TheraRadar
Data updated: Jun 28, 2026

DRONEDARONE HYDROCHLORIDE · GLENMARK GENERICS

Generic · see MULTAQ Trial Activity: Mature 1 active trials
Cardiovascular Approved 2009-07-01

DRONEDARONE HYDROCHLORIDE is FDA-approved to treat 1 condition (same as MULTAQ).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Sanofi conducting 7 trials (64%)
2 indications explored (Focused)
→ atrial fibrillation (10 trials)
→ atrial fibrillation (af) (1 trials)
1
Indication
--
Phase 3 Trials
17
Years on Market

Details

Status
Prescription
First Approved
2009-07-01
Routes
ORAL
Dosage Forms
TABLET

Companies

GLENMARK GENERICS WATSON LABS INC Novartis Lupin ALKEM LABS LTD
Active Ingredient: DRONEDARONE HYDROCHLORIDE

DRONEDARONE HYDROCHLORIDE Approval History

2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2024 to 2024
Jan 2024 ORIGINAL
Update
FDA Letter

What DRONEDARONE HYDROCHLORIDE Treats

1 indications

DRONEDARONE HYDROCHLORIDE is approved for 1 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as MULTAQ (same active ingredient).

Source: FDA Label
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

DRONEDARONE HYDROCHLORIDE FDA Label Details

Indications & Usage

DRONEDARONE HYDROCHLORIDE is FDA-approved to treat 1 condition — same approved indications as MULTAQ.

Looking for the branded version?

MULTAQ

Full clinical data, patents, trials, and competitive landscape for dronedarone hydrochloride.

See MULTAQ

Data Sources

FDA Approval: ANDA205903 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment