Watson confirms patent challenge for generic Pataday

PARSIPPANY, N.J. — Watson Pharmaceuticals has filed a regulatory approval application with the Food and Drug Administration for a generic drug for eye disease, the company said Tuesday.

Watson is seeking approval for olopatadine hydrochloride ophthalmic solution in the 0.2% strength. The drug, used to treat itching in the eye resulting from allergic conjunctivitis, is a generic version of Alcon’s Pataday.

Alcon, along with biotechnology company Kyowa Hakko Kirin, sued Watson last Thursday in the U.S. District Court for the Southern District of Indiana, alleging that Watson’s regulatory filing infringes two of their patents. Under the Hatch-Waxman Act of 1984, the FDA can’t give final approval until October 2013, or until both companies reach a settlement. The two patents are scheduled to expire between 2015 and 2024.

Pataday had sales of $224 million during the 12-month period ended in April, according to IMS Health.

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