AstraZeneca filed a lawsuit Oct. 26 to stop a subsidiary of Watson Pharmaceuticals, Watson Laboratories, from launching a generic version of its blockbuster cholesterol drug rosuvastatin (Crestor).
Watson filed a new drug application (NDA) under Section 505(b)(2) of the Federal Food and Drug Cosmetic Act with the FDA seeking approval to market rosuvastatin zinc 5, 10, 20 and 40 mg tablets.
The Morristown, N.J.-based Watson said its rosuvastatin zinc tablets are a new salt version of AstraZeneca's Crestor tablets, which is indicated, as an adjunct to diet, to lower LDL cholesterol, raise HDL cholesterol and slow the progression of atherosclerosis.
The London-based AstraZeneca filed suit against Watson in the U.S. District Court for the District of Delaware seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent No. RE 37,314 in 2016.
AstraZeneca's lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's NDA until March 30, 2013, or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
For the twelve months prior to June 30, Crestor had total U.S. sales of approximately $3.5 billion according to IMS Health data.