Teva files for generic of OSI's Tarceva

OSI Pharmaceuticals has been advised via a Paragraph IV Certification that Teva Pharmaceuticals USA has submitted an Abbreviated New Drug  Application to the US Food and Drug Administration requesting permission  to manufacture and market a generic version of Tarceva (erlotinib).

OSI is currently reviewing the Notice Letter and has 45 days from the  date of receipt to commence a patent infringement law suit against Teva  and expects to file suit in that time frame. Tarceva is currently  protected by three patents that are listed in the FDA's Approved Drugs  Products List (Orange Book). A law suit brought with respect to one or  more of those patents would restrict the FDA from approving Teva's ANDA  until May 18, 2012 (the statutory stay period), unless an adverse court  ruling occurs prior to such time, the US drugmaker notes.