India and Mahwah, New Jersey, March 23, 2023: Glenmark Pharmaceuticals Ltd. (Glenmark), an innovation-driven, global pharmaceuticals company has received final approval by the United States Food & Drug Administration (U.S. FDA) for Calcipotriene and Betamethasone Dipropionate Foam, 0.005%|0.064%, the generic version of Enstilar®1 Foam, 0.005%|0.064%, of Leo Pharma AS.
With respect to 180-day generic drug exclusivity, the FDA noted that Glenmark was the first ANDA applicant to submit a substantially complete ANDA with a paragraph IV certification for Calcipotriene and Betamethasone Dipropionate Foam, 0.005%|0.064%. Therefore, with this approval, Glenmark is eligible for 180-days of generic drug exclusivity for Calcipotriene and Betamethasone Dipropionate Foam, 0.005%|0.064%.
According to IQVIATM sales data for the 12-month period ending January 2023, the Enstilar® Foam, 0.005%|0.064% market2 achieved annual sales of approximately $93.6 million*.
Glenmark’s current portfolio consists of 183 products authorized for distribution in the U.S. marketplace and 45 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.