Mylan Inc.
Mylan Confirms First-to-File Patent Challenge Relating to Sleep-Disorder Drug Nuvigil
Published in Mental Health Law Weekly, January 30th, 2010
Mylan Inc. (NASDAQ:MYL) confirmed that it was sued by Cephalon Inc. and Cephalon France in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) 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...
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