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PARSIPPANY, N.J., and MONTREAL — Actavis Inc. plans to launch generic versions of Ziana and Zyclara through an agreement with Medicis Pharmaceutical Corp., a subsidiary of Valeant Pharmaceuticals International Inc.
Actavis said Wednesday that it has reached settlement agreements with Medicis that resolve outstanding patent litigation related to Actavis’ Abbreviated New Drug Application (ANDA) for clindamycin and tretinoin gel, a generic version of Ziana, as well as Actavis’ ANDA for imiquimod cream, a generic version of Zyclara.
Under the agreement related to Actavis’ generic version of Ziana, Actavis can launch its generic product in July 2016 or earlier under certain circumstances. With the agreement for Actavis’ generic version of Zyclara, Actavis may roll out its generic on Jan. 1, 2019, or earlier under certain circumstances.
Valeant will receive a share of the economics from the generic products sold under the agreements, according to Actavis.
Ziana is indicated for the topical treatment of acne vulgaris in patients 12 years or older. Zyclara is a prescription medicine for skin use to treat actinic keratosis on the full face or balding scalp in adults with a normal immune function.
