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 18h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SOTYLIZE is an oral solution containing sotalol hydrochloride, a dual-action antiarrhythmic combining beta-blocker (Class II) and potassium channel-blocking (Class III) properties. It is indicated for documented, life-threatening ventricular arrhythmias. The l-isomer drives beta-blocking activity while both isomers contribute Class III effects at doses ≥160 mg/day.
$0.018BPart D
Peak8.9 years to LOEProduct is at peak commercial maturity with minimal spending (~$18K in 2023) indicating a niche, stable franchise with small brand 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.