Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Tacrolimus Ointment, 0.1%, the generic version of Protopic Ointment, 0.1%, of Leo Pharma AS.
According to IQVIATM sales data for the 12 month period ending February 2018, the Protopic Ointment, 0.1% market2 achieved annual sales of approximately $109.0 million. Glenmark’s current portfolio consists of 132 products authorized for distribution in the U.S. marketplace and 61 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.