Mylan Inc confirmed that the company and its subsidiary Mylan Pharmaceuticals Inc have been sued by Hoffmann-La Roche Inc in connection with the filing of an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for Capecitabine tablets, 150 mg and 500 mg, the generic version of Xeloda tablets, a chemotherapy treatment for breast and colorectal cancer.
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. Hoffmann-La Roche filed a lawsuit April 8 in the US District Court for the District of New Jersey alleging infringement of US Patent No 5,472,949.
Xeloda tablets, 150 mg and 500 mg, had approximately $447 million in sales for the 12 months ending December 31, 2008, according to IMS Health. Currently, Mylan has 117 ANDAs pending FDA approval, 33 of which are potential first-to-file opportunities.