Glenmark receives ANDA approval for Fingolimod Capsules

Glenmark Pharmaceuticals has been granted final approval by the United States Food & Drug Administration (US FDA) for Fingolimod Capsules, 0.5 mg, the generic version of Gilenya Capsules, 0.5 mg, of Novartis Pharmaceuticals.

According to IQVIATM sales data for the 12 month period ending April 2020, the Gilenya Capsules, 0.5 mg market achieved annual sales of approximately $2.1 billion. Glenmark’s current portfolio consists of 164 products authorized for distribution in the U.S. marketplace and 44 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.