NDAORALCAPSULE
Approved
Oct 1999
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
4/8 — Partial
TIKOSYN (dofetilide) by Pfizer is clinical pharmacology mechanism of action dofetilide shows vaughan williams class iii antiarrhythmic activity. First approved in 1999.
Drug data last refreshed 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TIKOSYN (dofetilide) is a Class III antiarrhythmic agent that blocks the rapid component of the delayed rectifier potassium current (IKr) to prolong cardiac action potential duration and refractory period. It is indicated for conversion and maintenance of atrial fibrillation and atrial flutter, with no negative inotropic effects. The drug works through predictable, concentration-dependent prolongation of repolarization in atrial and ventricular tissue.
$0.79MPart D
LOE ApproachingDeclining
Product approaching loss of exclusivity with minimal Part D utilization (626 claims, $790K spending in 2023), signaling transition away from growth-stage team structures toward maintenance and transition planning.
Mechanism of Action
CLINICAL PHARMACOLOGY Mechanism of Action Dofetilide shows Vaughan Williams Class III antiarrhythmic activity. The mechanism of action is blockade of the cardiac ion channel carrying the rapid component of the delayed rectifier potassium current, I Kr . At concentrations covering several orders of…
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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.