Glenmark Pharmaceuticals Ltd (Glenmark) has received tentative approval by the United States Food & Drug Administration (U.S. FDA) for Dabigatran Etexilate Capsules, 75 mg, 110 mg, and 150 mg, the generic version of Pradaxa 1 Capsules, 75 mg, 110 mg, and 150 mg, of Boehringer Ingelheim Pharmaceuticals, Inc.

According to IQVIATM sales data for the 12 month period ending October 2020, the Pradax Capsules, 75 mg, 110 mg, and 150 mg market2 achieved annual sales of approximately $550.9 million*.

Glenmark’s current portfolio consists of 166 products authorized for distribution in the U.S. marketplace and 45 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.