Glenmark Pharmaceuticals and its US arm have entered into a settlement and licence agreement with Triax Pharmaceuticals, LLC, Astellas Pharma Europe BV and Astellas Pharma International BV to resolve a US patent infringement suit related to Glenmark’s filing of an abbreviated new drug application (ANDA) for 0.1% hydrocortisone butyrate cream, Glenmark’s generic version of Locoid Lipocream.
Subject to the terms of the agreement, Glenmark will be permitted to market and distribute Glenmark’s 0.1% hydrocortisone butyrate cream under a royalty-bearing licence 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.
According to IMS Health data, for 2010, Locoid Lipocream achieved sales of approximately $38 million.