ABIRATERONE ACETATE | A208327 | AMNEAL PHARMACEUTICALS OF NEW YORK LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
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 |
|---|---|---|---|---|
Amendment to Suitability Petition from MSN Laboratories Private Limited FDA-2025-P-2547 · 10 docket documents MSN Laboratories Private Limited filed this amendment to Docket ID FDA-2025-P-2547 in response to an FDA information request regarding a suitability petition for Abiraterone Acetate Tablets 1000 mg, submitting proposed product labeling for the drug indicated for treating metastatic castration-resist | Suitability | 2025-08-11 | Granted | MSN Laboratories Private Limited |
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 |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$3.02
per ea
Lowest NADAC/Unit
$0.8305
per ea
Brand NDCs
0
Generic NDCs
5
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 60219175406ABIRATERONE ACETATE 500 MG TAB | $3.02 | EA | Generic | — | 2026-06-17 |
| 69238175406ABIRATERONE ACETATE 500 MG TAB | $3.02 | EA | Generic | — | 2026-06-17 |
| 60687079021ABIRATERONE ACETATE 250 MG TAB | $0.8305 | EA | Generic | — | 2026-06-17 |
| 69238116507ABIRATERONE ACETATE 250 MG TAB | $0.8305 | EA | Generic | — | 2026-06-17 |
| 60219116507ABIRATERONE ACETATE 250 MG TAB | $0.8305 | EA | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.