Alembic Pharmaceuticals Ltd. has received tentative approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Binimetinib Tablets, 45 mg, further strengthening its oncology portfolio in the United States.

The company had previously secured tentative approval for Binimetinib Tablets, 15 mg. The approved ANDA is therapeutically equivalent to Mektovi (Binimetinib) Tablets, 15 mg, marketed by Array.

Binimetinib is a kinase inhibitor indicated, in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma harboring a BRAF V600E or V600K mutation. It is also approved for use with encorafenib in adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation.

According to the FDA's Paragraph IV Certifications List, Alembic is the sole first applicant to file an ANDA for Binimetinib Tablets, 45 mg, with a Paragraph IV certification under the Hatch-Waxman Act. Subject to final approval, the company may qualify for 180 days of generic marketing exclusivity in the United States.

According to IQVIA data, Binimetinib Tablets recorded an estimated U.S. market size of US$259 million for the 12 months ending March 2026.

With this approval, Alembic's cumulative USFDA tally has reached 242 ANDA approvals, comprising 222 final approvals and 20 tentative approvals.