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news.Barr Pharmaceuticals has initiated a challenge of the patents listed by Novartis Pharmaceuticals in connection with its Ritalin LA extended-release capsules, 10mg, 20mg, 30mg and 40mg.
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Barr has filed its abbreviated new drug application (ANDA) containing a paragraph IV certification for a generic Ritalin LA product with the Food & Drug Administration in May 2007, and received notification of the application’s acceptance for filing in September 2007. Following receipt of the notice from the FDA that Barr’s ANDA had been accepted for filing, Barr notified the new drug application (NDA) and patent holders.
On November 2, 2007, Celgene Corporation, Novartis Pharmaceuticals Corporation and Novartis Pharma have filed suit in the US District Court of New Jersey (Newark) to prevent Barr from proceeding with the commercialization of its product. This action formally initiates the patent challenge process under the Hatch-Waxman Act.