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Cephalon and Eurand fight generic competition

Cephalon and Eurand have filed a patent infringement lawsuit against generic pharmaceutical companies Mylan and Barr

Cephalon and Eurand have filed a patent infringement lawsuit against generic pharmaceutical companies Mylan and Barr.

The lawsuit concerns the muscle relaxant Amrix, which was developed by Eurand and is marketed in North America by Cephalon. Mylan and Barr have both submitted Abbreviated New Drug Applications (ANDAs) to the US Food and Drug Administration (FDA) for approval to sell generic equivalents of two strengths of Amrix.

Mylan claims that the patent will not be infringed, and Barr says the patent concerning Amrix is invalid. Under the terms of the lawsuit, the FDA is unable to approve the ANDAs until either a court rules in favour of Mylan and Barr or 30 months after the receipt of the ANDAs by the FDA.

"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 to be valid and enforceable. The patent position for this product is strong and we intend to vigorously defend the Amrix intellectual property."

Linked into the patented drug delivery formulation technologies used to develop Amrix, Cephalon has a three-year marketing exclusivity period meaning the FDA is unable to approve any generic version of Amrix until February 2010.

27th November 2008

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