Gilead Sciences, Inc. announced that it has filed a lawsuit in U.S. District Court in New Jersey against Lupin Limited for infringement against Gilead’s patents for Ranexa (ranolazine extended-release tablets). The lawsuit is based on an Abbreviated New Drug Application filed by Lupin, which seeks approval to manufacture and market a generic version of Ranexa before the expiration of Gilead’s Ranexa patents.
Ranexa is currently protected by 10 patents, which are listed in the FDA’s Approved Drug Products List, and all 10 patents would need to be invalidated, expire or not be infringed before a generic version of Ranexa could be marketed.
Gilead has full confidence in the validity of its patents and plans to vigorously defend the intellectual property rights of Ranexa.
Date: July 15, 2010
Source: Gilead Sciences, Inc.
Filed Under: Drug Discovery