Cephalon, Inc announced receipt of a Paragraph IV Certification Notice Letter on October 20, 2009 regarding an Abbreviated New Drug Application (ANDA) submitted to the US Food and Drug Administration (FDA) by Teva Pharmaceuticals USA, Inc requesting approval to market and sell a generic version of the 50 mg, 100 mg, 150 mg, 200 mg and 250 mg strengths of Nuvigil (armodafinil) tablets [C-IV]. In the Notice Letter, Teva alleges that US Patent Nos. 7,132,570 (the "'570 Patent"), 7,297,346 (the "'346 Patent") and RE37,516 (the "'516 Patent") issued to Cephalon are invalid, unenforceable and/or will not be infringed by Teva's manufacture, use or sale of the product described in Teva's ANDA submission.
Cephalon is currently reviewing the Notice Letter. By statute, if Cephalon initiates a patent infringement lawsuit against Teva within 45 days of Cephalon's receipt of the Notice Letter, then the FDA would be automatically precluded from approving the Teva ANDA until the earlier of entry of a district court decision finding the patents invalid or not infringed or 30 months from the receipt of the Notice Letter by Cephalon.
Cephalon has a three-year period of marketing exclusivity for Nuvigil that extends until June 15, 2010. In addition, including the six-month paediatric extension, the '516 Patent, the '346 Patent, and the '570 Patent expire on April 6, 2015, May 29, 2024, and June 18, 2024, respectively. Teva's Notice Letter does not challenge Orange Book-listed U.S. Patent No. 4,927,855 (the "'855 Patent"), which provides additional protection until October 22, 2010, the expiration date of the '855 Patent.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and commercialization of many unique products in four core therapeutic areas: central nervous system, inflammatory diseases, pain and oncology.