Intas Pharmaceuticals and its wholly owned subsidiary Accord Healthcare Inc. recently entered into a settlement and license agreement with Hoffmann-La Roche Inc. As per the agreement it will resolve pending patent litigation related to Xeloda tablets, 150 mg and 500 mg, known generically as capecitabine tablets.
This product is an orally administered chemotherapeutic agent used in the treatment of metastatic breast and colorectal cancers. According to IMS Health in the US Xeloda tablets registered sales of approximately $ 706.2 million for the 12 months ending Dec 31, 2012.
Hoffmann-La Roche had filed patent infringement suit against Accord Healthcare and Intas Pharmaceuticals Ltd. following Accord’s submission to the US Food and Drug Administration of an Abbreviated New Drug Application (ANDA) for a generic version of Xeloda tablets.
As part of the agreement, Hoffman La Roche Inc. 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.
EP News Bureau – Mumbai