DOXEPIN HYDROCHLORIDE | N022036 | CURRAX PHARMACEUTICALS LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2019-08-23 | Terminated 2020-07-30 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Somaxon Pharmaceuticals, Inc. - Citizen Petition FDA-2011-P-0767 · 3 docket documents Somaxon Pharmaceuticals, Inc. filed this citizen petition under section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA decline to grant any abbreviated new drug application for generic doxepin products listing SILENOR as the reference listed drug if the application relies | 505(q) | 2011-10-31 | Partially Denied | — |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2010-P-0278 · 4 docket documents Lachman Consultant Services, Inc. filed this citizen petition on behalf of a client requesting that the FDA determine whether Silenor (doxepin hydrochloride) Tablets, 3 mg and 6 mg base (NDA 022036), approved March 17, 2010 and held by Somaxon Pharmaceuticals, Inc., has been voluntarily withheld fro | 505(q) | 2010-06-17 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 7915307 | Aug 24, 2027 | — | — | — | — | |
| 8513299 | Sep 7, 2030 | — | — | — | — | |
| 9107898 | May 1, 2028 | — | — | — | — | |
| 9486437 | May 18, 2027 | — | — | — | — | |
| 9532971 | Jun 1, 2029 | — | — | Yes | — | — |
| 9572814 | Jul 20, 2027 | — | — | — | — | |
| 9861607 | May 18, 2027 | — | — | — | — | |
| 9907780 | Apr 11, 2028 | — | — | Yes | — | — |
| 10238620 | May 18, 2027 | — | — | — | — | |
| 10548871 | Apr 11, 2028 | — | — | — | — | |
| 10653660 | Jul 20, 2027 | — | — | — | — | |
| 10653662 | May 18, 2027 | — | — | — | — | |
| 11096920 | Apr 11, 2028 | — | — | — | — | |
| 11110074 | Jul 20, 2027 | — | — | — | — | |
| 11234954 | Jan 18, 2028 | — | — | — | — | |
| 12083090 | May 18, 2027 | — | — | — | — |