Cephalon, Inc. it has filed a lawsuit in U.S. District Court in Delaware against Teva Pharmaceuticals USA, Inc. for infringement of U.S. Patent Nos. 7,132,570 (the "'570 Patent"), 7,297,346 (the "'346 Patent") and RE37,516 (the "'516 Patent") for the Cephalon product NUVIGIL® (armodafinil) Tablets [C-IV]. Cephalon has a three-year period of marketing exclusivity for NUVIGIL that extends until June 15, 2010. In addition, including the six-month pediatric 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 did 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. The lawsuit is based upon an Abbreviated New Drug Application (ANDA) filed by Teva seeking FDA approval for a generic equivalent of armodafinil to be sold in the United States. Teva alleges that the above NUVIGIL patents are invalid, unenforceable and/or will not be infringed by Teva's manufacture, use or sale of the product described in its ANDA.
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