Actavis, Inc., a global, integrated specialty pharmaceutical company, has filed an Abbreviated New Drug Application (ANDA) with the US 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 US District Court for the District of New Jersey seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of certain US 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, Nucynta ER had total US sales of approximately $86 million according to IMS Health data.