COCAINE HYDROCHLORIDE | N209963 | LXO IRELAND DESIGNATED ACTIVITY CO
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2020-06-08 | Terminated 2021-10-20 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Latham & Watkins, LLP on behalf of Genus Lifesciences, Inc FDA-2019-P-3855 · 25 docket documents Latham & Watkins LLP, on behalf of Genus Lifesciences Inc., filed this citizen petition under sections 505(e) and 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA rescind its acceptance for filing of Lannett Company Inc.'s 505(b)(2) application for a cocaine hydrochloride p | 505(q) | 2019-08-16 | Denied | Genus Lifesciences, Inc |
Citizen Petition from K&L Gates LLP on behalf of Genus Lifesciences, Inc. FDA-2019-P-0538 · 22 docket documents K&L Gates LLP filed this citizen petition on behalf of Genus Lifesciences, Inc. under Section 505(q) of the Federal Food, Drug, and Cosmetic Act, requesting that the FDA refuse to accept any submissions by Lannett Company, Inc. in furtherance of its 505(b)(2) application for cocaine hydrochloride 4% | 505(q) | 2019-02-04 | Open | Genus Lifesciences, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 9867815 | Feb 7, 2037 | — | — | — | — | |
| 10016407 | Feb 7, 2037 | — | — | — | — | |
| 10149843 | Feb 7, 2037 | — | — | — | — | |
| 10231961 | Feb 7, 2037 | — | — | Yes | — | — |
| 10413505 | Feb 7, 2037 | — | — | — | — | |
| 10420760 | Feb 7, 2037 | — | — | — | — | |
| 10857095 | Feb 7, 2037 | — | — | — | — | |
| 10894012 | Feb 7, 2037 | — | — | — | — | |
| 10933060 | Feb 7, 2037 | — | — | — | — | |
| 10973811 | Feb 7, 2037 | — | — | — | — | |
| 10987347 | Feb 7, 2037 | — | — | — | — | |
| 11040032 | Feb 7, 2037 | — | — | Yes | — | — |