Glenmark Pharmaceuticals Inc., USA (Glenmark), a subsidiary of Glenmark Pharmaceuticals, Mumbai, has received tentative approval from United States Food & Drug Administration (FDA) for calcipotriene cream, 0.005 per cent, the therapeutic equivalent of Dovonex topical cream, 0.005 per cent of Leo Pharma A/S.
Glenmark will market this product upon receiving final approval of its calcipotriene cream, 0.005 per cent ANDA. The patents listed in the Orange Book for Dovonex cream are scheduled to expire on June 9, 2015.
Dovonex is indicated for the treatment of plaque psoriasis. According to IMS Health sales data for the 12 month period ending March 2015, the Dovonex market achieved annual sales of approximately USD 92.8 million.
Glenmark’s current portfolio consists of 97 products authorised for distribution in the US marketplace and 67 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.