Actavis confirms generic Treanda patent challenge
US generics drug major Actavis (NYSE: ACT) confirms that it has filed an Abbreviated New Drug Application with the US Food and Drug Administration for approval to market a generic version of Cephalon’s Treanda (bendamustine hydrochloride for Injection, 25mg/vial and 100mg/vial), a treatment for chronic lymphocytic leukemia and non-Hodgkin's lymphoma.
Cephalon, now a subsidiary of Israel’s Teva Pharmaceutical Industries (NYSE: TEVA) 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 law suit 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.
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