Glenmark Pharmaceuticals Receives ANDA Approval for Lacosamide Tablets USP, 50 mg, 100 mg, 150 mg and 200 mg

Glenmark Pharmaceuticals Inc., USA (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for its Lacosamide Tablets USP, 50 mg, 100 mg, 150 mg and 200 mg, the generic version of Vimpat Tablets, 50 mg, 100 mg, 150 mg and 200 mg of UCB, Inc.

The company said that it plans to launch the product immediately.

Commenting on the development, Robert Crockart, Chief Commercial Officer, Glenmark
Pharmaceuticals Ltd, said, “The FDA approval for generic Lacosamide Tablets USP reiterates our
ongoing commitment to make treatment options more accessible for patients. We look forward to
quickly launching this product in the U.S. market.”

According to IQVIA sales data for the 12 month period ending January 2022, the Vimpat Tablets, 50
mg, 100 mg, 150 mg and 200 mg market achieved annual sales of approximately $1.7 billion.
Glenmark’s current portfolio consists of 174 products authorized for distribution in the U.S.
marketplace and 45 ANDA’s pending approval with the U.S. FDA.