MONTVALE, N.J., Nov. 26 /PRNewswire/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patent listed by Anesta in connection with its Amrix(R) (cyclobenzaprine hydrochloride) extended-release capsules, 15mg and 30mg.
Barr filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic version of Amrix with the U.S. Food & Drug Administration (FDA), and following receipt of the notice from the FDA that Barr's ANDA had been accepted for filing, Barr notified the New Drug Application (NDA) holder and patent owner.
On November 26, 2008, Eurand, Inc., Cephalon, Inc., and Anesta AG 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.
Amrix (cyclobenzaprine hydrochloride) extended-release capsules, 15mg and 30mg had annual sales of approximately $53 million in the U.S., based on IMS sales data ending September 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.
Forward-Looking Statements
This communication contains 'forward-looking statements' which represent the current expectations and beliefs of management of Barr Pharmaceuticals, Inc. (the 'Company') concerning the proposed merger of the Company (the 'merger') with Boron Acquisition Corp., a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd. (the 'Teva') and other future events and their potential effects on the Company.
