NDAINJECTIONINJECTABLE
Approved
Feb 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
AMIODARONE HYDROCHLORIDE (amiodarone hydrochloride) by Medica Corp is drug, but it possesses electrophysiologic characteristics of all four vaughan williams classes. First approved in 2004.
Drug data last refreshed 15h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Amiodarone hydrochloride is a multi-class antiarrhythmic agent used to treat serious ventricular and supraventricular arrhythmias. It works through unique electrophysiologic properties spanning all four Vaughan Williams classes, blocking sodium, potassium, and calcium channels while exerting antisympathetic effects. The drug prolongs cardiac action potential duration and refractory periods across all cardiac tissues, reducing automaticity and slowing conduction.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%), suggesting transition planning and defensive positioning are active priorities for the commercial team.
Mechanism of Action
drug, but it possesses electrophysiologic characteristics of all four Vaughan Williams classes. Like class I drugs, amiodarone blocks sodium channels at rapid pacing frequencies, and like class II drugs, amiodarone exerts a noncompetitive antisympathetic action. One of its main effects, with…
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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.