SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Dec. 9, 2020 /PRNewswire/ — United Therapeutics Corporation (Nasdaq: UTHR) announced today that the United States Food and Drug Administration (FDA) has granted orphan drug designation to treprostinil for the treatment of patients with idiopathic pulmonary fibrosis (IPF). United Therapeutics intends to initiate a phase 3 study, called TETON, to evaluate the use of Tyvaso® (treprostinil) Inhalation Solution in patients with IPF. FDA recently cleared United Therapeutics’ investigational new drug application (IND) for the TETON study, and the company expects to commence enrollment in 2021. Orphan drug designation is the first step in receiving orphan drug exclusivity following approval, which confers seven years of market exclusivity for the relevant indication. This exclusivity would also benefit Treprostinil Technosphere®, United Therapeutics’ next-generation dry powder inhalation form of treprostinil, upon FDA approval of that product for the IPF indication.