Patents whose numbers are in italics have been extended under 35 USC 156. Unless otherwise noted, all expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
Products tagged as [GENERIC] have had a generic equivalent approved for at least one strength of the product.
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9993466 DP* Donepezil transdermal delivery system Claim Types: Device Pat. Sub. Date(s): All strengths: Apr 6, 2022 | Jul 26, 2037 | |
| Pat. No. 10016372 Transdermal delivery systems with pharmacokinetics bioequivalent to oral delivery Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Apr 6, 2022 | Jul 26, 2037 | U-3334: A method of transdermal delivery of donepezil for treating mild, moderate and severe dementia of the Alzheimer's type |
| Pat. No. 10300025 DP* Donepezil transdermal delivery system Claim Types: Formulation Pat. Sub. Date(s): All strengths: Apr 6, 2022 | Jul 26, 2037 | |
| Pat. No. 10307379 DP* Donepezil transdermal delivery system Claim Types: Formulation Pat. Sub. Date(s): All strengths: Apr 6, 2022 | Jul 26, 2037 | |
| Pat. No. 10835499 DP* Systems and methods for long term transdermal administration Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Apr 6, 2022 | May 20, 2038 | U-3334: A method of transdermal delivery of donepezil for treating mild, moderate and severe dementia of the Alzheimer's type |
| Pat. No. 10966936 DP* Systems comprising a composite backing and methods for long term transdermal administration Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Apr 6, 2022 | Aug 11, 2038 | U-3334: A method of transdermal delivery of donepezil for treating mild, moderate and severe dementia of the Alzheimer's type |
| Pat. No. 11103463 Methods for treating Alzheimer's disease with donepezil transdermal system Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 6, 2022 | Jul 26, 2037 | U-3334: A method of transdermal delivery of donepezil for treating mild, moderate and severe dementia of the Alzheimer's type |
acetylcholinesterase inhibitor
ARICEPT (TABLET) (ORAL) DONEPEZIL HYDROCHLORIDE [GENERIC AB]
Drug Classes: Antidementia Agents:Cholinesterase Inhibitors == acetylcholinesterase inhibitor
NDA Applicant: EISAI INC NDA No.: 022568 Prod. No.: 001 RX (23MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8481565 DP* Method for stabilizing anti-dementia drug Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 9, 2013 | Oct 4, 2026 |
acetylcholinesterase inhibitor
NAMZARIC (CAPSULE, EXTENDED RELEASE) (ORAL) DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Drug Classes: Antidementia Agents:Cholinesterase Inhibitors == acetylcholinesterase inhibitor == Antidementia Agents:N-methyl-D-aspartate (NMDA) Receptor Antagonist == Antidementia Agents:Antidementia Agents, Other
NDA Applicant: ALLERGAN NDA No.: 206439 Prod. No.: 001 RX (10MG;14MG); 002 RX (10MG;28MG); 003 RX (10MG;7MG); 004 RX (10MG;21MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8039009 Modified release formulations of memantine oral dosage forms Claim Types: Method of use Pat. Sub. Date(s): 001: None; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 | Sep 24, 2029 *PED | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8058291 Methods and compositions for the treatment of CNS-related conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 22, 2015; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 | Dec 5, 2029 | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8168209 DP* Method and composition for administering an NMDA receptor antagonist to a subject Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 22, 2015; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 | May 22, 2026 *PED | |
| Pat. No. 8173708 Method and composition for administering an NMDA receptor antagonist to a subject Claim Types: Method of administration Pat. Sub. Date(s): 001: Jan 22, 2015; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 | May 22, 2026 *PED | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8283379 Methods and compositions for the treatment of CNS-related conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 22, 2015; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 | May 22, 2026 *PED | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8293794 DP* Methods and compositions for the treatment of CNS-related conditions Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 22, 2015; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 | Nov 22, 2025 | |
| Pat. No. 8329752 DP* Composition for administering an NMDA receptor antagonist to a subject Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 16, 2016; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 | May 22, 2026 *PED | |
| Pat. No. 8338485 DP* Compositions for the treatment of CNS-related conditions Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 16, 2016; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 | Nov 22, 2025 | |
| Pat. No. 8338486 Methods for the treatment of CNS-related conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 16, 2016; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 | Nov 22, 2025 | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8362085 Method for administering an NMDA receptor antagonist to a subject Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 16, 2016; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 | May 22, 2026 *PED | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8580858 Compositions for the treatment of CNS-related conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 16, 2016; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 | Nov 22, 2025 | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8598233 DP* Method for administering an NMDA receptor antagonist to a subject Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 16, 2016; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 | May 22, 2026 *PED |
adenosine receptor agonist
LEXISCAN (SOLUTION) (INTRAVENOUS) REGADENOSON [GENERIC AP]
Drug Classes: adenosine receptor agonist == pharmacologic stress agent
NDA Applicant: ASTELLAS NDA No.: 022161 Prod. No.: 001 RX (0.4MG/5ML (0.08MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE47301 DP* Process for preparing an A2A-adenosine receptor agonist and its polymorphs Claim Types: Product-by-process; Formulation; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Apr 2, 2019 | Feb 2, 2027 | |
| Pat. No. 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. 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 |
adenosine triphosphate-citrate lyase (ACL) inhibitor
NEXLETOL (TABLET) (ORAL) BEMPEDOIC ACID
Drug Classes: Cardiovascular Agents:Dyslipidemics, Other == adenosine triphosphate-citrate lyase (ACL) inhibitor
NDA Applicant: ESPERION THERAPS INC NDA No.: 211616 Prod. No.: 001 RX (180MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7335799 DS* Hydroxyl compounds and compositions for cholesterol management and related uses Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Mar 6, 2020 | Dec 3, 2025 | |
| Pat. No. 8497301 Hydroxyl compounds and compositions for cholesterol management and related uses Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 6, 2020 | Dec 23, 2023 | U-2747: Use of NEXLETOL as an adjunct to diet and maximally tolerated statin therapy to lower LDL-C in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease |
| Pat. No. 9000041 Hydroxyl compounds and compositions for cholesterol management and related uses Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 6, 2020 | Dec 23, 2023 | U-2747: Use of NEXLETOL as an adjunct to diet and maximally tolerated statin therapy to lower LDL-C in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease |
| Pat. No. 9624152 Hydroxyl compounds and compositions for cholesterol management and related uses Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 6, 2020 | Dec 23, 2023 | U-2748: Use of NEXLETOL as an adjunct to diet and maximally tolerated statin therapy for inhibiting cholesterol synthesis to lower LDL-C in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease |
| Pat. No. 10118881 Hydroxyl compounds and compositions for cholesterol management and related uses Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 6, 2020 | Dec 23, 2023 | U-2747: Use of NEXLETOL as an adjunct to diet and maximally tolerated statin therapy to lower LDL-C in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease |
| Pat. No. 10941095 Hydroxyl compounds and compositions for cholesterol management and related uses Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 31, 2021 | Dec 23, 2023 | U-2747: Use of NEXLETOL as an adjunct to diet and maximally tolerated statin therapy to lower LDL-C in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Feb 21, 2025 |
adenosine triphosphate-citrate lyase (ACL) inhibitor
NEXLIZET (TABLET) (ORAL) BEMPEDOIC ACID; EZETIMIBE
Drug Classes: Cardiovascular Agents:Dyslipidemics, Other == adenosine triphosphate-citrate lyase (ACL) inhibitor == Cardiovascular Agents:Cardiovascular Combinations == dietary cholesterol absorption inhibitor
NDA Applicant: ESPERION THERAPS INC NDA No.: 211617 Prod. No.: 001 RX (180MG;10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7335799 DS* Hydroxyl compounds and compositions for cholesterol management and related uses Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Mar 6, 2020 | Dec 3, 2025 | |
| Pat. No. 8497301 Hydroxyl compounds and compositions for cholesterol management and related uses Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 6, 2020 | Dec 23, 2023 | U-2746: Use of NEXLIZET as an adjunct to diet and maximally tolerated statin therapy to lower LDL-C in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease |
| Pat. No. 9000041 Hydroxyl compounds and compositions for cholesterol management and related uses Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 6, 2020 | Dec 23, 2023 | U-2746: Use of NEXLIZET as an adjunct to diet and maximally tolerated statin therapy to lower LDL-C in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease |
| Pat. No. 9624152 Hydroxyl compounds and compositions for cholesterol management and related uses Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 6, 2020 | Dec 23, 2023 | U-2749: Use of NEXLIZET as an adjunct to diet and maximally tolerated statin therapy for inhibiting cholesterol synthesis to lower LDL-C in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease |
| Pat. No. 10118881 Hydroxyl compounds and compositions for cholesterol management and related uses Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 6, 2020 | Dec 23, 2023 | U-2746: Use of NEXLIZET as an adjunct to diet and maximally tolerated statin therapy to lower LDL-C in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease |
| Pat. No. 10912751 Fixed dose combinations and formulations comprising ETC1002 and ezetimibe and methods of treating or reducing the risk of cardiovascular disease Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 14, 2021 | Mar 14, 2036 | U-3224: A method of treating heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease by decreasing the level of LDL-C using a fixed dose combination of 180 mg bempedoic acid and 10 mg ezetimibe |
| Pat. No. 10941095 Hydroxyl compounds and compositions for cholesterol management and related uses Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 31, 2021 | Dec 23, 2023 | U-2746: Use of NEXLIZET as an adjunct to diet and maximally tolerated statin therapy to lower LDL-C in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Feb 21, 2025 | |
| Exclusivity Code: NP - New product | Feb 26, 2023 |
aldosterone antagonist
CAROSPIR (SUSPENSION) (ORAL) SPIRONOLACTONE
Drug Classes: Cardiovascular Agents:Diuretics, Potassium-sparing == Cardiovascular Agents:Cardiovascular Combinations == aldosterone antagonist
NDA Applicant: CMP DEV LLC NDA No.: 209478 Prod. No.: 001 RX (25MG/5ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9757394 DP* Spironolactone aqueous formulations Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 21, 2017 | Oct 28, 2036 | U-2109: CAROSPIR is indicated for treatment of NYHA class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure |
| Pat. No. 10493083 DP* Spironolactone aqueous compositions Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): 001: Jan 2, 2020 | Oct 28, 2036 | |
| Pat. No. 10624906 DP* Spironolactone aqueous compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 27, 2020 | Oct 28, 2036 | |
| Pat. No. 10660907 DP* Spironolactone aqueous compositions Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): 001: Jun 15, 2020 | Oct 28, 2036 | |
| Pat. No. 10888570 DP* Spironolactone aqueous compositions Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): 001: Jan 15, 2021 | Oct 28, 2036 | |
| Pat. No. 11389461 DP* Spironolactone aqueous compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 22, 2022 | Oct 28, 2036 | |
| Pat. No. 11395828 Spironolactone aqueous compositions Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 2, 2022 | Oct 28, 2036 | U-2109: CAROSPIR is indicated for treatment of NYHA class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure U-3401: CAROSPIR is indicated as an add-on therapy for the treatment of hypertension, to lower blood pressure in adult patients who are not adequately controlled on other agents U-3402: CAROSPIR is indicated for the management of edema in adult cirrhotic patients when edema is not responsive to fluid and sodium restriction |
alkaloid
COLCRYS (TABLET) (ORAL) COLCHICINE [GENERIC AB]
Drug Classes: Antigout Agents == alkaloid
NDA Applicant: TAKEDA PHARMS USA NDA No.: 022352 Prod. No.: 001 RX (0.6MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7601758 Methods for concomitant administration of colchicine and macrolide antibiotics in the treatment of gout flares Claim Types: Method of use Pat. Sub. Date(s): 001: None | Feb 10, 2029 | U-1007: Method of treating gout flares |
| Pat. No. 7619004 Methods for concomitant administration of colchicine and macrolide antibiotics Claim Types: Method of administration Pat. Sub. Date(s): 001: None | Dec 3, 2028 | U-1020: Method of using colchicine for the prophylaxis of gout flares |
| Pat. No. 7820681 Methods for concomitant administration of colchicine and a second active agent Claim Types: Method of use Pat. Sub. Date(s): 001: None | Feb 17, 2029 | U-1020: Method of using colchicine for the prophylaxis of gout flares |
| Pat. No. 7906519 Methods for concomitant administration of colchicine and a second active agent Claim Types: Method of use Pat. Sub. Date(s): 001: None | Feb 17, 2029 | U-1116: Method of administering colchicine to familial mediterranean fever patients |
| Pat. No. 7915269 Methods for concomitant administration of colchicine and a second active agent Claim Types: Method of administration Pat. Sub. Date(s): 001: None | Feb 17, 2029 | U-1007: Method of treating gout flares |
| Pat. No. 7935731 Methods for concomitant administration of colchicine and macrolide antibiotics Claim Types: Method of administration Pat. Sub. Date(s): 001: Jun 24, 2011 | Dec 3, 2028 | U-1116: Method of administering colchicine to familial mediterranean fever patients |
| Pat. No. 7964647 Colchicine compositions and methods Claim Types: Method of administration Pat. Sub. Date(s): 001: Jun 24, 2011 | Oct 6, 2028 | U-1007: Method of treating gout flares |
| Pat. No. 7964648 Methods for concomitant administration of colchicine and a second active agent Claim Types: Method of administration Pat. Sub. Date(s): 001: Jun 24, 2011 | Oct 6, 2028 | U-1161: For the treatment and prophylaxis of gout flares & the treatment of familial Mediterranean fever |
| Pat. No. 7981938 Colchicine compositions and methods Claim Types: Method of administration Pat. Sub. Date(s): 001: Jul 22, 2011 | Oct 6, 2028 | U-1166: A method for treatment of gout flares during prophylaxis |
| Pat. No. 8093296 Methods for concomitant administration of colchicine and macrolide antibiotics Claim Types: Method of administration Pat. Sub. Date(s): 001: Jan 13, 2012 | Oct 6, 2028 | U-1007: Method of treating gout flares |
| Pat. No. 8093297 Methods for concomitant administration of colchicine and a second active agent Claim Types: Method of administration Pat. Sub. Date(s): 001: Jan 13, 2012 | Oct 6, 2028 | U-1161: For the treatment and prophylaxis of gout flares & the treatment of familial Mediterranean fever |
| Pat. No. 8093298 Methods for concomitant administration of colchicine and macrolide antibiotics Claim Types: Method of administration Pat. Sub. Date(s): 001: Jan 13, 2012 | Oct 6, 2028 | U-1116: Method of administering colchicine to familial mediterranean fever patients |
| Pat. No. 8097655 Methods for concomitant administration of colchicine and macrolide antibiotics Claim Types: Method of administration Pat. Sub. Date(s): 001: Jan 27, 2012 | Oct 6, 2028 | U-1020: Method of using colchicine for the prophylaxis of gout flares |
| Pat. No. 8415395 Colchicine compositions and methods Claim Types: Method of use Pat. Sub. Date(s): 001: May 8, 2013 | Oct 6, 2028 | U-1007: Method of treating gout flares |
| Pat. No. 8415396 Colchine compositions and methods Claim Types: Method of use Pat. Sub. Date(s): 001: May 8, 2013 | Oct 6, 2028 | U-1007: Method of treating gout flares |
| Pat. No. 8440721 Methods for concomitant administration of colchicine and a second active agent Claim Types: Method of administration Pat. Sub. Date(s): 001: Jun 10, 2013 | Feb 17, 2029 | U-1007: Method of treating gout flares |
| Pat. No. 8440722 Methods for concomitant administration of colchicine and a second active agent Claim Types: Method of administration Pat. Sub. Date(s): 001: Jun 10, 2013 | Feb 17, 2029 | U-1020: Method of using colchicine for the prophylaxis of gout flares |
alkaloid
GLOPERBA (SOLUTION) (ORAL) COLCHICINE
Drug Classes: Antigout Agents == alkaloid
NDA Applicant: SCILEX PHARMS NDA No.: 210942 Prod. No.: 001 RX (0.6MG/5ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9907751 DP* Composition and method of use of colchicine oral liquid Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 26, 2019 | Nov 22, 2036 | |
| Pat. No. 10226423 DP* Colchicine drug-to-drug interactions Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 27, 2019 | Dec 20, 2037 | |
| Pat. No. 10383820 DP* Colchicine drug-to-drug interactions Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 28, 2019 | Nov 22, 2036 | U-2814: A method of prophylactic treatment of gout flares in adults comprises administering to a patient a liquid colchicine oral solution |
| Pat. No. 10383821 DP* Colchicine drug-to-drug interactions Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 28, 2019 | Nov 22, 2036 |
alkaloid
MITIGARE (CAPSULE) (ORAL) COLCHICINE
Drug Classes: Antigout Agents == alkaloid
NDA Applicant: HIKMA INTL PHARMS NDA No.: 204820 Prod. No.: 001 RX (0.6MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8927607 Methods of colchicine administration Claim Types: Method of administration Pat. Sub. Date(s): 001: Jan 20, 2015 | Aug 22, 2033 | U-1020: Method of using colchicine for the prophylaxis of gout flares |
| Pat. No. 9399036 Methods of colchicine administration Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Aug 23, 2016 | Aug 22, 2033 | U-1020: Method of using colchicine for the prophylaxis of gout flares |
| Pat. No. 9555029 Methods of colchicine administration Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Feb 14, 2017 | Aug 22, 2033 | U-1020: Method of using colchicine for the prophylaxis of gout flares |
| Pat. No. 9675613 Methods of colchicine administration Claim Types: Method of administration Pat. Sub. Date(s): 001: Jun 20, 2017 | Aug 22, 2033 | U-1020: Method of using colchicine for the prophylaxis of gout flares |
| Pat. No. 9789108 Methods of colchicine administration Claim Types: Method of administration Pat. Sub. Date(s): 001: Nov 13, 2017 | Aug 22, 2033 | U-1020: Method of using colchicine for the prophylaxis of gout flares |
alkylating drug
BELRAPZO (SOLUTION) (IV (INFUSION)) BENDAMUSTINE HYDROCHLORIDE
Drug Classes: Antineoplastics:Alkylating Agents == alkylating drug
NDA Applicant: EAGLE PHARMS NDA No.: 205580 Prod. No.: 001 RX (100MG/4ML (25MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8609707 DP* Formulations of bendamustine Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 1, 2018 | Aug 11, 2031 | U-1971: For the treatment of patients with chronic lymphocytic leukemia U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma |
| Pat. No. 8791270 DP* Bendamustine pharmaceutical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 1, 2018 | Jan 12, 2026 | U-1971: For the treatment of patients with chronic lymphocytic leukemia U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma |
| Pat. No. 9265831 DP* Formulations of bendamustine Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 1, 2018 | Jan 28, 2031 | |
| Pat. No. 9572796 DP* Formulations of bendamustine Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 1, 2018 | Jan 28, 2031 | U-1971: For the treatment of patients with chronic lymphocytic leukemia U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma |
| Pat. No. 9572797 Formulations of bendamustine Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 1, 2018 | Jan 28, 2031 | U-1971: For the treatment of patients with chronic lymphocytic leukemia U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma |
| Pat. No. 10010533 DP* Formulations of bendamustine Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 3, 2018 | Jan 28, 2031 | |
| Pat. No. 11103483 DP* Formulations of bendamustine Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 31, 2021 | Jan 28, 2031 | U-1971: For the treatment of patients with chronic lymphocytic leukemia U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s) | Dec 7, 2022 |
alkylating drug
BENDEKA (SOLUTION) (IV (INFUSION)) BENDAMUSTINE HYDROCHLORIDE
Drug Classes: Antineoplastics:Alkylating Agents == alkylating drug
NDA Applicant: EAGLE PHARMS NDA No.: 208194 Prod. No.: 001 RX (100MG/4ML (25MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8609707 DP* Formulations of bendamustine Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Dec 11, 2015 | Aug 11, 2031 | U-1542: For use in the treatment of patients with chronic lymphocytic leukemia and/or non-hodgkins lymphoma |
| Pat. No. 8791270 DP* Bendamustine pharmaceutical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jan 7, 2016 | Jan 12, 2026 | U-1790: For use in treatment of patients with chronic lymphocytic leukemia (CLL) and/or non-hodgkin's lymphoma |
| Pat. No. 9000021 Method of treating bendamustine-responsive conditions in patients requiring reduced volumes for administration Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 11, 2015 | Mar 15, 2033 | U-1542: For use in the treatment of patients with chronic lymphocytic leukemia and/or non-hodgkins lymphoma |
| Pat. No. 9034908 Formulations of bendamustine Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 11, 2015 | Mar 15, 2033 | U-1542: For use in the treatment of patients with chronic lymphocytic leukemia and/or non-hodgkins lymphoma |
| Pat. No. 9144568 Formulations of bendamustine Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 11, 2015 | Mar 15, 2033 | U-1542: For use in the treatment of patients with chronic lymphocytic leukemia and/or non-hodgkins lymphoma |
| Pat. No. 9265831 DP* Formulations of bendamustine Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 1, 2016 | Jan 28, 2031 | |
| Pat. No. 9572796 DP* Formulations of bendamustine Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Feb 21, 2017 | Jan 28, 2031 | U-1971: For the treatment of patients with chronic lymphocytic leukemia U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma |
| Pat. No. 9572797 Formulations of bendamustine Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 21, 2017 | Jan 28, 2031 | U-1971: For the treatment of patients with chronic lymphocytic leukemia U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma |
| Pat. No. 9572887 Formulations of bendamustine Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 21, 2017 | Mar 15, 2033 | U-1971: For the treatment of patients with chronic lymphocytic leukemia U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma |
| Pat. No. 9579384 Method of treating bendamustine-responsive conditions in patients requiring reduced volumes for administration Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 28, 2017 | Mar 15, 2033 | U-1971: For the treatment of patients with chronic lymphocytic leukemia U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma |
| Pat. No. 9597397 Formulations of bendamustine Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 21, 2017 | Mar 15, 2033 | U-1971: For the treatment of patients with chronic lymphocytic leukemia U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma |
| Pat. No. 9597398 Formulations of bendamustine Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 21, 2017 | Mar 15, 2033 | U-1971: For the treatment of patients with chronic lymphocytic leukemia |
| Pat. No. 9597399 Formulations of bendamustine Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 21, 2017 | Mar 15, 2033 | U-1971: For the treatment of patients with chronic lymphocytic leukemia U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma |
| Pat. No. 10010533 DP* Formulations of bendamustine Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 3, 2018 | Jan 28, 2031 | |
| Pat. No. 10052385 Formulations of bendamustine Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 22, 2018 | Mar 15, 2033 | U-1971: For the treatment of patients with chronic lymphocytic leukemia U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma |
| Pat. No. 11103483 DP* Formulations of bendamustine Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 31, 2021 | Jan 28, 2031 | U-1971: For the treatment of patients with chronic lymphocytic leukemia U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma |
| 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
CYCLOPHOSPHAMIDE (SOLUTION) (INTRAVENOUS) CYCLOPHOSPHAMIDE
Drug Classes: Antineoplastics:Alkylating Agents == alkylating drug
NDA Applicant: EUGIA PHARMA SPECLTS NDA No.: 210735 Prod. No.: 001 RX (500MG/2.5ML (200MG/ML)); 002 RX (1GM/5ML (200MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9662342 DP* Formulations of cyclophosphamide liquid concentrate Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 3, 2021 | Jun 26, 2035 |
alkylating drug
CYCLOPHOSPHAMIDE (SOLUTION) (INTRAVENOUS) CYCLOPHOSPHAMIDE
Drug Classes: Antineoplastics:Alkylating Agents == alkylating drug
NDA Applicant: INGENUS PHARMS LLC NDA No.: 212501 Prod. No.: 001 RX (500MG/2.5ML (200MG/ML)); 002 RX (1GM/5ML (200MG/ML)); 003 RX (2GM/10ML (200MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10993952 DP* Stable ready to use cyclophosphamide liquid formulations Claim Types: Formulation Pat. Sub. Date(s): 001: May 4, 2021; 002: May 4, 2021; 003: Mar 28, 2022 | Feb 15, 2036 |
alkylating drug
EVOMELA (POWDER) (INTRAVENOUS) MELPHALAN HYDROCHLORIDE
Drug Classes: Antineoplastics:Alkylating Agents == 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 | |
| Pat. No. 10864183 DP* Injectable nitrogen mustard compositions comprising a cyclodextrin derivative and methods of making and using the same Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 15, 2020 | May 28, 2030 | |
| Pat. No. 10940128 DP* Injectable melphalan compositions comprising a cyclodextrin derivative and methods of making and using the same Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Mar 19, 2021 | Jun 14, 2030 | U-3086: For high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma |
| Pat. No. 11020363 DP* Injectable nitrogen mustard compositions comprising a cyclodextrin derivative and methods of making and using the same Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 10, 2021 | May 28, 2030 | |
| 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
JELMYTO (POWDER) (PYELOCALYCEAL) MITOMYCIN
Drug Classes: alkylating drug
NDA Applicant: UROGEN PHARMA NDA No.: 211728 Prod. No.: 001 RX (40MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9040074 DP* Material and method for treating internal cavities Claim Types: Formulation; Method of administration Pat. Sub. Date(s): 001: Apr 29, 2020 | Jan 20, 2031 | |
| Pat. No. 9950069 DP* Material and method for treating internal cavities Claim Types: Formulation; Method of administration Pat. Sub. Date(s): 001: Apr 29, 2020 | Jan 20, 2031 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Apr 15, 2023 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 15, 2027 | ODE-289: Indicated for the treatment of adult patients with low-grade upper tract urothelial cancer (LG-UTUC) |
alkylating drug
MITOSOL (FOR SOLUTION) (TOPICAL) MITOMYCIN
Drug Classes: alkylating drug
NDA Applicant: MOBIUS THERAP NDA No.: 022572 Prod. No.: 001 RX (0.2MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7806265 DP* Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application Claim Types: Drug in a container; Kit Pat. Sub. Date(s): 001: Mar 22, 2012 | Feb 1, 2029 | |
| Pat. No. 8186511 DP* Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application Claim Types: Drug in a container Pat. Sub. Date(s): 001: Jun 25, 2012 | Jul 19, 2026 | |
| Pat. No. 9205075 DP* Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application Claim Types: Kit Pat. Sub. Date(s): 001: Jan 6, 2016 | Jul 19, 2026 | |
| Pat. No. 9539241 DS* DP* Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 10, 2017 | Jan 2, 2028 | U-2095: MITOSOL is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery. It is intended for topical application to the site of glaucoma filtration surgery |
| Pat. No. 9649428 Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application Claim Types: Kit Pat. Sub. Date(s): 001: Jun 9, 2017 | May 21, 2029 | U-2095: MITOSOL is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery. It is intended for topical application to the site of glaucoma filtration surgery |
alkylating drug
PEPAXTO (POWDER) (INTRAVENOUS) MELPHALAN FLUFENAMIDE HYDROCHLORIDE
Drug Classes: Antineoplastics:Alkylating Agents == alkylating drug
NDA Applicant: ONCOPEPTIDES AB NDA No.: 214383 Prod. No.: 001 DISC (EQ 20MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6992207 DS* DP* Melphalan derivatives and their use as cancer chemotherapeutic drugs Claim Types: Compound; Process; Composition; Method of use Pat. Sub. Date(s): 001: Mar 24, 2021 | Jun 25, 2023 | U-3093: In combination with dexamethasone to treat relapsed or refactory multiple myeloma (refactory to at least 1 proteasome inhibitor, 1 immunomodulatory agent, and 1 anti-cd38 mab) in adults who received at least 4 prior lines of therapy |
| Pat. No. 10285946 DP* Lyophilized preparations of melphalan flufenamide Claim Types: Formulation; Kit Pat. Sub. Date(s): 001: Mar 24, 2021 | Apr 25, 2032 | |
| Pat. No. 10322182 DP* Lyophilized preparation of cytotoxic dipeptides Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 24, 2021 | Apr 25, 2032 | |
| Pat. No. 10543274 Lyophilized preparation of cytotoxic dipeptides Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 24, 2021 | Apr 25, 2032 | U-3093: In combination with dexamethasone to treat relapsed or refactory multiple myeloma (refactory to at least 1 proteasome inhibitor, 1 immunomodulatory agent, and 1 anti-cd38 mab) in adults who received at least 4 prior lines of therapy |
| Pat. No. 10869928 DP* Lyophilized preparation of cytotoxic dipeptides Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 24, 2021 | Apr 25, 2032 | |
| Pat. No. 11344622 Lyophilized preparation of cytotoxic dipeptides Claim Types: Method of using a product-by-process Pat. Sub. Date(s): 001: Jun 17, 2022 | Apr 25, 2032 | U-3093: In combination with dexamethasone to treat relapsed or refactory multiple myeloma (refactory to at least 1 proteasome inhibitor, 1 immunomodulatory agent, and 1 anti-cd38 mab) in adults who received at least 4 prior lines of therapy |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Feb 26, 2026 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Feb 26, 2028 | ODE-348: Treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD-38 directed monoclonal antibody |
alkylating drug
TEMODAR (POWDER) (INTRAVENOUS) TEMOZOLOMIDE
Drug Classes: Antineoplastics:Alkylating Agents == 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) (INTRACAVITARY, INTRAVENOUS, INTRAVESICAL) THIOTEPA [GENERIC AP]
Drug Classes: alkylating drug
NDA Applicant: ADIENNE SA NDA No.: 208264 Prod. No.: 001 RX (15MG/VIAL); 002 RX (100MG/VIAL)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity | Jan 26, 2024 | ODE-129: Indicated for reducing the risk of graft rejection when used in conjunction with high-dose busulfan & cyclophosphamide as a preparative regimen for allogenic hematopoietic progenitor cell transplantation for peds. patients with class 3 beta-thalassemia |
alkylating drug
TREANDA (POWDER) (IV (INFUSION)) BENDAMUSTINE HYDROCHLORIDE
Drug Classes: Antineoplastics:Alkylating Agents == alkylating drug
NDA Applicant: CEPHALON NDA No.: 022249 Prod. No.: 001 RX (100MG/VIAL); 002 RX (25MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8436190 DP* Bendamustine pharmaceutical compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 4, 2013 | Apr 26, 2031 *PED | |
| Pat. No. 8445524 DS* DP* Solid forms of bendamustine hydrochloride Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use; Process Pat. Sub. Date(s): All strengths: Jun 4, 2013 | Sep 26, 2029 *PED | U-1402: For use in the treatment of patients with chronic lymphocytic leukemia (CLL) and/or indolent B-cell non-Hodgkin lymphoma (NHL) |
| Pat. No. 8609863 DP* Bendamustine pharmaceutical compositions Claim Types: Formulation; Product-by-process Pat. Sub. Date(s): All strengths: Jan 16, 2014 | Jul 12, 2026 *PED | |
| Pat. No. 8669279 DP* Solid forms of bendamustine hydrochloride Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): All strengths: Oct 30, 2014 | Sep 26, 2029 *PED | U-1402: For use in the treatment of patients with chronic lymphocytic leukemia (CLL) and/or indolent B-cell non-Hodgkin lymphoma (NHL) |
| Pat. No. 8791270 DP* Bendamustine pharmaceutical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 29, 2014 | Jul 12, 2026 *PED | U-1542: For use in the treatment of patients with chronic lymphocytic leukemia and/or non-hodgkins lymphoma |
| Pat. No. 8883836 DP* Solid forms of bendamustine hydrochloride Claim Types: Method of use; Product-by-process; Process Pat. Sub. Date(s): All strengths: Nov 13, 2014 | Sep 26, 2029 *PED | U-1402: For use in the treatment of patients with chronic lymphocytic leukemia (CLL) and/or indolent B-cell non-Hodgkin lymphoma (NHL) |
| Pat. No. 8895756 DP* Bendamustine pharmaceutical compositions Claim Types: Drug in a container Pat. Sub. Date(s): All strengths: Nov 26, 2014 | Jul 12, 2026 *PED | |
| Pat. No. 9533955 DP* Solid forms of bendamustine hydrochloride Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: None; 002: Jan 13, 2017 | 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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s) | Dec 7, 2022 |
alkylating drug
TREANDA (SOLUTION) (IV (INFUSION)) BENDAMUSTINE HYDROCHLORIDE
Drug Classes: Antineoplastics:Alkylating Agents == 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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s) | Dec 7, 2022 |
alkylating drug
VALCHLOR (GEL) (TOPICAL) MECHLORETHAMINE HYDROCHLORIDE
Drug Classes: Antineoplastics:Alkylating Agents == alkylating drug
NDA Applicant: HELSINN NDA No.: 202317 Prod. No.: 001 RX (EQ 0.016% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7838564 DP* Stabilized compositions of volatile alkylating agents and methods of using thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 13, 2013 | Mar 7, 2026 | |
| Pat. No. 7872050 Stabilized compositions of volatile alkylating agents and methods of using thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 13, 2013 | Jul 8, 2029 | U-1427: Alkylating drug indicated for the topical treatment of stage ia and ib mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin directed therapy |
| Pat. No. 8450375 DP* Stabilized compositions of volatile alkylating agents and methods of using thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 13, 2013 | Mar 7, 2026 | |
| Pat. No. 8501818 DP* Stabilized compositions of alkylating agents and methods of using same Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 13, 2013 | Mar 7, 2026 | |
| Pat. No. 8501819 Stabilized compositions of volatile alkylating agents and methods of using thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 13, 2013 | Mar 7, 2026 | U-1427: Alkylating drug indicated for the topical treatment of stage ia and ib mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin directed therapy |
| Pat. No. 9382191 DP* Stabilized compositions of volatile alkylating agents and methods of using thereof Claim Types: Composition Pat. Sub. Date(s): 001: Jul 26, 2016 | Mar 7, 2026 |
alkylating drug
YONDELIS (POWDER) (INTRAVENOUS) TRABECTEDIN
Drug Classes: Antineoplastics:Alkylating Agents == 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: 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 |
alkylating drug
ZEPZELCA (POWDER) (INTRAVENOUS) LURBINECTEDIN
Drug Classes: Antineoplastics:Alkylating Agents == alkylating drug
NDA Applicant: JAZZ NDA No.: 213702 Prod. No.: 001 RX (4MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7763615 DS* DP* Ecteinascidin analogs for use as antitumour agents Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jun 23, 2020 | Dec 13, 2024 | U-2836: Treatment of adult patients with small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jun 15, 2025 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 15, 2027 | ODE-304: Indicated for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy |
allylamine antifungal
NAFTIN (GEL) (TOPICAL) NAFTIFINE HYDROCHLORIDE
Drug Classes: Antifungals == allylamine antifungal
NDA Applicant: SEBELA IRELAND LTD NDA No.: 204286 Prod. No.: 001 RX (2%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8778365 DP* Topical compositions and methods for making and using same Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 22, 2014 | Jan 31, 2033 | |
| Pat. No. 9161914 Topical compositions and methods for making and using same Claim Types: Method of use; Formulation Pat. Sub. Date(s): 001: Nov 3, 2015 | Jan 31, 2033 | U-540: Treatment of fungal infections |
| Pat. No. 10166205 DP* Topical compositions and methods for making and using same Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 19, 2019 | Jan 31, 2033 | |
| Pat. No. 10166206 DP* Topical compositions and methods for making and using same Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 19, 2019 | Jan 31, 2033 | |
| Pat. No. 10695303 DP* Topical compositions and methods for making and using same Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 27, 2020 | Jan 31, 2033 | |
| Pat. No. 10729667 DP* Topical compositions and methods for making and using same Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 31, 2020 | Jan 31, 2033 |
alpha adrenergic agonist
ADRENACLICK (INJECTABLE) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha adrenergic agonist == beta adrenergic agonist == catecholamine
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. 10166334 DP* Medicine injection apparatuses Claim Types: Device Pat. Sub. Date(s): All strengths: Feb 11, 2020 | Jan 21, 2025 |
alpha adrenergic agonist
ADRENALIN (SOLUTION) (INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: PAR STERILE PRODUCTS NDA No.: 204200 Prod. No.: 001 RX (EQ 1MG BASE/ML (EQ 1MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9119876 DP* Epinephrine formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 14, 2016 | Mar 13, 2035 | |
| Pat. No. 9295657 Epinephrine formulations Claim Types: Method Pat. Sub. Date(s): 001: Apr 12, 2016 | Mar 13, 2035 | U-1829: Emergency treatment of allergic reactions (Type I), including anaphylaxis |
alpha adrenergic agonist
ADRENALIN (SOLUTION) (INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS) EPINEPHRINE [GENERIC AP]
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: PAR STERILE PRODUCTS NDA No.: 204640 Prod. No.: 001 RX (EQ 30MG BASE/30ML (EQ 1MG BASE/ML))
| 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 == Analgesics:Nonsteroidal Anti-inflammatory Drugs == 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 == Analgesics:Nonsteroidal Anti-inflammatory Drugs == 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
ALPHAGAN P (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE [GENERIC AT]
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations == 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: Dermatological Agents:Acne and Rosacea Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations == 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 |
alpha adrenergic agonist
AUVI-Q (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: KALEO INC NDA No.: 201739 Prod. No.: 001 RX (EQ 0.3MG/DELIVERY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7731686 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 22, 2013 | 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 | 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 | 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 | 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 | 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 | Mar 21, 2025 | |
| Pat. No. 8021344 DP* Medicament delivery device configured to produce an audible output Claim Types: Device Pat. Sub. Date(s): 001: Jul 26, 2013 | Nov 2, 2029 | |
| Pat. No. 8206360 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Mar 21, 2013 | Feb 27, 2027 | |
| Pat. No. 8226610 DP* Medical injector with compliance tracking and monitoring Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Aug 21, 2012 | Apr 10, 2029 | |
| Pat. No. 8231573 DP* Medicament delivery device having an electronic circuit system Claim Types: Device Pat. Sub. Date(s): 001: Aug 21, 2012 | Nov 25, 2028 | |
| Pat. No. 8313466 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2012 | Nov 23, 2024 | |
| Pat. No. 8361029 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 22, 2013 | Nov 23, 2024 | |
| Pat. No. 8425462 DP* Devices, systems, and methods for medicament delivery Claim Types: Device; Method of use Pat. Sub. Date(s): 001: May 23, 2013 | Nov 23, 2024 | |
| Pat. No. 8608698 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Jan 15, 2014 | Nov 23, 2024 | |
| Pat. No. 8920377 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Jan 29, 2015 | Nov 23, 2024 | |
| Pat. No. 8926594 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 5, 2015 | Mar 31, 2026 | |
| Pat. No. 9056170 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: 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): 001: 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): 001: 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): 001: Mar 23, 2016 | Feb 1, 2026 | |
| Pat. No. 9278182 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: 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): 001: 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): 001: Aug 30, 2017 | Nov 23, 2024 | |
| Pat. No. 10314977 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Jun 11, 2019 | Nov 23, 2024 | |
| Pat. No. 10335549 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Jul 2, 2019 | Apr 30, 2025 | |
| Pat. No. 10737028 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Aug 25, 2020 | Nov 23, 2024 | |
| Pat. No. 10960155 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Apr 22, 2021 | Jun 25, 2026 |
alpha adrenergic agonist
AUVI-Q (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: KALEO INC NDA No.: 201739 Prod. No.: 002 RX (EQ 0.15MG/DELIVERY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7731686 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: None | Jun 1, 2026 | |
| Pat. No. 7731690 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: None | Jan 15, 2025 | |
| Pat. No. 7749194 DP* Devices, systems, and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: None | Oct 30, 2028 | |
| Pat. No. 7918823 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: None | Nov 23, 2024 | |
| Pat. No. 7947017 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: None | Mar 12, 2028 | |
| Pat. No. 8016788 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 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): 002: Jul 26, 2013 | Nov 2, 2029 | |
| Pat. No. 8206360 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: None | Feb 27, 2027 | |
| Pat. No. 8226610 DP* Medical injector with compliance tracking and monitoring Claim Types: Device; Method of use Pat. Sub. Date(s): 002: None | Apr 10, 2029 | |
| Pat. No. 8231573 DP* Medicament delivery device having an electronic circuit system Claim Types: Device Pat. Sub. Date(s): 002: None | Nov 25, 2028 | |
| Pat. No. 8313466 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: None | Nov 23, 2024 | |
| Pat. No. 8361029 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: None | Nov 23, 2024 | |
| Pat. No. 8425462 DP* Devices, systems, and methods for medicament delivery Claim Types: Device; Method of use Pat. Sub. Date(s): 002: None | Nov 23, 2024 | |
| Pat. No. 8608698 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: Jan 15, 2014 | Nov 23, 2024 | |
| Pat. No. 8920377 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: Jan 29, 2015 | Nov 23, 2024 | |
| Pat. No. 8926594 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: Feb 5, 2015 | Mar 31, 2026 | |
| Pat. No. 9056170 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: 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): 002: 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): 002: 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): 002: Mar 23, 2016 | Feb 1, 2026 | |
| Pat. No. 9278182 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: 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): 002: 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): 002: Aug 30, 2017 | Nov 23, 2024 | |
| Pat. No. 10314977 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: Jun 11, 2019 | Nov 23, 2024 | |
| Pat. No. 10335549 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: Jul 2, 2019 | Apr 30, 2025 | |
| Pat. No. 10688244 DP* Medicament delivery device and methods for delivering drugs to infants and children Claim Types: Method of administration; Device Pat. Sub. Date(s): 002: Nov 4, 2020 | Dec 21, 2037 | U-2980: Method of treating an allergic reaction using an auto-injector |
| Pat. No. 10737028 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: Aug 25, 2020 | Nov 23, 2024 | |
| Pat. No. 10842938 DP* Medicament delivery device and methods for delivering drugs to infants and children Claim Types: Method of administration; Device Pat. Sub. Date(s): 002: Dec 10, 2020 | Dec 21, 2037 | U-2980: Method of treating an allergic reaction using an auto-injector |
| Pat. No. 10960155 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: Apr 22, 2021 | Jun 25, 2026 |
alpha adrenergic agonist
AUVI-Q (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: KALEO INC NDA No.: 201739 Prod. No.: 003 RX (EQ 0.1MG/DELIVERY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 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 | |
| Pat. No. 10688244 DP* Medicament delivery device and methods for delivering drugs to infants and children Claim Types: Method of administration; Device Pat. Sub. Date(s): 003: Nov 4, 2020 | Dec 21, 2037 | U-2980: Method of treating an allergic reaction using an auto-injector |
| Pat. No. 10737028 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Aug 25, 2020 | Nov 23, 2024 | |
| Pat. No. 10842938 DP* Medicament delivery device and methods for delivering drugs to infants and children Claim Types: Method of administration; Device Pat. Sub. Date(s): 003: Dec 10, 2020 | Dec 21, 2037 | U-2980: Method of treating an allergic reaction using an auto-injector |
| Pat. No. 10960155 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Apr 22, 2021 | Jun 25, 2026 |
alpha adrenergic agonist
CLARINEX D 24 HOUR (TABLET, EXTENDED RELEASE) (ORAL) DESLORATADINE; PSEUDOEPHEDRINE SULFATE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Antihistamines == histamine-1 (H1) receptor antagonist == alpha adrenergic agonist
NDA Applicant: ORGANON NDA No.: 021605 Prod. No.: 001 DISC (5MG;240MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| 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. 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
COMBIGAN (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE; TIMOLOL MALEATE [GENERIC AB]
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations == alpha adrenergic agonist == Antimigraine Agents:Antimigraine Agents, Other == Cardiovascular Agents:Beta-adrenergic Blocking Agents == 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. 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
EMERPHED (SOLUTION) (INTRAVENOUS) EPHEDRINE SULFATE
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == norepinephrine-releasing agent
NDA Applicant: NEXUS PHARMS NDA No.: 213407 Prod. No.: 001 RX (50MG/10ML (5MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11090278 Compositions comprising ephedrine or an ephedrine salt and methods of making and using same Claim Types: Method of administration Pat. Sub. Date(s): 001: Aug 13, 2021 | May 16, 2040 | U-3183: Use of ephedrine sulfate for treating hypotension |
| Pat. No. 11241400 Compositions comprising ephedrine or an ephedrine salt and methods of making and using same Claim Types: Method of administration Pat. Sub. Date(s): 001: Feb 22, 2022 | May 16, 2040 | U-3183: Use of ephedrine sulfate for treating hypotension |
alpha adrenergic agonist
EPHEDRINE SULFATE (SOLUTION) (INTRAVENOUS) EPHEDRINE SULFATE
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == norepinephrine-releasing agent
NDA Applicant: ENDO VENTURES NDA No.: 213994 Prod. No.: 001 RX (50MG/10ML (5MG/ML)); 002 RX (25MG/5ML (5MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10869845 DP* Ephedrine compositions and methods Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 22, 2020; 002: May 19, 2022 | Jan 22, 2040 |
alpha adrenergic agonist
EPINEPHRINE (SOLUTION) (INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: BELCHER NDA No.: 205029 Prod. No.: 001 RX (1MG/ML (1MG/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: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: MYLAN SPECIALITY LP NDA No.: 019430 Prod. No.: 001 RX (0.3MG/DELIVERY); 002 RX (0.15MG/DELIVERY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7449012 DP* Automatic injector Claim Types: Device Pat. Sub. Date(s): All strengths: None | Sep 11, 2025 | |
| Pat. No. 7794432 DP* Automatic injector with kickback attenuation Claim Types: Device; Process Pat. Sub. Date(s): All strengths: None | Sep 11, 2025 | |
| Pat. No. 8048035 DP* Automatic injector with needle cover Claim Types: Device Pat. Sub. Date(s): 001: Nov 25, 2011; 002: None | Sep 11, 2025 | |
| Pat. No. 8870827 DP* Automatic injector Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 30, 2014 | Sep 11, 2025 | |
| Pat. No. 9586010 DP* Automatic injector with needle cover Claim Types: Device Pat. Sub. Date(s): All strengths: May 12, 2017 | Sep 11, 2025 |
alpha adrenergic agonist
LUMIFY (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations == 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 |
| Pat. No. 9259425 Compositions and methods for eye whitening Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 27, 2021 | Jul 14, 2030 | U-2222: Relieves redness of the eye due to minor eye irritations |
alpha adrenergic agonist
MIRVASO (GEL) (TOPICAL) BRIMONIDINE TARTRATE
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations == 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
PRIMATENE MIST (AEROSOL, METERED) (INHALATION) EPINEPHRINE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: ARMSTRONG PHARMS NDA No.: 205920 Prod. No.: 001 OTC (0.125MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8367734 DP* Stable epinephrine suspension formulation with high inhalation delivery efficiency Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 17, 2018 | Jan 26, 2026 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Nov 7, 2021 |
alpha adrenergic agonist
QOLIANA (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE [GENERIC AT]
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations == 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: Dermatological Agents:Acne and Rosacea Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations == alpha adrenergic agonist == carbonic anhydrase inhibitor
NDA Applicant: ALCON LABS INC NDA No.: 204251 Prod. No.: 001 RX (0.2%;1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9044484 DP* Aqueous pharmaceutical compositions containing borate-polyol complexes Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 9, 2015 | Oct 30, 2030 | |
| Pat. No. 9421265 DP* Aqueous pharmaceutical compositions containing borate-polyol complexes Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 24, 2016 | Jun 17, 2030 |
alpha adrenergic agonist
SYMJEPI (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: ADAMIS PHARMS CORP NDA No.: 207534 Prod. No.: 001 RX (0.3MG/0.3ML (0.3MG/0.3ML)); 002 RX (0.15MG/0.3ML (0.15MG/0.3ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11141540 DP* Syringe devices Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Jun 16, 2022 | Oct 20, 2036 | U-3379: A method for administering a therapeutic dose of epinephrine |
alpha adrenergic agonist
TWINJECT 0.3; TWINJECT 0.15 (INJECTABLE) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha adrenergic agonist == beta adrenergic agonist == catecholamine
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: Ophthalmic Agents:Ophthalmic Anti-allergy Agents == Respiratory Tract/ Pulmonary Agents:Antihistamines == 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. 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: Cardiovascular Agents:Beta-adrenergic Blocking Agents == alpha adrenergic blocker == beta-adrenergic receptor inhibitor
NDA Applicant: WOODWARD NDA No.: 022012 Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (40MG); 004 RX (80MG)
| 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. 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 |
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: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Ophthalmic Agents:Ophthalmic Anti-inflammatories == cyclooxygenase inhibitor == Ophthalmic Agents:Ophthalmic Combinations == alpha-1 adrenergic receptor agonist
NDA Applicant: RAYNER SURGICAL NDA No.: 205388 Prod. No.: 001 RX (EQ 0.3% BASE;EQ 1% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8173707 Ophthalmologic irrigation solutions and method Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 13, 2014 | Jan 30, 2024 *PED | U-1518: Maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain |
| Pat. No. 8586633 DP* Ophthalmologic irrigation solutions and method Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 13, 2014 | Jan 30, 2024 *PED | |
| Pat. No. 9066856 DP* Stable preservative-free mydriatic and anti-inflammatory solutions for injection Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 13, 2015 | Apr 23, 2034 *PED | |
| Pat. No. 9278101 Ophthalmologic irrigation solutions and method Claim Types: Method of administration Pat. Sub. Date(s): 001: Mar 9, 2016 | Jan 30, 2024 *PED | U-1518: Maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain |
| Pat. No. 9399040 DP* Ophthalmologic irrigation solutions and method Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 28, 2016 | Jan 30, 2024 *PED | |
| Pat. No. 9486406 DP* Stable preservative-free mydriatic and anti-inflammatory solutions for injection Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 9, 2016 | Apr 23, 2034 *PED | |
| Pat. No. 9855246 DP* Stable preservative-free mydriatic and anti-inflammatory solutions for injection Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 5, 2018 | Oct 23, 2033 |
alpha-1 adrenergic receptor agonist
PHENYLEPHRINE HYDROCHLORIDE (SOLUTION/DROPS) (OPHTHALMIC) PHENYLEPHRINE HYDROCHLORIDE
Drug Classes: Ophthalmic Agents:Ophthalmic Combinations == 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 |
aluminum complex
SUCRALFATE (SUSPENSION) (ORAL) SUCRALFATE [GENERIC AB]
Drug Classes: Gastrointestinal Agents:Protectants == aluminum complex
NDA Applicant: VISTAPHARM NDA No.: 211884 Prod. No.: 001 RX (1GM/10ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Sep 11, 2022 |
amide local anesthetic
AKTEN (GEL) (OPHTHALMIC) LIDOCAINE HYDROCHLORIDE
Drug Classes: Anesthetics:Local Anesthetics == amide local anesthetic == antiarrhythmic
NDA Applicant: THEA PHARMA NDA No.: 022221 Prod. No.: 001 RX (3.5%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8759401 DP* Aqueous gel formulation and method for inducing topical anesthesia Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jun 30, 2014 | Jul 24, 2026 | U-1523: Method of inducing topical anesthesia in the eye |
amide local anesthetic
EXPAREL (INJECTABLE, LIPOSOMAL) (INJECTION) BUPIVACAINE
Drug Classes: Anesthetics:Local Anesthetics == amide local anesthetic
NDA Applicant: PACIRA PHARMS INC NDA No.: 022496 Prod. No.: 001 RX (133MG/10ML (13.3MG/ML)); 002 RX (266MG/20ML (13.3MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11033495 DP* Manufacturing of bupivacaine multivesicular liposomes Claim Types: Product-by-process; Method of use Pat. Sub. Date(s): All strengths: Jul 30, 2021 | Jan 22, 2041 | U-3182: Method of providing postsurgical pain management, for example, via infiltration for local analgesia or via interscalene brachial plexus nerve block for regional analgesia |
| Pat. No. 11179336 DP* Manufacturing of bupivacaine multivesicular liposomes Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Nov 30, 2021 | Jan 22, 2041 | U-3250: Method of treating pain, for example, treating postsurgical pain via infiltration for local analgesia or via interscalene brachial plexus nerve block for regional analgesia |
| Pat. No. 11278494 DP* Manufacturing of bupivacaine multivesicular liposomes Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Apr 4, 2022 | Jan 22, 2041 | U-3250: Method of treating pain, for example, treating postsurgical pain via infiltration for local analgesia or via interscalene brachial plexus nerve block for regional analgesia |
| Pat. No. 11304904 DP* Manufacturing of bupivacaine multivesicular liposomes Claim Types: Product-by-process; Method of use Pat. Sub. Date(s): All strengths: Apr 21, 2022 | Jan 22, 2041 | U-3346: Method of providing local or regional analgesia via infiltration for local analgesia or via interscalene brachial plexus nerve block or femoral nerve block for regional analgesia |
| Pat. No. 11311486 DP* Manufacturing of bupivacaine multivesicular liposomes Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Apr 27, 2022 | Jan 22, 2041 | U-3250: Method of treating pain, for example, treating postsurgical pain via infiltration for local analgesia or via interscalene brachial plexus nerve block for regional analgesia |
| Pat. No. 11357727 DP* Manufacturing of bupivacaine multivesicular liposomes Claim Types: Product-by-process; Method of using a product-by-process Pat. Sub. Date(s): All strengths: Jun 16, 2022 | Jan 22, 2041 | U-3380: Method of treating pain, for example, via infiltration for local analgesia or via interscalene brachial plexus nerve block for regional analgesia |
| Pat. No. 11426348 DP* Compositions of bupivacaine multivesicular liposomes Claim Types: Formulation claimed by its inherent performace characteristics; Method of use Pat. Sub. Date(s): All strengths: Sep 2, 2022 | Jan 22, 2041 | U-3380: Method of treating pain, for example, via infiltration for local analgesia or via interscalene brachial plexus nerve block for regional analgesia |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Mar 22, 2024 |
amide local anesthetic
NAROPIN (SOLUTION) (INJECTION) ROPIVACAINE HYDROCHLORIDE [GENERIC AP]
Drug Classes: amide local anesthetic
NDA Applicant: FRESENIUS KABI USA NDA No.: 020533 Prod. No.: 006 RX (200MG/100ML (2MG/ML)); 007 RX (400MG/200ML (2MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7828787 DP* Connector for packaging containing medical fluids and packaging for medical fluids Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 6, 2014 | Oct 18, 2025 | |
| Pat. No. 7857802 DP* Connector for medical liquid-containing packages and medical liquid-containing packages Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 6, 2014 | Nov 28, 2026 | |
| Pat. No. 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: Anesthetics:Local Anesthetics == 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. 10350180 DP* Solid-forming local anesthetic formulations for pain control Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 4, 2019 | Jan 14, 2031 | |
| Pat. No. 10603293 DP* Solid-forming local anesthetic formulations for pain control Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 14, 2020 | Jan 14, 2031 | |
| Pat. No. 10751305 DP* Solid-forming topical formulations for pain control Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 21, 2020 | Jan 14, 2031 |
amide local anesthetic
POSIMIR (SOLUTION, EXTENDED RELEASE) (INFILTRATION) BUPIVACAINE
Drug Classes: Anesthetics:Local Anesthetics == amide local anesthetic
NDA Applicant: INNOCOLL NDA No.: 204803 Prod. No.: 001 RX (660MG/5ML (132MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8153149 DP* Controlled delivery system Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 2, 2021 | Sep 15, 2025 | |
| Pat. No. 8153661 Controlled delivery system Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 2, 2021 | Sep 15, 2025 | U-3074: Method for providing sustained local anesthesia for at least 24 hours |
| Pat. No. 8753665 DP* Controlled delivery system Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Mar 2, 2021 | Sep 15, 2025 | U-3074: Method for providing sustained local anesthesia for at least 24 hours |
| Pat. No. 8846072 DP* Controlled delivery system Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Mar 2, 2021 | Sep 15, 2025 | U-3074: Method for providing sustained local anesthesia for at least 24 hours |
| Pat. No. 11400019 DP* Sustained release drug delivery systems with reduced impurities and related methods Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): 001: Sep 1, 2022 | Jan 12, 2041 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Feb 1, 2024 |
amide local anesthetic
XARACOLL (IMPLANT) (IMPLANTATION) BUPIVACAINE HYDROCHLORIDE
Drug Classes: Anesthetics:Local Anesthetics == amide local anesthetic
NDA Applicant: INNOCOLL PHARMS NDA No.: 209511 Prod. No.: 001 RX (100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE47826 Drug delivery device for providing local analgesia, local anesthesia or nerve blockage Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 28, 2020 | May 20, 2029 | U-2949: A method for inducing a post-surgical analgesia sparing effect by implanting at the surgical site a collagen sponge containing bupivacaine HCl which provides local anesthesia for up to 24 hours following implantation |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Aug 28, 2023 |
amide local anesthetic
ZINGO (SYSTEM) (INTRADERMAL) LIDOCAINE HYDROCHLORIDE
Drug Classes: Anesthetics:Local Anesthetics == 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: Anesthetics:Local Anesthetics == amide local anesthetic == antiarrhythmic
NDA Applicant: SCILEX PHARMS NDA No.: 207962 Prod. No.: 001 RX (1.8%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9283174 DP* Non-aqueous patch Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 12, 2018 | May 10, 2031 | |
| Pat. No. 9925264 DP* Non-aqueous patch Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 25, 2018 | May 10, 2031 | U-2267: Method for relieving the pain associated with post-herpetic neuralgia |
| Pat. No. 9931403 DP* Non-aqueous patch Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 25, 2018 | May 10, 2031 | |
| Pat. No. 10765640 DP* Non-aqueous patch Claim Types: Device Pat. Sub. Date(s): 001: Oct 6, 2020 | May 10, 2031 | |
| Pat. No. 10765749 DP* Non-aqueous patch Claim Types: Device Pat. Sub. Date(s): 001: Oct 6, 2020 | May 10, 2031 | |
| Pat. No. 11278623 DP* Non-aqueous patch Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 1, 2022 | May 10, 2031 |
amide local anesthetic
ZYNRELEF KIT (SOLUTION, EXTENDED RELEASE) (PERIARTICULAR) BUPIVACAINE; MELOXICAM
Drug Classes: Anesthetics:Local Anesthetics == amide local anesthetic == Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: HERON THERAPS INC NDA No.: 211988 Prod. No.: 002 RX (200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)); 004 RX (400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)) NDA No.: 211988 Prod. No.: 001 DISC (60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)); 003 DISC (300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9592227 DP* Compositions of a polyorthoester and an aprotic solvent Claim Types: Formulation; Method of administration; Method of use Pat. Sub. Date(s): All strengths: May 26, 2021 | Mar 13, 2034 | U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation |
| Pat. No. 9694079 DP* Long-acting polymeric delivery systems Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: May 26, 2021 | Apr 20, 2035 | U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation |
| Pat. No. 9744163 DP* Compositions of a polyorthoester and an aprotic solvent Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 26, 2021 | Mar 13, 2034 | |
| Pat. No. 9801945 DP* Long-acting polymeric delivery systems Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: May 26, 2021 | Apr 20, 2035 | U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation |
| Pat. No. 9913909 Compositions of a polyorthoester and an aprotic solvent Claim Types: Method of administration; Method of use Pat. Sub. Date(s): All strengths: May 26, 2021 | Mar 13, 2034 | U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation |
| Pat. No. 10098957 Long-acting polymeric delivery systems Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 26, 2021 | Apr 20, 2035 | U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation |
| Pat. No. 10213510 DP* Long-acting polymeric delivery systems Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: May 26, 2021 | Apr 20, 2035 | U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation |
| Pat. No. 10398686 DP* Compositions of a polyorthoester and an aprotic solvent Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 26, 2021 | Mar 13, 2034 | |
| Pat. No. 10632199 DP* Long-acting polymeric delivery systems Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: May 26, 2021 | Apr 20, 2035 | U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation |
| Pat. No. 10898575 DP* Long-acting polymeric delivery systems Claim Types: Formulation; Method of use; Method of Use claimed by its inherent performace characteristics Pat. Sub. Date(s): All strengths: May 26, 2021 | Apr 20, 2035 | U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation |
| Pat. No. 10980886 DP* Compositions of a polyorthoester and an organic acid excipient Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 26, 2021 | Apr 20, 2035 | |
| Pat. No. 11083730 DP* Long-acting polymeric delivery systems Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Aug 25, 2021 | Apr 20, 2035 | U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation |
| Pat. No. 11083797 DP* Long-acting polymeric delivery systems Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Aug 25, 2021 | Apr 20, 2035 | U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation |
| Pat. No. 11253504 Compositions of a polyorthoester and an aprotic solvent Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 2, 2022 | Mar 13, 2034 | U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | May 12, 2024 |
aminoglycoside antibacterial
ARIKAYCE KIT (SUSPENSION, LIPOSOMAL) (INHALATION) AMIKACIN SULFATE
Drug Classes: Antibacterials:Aminoglycosides == aminoglycoside antibacterial
NDA Applicant: INSMED INC NDA No.: 207356 Prod. No.: 001 RX (EQ 590MG BASE/8.4ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7718189 DP* Sustained release of antiinfectives Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 24, 2018 | Jun 6, 2025 | U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen |
| Pat. No. 8226975 DP* Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof Claim Types: Kit; Method of use Pat. Sub. Date(s): 001: Oct 24, 2018 | Aug 15, 2028 | |
| Pat. No. 8632804 Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 24, 2018 | Dec 5, 2026 | U-2416: Treating mycobacterium avium complex (MAC) lung disease in adults with cystic fibrosis as part of a combination drug regimen |
| Pat. No. 8642075 DP* Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 24, 2018 | Dec 5, 2026 | |
| Pat. No. 8679532 Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 24, 2018 | Dec 5, 2026 | U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen |
| Pat. No. 8802137 DP* Sustained release of antiinfectives Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 24, 2018 | Apr 8, 2024 | U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen |
| Pat. No. 9566234 DP* Systems for treating pulmonary infections Claim Types: Kit; Method of use Pat. Sub. Date(s): 001: Oct 24, 2018 | Jan 18, 2034 | U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen |
| Pat. No. 9827317 DP* Sustained release of antiinfectives Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 24, 2018 | Apr 8, 2024 | U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen |
| Pat. No. 9895385 Methods for treating pulmonary non-tuberculous mycobacterial infections Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 24, 2018 | May 15, 2035 | U-2417: Treating mycobacterium avium complex (MAC) lung disease in non-cystic fibrosis adults as part of a combination antibacterial drug regimen |
| Pat. No. 10251900 Methods for treating pulmonary non-tuberculous mycobacterial infections Claim Types: Method of use Pat. Sub. Date(s): 001: May 2, 2019 | May 15, 2035 | U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen |
| Pat. No. 10751355 Methods for treating pulmonary non-tuberculous mycobacterial infections Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 24, 2020 | May 15, 2035 | U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Sep 28, 2030 GAIN | ODE-214: Tx of MAC lung disease in adults with limited or no alternative tx options as part of a combo antibacterial drug regimen who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy |
aminoglycoside antibacterial
BETHKIS (SOLUTION) (INHALATION) TOBRAMYCIN [GENERIC AN]
Drug Classes: Antibacterials:Aminoglycosides == Ophthalmic Agents:Ophthalmic Anti-Infectives == Ophthalmic Agents:Ophthalmic Combinations == Respiratory Tract/ Pulmonary Agents:Cystic Fibrosis Agents == aminoglycoside antibacterial
NDA Applicant: CHIESI 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: Antibacterials:Aminoglycosides == Ophthalmic Agents:Ophthalmic Anti-Infectives == Ophthalmic Agents:Ophthalmic Combinations == Respiratory Tract/ Pulmonary Agents:Cystic Fibrosis Agents == aminoglycoside antibacterial
NDA Applicant: MYLAN SPECIALITY LP NDA No.: 201688 Prod. No.: 001 RX (28MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE47526 DP* Aerosolization apparatus with air inlet shield Claim Types: Device Pat. Sub. Date(s): 001: Jun 1, 2020 | Apr 9, 2024 | |
| Pat. No. 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. 7516741 DP* Aerosolization apparatus with feedback mechanism Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Apr 19, 2013 | Jan 11, 2024 | |
| Pat. No. 7559325 DP* Aerosolization apparatus with air inlet shield Claim Types: Device Pat. Sub. Date(s): 001: Apr 19, 2013 | Oct 27, 2025 | |
| Pat. No. 8069851 DP* Aeorosolization apparatus with air inlet shield Claim Types: Device Pat. Sub. Date(s): 001: Apr 19, 2013 | Sep 24, 2024 | |
| Pat. No. 8664187 Methods of treatment of endobronchial infections Claim Types: Method of improving a treatment; Method of use Pat. Sub. Date(s): 001: Jun 17, 2019 | Jun 20, 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; Method of administration Pat. Sub. Date(s): 001: Jun 17, 2019 | Sep 12, 2028 | U-909: Treatment of cystic fibrosis patients with pseudomonas aeruginosa |
| Pat. No. 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: Hormonal Agents, Stimulant/ Replacement/ Modifying (Adrenal) == Inflammatory Bowel Disease Agents:Glucocorticoids == Ophthalmic Agents:Ophthalmic Anti-inflammatories == corticosteroid == Antibacterials:Aminoglycosides == Ophthalmic Agents:Ophthalmic Anti-Infectives == Ophthalmic Agents:Ophthalmic Combinations == Respiratory Tract/ Pulmonary Agents:Cystic Fibrosis Agents == aminoglycoside antibacterial
NDA Applicant: EYEVANCE 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: Anti-Addiction/ Substance Abuse Treatment Agents:Smoking Cessation Agents == Antidepressants:Antidepressants, Other == aminoketone
NDA Applicant: BAUSCH NDA No.: 022108 Prod. No.: 001 RX (174MG); 002 RX (348MG); 003 RX (522MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7241805 DP* Modified release formulations of a bupropion salt Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Jun 27, 2026 | |
| Pat. No. 7569610 Modified release formulations of a bupropion salt Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Jun 27, 2026 | U-997: Treatment of major depressive disorder by dosing at intervals of 24 hours |
| Pat. No. 7572935 DP* Modified release formulations of a bupropion salt Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jun 27, 2026 | |
| Pat. No. 7585897 DP* Modified release formulations of a bupropion salt Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jun 27, 2026 | |
| Pat. No. 7645802 DP* Bupropion hydrobromide and therapeutic applications Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Jun 27, 2026 | |
| Pat. No. 7649019 DP* Modified release formulations of a bupropion salt Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jun 27, 2026 | |
| Pat. No. 7662407 DP* Modified release formulations of a bupropion salt Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jun 27, 2026 | |
| Pat. No. 7671094 DP* Bupropion hydrobromide and therapeutic applications Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Jun 27, 2026 |
aminoketone
CONTRAVE (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Smoking Cessation Agents == Antidepressants:Antidepressants, Other == aminoketone == Anti-Addiction/ Substance Abuse Treatment Agents:Alcohol Deterrents/Anti-craving == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Dependence == Anti-Obesity Agents == opioid antagonist
NDA Applicant: NALPROPION NDA No.: 200063 Prod. No.: 001 RX (90MG;8MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7375111 DP* Compositions for affecting weight loss Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 6, 2014 | Mar 26, 2025 | |
| Pat. No. 7462626 Compositions for affecting weight loss Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 6, 2014 | Jul 20, 2024 | U-1583: For chronic weight management for treating overweight or obesity |
| Pat. No. 8088786 DP* Layered pharmaceutical formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 6, 2014 | Feb 3, 2029 | |
| Pat. No. 8318788 Layered pharmaceutical formulations Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 6, 2014 | Nov 8, 2027 | U-1584: Use of naltrexone and bupropion in a layered formulation for chronic weight management for affecting weight loss |
| Pat. No. 8722085 Methods for administering weight loss medications Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Oct 6, 2014 | Nov 8, 2027 | U-1585: Use of naltrexone and bupropion based on an escalating dose schedule |
| Pat. No. 8815889 Compositions and methods for increasing insulin sensitivity Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 6, 2014 | Jul 20, 2024 | U-1586: For effect on blood glucose parameters in patients with insulin resistance |
| Pat. No. 8916195 Sustained release formulation of naltrexone Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 20, 2015 | Feb 2, 2030 | U-1639: Use of naltrexone and bupropion in extended-release form for chronic weight management for treating overweight or obesity |
| Pat. No. 9107837 Sustained release formulation of naltrexone Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 3, 2015 | Jun 4, 2027 | U-1639: Use of naltrexone and bupropion in extended-release form for chronic weight management for treating overweight or obesity |
| Pat. No. 9125868 Methods for administering weight loss medications Claim Types: Method of administration Pat. Sub. Date(s): 001: Oct 15, 2015 | Nov 8, 2027 | U-1585: Use of naltrexone and bupropion based on an escalating dose schedule |
| Pat. No. 9248123 Methods of providing weight loss therapy in patients with major depression Claim Types: Method of administration Pat. Sub. Date(s): 001: Feb 17, 2016 | Jan 13, 2032 | U-1808: Use of naltrexone and bupropion for chronic weight management for treating overweight or obesity in patients with major depressive disorder |
| Pat. No. 9633575 Methods of treating overweight and obesity Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 29, 2021 | Jun 25, 2033 | U-1583: For chronic weight management for treating overweight or obesity |
| Pat. No. 10231964 Compositions and methods for weight loss in at risk patient populations Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 17, 2019 | Jul 2, 2034 | U-1583: For chronic weight management for treating overweight or obesity |
| Pat. No. 10307376 Methods for administering weight loss medications Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 17, 2019 | Nov 8, 2027 | U-1585: Use of naltrexone and bupropion based on an escalating dose schedule |
| Pat. No. 10403170 Methods of treating overweight and obesity Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 29, 2021 | Jun 5, 2033 | U-1583: For chronic weight management for treating overweight or obesity |
| Pat. No. 10828294 Compositions and methods for weight loss in at risk patient populations Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 14, 2020 | Jul 2, 2034 | U-1583: For chronic weight management for treating overweight or obesity |
| Pat. No. 10835527 Compositions and methods for reducing major adverse cardiovascular events Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 14, 2020 | Jul 2, 2034 | U-1583: For chronic weight management for treating overweight or obesity |
| Pat. No. 11033543 Methods of providing weight loss therapy in patients with major depression Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 22, 2021 | Jan 10, 2031 | U-1583: For chronic weight management for treating overweight or obesity |
| Pat. No. 11139056 Methods of treating overweight and obesity Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 29, 2021 | Jun 5, 2033 | U-1583: For chronic weight management for treating overweight or obesity |
| Pat. No. 11278544 Compositions for affecting weight loss Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 24, 2022 | Apr 21, 2024 | U-1583: For chronic weight management for treating overweight or obesity |
| Pat. No. 11324741 Methods for treating visceral fat conditions Claim Types: Method of use Pat. Sub. Date(s): 001: May 19, 2022 | May 29, 2029 | U-1583: For chronic weight management for treating overweight or obesity |
aminoketone
FORFIVO XL (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROCHLORIDE
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Smoking Cessation Agents == Antidepressants:Antidepressants, Other == aminoketone
NDA Applicant: ALMATICA 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 |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
ACULAR LS (SOLUTION/DROPS) (OPHTHALMIC) KETOROLAC TROMETHAMINE [GENERIC AT]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Ophthalmic Agents:Ophthalmic Anti-inflammatories == cyclooxygenase inhibitor
NDA Applicant: ALLERGAN NDA No.: 021528 Prod. No.: 001 RX (0.4%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8008338 DS* DP* Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 23, 2011 | Nov 24, 2027 *PED | U-1181: A method of treating or preventing ocular pain in a patient |
| Pat. No. 8207215 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 23, 2012 | Nov 28, 2024 *PED | U-1251: A method of controlling postoperative ocular pain and burning/stinging in a patient |
| Pat. No. 8377982 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of administration Pat. Sub. Date(s): 001: Mar 18, 2013 | Nov 28, 2024 *PED | U-1363: A method of treating or preventing ocular pain and burning/stinging following corneal surgery |
| Pat. No. 8541463 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 22, 2013 | Nov 28, 2024 *PED | U-1441: A method of treating or reducing ocular pain and burning/stinging |
| Pat. No. 8648107 DP* Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 4, 2014 | May 28, 2024 | |
| Pat. No. 8906950 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 8, 2015 | May 28, 2024 | U-1626: A method of treating or preventing ocular pain and burning |
| Pat. No. 8946281 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Mar 4, 2015 | May 28, 2024 | U-1662: A method of treating ocular pain |
| Pat. No. 9216167 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 20, 2016 | May 28, 2024 | U-1800: A method of treating ocular pain and/or enhancing ocular comfort |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
ACUVAIL (SOLUTION/DROPS) (OPHTHALMIC) KETOROLAC TROMETHAMINE
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Ophthalmic Agents:Ophthalmic Anti-inflammatories == cyclooxygenase inhibitor
NDA Applicant: ALLERGAN NDA No.: 022427 Prod. No.: 001 RX (0.45%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7842714 DS* DP* Ketorolac tromethamine compositions for treating ocular pain Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 30, 2010 | Aug 15, 2029 | |
| Pat. No. 8512717 DP* Compositions for delivery of therapeutics into the eyes and methods for making and using same Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 19, 2013 | Mar 7, 2028 | |
| Pat. No. 8992952 DP* Compositions for delivery of therapeutics into the eyes and methods for making and using same Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 10, 2015 | Aug 5, 2024 | |
| Pat. No. 9192571 DP* Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 21, 2015 | Mar 7, 2028 |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
ADVIL ALLERGY SINUS (TABLET) (ORAL) CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Drug Classes: histamine-1 (H1) receptor antagonist == Analgesics:Nonsteroidal Anti-inflammatory Drugs == 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 |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
ADVIL ALLERGY SINUS, CHILDREN'S (SUSPENSION) (ORAL) CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Drug Classes: histamine-1 (H1) receptor antagonist == Analgesics:Nonsteroidal Anti-inflammatory Drugs == 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 |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
ADVIL DUAL ACTION WITH ACETAMINOPHEN (TABLET) (ORAL) ACETAMINOPHEN; IBUPROFEN
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: GLAXOSMITHKLINE NDA No.: 211733 Prod. No.: 001 OTC (250MG;125MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NP - New product | Feb 28, 2023 |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
ADVIL PM (CAPSULE) (ORAL) DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN [GENERIC OTC]
Drug Classes: Antiemetics:Antiemetics, Other == Antiparkinson Agents:Anticholinergics == Respiratory Tract/ Pulmonary Agents:Antihistamines == histamine-1 (H1) receptor antagonist == Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: GLAXOSMITHKLINE NDA No.: 021393 Prod. No.: 001 OTC (25MG;EQ 200MG FREE ACID AND POTASSIUM SALT)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8883849 Treatment of sleep disturbances Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 9, 2014 | Jan 17, 2022 | U-1618: A method of treating a patient suffering from a pain associated sleep disturbance comprising administering a liquid composition formulated inside a soft gel capsule, as claimed, to the patient |
| Pat. No. 9155718 DP* Treatment of sleep disturbances Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 10, 2015 | Jan 17, 2022 |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
ADVIL PM (TABLET) (ORAL) DIPHENHYDRAMINE CITRATE; IBUPROFEN [GENERIC OTC]
Drug Classes: Antiemetics:Antiemetics, Other == Antiparkinson Agents:Anticholinergics == Respiratory Tract/ Pulmonary Agents:Antihistamines == histamine-1 (H1) receptor antagonist == Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: GLAXOSMITHKLINE NDA No.: 021394 Prod. No.: 001 OTC (38MG;200MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8263647 DP* Treatment of sleep disturbances Claim Types: Formulation Pat. Sub. Date(s): 001: None | May 30, 2022 |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
ADVIL, CHILDREN'S FLAVORED (SUSPENSION) (ORAL) IBUPROFEN [GENERIC OTC]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: GLAXOSMITHKLINE NDA No.: 020589 Prod. No.: 002 OTC (100MG/5ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10238640 DP* Pharmaceutical suspension composition Claim Types: Formulation Pat. Sub. Date(s): 002: Apr 24, 2019 | May 25, 2024 |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
ANJESO (SOLUTION) (INTRAVENOUS) MELOXICAM
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: BAUDAX NDA No.: 210583 Prod. No.: 001 RX (30MG/ML (30MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8512727 DP* Nanoparticulate meloxicam formulations Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: Mar 6, 2020 | Dec 25, 2022 | U-2750: Management of moderate-to-severe pain by intravenous injection |
| Pat. No. 9974746 DP* Reduction of flake-like aggregation in nanoparticulate active agent compositions Claim Types: Product-by-process Pat. Sub. Date(s): 001: Mar 6, 2020 | May 26, 2030 | |
| Pat. No. 10463673 DP* Nanoparticulate meloxicam formulations Claim Types: Formulation; Method of administration Pat. Sub. Date(s): 001: Mar 6, 2020 | Feb 24, 2024 | U-2750: Management of moderate-to-severe pain by intravenous injection |
| Pat. No. 10471067 DP* Nanoparticulate meloxicam formulations Claim Types: Formulation; Method of administration Pat. Sub. Date(s): 001: Mar 6, 2020 | Feb 24, 2024 | U-2750: Management of moderate-to-severe pain by intravenous injection |
| Pat. No. 10709713 Nanoparticulate meloxicam formulations Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 24, 2020 | May 26, 2030 | U-2750: Management of moderate-to-severe pain by intravenous injection |
| Pat. No. 10881663 Method of treating pain in elderly patients with mild renal impairment Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 19, 2021 | Mar 8, 2039 | U-3038: Management of moderate-to-severe pain by intravenous injection in patients with mild renal impairment |
| Pat. No. 11253478 DP* Reduction of flake-like aggregation in nanoparticulate active agent compositions Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Mar 4, 2022 | May 26, 2030 | U-3318: Management of moderate-to-severe pain by injection |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Feb 20, 2023 |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
CALDOLOR (SOLUTION) (INTRAVENOUS) IBUPROFEN
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: CUMBERLAND PHARMS NDA No.: 022348 Prod. No.: 001 DISC (400MG/4ML (100MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: M - Miscellaneous | Nov 19, 2024 | M-128: Clinical trial study results |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
CALDOLOR (SOLUTION) (INTRAVENOUS) IBUPROFEN
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: CUMBERLAND PHARMS NDA No.: 022348 Prod. No.: 002 RX (800MG/8ML (100MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8735452 Treating patients with intravenous ibuprofen Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 002: Jun 4, 2014 | Sep 30, 2029 | U-981: Management of mild to moderate pain, management of moderate to severe pain as an adjunct to opioid analgesics, reduction in fever through anti-inflammatory, analgesic, and antipyretic activity |
| Pat. No. 8871810 Treating critically ill patients with intravenous ibuprofen Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 12, 2014 | Sep 30, 2029 | U-981: Management of mild to moderate pain, management of moderate to severe pain as an adjunct to opioid analgesics, reduction in fever through anti-inflammatory, analgesic, and antipyretic activity |
| Pat. No. 9012508 Administration of intravenous ibuprofen Claim Types: Method of use Pat. Sub. Date(s): 002: May 4, 2015 | Sep 14, 2030 | U-981: Management of mild to moderate pain, management of moderate to severe pain as an adjunct to opioid analgesics, reduction in fever through anti-inflammatory, analgesic, and antipyretic activity |
| Pat. No. 9114068 Treating patients with intravenous ibuprofen Claim Types: Method of use Pat. Sub. Date(s): 002: Sep 18, 2015 | Sep 30, 2029 | U-1735: Methods of treating pain, inflammation and/or fever with intravenous ibuprofen such that mean arterial blood pressure does not increase the dosage interval |
| Pat. No. 9138404 Treating critically ill patients with intravenous ibuprofen Claim Types: Method of administration Pat. Sub. Date(s): 002: Oct 27, 2015 | Sep 30, 2029 | U-1756: Methods of treating pain, inflammation and/or fever in a critically ill patient with intravenous ibuprofen in need thereof |
| Pat. No. 9295639 Treating critically ill patients with intravenous ibuprofen Claim Types: Method of use Pat. Sub. Date(s): 002: May 2, 2016 | Sep 30, 2029 | U-1756: Methods of treating pain, inflammation and/or fever in a critically ill patient with intravenous ibuprofen in need thereof |
| Pat. No. 9649284 Treating critically ill patients with intravenous ibuprofen Claim Types: Method of administration Pat. Sub. Date(s): 002: Jun 9, 2017 | Sep 30, 2029 | U-2018: Management of mild to moderate pain, management of moderate to severe pain as an adjunct to opioid analgesics in a critically ill patient with intravenous ibuprofen in need thereof |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Nov 19, 2024 | M-128: Clinical trial study results |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
CALDOLOR (SOLUTION) (INTRAVENOUS) IBUPROFEN
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: CUMBERLAND PHARMS NDA No.: 022348 Prod. No.: 003 RX (800MG/200ML (4MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8735452 Treating patients with intravenous ibuprofen Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 003: Sep 23, 2019 | Sep 30, 2029 | U-981: Management of mild to moderate pain, management of moderate to severe pain as an adjunct to opioid analgesics, reduction in fever through anti-inflammatory, analgesic, and antipyretic activity |
| Pat. No. 8871810 Treating critically ill patients with intravenous ibuprofen Claim Types: Method of use Pat. Sub. Date(s): 003: Sep 23, 2019 | Sep 30, 2029 | U-981: Management of mild to moderate pain, management of moderate to severe pain as an adjunct to opioid analgesics, reduction in fever through anti-inflammatory, analgesic, and antipyretic activity |
| Pat. No. 9012508 Administration of intravenous ibuprofen Claim Types: Method of use Pat. Sub. Date(s): 003: Sep 23, 2019 | Sep 14, 2030 | U-981: Management of mild to moderate pain, management of moderate to severe pain as an adjunct to opioid analgesics, reduction in fever through anti-inflammatory, analgesic, and antipyretic activity |
| Pat. No. 9072661 Injectable ibuprofen formulation Claim Types: Formulation; Drug in a container; Method of use Pat. Sub. Date(s): 003: Sep 4, 2019 | Mar 16, 2032 | U-2264: Methods of treating pain, inflammation, fever, patent ductus arteriosis with aqueous composition |
| Pat. No. 9072710 Injectable ibuprofen formulation Claim Types: Formulation; Drug in a container; Process; Method of use Pat. Sub. Date(s): 003: Sep 10, 2019 | Mar 16, 2032 | U-2266: Methods of making aqueous composition and treating pain, inflammation, fever, patent ductus arteriosis with aqueous composition |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Nov 19, 2024 | M-128: Clinical trial study results |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
CAMBIA (FOR SOLUTION) (ORAL) DICLOFENAC POTASSIUM [GENERIC AB]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Dermatological Agents:Dermatological Agents, Other == Ophthalmic Agents:Ophthalmic Anti-inflammatories
NDA Applicant: ASSERTIO NDA No.: 022165 Prod. No.: 001 RX (50MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7759394 DS* DP* Diclofenac formulations and methods of use Claim Types: Method of administration Pat. Sub. Date(s): 001: None | Jun 16, 2026 | U-436: Acute treatment of migraine attacks with or without aura in adults |
| Pat. No. 8097651 DS* DP* Diclofenac formulations and methods of use Claim Types: Method of use Pat. Sub. Date(s): 001: None | Jun 16, 2026 | U-436: Acute treatment of migraine attacks with or without aura in adults |
| Pat. No. 8927604 Diclofenac formulations and methods of use Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 21, 2015 | Jun 16, 2026 | U-436: Acute treatment of migraine attacks with or without aura in adults |
| Pat. No. 9827197 DP* Diclofenac formulations and methods of use Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Dec 5, 2017 | Jun 16, 2026 |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
CONSENSI (TABLET) (ORAL) AMLODIPINE BESYLATE; CELECOXIB
Drug Classes: Cardiovascular Agents:Calcium Channel Blocking Agents, Dihydropyridines == Cardiovascular Agents:Cardiovascular Combinations == calcium channel blocker == dihydropyridine calcium channel blocker == Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: PURPLE BIOTECH NDA No.: 210045 Prod. No.: 001 DISC (EQ 2.5MG BASE;200MG); 002 DISC (EQ 5MG BASE;200MG); 003 DISC (EQ 10MG BASE;200MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9408837 Ameliorating drug-induced elevations in blood pressure by adjunctive use of antihypertensive drugs Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 11, 2020 | Feb 28, 2030 | U-2410: Treatment of adult patients for whom treatment with both amlodipine for hypertension and celecoxib for osteoarthritis are appropriate |
| Pat. No. 9662315 DP* Ameliorating drug-induced elevations in blood pressure by adjunctive use of antihypertensive drugs Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 16, 2018 | May 22, 2029 | U-2410: Treatment of adult patients for whom treatment with both amlodipine for hypertension and celecoxib for osteoarthritis are appropriate |
| Pat. No. 10350171 DP* Celecoxib and amlodipine formulation and method of making the same Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: Sep 6, 2019 | Jun 14, 2038 | |
| Pat. No. 10925835 Celecoxib and amlodipine formulation and method of making the same Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 22, 2021 | Jun 14, 2038 | U-2410: Treatment of adult patients for whom treatment with both amlodipine for hypertension and celecoxib for osteoarthritis are appropriate |
| Pat. No. 10945960 DP* Celecoxib and amlodipine formulation and method of making the same Claim Types: Formulation Pat. Sub. Date(s): All strengths: Mar 22, 2021 | Jun 14, 2038 |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
DUEXIS (TABLET) (ORAL) FAMOTIDINE; IBUPROFEN [GENERIC AB]
Drug Classes: Gastrointestinal Agents:Histamine2 (H2) Receptor Antagonists == histamine-2 (H2) receptor antagonist == Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: HORIZON NDA No.: 022519 Prod. No.: 001 RX (26.6MG;800MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8067451 DP* Methods and medicaments for administration of ibuprofen Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 30, 2011 | Jul 18, 2026 | U-1196: Relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease risk of developing upper gastrointestinal ulcers in patients who are taking ibuprofen for those indications |
| Pat. No. 8309127 DP* Stable compositions of famotidine and ibuprofen Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 13, 2012 | Jul 18, 2026 | |
| Pat. No. 8318202 DP* Stable compositions of famotidine and ibuprofen Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 27, 2012 | Jul 18, 2026 | |
| Pat. No. 8449910 DP* Stable compositions of famotidine and ibuprofen Claim Types: Formulation Pat. Sub. Date(s): 001: May 28, 2013 | Jul 18, 2026 | |
| Pat. No. 8501228 Stable compositions of famotidine and ibuprofen Claim Types: Method of administration Pat. Sub. Date(s): 001: Aug 6, 2013 | Jul 18, 2026 | U-1196: Relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease risk of developing upper gastrointestinal ulcers in patients who are taking ibuprofen for those indications |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
DYLOJECT (SOLUTION) (INTRAVENOUS) DICLOFENAC SODIUM
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Dermatological Agents:Dermatological Agents, Other == Ophthalmic Agents:Ophthalmic Anti-inflammatories
NDA Applicant: JAVELIN PHARMS INC NDA No.: 022396 Prod. No.: 001 DISC (37.5MG/ML (37.5MG/ML)**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8946292 Formulations of low dose diclofenac and beta-cyclodextrin Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 27, 2015 | Mar 22, 2027 | U-1659: Management of pain |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
ELYXYB (SOLUTION) (ORAL) CELECOXIB
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: BDSI NDA No.: 212157 Prod. No.: 001 RX (25MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9572819 DP* Oral composition of celecoxib for treatment of pain Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: May 11, 2020 | May 27, 2036 | U-2718: Acute treatment of migraine with or without aura in adults |
| Pat. No. 9795620 DP* Oral composition of celecoxib for treatment of pain Claim Types: Method of use Pat. Sub. Date(s): 001: May 11, 2020 | May 27, 2036 | U-2718: Acute treatment of migraine with or without aura in adults |
| Pat. No. 9949990 DP* Oral composition of celecoxib for treatment of pain Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: May 11, 2020 | May 27, 2036 | U-2718: Acute treatment of migraine with or without aura in adults |
| Pat. No. 10376527 DP* Oral composition of celecoxib for treatment of pain Claim Types: Method of use Pat. Sub. Date(s): 001: May 11, 2020 | May 27, 2036 | U-2718: Acute treatment of migraine with or without aura in adults |
| Pat. No. 10722456 DP* Oral composition of celecoxib for treatment of pain Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 14, 2020 | May 27, 2036 | U-2718: Acute treatment of migraine with or without aura in adults |
| Pat. No. 10799517 DP* Oral composition of celecoxib for treatment of pain Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 28, 2020 | May 27, 2036 | U-2718: Acute treatment of migraine with or without aura in adults |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | May 5, 2023 |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
FENOPROFEN CALCIUM (CAPSULE) (ORAL) FENOPROFEN CALCIUM [GENERIC AB]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: RISING NDA No.: 214475 Prod. No.: 001 RX (EQ 400MG BASE)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Feb 11, 2023 |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
LICART (SYSTEM) (TOPICAL) DICLOFENAC EPOLAMINE
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Dermatological Agents:Dermatological Agents, Other == Ophthalmic Agents:Ophthalmic Anti-inflammatories
NDA Applicant: IBSA INST BIO NDA No.: 206976 Prod. No.: 001 RX (1.3%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11344520 Effects of heparin on topical use of plasters containing a non-steroidal anti-inflammatory drug Claim Types: Method of administration Pat. Sub. Date(s): 001: Jun 29, 2022 | Feb 20, 2035 | U-3393: Method of treating acute pain due to minor strains, sprains, and contusions using a diclofenac patch containing heparin for once daily administration where heparin is not released |
| Pat. No. 11351133 Effects of heparin on topical use of plasters containing a non-steroidal anti-inflammatory drug Claim Types: Method of administration Pat. Sub. Date(s): 001: Jun 29, 2022 | Feb 20, 2035 | U-3393: Method of treating acute pain due to minor strains, sprains, and contusions using a diclofenac patch containing heparin for once daily administration where heparin is not released |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Dec 19, 2021 |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
NAPROXEN SODIUM (CAPSULE) (ORAL) NAPROXEN SODIUM [GENERIC OTC]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: BIONPHARMA INC NDA No.: 021920 Prod. No.: 001 OTC (EQ 200MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9693978 DP* Solvent system for enhancing the solubility of pharmaceutical agents Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: Nov 13, 2017 | Mar 3, 2026 | |
| Pat. No. 9693979 DP* Liquid dosage forms of sodium naproxen Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Nov 13, 2017 | Mar 3, 2026 | |
| Pat. No. 10022344 DP* Liquid dosage forms of sodium naproxen Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: Jul 23, 2018 | Mar 3, 2026 | U-1731: Temporary relief of minor aches and pains U-1732: Temporary reduction of fever |
| Pat. No. 10028925 DP* Liquid dosage forms of sodium naproxen Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Jul 24, 2018 | Mar 3, 2026 | U-1731: Temporary relief of minor aches and pains U-1732: Temporary reduction of fever |
| Pat. No. 11090280 DP* Liquid dosage forms of sodium naproxen Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 24, 2021 | Mar 3, 2026 | U-1731: Temporary relief of minor aches and pains U-1732: Temporary reduction of fever |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
NEOPROFEN (INJECTABLE) (INTRAVENOUS) IBUPROFEN LYSINE [GENERIC AP]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: RECORDATI RARE NDA No.: 021903 Prod. No.: 001 RX (EQ 20MG BASE/2ML (EQ 10MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8415337 DS* DP* Ibuprofen compositions and methods of making same Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): 001: Apr 11, 2013 | Mar 2, 2032 |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
OMIDRIA (SOLUTION) (IRRIGATION) KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE [GENERIC AT]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Ophthalmic Agents:Ophthalmic Anti-inflammatories == cyclooxygenase inhibitor == Ophthalmic Agents:Ophthalmic Combinations == alpha-1 adrenergic receptor agonist
NDA Applicant: RAYNER SURGICAL NDA No.: 205388 Prod. No.: 001 RX (EQ 0.3% BASE;EQ 1% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8173707 Ophthalmologic irrigation solutions and method Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 13, 2014 | Jan 30, 2024 *PED | U-1518: Maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain |
| Pat. No. 8586633 DP* Ophthalmologic irrigation solutions and method Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 13, 2014 | Jan 30, 2024 *PED | |
| Pat. No. 9066856 DP* Stable preservative-free mydriatic and anti-inflammatory solutions for injection Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 13, 2015 | Apr 23, 2034 *PED | |
| Pat. No. 9278101 Ophthalmologic irrigation solutions and method Claim Types: Method of administration Pat. Sub. Date(s): 001: Mar 9, 2016 | Jan 30, 2024 *PED | U-1518: Maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain |
| Pat. No. 9399040 DP* Ophthalmologic irrigation solutions and method Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 28, 2016 | Jan 30, 2024 *PED | |
| Pat. No. 9486406 DP* Stable preservative-free mydriatic and anti-inflammatory solutions for injection Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 9, 2016 | Apr 23, 2034 *PED | |
| Pat. No. 9855246 DP* Stable preservative-free mydriatic and anti-inflammatory solutions for injection Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 5, 2018 | Oct 23, 2033 |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
PENNSAID (SOLUTION) (TOPICAL) DICLOFENAC SODIUM
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Dermatological Agents:Dermatological Agents, Other == Ophthalmic Agents:Ophthalmic Anti-inflammatories
NDA Applicant: NUVO PHARMS INC NDA No.: 020947 Prod. No.: 001 DISC (1.5%**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8217078 Treatment of pain with topical diclofenac Claim Types: Method of administration Pat. Sub. Date(s): 001: Jul 11, 2012 | Jul 10, 2029 | U-1248: Use of topical diclofenac on the knee and a second topical medication on the same knee |
| Pat. No. 8546450 Treatment of pain with topical diclofenac compounds Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Oct 4, 2013 | Aug 9, 2030 | U-1435: Combination use of topical diclofenac on the knee and administration of an oral NSAID. U-1436: Use of topical diclofenac on the knee and a second topical agent selected from sunscreen and insect repellant |
| Pat. No. 8618164 Treatment of pain with topical diclofenac compounds Claim Types: Method of administration Pat. Sub. Date(s): 001: Jan 10, 2014 | Jul 10, 2029 | U-1477: Use of topical diclofenac on the knee and a second topical prescription medication on the same knee |
| Pat. No. 8741956 Treatment of pain with topical diclofenac Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jun 5, 2014 | Jul 10, 2029 | U-1435: Combination use of topical diclofenac on the knee and administration of an oral NSAID. |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
PENNSAID (SOLUTION) (TOPICAL) DICLOFENAC SODIUM [GENERIC AB]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Dermatological Agents:Dermatological Agents, Other == Ophthalmic Agents:Ophthalmic Anti-inflammatories
NDA Applicant: HORIZON NDA No.: 204623 Prod. No.: 001 RX (2%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8217078 Treatment of pain with topical diclofenac Claim Types: Method of administration Pat. Sub. Date(s): 001: Feb 25, 2014 | Jul 10, 2029 | U-1477: Use of topical diclofenac on the knee and a second topical prescription medication on the same knee |
| Pat. No. 8252838 DP* Diclofenac topical formulation Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Feb 25, 2014 | Apr 21, 2028 | U-1489: Use of topical diclofenac on a joint for treating osteoarthritis |
| Pat. No. 8546450 Treatment of pain with topical diclofenac compounds Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Feb 25, 2014 | Aug 9, 2030 | U-1435: Combination use of topical diclofenac on the knee and administration of an oral NSAID. U-1436: Use of topical diclofenac on the knee and a second topical agent selected from sunscreen and insect repellant |
| Pat. No. 8563613 DP* Diclofenac topical formulation Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Feb 25, 2014 | Oct 17, 2027 | U-1488: Use of topical diclofenac for treating pain |
| Pat. No. 8618164 Treatment of pain with topical diclofenac compounds Claim Types: Method of administration Pat. Sub. Date(s): 001: Feb 25, 2014 | Jul 10, 2029 | U-1477: Use of topical diclofenac on the knee and a second topical prescription medication on the same knee |
| Pat. No. 8741956 Treatment of pain with topical diclofenac Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jun 5, 2014 | Jul 10, 2029 | U-1435: Combination use of topical diclofenac on the knee and administration of an oral NSAID. |
| Pat. No. 8871809 Diclofenac topical formulation Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 18, 2014 | Oct 17, 2027 | U-1614: Use of topical diclofenac sodium for treating pain |
| Pat. No. 9066913 DP* Diclofenac topical formulation Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jun 30, 2015 | Oct 17, 2027 | U-1488: Use of topical diclofenac for treating pain |
| Pat. No. 9101591 DP* Diclofenac topical formulation Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 11, 2015 | Oct 17, 2027 | U-1488: Use of topical diclofenac for treating pain |
| Pat. No. 9132110 Treatment of pain with topical diclofenac Claim Types: Method of administration Pat. Sub. Date(s): 001: Sep 16, 2015 | Oct 17, 2027 | U-1488: Use of topical diclofenac for treating pain |
| Pat. No. 9168304 DP* Diclofenac topical formulation Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 27, 2015 | Oct 17, 2027 | |
| Pat. No. 9168305 Diclofenac topical formulation Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 27, 2015 | Oct 17, 2027 | U-1488: Use of topical diclofenac for treating pain |
| Pat. No. 9220784 Diclofenac topical formulation Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 28, 2016 | Oct 17, 2027 | U-1488: Use of topical diclofenac for treating pain |
| Pat. No. 9339551 Diclofenac topical formulation Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 16, 2016 | Oct 17, 2027 | U-1488: Use of topical diclofenac for treating pain |
| Pat. No. 9339552 DP* Diclofenac topical formulation Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jun 16, 2016 | Oct 17, 2027 | U-1488: Use of topical diclofenac for treating pain |
| Pat. No. 9370501 Treatment of pain with topical diclofenac Claim Types: Method of administration Pat. Sub. Date(s): 001: Jul 19, 2016 | Jul 10, 2029 | U-1614: Use of topical diclofenac sodium for treating pain |
| Pat. No. 9375412 Treatment of pain with topical diclofenac Claim Types: Method of administration Pat. Sub. Date(s): 001: Jul 26, 2016 | Jul 10, 2029 | U-1614: Use of topical diclofenac sodium for treating pain |
| Pat. No. 9415029 Treatment of pain with topical diclofenac Claim Types: Method of administration Pat. Sub. Date(s): 001: Sep 13, 2016 | Jul 10, 2029 | U-1614: Use of topical diclofenac sodium for treating pain |
| Pat. No. 9539335 Diclofenac topical formulation Claim Types: Method of use; Process Pat. Sub. Date(s): 001: Feb 6, 2016 | Oct 17, 2027 | U-1614: Use of topical diclofenac sodium for treating pain |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
QMIIZ ODT (TABLET, ORALLY DISINTEGRATING) (ORAL) MELOXICAM
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: TERSERA NDA No.: 211210 Prod. No.: 001 DISC (7.5MG); 002 DISC (15MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8545879 DP* Fast disintegrating compositions of meloxicam Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 24, 2018 | Aug 31, 2030 |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
SEGLENTIS (TABLET) (ORAL) CELECOXIB; TRAMADOL HYDROCHLORIDE
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: KOWA PHARMS NDA No.: 213426 Prod. No.: 001 RX (56MG;44MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8598152 DS* DP* Co-crystals of tramadol and coxibs Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Nov 12, 2021 | Apr 19, 2030 | |
| Pat. No. 8846744 DP* Pharmaceutical compositions of co-crystals of tramadol and coxibs Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Nov 12, 2021 | Jun 3, 2031 | |
| Pat. No. 9012440 DS* DP* Co-crystals of tramadol and coxibs Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Nov 12, 2021 | Apr 19, 2030 | |
| Pat. No. 10238668 DS* DP* Co-crystals of tramadol and coxibis Claim Types: New polymorph, salt or hydrate; Method of use Pat. Sub. Date(s): 001: Nov 12, 2021 | Apr 19, 2030 | U-3244: A method for treatment of pain in adults using tramadol hydrochloride and celecoxib |
| Pat. No. 10245276 DS* DP* Co-crystals of tramadol and coxibs Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Nov 12, 2021 | Apr 19, 2030 | |
| Pat. No. 10548909 Co-crystals of tramadol and coxibs Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 12, 2021 | Apr 19, 2030 | U-3244: A method for treatment of pain in adults using tramadol hydrochloride and celecoxib |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Oct 15, 2024 |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
TIVORBEX (CAPSULE) (ORAL) INDOMETHACIN
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: GENUS NDA No.: 204768 Prod. No.: 001 DISC (20MG); 002 DISC (40MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8734847 DP* Formulation of indomethacin Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 27, 2014 | Apr 23, 2030 | |
| Pat. No. 8992982 DP* Formulation of indomethacin Claim Types: Formulation Pat. Sub. Date(s): All strengths: Apr 3, 2015 | Apr 23, 2030 | |
| Pat. No. 9089471 Formulation of indomethacin Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 27, 2015 | Apr 23, 2030 | U-55: Treatment of pain |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
TREXIMET (TABLET) (ORAL) NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE [GENERIC AB]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Antimigraine Agents:Serotonin (5-HT) Receptor Agonists == serotonin 5-HT1B/1D receptor agonist (triptan)
NDA Applicant: CURRAX NDA No.: 021926 Prod. No.: 001 RX (500MG;EQ 85MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7332183 DP* Multilayer dosage forms containing NSAIDs and triptans Claim Types: Formulation; Method of use; Method of administration Pat. Sub. Date(s): 001: None | Apr 2, 2026 *PED | U-867: Treatment of migraine |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
TREXIMET (TABLET) (ORAL) NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Antimigraine Agents:Serotonin (5-HT) Receptor Agonists == serotonin 5-HT1B/1D receptor agonist (triptan)
NDA Applicant: CURRAX NDA No.: 021926 Prod. No.: 002 DISC (60MG;EQ 10MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7332183 DP* Multilayer dosage forms containing NSAIDs and triptans Claim Types: Formulation; Method of use; Method of administration Pat. Sub. Date(s): 002: Jul 27, 2015 | Apr 2, 2026 *PED | U-1719: Acute treatment of migraine |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
VIMOVO (TABLET, DELAYED RELEASE) (ORAL) ESOMEPRAZOLE MAGNESIUM; NAPROXEN [GENERIC AB]
Drug Classes: Gastrointestinal Agents:Proton Pump Inhibitors == Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: HORIZON NDA No.: 022511 Prod. No.: 001 RX (EQ 20MG BASE;500MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8852636 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 29, 2014 | May 31, 2022 | U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer |
| Pat. No. 8858996 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDS Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 29, 2014 | May 31, 2022 | U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer |
| Pat. No. 8945621 Method for treating a patient at risk for developing an NSAID-associated ulcer Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Mar 2, 2015 | Oct 17, 2031 | U-1661: Risk-reduction of NSAID-associated gastric ulcers in patients also taking low dose aspirin |
| Pat. No. 9161920 Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 12, 2015 | May 31, 2022 | U-1760: Risk-reduction of nsaid gastric ulcer in patients requiring chronic nsaid treatment |
| Pat. No. 9198888 Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Dec 17, 2015 | May 31, 2022 | U-1781: Risk-reduction of NSAID-associated gastric ulcer in patients requiring NSAID treatment |
| Pat. No. 9220698 Method for delivering a pharmaceutical composition to patient in need thereof Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 28, 2016 | Mar 10, 2031 | U-1781: Risk-reduction of NSAID-associated gastric ulcer in patients requiring NSAID treatment |
| Pat. No. 9345695 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 23, 2016 | May 31, 2022 | |
| Pat. No. 9393208 Method for delivering a pharmaceutical composition to patient in need thereof Claim Types: Method of administration Pat. Sub. Date(s): 001: Aug 17, 2016 | Sep 3, 2029 | U-1781: Risk-reduction of NSAID-associated gastric ulcer in patients requiring NSAID treatment |
| Pat. No. 9707181 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 17, 2017 | May 31, 2022 |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
VIMOVO (TABLET, DELAYED RELEASE) (ORAL) ESOMEPRAZOLE MAGNESIUM; NAPROXEN [GENERIC AB]
Drug Classes: Gastrointestinal Agents:Proton Pump Inhibitors == Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: HORIZON NDA No.: 022511 Prod. No.: 002 RX (EQ 20MG BASE;375MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8852636 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Oct 29, 2014 | May 31, 2022 | U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer |
| Pat. No. 8858996 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDS Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Oct 29, 2014 | May 31, 2022 | U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer |
| Pat. No. 8945621 Method for treating a patient at risk for developing an NSAID-associated ulcer Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 002: Mar 2, 2015 | Oct 17, 2031 | U-1661: Risk-reduction of NSAID-associated gastric ulcers in patients also taking low dose aspirin |
| Pat. No. 9161920 Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 12, 2015 | May 31, 2022 | U-1760: Risk-reduction of nsaid gastric ulcer in patients requiring chronic nsaid treatment |
| Pat. No. 9198888 Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Dec 17, 2015 | May 31, 2022 | U-1781: Risk-reduction of NSAID-associated gastric ulcer in patients requiring NSAID treatment |
| Pat. No. 9345695 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation Pat. Sub. Date(s): 002: Jun 23, 2016 | May 31, 2022 | |
| Pat. No. 9393208 Method for delivering a pharmaceutical composition to patient in need thereof Claim Types: Method of administration Pat. Sub. Date(s): 002: Aug 17, 2016 | Sep 3, 2029 | U-1781: Risk-reduction of NSAID-associated gastric ulcer in patients requiring NSAID treatment |
| Pat. No. 9707181 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation Pat. Sub. Date(s): 002: Aug 17, 2017 | May 31, 2022 |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
VIVLODEX (CAPSULE) (ORAL) MELOXICAM
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: ICEUTICA OPERATIONS NDA No.: 207233 Prod. No.: 001 DISC (5MG**); 002 DISC (10MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9526734 DP* Formulation of meloxicam Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 30, 2016 | Mar 31, 2033 | |
| Pat. No. 9649318 DP* Formulation of meloxicam Claim Types: Composition Pat. Sub. Date(s): All strengths: May 16, 2017 | Mar 31, 2035 | |
| Pat. No. 9808468 Formulation of meloxicam Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 22, 2017 | Mar 31, 2035 | U-2160: Management of osteoarthritis pain by administering 5 mg of meloxicam U-2165: Management of osteoarthritis pain by administering 10 mg of meloxicam |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
ZIPSOR (CAPSULE) (ORAL) DICLOFENAC POTASSIUM [GENERIC AB]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Dermatological Agents:Dermatological Agents, Other == Ophthalmic Agents:Ophthalmic Anti-inflammatories
NDA Applicant: ASSERTIO NDA No.: 022202 Prod. No.: 001 RX (25MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7662858 Method of treating post-surgical acute pain Claim Types: Method of administration Pat. Sub. Date(s): 001: None | Feb 24, 2029 | U-1035: Nonsteroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain |
| Pat. No. 7884095 Method of treating post-surgical acute pain Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 22, 2011 | Feb 24, 2029 | U-1111: Nonsteroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain |
| Pat. No. 7939518 Method of treating post-surgical acute pain Claim Types: Method of use Pat. Sub. Date(s): 001: May 19, 2011 | Feb 24, 2029 | U-980: Nonsteroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain |
| Pat. No. 8110606 Method of treating post-surgical acute pain Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 13, 2012 | Feb 24, 2029 | U-980: Nonsteroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain |
| Pat. No. 8623920 Method of treating post-surgical acute pain Claim Types: Method of administration Pat. Sub. Date(s): 001: Feb 5, 2014 | Feb 24, 2029 | U-1482: Diclofenac potassium for relief of mild to moderate acute pain |
| Pat. No. 9561200 Method of treating post-surgical acute pain Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 14, 2017 | Feb 24, 2029 | U-1482: Diclofenac potassium for relief of mild to moderate acute pain |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | May 25, 2024 |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
ZORVOLEX (CAPSULE) (ORAL) DICLOFENAC
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Dermatological Agents:Dermatological Agents, Other == Ophthalmic Agents:Ophthalmic Anti-inflammatories
NDA Applicant: ZYLA NDA No.: 204592 Prod. No.: 001 DISC (18MG**); 002 DISC (35MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8679544 DP* Formulation of diclofenac Claim Types: Formulation Pat. Sub. Date(s): All strengths: Mar 25, 2014 | Apr 23, 2030 | |
| Pat. No. 8999387 Formulation of diclofenac Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 7, 2015 | Apr 23, 2030 | U-55: Treatment of pain |
| Pat. No. 9017721 DP* Formulation of diclofenac Claim Types: Formulation Pat. Sub. Date(s): All strengths: Apr 29, 2015 | Apr 23, 2030 | |
| Pat. No. 9173854 DP* Formulation of diclofenac Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 5, 2015 | Apr 23, 2030 | |
| Pat. No. 9180095 Formulation of diclofenac Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 12, 2015 | Apr 23, 2030 | U-55: Treatment of pain |
| Pat. No. 9180096 DP* Formulation of diclofenac Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 12, 2015 | Apr 23, 2030 | |
| Pat. No. 9186328 Formulation of diclofenac Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 19, 2015 | Apr 23, 2030 | U-55: Treatment of pain |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
ZYNRELEF KIT (SOLUTION, EXTENDED RELEASE) (PERIARTICULAR) BUPIVACAINE; MELOXICAM
Drug Classes: Anesthetics:Local Anesthetics == amide local anesthetic == Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: HERON THERAPS INC NDA No.: 211988 Prod. No.: 002 RX (200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)); 004 RX (400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)) NDA No.: 211988 Prod. No.: 001 DISC (60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)); 003 DISC (300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9592227 DP* Compositions of a polyorthoester and an aprotic solvent Claim Types: Formulation; Method of administration; Method of use Pat. Sub. Date(s): All strengths: May 26, 2021 | Mar 13, 2034 | U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation |
| Pat. No. 9694079 DP* Long-acting polymeric delivery systems Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: May 26, 2021 | Apr 20, 2035 | U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation |
| Pat. No. 9744163 DP* Compositions of a polyorthoester and an aprotic solvent Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 26, 2021 | Mar 13, 2034 | |
| Pat. No. 9801945 DP* Long-acting polymeric delivery systems Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: May 26, 2021 | Apr 20, 2035 | U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation |
| Pat. No. 9913909 Compositions of a polyorthoester and an aprotic solvent Claim Types: Method of administration; Method of use Pat. Sub. Date(s): All strengths: May 26, 2021 | Mar 13, 2034 | U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation |
| Pat. No. 10098957 Long-acting polymeric delivery systems Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 26, 2021 | Apr 20, 2035 | U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation |
| Pat. No. 10213510 DP* Long-acting polymeric delivery systems Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: May 26, 2021 | Apr 20, 2035 | U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation |
| Pat. No. 10398686 DP* Compositions of a polyorthoester and an aprotic solvent Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 26, 2021 | Mar 13, 2034 | |
| Pat. No. 10632199 DP* Long-acting polymeric delivery systems Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: May 26, 2021 | Apr 20, 2035 | U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation |
| Pat. No. 10898575 DP* Long-acting polymeric delivery systems Claim Types: Formulation; Method of use; Method of Use claimed by its inherent performace characteristics Pat. Sub. Date(s): All strengths: May 26, 2021 | Apr 20, 2035 | U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation |
| Pat. No. 10980886 DP* Compositions of a polyorthoester and an organic acid excipient Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 26, 2021 | Apr 20, 2035 | |
| Pat. No. 11083730 DP* Long-acting polymeric delivery systems Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Aug 25, 2021 | Apr 20, 2035 | U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation |
| Pat. No. 11083797 DP* Long-acting polymeric delivery systems Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Aug 25, 2021 | Apr 20, 2035 | U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation |
| Pat. No. 11253504 Compositions of a polyorthoester and an aprotic solvent Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 2, 2022 | Mar 13, 2034 | U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | May 12, 2024 |
Analgesics:Opioid Analgesics, Long-acting
ARYMO ER (TABLET, EXTENDED RELEASE) (ORAL) MORPHINE SULFATE [Has competitive generic]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: ZYLA NDA No.: 208603 Prod. No.: 001 DISC (15MG); 002 DISC (30MG); 003 DISC (60MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9044402 DP* Abuse-deterrent pharmaceutical compositions for controlled release Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Feb 8, 2017 | Jul 1, 2033 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9549899 DP* Abuse deterrent pharmaceutical compositions for controlled release Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Feb 21, 2017 | Jul 1, 2033 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
Analgesics:Opioid Analgesics, Long-acting
BELBUCA (FILM) (BUCCAL) BUPRENORPHINE HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Dependence == partial opioid agonist
NDA Applicant: BDSI NDA No.: 207932 Prod. No.: 001 RX (EQ 0.075MG BASE); 002 RX (EQ 0.15MG BASE); 003 RX (EQ 0.3MG BASE); 004 RX (EQ 0.45MG BASE); 005 RX (EQ 0.6MG BASE); 006 RX (EQ 0.75MG BASE); 007 RX (EQ 0.9MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8147866 DP* Transmucosal delivery devices with enhanced uptake Claim Types: Method of administration; Formulation Pat. Sub. Date(s): All strengths: Nov 20, 2015 | Jul 23, 2027 | U-1769: Treatement [sic, Treatment] of pain by transmucosal delivery of buprenorphine |
| Pat. No. 9655843 DP* Transmucosal delivery devices with enhanced uptake Claim Types: Method of administration; Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 13, 2017 | Jul 23, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9901539 Transmucosal drug delivery devices for use in chronic pain relief Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 28, 2018 | Dec 21, 2032 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
Analgesics:Opioid Analgesics, Long-acting
BUNAVAIL (FILM) (BUCCAL) BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Dependence == partial opioid agonist == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Reversal Agents == opioid antagonist
NDA Applicant: BDSI NDA No.: 205637 Prod. No.: 001 DISC (EQ 2.1MG BASE;EQ 0.3MG BASE); 002 DISC (EQ 4.2MG BASE;EQ 0.7MG BASE); 003 DISC (EQ 6.3MG BASE;EQ 1MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8147866 DP* Transmucosal delivery devices with enhanced uptake Claim Types: Method of administration; Formulation Pat. Sub. Date(s): All strengths: Jun 20, 2014 | Jul 23, 2027 | U-1521: Maintenance treatment of opioid dependence |
| Pat. No. 8703177 DP* Abuse-resistant mucoadhesive devices for delivery of buprenorphine Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 20, 2014 | Aug 20, 2032 | |
| Pat. No. 9522188 DP* Abuse resistant transmucosal drug delivery device Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 20, 2016 | Apr 24, 2035 | |
| Pat. No. 9655843 DP* Transmucosal delivery devices with enhanced uptake Claim Types: Method of administration; Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 13, 2017 | Jul 23, 2027 | U-2017: Treatment of opioid dependence |
Analgesics:Opioid Analgesics, Long-acting
CONZIP (CAPSULE, EXTENDED RELEASE) (ORAL) TRAMADOL HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: CIPHER PHARMS INC NDA No.: 022370 Prod. No.: 001 RX (100MG); 002 RX (200MG); 003 RX (300MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7858118 DP* Extended release composition containing Tramadol Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Apr 11, 2022 | U-1104: Use of tramadol for the management of moderate to moderately severe chronic pain |
Analgesics:Opioid Analgesics, Long-acting
DILAUDID-HP (INJECTABLE) (INJECTION) HYDROMORPHONE HYDROCHLORIDE [Has competitive generic]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: FRESENIUS KABI USA NDA No.: 019034 Prod. No.: 003 RX (1MG/ML); 004 RX (2MG/ML) NDA No.: 019034 Prod. No.: 001 DISC (10MG/ML); 002 DISC (250MG/VIAL); 005 DISC (4MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9248229 DP* Packaging system for oxygen-sensitive drugs Claim Types: Drug in a container Pat. Sub. Date(s): All strengths: Feb 5, 2018 | Mar 12, 2034 | |
| Pat. No. 9731082 DP* Drug container Claim Types: Device; Process Pat. Sub. Date(s): All strengths: Feb 5, 2018 | Apr 23, 2032 |
Analgesics:Opioid Analgesics, Long-acting
EMBEDA (CAPSULE, EXTENDED RELEASE) (ORAL) MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist == Anti-Addiction/ Substance Abuse Treatment Agents:Alcohol Deterrents/Anti-craving == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Dependence == Anti-Obesity Agents == opioid antagonist
NDA Applicant: ALPHARMA PHARMS NDA No.: 022321 Prod. No.: 001 DISC (20MG;0.8MG**); 002 DISC (30MG;1.2MG**); 003 DISC (50MG;2MG**); 004 DISC (60MG;2.4MG**); 005 DISC (80MG;3.2MG**); 006 DISC (100MG;4MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7682633 Pharmaceutical composition Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Jun 19, 2027 | U-1510: Management of pain severe enough to require daily, around-the-clock, long term opioid treatement by orally administering an intact composition as claimed. |
| Pat. No. 7682634 DP* Pharmaceutical compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jun 19, 2027 | |
| Pat. No. 7815934 DP* Sequestering subunit and related compositions and methods Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 19, 2010; 002: None; 003: None; 004: None; 005: None; 006: None | Dec 12, 2027 | |
| Pat. No. 8158156 Abuse-deterrent multi-layer pharmaceutical composition comprising an opioid antagonist and an opioid agonist Claim Types: Method of use Pat. Sub. Date(s): 001: May 10, 2012; 002: None; 003: None; 004: None; 005: None; 006: None | Jun 19, 2027 | U-1510: Management of pain severe enough to require daily, around-the-clock, long term opioid treatement by orally administering an intact composition as claimed. |
| Pat. No. 8623418 Pharmaceutical composition Claim Types: Method of use; Method of administration Pat. Sub. Date(s): All strengths: Jan 22, 2015 | Nov 7, 2029 | U-1640: Treatment of moderate to severe chronic pain by administering an intact composition as claimed |
| Pat. No. 8685443 Sequestering subunit and related compositions and methods Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Jul 3, 2025 | U-1508: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment by orally administering a plurality of composite subunits as claimed |
| Pat. No. 8685444 DP* Sequestering subunit and related compositions and methods Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jul 3, 2025 | |
| Pat. No. 8846104 DP* Pharmaceutical compositions for the deterrence and/or prevention of abuse Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 28, 2014 | Jun 19, 2027 | |
| Pat. No. 8877247 DP* Abuse-deterrent multi-layer pharmaceutical composition comprising an opioid antagonist and an opioid agonist Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 1, 2014 | Jun 19, 2027 |
Analgesics:Opioid Analgesics, Long-acting
FENTORA (TABLET) (BUCCAL, SUBLINGUAL) FENTANYL CITRATE [GENERIC AB]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: CEPHALON NDA No.: 021947 Prod. No.: 001 RX (EQ 0.1MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7862832 DP* Generally linear effervescent oral fentanyl dosage form and methods of administering Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 25, 2011 | Jun 15, 2028 | |
| Pat. No. 7862833 DP* Effervescent oral opiate dosage forms and methods of administering opiates Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 25, 2011 | Jun 15, 2028 | |
| Pat. No. 8092832 DP* Generally linear effervescent oral fentanyl dosage form and methods of administering Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 13, 2012 | Dec 30, 2024 |
Analgesics:Opioid Analgesics, Long-acting
FENTORA (TABLET) (BUCCAL, SUBLINGUAL) FENTANYL CITRATE [GENERIC AB]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: CEPHALON NDA No.: 021947 Prod. No.: 002 RX (EQ 0.2MG BASE); 003 RX (EQ 0.4MG BASE); 004 RX (EQ 0.6MG BASE); 005 RX (EQ 0.8MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7862832 DP* Generally linear effervescent oral fentanyl dosage form and methods of administering Claim Types: Formulation Pat. Sub. Date(s): 002: None; 003: None; 004: None; 005: Apr 25, 2011 | Jun 15, 2028 | |
| Pat. No. 7862833 DP* Effervescent oral opiate dosage forms and methods of administering opiates Claim Types: Formulation Pat. Sub. Date(s): 002: None; 003: None; 004: None; 005: Apr 25, 2011 | Jun 15, 2028 | |
| Pat. No. 8092832 DP* Generally linear effervescent oral fentanyl dosage form and methods of administering Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Dec 30, 2024 | |
| Pat. No. 8119158 DP* Effervescent oral fentanyl dosage form and methods of administering fentanyl Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 002: Feb 23, 2012; 003: None; 004: None; 005: None | Dec 30, 2024 |
Analgesics:Opioid Analgesics, Long-acting
HYSINGLA ER (TABLET, EXTENDED RELEASE) (ORAL) HYDROCODONE BITARTRATE [GENERIC AB]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Respiratory Tract/ Pulmonary Agents:Cold-Cough == opioid agonist
NDA Applicant: PURDUE PHARMA LP NDA No.: 206627 Prod. No.: 001 RX (20MG); 002 RX (30MG); 003 RX (40MG); 004 RX (60MG); 005 RX (80MG); 006 RX (100MG); 007 RX (120MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8309060 DP* Abuse-proofed dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Nov 21, 2014 | Nov 20, 2023 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 8529948 DP* Pharmaceutical formulation containing gelling agent Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 21, 2014 | Aug 6, 2022 | |
| Pat. No. 8808740 DP* Encased tamper resistant controlled release dosage forms Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Nov 21, 2014 | Dec 21, 2031 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9084816 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 21, 2015 | Aug 24, 2027 | |
| Pat. No. 9095614 Tamper resistant dosage forms Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 4, 2015 | Aug 24, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9095615 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 4, 2015 | Aug 24, 2027 | |
| Pat. No. 9486412 DP* Tamper resistant dosage forms Claim Types: Product-by-process Pat. Sub. Date(s): All strengths: Nov 8, 2016 | Aug 24, 2027 | |
| Pat. No. 9486413 DP* Tamper resistant dosage forms Claim Types: Product-by-process Pat. Sub. Date(s): All strengths: Nov 8, 2016 | Aug 24, 2027 | |
| Pat. No. 9492389 DP* Tamper resistant dosage forms Claim Types: Product-by-process Pat. Sub. Date(s): All strengths: Nov 16, 2016 | Aug 24, 2027 | |
| Pat. No. 9492390 Tamper resistant dosage forms Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 17, 2016 | Aug 24, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9492391 Tamper resistant dosage forms Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 17, 2016 | Aug 24, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9545380 Tamper resistant dosage forms Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 17, 2017 | Aug 24, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9572779 DP* Encased tamper resistant controlled release dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 21, 2017 | Dec 21, 2031 | |
| Pat. No. 9675610 DP* Abuse-proofed dosage form Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 12, 2017 | Jun 16, 2023 | |
| Pat. No. 9750703 DP* Encased tamper resistant controlled release dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 14, 2017 | Dec 21, 2031 | |
| Pat. No. 9763933 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 19, 2017 | Aug 24, 2027 | |
| Pat. No. 9770416 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 27, 2017 | Aug 24, 2027 | |
| Pat. No. 9775809 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 4, 2017 | Aug 24, 2027 | |
| Pat. No. 9861584 DP* Tamper resistant controlled release dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jan 10, 2018 | Dec 21, 2031 | |
| Pat. No. 9872837 DP* Tamper resistant controlled release dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jan 23, 2018 | Dec 21, 2031 | |
| Pat. No. 10130591 DP* Abuse-proofed dosage form Claim Types: Method of use; Product-by-process Pat. Sub. Date(s): All strengths: Nov 27, 2018 | Nov 20, 2023 | U-1819: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate |
| Pat. No. 10369109 DP* Abuse-proofed dosage form Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 9, 2019 | Jun 16, 2023 | |
| Pat. No. 11304908 DP* Tamper resistant dosage forms Claim Types: Product-by-process Pat. Sub. Date(s): All strengths: Apr 21, 2022 | Aug 24, 2027 | |
| Pat. No. 11304909 Tamper resistant dosage forms Claim Types: Method of use of a product-by-process Pat. Sub. Date(s): All strengths: Apr 21, 2022 | Aug 24, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
Analgesics:Opioid Analgesics, Long-acting
IONSYS (SYSTEM) (IONTOPHORESIS, TRANSDERMAL) FENTANYL HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: THE MEDICINES CO NDA No.: 021338 Prod. No.: 001 DISC (EQ 40MCG BASE/ACTIVATION)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6881208 Method and device for transdermal electrotransport delivery of fentanyl and sufentanil Claim Types: Method of administration Pat. Sub. Date(s): 001: None | Apr 19, 2022 | U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride |
| Pat. No. 6975902 DP* Reservoir and a series of related reservoirs for use in an electrotransport drug delivery device and devices comprised thereof Claim Types: Device; Drug in a container Pat. Sub. Date(s): 001: None | Apr 1, 2024 | |
| Pat. No. 8301238 DP* Two-part electrotransport device Claim Types: Device Pat. Sub. Date(s): 001: None | Sep 30, 2031 | |
| Pat. No. 8428708 Self-test for analgesic product Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: None | May 21, 2032 | U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride |
| Pat. No. 8428709 DP* Current control for electrotransport drug delivery Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: May 28, 2015 | Jun 11, 2032 | U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride |
| Pat. No. 8781571 DP* Switch validation circuit and method Claim Types: Device; Method of improving a treatment Pat. Sub. Date(s): 001: May 28, 2015 | Mar 31, 2032 | U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride |
| Pat. No. 9095706 DP* Self-test for analgesic product Claim Types: Device Pat. Sub. Date(s): 001: Aug 6, 2015 | Feb 3, 2033 | |
| Pat. No. 9364656 Method of storing an electrotransport drug delivery device Claim Types: Process Pat. Sub. Date(s): 001: Jun 21, 2016 | Sep 30, 2031 | U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride |
| Pat. No. 9731121 DP* Switch validation circuit and method Claim Types: Device Pat. Sub. Date(s): 001: Sep 12, 2017 | Oct 17, 2031 |
Analgesics:Opioid Analgesics, Long-acting
LAZANDA (SPRAY, METERED) (NASAL) FENTANYL CITRATE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: BTCP PHARMA NDA No.: 022569 Prod. No.: 001 DISC (EQ 0.1MG BASE); 002 DISC (EQ 0.4MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8216604 Method of managing or treating pain Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 19, 2012; 002: None | Oct 3, 2024 | U-767: Management of breakthrough pain in patients with cancer |
| Pat. No. 8889176 Method of managing or treating pain Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Dec 12, 2014 | Jan 16, 2024 | U-767: Management of breakthrough pain in patients with cancer |
| Pat. No. 9078814 DP* Intranasal spray device containing pharmaceutical composition Claim Types: Drug in a container Pat. Sub. Date(s): All strengths: Aug 11, 2015 | Jan 8, 2024 | |
| Pat. No. 9731869 DP* Container Claim Types: Packaging or device material Pat. Sub. Date(s): All strengths: Sep 1, 2017 | Jan 26, 2032 | |
| Pat. No. 9814705 DP* Intranasal spray device containing pharmaceutical composition Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 13, 2017 | Jan 8, 2024 |
Analgesics:Opioid Analgesics, Long-acting
LAZANDA (SPRAY, METERED) (NASAL) FENTANYL CITRATE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: BTCP PHARMA NDA No.: 022569 Prod. No.: 003 DISC (EQ 0.3MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9731869 DP* Container Claim Types: Packaging or device material Pat. Sub. Date(s): 003: Sep 1, 2017 | Jan 26, 2032 | |
| Pat. No. 9814705 DP* Intranasal spray device containing pharmaceutical composition Claim Types: Device Pat. Sub. Date(s): 003: Dec 13, 2017 | Jan 8, 2024 |
Analgesics:Opioid Analgesics, Long-acting
MORPHABOND ER (TABLET, EXTENDED RELEASE) (ORAL) MORPHINE SULFATE [Has competitive generic]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: DAIICHI SANKYO INC NDA No.: 206544 Prod. No.: 001 DISC (15MG); 002 DISC (30MG); 003 DISC (60MG); 004 DISC (100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7955619 DP* Abuse resistant drugs, method of use and method of making Claim Types: Formulation; Product-by-process Pat. Sub. Date(s): All strengths: Mar 24, 2016 | Aug 12, 2028 | |
| Pat. No. 10314788 DP* Pharmaceutical compositions configured to deter dosage form splitting Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 10, 2019 | Aug 12, 2028 |
Analgesics:Opioid Analgesics, Long-acting
MORPHINE SULFATE (SOLUTION) (ORAL) MORPHINE SULFATE [GENERIC AA]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: HIKMA NDA No.: 022195 Prod. No.: 001 RX (10MG/5ML); 002 RX (20MG/5ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NPP - New patient population | Jun 2, 2024 |
Analgesics:Opioid Analgesics, Long-acting
MORPHINE SULFATE (TABLET) (ORAL) MORPHINE SULFATE [GENERIC AB]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: HIKMA NDA No.: 022207 Prod. No.: 001 RX (15MG); 002 RX (30MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NPP - New patient population | Jun 2, 2024 |
Analgesics:Opioid Analgesics, Long-acting
MORPHINE SULFATE (SOLUTION) (INTRAMUSCULAR, INTRAVENOUS) MORPHINE SULFATE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: FRESENIUS KABI USA NDA No.: 204223 Prod. No.: 001 RX (2MG/ML (2MG/ML)); 002 RX (4MG/ML (4MG/ML)); 003 RX (5MG/ML (5MG/ML)); 004 RX (8MG/ML (8MG/ML)); 005 RX (10MG/ML (10MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9072781 DP* Morphine formulations Claim Types: Formulation; Kit Pat. Sub. Date(s): All strengths: Jul 13, 2015 | Mar 12, 2034 | |
| Pat. No. 9192608 Morphine formulations Claim Types: Method of use; Method of improving a treatment Pat. Sub. Date(s): All strengths: Dec 4, 2015 | Mar 12, 2034 | U-43: Management of chronic pain in patients requiring opioid analgesia U-55: Treatment of pain |
| Pat. No. 9248229 DP* Packaging system for oxygen-sensitive drugs Claim Types: Drug in a container Pat. Sub. Date(s): All strengths: Feb 17, 2016 | Mar 12, 2034 |
Analgesics:Opioid Analgesics, Long-acting
MORPHINE SULFATE (TABLET) (ORAL) MORPHINE SULFATE [GENERIC AB]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: ALKEM LABS LTD NDA No.: 212451 Prod. No.: 001 RX (15MG); 002 RX (30MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Aug 10, 2021 |
Analgesics:Opioid Analgesics, Long-acting
NUCYNTA (TABLET) (ORAL) TAPENTADOL HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: COLLEGIUM PHARM INC NDA No.: 022304 Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 75MG BASE); 003 RX (EQ 100MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE39593 DS* DP* [Extended 1508 days (4.1 years)] 1-phenyl-3-dimethylaminopropane compounds with a pharmacological effects Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Jul 21, 2011 | Aug 5, 2022 | U-931: Relief of moderate to severe acute pain |
| Pat. No. 7994364 DS* DP* Crystalline forms of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use Pat. Sub. Date(s): 001: Sep 2, 2011; 002: None; 003: None | Jun 27, 2025 | U-931: Relief of moderate to severe acute pain |
Analgesics:Opioid Analgesics, Long-acting
NUCYNTA (SOLUTION) (ORAL) TAPENTADOL HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: COLLEGIUM PHARM INC NDA No.: 203794 Prod. No.: 001 DISC (EQ 20MG BASE/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE39593 DS* DP* [Extended 1508 days (4.1 years)] 1-phenyl-3-dimethylaminopropane compounds with a pharmacological effects Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Oct 24, 2012 | Aug 5, 2022 | U-1289: Management of moderate to severe acute pain |
| Pat. No. 7994364 DS* DP* Crystalline forms of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use Pat. Sub. Date(s): 001: Oct 24, 2012 | Jun 27, 2025 | U-1289: Management of moderate to severe acute pain |
Analgesics:Opioid Analgesics, Long-acting
NUCYNTA ER (TABLET, EXTENDED RELEASE) (ORAL) TAPENTADOL HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: COLLEGIUM PHARM INC NDA No.: 200533 Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 100MG BASE); 003 RX (EQ 150MG BASE); 004 RX (EQ 200MG BASE); 005 RX (EQ 250MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE39593 DS* DP* [Extended 1508 days (4.1 years)] 1-phenyl-3-dimethylaminopropane compounds with a pharmacological effects Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Sep 19, 2011; 002: None; 003: None; 004: None; 005: None | Aug 5, 2022 | U-1178: Relief of moderate to severe chronic pain U-1276: Management of neuropathic pain associated with diabetic peripheral neuropathy |
| Pat. No. 7994364 DS* DP* Crystalline forms of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use Pat. Sub. Date(s): 001: Sep 2, 2011; 002: None; 003: None; 004: None; 005: None | Jun 27, 2025 | U-1178: Relief of moderate to severe chronic pain U-1276: Management of neuropathic pain associated with diabetic peripheral neuropathy |
| Pat. No. 8075872 DP* Abuse-proofed dosage form Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Jan 9, 2012; 002: None; 003: None; 004: None; 005: None | Nov 20, 2023 | |
| Pat. No. 8114383 DP* DLR* Abuse-proofed dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 14, 2012; 002: None; 003: None; 004: None; 005: None | Oct 10, 2024 | |
| Pat. No. 8309060 DP* Abuse-proofed dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Dec 5, 2012; 002: None; 003: None; 004: None; 005: None | Nov 20, 2023 | U-1178: Relief of moderate to severe chronic pain U-1276: Management of neuropathic pain associated with diabetic peripheral neuropathy |
| Pat. No. 8420056 DP* Abuse-proofed dosage form Claim Types: Formulation; Process; Product-by-process Pat. Sub. Date(s): 001: May 2, 2013; 002: None; 003: None; 004: None; 005: None | Nov 20, 2023 | |
| Pat. No. 8536130 Use of 1 phenyl-3-dimethylamino-propane compounds for treating neuropathic pain Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Sep 22, 2028 | U-1276: Management of neuropathic pain associated with diabetic peripheral neuropathy |
| Pat. No. 11007156 DP* Prolonged release pharmaceutical composition containing 3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 17, 2021 | Oct 22, 2022 | U-1178: Relief of moderate to severe chronic pain U-1276: Management of neuropathic pain associated with diabetic peripheral neuropathy |
| Pat. No. 11344512 Titration of tapentadol Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 29, 2022 | Apr 21, 2028 | U-3391: A method of titrating an opioid to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatments are inadequate U-3392: A method of titrating an opioid to manage neuropathic pain associated with diabetic peripheral neuropathy severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate |
Analgesics:Opioid Analgesics, Long-acting
OBREDON (SOLUTION) (ORAL) GUAIFENESIN; HYDROCODONE BITARTRATE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Cold-Cough == expectorant == Analgesics:Opioid Analgesics, Long-acting == opioid agonist
NDA Applicant: SOVEREIGN PHARMS NDA No.: 205474 Prod. No.: 001 DISC (200MG/5ML;2.5MG/5ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9549907 DS* DP* Immediate release oral guaifenesin solution Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jun 30, 2017 | Nov 13, 2035 | U-2023: A method of increasing the bioavailability of guaifenesin in a solution containing 54% to 66% by weight of propylene glycol and glycerol, wherein the method increases the cmax by at least 1.5 and/or increases the auc (0-inf) by at least 1.4 |
| Pat. No. 9808431 DS* DP* Immediate release oral guaifenesin solution Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 16, 2018 | Nov 13, 2035 | U-2023: A method of increasing the bioavailability of guaifenesin in a solution containing 54% to 66% by weight of propylene glycol and glycerol, wherein the method increases the cmax by at least 1.5 and/or increases the auc (0-inf) by at least 1.4 |
| Pat. No. 10105324 DS* DP* Immediate release oral guaifenesin solution Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 16, 2018 | Nov 13, 2035 | U-2023: A method of increasing the bioavailability of guaifenesin in a solution containing 54% to 66% by weight of propylene glycol and glycerol, wherein the method increases the cmax by at least 1.5 and/or increases the auc (0-inf) by at least 1.4 |
Analgesics:Opioid Analgesics, Long-acting
ONSOLIS (FILM) (BUCCAL) FENTANYL CITRATE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: ADALVO NDA No.: 022266 Prod. No.: 001 DISC (EQ 0.2MG BASE); 002 DISC (EQ 0.4MG BASE); 003 DISC (EQ 0.6MG BASE); 004 DISC (EQ 0.8MG BASE); 005 DISC (EQ 1.2MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9597288 DP* Transmucosal delivery devices with enhanced uptake Claim Types: Method of administration; Formulation; Method of use Pat. Sub. Date(s): All strengths: Apr 3, 2017 | Jul 23, 2027 | U-767: Management of breakthrough pain in patients with cancer |
Analgesics:Opioid Analgesics, Long-acting
OPANA (TABLET) (ORAL) OXYMORPHONE HYDROCHLORIDE [Has competitive generic]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: ENDO PHARMS NDA No.: 021611 Prod. No.: 001 DISC (5MG); 002 DISC (10MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: M - Miscellaneous | Oct 25, 2022 | M-14: Additional clinical trial information added to pediatric use subsection |
Analgesics:Opioid Analgesics, Long-acting
OPANA ER (TABLET, EXTENDED RELEASE) (ORAL) OXYMORPHONE HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: ENDO PHARMS NDA No.: 021610 Prod. No.: 001 DISC (5MG**); 002 DISC (10MG**); 003 DISC (20MG**); 004 DISC (40MG**); 005 DISC (7.5MG**); 006 DISC (15MG**); 007 DISC (30MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7276250 DP* Sustained release formulations of oxymorphone Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Feb 4, 2023 | U-826: Relief of moderate to severe pain |
| Pat. No. 8309112 DP* Coatings for implantable medical devices comprising hydrophilic substances and methods for fabricating the same Claim Types: Formulation Pat. Sub. Date(s): All strengths: Mar 18, 2021 | Feb 4, 2023 | |
| Pat. No. 8329216 DP* Oxymorphone controlled release formulations Claim Types: Formulation; Method of use; Product-by-process Pat. Sub. Date(s): All strengths: Mar 18, 2021 | Feb 4, 2023 | |
| Pat. No. 8808737 Method of treating pain utilizing controlled release oxymorphone pharmaceutical compositions and instruction on dosing for renal impairment Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 18, 2021 | Jun 21, 2027 | U-3085: Dose modification for renal impairment |
| Pat. No. 8871779 DS* Process for preparing morphinan-6-one products with low levels of .alpha.,.beta.-unsaturated ketone compounds Claim Types: Formulation Pat. Sub. Date(s): All strengths: Mar 18, 2021 | Nov 22, 2029 |
Analgesics:Opioid Analgesics, Long-acting
OPANA ER (TABLET, EXTENDED RELEASE) (ORAL) OXYMORPHONE HYDROCHLORIDE [Has competitive generic]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: ENDO PHARMS NDA No.: 201655 Prod. No.: 001 DISC (5MG); 002 DISC (7.5MG); 003 DISC (10MG); 004 DISC (15MG); 005 DISC (20MG); 006 DISC (30MG); 007 DISC (40MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7851482 DS* Method for making analgesics Claim Types: Composition; Method of use; Process Pat. Sub. Date(s): 001: Mar 22, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None | Jul 10, 2029 | |
| Pat. No. 8075872 DP* Abuse-proofed dosage form Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Dec 13, 2011; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None | Nov 20, 2023 | |
| Pat. No. 8114383 DP* Abuse-proofed dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 21, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None | Aug 8, 2024 | |
| Pat. No. 8192722 DP* Abuse-proof dosage form Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Jun 5, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None | Sep 15, 2025 | |
| Pat. No. 8309060 DP* Abuse-proofed dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 13, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None | Nov 20, 2023 | |
| Pat. No. 8309122 DP* Oxymorphone controlled release formulations Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 13, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None | Feb 4, 2023 | |
| Pat. No. 8329216 DP* Oxymorphone controlled release formulations Claim Types: Formulation; Method of use; Product-by-process Pat. Sub. Date(s): 001: Dec 11, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None | Feb 4, 2023 | |
| Pat. No. 8808737 Method of treating pain utilizing controlled release oxymorphone pharmaceutical compositions and instruction on dosing for renal impairment Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 7, 2014 | Jun 21, 2027 | U-1598: Method of administration of controlled release oxymorphone |
| Pat. No. 8871779 DS* Process for preparing morphinan-6-one products with low levels of .alpha.,.beta.-unsaturated ketone compounds Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 7, 2014 | Nov 22, 2029 |
Analgesics:Opioid Analgesics, Long-acting
OXAYDO (TABLET) (ORAL) OXYCODONE HYDROCHLORIDE [Has competitive generic]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: ZYLA NDA No.: 202080 Prod. No.: 001 RX (5MG); 002 RX (7.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7201920 DP* Methods and compositions for deterring abuse of opioid containing dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 14, 2011 | Mar 16, 2025 | |
| Pat. No. 7510726 DP* Methods and compositions for deterring abuse of opioid containing dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 14, 2011 | Nov 26, 2023 | |
| Pat. No. 7981439 DP* Methods and compositions for deterring abuse of drugs susceptible to abuse and dosage forms thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 9, 2011; 002: None | Nov 26, 2023 | |
| Pat. No. 8409616 DP* Extended release opioid abuse deterrent compositions and methods of making same Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Nov 26, 2023 | |
| Pat. No. 8637540 DP* Compositions for deterring abuse of opioid containing dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 20, 2014 | Nov 26, 2023 | |
| Pat. No. 9492443 DP* Abuse deterrent compositions and methods of making same Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 18, 2016 | May 26, 2024 |
Analgesics:Opioid Analgesics, Long-acting
OXYCONTIN (TABLET, EXTENDED RELEASE) (ORAL) OXYCODONE HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: PURDUE PHARMA LP NDA No.: 022272 Prod. No.: 001 RX (10MG); 002 RX (15MG); 003 RX (20MG); 004 RX (30MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8309060 DP* Abuse-proofed dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Nov 14, 2012 | Nov 20, 2023 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 8808741 Tamper resistant dosage forms Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 19, 2014 | Aug 24, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 8894987 DP* Tamper resistant dosage forms Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: Nov 25, 2014 | Mar 29, 2030 | |
| Pat. No. 8894988 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 25, 2014 | Aug 24, 2027 | |
| Pat. No. 9073933 DS* Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Aug 3, 2015 | Mar 30, 2025 | |
| Pat. No. 9492389 DP* Tamper resistant dosage forms Claim Types: Product-by-process Pat. Sub. Date(s): All strengths: Nov 16, 2016 | Aug 24, 2027 | |
| Pat. No. 9492391 Tamper resistant dosage forms Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 16, 2016 | Aug 24, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9492392 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 16, 2016 | Aug 24, 2027 | |
| Pat. No. 9492393 Tamper resistant dosage forms Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 16, 2016 | Aug 24, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9522919 DS* DP* Oxycodone compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 20, 2016 | Mar 30, 2025 | |
| Pat. No. 9675610 DP* Abuse-proofed dosage form Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 12, 2017 | Jun 16, 2023 | |
| Pat. No. 9763933 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 19, 2017 | Aug 24, 2027 | |
| Pat. No. 9770416 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 27, 2017 | Aug 24, 2027 | |
| Pat. No. 9775808 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 4, 2017 | Aug 24, 2027 | |
| Pat. No. 10130591 DP* Abuse-proofed dosage form Claim Types: Method of use; Product-by-process Pat. Sub. Date(s): All strengths: Nov 27, 2018 | Nov 20, 2023 | U-1819: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate |
| Pat. No. 10369109 DP* Abuse-proofed dosage form Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 9, 2019 | Jun 16, 2023 | |
| Pat. No. 10407434 DS* Process for preparing oxycodone compositions Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: Sep 10, 2019 | Mar 30, 2025 | |
| Pat. No. 10675278 DP* Crush resistant delayed-release dosage forms Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Jun 10, 2020 | Nov 20, 2023 | |
| Pat. No. 10696684 DS* Process for preparing oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone Claim Types: Product-by-process; Composition Pat. Sub. Date(s): All strengths: Jun 30, 2020 | Mar 30, 2025 | |
| Pat. No. 11304908 DP* Tamper resistant dosage forms Claim Types: Product-by-process Pat. Sub. Date(s): All strengths: Apr 21, 2022 | Aug 24, 2027 | |
| Pat. No. 11304909 Tamper resistant dosage forms Claim Types: Method of use of a product-by-process Pat. Sub. Date(s): All strengths: Apr 21, 2022 | Aug 24, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
Analgesics:Opioid Analgesics, Long-acting
OXYCONTIN (TABLET, EXTENDED RELEASE) (ORAL) OXYCODONE HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: PURDUE PHARMA LP NDA No.: 022272 Prod. No.: 005 RX (40MG); 006 RX (60MG); 007 RX (80MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8309060 DP* Abuse-proofed dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Nov 14, 2012 | Nov 20, 2023 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 8808741 Tamper resistant dosage forms Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 19, 2014 | Aug 24, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 8894988 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 25, 2014 | Aug 24, 2027 | |
| Pat. No. 9073933 DS* Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Aug 3, 2015 | Mar 30, 2025 | |
| Pat. No. 9492389 DP* Tamper resistant dosage forms Claim Types: Product-by-process Pat. Sub. Date(s): All strengths: Nov 16, 2016 | Aug 24, 2027 | |
| Pat. No. 9492391 Tamper resistant dosage forms Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 16, 2016 | Aug 24, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9492392 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 16, 2016 | Aug 24, 2027 | |
| Pat. No. 9492393 Tamper resistant dosage forms Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 16, 2016 | Aug 24, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9522919 DS* DP* Oxycodone compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 20, 2016 | Mar 30, 2025 | |
| Pat. No. 9675610 DP* Abuse-proofed dosage form Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 12, 2017 | Jun 16, 2023 | |
| Pat. No. 9763933 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 19, 2017 | Aug 24, 2027 | |
| Pat. No. 9770416 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 27, 2017 | Aug 24, 2027 | |
| Pat. No. 9775808 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 4, 2017 | Aug 24, 2027 | |
| Pat. No. 10130591 DP* Abuse-proofed dosage form Claim Types: Method of use; Product-by-process Pat. Sub. Date(s): All strengths: Nov 27, 2018 | Nov 20, 2023 | U-1819: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate |
| Pat. No. 10369109 DP* Abuse-proofed dosage form Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 9, 2019 | Jun 16, 2023 | |
| Pat. No. 10407434 DS* Process for preparing oxycodone compositions Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: Sep 10, 2019 | Mar 30, 2025 | |
| Pat. No. 10675278 DP* Crush resistant delayed-release dosage forms Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Jun 10, 2020 | Nov 20, 2023 | |
| Pat. No. 10696684 DS* Process for preparing oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone Claim Types: Product-by-process; Composition Pat. Sub. Date(s): All strengths: Jun 30, 2020 | Mar 30, 2025 | |
| Pat. No. 11304908 DP* Tamper resistant dosage forms Claim Types: Product-by-process Pat. Sub. Date(s): All strengths: Apr 21, 2022 | Aug 24, 2027 | |
| Pat. No. 11304909 Tamper resistant dosage forms Claim Types: Method of use of a product-by-process Pat. Sub. Date(s): All strengths: Apr 21, 2022 | Aug 24, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
Analgesics:Opioid Analgesics, Long-acting
PROBUPHINE (IMPLANT) (IMPLANTATION) BUPRENORPHINE HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Dependence == partial opioid agonist
NDA Applicant: TITAN PHARMS NDA No.: 204442 Prod. No.: 001 DISC (EQ 80MG BASE/IMPLANT)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7736665 Implantable polymeric device for sustained release of buprenorphine Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2016 | Apr 25, 2024 | U-1878: For opioid dependence |
Analgesics:Opioid Analgesics, Long-acting
QDOLO (SOLUTION) (ORAL) TRAMADOL HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: ATHENA NDA No.: 214044 Prod. No.: 001 RX (5MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11103452 DP* Tramadol hydrochloride solution Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 2, 2021 | Sep 1, 2040 | U-3197: Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate |
Analgesics:Opioid Analgesics, Long-acting
ROXYBOND (TABLET) (ORAL) OXYCODONE HYDROCHLORIDE [Has competitive generic]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: PROTEGA PHARMS NDA No.: 209777 Prod. No.: 001 RX (5MG); 002 RX (15MG); 003 RX (30MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7955619 DP* Abuse resistant drugs, method of use and method of making Claim Types: Formulation; Product-by-process Pat. Sub. Date(s): All strengths: May 19, 2017 | Aug 12, 2028 | |
| Pat. No. 10314788 DP* Pharmaceutical compositions configured to deter dosage form splitting Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 10, 2019 | Aug 12, 2028 |
Analgesics:Opioid Analgesics, Long-acting
RYZOLT (TABLET, EXTENDED RELEASE) (ORAL) TRAMADOL HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: PURDUE PHARMA NDA No.: 021745 Prod. No.: 001 DISC (100MG**); 002 DISC (200MG**); 003 DISC (300MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7988998 DP* Sustained-release tramadol formulations with 24-hour efficacy Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 1, 2011; 002: None; 003: None | Oct 27, 2023 |
Analgesics:Opioid Analgesics, Long-acting
SEGLENTIS (TABLET) (ORAL) CELECOXIB; TRAMADOL HYDROCHLORIDE
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: KOWA PHARMS NDA No.: 213426 Prod. No.: 001 RX (56MG;44MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8598152 DS* DP* Co-crystals of tramadol and coxibs Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Nov 12, 2021 | Apr 19, 2030 | |
| Pat. No. 8846744 DP* Pharmaceutical compositions of co-crystals of tramadol and coxibs Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Nov 12, 2021 | Jun 3, 2031 | |
| Pat. No. 9012440 DS* DP* Co-crystals of tramadol and coxibs Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Nov 12, 2021 | Apr 19, 2030 | |
| Pat. No. 10238668 DS* DP* Co-crystals of tramadol and coxibis Claim Types: New polymorph, salt or hydrate; Method of use Pat. Sub. Date(s): 001: Nov 12, 2021 | Apr 19, 2030 | U-3244: A method for treatment of pain in adults using tramadol hydrochloride and celecoxib |
| Pat. No. 10245276 DS* DP* Co-crystals of tramadol and coxibs Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Nov 12, 2021 | Apr 19, 2030 | |
| Pat. No. 10548909 Co-crystals of tramadol and coxibs Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 12, 2021 | Apr 19, 2030 | U-3244: A method for treatment of pain in adults using tramadol hydrochloride and celecoxib |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Oct 15, 2024 |
Analgesics:Opioid Analgesics, Long-acting
SUBLOCADE (SOLUTION, EXTENDED RELEASE) (SUBCUTANEOUS) BUPRENORPHINE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Dependence == partial opioid agonist
NDA Applicant: INDIVIOR INC NDA No.: 209819 Prod. No.: 001 RX (100MG/0.5ML (100MG/0.5ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8921387 DP* Injectable flowable composition comprising buprenorphine Claim Types: Method of use; Formulation Pat. Sub. Date(s): 001: Dec 13, 2017 | Jan 6, 2032 | U-2173: Treating opioid dependence by administering buprenorphine U-2174: Treating opioid dependency by administering buprenorphine once per month |
| Pat. No. 8975270 DP* Injectable flowable composition comprising buprenorphine Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Dec 13, 2017 | Sep 5, 2031 | U-2175: Treating opioid dependency by administering buprenorphine once monthly U-2206: Treating opioid dependency by administering buprenorphine |
| Pat. No. 9272044 Injectable flowable composition buprenorphine Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 13, 2017 | Jun 6, 2031 | U-2176: Treating opioid addiction by administering buprenorphine U-2177: Treating opioid addiction by subcutaneous injection of buprenorphine U-2178: Treating opioid addiction by administering buprenorphine composition with 28 day dose duration U-2209: Treating opioid addiction by administering buprenorphine once per month |
| Pat. No. 9498432 DP* Injectable flowable composition comprising buprenorphine Claim Types: Formulation; Process; Kit; Drug in a container Pat. Sub. Date(s): 001: Dec 13, 2017 | Jun 6, 2031 | U-2179: In situ formation of solid buprenorphine composition |
| Pat. No. 9782402 DP* Injectable composition comprising buprenorphine Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Dec 13, 2017 | Jun 6, 2031 | U-2176: Treating opioid addiction by administering buprenorphine U-2180: Treating addiction with 100 mg or 300 mg dose of buprenorphine U-2207: Treating addiction by subcutaneous injection of buprenorphine U-2208: Treating addiction by once per month administration of buprenorphine |
| Pat. No. 9827241 DP* Injectable flowable composition comprising buprenorphine Claim Types: Formulation; Method of use; Method of administration Pat. Sub. Date(s): 001: Dec 13, 2017 | Jun 6, 2031 | U-2174: Treating opioid dependency by administering buprenorphine once per month U-2181: Treating opioid dependency by subcutaneously administering buprenorphine U-2206: Treating opioid dependency by administering buprenorphine U-2210: Treating opioid addiction by 100 mg or 300 mg dose buprenorphine U-2211: Treating opioid addiction by administration of buprenorphine |
| Pat. No. 10198218 Injectable flowable composition comprising buprenorphine Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 15, 2019 | Jun 6, 2031 | U-2489: Treatment of moderate to severe opioid use disorder |
| Pat. No. 10558394 DP* Injectable flowable composition comprising buprenorphine Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): 001: Feb 18, 2020 | Jun 25, 2031 | |
| Pat. No. 10592168 Injectable flowable composition comprising buprenorphine Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 19, 2020 | Jun 6, 2031 | U-2489: Treatment of moderate to severe opioid use disorder |
| Pat. No. 11000520 Buprenorphine dosing regimens Claim Types: Method of use Pat. Sub. Date(s): 001: May 20, 2021 | Nov 6, 2035 | U-3111: Treating opioid use disorder |
Analgesics:Opioid Analgesics, Long-acting
SUBLOCADE (SOLUTION, EXTENDED RELEASE) (SUBCUTANEOUS) BUPRENORPHINE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Dependence == partial opioid agonist
NDA Applicant: INDIVIOR INC NDA No.: 209819 Prod. No.: 002 RX (300MG/1.5ML (200MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8921387 DP* Injectable flowable composition comprising buprenorphine Claim Types: Method of use; Formulation Pat. Sub. Date(s): 002: Dec 13, 2017 | Jan 6, 2032 | U-2173: Treating opioid dependence by administering buprenorphine U-2174: Treating opioid dependency by administering buprenorphine once per month |
| Pat. No. 8975270 DP* Injectable flowable composition comprising buprenorphine Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Dec 13, 2017 | Sep 5, 2031 | U-2175: Treating opioid dependency by administering buprenorphine once monthly U-2206: Treating opioid dependency by administering buprenorphine |
| Pat. No. 9272044 Injectable flowable composition buprenorphine Claim Types: Method of use Pat. Sub. Date(s): 002: Dec 13, 2017 | Jun 6, 2031 | U-2176: Treating opioid addiction by administering buprenorphine U-2177: Treating opioid addiction by subcutaneous injection of buprenorphine U-2178: Treating opioid addiction by administering buprenorphine composition with 28 day dose duration U-2209: Treating opioid addiction by administering buprenorphine once per month |
| Pat. No. 9498432 DP* Injectable flowable composition comprising buprenorphine Claim Types: Formulation; Process; Kit; Drug in a container Pat. Sub. Date(s): 002: Dec 13, 2017 | Jun 6, 2031 | U-2179: In situ formation of solid buprenorphine composition |
| Pat. No. 9782402 DP* Injectable composition comprising buprenorphine Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Dec 13, 2017 | Jun 6, 2031 | U-2176: Treating opioid addiction by administering buprenorphine U-2180: Treating addiction with 100 mg or 300 mg dose of buprenorphine U-2207: Treating addiction by subcutaneous injection of buprenorphine U-2208: Treating addiction by once per month administration of buprenorphine |
| Pat. No. 9827241 DP* Injectable flowable composition comprising buprenorphine Claim Types: Formulation; Method of use; Method of administration Pat. Sub. Date(s): 002: Dec 13, 2017 | Jun 6, 2031 | U-2174: Treating opioid dependency by administering buprenorphine once per month U-2181: Treating opioid dependency by subcutaneously administering buprenorphine U-2206: Treating opioid dependency by administering buprenorphine U-2210: Treating opioid addiction by 100 mg or 300 mg dose buprenorphine U-2211: Treating opioid addiction by administration of buprenorphine |
| Pat. No. 10198218 Injectable flowable composition comprising buprenorphine Claim Types: Method of use Pat. Sub. Date(s): 002: Feb 15, 2019 | Jun 6, 2031 | U-2489: Treatment of moderate to severe opioid use disorder |
| Pat. No. 10558394 DP* Injectable flowable composition comprising buprenorphine Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): 002: Jul 16, 2020 | Jun 25, 2031 | |
| Pat. No. 10592168 Injectable flowable composition comprising buprenorphine Claim Types: Method of use Pat. Sub. Date(s): 002: Mar 19, 2020 | Jun 6, 2031 | U-2489: Treatment of moderate to severe opioid use disorder |
| Pat. No. 10646484 Methods to treat opioid use disorder Claim Types: Method of use Pat. Sub. Date(s): 002: May 12, 2020 | Jun 22, 2038 | U-2489: Treatment of moderate to severe opioid use disorder |
| Pat. No. 11000520 Buprenorphine dosing regimens Claim Types: Method of use Pat. Sub. Date(s): 002: May 20, 2021 | Nov 6, 2035 | U-3111: Treating opioid use disorder |
Analgesics:Opioid Analgesics, Long-acting
SUBOXONE (FILM) (BUCCAL, SUBLINGUAL) BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE [GENERIC AB]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Dependence == partial opioid agonist == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Reversal Agents == opioid antagonist
NDA Applicant: INDIVIOR INC NDA No.: 022410 Prod. No.: 001 RX (EQ 2MG BASE;EQ 0.5MG BASE); 002 RX (EQ 8MG BASE;EQ 2MG BASE); 003 RX (EQ 4MG BASE;EQ 1MG BASE); 004 RX (EQ 12MG BASE;EQ 3MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8017150 DP* Polyethylene oxide-based films and drug delivery systems made therefrom Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 4, 2011; 002: None; 003: None; 004: None | Feb 13, 2023 | |
| Pat. No. 8475832 DP* Sublingual and buccal film compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jul 3, 2013; 002: None; 003: None; 004: None | Mar 26, 2030 | U-1411: This drug is administered by sublingual route to humans for maintenance treatment of opioid dependence |
| Pat. No. 8603514 DP* Uniform films for rapid dissolve dosage form incorporating taste-masking compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Apr 3, 2024 | U-1464: Treatment of opioid dependence/sublingual or buccal application |
| Pat. No. 9687454 DP* Sublingual and buccal film compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 14, 2017 | Aug 7, 2029 | U-1464: Treatment of opioid dependence/sublingual or buccal application |
| Pat. No. 9855221 DP* Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jan 3, 2018 | Feb 14, 2022 | |
| Pat. No. 9931305 DP* Uniform films for rapid dissolve dosage form incorporating taste-masking compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: Apr 3, 2018 | Feb 14, 2022 | |
| Pat. No. 10285910 DP* Sublingual and buccal film compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 7, 2019 | Oct 11, 2022 | |
| Pat. No. 11135216 DP* Sublingual and buccal film compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Oct 21, 2021 | Aug 7, 2029 | U-3111: Treating opioid use disorder |
Analgesics:Opioid Analgesics, Long-acting
SUBSYS (SPRAY) (SUBLINGUAL) FENTANYL
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: BTCP PHARMA NDA No.: 202788 Prod. No.: 001 DISC (0.1MG); 003 DISC (0.4MG); 004 DISC (0.6MG); 006 DISC (1.2MG); 007 DISC (1.6MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8486972 DP* Sublingual fentanyl spray Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 30, 2013 | Apr 27, 2030 | |
| Pat. No. 8486973 Sublingual fentanyl spray Claim Types: Method of use; Method of administration; Process Pat. Sub. Date(s): All strengths: Jul 30, 2013 | Apr 27, 2030 | U-55: Treatment of pain |
| Pat. No. 8835459 DP* Sublingual fentanyl spray Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 24, 2014 | Jan 25, 2027 | |
| Pat. No. 8835460 DP* Sublingual fentanyl spray and methods of treating pain Claim Types: Formulation; Device; Method of use Pat. Sub. Date(s): 001: Sep 24, 2014; 003: Sep 24, 2014; 004: Sep 24, 2014; 006: Sep 24, 2014; 007: Sep 29, 2014 | Jan 25, 2027 | U-55: Treatment of pain |
| Pat. No. 9241935 DP* Sublingual fentanyl spray Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 18, 2016 | Jan 25, 2027 | |
| Pat. No. 9289387 DP* Method of treating pain by administering sublingual fentanyl spray Claim Types: Method of administration Pat. Sub. Date(s): All strengths: May 15, 2017 | Jan 25, 2027 | U-55: Treatment of pain |
| Pat. No. 9642797 DP* Sublingual fentanyl spray and methods of use to treat pain Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: May 15, 2017 | Jan 25, 2027 | U-55: Treatment of pain |
| Pat. No. 9642844 DP* Sublingual fentanyl spray Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 15, 2017 | Jan 25, 2027 | |
| Pat. No. 10016403 DP* Sublingual fentanyl spray Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 10, 2018 | Jan 25, 2027 | |
| Pat. No. 10610523 DP* Sublingual fentanyl spray Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 22, 2020; 003: Apr 22, 2020; 004: Apr 22, 2020; 006: May 6, 2020; 007: May 6, 2020 | Jan 25, 2027 |
Analgesics:Opioid Analgesics, Long-acting
SUBSYS (SPRAY) (SUBLINGUAL) FENTANYL
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: BTCP PHARMA NDA No.: 202788 Prod. No.: 002 DISC (0.2MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8486972 DP* Sublingual fentanyl spray Claim Types: Formulation Pat. Sub. Date(s): 002: Jul 30, 2013 | Apr 27, 2030 | |
| Pat. No. 8486973 Sublingual fentanyl spray Claim Types: Method of use; Method of administration; Process Pat. Sub. Date(s): 002: Jul 30, 2013 | Apr 27, 2030 | U-55: Treatment of pain |
| Pat. No. 8835460 DP* Sublingual fentanyl spray and methods of treating pain Claim Types: Formulation; Device; Method of use Pat. Sub. Date(s): 002: Sep 29, 2014 | Jan 25, 2027 | U-55: Treatment of pain |
| Pat. No. 9241935 DP* Sublingual fentanyl spray Claim Types: Formulation Pat. Sub. Date(s): 002: Feb 18, 2016 | Jan 25, 2027 | |
| Pat. No. 9289387 DP* Method of treating pain by administering sublingual fentanyl spray Claim Types: Method of administration Pat. Sub. Date(s): 002: May 15, 2017 | Jan 25, 2027 | U-55: Treatment of pain |
| Pat. No. 9642797 DP* Sublingual fentanyl spray and methods of use to treat pain Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: May 15, 2017 | Jan 25, 2027 | U-55: Treatment of pain |
| Pat. No. 9642844 DP* Sublingual fentanyl spray Claim Types: Formulation Pat. Sub. Date(s): 002: May 15, 2017 | Jan 25, 2027 | |
| Pat. No. 10016403 DP* Sublingual fentanyl spray Claim Types: Formulation Pat. Sub. Date(s): 002: Aug 10, 2018 | Jan 25, 2027 | |
| Pat. No. 10610523 DP* Sublingual fentanyl spray Claim Types: Formulation Pat. Sub. Date(s): 002: Apr 22, 2020 | Jan 25, 2027 |
Analgesics:Opioid Analgesics, Long-acting
SUBSYS (SPRAY) (SUBLINGUAL) FENTANYL
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: BTCP PHARMA NDA No.: 202788 Prod. No.: 005 DISC (0.8MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8486972 DP* Sublingual fentanyl spray Claim Types: Formulation Pat. Sub. Date(s): 005: Jul 30, 2013 | Apr 27, 2030 | |
| Pat. No. 8486973 Sublingual fentanyl spray Claim Types: Method of use; Method of administration; Process Pat. Sub. Date(s): 005: Jul 30, 2013 | Apr 27, 2030 | U-55: Treatment of pain |
| Pat. No. 8835460 DP* Sublingual fentanyl spray and methods of treating pain Claim Types: Formulation; Device; Method of use Pat. Sub. Date(s): 005: Sep 24, 2014 | Jan 25, 2027 | U-55: Treatment of pain |
| Pat. No. 9241935 DP* Sublingual fentanyl spray Claim Types: Formulation Pat. Sub. Date(s): 005: Feb 18, 2016 | Jan 25, 2027 | |
| Pat. No. 9289387 DP* Method of treating pain by administering sublingual fentanyl spray Claim Types: Method of administration Pat. Sub. Date(s): 005: May 15, 2017 | Jan 25, 2027 | U-55: Treatment of pain |
| Pat. No. 9642797 DP* Sublingual fentanyl spray and methods of use to treat pain Claim Types: Formulation; Method of use Pat. Sub. Date(s): 005: May 15, 2017 | Jan 25, 2027 | U-55: Treatment of pain |
| Pat. No. 9642844 DP* Sublingual fentanyl spray Claim Types: Formulation Pat. Sub. Date(s): 005: May 15, 2017 | Jan 25, 2027 | |
| Pat. No. 10016403 DP* Sublingual fentanyl spray Claim Types: Formulation Pat. Sub. Date(s): 005: Aug 10, 2018 | Jan 25, 2027 | |
| Pat. No. 10610523 DP* Sublingual fentanyl spray Claim Types: Formulation Pat. Sub. Date(s): 005: Apr 22, 2020 | Jan 25, 2027 |
Analgesics:Opioid Analgesics, Long-acting
TARGINIQ (TABLET, EXTENDED RELEASE) (ORAL) NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Reversal Agents == opioid antagonist == Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: PURDUE PHARMA LP NDA No.: 205777 Prod. No.: 001 DISC (5MG;10MG); 002 DISC (10MG;20MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8846090 DP* Matrix for sustained, invariant and independent release of active compounds Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 30, 2014 | Apr 4, 2023 | |
| Pat. No. 8846091 DP* Matrix for sustained, invariant and independent release of active compounds Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 30, 2014 | Apr 4, 2023 | |
| Pat. No. 8969369 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Mar 3, 2015 | May 10, 2022 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9056051 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 30, 2015 | May 10, 2022 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9073933 DS* Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Aug 3, 2015 | Mar 30, 2025 | |
| Pat. No. 9084729 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 22, 2015 | May 10, 2022 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9161937 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Oct 27, 2015 | May 10, 2022 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9168252 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Oct 27, 2015 | May 10, 2022 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9283216 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Mar 15, 2016 | May 10, 2022 | U-1819: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate |
| Pat. No. 9283221 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Mar 15, 2016 | May 10, 2022 | U-1819: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate |
| Pat. No. 9345701 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: May 24, 2016 | May 10, 2022 | U-1819: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate |
| Pat. No. 9511066 Abuse-resistant controlled-release opioid dosage form Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 6, 2016 | May 10, 2022 | U-1921: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate by providing an abuse-deterrent oral controlled release combination drug product |
| Pat. No. 9522919 DS* DP* Oxycodone compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 20, 2016 | Mar 30, 2025 | |
| Pat. No. 9555000 DP* Pharmaceutical preparation containing oxycodone and naloxone Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Feb 1, 2017 | Apr 4, 2023 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9907793 DP* Pharmaceutical preparation containing oxycodone and naloxone Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Mar 6, 2018 | Apr 4, 2023 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
Analgesics:Opioid Analgesics, Long-acting
TARGINIQ (TABLET, EXTENDED RELEASE) (ORAL) NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Reversal Agents == opioid antagonist == Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: PURDUE PHARMA LP NDA No.: 205777 Prod. No.: 003 DISC (20MG;40MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8846090 DP* Matrix for sustained, invariant and independent release of active compounds Claim Types: Formulation Pat. Sub. Date(s): 003: Sep 30, 2014 | Apr 4, 2023 | |
| Pat. No. 8846091 DP* Matrix for sustained, invariant and independent release of active compounds Claim Types: Formulation Pat. Sub. Date(s): 003: Sep 30, 2014 | Apr 4, 2023 | |
| Pat. No. 8969369 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): 003: Mar 3, 2015 | May 10, 2022 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9056051 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): 003: Jun 30, 2015 | May 10, 2022 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9073933 DS* Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone Claim Types: Formulation; Process Pat. Sub. Date(s): 003: Aug 3, 2015 | Mar 30, 2025 | |
| Pat. No. |