Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application for Binimetinib tablets for treatment of lung cancer. According to the company's regulatory filing, the approved ANDA is therapeutically equivalent to the reference listed drug product, Mektovi Tablets (15 mg), of Array BioPharma Inc. This approval positions Alembic as eligible for 180 days of generic drug exclusivity for Binimetinib Tablets, 15 mg and 45 mg strengths.
The approved 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. Additionally, it is indicated, in combination with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation. According to IQVIA, Binimetinib tablets have an estimated market size of $282 million for the 12 months ending September 2026. Alembic secured its exclusivity position by being one of the first ANDA applicants for the 15 mg strength and the sole first applicant for the 45 mg strength to submit a substantially complete ANDA with a paragraph IV certification.
With this approval, Alembic has a cumulative total of 248 ANDA approvals from the USFDA, comprising 230 final approvals and 18 tentative approvals. This latest addition strengthens the company's position in the oncology therapeutics market, particularly in lung cancer treatments where Binimetinib's combination therapy with encorafenib addresses specific genetic mutations in cancer patients.
