The Battle over Generic Lyrica

On Thursday, July 19, 2012, Pfizer Pharmaceuticals along with Northwestern University won the first legal battle over the release of pregabalin, the generic formulation of Lyrica.  Lyrica is an anticonvulsant which is approved to treat diabetic neuropathy, post herpetic neuralgia, partial onset seizures in adults and fibromyalgia.  Recently, the FDA also approved its use for the treatment of neuropathic pain associated with spinal cord injuries. 

Pfizer Pharmaceuticals and Northwestern University own the patents for the active ingredient pregabalin and its indications. Collectively, they filed patent infringement lawsuits in 2009 against several companies which applied to the FDA for approval to market a generic version of Lyrica before expiration of the patents.  These defendant companies included TEVA of Israel, Lupin LTD and Sun Pharmaceuticals of India as well as Mylan and Watson from the United States.  A trial was held in October of 2011 before Judge Sleet of the U.S. District Court of Delaware, but no decision was rendered at that time. The pharmaceutical companies involved reached an agreement not to put generic products on the market before July 20, 2012 or until Judge Sleet had rendered a decision, whichever came first. 

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