Bengaluru, July 18, 2024: Glenmark Pharmaceuticals Ltd. (Glenmark) 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 equivalent1 to Topamax®2 Capsules, 15 mg and 25 mg of Janssen Pharmaceuticals, Inc., and will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA.
According to IQVIATM sales data for the 12-month period ending May 2024, the Topamax® Capsules, 15 mg and 25 mg market3 achieved annual sales of approximately $21.9 million*.
Glenmark’s current portfolio consists of 198 products authorized 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.
