Mylan is first to file for generic Xeloda; Roche files suit

US generic giant Mylan is being by Swiss drug major Roche after it filed an Abbreviated New Drug Application with the Food and Drug  Administration for a generic version of Xeloda (capecitabine), a  chemotherapy treatment for breast and colorectal cancer.

Xeloda tablets, 150mg and 500mg, generated sales of approximately $447.0  million in the 12 months ending December 31, 2008, according to IMS  Health.

Mylan believes it is the first company to have filed a substantially  complete ANDA containing a Paragraph IV certification for the product  and expects to qualify for 180 days of sole marketing exclusivity once  final FDA approval is obtained. Roche filed a law suit on April 8 in the  US District Court for the District of New Jersey alleging infringement  of US patent No 5,472,949.