Perrigo Company has filed with the US Food and Drug Administration (FDA) an Abbreviated New Drug Application (ANDA) for butoconazole nitrate vaginal cream, 2 per cent and has notified KV Pharmaceutical Company, the owner of the New Drug Application (NDA) as well as FemmePharma, the listed owner of the patent, of its ANDA filing. KV is a licensee under the patent. Perrigo believes it is first-to-file on this product.
On July 29, 2010, KV Pharmaceutical Company filed suit in the United States District Court for the District of Delaware, alleging patent infringement to prevent Perrigo from proceeding with the commercialization of this product. This action formally initiates the process under the Hatch-Waxman Act. The suit also named FemmePharma as a defendant as it had not agreed to join KV as a plaintiff in the suit.
Gynazole·1 (butoconazole nitrate) vaginal cream, 2 per cent is indicated for the local treatment of vulvovaginal candidiasis (infections cause by Candida). Prior to its being discontinued in January 2009 due to manufacturing issues at KV, its annual sales were approximately $28 million annually, as measured by Wolters Kluwer Health.
Perrigo's Chairman and CEO Joseph C. Papa stated, "This filing is another example of our investment in new products and expansion of our product portfolio. The first to file status also reflects Perrigo's continued focus on being first to market with new products. As always, Perrigo is committed to making quality healthcare more affordable for our customers."
Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription (Rx) pharmaceuticals, nutritional products, and active pharmaceutical ingredients (API), and pharmaceutical and medical diagnostic products.