Barr Confirms Patent Challenge of Ritalin LA

Barr Laboratories is challenging the patents listed by Novartis Pharmaceuticals in connection with its Ritalin LA extended-release capsules, 10, 20, 30 and 40 mg.

Barr filed its abbreviated new drug application containing a Paragraph IV certification for a generic Ritalin LA (methylphenidate hydrochloride) product with the FDA in May and received notification of the application’s acceptance for filing in September.

Celgene and Novartis filed suit Nov. 2 in the U.S. District Court of New Jersey to prevent Barr from proceeding with the commercialization of the product, Barr said.

Ritalin LA extended-release capsules are indicated for the treatment of attention deficit hyperactivity disorder.