ENZALUTAMIDE | N203415 | ASTELLAS PHARMA US INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
ASTELLAS PHARMA INC. et al v. ASCENT PHARMACEUTICALS, INC. 3 patentsANDA 220025enzalutamide | D.N.J. | 2025-01-02 | Terminated 2025-06-30 | — |
| D. Del. | 2018-05-17 | Terminated 2019-09-05 | — | |
Astellas Pharma Inc. et al v. Roxane Laboratories, Inc. et al 3 patentsANDA 209534enzalutamide | D. Del. | 2017-05-09 | Terminated 2018-12-07 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Amendment to Suitability Petition from Pharmobedient Consulting, LLC FDA-2025-P-5432 Pharmobedient Consulting, LLC filed an amendment to its October 15, 2025 suitability petition seeking permission to file an ANDA for Enzalutamide Oral Solution, 160 mg/5 mL. The amendment corrects the characterization of the proposed changes to include both a strength change and dosage form change r | Suitability | 2025-10-31 | Open | Pharmobedient Consulting, LLC |
Suitability Petition from Pharmobedient Consulting, LLC FDA-2025-P-5432 Pharmobedient Consulting, LLC filed a suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Enzalutamide Oral Solution, 160 mg/5 mL, suitable for submission as an Abbreviated New Drug Application, with the Reference Listed Drug be | Suitability | 2025-10-16 | Open | Pharmobedient Consulting, LLC |
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 | — | — | — | — | |
| 8183274 | Aug 24, 2026 | — | — | — | — | |
| 8183274 | Aug 24, 2026 | — | — | — | — | |
| 9126941 | May 15, 2026 | — | — | — | — | |
| 9126941 | May 15, 2026 | — | — | — | — | |
| 9126941 | May 15, 2026 | — | — | — | — | |
| 9126941 | May 15, 2026 | — | — | — | — | |
| 12161628 | Feb 23, 2037 | — | — | — | — | |
| 12161628 | Feb 23, 2037 | — | — | — | — | |
| 12161628 | Feb 23, 2037 | — | — | — | — | |
| 12161628 | Feb 23, 2037 | — | — | — | — |
| Code | Date | Status |
|---|---|---|
| I-926 | Nov 17, 2026 | < 1 year |