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Data updated: Jun 28, 2026

REMODULIN (treprostinil) · UNITED THERAP

Cardiovascular Approved 2002-05-21

REMODULIN is FDA-approved to treat 3 conditions (same as TYVASO DPI).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
4
Indications
--
Phase 3 Trials
2
Priority Reviews
24
Years on Market

Details

Status
Discontinued
First Approved
2002-05-21
Patent Cliff
2029

Pro Metrics

Patent cliff and revenue data

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Routes
INTRAVENOUS, SUBCUTANEOUS
Dosage Forms
SOLUTION, INJECTABLE

Companies

UNITED THERAP
Active Ingredient: TREPROSTINIL

REMODULIN Approval History

2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
132 FDA actions from 2002 to 2023 · 2 indication expansions
Mar 2023 SUPPL
Label · Labeling
FDA Letter Label
Jul 2021 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter Label
Jul 2018 ORIGINAL
New Form · Type 3 - New Dosage Form
FDA Letter Label

What REMODULIN Treats

3 indications

REMODULIN is approved for 3 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as TYVASO DPI (same active ingredient).

Source: FDA Label
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Clinical Trial Registry

13 trials
Trial Sponsor ID Phase Status Title
NCT04005469 974570-5 Ph 1, Ph 2 recruiting Safety and Efficacy of Treprostinil (Remodulin®) In Reducing Ischemia-Reperfusion Injury During Kidney Transplantation
NCT05564637 results posted 22-004971 Ph 2 completed A Study of Treprostinil to Treat Interstitial Lung Disease Pulmonary Hypertension
NCT07177703 Tre-ImPAH Ph 2 not yet recruiting Efficacy and Safety of Treprostinil in Intermediate-Risk Pulmonary Arterial Hypertension
NCT01481974 STUDY19100094 Ph 1 completed Safety and Efficacy of Treprostinil in Ischemia and Reperfusion Injury in Adult Orthotopic Liver Transplantation
NCT05067270 results posted 18278 I8B-MC-ITTC, 2021-001987-18 Ph 1 completed A Study of Infusion Site Pain After Infusion of Excipients in Participants With Type 1 Diabetes Mellitus
NCT04675944 BIA-51058-106 2017-000245-43 Ph 1 completed Effect of BIA 5-1058 on the Steady State Pharmacokinetics of Treprostinil
NCT02865733 SJTUMS-201607 Ph 3 completed Study of Remodulin® in Pediatric Pulmonary Hypertension With Single Ventricular Physiology After Fontan Surgery
NCT00705133 results posted 07-11-087-01 Ph 2 completed Treprostinil Therapy For Patients With Interstitial Lung Disease And Severe Pulmonary Arterial Hypertension
NCT02769624 results posted 2015-1491 Ph 2 terminated Acute Effects of Inhaled Treprostinil in Fontan Patients
NCT02770521 results posted 16071 I8B-JE-ITRK Ph 1 completed A Study of Treprostinil and a New Formulation of LY900014 in Healthy Japanese Participants
NCT02847260 RAPID results posted REM-PH-416 Ph 4 completed Safety and Tolerability of Rapid Dose Titration of Subcutaneous Remodulin® Therapy in PAH Subjects (RAPID)
NCT01268553 results posted Tyvaso Switch Ph 4 completed Transition From Injectable Prostacyclin Medication to Inhaled Prostacyclin Medication
NCT01082484 INFLUX-IT-VS 2009-016301-42 Ph 1, Ph 2 completed Cutaneous Iontophoresis of Iloprost and Treprostinil in Healthy Volunteers
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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

REMODULIN FDA Label Details

Indications & Usage

FDA Label (PDF)

REMODULIN is FDA-approved to treat 3 conditions — same approved indications as TYVASO DPI.

View full patent landscape →
5 OB patents · 2 families · 70 international docs across 8 countries

REMODULIN Patents & Exclusivity

Latest Patent: Mar 2029

Patents (5 active)

US7999007 Expires Mar 29, 2029
US9593066 Expires Dec 15, 2028
US11723887 Expires Dec 15, 2028
US8653137 Expires Sep 5, 2028
US8658694 Expires Sep 5, 2028
Source: FDA Orange Book

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Patent Timeline

  • • Cliff: 2029
  • • 336 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

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  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA208276 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.