Barr Pharma Confirms Patent Challenge Of Avodart Soft Gelatin Capsules, 0.5mg - Quick Facts

(RTTNews) - Barr Pharmaceuticals, Inc. (BRL | news | PowerRating | PR Charts ) confirmed on Tuesday that its subsidiary, Barr Laboratories had indeed begun a challenge of the patents listed by GlaxoSmithKline in connection with its Avodart, 0.5mg soft gelatin capsules.

The company stated that it believes it was the first to file an Abbreviated New Drug Application with the U.S FDA in October 2007, and had received notification of the application's acceptance for filing in January 2008, following which it had informed the New Drug Application and patent holder.

However, GlaxoSmithKline has filed suit in the U.S. District Court for the District of Delaware on February 25, 2008 to prevent Barr from proceeding with the commercialization of its product. This has resulted in the patent challenge process under the Hatch-Waxman Act, stated Barr.

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