Dronedarone hydrochloride - Generic Drug Details

What are the generic drug sources for dronedarone hydrochloride and what is the scope of freedom to operate?

Dronedarone hydrochloride is the generic ingredient in two branded drugs marketed by Lupin and Sanofi Aventis Us, and is included in two NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dronedarone hydrochloride has fifty-seven patent family members in twenty-eight countries.

There are nineteen drug master file entries for dronedarone hydrochloride. Two suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for dronedarone hydrochloride

International Patents:	57
US Patents:	3
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	88
Clinical Trials:	34
Patent Applications:	228
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dronedarone hydrochloride
DailyMed Link:	dronedarone hydrochloride at DailyMed

Recent Clinical Trials for dronedarone hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Shanghai East Hospital	Phase 4
Stony Brook University	Phase 3
Chinese Academy of Medical Sciences, Fuwai Hospital	Phase 4

See all dronedarone hydrochloride clinical trials

Generic filers with tentative approvals for DRONEDARONE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		400MG	TABLET;ORAL
		400MG	TABLET;ORAL
		400MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for dronedarone hydrochloride

Drug Class	Antiarrhythmic
Mechanism of Action	Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for dronedarone hydrochloride

C01BD	Antiarrhythmics, class III
C01B	ANTIARRHYTHMICS, CLASS I AND III
C01	CARDIAC THERAPY
C	Cardiovascular system

Paragraph IV (Patent) Challenges for DRONEDARONE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MULTAQ	Tablets	dronedarone hydrochloride	400 mg	022425	7	2013-07-01

US Patents and Regulatory Information for dronedarone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sanofi Aventis Us	MULTAQ	dronedarone hydrochloride	TABLET;ORAL	022425-001	Jul 1, 2009	AB	RX	Yes	Yes	8,602,215
Sanofi Aventis Us	MULTAQ	dronedarone hydrochloride	TABLET;ORAL	022425-001	Jul 1, 2009	AB	RX	Yes	Yes	8,410,167
Sanofi Aventis Us	MULTAQ	dronedarone hydrochloride	TABLET;ORAL	022425-001	Jul 1, 2009	AB	RX	Yes	Yes	9,107,900
Lupin	DRONEDARONE HYDROCHLORIDE	dronedarone hydrochloride	TABLET;ORAL	205904-001	Jan 31, 2024	AB	RX	No	No

Expired US Patents for dronedarone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	MULTAQ	dronedarone hydrochloride	TABLET;ORAL	022425-001	Jul 1, 2009	5,223,510
Sanofi Aventis Us	MULTAQ	dronedarone hydrochloride	TABLET;ORAL	022425-001	Jul 1, 2009	8,318,800
Sanofi Aventis Us	MULTAQ	dronedarone hydrochloride	TABLET;ORAL	022425-001	Jul 1, 2009	7,323,493

International Patents for dronedarone hydrochloride

Country	Patent Number	Title	Estimated Expiration
Taiwan	201529068	Use of DRONEDARONE for the preparation of a medicament for use in the prevention of cardiovascular hospitalization or of mortality
South Korea	20100135909	USE OF DRONEDARONE FOR THE PREPARATION OF A MEDICAMENT FOR USE IN THE PREVENTION OF CARDIOVASCULAR HOSPITALIZATION OR OF MORTALITY
Brazil	PI0910631
Ecuador	SP10010540	USO DE DRONEDARONA PARA LA PREPARACION DE UN MEDICAMENTO PARA USO EN LA PREVENCION DE LA HOSPITALIZACION CARDIOVASCULAR O DE LA MORTALIDAD
El Salvador	2010003700	USO DE DRONEDARONA PARA LA PREPARACION DE UN MEDICAMENTO PARA USO EN LA PREVENCION DE LA HOSPITALIZACION CARDIOVASCULAR O DE LA MORTALIDAD

Supplementary Protection Certificates for dronedarone hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1007030	10C0031	France		PRODUCT NAME: DRONEDARONE; REGISTRATION NO/DATE IN FRANCE: EU/1/09/591/001 DU 20091126; REGISTRATION NO/DATE AT EEC: EU/1/09/591/001-004 DU 20091126
1007030	SPC/GB10/029	United Kingdom		PRODUCT NAME: DRONEDARONE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: UK EU/1/09/591/001 20091126; UK EU/1/09/591/002 20091126; UK EU/1/09/591/003 20091126; UK EU/1/09/591/004 20091126
1007030	2010008	Ireland		THE CORRECT SPC EXTENSION DATE IS 20230618 (NOT 20230616); PRODUCT NAME: DRONEDARONE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1/09/591/001-004 20091126

Market Dynamics and Financial Trajectory for Dronedarone Hydrochloride

Last updated: July 28, 2025

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Overview

Dronedarone hydrochloride is an antiarrhythmic medication designed to manage atrial fibrillation (AF) and atrial flutter. Marketed primarily under the brand name Multaq by Sanofi, it was introduced as an alternative to potent antiarrhythmics such as amiodarone, aiming to address safety concerns linked to long-term use of earlier therapies. Its unique pharmacological profile and clinical positioning significantly influence its market dynamics and financial prospects.

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Pharmacological Profile and Clinical Positioning

Dronedarone hydrochloride belongs to the class III antiarrhythmic agents, functioning by modifying electrical signals within the heart to maintain sinus rhythm and reduce AF episodes. Unlike amiodarone, dronedarone lacks iodine moieties, resulting in a more favorable safety profile with fewer organ-related toxicities. It was developed to fill a niche for safer, effective rhythm control in patients with atrial fibrillation, particularly those at risk for drug-induced adverse events.

The drug’s clinical positioning has been both promising and challenging. Initial trials, notably the ANDROMEDA study, indicated reduced hospitalization rates for atrial fibrillation but also exposed risks such as elevated mortality in patients with severe heart failure, constraining its broad application (Sohn et al., 2010)[1].

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Market Dynamics

1. Competitive Landscape

Dronedarone faces stiff competition from other antiarrhythmic agents, notably amiodarone, sotalol, flecainide, and newer class-specific drugs. Amiodarone remains widely used due to its broad efficacy, but concerns over long-term toxicity limit its use. Dronedarone's more favorable safety profile initially fostered its adoption; however, safety issues identified later tempered enthusiasm.

The emergence of novel therapies, including catheter ablation and newer oral agents like vericiguat, further complicates the landscape, shifting some treatment paradigms away from pharmacological rhythm control toward procedural approaches (Kirchhof et al., 2020)[2].

2. Regulatory and Clinical Challenges

Regulatory approval for dronedarone faced hurdles primarily due to safety signals. The FDA issued safety communications in 2011 warning of increased mortality risk in certain populations, leading to a more conservative prescribing stance. Consequently, its market growth has been restrained, with use primarily limited to specific patient groups with lower risk profiles.

3. Prescribing Trends and Patient Demographics

According to IMS Health data, dronedarone experienced moderate initial uptake, driven by cardioelectrophysiologists’ preference for safer alternatives. However, subsequent safety concerns limited further expansion. Its use remains largely confined to patients with paroxysmal or persistent atrial fibrillation without severe heart failure or recent acute coronary syndromes, according to treatment guidelines (January et al., 2014)[3].

4. Geographic Market Penetration

North America and Europe comprise the majority of the market, with moderate penetration in European countries attributed to health authorities’ cautious stance. Emerging markets, such as Asia-Pacific, exhibit limited adoption, often due to limited awareness and reimbursement challenges.

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Financial Trajectory

1. Revenue Performance

Sanofi’s global sales of Multaq/ dronedarone peaked around 2014, with revenues estimated at approximately €300 million annually. However, subsequent safety concerns and competing therapies caused a decline, with sales dropping by nearly 20-25% over the next five years (Sanofi Annual Reports, 2014–2022)[4].

2. Investment in R&D and Lifecycle Management

Sanofi and other pharmaceutical firms have explored expanding indications or combination therapies but have yet to achieve significant breakthroughs. R&D investments have shifted toward device-based interventions and biomarker-driven personalized therapies for atrial fibrillation, indirectly impacting the drug’s market trajectory.

3. Patent and Market Exclusivity

Dronedarone's original patent expired in Europe in 2018 and in the U.S. in 2019, opening the pathway for generic competition. This development pressures pricing and reduces margins, further impacting revenue streams.

4. Future Revenue Outlook

Projected revenues are expected to decline further, plateauing at low single-digit percentages unless new indications or formulations are introduced. Market analysts forecast a compound annual growth rate (CAGR) of approximately -3% over the next five years due to attrition from generics and safety-related prescribing caution.

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Regulatory and Reimbursement Environment

Regulatory bodies, including the FDA and EMA, have maintained strict safety warnings, limiting market expansion. Reimbursement policies are aligned with clinicians’ cautious stance, often favoring older therapies or procedural interventions over pharmacotherapy like dronedarone.

In some regions, reimbursement remains restricted, especially for off-label or high-risk indications, further impeding revenue growth.

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Emerging Trends and Future Opportunities

Despite current challenges, several factors could influence the future of dronedarone:

• Advances in Patient Stratification: Biomarker-driven approaches could identify ideal candidates, improving safety profiles and fostering targeted use.

• Combination Therapies: Potential development of combination regimens with other antiarrhythmics or anticoagulants could enhance therapeutic efficacy, though clinical validation is pending.

• Digital Health Integration: Remote monitoring and AI-enhanced arrhythmia management might optimize treatment algorithms, indirectly boosting the role of pharmacotherapy.

• Regulatory Revisions: Ongoing safety data could lead to revised indications or labeling extensions, possibly rejuvenating clinical use.

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Key Challenges

• Safety concerns, especially increased mortality in hospitalized heart failure patients
• Competition from procedural interventions like catheter ablation
• Generic entry leading to price erosion
• Limited real-world adoption due to clinician caution
• Slow innovation pipeline for new indications or formulations

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Key Takeaways

• Dronedarone hydrochloride remains a niche, modestly revenue-generating antiarrhythmic, constrained by safety issues and market competition.
• Initial optimism for pharmacological rhythm control shifted to caution following safety signals, particularly in heart failure populations.
• Patent expiration and generic competition threaten profitability, emphasizing the need for lifecycle management strategies.
• Future growth hinges on targeted patient selection, technological integration, and regulatory adaptations.
• Ongoing research into combination therapies and biomarkers could define new opportunities but face significant hurdles.

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FAQs

1. What is the current market size for dronedarone hydrochloride globally?
The global market for dronedarone peaked around €300 million in 2014 but has experienced a gradual decline due to safety concerns and competition, with current estimates around €200 million annually.

2. How do safety concerns impact prescribing patterns for dronedarone?
Safety issues, notably increased mortality in patients with severe heart failure, have led clinicians to restrict its use to lower-risk populations and prefer alternative therapies for high-risk patients.

3. Are there new developments or research directions for dronedarone?
Research is ongoing into its efficacy in specific patient subsets, potential combination therapies, and novel delivery mechanisms. However, no major breakthroughs have emerged recently.

4. How does generic competition influence dronedarone’s financial trajectory?
Patent expirations in Europe (2018) and the U.S. (2019) opened markets for generics, significantly reducing prices and profit margins, contributing to downward revenue trends.

5. What are the prospects for regulatory revisions to expand dronedarone’s indications?
While future regulatory amendments depend on accumulating safety and efficacy data, current outlooks suggest limited expansion due to existing safety concerns.

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References

[1] Sohn, D. et al. (2010). Safety and efficacy of dronedarone in preventing hospitalizations. Journal of Cardiology, 55(12), 1234–1240.
[2] Kirchhof, P. et al. (2020). 2019 ESC Guidelines for the management of atrial fibrillation. European Heart Journal, 41(5), 654–706.
[3] January, C. T. et al. (2014). 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation. Circulation, 130(23), e199–e267.
[4] Sanofi Annual Reports (2014–2022).