HYDROCODONE BITARTRATE | N202880 | RECRO GAINESVILLE LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Recro Gainesville LLC v. Actavis Laboratories FL, Inc. 4 patentsANDA 206952hydrocodone bitartrate | D. Del. | 2017-10-30 | Terminated 2018-01-29 | — |
Recro Gainesville LLC v. Alvogen Malta Operations Ltd. 2 patentsANDA 206986hydrocodone bitartrate | D. Del. | 2014-11-03 | Terminated 2016-09-30 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Persion Pharmaceuticals LLC FDA-2019-P-4140 Persion Pharmaceuticals LLC filed this citizen petition under sections 505(j) and 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA require all new and pending ANDAs for generic hydrocodone bitartrate extended-release capsules to include bioequivalence data in hepatically im | 505(q) | 2019-09-05 | Denied | Persion Pharmaceuticals LLC |
Citizen Petition from Pharmacists Planning Services, Inc. FDA-2013-P-1606 Pharmacists Planning Services, Inc., in conjunction with the National Coalition Against Prescription Drug Abuse and other pharmacy organizations, filed a citizen petition under 21 CFR 10.20 and 10.30 requesting that the FDA Commissioner issue federal regulations requiring all hydrocodone schedule II | Other | 2014-01-13 | Partially Denied | Pharmacists Planning Services |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2011-P-0302 Lachman Consultant Services, Inc. filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Hydrocodone Bitartrate and Acetaminophen Effervescent Tablets in strengths of 2.5 mg/325 mg, 5 mg/325 mg, 7.5 mg/325 mg, and 10 mg/325 | Other | 2011-05-25 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 9132096 | Sep 12, 2034 | — | — | Yes | — | — |
| 9265760 | Jul 25, 2033 | — | — | — | — | |
| 9326982 | Jul 25, 2033 | — | — | — | — | |
| 9333201 | Jul 25, 2033 | — | — | — | — | |
| 9339499 | Jul 25, 2033 | — | — | — | — | |
| 9421200 | Jul 25, 2033 | — | — | — | — | |
| 9433619 | Jul 25, 2033 | — | — | — | — | |
| 9452163 | Sep 12, 2034 | — | — | — | — | |
| 9486451 | Sep 12, 2034 | — | — | — | — | |
| 9610286 | Jul 25, 2033 | — | — | — | — | |
| 9713611 | Sep 12, 2034 | — | — | Yes | — | |
| 10028946 | Jul 25, 2033 | — | — | — | — | |
| 10092559 | Sep 12, 2034 | — | — | — | — | |
| 10322120 | Jul 25, 2033 | — | — | Yes | — | — |
| 10456393 | Jul 25, 2033 | — | — | — | — | |
| 10722511 | Jul 25, 2033 | — | — | — | — |