Glenmark Pharma bags USFDA nod for Calcipotriene and Betamethasone Dipropionate Foam

Mumbai: Glenmark Pharmaceuticals Ltd., a global pharmaceuticals company has received final approval from the United States Food & Drug Administration (U.S. FDA) for Calcipotriene and Betamethasone Dipropionate Foam, 0.005%|0.064%.

The drug is an analogue and synthetic corticosteroid fixed-dose combination foam formulation, which is used for the topical treatment of plaque psoriasis in adults.

The product is a 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 Abbreviated New Drug Application (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%," the company stated in a release.

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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 U.S. marketplace and 45 ANDA’s pending approval with the U.S. FDA.

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