USFDA tentative approval for Alembic's Binimetinib Tablets, 45 mg

Regulatory Product ApprovalBusiness Updates View source PDF

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AI summary

Alembic Pharmaceuticals has received USFDA tentative approval for its generic Binimetinib Tablets 45 mg, used to treat certain metastatic melanoma and lung cancer patients. Alembic is the sole first applicant to file with a Paragraph IV certification, making it potentially eligible for 180 days of US generic marketing exclusivity upon final approval. The drug has an estimated US market size of around USD 259 million (IQVIA, twelve months ending March 2026). This adds to Alembic's earlier tentative approval for the 15 mg strength, taking its cumulative ANDA tally to 242.

Likely market impact

Positive for Alembic's US generics pipeline. Sole first applicant status could unlock 180-day exclusivity on a USD 259 million market after final approval.