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Barr filed its Abbreviated New Drug Application (ANDA) containing aparagraph IV certification for a generic Focalin XR product with the U.S. Food& Drug Administration (FDA) in June 2007, and received notification of theapplication's acceptance for filing in October 2007. Following receipt of thenotice from the FDA that Barr's ANDA had been accepted for filing, Barrnotified the New Drug Application (NDA) and patent holder.
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On November 16, 2007, Elan Corporation, PLC and Elan Pharma InternationalLtd. filed suit in the U.S. District Court for the District of Delaware toprevent Barr from proceeding with the commercialization of its product. Thisaction formally initiates the patent challenge process under the Hatch-WaxmanAct.
Focalin XR (dexmethylphenidate hydrochloride) extended-release capsulesare indicated for the treatment of Attention Deficit Hyperactivity Disorder(ADHD) in patients aged 6 years and older. The product had sales ofapproximately $252 million in the U.S., based on IMS sales data endingSeptember 2007.
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.
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 or non-infringement of patents covering our products; the difficulty of predictingthe timing of FDA approvals; court and FDA decisions on exclusivity periods;the ability of competitors to extend exclusivity periods for their products;our ability to complete product development activities in the timeframes andfor the costs we expect; market and customer acceptance and demand for ourpharmaceutical products; our dependence on revenues from significantcustomers; reimbursement policies of third party payors; our dependence onrevenues from significant products; the use of estimates in the preparation ofour financial statements; the impact of competitive products and pricing onproducts, including the launch of authorized generics; the ability to launchnew products in the timeframes we expect
