Glenmark Pharmaceuticals receives ANDA approval for Topiramate Extended-release Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg

Glenmark Pharmaceuticals Limited (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Topiramate Extended-Release Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg, the generic version of Qudexy®1 XR Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg, of Upsher-Smith Laboratories, LLC.

According to IQVIATM sales data for the 12-month period ending December 2020, the Qudexy® XR Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg market2 achieved annual sales of approximately $120.8 million.

Glenmark's current portfolio consists of 169 products authorized for distribution in the U.S. marketplace and 43 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.

1All brand names and trademarks are the property of their respective owners.

2Market includes brand and all available therapeutic equivalents

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( With inputs from ANI )