PARSIPPANY, N.J. — Watson Pharmaceuticals is challenging the patent protection on a drug made by Abbott for treating cholesterol, the company said.
Watson, through a subsidiary, filed with the Food and Drug Administration for approval of niacin extended-release tablets in the 500-mg and 1,000-mg strengths. The drug is a generic version of Abbott's Niaspan.
Abbott filed a lawsuit against Watson Friday in the U.S. District Court for the District of Delaware to try and prevent Watson from commercializing its drug before the expiration of two of Abbott's patents, set to take place in May 2017 and March 2018, according to the FDA. Under the Hatch-Waxman Act of 1984, the law that created an abbreviated approval pathway for generic pharmaceuticals, the lawsuit puts a stay of final FDA approval on Watson's drug that will last for 30 months or until the two companies reach a settlement.
Niaspan had sales of about $1.2 billion during the 12-month period ended in January, according to IMS Health.