NDAORALTABLETPriority Review
Approved
Oct 1992
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
5/8 — Partial
Priority Review
BETAPACE (sotalol hydrochloride) by Enterprise Therapeutics is beta-adrenoreceptor blocking (vaughan williams class ii) and cardiac action potential duration prolongation (vaughan williams class iii) antiarrhythmic properties. Approved for documented, life-threatening ventricular arrhythmias, such and 2 more indications. First approved in 1992.
Drug data last refreshed 10h ago · AI intelligence enriched 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BETAPACE (sotalol hydrochloride) is an oral antiarrhythmic tablet combining Class II beta-blockade with Class III action potential prolongation. It treats documented life-threatening ventricular arrhythmias and atrial fibrillation by reducing heart rate and prolonging cardiac refractoriness. The beta-blocking effect is non-cardioselective and maximal at 320–640 mg/day, while Class III effects emerge at ≥160 mg/day.
$0.677MPart D
LOE ApproachingDeclining
Product faces imminent loss of exclusivity with shrinking market presence; brand team likely focused on generic transition planning rather than growth initiatives.
Mechanism of Action
beta-adrenoreceptor blocking (Vaughan Williams Class II) and cardiac action potential duration prolongation (Vaughan Williams Class III) antiarrhythmic properties. The two isomers of sotalol have similar Class III antiarrhythmic effects, while the l-isomer is responsible for virtually all of the…
Indications (4)
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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.