Actavis Announces Acanya Gel Patent Challenge Settlement

May 12, 2014

Actavis plc has entered into an agreement with Valeant Pharmaceuticals International to settle all outstanding patent litigation related to the 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 in July 1, 2018 or earlier under certain circumstances.  Other details of the settlement were not disclosed.

Launch of Actavis is contingent upon Actavis receiving final FDA approval on its Abbreviated New Drug Application (ANDA) 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 ending February 28, 2014, Acanya had total US sales of approximately $121 million, according to IMS Health data.

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