Mylan Inc. (MYL) confirmed that it was sued by Cephalon Inc. (CEPH) and Cephalon France in connection with the filing of an Abbreviated New Drug Application with the U.S. Food and Drug Administration for Armodafinil Tablets, 50 mg, 150 mg and 250 mg.
Armodafinil Tablets are the generic version of Nuvigil Tablets, which are used to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea/hypnea syndrome, narcolepsy and shift work sleep disorder.
Mylan believes it is the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for the above-noted strengths of this product and expects to qualify for 180 days of marketing exclusivity upon final FDA approval. Cephalon and Cephalon France filed lawsuits in the U.S. District Court for the District of Delaware and the U.S. District Court for the Northern District of West Virginia alleging patent infringement.
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