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Orenitram

(Treprostinil Diolamine)

Small molecule

United Therapeutics

0

Indications

2

Total Trials

0

Active Trials

0

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

7

Patents

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Withdrawn·UUnknown Sponsor·Phase 2·NCT04882774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[3]

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]
OpenFDA — FDA approval records (NDA NDA203496). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Orenitram. U.S. Food & Drug Administration.
[5]
SEC EDGAR — United Therapeutics company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: United Therapeutics

Patent Landscape[4]

Patent Cliff

Dec 15, 2028

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

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