Generic

Actavis Seeks FDA Approval for Generic Letairis; Gilead Files Lawsuit

Source: Zacks

Apr 08, 2015

Actavis plc is seeking FDA approval for its generic version of Gilead Sciences' Letairis, a pulmonary arterial hypertension treatment, and Gilead has filed a patent infringement lawsuit.

Gilead and Royalty Pharma Collection Trust filed a patent infringement lawsuit against Actavis in the U.S. District Court for the District of Delaware, which will prevent the FDA from granting final approval for Actavis's generic for up to 30 months or until the court resolves the matter.

According IMS Health, Letairis global sales were $595 million in 2014.

Last November, Actavis announced its acquisition of Allergan for approximately $66 billion, placing Allergan among the top 10 global pharmaceutical companies.

Read the Zacks press release