OXYMORPHONE HYDROCHLORIDE | N201655 | ENDO PHARMACEUTICALS INC
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2014-00160 | 7851482 | IPR | Amneal Pharmaceuticals, LLC | Terminated-Settled | 2013-11-18 | — |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Endo Pharmaceuticals Inc. et al v. Actavis LLC, et al. 3 patentsANDA 79-046, 20-3930oxymorphone hydrochloride | D. Del. | 2014-11-07 | Terminated 2019-06-21 | — |
Endo Pharmaceuticals Inc. et al v Sun Pharmaceutical Laboratories Ltd. et al 2 patentsANDA 203506, 204527oxymorphone hydrochloride | D. Del. | 2014-11-07 | Terminated 2018-09-04 | — |
Endo Pharmaceuticals Inc. et al v. Teva Pharmaceuticals USA Inc. et al 2 patentsANDA 204324oxymorphone hydrochloride | D. Del. | 2014-11-07 | Terminated 2019-05-20 | — |
Endo Pharmaceuticals Inc. et al v. Actavis Inc. et al 6 patentsANDA 20-3930oxymorphone hydrochloride | S.D.N.Y. | 2013-01-18 | Terminated 2016-06-29 | — |
Endo Pharmaceuticals Inc. et al v. IMPAX Laboratories, Inc. 6 patentsANDA 20-4211oxymorphone hydrochloride | S.D.N.Y. | 2013-01-18 | Terminated 2016-06-29 | — |
Endo Pharmaceuticals Inc. et al v. Par Pharmaceutical Companies, Inc. et al 6 patentsANDA 20-4340oxymorphone hydrochloride | S.D.N.Y. | 2012-12-19 | Terminated 2015-01-15 | — |
Endo Pharmaceuticals Inc. v. Actavis Inc. et al 3 patentsANDA 79-046oxymorphone hydrochloride | S.D.N.Y. | 2012-12-11 | Terminated 2016-06-29 | — |
Endo Pharmaceuticals Inc. et al v. Sandoz Inc. 5 patentsANDA 20-4321oxymorphone hydrochloride | S.D.N.Y. | 2012-11-14 | Terminated 2015-03-23 | — |
Endo Pharmaceuticals Inc. et al v. Impax Laboratories, Inc. et al 5 patentsANDA 20-4334oxymorphone hydrochloride | S.D.N.Y. | 2012-11-14 | Terminated 2016-06-29 | — |
Endo Pharmaceuticals Inc. et al v. Amneal Pharmaceuticals, LLC et al 2 patentsANDA 20-4294oxymorphone hydrochloride | S.D.N.Y. | 2012-11-07 | Terminated 2016-06-29 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Endo Pharmaceuticals Inc. - Citizen Petition FDA-2012-P-0951 · 5 docket documents Endo Pharmaceuticals Inc. filed this citizen petition under Section 505(q) of the Federal Food, Drug, and Cosmetic Act on August 31, 2012, requesting that the FDA require any ANDA referencing Opana ER CRF (oxymorphone HCl extended-release crush-resistant tablets, approved under NDA No. 201655) to co | 505(q) | 2012-09-26 | Denied | — |
Endo Pharmaceuticals Inc. - Citizen Petition FDA-2012-P-0895 · 12 docket documents Endo Pharmaceuticals Inc. filed this citizen petition under sections 505(j) and 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that FDA determine that the discontinued non-crush-resistant version of Opana ER (oxymorphone HCl) extended-release tablets approved under NDA No. 021610 was | 505(q) | 2012-09-11 | Granted | — |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2012-P-0292 · 4 docket documents Lachman Consultant Services, Inc. filed this citizen petition under Section 505(j) of the Federal Food, Drug and Cosmetic Act requesting that the FDA designate Opana ER (oxymorphone hydrochloride) Extended-release Tablets subject to NDA 201655, held by Endo Pharmaceuticals, as a second reference lis | 505(q) | 2012-04-23 | Withdrawn | — |
Atavis, Inc. - Citizen Petition FDA-2011-P-0924 · 5 docket documents Actavis, Inc. filed this citizen petition on December 14, 2011, requesting that the FDA determine that OPANA (oxymorphone hydrochloride) Extended-Release Tablets in strengths of 5 mg through 40 mg, approved under NDA 201655, were not voluntarily withdrawn for safety or efficacy reasons, as required | 505(q) | 2012-01-24 | Open | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.