Barr confirms patent challenge to Novartis Ritalin

US generics firm Barr Laboratories says it has initiated a challenge of the patents listed by Novartis Pharmaceuticals in connection with its Ritalin LA (methylphenidate hydrochloride) extended-release capsules, 10mg, 20mg, 30mg and 40mg.

Barr filed its Abbreviated New Drug Application containing a paragraph IV certification for a generic Ritalin LA product with the Food & Drug Administration in May, and received notification of the application's acceptance for filing in September. Following receipt of the notice from the FDA that its ANDA had been accepted for filing, Barr notified the New Drug Application and patent holders.

On November 2, Celgene, Novartis Pharmaceuticals Corporation and Novartis Pharma AG filed suit in the US District Court of New Jersey (Newark) to prevent Barr from proceeding with the commercialization of its product. This action formally initiates the patent challenge process under the Hatch-Waxman Act.