Alembic Pharma Gets USFDA Final Approval for Binimetinib Tablets
Alembic Pharmaceuticals received USFDA final approval for Binimetinib Tablets (15 mg and 45 mg). This enables 180 days of generic exclusivity. The estimated market size is $282 million. This is Alembic's 230th final USFDA ANDA approval.
USFDA approval of a drug, especially with exclusivity, has a direct and substantial positive impact on the company's revenue, market position, and overall financial performance.
The USFDA approval for a new drug product is a significant positive development for the company, potentially leading to increased revenue and market share.
Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Binimetinib Tablets, in 15 mg and 45 mg strengths. This approval makes the ANDA therapeutically equivalent to the reference listed drug product, Mektovi Tablets, 15 mg, by Array BioPharma Inc. Binimetinib is a kinase inhibitor used in combination with encorafenib for treating specific types of melanoma and non-small cell lung cancer.
Alembic was among the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Binimetinib Tablets, making it eligible for 180 days of generic drug exclusivity for both strengths. The estimated market size for Binimetinib tablets is US$ 282 million for the twelve months ending September 2026, according to IQVIA.
This approval adds to Alembic's portfolio, bringing their cumulative total of USFDA ANDA approvals to 248, comprising 230 final approvals and 18 tentative approvals.
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Alembic Pharmaceuticals Limited filed this with the NSE as a statutory disclosure, categorised under product launches. It is a primary document, not a recommendation, and the desk marks it high impact, which is the band that most often changes something.
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See the model portfoliosA plain-language summary of a public exchange filing by Alembic Pharmaceuticals Limited. Read the original for the full detail.