DUBLIN, Feb. 7, 2017 /PRNewswire/ -- Perrigo Company plc (NYSE; TASE: PRGO) announced that it 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."
Perrigo Company plc, a leading global over-the-counter ("OTC") consumer goods and pharmaceutical company, offers patients and customers high quality products at affordable prices. From its beginnings in 1887 as a packager of home remedies, Perrigo, headquartered in Ireland, has grown to become the world's largest manufacturer of OTC healthcare products and supplier of infant formulas for the store brand market. The Company is also a leading provider of generic extended topical prescription products and receives royalties from the sales of the multiple sclerosis drug Tysabri®. Perrigo provides Quality Affordable Healthcare Products® across a wide variety of product categories and geographies primarily in North America, Europe, and Australia, as well as other markets, including Israel, China and Latin America.
Certain statements in this press release are "forward-looking statements." These statements relate to future events or the Company's future financial performance and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "potential" or the negative of those terms or other comparable terminology. The Company has based these forward-looking statements on its current expectations, assumptions, estimates and projections. While the Company believes these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond the Company's control, including the timing, amount and cost of share repurchases, future impairment charges, the ability to achieve its guidance and the ability to execute and achieve the desired benefits of announced initiatives. These and other important factors, including those discussed under "Risk Factors" in the Company's Form 10-KT for the six-month period ended December 31, 2015, as well as the Company's subsequent filings with the SEC, may cause actual results, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. The forward-looking statements in this press release are made only as of the date hereof, and unless otherwise required by applicable securities laws, the Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/perrigo-confirms-patent-challenge-for-generic-version-of-onexton-gel-300403304.html
SOURCE Perrigo Company plc