Impax Labs sued by Johnson & Johnson unit over Concerta patent

In a second law suit filed against it in a matter of days, US generic drugmaker Impax Laboratories (Nasdaq: IPXL) says that Alza Corp, a subsidiary of drug major Johnson & Johnson (NYSE: JNJ), has filed suit for patent infringement against Impax in the US District Court for the District of Delaware in connection with Concerta (methylphenidate hydrochloride) extended-release 54mg tablets, a treatment for attention-deficit hyperactivity disorder (ADHD).

Earlier this week, Impax was also sued by Abbott Laboratories for patent infringement of the latter’s cholesterol lowering drug Simcor (niacin/simvastatin; The Pharma Letter November 29). Impax shares fell 2% to $18.77 on the latest news.

Impax filed its Abbreviated New Drug Application for a generic version of Concerta with the US Food and Drug Administration in November 2002, and submitted Paragraph IV patent certifications in connection with two patents that were listed in the FDA’s Orange Book in 2005. Following a court decision of patent invalidity with respect to one of the Concerta patents and submission of a major amendment to its ANDA, Impax amended its notice letter to the New Drug Application holder and patent owners to provide amended bases for its paragraph IV certification.