Alembic Pharmaceuticals Limited has announced the receipt of final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Binimetinib Tablets, in both 15 mg and 45 mg strengths. This approval, therapeutically equivalent to Mektovi Tablets, marks a significant step for Alembic in the US market, opening doors to potential generic drug exclusivity. The market for Binimetinib tablets is estimated at US$ 282 million.
USFDA Greenlights Alembic’s Binimetinib Tablets
Alembic Pharmaceuticals Limited announced on November 14, 2026, that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Binimetinib Tablets. This approval covers both 15 mg and 45 mg dosage strengths.
Therapeutic Equivalence and Market Potential
The approved ANDA is therapeutically equivalent to the reference listed drug product, Mektovi Tablets, 15 mg, manufactured by Array BioPharma Inc. Binimetinib is indicated for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, and also for metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, when used in combination with encorafenib.
Generic Drug Exclusivity Secured
Alembic Pharmaceuticals was one of the first ANDA applicants for the 15 mg strength and the sole first applicant for the 45 mg strength to submit a substantially complete ANDA with a paragraph IV certification. Consequently, with this approval, Alembic is eligible for 180 days of generic drug exclusivity for Binimetinib Tablets in both strengths. The estimated market size for Binimetinib tablets was US$ 282 million for the twelve months ending September 2026, according to IQVIA data.
Company Milestones
This approval adds to Alembic’s growing portfolio of USFDA approvals, bringing their cumulative total to 248 ANDA approvals, comprising 230 final and 18 tentative approvals.
A press release detailing this development has been issued. The company has requested that this information be taken on record by the exchanges.
Source: BSE
