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Barr Confirms Patent Challenge of Xopenex Inhalation Solution, 0.31mg/3mL, 0.63mg/3mL and 1.25mg/3mL

Published in Medical Letter on the CDC and FDA, August 5th, 2007

Barr Pharmaceuticals, Inc. (NYSE:BRL) today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by Sepracor Inc. in connection with its Xopenex(R) (Levalbuterol Hydrochloride) 0.31mg/3mL, 0.63mg/3mL and 1.25mg/3mL.

Barr filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic Xopenex product with the U.S. Food & Drug Administration (FDA) in March 2007, and received notification of the application's acceptance for filing in May 2007. Following receipt of the notice from the FDA, Barr notified Sepracor, the New Drug Application (NDA) and patent owner.

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