Mylan Inc.today confirmed that it was sued by Cephalon Inc. and Cephalon France inconnection with the filing of an Abbreviated New Drug Application (ANDA) withthe U.S. Food and Drug Administration (FDA) for Armodafinil Tablets, 50 mg,150 mg and 250 mg. Armodafinil Tablets are the generic version of NuvigilTablets, which are used to improve wakefulness in patients with excessivesleepiness associated with obstructive sleep apnea/hypnea syndrome, narcolepsyand shift work sleep disorder. Mylan believes it is the first company to have filed a substantiallycomplete ANDA containing a Paragraph IV certification for the above-notedstrengths of this product and expects to qualify for 180 days of marketingexclusivity upon final FDA approval. Cephalon and Cephalon France filedlawsuits 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 patentinfringement. Nuvigil Tablets had approximately $42.3 million in sales for theabove-mentioned strengths for the six months ending Sept. 30, according to IMSHealth. Currently, Mylan has 141 ANDAs pending FDA approval representing $87.5billion in annual brand sales, according to IMS. Thirty-eight of these pendingANDAs are potential first-to-file opportunities, representing $19.3 billion inannual brand sales, according to IMS.
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