Watson faces patent challenge over generic Vigamox
PARSIPPANY, N.J. — Watson announced that its subsidiary is seeking approval to market a generic version of a bacterial conjunctivitis treatment.
Watson Labs filed an abbreviated new drug application with the Food and Drug Administration for moxifloxacin hydrochloride ophthalmic solution USP in the 0.5% strength. The antibiotic solution is a generic version of Alcon's Vigamox, which had total U.S. sales of about $281 million ended in February, according to IMS Health.
On Thursday, Alcon and Alcon Research filed suit against the generic drug maker in the U.S. District Court for the District of Delaware seeking to prevent Watson from commercializing its product prior to the expiration of its patents for Vigamox.
Alcon's lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's abbreviated new drug application until Sept. 1, 2013, or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.