DUBLIN — Actavis on Tuesday confirmed that it has filed an abbreviated new drug application with the Food and Drug Administration 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 May 23, 2014 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 U.S. 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 Jan. 31, 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 Feb. 28, 2014, Onglyza had total U.S. sales of approximately $532 million, according to IMS Health data.