Glenmark Pharmaceuticals Limited and Glenmark Generics Inc., USA (Glenmark) have entered into a settlement and license agreement with Triax Pharmaceuticals, LLC, Astellas Pharma Europe B V and Astellas Pharma International B V (Astellas and Triax) to resolve a United States (US) patent infringement suit related to Glenmark’s filing of an Abbreviated New Drug Application (ANDA) for 0.1 per cent hydrocortisone butyrate cream, Glenmark’s generic version of Locoid Lipocream.
Subject to the terms of the settlement and license agreement, Glenmark will be permitted to market and distribute Glenmark’s 0.1 per cent hydrocortisone butyrate cream under a royalty-bearing license from Astellas and Triax in the US near the end of 2013. Glenmark believes that it is entitled to 180 days of exclusivity with respect to its hydrocortisone butyrate cream, as the first generic company to file an ANDA for the product.
Locoid Lipocream is available as a 0.1per cent hydrocortisone butyrate topical corticosteroid cream. According to IMS Health data, for 2010, Locoid Lipocream achieved sales of approximately USD 38 million.
Glenmark Generics Limited (GGL) is a subsidiary of Glenmark Pharmaceuticals Limited (Glenmark) and aims to be a global integrated Generic and API leader. GGL has an established presence in North America, a developing EU presence and Argentina and maintains marketing front-ends in these countries.