Glenmark Pharmaceuticals Receives ANDA Approval for Ezetimibe and Simvastatin Tablets

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, a generic version of Vytorin®[1] Tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, of MSD International GmbH.

According to IQVIA™ sales data for the 12-month period ending April 2019, the Vytorin® Tablets market[2] achieved annual sales of approximately $92.4 million*. Glenmark's current portfolio consists of 157 products authorized for distribution in the U.S. marketplace and 58 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.

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

[2]Market includes brand and all available therapeutic equivalents

*IQVIA™ National Sales Perspectives: Retail & Non-Retail, April 2019