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 ph
|SOURCE Watson Pharmaceuticals, Inc.|
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