Florida based Watson Laboratories Inc., a subsidiary of Watson Pharmaceuticals Inc. has filed an Abbreviated New Drug Application (ANDA) with the US 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, 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 US 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, Niaspan had total US sales of approximately $1.2 billion according to IMS Health data.
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.