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Ahmedabad-based Intas Pharmaceuticals and its wholly owned US-based subsidiary Accord Healthcare Inc has entered into a settlement and license agreement with Hoffmann-La Roche Inc that will resolve pending patent litigation related to Xeloda tablets which is used for metastatic breast and colorectal cancers.
Xeloda is available in dose strengths of 150 and 500 mg and is known generically as Capecitabine tablets. This product is an orally administered chemotherapeutic agent.
Hoffmann-La Roche Inc. had filed patent infringement suit against Accord Healthcare and Intas Pharma following Accord's submission to the US Food and Drug
Administration (USFDA) of an abbreviated new drug application (ANDA) for a generic version of Xeloda tablets. According to IMS Health, sales of Xeloda in the US stood at $ 706.2 million (Rs 4219.8 crore ) for the year 2012. As part of the agreement, Hoffman La Roche has granted Accord a license to enter the US market with a generic version of Xeloda tablets ahead of its exclusivity period.
"Pursuant to the agreement, pending litigation would be dismissed. All other terms and conditions of the settlement are confidential, and the agreement itself is subject to review by the US Department of Justice and the Federal Trade Commission," a company statement here said.
Accord Healthcare Inc is the wholly owned subsidiary of Intas in the US and is now the second largest Indian player in the US generic injectable space, Intas claimed.
