ALLEGAN — Perrigo Co. (Nasdaq: PRGO) announced that it has filed with the U.S. Food and Drug Administration an Abbreviated New Drug Application for testosterone gel 1.62 percent and that it has notified AbbVie Inc., the owner of the Reference Listed Drug of its filing.
On Feb. 15, 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.”
Previously, on Nov. 2, Perrigo announced that it filed with the FDA a New Drug Application for testosterone gel 1.0% and that it notified Abbott Products Inc., the owner of the Reference Listed Drug of its filing.
From its beginnings as a packager of generic home remedies in 1887, Allegan-based Perrigo has grown to become a global provider of over-the-counter and generic prescription pharmaceuticals, infant formulas, nutritional products, pet health, dietary supplements and active pharmaceutical ingredients. The company is the world’s largest manufacturer of OTC pharmaceutical products for the store brand market. The company’s primary markets and locations of operations include the United States, Israel, Mexico, the United Kingdom, India, China and Australia.
More at www.perrigo.com.