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news.Barr Laboratories has confirmed that Celgene Corporation has filed a suit to prevent it from proceeding with the commercialization of its generic version of Celgene's Thalomid capsules.
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<p>Barr filed an abbreviated new drug application for a generic version of Thalomid 200mg capsules with the FDA in September 2006, claiming that the patents protecting Thalomid from generic competition are invalid, unenforceable or not infringed by Barr's product. <br /><br />Thalomid is used in the treatment of some cancers and complications associated with leprosy. In December 2006, Barr amended its application to include the 50 mg and 100 mg capsule strengths.<br /><br />After Barr filed its application, the US Patent and Trade Office issued a new patent for Celgene's Thalomid capsule product which Barr also deemed to be invalid. Barr amended its abbreviated new drug application on file with the FDA to certify against the new patent<br /><br />Thalomid capsules, 50mg, 100mg and 200mg had annual sales of approximately $417 million for the twelve months ended November 2006, based on IMS sales data.</p>