Glenmark Generics Ltd today told the Bombay Stock Exchange that the company has received ANDA (abbreviated new drug application) approval from the US Food and Drugs Administration for Ciclopirox Olamine cream, and will commence marketing and distribution of the product in the US market.
This comes after Glenmark Generics Inc, the US unit of Glenmark Generics Ltd, settled all pending litigation with Medicis Pharmaceutical Corp relating to patent actions regarding Fluocinonide. This is the generic version of Medicis' Vanos cream, while Ciclopirox Olamine is the generic version of Medicis' Laprox gel, it said.
Under terms of the settlement, Glenmark would be able to market and distribute its generic version of Vanos cream under license from Medicis as early as December 2013, it said. In addition, Glenmark would have a license to launch a generic version of Laprox gel, supplied by Medicis immediately, it added.
In a separate statement, Glenmark Pharmaceuticals also said it has entered a pact with Medicis to co-develop and sell a speciality pharmaceutical product in North America for treatment of acne vulgaris.
Glenmark will get a one time upfront payment of $5 million from Medicis and is eligible to get additional payments on achieving certain development milestones and royalty upon commercialisation, it said.
Ciclopirox Olamine cream generated $8 million of sales in the 12-month period ended September 2009. It is indicated for the topical treatment of dermatological infections.