Item 8.01 Other Events.

On November 2, 2009 (the "Actavis Notice Date"), Cephalon, Inc. ("Cephalon") received a Paragraph IV certification notice letter (the "Actavis Notice Letter") regarding an Abbreviated New Drug Application ("ANDA") submitted to the U.S. Food and Drug Administration (the "FDA") by Actavis Pharma Manufacturing Pvt Ltd., by and through its agent Actavis Inc. (collectively, "Actavis"), requesting approval to market and sell a generic version of NUVIGILŪ (armodafinil) Tablets [C-IV].

On November 3, 2009 (the "Mylan Notice Date", and together with the Actavis Notice Date, the "Notice Dates"), Cephalon received a Paragraph IV certification notice letter (the "Mylan Notice Letter", and together with the Actavis Notice Letter, the "Notice Letters" ) regarding an ANDA submitted to the FDA by Mylan Pharmaceuticals, Inc. ("Mylan") requesting approval to market and sell a generic version of NUVIGIL.

In their Notice Letters, Actavis and Mylan each claim that U.S. Patent Nos. RE37,516 ("the '516 patent"), 7,297,346 ("the '346 patent") and 7,132,570 ("the '570 patent") issued to Cephalon are invalid, unenforceable and/or will not be infringed by the respective party's manufacture, use or sale of the products described in the applicable ANDA. 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. The Notice Letters do 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.

Cephalon is currently reviewing the Notice Letters. By statute, if Cephalon initiates a patent infringement lawsuit against Actavis and/or Mylan within 45 days of the applicable Notice Date, then the FDA would be automatically precluded from approving the applicable party's ANDA until the earlier of entry of a district court decision finding the patents invalid or not infringed or 30 months from the applicable Notice Date.

As disclosed in Cephalon's Current Report on Form 8-K filed October 22, 2009, Cephalon previously received a Paragraph IV certification notice letter relating to an ANDA submitted to the FDA by Teva Pharmaceuticals USA, Inc. requesting approval to market and sell a generic version of NUVIGIL.

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