Actavis Confirms Generic Onglyza Patent Challenge

Actavis plc has filed an Abbreviated New Drug Application (ANDA) with FDA seeking approval to market Saxagliptin Hydrochloride Tablets, 2.5 mg and 5 mg. Actavis' ANDA product is a generic version of AstraZeneca and Bristol-Myers Squibb's Onglyza, which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

AstraZeneca AB filed suit against Actavis on 23 May 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 US Patent No. 7,951,400. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' ANDA until 31 January 2017, 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 Onglyza and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.

For the 12 months ending 28 February 2014, Onglyza had total US sales of approximately $532 million, according to IMS Health data.