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NOREPINEPHRINE BITARTRATE
Norepinephrine Bitartrate is a marketed drug primarily indicated for severe, acute hypotension. Its key strength lies in its well-established mechanism for addressing critical hypotensive conditions, supported by a key composition patent expiring in 2028. The primary risk is the potential increase in competition as the patent approaches expiration.
At a glance
| Generic name | NOREPINEPHRINE BITARTRATE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1950 |
Approved indications
- Severe, acute hypotension
- Acute hypotensive states
Common side effects
- Hypertension
- Bradycardia
- Ischemic injury
- Anxiety
- Headache
- Respiratory difficulty
- Extravasation necrosis at injection site
- Pulmonary edema
Serious adverse events
- Tissue Ischemia
- Hypotension
- Cardiac Arrhythmias
Drug interactions
- Monoamine oxidase inhibitors (MAOIs)
- Tricyclic antidepressants (e.g., amitriptyline, nortriptyline, protriptyline, clomipramine, desipramine, imipramine)
- Antidiabetics
- Halogenated anesthetics (e.g., cyclopropane, desflurane, enflurane, isoflurane, and sevoflurane)
Key clinical trials
- Sympathetic Neurovascular Transduction: Role of Adrenergic Receptors and Sex Differences (PHASE4)
- Early Norepinephrine in Trauma Patients With Hemorrhagic Shock (PHASE1, PHASE2)
- Early Administration of Norepinephrine in Sepsis (PHASE4)
- Using Vasopressor Medication to Support Blood Pressure During Intubation Procedure (PHASE3)
- Norepinephrine for Prevention of Intraoperative Hypotension in Infants Undergoing Kasai Portoenterostomy (PHASE3)
- Effects of Vasopressor on the Graft Blood Flow in TRAM (NA)
- Comparison of Two Different Norepinephrine Bolus Doses for Management of Spinal Anesthesia-Induced Maternal Hypotension (PHASE4)
- Determination of the ED50 and ED95 of Prophylactic Norepinephrine Infusion for Preventing Post-induction Hypotension in Elderly Patients Undergoing Major Abdominal Surgery (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- NOREPINEPHRINE BITARTRATE CI brief — competitive landscape report
- NOREPINEPHRINE BITARTRATE updates RSS · CI watch RSS