Impax confirms patent challenge for generic Concerta

HAYWARD, Calif. — A generic version of a drug indicated to treat attention deficit hyperactivity disorder has hit a roadblock.

Impax Labs on Tuesday confirmed that Alza Corp., a subsidiary of Johnson & Johson, filed a patent infringement suit against Impax in connection with Concerta (methylphenidate hydrochloride) extended-release 54-mg tablets. Impax filed its abbreviated new drug application for a generic version of Concerta with the 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.

Impax said its generic Concerta products are part of its strategic alliance agreement with Teva Pharmaceuticals. Once the ANDA is approved by the FDA, Teva will commercialize the products, the drug maker said.

U.S. sales of Concerta in the 54-mg strength approximately were $365 million for the 12 months ended Sept. 30, according to Wolters Kluwer.