US Pharm. 2010;35(2):36.
Mylan Inc. confirmed that it was being sued by Cephalon, Inc., and Cephalon France in connection with the filing of an Abbreviated New Drug Application (ANDA) with the 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 file 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 FDA approval. Cephalon, Inc., 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.