Actavis Confirms Patent Challenge With Gilead Sciences To Market Ambrisentan

(RTTNews) - Actavis plc (ACT) confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. FDA seeking approval to market Ambrisentan Tablets, 5 mg and 10 mg. The company's ANDA product is a generic version of Gilead Sciences, Inc.'s Letairis, which is a treatment for pulmonary arterial hypertension.

Gilead Sciences Inc. and Royalty Pharma Collection Trust filed suit against the company on April 1, 2015 seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of their U.S. Patent. The lawsuit resulted in a stay of final FDA approval of Actavis' ANDA for up to 30 months or until final resolution of the matter before the court, whichever occurs sooner.