Watson Pharmaceuticals, Inc. confirmed
that its subsidiary, Watson Laboratories, Inc., filed a new drug
application under Section 505(b)(2) of the Federal Food and Drug
Cosmetic Act (FFDCA) with the US Food and Drug Administration (FDA)
seeking approval to market rosuvastatin zinc 5, 10, 20 and 40 mg
tablets. Watson's rosuvastatin zinc tablets are a new salt version of
AstraZeneca's Crestor tablets. Crestor is indicated, as an adjunct to
diet, to lower LDL cholesterol, raise HDL cholesterol, and slow the
progression of atherosclerosis.
AstraZeneca filed suit against Watson
on October 26, 2010 in the United States District Court for the
District of Delaware seeking to prevent Watson from commercializing
its product prior to the expiration of US Patent No. RE 37,314.
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 ending June 30,
2010, Crestor had total US sales of approximately $3.5 billion
according to IMS Health data.
Watson Pharmaceuticals, Inc. is a
leading global specialty pharmaceutical company. The company is
engaged in the development, manufacturing, marketing and distribution
of generic pharmaceuticals and specialized branded pharmaceutical
products focused on Urology and Women's Health.