Glenmark Pharmaceuticals has launched rufinamide tablets USP, 200 mg and 400 mg, a therapeutic equivalent of Banzel tablets, 200 mg and 400 mg of Eisai.

Glenmark was one of the first ANDA applicants to submit a substantially complete ANDA for rufinamide tablets USP, 200 mg and 400 mg, with a paragraph IV certification and received final approval on May 16, 2016.

Commenting on the launch, Sanjeev Krishan, president, Glenmark North America said, “We are very pleased to be one of the first generic companies in the US to offer lower cost alternative to Banzel tablets, 200 mg and 400 mg. The launch is our commitment to provide quality and affordable healthcare to our markets for patients.”

According to IQVIA sales data for the 12 month period ending April 2021, the Banzel tablets, 200 mg and 400 mg market achieved annual sales of approximately $285.3 million.

Glenmark’s current portfolio consists of 172 products authorised for distribution in the US marketplace and 45 ANDA’s pending approval with the US FDA.