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Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.

BINIMETINIB

ANDA

Tentative Approval

BINIMETINIB | A217678 | ALEMBIC PHARMS LTD

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Array BioPharma, Inc. v. Alembic Pharmaceuticals Limited et al. 1:2022cv01277 10 patentsANDA 217678binimetinib	D. Del.	2022-09-28	Terminated 2025-06-10	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain3 active DMFs

3 active API suppliers hold Drug Master Files for this ingredient.

MSN LABORATORIES PRIVATE LTDBINIMETINIB

DMF 364342021

ALEMBIC PHARMACEUTICALS LTDBINIMETINIB

DMF 366002021

VALARY LAB PRIVATE LTDBINIMETINIB

DMF 408052024

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 31, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 15MG

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TABLET;ORAL | TA Date: 2026-06-18 00:00:00

No patent or exclusivity listings for this strength.