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Barr Signs Amended Agreement to Extend Distribution of Ciprofloxacin

WOODCLIFF LAKE, N.J., Sept. 25 /PRNewswire-FirstCall/ -- Barr Laboratories, Inc. (NYSE: BRL) today announced that it has signed an amended supply agreement with Bayer Pharmaceuticals Corporation (Bayer) that will enable Barr to continue to distribute its alternative brand of ciprofloxacin tablets and oral suspension products during any period of pediatric exclusivity that may be granted to Bayer for its Cipro(R) (Ciprofloxacin HCl) antibiotic. Bayer has previously indicated that it expects to receive pediatric exclusivity for its Cipro product under rules established by the FDA for companies who conduct requested studies on safety and efficacy in pediatric patients. Bayer's pediatric exclusivity, if granted, would expire on June 9, 2004.

In June 2003, Barr began marketing Ciprofloxacin Hydrochloride, pursuant to a license that resulted from a 1997 settlement of a patent challenge. Barr's distributed ciprofloxacin product competes in a market that had annual sales of approximately $1.1 billion for the twelve months ending July 2003.

"We are pleased to have reached an agreement with Bayer that allows Barr to continue to provide an alternative brand of ciprofloxacin products during any period of pediatric exclusivity that may be granted to Bayer," said Bruce L. Downey, Barr's Chairman and CEO.

In January 1997 Barr and Bayer signed a non-exclusive distribution agreement that provided Barr with the right to begin distributing ciprofloxacin products six months prior to the expiration of the patent protecting Bayer's Cipro in December 2003. Currently Barr purchases ciprofloxacin products that are manufactured under Bayer's New Drug Application (NDA) for Cipro directly from Bayer and markets the ciprofloxacin products under its own label.

Ciprofloxacin is an antibiotic used to treat various types of infections, including urinary tract infections.

Barr Laboratories, Inc. is a specialty pharmaceutical company engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals.

Safe Harbor Statement: To the extent that any statements made in this report contain information that is not historical, these statements are essentially forward-looking. These statements are subject to risks and uncertainties that cannot be predicted or quantified and, consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include: the difficulty in predicting the timing and outcome of legal proceedings, including those relating to patent challenge settlements and patent infringement cases; the difficulty of predicting the timing of U.S. Food and Drug Administration, or FDA, approvals; court and FDA decisions on exclusivity periods; the ability of competitors to extend exclusivity periods past initial patent terms; market and customer acceptance and demand for our pharmaceutical products; reimbursement policies of third party payors; our ability to market our proprietary products; the successful integration of acquired businesses and products into our operations; the use of estimates in the preparation of our financial statements; the impact of competitive products and pricing; the ability to develop and launch new products on a timely basis; the availability of raw materials; availability of any product we purchase and sell as a distributor; the regulatory environment; fluctuations in operating results, including spending for research and development, sales and marketing and patent challenge activities; and, other risks detailed from time-to-time in our filings with the Securities and Exchange Commission, or SEC.

Forward-looking statements can be identified by the use of words such as "expects," "plans," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning. These statements are subject to risks and uncertainties that cannot be predicted or quantified and, consequently, actual results may differ materially from those expressed or implied by such forward-looking statement. The Company undertakes no obligation to publicly update any forward-looking statements.

NOTE TO EDITORS: Barr Laboratories, Inc. news releases are available free of charge through PR Newswire's News On-Call site at http://www.prnewswire.com/corp/089750.html. Barr news releases and corporate information are also available on Barr's website (www.barrlabs.com). For complete indications, warnings and contraindications, contact Barr Laboratories' Product Information Department at 1-800-Barr Lab. Cipro(R) is a registered trademark of Bayer Pharmaceuticals Corporation.

CONTACT:
Carol A. Cox
Barr Laboratories, Inc.
201-930-3720
ccox@barrlabs.com

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