NDAINJECTIONINJECTABLEPriority Review
Approved
Dec 1986
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
4/8 — Partial
Priority Review
BREVIBLOC (esmolol hydrochloride) by Baxter 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 diabetic foot ulcer, septic shock, stress response and 1 more indications. First approved in 1986.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BREVIBLOC (esmolol hydrochloride) is a beta-1 selective adrenergic receptor blocking agent administered intravenously with a 9-minute half-life and rapid onset/offset. It is used off-label across multiple acute care indications including diabetic foot ulcer, septic shock, stress response, and cerebral hemodynamics management. The drug works by inhibiting beta-1 receptors in cardiac muscle, with cardioselective effects at therapeutic doses.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100); brand team likely focused on defending market share and managing generic transition strategy.
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.