Perrigo Company has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for clindamycin, benzoyl peroxide topical gel, the generic version of Onexton® gel (clindamycin phosphate 1.2% and benzoyl peroxide 3.75%). Perrigo has notified Valeant Pharmaceuticals North America LLC and Dow Pharmaceutical Sciences, Inc. (Valeant) the owner of both the New Drug Application and patents listed in FDA's Orange Book, of its filing.
On February 3, 2017, Valeant filed suit in the United States District Court for the District of New Jersey alleging patent infringement. This action formally initiates the litigation process under the Hatch-Waxman Act.
Onexton® gel (clindamycin phosphate 1.2% and benzoyl peroxide 3.75%) is a prescription medicine indicated for the once-daily treatment of comedonal (non-inflammatory) and inflammatory acne. Branded sales for the 12 months ending December 2016 were approximately $139 million.
Perrigo's CEO John T. Hendrickson stated, "This filing demonstrates Perrigo's commitment to providing Quality Affordable Healthcare Products® to our customers and consumers around the world. The Rx team continues to invest in the development of important products that drive savings for patients and the healthcare system."