ALLEGAN — Perrigo Co. (Nasdaq: PRGO) announced that it has filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration for testosterone topical solution, the generic version of Axiron Topical Solution.
Perrigo also announced that it has received final approval for the generic version of Sanctura XR. Perrigo had previously prevailed in litigation at both the district and appellate levels. The product has begun shipping immediately.
Perrigo previously notified Eli Lilly, the owner of the New Drug Application and Acrux DDS Pty Ltd., owners of patents listed in FDA’s Orange Book and Lilly and Acrux filed suit in the United States District Court for the Southern District of Indiana on May 24. To our knowledge Perrigo is the only company that has been sued at this time.
Axiron topical solution (testosterone) is a prescription medicine used to treat adult males who have low or no testosterone. Annual sales were approximately $229 million annually, as measured by Symphony Health Solutions.
“This filing is another example of our long-term investment in bringing new products to market,” said Perrigo chairman and CEO Joseph C. Papa. “As always, Perrigo is committed to making quality healthcare more affordable for our customers.”
Meanwhile, Sanctura XR (Trospium Chloride Extended-release Capsules, 60 mg), is a once-daily medication for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency. It has annual sales of approximately $54 million, as measured by Symphony Health Solutions.
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, animal 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 logistics operations have evolved over the years to include the United States, Israel, Mexico, the United Kingdom, India, China and Australia.
More at www.perrigo.com.