NDAINTRAVENOUSSOLUTION
Approved
Nov 2020
Lifecycle
Peak
Competitive Pressure
30/100
Data completeness
4/8 — Partial
LABETALOL HYDROCHLORIDE (labetalol hydrochloride) by Hikma is alpha1-adrenergic blocking and competitive beta-adrenergic blocking activity. Approved for severe hypertension, to lower blood pressure, hypertension. First approved in 2020.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Labetalol hydrochloride is a combined alpha-1 and beta-adrenergic blocking agent administered intravenously for acute management of severe hypertension. It works through dual mechanism: alpha-blockade causing vasodilation and beta-blockade reducing heart rate and cardiac output, with an alpha-to-beta activity ratio of approximately 1:7. The drug is indicated for severe hypertension and acute blood pressure reduction in clinical settings.
Peak
Product is at peak commercial lifecycle with no patent expiration data, suggesting stable revenue base and mature team structure; moderate competitive pressure (30/100) indicates focused commercial execution.
Mechanism of Action
alpha1-adrenergic blocking and competitive beta-adrenergic blocking activity. In man, the ratio of alpha- to beta-blockade has been estimated to be approximately 1:7 following intravenous administration. Beta 2 -agonist activity has been demonstrated in animals with minimal beta 1 -agonist activity…
Indications (3)
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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.