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June 5, 2013 /PRNewswire/ -- Actavis, Inc. (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 Drospirenone/Ethinyl Estradiol/Levomefolate Calcium Tablets And Levomefolate Calcium Tablets. Actavis' ANDA product is a generic version of Bayer's Safyral
®, which is approved to prevent pregnancy in women who elect to use an oral contraceptive, and to provide a daily dose of folate supplementation.
Merck & CIE, Bayer Pharma AG and Bayer Healthcare Pharmaceuticals Inc. filed suit against Actavis on
June 4, 2013, in the U.S. District Court for the District of
Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of U.S. patent no. 6441168 (the '168 patent). 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, Actavis believes it may be a "first applicant" to file an ANDA for the generic version of Safyral
® and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.
For the 12 months ending
April 30, 2013, Safyral
® had total U.S. sales of approximately
$19 million according to IMS Health data.
Actavis, Inc. (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
Parsippany, New Jersey, USA.
Operating as Actavis Pharma, Actavis develops, manufactures and markets generic, branded generic, legacy brands and Over-the-Counter (OTC) products in more than 60 countries. Actavis Specialty Brands is Actavis' global branded specialty pharmaceutical business focused in the Urology and Women's Health therapeutic categories. 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.