Mylan confirms first-to-file patent challenge to Cephalon's sleep-disorder drug Nuvigil
US generic drug major Mylan yesterday confirmed that it was sued by Cephalon and Cephalon France in connection with the filing of an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration for armodafinil tablets, 50mg, 150mg and 250mg, the generic version of Nuvigil, which is used to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea/hypnea syndrome, narcolepsy and shift work sleep disorder.
Cephalon filed suit against Mylan on last in the US District Court for the District of Delaware and the District Court for the Northern District of West Virginia, alleging that Mylan's abbreviated new drug application infringes two Cephalon patents
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.
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