Watson Pharmaceuticals Inc. (WPI) confirmed that its unit, Watson Laboratories Inc., Florida, filed an Abbreviated New Drug Application or ANDA with the U.S. Food and Drug Administration or 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 a suit against Watson on March 16, 2012, in the U.S. 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.
According to IMS Health data, NIASPAN had total U.S. sales of nearly $1.2 billion.
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