Actavis, Inc., and Valeant Pharmaceuticals International, Inc., today announced that Actavis has reached settlement agreements with Medicis Pharmaceutical Corporation, a subsidiary of Valeant Pharmaceuticals International, Inc., resolving 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 terms of the agreement related to Actavis' generic version of Ziana, Actavis may launch its generic product in July 2016, or earlier under certain circumstances.
Under the terms of the agreement related to Actavis' generic version of Zyclara, Actavis may launch its generic product 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. Other terms of the agreements have not been disclosed.
Ziana is a lincosamide antibiotic and retinoid combination product indicated for the topical treatment of acne vulgaris in patients 12 years or older. Zyclara is a prescription medicine for skin use only to treat actinic keratosis on the full face or balding scalp in adults with a normal immune function.