ALLEGAN — Perrigo Co. (Nasdaq: PRGO) announced that it has filed with the United States Food and Drug Administration a New Drug Application for testosterone gel 1.0 percent and that it has notified Abbott Products Inc., the owner of the Reference Listed Drug of its filing.
On Oct. 31, Abbott filed suit against Perrigo in the United States District Court for the District of New Jersey, alleging patent infringement. This action formally initiates the process under the Hatch-Waxman Act.
Androgel 1.0% (testosterone gel 1.0%) is indicated to treat adult males who have low or no testosterone. Annual sales were approximately $900 million annually, as measured by Wolters Kluwer Health.
Said Perrigo’s Chairman and CEO Joseph C. Papa: “This filing is another example of our investment in new products and expansion of our extended topicals pipeline. As always, Perrigo is committed to making quality healthcare more affordable for our customers.”
Perrigo develops, manufactures and distributes over-the-counter and generic prescription pharmaceuticals, infant formulas, nutritional products, and active pharmaceutical ingredients. The company is the world’s largest manufacturer of OTC pharmaceutical products and infant formulas, both for the store brand market. The company’s primary markets and locations of manufacturing and logistics operations are the United States, Israel, Mexico, the United Kingdom and Australia.
More at www.perrigo.com.