Product Details
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Mektovi Tablets, 15 mg, of Array BioPharma Inc. (Array).
Indications
Binimetinib is a kinase inhibitor indicated:
- In combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation
- In combination with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation
Market Exclusivity
Alembic was one of the first ANDA applicants for 15 mg and sole first applicant for 45 mg to submit substantially complete ANDA with a paragraph IV certification. With this approval, Alembic is eligible for 180 days of generic drug exclusivity for Binimetinib Tablets, 15 mg and 45 mg.
Market Size
Binimetinib tablets have an estimated market size of US$ 282 million for twelve months ending September 2026 according to IQVIA.
Cumulative Approvals
Alembic has a cumulative total of 248 ANDA approvals from the USFDA, comprising 230 final approvals and 18 tentative approvals.
Company Background
Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company that has been operating since 1907. The company manufactures and markets generic pharmaceutical products worldwide with state-of-the-art research and manufacturing facilities approved by regulatory authorities including the USFDA. Alembic is one of the leaders in branded generics in India with a field force of over 5,800.