Watson confirms Abbott Niaspan patent challenge

USA-based Watson Pharmaceuticals (NYSE: WPI) has confirmed that its subsidiary, Watson Laboratories, filed an Abbreviated New Drug Application with the Food and Drug Administration seeking approval to market niacin extended-release tablets, 500mg and 1,000mg, generic versions of Niaspan, a cholesterol-lowerer marketed by health care major Abbott Laboratories (NYSE: ABT).

Abbott Laboratories and affiliate Abbott Respiratory filed suit against Watson on March 16, 2012, in the US 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 law suit 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.