NDAORALTABLETPriority Review
Approved
Jul 2009
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
19
Data completeness
5/8 — Partial
Priority Review
MULTAQ (dronedarone) by Sanofi. Approved for antiarrhythmic [epc]. First approved in 2009.
Drug data last refreshed 10h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MULTAQ (dronedarone) is an oral antiarrhythmic agent approved in 2009 for the treatment of atrial fibrillation and atrial flutter. It is a small-molecule drug that works through multiple ion channel blockade to restore and maintain normal heart rhythm. The drug is indicated for patients with paroxysmal or persistent atrial fibrillation to reduce cardiovascular hospitalization.
$409MPart D
Peak4.8 years to LOEThe product is at peak lifecycle with $409M in Part D spending and over 310K claims annually, indicating a stable, mature commercial infrastructure with moderate team size.
Mechanism of Action
Pharmacologic Class:
Antiarrhythmic
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (19)
Early Dronedarone Versus Usual Care to Improve Outcomes in Persons With Newly Diagnosed Atrial Fibrillation
Started Oct 2021
339 enrolled
Atrial Fibrillation
Systematic Review and Meta-Analysis of Multaq® for Safety in Atrial Fibrillation
Started Sep 2021
87,810 enrolled
Atrial Fibrillation
Effect of Dronedarone on Atrial Fibrosis Progression and Atrial Fibrillation Recurrence
Started May 2021
22 enrolled
Atrial FibrillationAtrial Fibrillation Recurrent
Study to Evaluate the Effect of Ranolazine and Dronedarone When Given Alone and in Combination in Patients With Paroxysmal Atrial Fibrillation
Started Jan 2012
134 enrolled
Atrial Fibrillation
Drug Interaction Study With Dabigatran Etexilate and Dronedarone in Healthy Subjects
Started Feb 2011
36 enrolled
Healthy
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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.