NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE (norepinephrine bitartrate)
Norepinephrine bitartrate is a catecholamine used to raise blood pressure in adult patients experiencing severe, acute hypotension. It helps patients in acute hypotensive states by restoring blood pressure to more stable levels. This medication is typically used when a patient's blood pressure has dropped dangerously low and requires immediate intervention.
How NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE Works
This medication works by acting as a peripheral vasoconstrictor through alpha-adrenergic action to narrow blood vessels. It also serves as an inotropic stimulator of the heart and dilates the coronary arteries via beta-adrenergic action. These combined actions help the body restore and maintain adequate blood pressure levels.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2021-01-15
- Patent Cliff
- 2041
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE Approval History
What NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE Treats
1 indicationsNOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE is approved for 1 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypotension
NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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.
Drugs Similar to NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE
3 of 16FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05997732 STARS | Pro00126600 | Ph 4 | recruiting | Sympathetic Neurovascular Transduction: Role of Adrenergic Receptors and Sex Differences |
| NCT05836272 EA-NE-TUN | Tunisian ICUs association | Ph 4 | recruiting | Early Administration of Norepinephrine in Sepsis |
| NCT05521152 | MD-12-2021 | Ph 3 | completed | Norepinephrine for Prevention of Intraoperative Hypotension in Infants Undergoing Kasai Portoenterostomy |
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.
NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE FDA Label Details
Indications & Usage
FDA Label (PDF)NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE is indicated for the treatment of Hypotension.
NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE Patents & Exclusivity
Patents (12 active)
Pro Intelligence Preview
Deep insights for NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2041
- • 118 active patents
Trial Analysis
- • 3 total trials
- • Stage: Expansion
Competitive Landscape
- • 16 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.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment