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 16m ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BETAPACE is an oral antiarrhythmic tablet containing sotalol hydrochloride, approved in 1992 for documented life-threatening ventricular arrhythmias and atrial fibrillation. It combines dual Vaughan Williams Class II (beta-blocking) and Class III (action potential prolongation) mechanisms, with the l-isomer providing beta-blockade and both isomers contributing antiarrhythmic effects.
$0.677MPart D
LOE ApproachingDeclining
BETAPACE faces declining commercial trajectory with loss of exclusivity approaching; brand team will likely shift to defensive strategies and cost management.
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.