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 MSN Laboratories Private Limited FDA-2025-P-2547 · 10 docket documents MSN Laboratories Private Limited filed this petition seeking a declaration from the FDA Commissioner that Abiraterone Acetate Tablets USP, 5000 mg, are suitable for submission as an Abbreviated New Drug Application (ANDA). The petitioner bases the request on the FDA's prior approval of an ANDA for A | Suitability | 2025-07-23 | Granted | MSN Laboratories Private Limited |
Suitability Petition from Pilnova Pharma, Inc FDA-2025-P-1602 · 8 docket documents 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 | Granted | Pilnova Pharma, Inc |
Citizen Petition from Anne A. Shirinian-Orlando FDA-2018-P-2749 · 4 docket documents Anne A. Shirinian-Orlando filed this petition under Section 355(e) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA issue strict dosage and administration guidelines for prostate cancer chemotherapy medications including Zytiga (abiraterone acetate), Jevtana (cabazitaxel), and Xta | Other | 2018-07-18 | Open | Anne A. Shirinian-Orlando |
Citizen Petition from Hyman Phelps and McNamara PC FDA-2015-P-2374 · 5 docket documents The law firm Hyman, Phelps & McNamara P.C., on behalf of a client, submitted a citizen petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine Abiraterone Acetate Tablets, 500mg, is suitable for submission in an ANDA, with bioequivalenc | Other | 2015-07-14 | Withdrawn | Hyman Phelps and McNamara PC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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