Barr Confirms Patent Challenge Of FazaClo® Orally Disintegrating Tablets, 25mg And 100mg

Barr Pharmaceuticals, Inc. recently confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by Azur Pharma International in connection with its FazaClo (clozapine) orally disintegrating tablets, 25mg and 100mg. The Company believes that it is the first to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for FazaClo.

On August 21, 2008, Cima Labs, Inc., Azur Pharma Limited, and Azur Pharma International III Limited 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.

FazaClo (clozapine) orally disintegrating tablets, 25mg and 100mg had annual sales of approximately $34 million in the U.S., based on IMS sales data for the twelve month period ending June 2008.

About Barr Pharmaceuticals, Inc.
Barr Pharmaceuticals, Inc. is a global specialty pharmaceutical company that operates in more than 30 countries worldwide and is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients. A holding company, Barr operates through its principal subsidiaries: Barr Laboratories, Inc., Duramed Pharmaceuticals, Inc. and PLIVA d.d. and its subsidiaries. The Barr Group of companies markets more than 120 generic and 27 proprietary products in the U.S. and approximately 1,025 products globally outside of the U.S. For more information, visit www.barrlabs.com.

SOURCE: Barr Pharmaceuticals, Inc.