Warner Chilcott settles with Zydus over generic Asacol HD

Zydus can launch drug in 2015 or 2016, depending on FDA approval

DUBLIN — A subsidiary of Actavis has reached a settlement with a generic drug maker that will allow the launch of a generic version of a treatment for ulcerative colitis in 2015.

Actavis said its Warner Chilcott subsidiary had settled with Zydus Pharmaceuticals USA and Cadila Healthcare over Zydus' generic version of Asacol HD (mesalamine) delayed-release tablets.

Financial terms of the deal were not disclosed, but Warner Chilcott will give Zydus a royalty-bearing license to market its generic product starting in November 2015, pending its approval by the Food and Drug Administration. If Zydus does not receive FDA approval, it will be allowed to market an authorized generic version of the drug starting in July 2016.

Asacol HD had sales of $122 million during the quarter that ended on June 30, according to Warner Chilcott.

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