Generic player Mylan confirmed (in a pess release Here) that Mylan have been sued by innovator Hoffmann-La Roche Inc. in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. 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.
Following patent are listed in Orange Book: for this product
US4966891 (Expiry: Jan 13, 2011): which covers Fluorocytidine derivatives like Capecitabine as product
US5472949 (Expiry: Dec 14, 2013): Which covers N4 -(substituted-oxycarbonyl)-5'-deoxy-5-fluorocytidine compounds as product
Innovator Hoffmann-La Roche filed a lawsuit on April 8, 2009 in the U.S. District Court for the District of New Jersey alleging infringement of ‘949 patent. Possibly, Mylan may have filed Para III against ‘891 patent.
Xeloda Tablets, 150 mg and 500 mg, had approximately $447 million in sales for the 12 months ending Dec. 31, 2008, according to IMS Health. Currently, Mylan has 117 ANDAs pending FDA approval, 33 of which are potential first-to-file opportunities.
Innovator got approval to market this drug in US on Apr 30, 1998
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