Alembic Pharmaceuticals Limited announced it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Binimetinib Tablets, 45 mg. This follows the company's previous tentative approval for Binimetinib Tablets, 15mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Mektovi Tablets, 15 mg of Array. Binimetinib is a kinase inhibitor indicated for:
- Treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with encorafenib
- Treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, in combination with encorafenib
Based on FDA's Paragraph IV Certifications List, Alembic is the sole first applicant to have filed its ANDA for Binimetinib Tablets, 45mg, containing a Paragraph IV certification under the provisions of the Hatch-Waxman Act. Upon final approval of this ANDA by the USFDA, Alembic may be eligible for 180 days of generic marketing exclusivity in the US.
Market Size and Company Background
Binimetinib Tablets have an estimated market size of US$259 million for twelve months ending March 2026 according to IQVIA data.
Alembic has a cumulative total of 242 ANDA approvals from USFDA, comprising 222 final approvals and 20 tentative approvals.
The disclosure was made to the stock exchanges via letter dated 19th June, 2026, signed by Manisha Saraf, Company Secretary, in compliance with regulatory requirements.