions containing it Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): All strengths: Dec 29, 2015 | Apr 15, 2023 | U-3: Treatment of hypertension |
| Pat. No. 7846961 DS* DP* .alpha. crystalline form of the arginine salt of perindopril, a process for its preparation and pharm Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use Pat. Sub. Date(s): All strengths: Dec 29, 2015 | Oct 5, 2029 | U-3: Treatment of hypertension |
angiotensin converting enzyme inhibitor
QBRELIS (SOLUTION) (ORAL) LISINOPRIL
Drug Classes: angiotensin converting enzyme inhibitor
NDA Applicant: SILVERGATE PHARMS 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 |
angiotensin II receptor blocker
BYVALSON (TABLET) (ORAL) NEBIVOLOL HYDROCHLORIDE; VALSARTAN
Drug Classes: beta-adrenergic receptor inhibitor; angiotensin II receptor blocker
NDA Applicant: ALLERGAN 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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NC - New combination | Jun 3, 2019 |
angiotensin II receptor blocker
EDARBI (TABLET) (ORAL) AZILSARTAN KAMEDOXOMIL
Drug Classes: angiotensin II receptor blocker
NDA Applicant: ARBOR PHARMS LLC NDA No.: 200796 Prod. No.: 001 RX (EQ 40MG MEDOXOMIL); 002 RX (EQ 80MG MEDOXOMIL)
| 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: ARBOR PHARMS LLC 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
Drug Classes: neprilysin inhibitor; angiotensin II receptor blocker
NDA Applicant: NOVARTIS PHARMS CORP NDA No.: 207620 Prod. No.: 001 RX (24MG;26MG); 002 RX (49MG;51MG); 003 RX (97MG;103MG)
| 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 14, 2023 *PED | |
| Pat. No. 8404744 DP* Methods of treatment and pharmaceutical composition Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 6, 2015 | Jul 14, 2023 *PED | |
| Pat. No. 8796331 Methods of treatment and pharmaceutical composition Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 6, 2015 | Jul 14, 2023 *PED | U-1723: Treatment of heart failure |
| Pat. No. 8877938 DS* DP* Compounds containing S-N-valeryl-N-{[2'-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl}-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations Claim Types: Compound; Composition; Formulation 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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jan 7, 2021 PED | |
| Exclusivity Code: NPP - New patient population | Apr 1, 2023 PED |
angiotensin II receptor blocker
EXFORGE (TABLET) (ORAL) AMLODIPINE BESYLATE; VALSARTAN [GENERIC AB]
Drug Classes: dihydropyridine calcium channel blocker; angiotensin II receptor blocker
NDA Applicant: NOVARTIS NDA No.: 021990 Prod. No.: 002 RX (EQ 5MG BASE;160MG); 003 RX (EQ 10MG BASE;160MG); 004 RX (EQ 5MG BASE;320MG); 005 RX (EQ 10MG BASE;320MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6395728 DP* Method of treatment and pharmaceutical composition Claim Types: Method of use; Composition; Formulation Pat. Sub. Date(s): All strengths: None | Jul 8, 2019 |
angiotensin II receptor blocker
EXFORGE HCT (TABLET) (ORAL) AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN [GENERIC AB]
Drug Classes: dihydropyridine calcium channel blocker; thiazide diuretic; angiotensin II receptor blocker
NDA Applicant: NOVARTIS NDA No.: 022314 Prod. No.: 001 RX (5MG;12.5MG;160MG); 002 RX (5MG;25MG;160MG); 003 RX (10MG;12.5MG;160MG); 004 RX (10MG;25MG;160MG); 005 RX (10MG;25MG;320MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8101599 DP* Pharmaceutical composition containing anti-hypertensive agents Claim Types: Formulation; Kit Pat. Sub. Date(s): 001: Jan 30, 2012; 002: None; 003: None; 004: None; 005: None | May 16, 2023 | |
| Pat. No. 8475839 DP* Formulation Claim Types: Pat. Sub. Date(s): All strengths: Aug 1, 2013 | Nov 16, 2023 *PED |
angiotensin II receptor blocker
GIAPREZA (SOLUTION) (INTRAVENOUS) ANGIOTENSIN II ACETATE
Drug Classes: vasoconstrictor; angiotensin II receptor blocker; angiotensin converting enzyme inhibitor
NDA Applicant: LA JOLLA PHARMA NDA No.: 209360 Prod. No.: 001 RX (EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)) NDA No.: 209360 Prod. No.: 002 DISC (EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9220745 Angiotensin II alone or in combination for the treatment of hypotension Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 22, 2018 | Dec 18, 2034 | U-2217: Treating high output shock with angiotensin II by increasing mean arterial pressure in patients treated with catecholamines and reducing catecholamine use U-2218: Maintaining mean arterial pressure of about 65 mmHg or higher with angiotensin II in shock patients treated with catecholamines and reducing catecholamine use |
| Pat. No. 9572856 Method of treating low blood pressure Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 22, 2018 | Nov 20, 2030 | U-2221: Treating refractory hypotension with about 20 ng/kg/min angiotensin II in a patient receiving vasopressor |
| Pat. No. 9867863 Method of treating low blood pressure Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 14, 2018 | Dec 16, 2029 | U-2231: Treating refractory hypotension with about 5 ng/kg/min to about 20 ng/kg/min angiotensin II in a patient receiving vasopressor |
| Pat. No. 10028995 Angiotensin II alone or in combination for the treatment of hypotension Claim Types: Method of improving a treatment Pat. Sub. Date(s): All strengths: Aug 2, 2018 | Dec 18, 2034 | U-2338: Maintaining mean arterial pressure of about 65 mmHg or above with about 1 ng/kg/min to about 40 ng/kg/min angiotensin II in hypotensive patients treated with vasopressin or a vasopressin analogue and reducing vasopressin or vasopressin analogue use |
| Pat. No. 10335451 Method of treating low blood pressure Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 26, 2019 | Dec 16, 2029 | U-2581: Treating hypotension with about 20 ng/kg/min to about 40 ng/kg/min angiotensin II in a human subject having septic shock |
| Pat. No. 10493124 Angiotensin II alone or in combination for the treatment of hypotension Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 20, 2019 | Dec 18, 2034 | U-2679: Treating low blood pressure with angiotensin II at an initial rate of about 20 ng/kg/min and titrating down to achieve and/or maintain a map of about 65 mm Hg or above |
| Pat. No. 10500247 Method of treating low blood pressure Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 20, 2019 | Dec 16, 2029 | U-2680: Treating low blood pressure with angiotensin II with an initial rate of about 5 ng/kg/min to about 20 ng/kg/min in a subject having refractory hypotension or severe hypotension U-2681: Treating low blood pressure with angiotensin II with an initial rate of about 5 ng/kg/min to about 20 ng/kg/min in a subject having refractory hypotension or severe hypotension, and titrating the rate up |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Dec 21, 2022 |
angiotensin II receptor blocker
MICARDIS (TABLET) (ORAL) TELMISARTAN [GENERIC AB]
Drug Classes: angiotensin II receptor blocker
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 020850 Prod. No.: 001 RX (40MG); 003 RX (20MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6358986 Polymorphs of telmisartan Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jan 10, 2020 |
angiotensin II receptor blocker
MICARDIS (TABLET) (ORAL) TELMISARTAN [GENERIC AB]
Drug Classes: angiotensin II receptor blocker
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 020850 Prod. No.: 002 RX (80MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6358986 Polymorphs of telmisartan Claim Types: Formulation Pat. Sub. Date(s): 002: None | Jan 10, 2020 | |
| Pat. No. 7998953 Use of inhibitors of the renin-angiotensin system Claim Types: Method of use Pat. Sub. Date(s): 002: Sep 9, 2011 | Jun 6, 2020 | U-1177: Reduction of cardiac tissue damage associated with myocardial infarction |
| Pat. No. 8003679 Use of inhibitors of the renin-angiotensin system Claim Types: Method of use Pat. Sub. Date(s): 002: Sep 9, 2011 | Oct 6, 2022 | U-1176: Treatment or prevention of stroke |
angiotensin II receptor blocker
MICARDIS HCT (TABLET) (ORAL) HYDROCHLOROTHIAZIDE; TELMISARTAN [GENERIC AB]
Drug Classes: thiazide diuretic; angiotensin II receptor blocker
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 021162 Prod. No.: 001 RX (12.5MG;40MG); 002 RX (12.5MG;80MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6358986 Polymorphs of telmisartan Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jan 10, 2020 |
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
VERMOX (TABLET, CHEWABLE) (ORAL) MEBENDAZOLE
Drug Classes: anthelmintic
NDA Applicant: JANSSEN PHARMS NDA No.: 208398 Prod. No.: 001 DISC (500MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NS - New strength | Oct 19, 2019 |