Glenmark receives tentative approval for generic version of Pradaxa Capsules

19 Apr 2017 Evaluate

Glenmark Pharmaceuticals has received tentative ANDA approval for Dabigatran Etexilate Capsules, 75 mg, 110 mg and 150 mg. Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (USFDA) 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 market achieved annual sales of approximately $913 million.

Glenmark’s current portfolio consists of 114 products authorized for distribution in the US marketplace and 65 ANDA’s pending approval with the USFDA. 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.



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