Mylan confirms first-to-file challenge for chemotherapy treatment

PITTSBURGH Mylan Inc. and its subsidiary confirmed Tuesday they have been sued by Roche in connection to a filing for a chemotherapy treatment.

Mylan sought to receive FDA approval for Capecitabine tablets, in 150-mg and 500-mg strengths. It is 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, Roche's Nutley, N.J.-based subsidiary, filed a lawsuit April 8 in the U.S. District Court for the District of New Jersey, alleging infringement of U.S. Patent No. 5,472,949.

Xeloda tablets (150-mg and 500-mg) had approximately $447 million in sales for the 12 months ended Dec. 31, 2008, according to IMS Health. Currently, Mylan has 117 ANDAs pending FDA approval, 33 of which are potential first-to-file opportunities.

Last month, Mylan confirmed four first-to-file challenges for various medications. On Monday, the company announced it settled its patent suit with Schering Plough over a generic version of Clarinex, an allergy medication.