Glenmark Pharmaceuticals Ltd and Glenmark Generics Inc., USA, confirmed on Monday Triax Pharmaceuticals, LLC, Astellas Pharma Europe BV and Astellas Pharma International BV have filed a patent infringement suit on November 4, 2010 in the US district court for the district of Delaware seeking to prevent Glenmark from commercializing its abbreviated new drug application (ANDA) for hydrocortisone butyrate cream 0.1%; their generic version of Locoid Lipocream, prior to expiration of the Orange Book patent.
Astellas and Triax’s suit was filed under the provisions of the Hatch-Waxman Act resulting in a stay of final FDA approval of Glenmark’s ANDA for up to 30 months or until final resolution of the matter before the court, whichever occurs sooner. Based on information published by the USFDA, Glenmark believes it is the first applicant to file an ANDA with a paragraph IV certification for a generic version of Locoid Lipocream, and should its product be approved Glenmark will be entitled to 180 days of generic market exclusivity.
For the 12-month period ending September 2010, Locoid Lipocream achieved sales of $38 million according to IMS Health.
