ABIRATERONE ACETATE | N202379 | JANSSEN BIOTECH INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
BTG INTERNATIONAL LIMITED et al v. QILU PHARMACEUTICAL CO., LTD. et al 1 patentANDA 212462abiraterone acetate | D.N.J. | 2018-11-28 | Terminated 2019-05-28 | — |
BTG INTERNATIONAL LIMITED et al v. MSN PHARMACEUTICALS INC. et al 1 patentANDA 210686abiraterone acetate | D.N.J. | 2018-02-20 | Terminated 2019-05-30 | — |
BTG INTERNATIONAL LIMITED et al v. AMNEAL PHARMACEUTICALS LLC,. et al 2 patentsANDA 208274, 208327, 208453, 208371, 208416, 208446, 208168, 208440, 208432, 208339, 208380, 208349abiraterone acetate | D.N.J. | 2015-07-31 | Terminated 2022-02-14 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Pilnova Pharma, Inc FDA-2025-P-1602 Pilnova Pharma Inc. submitted this petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA determination that proposed Abiraterone Acetate Tablets 1000 mg is suitable for ANDA submission based on the reference listed drug ZYTIGA (abiraterone acetate) tabl | Suitability | 2025-06-09 | Open | Pilnova Pharma |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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