Barr Confirms Patent Challenge of Prevacid(R) SoluTab(TM) Delayed-Release Orally Disintegrating Tablets, 15mg and 30mg
Barr filed its Abbreviated New Drug Application (ANDA) containing aparagraph IV certification for a generic Prevacid SoluTab product with theU.S. Food & Drug Administration (FDA) in November 2007. Following receipt ofthe notice from the FDA that Barr's ANDA had been accepted for filing, Barrnotified the New Drug Application (NDA) and patent holder.
On June 9, 2008, Ethypharm, S.A., Takeda Pharmaceutical Co., Ltd. and TAPPharmaceuticals Inc. filed suits in the U.S. District Court for the Districtof Delaware to prevent Barr from proceeding with the commercialization of itsproduct. This action formally initiates the patent challenge process under theHatch-Waxman Act.
Prevacid SoluTab (lansoprazole) had annual sales of approximately $428million in the U.S., based on IMS sales data for the 12-month period endingMarch 2008.
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 120 generic and 27proprietary products in the U.S. and approximately 1,025 products globallyoutside of the U.S. For more information, visit www.barrlabs.com.
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 and our forecasts; the impact of competitive productsand pricing on products, including the launch of authorized generics; theability to launch new products in the timeframes we expect; the availabilityof raw materials; the availability of any product we purchase and sell as adistributor; the regulatory environment in the markets where we operate; ourexposure to product liab
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