AMIFAMPRIDINE PHOSPHATE | N208078 | CATALYST PHARMACEUTICALS INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2023-11-20 | Terminated 2023-12-08 | — | |
CATALYST PHARMACEUTICALS, INC. et al v. INVENTIA HEALTHCARE LIMITED 6 patentsANDA 218760amifampridine | D.N.J. | 2023-11-17 | Terminated 2024-08-01 | — |
Catalyst Pharmaceuticals, Inc. et al v. Lupin Ltd. et al 6 patentsANDA 217996amifampridine | D. Del. | 2023-03-02 | Terminated 2023-05-05 | — |
CATALYST PHARMACEUTICALS, INC. et al v. TEVA PHARMACEUTICALS, INC. et al 6 patentsANDA 218029amifampridine | D.N.J. | 2023-03-01 | Terminated 2025-01-10 | — |
CATALYST PHARMACEUTICALS, INC. et al v. ANNORA PHARMA PRIVATE LIMITED et al 6 patentsANDA 218007amifampridine | D.N.J. | 2023-03-01 | Active | — |
CATALYST PHARMACEUTICALS, INC. et al v. LUPIN LTD. et al 6 patentsANDA 217996amifampridine | D.N.J. | 2023-03-01 | Terminated 2025-08-28 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Catalyst Pharmaceuticals FDA-2021-P-0705 · 4 docket documents Catalyst Pharmaceuticals submitted this citizen petition on July 8, 2021, pursuant to Section 505 of the Federal Food, Drug and Cosmetic Act, requesting that the FDA require blinded, controlled clinical trials as evidence of efficacy and safety for any New Drug Application or supplement for amifampr | Other | 2021-07-13 | Partially Denied | Catalyst Pharmaceuticals |
Citizen Petition from Catalyst Pharmaceuticals FDA-2021-P-0559 · 3 docket documents Catalyst Pharmaceuticals filed this citizen petition pursuant to Section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA require blinded, controlled randomized clinical trials as evidence of efficacy and safety for any new drug application or supplement for amifampridine inte | 505(q) | 2021-07-07 | Withdrawn | Catalyst Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.