Cephalon and Eurand File Patent Infringement Lawsuit Against Mylan Pharmaceuticals and Barr Pharm...( FRAZER Pa. and PHILADELPHIA Nov. 26 /...)

FRAZER, Pa. and PHILADELPHIA, Nov. 26 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) and Eurand, Inc. (Nasdaq: EURX) today announced that they have filed a lawsuit in U.S. District Court in Delaware against Mylan Pharmaceuticals, Inc. and its subsidiary, Mylan, Inc., and Barr Pharmaceuticals, Inc. and its subsidiary, Barr Laboratories, Inc., for infringement of Eurand's U.S. Patent Number 7,387,793. This patent claims extended-release formulations containing the muscle relaxant cyclobenzaprine, including AMRIX(R) (Cyclobenzaprine Hydrochloride Extended-Release Capsules) and expires February 26, 2025.

The lawsuit is based upon Abbreviated New Drug Applications (ANDAs) filed by Mylan and Barr, each seeking U.S. Food and Drug Administration (FDA) approval for a generic equivalent of the 15 mg and 30 mg strengths of AMRIX to be sold in the United States. The Mylan ANDA alleges that the AMRIX patent will not be infringed by its manufacture, use or sale of the product described in its ANDA and reserves its right to challenge the validity and/or enforceability of the AMRIX patent. The Barr ANDA alleges that the AMRIX patent is invalid, unenforceable and/or will not be infringed by its manufacture, use or sale of the product described in its ANDA. AMRIX was approved by the FDA in February 2007 for short-term use as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.

"We believe that the proposed Mylan and Barr ANDA products will be found to infringe the AMRIX patent," said Jerry Pappert, Executive Vice President and General Counsel of Cephalon. "The AMRIX patent was approved by the United States Patent and Trademark Office and is presumed by law t
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