NDAINJECTIONINJECTABLEPriority Review
Approved
Dec 1986
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
4/8 — Partial
Priority Review
BREVIBLOC (esmolol hydrochloride) by Baxter International is (esmolol hydrochloride) injection is a beta 1 -selective (cardioselective) adrenergic receptor blocking agent with rapid onset, a very short duration of action, and no significant intrinsic sympathomimetic or membrane stabilizing activity at therapeutic dosages. Approved for noncompensatory sinus tachycardia where, the physician’s judgment, the rapid heart rate requires specific intervention. First approved in 1986.
Drug data last refreshed 14h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BREVIBLOC (esmolol hydrochloride) is a short-acting, beta-1 selective adrenergic receptor blocker administered intravenously with a 9-minute elimination half-life. It is indicated for noncompensatory sinus tachycardia where rapid heart rate requires specific clinical intervention. The drug works by inhibiting beta-1 receptors in cardiac muscle, providing rapid onset and offset of action suitable for acute perioperative settings.
LOE Approaching
Product faces imminent loss of exclusivity with moderate competitive pressure (30/100); commercial teams should anticipate portfolio transition or defensive strategies for branded formulations.
Mechanism of Action
(Esmolol Hydrochloride) injection is a beta 1 -selective (cardioselective) adrenergic receptor blocking agent with rapid onset, a very short duration of action, and no significant intrinsic sympathomimetic or membrane stabilizing activity at therapeutic dosages. Its elimination half-life after…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.