Alembic Pharmaceuticals Limited (Alembic) announced that 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 USFDA approval for Binimetinib Tablets, 15 mg.
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, in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as well as adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation. According to IQVIA data, Binimetinib Tablets have an estimated market size of US$ 259 million for the twelve months ending March 2026.
Based on the FDA’s Paragraph IV Certifications List, Alembic is the sole first applicant to have filed its ANDA for BinimetinibTablets, 45 mg, containing a Paragraph IV certification under the Hatch-Waxman Act. Upon final USFDA approval of this ANDA, Alembic may be eligible for 180 days of generic marketing exclusivity in the U.S. market.
This milestone brings Alembic’s cumulative total to 242 ANDA approvals (222 final approvals and 20 tentative approvals) from the USFDA.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
