USFDA tentative approval for Binimetinib 45mg Tablets

Regulatory Product ApprovalBusiness Updates View source PDF

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▲ positive · ▼ negative · ● neutral filings · teal = economic event · numbered = multiple that day (click to pick). Times IST.

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+3.8%1-day move

₹748.90

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₹754.80

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AI summary

Alembic Pharmaceuticals has received USFDA tentative approval for its ANDA for Binimetinib Tablets, 45 mg, used to treat unresectable or metastatic melanoma and NSCLC with BRAF mutations. Alembic is the sole first Paragraph IV filer and may get 180 days of generic marketing exclusivity in the US upon final approval. The drug has an estimated US market size of about 259 million dollars for 12 months ending March 2026 (IQVIA). Alembic now has 242 cumulative ANDA approvals (222 final and 20 tentative).

Likely market impact

Positive. Tentative approval strengthens Alembic's US pipeline and potential exclusivity, but revenue only starts after final approval and patent resolution.