H. Lundbeck and Forest laboratories has jointly filed a patent lawsuit in the U.S. District Court for the Eastern District of Michigan against Caraco for infringement of U.S. Reissued Patent RE34, 712 (the ‘712 patent) covering escitalopram oxalate, the active ingredient of antidepressant Lexapro. This lawsuit is result of ANDA Para IV certification made by Caraco with USFDA seeking marketing approval for generic Lexapro product in U.S. prior to expiration of the ‘712 patent which runs through March 2012.
Earlier, Lundbeck and Forest sued generic manufactures --- Ivax, Alphapharm and Cipla for infringing the ‘712 patent. However, later in October 2005 Lundbeck and Forest entered into settlement agreement with Alphapharm authorizing Alphapharm as authorized generic. And recently on July 13, 2006 U.S. District Court for the District of Delaware ruled in the favor of Lundbeck and Forest ruling that the ‘712 patent is valid and enforceable and infringed by Ivax proposed generic Lexapro product.
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