BINIMETINIB | N210498 | ARRAY BIOPHARMA INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Array BioPharma, Inc. v. Alembic Pharmaceuticals Limited et al. 10 patentsANDA 217678binimetinib | D. Del. | 2022-09-28 | Terminated 2025-06-10 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2025-P-0429 Hyman, Phelps & McNamara, P.C. filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that FDA declare Binimetinib Tablets, 45 mg, suitable for submission as an ANDA, with Array Biopharma's MEKTOVI Tablets, 15 mg, approved under NDA 210498, a | Suitability | 2025-02-12 | Open | Hyman |
Source: Regulations.gov. FDA citizen petitions matched by application number.