OXYMORPHONE HYDROCHLORIDE | N021610 | ENDO OPERATIONS LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Endo Pharmaceuticals Inc. v. Sandoz Inc. 3 patentsANDA 90565, 20-4321oxymorphone hydrochloride | S.D.N.Y. | 2013-05-15 | Terminated 2013-10-18 | — |
Endo Pharmaceuticals Inc. v. Roxane Laboratories, Inc. 3 patentsANDA 020822oxymorphone hydrochloride | S.D.N.Y. | 2013-05-15 | 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Tablets subject to NDA 201655, held by Endo Pharmaceuticals, as a second reference lis | 505(q) | 2012-04-23 | Withdrawn | — |
K&L Gates, LLP - Citizen Petition FDA-2011-P-0209 · 5 docket documents K&L Gates LLP filed this citizen petition on behalf of an unnamed petitioner requesting that the FDA Commissioner determine the discontinued 7.5 mg and 15 mg strengths of Opana ER (oxymorphone hydrochloride extended release tablets), the subject of NDA 021610 held by Endo Pharmaceuticals, were not w | 505(q) | 2011-04-12 | Granted | — |
Watson Laboratories, Inc. - Citizen Petition FDA-2011-P-0182 · 4 docket documents Watson Laboratories, Inc. filed this citizen petition under 21 CFR §10.25, §10.30, and §314.161 on March 21, 2011, requesting that the FDA determine whether Endo Pharmaceutical's Opana ER (oxymorphone hydrochloride) Extended-Release Tablets in 7.5 mg and 15 mg strengths (NDA 021610) were discontinue | 505(q) | 2011-03-25 | Granted | — |
Endo Pharmaceuticals, Inc. - Citizen Petition FDA-2010-P-0243 · 3 docket documents Endo Pharmaceuticals Inc. filed this citizen petition on May 13, 2010, under section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA publicly announce its position that new NDAs and ANDAs referencing Opana or Opana ER (oxymorphone hydrochloride tablets and extended-release | 505(q) | 2010-05-18 | Partially Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.