Mumbai, Mar 23:  Pharma major, Glenmark Pharma on Thursday said it 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 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% market achieved annual sales of approximately USD93.6 million.