The lawsuit was filed in connection with Glenmark‘s submission of an abbreviated new drug application (ANDA) for 0.1% hydrocortisone butyrate cream, Glenmark’s generic version of Locoid Lipocream.
As per the terms of the licensing and settlement agreement, Glenmark will get permission for marketing and distributing 0.1% hydrocortisone butyrate cream under a royalty-bearing license from Astellas and Triax in the US near the end of 2013.
With this settlement, Glenmark believes that it is eligible for 180 days of exclusivity with respect to its hydrocortisone butyrate cream, as the first generic company to file an ANDA for the product.