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news.Barr Laboratories, a subsidiary of Barr Pharmaceuticals has initiated a challenge of the patents listed by GlaxoSmithKline in connection with its Avodart soft gelatin capsules, 0.5mg.
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Barr filed its ANDA containing a paragraph IV certification for a generic Avodart product with the FDA in October 2007, and received notification of the application’s acceptance for filing in January 2008. 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 February 25, 2008, GlaxoSmithKline filed suit in 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.