Alembic Pharmaceuticals Limited has announced that it has received tentative approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Binimetinib Tablets, 45 mg. The company had earlier secured tentative approval for the 15 mg strength of the same drug.
The approved generic product is therapeutically equivalent to Mektovi Tablets, 15 mg, marketed by Array BioPharma. Binimetinib is a kinase inhibitor used in combination with encorafenib for the treatment of patients with specific forms of advanced cancer.
The medicine is indicated for patients with unresectable or metastatic melanoma carrying BRAF V600E or V600K mutations. It is also approved for use alongside encorafenib in adults suffering from metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation. These targeted therapies play a critical role in precision oncology by addressing cancers driven by specific genetic alterations.
A key highlight of the approval is Alembic’s position as the sole first applicant for the 45 mg strength of Binimetinib Tablets under a Paragraph IV certification filed pursuant to the Hatch-Waxman Act. This status could provide the company with 180 days of generic marketing exclusivity in the United States once the product receives final approval from the USFDA.
The opportunity is significant, as Binimetinib Tablets recorded an estimated U.S. market size of approximately US$259 million for the twelve months ending March 2026, according to IQVIA data.
With this latest development, Alembic continues to strengthen its presence in the highly competitive U.S. generics market. The company’s cumulative USFDA tally now stands at 242 ANDA approvals, comprising 222 final approvals and 20 tentative approvals.
The tentative approval reinforces Alembic’s growing focus on complex and specialty pharmaceutical products, particularly in the oncology segment, where demand for cost-effective treatment options continues to rise globally.
