Glenmark Pharmaceuticals has received final approval by the United States Food & Drug Administration (US 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*.