Glenmark gets FDA nod to sell anti-fungal cream in US

By Kumar Shankar Roy Nov 14 2009 , Kolkata

Glenmark Generics, as subsidiary of Mumbai-based Glenmark Pharmaceuticals, on Saturday announced that it will

commence marketing and distribution of Ciclopirox Olamine cream (0.77 per cent) following the US FDA approval for its generic drug application.

The cream, actually a synthetic antifungal agent for topical dermatologic treatment of superficial mycoses, generated sales of approximately $8 million in the 12-months period ending September, according to IMS Health.

Glenmark's version is the generic equivalent of Loprox cream marketed by US-based Medicis Pharma. The latest approval augments the breadth of Glenmark's semi-solid line, increasing their overall dermatological portfolio to 13 products, the company said in a statement.

Glenmark is currently locked in legal battle with Medicis over the gel version of Loprox, as reported by FC on November 10. "The cream is a separate product," clarified a Glenmark spokesperson from Mumbai.

The $500 million Medicis Pharma sued Glenmark Generics on October 30 following a para-IV challenge by the Indian company to sell a generic version of Medicis' Loprox gel. If Glenmark manages to the patent fight, it will get an opportunity to sell Loprox gel in the US market before the relevant patent expires in 2018.