Barr Pharmaceuticals confirms patent challenge of Focalin XR

Nov 21 2007

Barr Pharmaceuticals, Inc. has confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed for Focalin XR (dexmethylphenidate hydrochloride) extended-release capsules, 5mg, 10mg, 15mg & 20mg. Focalin XR is manufactured for the U.S. for Novartis Pharmaceuticals Corporation by Elan Holdings Inc.

Barr filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic Focalin XR product with the U.S. Food & Drug Administration (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 (NDA) and patent holder.

On November 16, 2007, Elan Corporation, PLC and Elan Pharma International Ltd. filed suit in the U.S. District Court for the District of Delaware to prevent Barr from proceeding with the commercialization of its product. This action formally initiates the patent challenge process under the Hatch-Waxman Act.

Focalin XR (dexmethylphenidate hydrochloride) extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older. The product had sales of approximately $252 million in the U.S., based on IMS sales data ending September 2007.

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