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Normal saline and epinephrine
Normal saline provides fluid resuscitation and volume expansion, while epinephrine acts as a sympathomimetic agonist to increase heart rate, blood pressure, and cardiac output.
Normal saline and epinephrine, marketed by Le Bonheur Children's Hospital, is a combination therapy currently available in the market. The key composition patent is set to expire in 2028, providing a period of exclusivity that supports market stability. The primary risk is the potential increase in competition following the patent expiry in 2028.
At a glance
| Generic name | Normal saline and epinephrine |
|---|---|
| Sponsor | Le Bonheur Children's Hospital |
| Drug class | Sympathomimetic amine and crystalloid fluid |
| Target | Alpha-1, alpha-2, beta-1, and beta-2 adrenergic receptors |
| Modality | Small molecule |
| Therapeutic area | Emergency Medicine / Critical Care |
| Phase | FDA-approved |
Mechanism of action
Normal saline (0.9% sodium chloride) is an isotonic crystalloid fluid used for intravascular volume replacement and maintenance of electrolyte balance. Epinephrine is a catecholamine that binds to alpha and beta adrenergic receptors, increasing myocardial contractility, heart rate, and peripheral vasoconstriction to restore perfusion pressure. Together, this combination is used in emergency resuscitation to restore hemodynamic stability.
Approved indications
- Cardiac arrest and cardiopulmonary resuscitation
- Severe hypotension and shock
- Anaphylaxis
Common side effects
- Tachycardia
- Hypertension
- Arrhythmias
- Tremor
- Anxiety
- Headache
Key clinical trials
- Jaw Muscle Pain Post Wisdom Molar Surgery (PHASE2)
- Effect of Adding a Low-Dose Epinephrine Bolus Prior to Infusion on Maternal Hemodynamic Stability During Cesarean Section (PHASE3)
- Comparing Reduction With ESD- Versus APC-TORe (NA)
- Mid-transverse Process Combined With Erector Spinae Block Versus Paravertebral Plane Block (NA)
- Evaluating Postoperative Pain and Antibacterial Effect of Ultrasonic and 980 nm Diode Laser Combination (NA)
- Cervicothoracic Sympathetic Block Evaluation for Post COVID Condition (PHASE4)
- Postop Pain Management in Pituitary Tumour Patients (PHASE4)
- Phase 3 Herniorrhaphy Study for Postoperative Analgesia (EPOCH 2) (PHASE3)
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 |
|---|---|
| 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:
- Normal saline and epinephrine CI brief — competitive landscape report
- Normal saline and epinephrine updates RSS · CI watch RSS
- Le Bonheur Children's Hospital portfolio CI