Glenmark Pharmaceuticals Receives FDA Approval for Topiramate Capsules

The United States Food & Drug Administration (U.S. FDA) has granted final approval to Glenmark Pharmaceuticals Ltd. (Glenmark) for Topiramate Capsules USP, 15 mg and 25 mg. The FDA has found that Glenmark's Topiramate Capsules USP, 15 mg and 25 mg are bioequivalent and therapeutically equivalent1 to Janssen Pharmaceuticals, Inc.'s Topamax®2 Capsules, 15 mg and 25 mg. Glenmark Pharmaceuticals Inc., USA will be responsible for distribution of the product in the United States.

For the year ending in May 2024, IQVIATM sales data indicates that the market for Topamax® Capsules, 15 mg and 25 mg, generated sales of about $21.9 million*. The 198 products in Glenmark's current portfolio are approved for sale in the US market, while the FDA has not yet approved 50 ANDAs. To complement and expedite the expansion of its current pipeline and portfolio, Glenmark continues to seek out and investigate external development collaborations in addition to these internal filings.