Orenitram

(Treprostinil Diolamine)

Phase 2Small molecule

United Therapeutics

Orenitram is one of 34 small molecule programs targeting Pulmonary Hypertension. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Pulmonary HypertensionActive, not recruiting

Pulmonary HypertensionPhase 2

Active, not recruiting

Competition

Competitive Landscape

154 competitors in Pulmonary Hypertension

#DrugCompanyPhaseTrials

Reata

Biogen

Phase 3

2 2

Diamox

Teva

Phase 3

2 3

Crestor

AstraZeneca

Phase 3

1 4

Lexapro

AbbVie

Phase 3

1 5

Accrufer

SShield Therapeutics

Phase 3

1 6

Zesly

MMezzion Pharma Co. Ltd

Phase 3

1 7

Distilled Water

GSK

Phase 3

2 8

Diluent

Sanofi

Phase 3

1 9

Remodulin

United Therapeutics

Phase 3

1 10

Iloprost Inhalation

Johnson & Johnson

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Pulmonary Hypertension1 trial

Telemonitoring to Treat Group 2 Pulmonary Hypertension

Withdrawn·UUnknown Sponsor·Phase 2·NCT04882774

Monotherapy1 trial

Phase III Clinical Worsening Study of UT-15C in Subjects With PAH Receiving Background Oral Monotherapy

Completed· United Therapeutics logo

United Therapeutics·Phase 3·NCT01560624·690 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 20, 2013

ORENITRAM

NDA NDA203496

Sources

References

[1]
ClinicalTrials.gov — 2 trial records for Treprostinil Diolamine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Treprostinil Diolamine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Treprostinil Diolamine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA203496). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Orenitram. U.S. Food & Drug Administration.
[6]
SEC EDGAR — United Therapeutics company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: United Therapeutics

Patent Landscape[5]

Patent Cliff

Jul 30, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9393203Apr 27, 2026

7417070Jul 30, 2026

8497393Dec 15, 2028

9604901Dec 15, 2028

8410169Feb 13, 2030

2 more patents

8349892Jan 22, 2031

8747897Aug 11, 2031

Orenitram

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Pulmonary Hypertension1 trial

Monotherapy1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

Related News