ORENITRAM

Peak

treprostinil

NDAORALTABLET, EXTENDED RELEASE
Approved
Dec 2013
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20

Mechanism of Action

beds, inhibition of platelet aggregation, and inhibition of smooth muscle cell proliferation.

Pharmacologic Class:

Prostacycline Vasodilator

Clinical Trials (5)

NCT07234032Phase 3Not Yet Recruiting

An Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

Started Apr 2026
344 enrolled
Pulmonary HypertensionInterstitial Lung Disease
NCT07179380Phase 3Recruiting

Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

Started Jan 2026
344 enrolled
Pulmonary HypertensionInterstitial Lung Disease
NCT07116681Phase 1Not Yet Recruiting

Effects of Inhaled Treprostinil on Exercise Performance in Exercise Induced Pulmonary Hypertension

Started Oct 2025
8 enrolled
Pulmonary Hypertension
NCT07037836Phase 2Recruiting

Inhaled Treprostinil (Tyvaso Nebulizer) For COPD Patients With Hypoxemia

Started Sep 2025
10 enrolled
COPD (Chronic Obstructive Pulmonary Disease)Hypoxemia
NCT07102316Phase 1Completed

A Study to Assess the Relative Bioavailability After a Single Inhalation Administration of Treprostinil Palmitil Inhalation Powder (TPIP) Formulation 2 (F2) to TPIP Formulation 3 (F3) in Healthy Participants

Started Aug 2025
42 enrolled
Healthy Volunteers

Loss of Exclusivity

LOE Date
Aug 11, 2031
66 months away
Patent Expiry
Aug 11, 2031
Exclusivity Expiry
Oct 18, 2026

Patent Records (5)

Patent #ExpiryTypeUse Code
9393203
Apr 27, 2026
Product
U-1877
7417070
Jul 30, 2026
Substance
9604901
Dec 15, 2028
Substance
8497393
Dec 15, 2028
Substance
9593066
Dec 15, 2028
Substance