Glenmark Pharmaceuticals Ltd. (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Apremilast Tablets, 10 mg, 20 mg and 30 mg, the generic version of Otezla®1 Tablets, 10 mg, 20 mg and 30 mg, of Amgen Inc. 

According to IQVIATM sales data for the 12-month period ending August 2023, the Otezla® Tablets, 10 mg, 20 mg, and 30 mg market2 achieved annual sales of approximately USD 3.7 billion*.

Glenmark’s current portfolio consists of 188 products authorized for distribution in the U.S. marketplace and 50 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.