Actavis plc has filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to market doxylamine succinate and pyridoxine hydrochloride delayed-release tablets, 10 mg/10 mg. Actavis’ ANDA product is a generic version of Duchesnay Inc.’s Diclegis, which is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.

Duchesnay Inc. and Duchesnay USA Inc., filed suit against Actavis on July 10, 2014, in the US District Court for the District of Delaware 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 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.

Based on available information, Actavis believes it may be a “first applicant” to file an ANDA for the generic version of Diclegis and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.

Source: Actavis