NDAORALTABLET
Approved
Feb 2000
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
4/8 — Partial
BETAPACE AF (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 2000.
Drug data last refreshed 23h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BETAPACE AF (sotalol hydrochloride) is an oral antiarrhythmic tablet combining beta-adrenergic blockade (Class II) with cardiac action potential prolongation (Class III) properties. It treats documented life-threatening ventricular arrhythmias and atrial fibrillation by slowing heart rate and stabilizing electrical activity. The drug's dual mechanism makes it effective at doses of 160 mg/day and above, where Class III effects become clinically significant.
$224KPart D
LOE ApproachingDeclining
Minimal commercial footprint with approaching loss of exclusivity signals small, defensive team focus on profit protection rather than expansion.
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.