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The FDA approved the Company's application on February 6, 2008, followingthe expiration of pediatric exclusivity associated with the earliest to expireof the patents listed with the FDA for Fosamax, 70 mg tablets. Barr obtainedfavorable resolutions with regard to the other patents listed for thisproduct. Barr is entitled to share 180 days of marketing exclusivity for its70 mg Alendronate Sodium product. This exclusivity bars the entry ofcompetition for this product against generic competitors, other than anauthorized generic and another company with which Barr shares exclusivity.
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"Barr is pleased to be able to provide people suffering from osteoporosisand Paget's disease with a more affordable generic alternative," said Bruce L.Downey, Barr's Chairman and Chief Executive Officer. "This is particularlycritical as our elderly population increases and seeks to maintain theirquality of life in their advanced years."
Barr's Alendronate Sodium product is indicated for the treatment andprevention of osteoporosis in postmenopausal women; for the treatment toincrease bone mass in men with osteoporosis; for the treatment ofglucocorticoid-induced osteoporosis in men and women receiving glucocorticoidsin a daily dosage equivalent to 7.5 mg or greater of prednisone and who havelow bone mineral density; and for the treatment of Paget's disease of bone inmen and women.
Fosamax Tablets, 70 mg had annual sales of approximately $1.7 billion inthe United States, based on IMS sales data for the 12 months ending November2007.
About Barr Pharmaceuticals, Inc.
Barr Pharmaceuticals, Inc. is a global specialty pharmaceutical companythat operates in more than 30 countries worldwide and is engaged in thedevelopment, manufacture and marketing of generic and proprietarypharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients. Aholding company, Barr operates through its principal subsidiaries: BarrLaboratories, Inc., Duramed Pharmaceuticals, Inc. and PLIVA d.d. and itssubsidiaries. The Barr Group of companies markets more than 115 generic and 25proprietary products in the U.S. and more than 1,200 products globally outsideof the U.S. For more information, visit www.barrlabs.com.
Forward-Looking Statements
Except for the historical information contained herein, the statementsmade in this press release constitute forward-looking statements within themeaning of Section 27A of the Securities Act of 1933 and Section 21E of theSecurities Exchange Act of 1934. Forward-looking statements can be identifiedby their use of words such as "expects," "plans," "projects," "will," "may,""anticipates," "believes," "should," "intends," "estimates" and other words ofsimilar meaning. Because such statements inherently involve risks anduncertainties that cannot be predicted or quantified, actual results maydiffer materially from those expressed or implied by such forward-lookingstatements depending upon a number of factors affecting the Company'sbusiness. These factors include, among others: the difficulty in predictingthe timing and outcome of legal proceedings, including patent-related matterssuch as patent challenge settlements and patent infringement cases; theoutcome of litigation arising from challenging the validity ornon-infringement of patents covering our products; the difficulty ofpredicting the timing of FDA approvals; court and FDA decisions on exclusivityperiods; the ability of competitors to extend exclusivity periods for theirproducts; our ability to complete product development activities in thetimeframes and for th
