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Glenmark Pharmaceuticals Ltd. (Glenmark), an innovation-driven, global pharmaceuticals company, has received final approval by the United States Food & Drug Administration (FDA) for calcipotriene and betamethasone dipropionate foam, 0.005%|0.064, the generic version of Enstilar 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 IQVIA sales data for the 12-month period ending January 2023, the Enstilar foam, 0.005%|0.064% market achieved annual sales of approximately $93.6 million.
Glenmark’s current portfolio consists of 183 products authorized for distribution in the US marketplace and 45 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.
Glenmark Pharmaceuticals Ltd. is an innovation-driven, global pharmaceutical company with a presence across branded, generics, and OTC segments; with a focus on therapeutic areas of respiratory, dermatology and oncology.
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