Glenmark Pharma enters into a settlement and license agreement hydrocortisone butyrate cream

25 May 2011 Evaluate

Glenmark Pharmaceuticals and Glenmark Generics Inc., USA 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% hydrocortisone butyrate cream, which is Glenmark’s generic version of Locoid Lipocream.

As per the agreement, Glenmark will be permitted to market and distribute Glenmark’s 0.1% hydrocortisone butyrate cream under a royalty-bearing license from Astellas and Triax in the US near the end of 2013. Glenmark is entitled to 180 days of exclusivity with respect to its hydrocortisone butyrate cream, as it the first generic company to file an ANDA for the product.

Locoid Lipocream is available as a 0.1% hydrocortisone butyrate topical corticosteroid cream. According to IMS Health data, for 2010, Locoid Lipocream achieved sales of approximately $38 million.

Glenmark Generics is a subsidiary of Glenmark Pharmaceuticals and aims to be a global integrated Generic and API leader. GGL has an established presence in North America, a developing presence in European Union (EU) and Argentina and maintains marketing front-ends in these countries. It primarily sells its FDF products in the USA and the EU, as well as its oncology FDF products in South America.

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