NDAORALSOLUTION
Approved
Oct 2014
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
5/8 — Partial
SOTYLIZE (sotalol hydrochloride) by R-Pharm US 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. First approved in 2014.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SOTYLIZE is an oral solution formulation of sotalol hydrochloride, a non-cardioselective beta-blocker (Class II antiarrhythmic) combined with potassium channel blocking activity (Class III antiarrhythmic). It is indicated for documented, life-threatening ventricular arrhythmias and works by reducing heart rate and prolonging cardiac action potential duration. The dual mechanism makes it effective at higher doses (160+ mg/day) for rhythm control in high-risk patients.
$0.018BPart D
Peak9.3 years to LOESOTYLIZE is at peak lifecycle with minimal Part D spending ($18K in 2023), suggesting a niche specialty market with a small, focused team.
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 (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.