Actavis, Inc. 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 Propofol Injection 10mg/mL. Actavis’ ANDA product is a generic version of Fresenius Kabi’s Diprivan, which is an intravenously administered sedative and anesthetic.
Fresenius Kabi USA, LLC filed suit against Actavis on June 6, 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 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.
For the 12 months ending April 30, 2013, brand and generic versions of Diprivan had total U.S. sales of approximately $212 million according to IMS Health data.
