Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted 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® Capsules, 75 mg, 110 mg and 150 mg of Boehringer Ingelheim Pharmaceuticals, Inc.
According to IMS Health sales data for the 12 month period ending February 2017, the Pradaxa® Capsules, 75 mg, 110 mg and 150 mg market1 achieved annual sales of approximately $913 million*.
Glenmark's current portfolio consists of 114 products authorized for distribution in the U.S. marketplace and 65 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.
All brand names and trademarks are the property of their respective owners.
1Market includes brand and all available therapeutic equivalents
*IMS Health National Sales Perspectives: Retail & Non-Retail, February 2017
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