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DUBLIN, Nov. 14, 2013 /PRNewswire/ -- Actavis plc (NYSE: ACT) today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Testosterone Topical Solution, 30mg/1.5mL. Actavis' ANDA product is a generic version of Eli Lilly and Company's Axiron
®, which is an androgen indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.
Eli Lilly and Company and Acrux DDS Pty Ltd. filed suit against Actavis on
November 12, 2013, in the U.S. District Court for the Southern District of
Indiana seeking to prevent Actavis from commercializing its ANDA product prior to the expiration certain of U.S. patents. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' ANDA for up to 30 months from the date the plaintiffs received notice of Actavis' ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
Based on available information, including a submission date listed on FDA's Paragraph IV Patent Certifications web site that is consistent with the date of Actavis' ANDA filing, Actavis believes it may be a "first applicant" to file an ANDA for a generic version of Axiron
® and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.
For the 12 months ending
September 30, 2013, Axiron
® had total U.S. sales of approximately
$257 million, according to IMS Health data.
Actavis plc (NYSE: ACT) is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products. Actavis has global headquarters in
Dublin, Ireland and U.S. administrative headquarters in
Parsippany, New Jersey, USA.
Actavis Pharma markets generic, branded generic, legacy brands and Over-the-Counter (OTC) products in more than 60 countries. Actavis Specialty Brands is a global branded specialty pharmaceutical business focused principally in the Urology and Women's Health therapeutic categories, as well as Gastroenterology and Dermatology. Actavis Specialty Brands also has a portfolio of five biosimilar products in development in Women's Health and Oncology. Actavis Global Operations has more than 30 manufacturing and distribution facilities around the world, and includes Anda, Inc., a U.S. pharmaceutical product distributor.