The lawsuits are based on abbreviated new drug applications (ANDA) filed by Teva and Mylan seeking permission to manufacture and market a generic version of Tarceva before the expiration of the three patents.
The filing of these lawsuits restricts the FDA from approving Teva and Mylan’s ANDAs until May 18, 2012, unless an adverse court ruling occurs prior to such time. OSI plans to vigorously protect and enforce the intellectual property rights of Tarceva.