ORENITRAM (treprostinil diolamine)
Orenitram helps patients with pulmonary arterial hypertension (PAH) categorized as WHO Group 1. It is used to slow the progression of the disease and improve a patient's exercise capacity. This medication is primarily prescribed for individuals with functional class II-III symptoms, including those with idiopathic, heritable, or connective tissue disease-related PAH.
How ORENITRAM Works
This drug works by mimicking prostacyclin to directly dilate the arterial vascular beds in the lungs and throughout the body. It also helps by preventing platelets from clumping and inhibiting the growth of smooth muscle cells. These actions collectively help manage the vascular issues associated with the condition.
Details
- Status
- Prescription
- First Approved
- 2013-12-20
- Patent Cliff
- 2031
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
ORENITRAM Approval History
What ORENITRAM Treats
1 indicationsORENITRAM is approved for 1 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pulmonary Arterial Hypertension
ORENITRAM Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ORENITRAM's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ORENITRAM treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ORENITRAM
3 of 18FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04882774 RECAPTURE | RECAP001 | Ph 2 | withdrawn | Telemonitoring to Treat Group 2 Pulmonary Hypertension |
| NCT01560624 FREEDOM-EV results posted | TDE-PH-310 | Ph 3 | completed | Phase III Clinical Worsening Study of UT-15C in Subjects With PAH Receiving Background Oral Monotherapy |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
ORENITRAM FDA Label Details
Indications & Usage
FDA Label (PDF)ORENITRAM is indicated for the treatment of Pulmonary Arterial Hypertension.
ORENITRAM Patents & Exclusivity
Patents (7 active)
Exclusivity
Pro Intelligence Preview
Deep insights for ORENITRAM
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • 200 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 18 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.