Alembic Pharmaceuticals has received tentative approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) Binimetinib Tablets, 45 mg. The company had previously received tentative approval for Binimetinib Tablets, 15mg. The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product, 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. It is also indicated, in combination with encorafenib, for the treatment of adult patients with metastatic Non Small Cell Lung Cancer (NSCLC) with a BRAF V600E mutation.

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.

Binimetinib Tablets have an estimated market size of USD 259 million for 12 months ending March 2026, according to IQVIA.

Alembic has a cumulative total of 242 ANDA approvals (222 final approvals and 20 tentative approvals) from FDA.