July 29, 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 Tapentadol Extended-release Tablets 50 mg, 100 mg, 150 mg and 200 mg. Actavis' ANDA product is a generic version of Janssen Pharmaceuticals, Inc.'s Nucynta
ER, which is approved for the management of moderate to severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
Janssen Pharmaceuticals, Inc. and Grunenthal GMBH filed suit against Actavis on
July 25, 2013
in the U.S. District Court for the District of
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 until
May 20, 2016
, or 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 Nucynta
ER and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.
For the 12 months ending
May 31, 2013
ER 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. Actavis has global headquarters in
Parsippany, New Jersey
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.