US Pharm. 2009;34(5):36-38.Mylan Inc. and its subsidary Mylan Pharmaceuticals Inc. have been sued by Hoffmann-LaRoche Inc. in connection with the filing of an ANDA with the 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 FDAapproval has been obtained.
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 U.S. Patent No. 5,472,949.