Glenmark Pharma launches anti-epileptic drug, Rufinamide, in the US

on Tuesday announced the launch of anti-epileptic drug Rufinamide tablets in the US market. Glenmark Pharmaceuticals Ltd has launched Rufinamide tablets USP in the strengths of 200 mg and 400 mg, the company said in a regulatory filing.

The newly launched drug is a therapeutic equivalent of Banzel tablets, 200 mg and 400 mg of Eisai, Inc.

Banzel tablets are used in combination with other medications to treat children with Lennox-Gastaut syndrome, a severe form of childhood epilepsy that also causes developmental and behavior problems.

Sanjeev Krishan, President, Glenmark North America said the company is one of the first generic companies in the US to offer lower-cost alternatives to Banzel tablets, 200 mg and 400 mg.

"The launch is our commitment to provide quality and affordable healthcare to our markets for patients," Krishan said.

Quoting IQVIA sales data for the 12 month period ending April 2021, Glenmark Pharma said the Banzel tablets, 200 mg and 400 mg market achieved annual sales of approximately USD 285.3 million.

Glenmark's current portfolio consists of 172 products authorized for distribution in the US marketplace and 45 ANDA's pending approval with the United States Food and Drug Administration (USFDA).