CANONSBURG – Three companies have sued Mylan Inc. over its filing to make generic versions of the muscle-relaxant Amrix, Mylan said Monday.
Cephalon Inc., Eurand Inc. and Anesta AG all have sued over the abbreviated new drug application to make cyclobenzaprine hydrochloride extended-release capsules.
Mylan said it believes it is the first company to file to make generic Amrix, and it expects to be awarded six months of marketing exclusivity once it receives final approval.
Eurand developed once-daily Amrix and Cephalon markets the drug in North America. Both Mylan and Barr Pharmaceuticals Inc. are looking to market their own versions of 15 mg and 30 mg Amrix capsules. The companies say their versions of cyclobenzaprine hydrochloride would not infringe on the Amrix patents.
Citing data from IMS Health, Mylan said Amrix generated approximately $53 million in sales for the year ending Sept. 30.
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