Valeant Pharmaceuticals International announced today that certain of its subsidiaries have entered into settlement agreements with affiliates of Actavis plc related to Actavis' generic versions of Acanya Gel, 1.2%/2.5%, and Tiazac XC.
Valeant's subsidiaries, Dow Pharmaceuticals Sciences, Inc. and Valeant Pharmaceuticals North America LLC, and Actavis' subsidiary, Watson Laboratories, Inc., entered into an agreement to settle all outstanding patent litigation related to Actavis' generic version of Acanya (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/2.5%.
Acanya Gel is a lincosamide antibiotic and benzoyl peroxide indicated for the topical treatment of acne vulgaris.
Under the terms of the agreement, Valeant will grant Actavis a license to market its generic Acanya Gel beginning July 1, 2018 or earlier under certain circumstances. Other details of the settlement were not disclosed. Launch of Actavis' generic product is contingent upon Actavis receiving final approval from the U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for generic Acanya Gel.
Additionally, Valeant's subsidiaries, Valeant Canada L.P. and Valeant International Bermuda, and Actavis Pharma Company have entered into an agreement to settle outstanding patent litigation related to Actavis' generic version of Tiazac XC (diltiazem hydrochloride) 180mg/240mg/300mg/360 mg capsules. Tiazac XC is a calcium cellular influx inhibitor (slow channel blocker) indicated for treatment of hypertension. It is marketed in Canada by Valeant Canada.
Under the terms of the agreement, which is pending approval from the Federal Court of Canada, it will result in a stay of this application until certain events occur and a dismissal of all remaining proceedings and appeals.