Mylan sued in connection with the filing of ANDA with FDA for Armodafinil Tablets

Jan 12 2010

Mylan Inc. (Nasdaq: MYL) today 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 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.

Nuvigil Tablets had approximately $42.3 million in sales for the above-mentioned strengths for the six months ending Sept. 30, according to IMS Health. Currently, Mylan has 141 ANDAs pending FDA approval representing $87.5 billion in annual brand sales, according to IMS. Thirty-eight of these pending ANDAs are potential first-to-file opportunities, representing $19.3 billion in annual brand sales, according to IMS.