PARSIPPANY, N.J., March 19, 2012 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc. – Florida, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Niacin Extended-release Tablets, 500 mg and 1000 mg. Watson's ANDA products are generic versions of Abbott Laboratories' NIASPAN®.
Abbott Laboratories and Abbott Respiratory LLC filed suit against Watson on March 16, 2012, in the United States District Court for the District of Delaware seeking to prevent Watson from commercializing its ANDA products prior to the expiration of U.S. Patent Nos. 6,080,428 and 6,469,035. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA for up to 30 months from the date the plaintiffs received notice of Watson's ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
For the twelve months ending January 31, 2012, NIASPAN® had total U.S. sales of approximately $1.2 billion according to IMS Health data.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. is a leading integrated global pharmaceutical company. The Company is engaged in the development 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.
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|SOURCE Watson Pharmaceuticals, Inc.|
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