Cephalon Inc., Eurand Inc. and Anesta AG collectively have sued Mylan and its subsidiary Mylan Pharmaceuticals Inc. by filing a lawsuit in the U.S. District Court for the District of Delaware in connection with the filing of an ANDA for Cyclobenzaprine Hydrochloride (HCl) Extended-release (ER) Capsules, 15 mg and 30 mg, the generic version of AMRIX(R) Capsules. The patent considered under infringement is US Patent No. 7,387,793. Mylan believes it is the first company to file ANDA containing a Paragraph IV certification for the product and expects to be awarded 180 days of sole marketing exclusivity once final approval is obtained. The ANDA was filed with the USFDA. Cyclobenzaprine HCl ER Capsules, a muscle relaxant introduced to the market in October 2007, had approximately $53 million in sales for the twelve months ending Sept. 30 and approximately $19 million for the quarter ending Sept. 30, according to IMS Health.
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