DUBLIN — Actavis on Monday announced that it has entered into an agreement with Valeant Pharmaceuticals International 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' product is contingent upon Actavis receiving final approval from the Food and Drug Administration on its abbreviated new drug application for generic Acanya Gel. Based on available information, Actavis believes it may be a "first applicant" to file an ANDA for the generic version of Acanya Gel and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.
For the 12 months ended Feb. 28, Acanya had total U.S. sales of approximately $121 million, according to IMS Health data.