Actavis challenges AstraZeneca’s diabetes drug Onglyza patent in the USA

Generics major Actavis (NYSE: ACT) yesterday confirmed that it has filed an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval to market a generic version of Anglo-Swedish pharma company AstraZeneca’s (LSE: AZN) type 2 diabetes drug Onglyza (saxagliptin).

Actavis says AstraZeneca filed suit against the Ireland-headquartered company on May 23, 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 law suit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' ANDA until January 31, 2017, or final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.

Based on currently available information, Actavis says it 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.