Glenmark Pharmaceuticals receives ANDA approval for Solifenacin Succinate Tablets

Glenmark Pharmaceuticals receives ANDA approval for Solifenacin Succinate Tablets

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Solifenacin Succinate Tablets, 5 mg and 10 mg, a generic version of Vesicare Tablets, 5 mg and 10 mg1 , of Astellas Pharma US, Inc. According to IQVIATM sales data for the 12 month period ending March 2019, the Vesicare Tablets, 5 mg and 10 mg market2 achieved annual sales of approximately $942.7 million.

Glenmark’s current portfolio consists of 154 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.