Focalin XR is manufactured by Elan Holdings for Novartis Pharmaceuticals. Barr filed its abbreviated new drug application (ANDA) containing a paragraph IV certification for a generic Focalin XR product with the FDA in June 2007, and received notification of the application’s acceptance for filing in October 2007. Following receipt of the notice from the FDA that Barr’s ANDA had been accepted for filing, Barr notified the new drug application and patent holder.
Focalin XR (dexmethylphenidate hydrochloride) extended-release capsules are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged six years and older.
Elan Corporation and Elan Pharma International have recently filed suit in the US District Court for the District of Delaware to prevent Barr from proceeding with the commercialization of its product.