Intas Pharma settles with Roche over Xeloda; Merck & Co wins injunction against Aprica

Indian drugmaker Intas Pharmaceuticals and its wholly owned subsidiary Accord Healthcare have entered into a settlement and license agreement with Swiss pharma major Roche (ROG: ROG)  that will resolve pending patent litigation related to Xeloda (capecitabine), used in the treatment of metastatic breast and colorectal cancers.

Roche’s US subsidiary had filed patent infringement suit against Accord Healthcare and Intas Pharmaceuticals following Accord's submission to the US Food and Drug Administration of an Abbreviated New Drug Application for a generic version of Xeloda, which had US sales of around $706 million in 2012, according to IMS Health data.

As part of the agreement, Roche has granted Accord a license to enter the US market with a generic version of Xeloda tablets ahead of its exclusivity period. Under 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.