, March 1, 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 Testosterone gel 10mg/0.5g. Actavis' ANDA product is a generic version of Endo Pharmaceuticals' Fortesta
, which is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.
Endo and Strakan International S.a r.l. filed suit against Actavis on
February 28, 2013
, in the U.S. District Court for the Eastern District of
Marshall Division seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of certain 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, Actavis believes it may be a "first applicant" to file an ANDA for the generic version of Fortesta
and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.
For the 12 months ending
December 31, 2012
had total U.S. sales of approximately
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. The Company has global and U.S. headquarters in
Parsippany, New Jersey
, USA, and international headquarters in Zug, Switzerland.
Actavis is the world's third-largest generics prescription drug manufacturer. Operating as Actavis Pharma, the Company develops, manufactures and markets generic, branded generic, legacy brands and Over-the-Counter (OTC) products in more than 60 countries. The Company is ranked in the top 3 in 12 global markets, the top 5 in 16 global markets, and in the top 10 in 33 global markets. Actavis Pharma also develops and out-licenses generic pharmaceutical products outside the U.S. through its Medis third-party business, the world's largest generic pharmaceutical out-licensing business. Medis has more than 300 customers globally, and offers a broad portfolio of more than 200 products.