Alembic Pharmaceuticals Secures USFDA Tentative Approval for Binimetinib Tablets, 45 mg

Alembic Pharmaceuticals Secures USFDA Tentative Approval for Binimetinib Tablets, 45 mg​

Alembic Pharmaceuticals Limited has received tentative approval from the U.S. Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) covering Binimetinib Tablets, 45 mg. This development follows a previous tentative approval obtained for Binimetinib Tablets, 15mg.

The approved ANDA is noted to be therapeutically equivalent to the reference listed drug product (RLD), Mektovi Tablets, 15 mg of Array. Kinase inhibitor Binimetinib is indicated in combination with encorafenib for treating patients with unresectable or metastatic melanoma exhibiting a BRAF V600E or V600K mutation. Furthermore, it is indicated in combination with encorafenib for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) who have a BRAF V600E mutation.

Market Status and Potential Exclusivity​

According to FDA's Paragraph IV Certifications List, Alembic holds a unique position as the sole first applicant to file its ANDA for Binimetinib Tablets, 45mg, which includes a Paragraph IV certification under the Hatch-Waxman Act. Upon final approval of this particular ANDA by the USFDA, the company may be eligible for up to 180 days of generic marketing exclusivity in the U.S.

The estimated market size for Binimetinib Tablets is US$ 259 million for a twelve-month period ending March 2026, as per IQVIA.

Alembic Pharmaceuticals Limited has a substantial track record with regulatory bodies globally, boasting a cumulative total of 242 ANDA approvals from the USFDA, comprising 222 final approvals and 20 tentative approvals.

Company Background​

Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company, with its origins dating back to 1907. Headquartered in India, Alembic manufactures and markets generic pharmaceutical products internationally. The company's state-of-the-art facilities are approved by regulatory authorities across many developed nations, including the USFDA.

APLLTD Stock Price Movement​

Shares of Alembic Pharmaceuticals Limited are edging higher to ₹758.05 as of 1:28 PM today, gaining 1.11%. The stock has traded within a tight intraday band, oscillating between a low of ₹744.35 and a high of ₹768.8.