Teva, Impax, J&J neurology news
Johnson & Johnson's Alza Corp. subsidiary and Ortho-McNeil-Janssen Pharmaceuticals Inc. unit filed suit in the U.S. District Court for the District of Delaware alleging that an ANDA from Teva and Impax for a generic version of the 18, 27 and 36 mg tablets of ADHD drug Concerta methylphenidate extended release infringes J&J's U.S. Patent No. 6,930,129. The ANDA contains a paragraph IV certification claiming the '129 patent, which covers a method of treating ADHD and expires Jan. 31, 2018, including a six-month pediatric exclusivity extension, is invalid or will not be infringed by a generic version of Concerta.
Last year, Alza filed suit against Teva and Impax to prevent them from marketing a generic version of the 54 mg dosage of Concerta. The once-daily Oros controlled extended-release formulation of methylphenidate had U.S. sales of about $929 million in 2010. ...