Glenmark Pharma receives ANDA tentative approval for Dabigatran Etexilate Capsules

Glenmark Pharmaceuticals Ltd (Glenmark) today announced that it 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.

In a regulatory filing, Glenmark Pharmaceuticals said, "Glenmark Pharmaceuticals receives ANDA tentative approval for Dabigatran Etexilate Capsules, 75 mg, 110 mg, and 150 mg."

According to IQVIATM sales data for the 12 months ending October 2020, the Pradaxa® Capsules, 75 mg, 110 mg, and 150 mg market 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 US 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.

Glenmark Pharmaceuticals Ltd. is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries. Glenmark's key therapy focus areas globally are respiratory, dermatology and oncology. It is ranked among the top 80 Pharma & Biotech companies of the world in terms of revenue (SCRIP 100 Rankings published in the year 2019).