Actavis plc, 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 bendamustine hydrochloride for injection, 25 mg/vial and 100 mg/vial. Actavis' ANDA product is a generic version of Cephalon's Treanda, a treatment for chronic lymphocytic leukaemia and non-Hodgkin's lymphoma.

Cephalon, Inc. filed suit against Actavis on January 31, 2014, in the US District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration certain of 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 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 September 30, 2013, Treanda had total US sales of approximately $682 million, according to IMS Health data.

Actavis plc is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products.