By Nathalie Tadena
Watson Pharmaceuticals Inc. (WPI) said it has filed an
abbreviated new-drug application with the U.S. Food and Drug
Administration to market a generic version of Pfizer Inc.'s (PFE)
Pristiq antidepressant.
Watson said Pfizer Friday filed suit against the company
concerning its patents on Pristiq. Watson said the lawsuit could
result in a stay of final FDA approval until August 2015.
Watson said it believes it may be a "first applicant" to file an
abbreviated new-drug application for Pristiq and may be entitled to
180 days of market exclusivity, if the application is approved.
Pristiq was approved in the U.S. in 2008 as a treatment for
major depressive disorder in adults. Pfizer inherited Pristiq with
its 2009 acquisition of Wyeth.
Watson has benefited from the introduction of a generic version
of Pfizer's blockbuster cholesterol drug Lipitor and its
introduction of authorized generic versions of Johnson &
Johnson's (JNJ) Concerta treatment for
attention-deficit/hyperactivity last year.
In April, Watson reported its first-quarter earnings rose 22% as
it recorded sharply higher revenue with a boost from new generic
drugs and as its branded pharmaceuticals and distribution business
also posted double-digit growth.
Shares closed at $71.72 Monday and were unchanged after hours.
The stock is up 19% since the start of the year.
Write to Nathalie Tadena at nathalie.tadena@dowjones.com