Actavis challenes Gilead PAH drug patent

Ireland-headquartered generics 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 ambrisentan tablets, a generic version of Gilead Sciences' (Nasdaq: GILD), Letairis, which is a treatment for pulmonary arterial hypertension (PAH).

Gilead and Royalty Pharma Collection Trust filed suit against Actavis on April 1, 2015, 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 number RE42,462. 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.

Patent expiries in USA and Europe