Impax confirms patent challenge for generic Concerta

HAYWARD, Calif. — Alza Corp. is attempting to block Impax Labs from developing a generic version of Alza's attention deficit hyperactivity disorder treatment.

Impax confirmed that Alza filed a patent infringement suit in the U.S. District Court for the District of Delaware against the generic drug maker in connection with Concerta (methylphenidate hydrochloride) extended-release tablets in the 18-mg, 27-mg and 36-mg strengths, which is designed to treat ADHD in children ages 6 years and older, adolescents and adults up to the age of 65 years.

Impax said its generic Concerta products are part of the company’s strategic alliance agreement with Teva Pharmaceuticals, in which Teva will commercialize the products if the Food and Drug Administration approves the related abbreviated new drug application.

According to Wolters Kluwer Health, U.S. sales of Concerta tablets in the 18-mg, 27-mg, 36-mg and 54-mg strengths were approximately $1.4 billion for the 12 months ended in February.

Login or Register to post a comment.