CLOBETASOL PROPIONATE | N209483 | PRIMUS PHARMACEUTICALS INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
ENCORE DERMATOLOGY INC. et al v. GLENMARK PHARMACEUTICALS LIMITED 1 patentANDA 214191clobetasol propionate | D.N.J. | 2020-03-06 | Terminated 2022-04-04 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Encore Dermatology Inc FDA-2020-P-2212 Encore Dermatology, Inc., the holder of the NDA for Impoyz (clobetasol propionate) 0.025% topical cream for moderate to severe plaque psoriasis, filed a citizen petition under section 505(q) requesting that FDA refuse to approve Glenmark Pharmaceuticals Limited's ANDA 214191 for a generic version of | 505(q) | 2020-11-19 | Open | Encore Dermatology Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 9855334 | Mar 11, 2035 | — | — | Yes | — | — |
| 9956231 | Aug 31, 2030 | — | — | Yes | — | |
| 9956231 | Aug 31, 2030 | — | — | Yes | — | |
| 9956231 | Aug 31, 2030 | — | — | Yes | — | |
| 9956231 | Aug 31, 2030 | — | — | Yes | — | |
| 9956231 | Aug 31, 2030 | — | — | Yes | — | |
| 9956231 | Aug 31, 2030 | — | — | Yes | — | |
| 10064875 | Aug 31, 2030 | — | — | Yes | — | |
| 10064875 | Aug 31, 2030 | — | — | Yes | — | |
| 10064875 | Aug 31, 2030 | — | — | Yes | — | |
| 10064875 | Aug 31, 2030 | — | — | Yes | — | |
| 10064875 | Aug 31, 2030 | — | — | Yes | — | |
| 10588914 | Aug 31, 2030 | — | — | Yes | — | |
| 11179465 | Aug 31, 2030 | — | — | Yes | — |