Barr confirms Entocort patent challenge

May 27 2008

Barr Pharmaceuticals, Inc. today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by AstraZeneca LP in connection with its Entocort(R) Enteric Coated Capsules (budesonide), 3mg.

The Company believes that it is the first to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for Entocort EC.

Barr filed its ANDA containing a paragraph IV certification for a generic Entocort EC product with the U.S. Food & Drug Administration (FDA) 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 May 22, 2008, AstraZeneca 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.

Entocort EC (budesonide) had annual sales of approximately $125 million in the U.S., based on IMS sales data for the twelve-month period ending March 2008.