Mylan enters settlement and license deal with Roche over Xeloda

US generic drugs giant Mylan (Nasdaq: MYL) says that it has entered into a settlement and license agreement with Swiss pharma major Roche (ROG: SIX), resolving litigation related to Xeloda (capecitabine) tablets, 150mg and 500mg, USP, an orally administered chemotherapeutic agent used in the treatment of metastatic breast and colorectal cancers.

Roche filed suit against Mylan in 2009, seeking to stop the company from selling a generic version of Xeloda in connection with the US firm’s filing of an Abbreviated New Drug Application with the US Food and Drug Administration for capecitabine, alleging infringement of US Patent No 5,472,949 (The Pharma Letter April 15, 2009). The first patent on Xeloda expired in January this year and the next one is do to do so in December 2013.

As a result of the agreement, the litigation was dismissed on September 21, 2011. Additional details are confidential, and the accord itself is subject to review by the US Department of Justice and the Federal Trade Commission.