Monday, generic drug maker Mylan Inc. (MYL) confirmed that it was sued by Cephalon Inc. (CEPH) and Cephalon France in connection with its filing of an Abbreviated New Drug Application for Armodafinil tablets, the generic version of Cephalon's sleep disorder drug, Nuvigil.
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.
Mylan had filed Abbreviated New Drug Application, or ANDA, for 50 mg, 150 mg, and 250 mg tablets of Nuvigil. The U.S. Food and Drug Administration approved Nuvigil in June 2007, and is currently reviewing it as a drug to combat jet lag.
On December 11, 2009, Cephalon Inc. filed a patent infringement lawsuit against Mylan in U.S. District Court in Delaware citing infringement of U.S. Patents for Nuvigil. In addition to Mylan, Cephalon has also sued Teva Pharmaceutical Industries Ltd (TEVA) and Watson Pharmaceuticals, Inc. (WPI) separately over Nuvigil patents.
Mylan said it believes it is the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for improving wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea/hypnea syndrome, narcolepsy, and shift work sleep disorder of Armodafinil. Paragraph IV Certification is a certification of invalidity or non-infringement of patents that is required to be filed along with the ANDA. Mylan also said it expects to qualify for 180 days of marketing exclusivity upon final FDA approval.
Nuvigil Tablets had approximately $42.3 million in sales for the indications applied for, through the Armodafinil ANDA, during the six months ending Sept. 30, 2009, Mylan said citing IMS Health data. Mylan currently 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, Mylan said.
MYL is currently gaining $0.19 or 1.09%, trading at $17.61 on a volume of 2.67 million shares on the Nasdaq.
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