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 has filed lawsuits in the US District Court for the District of Delaware and the US District Court for the Northern District of West Virginia alleging patent infringement.
Currently, Mylan has 141 ANDAs pending FDA approval representing $87.5 billion in annual brand sales, according to IMS.