Wednesday, August 14, 2013

Lupin and Gilead settle Ranexa Litigation

Prior to issuance of the court's decision, on August 9, 2013, Lupin and Gilead have reached an agreement to settle the patent litigation. Under the agreement, subject to certain conditions, Lupin would be allowed to launch a generic version of Ranexa on February 27, 2019. The settlement agreement must be filed with the Federal Trade Commission and Department of Justice for their review. Ranexa generates approximately $400m in annual sales in the US. 

Ranexa Litigation Background
In June 2010, Gilead Sciences, Inc. (Gilead) received notice that Lupin Limited (Lupin) submitted an abbreviated new drug application to the U.S. Food and Drug Administration requesting permission to manufacture and market a generic version of sustained release ranolazine. In the notice, Lupin alleges that ten of the patents associated with Ranexa® (ranolazine) are invalid, unenforceable and/or will not be infringed by Lupin's manufacture, use or sale of a generic version of Ranexa. In July 2010, after reviewing the notice, Gilead concluded that Lupin infringed its valid and enforceable patents and filed a lawsuit against Lupin in U.S. District Court in New Jersey for infringement of its patents for Ranexa. The trial took place in April and May 2013.

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