- Paragraph IV Litigation Underway -
MORRISTOWN, N.J., March 25, 2011 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiaries, Andrx Labs, LLC and Watson Laboratories, Inc. -- Florida, (collectively "Watson") filed Abbreviated New Drug Applications (ANDAs) with the U.S. Food and Drug Administration (FDA) seeking approval to market Oxycodone Hydrochloride Extended-Release tablets in the 10,15, 20, 30, 40, 60 and 80 mg strengths. Watson's Oxycodone Hydrochloride Extended-Release tablets are a generic version of Purdue Pharma's OxyContin®, which are indicated for the management of moderate to severe pain when continuous, around-the-clock opioid analgesic is needed for an extended period of time.
Purdue Pharma L.P. filed suit against Watson on March 23, 2011 in the United States District Courts for the Southern District of New York, District of Delaware and Southern District of Florida seeking to prevent Watson from commercializing their products prior to the expiration of U.S. Patents Nos. 6,488,963, 7,674,799, 7,674,800, 7,683,072 and 7,776,314. Purdue Pharma's lawsuits were filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDAs until August, 2013, or until final resolution of the matters before the courts, whichever occurs sooner, subject to any other exclusivities.
Based on available information, Watson believes it may be the first applicant to file ANDAs for several strengths of OxyContin® and, should the ANDAs be approved, may be entitled to 180 days of generic market exclusivity.
For the twelve months ending December 31, 2010, OxyContin® had total U.S. sales of approximately $3.1 billion according to IMS Health data.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. is an integrated global specialty pharmaceutical company. The Company is engaged in the development, manufacturing, marketing and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on Urology and Women's Health. Watson has operations in many of the world's established and growing international markets.
For press release and other company information, visit Watson Pharmaceuticals' Web site at http://www.watson.com.
Statements contained in this press release that refer to non-historical facts are forward-looking statements that reflect Watson's current perspective of existing information as of the date of this release. It is important to note that Watson's goals and expectations are not predictions of actual performance. Actual results may differ materially from Watson's current expectations depending upon a number of factors, risks and uncertainties affecting Watson's business. These factors include, among others, the difficulty of predicting the timing and outcome of the pending patent litigation; the difficulty of predicting the timing or outcome of product development efforts, including FDA and other regulatory agency approvals and actions, if any; the impact of competitive products and pricing; the timing and success of product launches; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations applicable to Watson and its third party manufacturers' facilities, products and/or businesses; changes in the laws and regulations, including Medicare and Medicaid, affecting among other things, pricing and reimbursement of pharmaceutical products; and such other risks and uncertainties detailed in Watson's periodic public filings with the Securities and Exchange Commission, including but not limited to Watson's annual report on Form 10-K for the year ended December 31,2010. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.
OxyContin® is a trademark of Purdue Pharma L.P.
SOURCE Watson Pharmaceuticals, Inc.