The companies have asked the Food and Drug Administration for approval of generic versions of the drug. Mylan and Barr are looking to market their own versions of 15 mg and 30 mg Amrix capsules. The companies said that their versions of cyclobenzaprine hydrochloride would not infringe on the Amrix patents.
Cephalon claimed otherwise and that patents on the drug, which are held by Anesta, do not expire until February of 2025. The lawsuit filing delays any FDA decision until either a judgment on the case is made, or 30 months from the October 2008 filing of the generic drug applications.
According to IMS Health, Barr said U.S. sales of Amrix totaled $53 million in the first nine months of the 2008.
Shares of Cephalon rose 24 cents to close at $70.86, while shares of Eurand rose 94 cents to close at $7.54 and shares of Mylan rose 24 cents to close at $9.24 Wednesday.
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