Data updated: Mar 10, 2026
REMODULIN
TREPROSTINIL
Approved 2002-05-21
4
Indications
--
Phase 3 Trials
2
Priority Reviews
23
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2002-05-21
- Routes
- INTRAVENOUS, SUBCUTANEOUS
- Dosage Forms
- INJECTABLE, SOLUTION
REMODULIN Approval History
Loading approval history...
What REMODULIN Treats
4 FDA approvalsOriginally approved for its first indication in 2002 . Covers 4 distinct patient populations.
- Other (4)
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
Loading...
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
ProREMODULIN Patents & Exclusivity
Latest Patent: Mar 2029
Patents (336 active)
US7999007
Expires Mar 29, 2029
US11723887
Expires Dec 15, 2028
US9593066
Expires Dec 15, 2028
US8653137
Expires Sep 5, 2028
US8658694
Expires Sep 5, 2028
+ 326 more patents
Source: FDA Orange Book
Want competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.