ENZALUTAMIDE | N213674 | ASTELLAS PHARMA US INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
ASTELLAS PHARMA INC. et al v. DR. REDDY'S LABORATORIES, INC. et al 4 patentsANDA 221187enzalutamide | D.N.J. | 2026-04-17 | Active | — |
| D.N.J. | 2025-09-10 | Terminated 2025-11-21 | — | |
| D.N.J. | 2025-07-25 | Terminated 2026-02-09 | — | |
ASTELLAS PHARMA INC. et al v. HIKMA PHARMACEUTICALS USA INC. 2 patentsANDA 218731enzalutamide | D.N.J. | 2025-01-16 | Terminated 2025-04-07 | — |
ASTELLAS PHARMA INC. v. SUN PHARMACEUTICAL INDUSTRIES, INC. et al 1 patentANDA 217302enzalutamide | D.N.J. | 2022-12-16 | Terminated 2023-10-30 | — |
ASTELLAS PHARMA INC. et al v. ZYDUS PHARMACEUTICALS (USA) INC. et al 1 patentANDA 217322enzalutamide | D.N.J. | 2022-07-08 | Terminated 2023-04-17 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Lachman Consulting Services Inc. FDA-2021-P-1296 Lachman Consulting Services Inc. filed this petition on behalf of a client under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting FDA approval to submit an ANDA for Enzalutamide film-coated tablets in 40 mg, 80 mg, 120 mg, and 160 mg strengths, with the reference product be | Suitability | 2021-12-08 | Granted | Lachman Consulting Services Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 7709517 | Aug 13, 2027 | — | Yes | Yes | — | — |
| 8183274 | Aug 24, 2026 | — | — | — | — | |
| 8183274 | Aug 24, 2026 | — | — | — | — | |
| 8183274 | Aug 24, 2026 | — | — | — | — | |
| 9126941 | May 15, 2026 | — | — | — | — | |
| 9126941 | May 15, 2026 | — | — | — | — | |
| 9126941 | May 15, 2026 | — | — | — | — | |
| 11839689 | Sep 11, 2033 | — | — | Yes | — | — |
| 12161628 | Feb 23, 2037 | — | — | — | — | |
| 12161628 | Feb 23, 2037 | — | — | — | — | |
| 12161628 | Feb 23, 2037 | — | — | — | — | |
| 12161628 | Feb 23, 2037 | — | — | — | — | |
| 12502357 | Sep 11, 2033 | — | — | — | — | |
| 12502357 | Sep 11, 2033 | — | — | — | — | |
| 12502357 | Sep 11, 2033 | — | — | — | — |
| Code | Date | Status |
|---|---|---|
| I-926 | Nov 17, 2026 | < 1 year |