Gilead files patent infringement suit against Lupin over Ranexa; Mylan's generic nabumetone cleared by FDA

16 July 2010

Gilead Sciences says it has filed a law suit in US District Court in New Jersey, USA, against Indian-owned Lupin for infringement of its patents for angina drug Ranexa (ranolazine extended-release tablets). The action 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 the drug's patents.

Ranexa is currently protected by 10 patents, which are listed in the Food and Drug Administration'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, says Gilead, adding that it 'has full confidence in the validity of its patents and plans to vigorously defend the intellectual property rights of Ranexa.'

Another generic nabumetone product approved for US market

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