Perrigo Company, the largest manufacturer of private label over-the-counter pharmaceuticals in the United States, has filed with the US Food and Drug Administration (FDA) an Abbreviated New Drug Application for testosterone gel 1.62% and that it has notified AbbVie Inc., the owner of the Reference Listed Drug of its filing.
On February 15, 2013, the Unimed Pharmaceuticals subsidiary of AbbVie and Besins Healthcare 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.
Androgel 1.62% (testosterone gel 1.62%) is indicated to treat males who have low or no testosterone. Annual sales were approximately $680 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 continued focus on bringing extended topicals to market. As always, Perrigo is committed to making quality healthcare more affordable for our customers and consumers."