Glenmark Pharmaceuticals’ Generic of Leo Pharma’s Enstilar Approved

The FDA has approved Glenmark Pharmaceuticals’ generic version of Leo Pharma’s Enstilar (calcipotriene and betamethasone dipropionate), for topical treatment of plaque psoriasis.

Calcipotriene is a vitamin D analog and betamethasone dipropionate is a corticosteroid.

Glenmark’s abbreviated new drug application (ANDA) received paragraph IV certification that allows the company to market a generic before the expiration of patents related to the brand-name drug.

Under the terms of the ANDA approval, Glenmark’s product is eligible for 180 days of generic drug exclusivity.