Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (FDA) for tacrolimus ointment, 0.1%, the generic version of Protopic ointment, 0.1%, of Leo Pharma AS.

According to IQVIA sales data for the 12 month period ending February 2018, the Protopic ointment, 0.1% market achieved annual sales of approximately $109.0 million.

Glenmark’s current portfolio consists of 132 products authorized for distribution in the US marketplace and 61 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.