Barr Confirms Patent Challenge of Ritalin(R) LA

WOODCLIFF LAKE, N.J., Nov. 2 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by Novartis Pharmaceuticals Corporation in connection with its Ritalin(R) LA (methylphenidate hydrochloride) extended-release capsules, 10mg, 20mg, 30mg and 40mg.

Barr filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic Ritalin LA product with the U.S. Food & Drug Administration (FDA) in May 2007, and received notification of the application's acceptance for filing in September 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 holders.

On November 2, 2007, Celgene Corporation, Novartis Pharmaceuticals Corporation and Novartis Pharma AG filed suit in the U.S. 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.

Ritalin LA (methylphenidate hydrochloride) extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). The product had sales of approximately $109 million in the U.S., based on IMS sales data ending August 2007.

About Barr Pharmaceuticals, Inc.

Barr Pharmaceuticals, Inc. is a global specialty pharmaceutical company that operates in more than 30 countries worldwide and is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients. A holding company, Barr operates through its principal subsidiaries: Barr Laboratories, Inc., Duramed Pharmaceuticals, Inc. and PLIVA d.d. and its subsidiaries. The Barr Group of companies markets more than 115 generic and 25 proprietary products in the U.S. and more than 1,200 products globally outside of the U.S.

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