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 | — |
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 |
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 |
Source: Regulations.gov. FDA citizen petitions matched by application number.