Barr Pharmaceuticals, Inc. today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by GlaxoSmithKline in connection with its Avodart(R) (dutasteride) soft gelatin capsules, 0.5mg. The Company believes that it is the first to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for Avodart.
Barr filed its ANDA containing a paragraph IV certification for a generic Avodart product with the U.S. Food & Drug Administration (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 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.
Avodart (dutasteride) had annual sales of approximately $362 million in the U.S., based on IMS sales data for the twelve-month period ending December 2007.