Perrigo Company, a company develops, manufactures and distributes OTC and generic prescription pharmaceuticals, nutritional products and APIs, has filed with the US Food and Drug Administration (US FDA) an Abbreviated New Drug Application for desoximetasone topical spray 0.25 per cent and that it has notified Taro Pharmaceuticals USA, Inc., the owner of the Reference Listed Drug of its filing.
On July 28, 2014, Taro filed suit against Perrigo in the United States District Court for the District of Delaware, alleging patent infringement. This action formally initiates the process under the Hatch-Waxman Act. Perrigo believes that it is a first filer for this opportunity, entitling it to 180 days of generic exclusivity.
Topicort Topical Spray 0.25 per cent (desoximetasone topical spray 0.25 per cent) is a topical corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older. Annual sales were approximately $29 million, as measured by Symphony Health Solutions.
Perrigo's chairman, president and chief executive officer, Joseph C. Papa stated, "This filing highlights our continued investment in new products and dedication to bringing topicals to market. Perrigo is committed to making quality healthcare more affordable for consumers around the globe."