Glenmark Pharmaceuticals receives ANDA approval for Topiramate Capsules USP, 15 mg and 25 mg

Glenmark Pharmaceuticals has received final approval by the United States Food & Drug Administration (U.S. FDA) for Topiramate Capsules USP, 15 mg and 25 mg. Glenmark’s Topiramate Capsules USP, 15 mg and 25 mg has been determined by the FDA to be bioequivalent and therapeutically equivalent (1) to Topamax (2) Capsules, 15 mg and 25 mg of Janssen Pharmaceuticals, and will be distributed in the U.S. by Glenmark Pharmaceuticals, USA.

According to IQVIA  sales data for the 12-month period ending May 2024, the Topamax Capsules, 15 mg and 25 mg market (3) achieved annual sales of approximately $21.9 million*. 

Glenmark’s current portfolio consists of 198 products authorised for distribution in the U.S. marketplace and 50 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

References:

1Glenmark’s Topiramate Capsules USP, 15 mg and 25 mg is only approved for the indication(s) listed in Glenmark’s approved label.

2All brand names and trademarks are the property of their respective owners.

3Market includes brand and all available therapeutic equivalents. Note: IQVIA data obtained by Glenmark is only available for all approved RLD indications. Glenmark’s product is only approved for the indications listed in Glenmark’s approved label and is not marketed for all RLD indications.

*IQVIATM National Sales Perspectives: Retail & Non-Retail, May 2024