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Perrigo Confirms First to File Patent Challenge for Generic Version of Aveed®

25-Nov-2014 | Source : AG-IP News | Visits : 5533
DUBLIN - Perrigo Company plc today announced in a press release that it has filed with the US Food and Drug Administration (FDA) an Abbreviated New Drug Application for testosterone undecanoate injection and that it has notified the owner of the Reference Listed Drug of its filing.

On November 20, 2014, Endo Pharmaceuticals Solutions Inc., Bayer Intellectual Property GmbH and Bayer Pharma AG 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 confirms that it is a first filer for this opportunity, entitling it to 180 days of generic exclusivity.
Aveed® (testosterone undecanoate) injection is a schedule II controlled substance indicated for testosterone replacement therapy in adult males for the conditions associated with a deficiency or absence of endogenous testosterone of primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired).
 
Perrigo's Chairman, President and CEO Joseph C. Papa stated, "This filing highlights our continued investment in bringing new products to market. Perrigo is committed to making quality healthcare more affordable for consumers around the world."

From its beginnings as a packager of generic home remedies in 1887, Perrigo Company plc, headquartered in Ireland, has grown to become a leading global healthcare supplier. Perrigo develops, manufactures and distributes over-the-counter (OTC) and generic prescription (Rx) pharmaceuticals, nutritional products and active pharmaceutical ingredients (API), and receives royalties from Multiple Sclerosis drug Tysabri®. The Company is the world's largest manufacturer of OTC healthcare products for the store brand market and an industry leader in pharmaceutical technologies. Perrigo's mission is to offer uncompromised "Quality Affordable Healthcare Products®" and it does so across a wide variety of product categories primarily in the United States, United Kingdom, Mexico, Israel and Australia, as well as more than 40 other key markets worldwide, including Canada, China and Latin America. Visit Perrigo on the Internet (http://www.perrigo.com).
 
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