DRONEDARONE HYDROCHLORIDE - Generic Drug Details

What are the generic 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:	35
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
Inha University Hospital	PHASE4
Shanghai East Hospital	Phase 4
Stony Brook University	Phase 3

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
Lupin	DRONEDARONE HYDROCHLORIDE	dronedarone hydrochloride	TABLET;ORAL	205904-001	Jan 31, 2024	AB	RX	No	No
Sanofi Aventis Us	MULTAQ	dronedarone hydrochloride	TABLET;ORAL	022425-001	Jul 1, 2009	AB	RX	Yes	Yes
Sanofi Aventis Us	MULTAQ	dronedarone hydrochloride	TABLET;ORAL	022425-001	Jul 1, 2009	AB	RX	Yes	Yes
Sanofi Aventis Us	MULTAQ	dronedarone hydrochloride	TABLET;ORAL	022425-001	Jul 1, 2009	AB	RX	Yes	Yes

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
Sanofi Aventis Us	MULTAQ	dronedarone hydrochloride	TABLET;ORAL	022425-001	Jul 1, 2009
Sanofi Aventis Us	MULTAQ	dronedarone hydrochloride	TABLET;ORAL	022425-001	Jul 1, 2009

International Patents for DRONEDARONE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Peru	20091809	USO DE DRONEDARONA PARA LA PREPARACION DE UN MEDICAMENTO PARA USO EN LA PREVENCION DE LA HOSPITALIZACION CARDIOVASCULAR O DE LA MORTALIDAD
Eurasian Patent Organization	201071204	ПРИМЕНЕНИЕ ДРОНЕДАРОНА ДЛЯ ПРИГОТОВЛЕНИЯ ЛЕКАРСТВЕННОГО СРЕДСТВА ДЛЯ ПРИМЕНЕНИЯ В ПРЕДОТВРАЩЕНИИ ГОСПИТАЛИЗАЦИИ В КАРДИОЛОГИЧЕСКОЕ ОТДЕЛЕНИЕ ИЛИ СМЕРТНОСТИ
World Intellectual Property Organization (WIPO)	2009144551
Tunisia	2010000454	USE OF DRONEDARONE FOR THE PREPARATION OF A MEDICAMENT FOR USE IN THE PREVENTION OF CARDIOVASCULAR HOSPITALISATION OR OF MORTATILY

Supplementary Protection Certificates for DRONEDARONE HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

Market Dynamics and Financial Trajectory for Dronedarone Hydrochloride

Last updated: February 13, 2026

Dronedarone hydrochloride, marketed as Multaq by Sanofi, is an antiarrhythmic agent approved for managing atrial fibrillation and atrial flutter. It was launched in 2011, aiming to provide an alternative to amiodarone with fewer side effects. Its market presence is shaped by clinical efficacy, safety profile, competitive landscape, regulatory decisions, and patent protections.

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Market Adoption and Therapeutic Positioning

Dronedarone's adoption remains limited within antiarrhythmic therapy. Clinical trials, notably the PALLAS and ATHENA studies, influence prescribing trends. The ATHENA trial demonstrated a reduction in cardiovascular hospitalization and mortality among atrial fibrillation patients, supporting its use. Conversely, the PALLAS trial showed increased adverse events, resulting in caution among clinicians. The drug’s positioning as a second-line agent depends on regional guidelines and physician comfort with its safety profile.

Market Penetration & Revenue Estimates

Sanofi's financial disclosures and industry estimates suggest modest sales volumes. In 2022, estimated global sales hovered around $200 million to $250 million. Key markets include the US, Europe, and Japan, where drug approval and reimbursement policies influence uptake.

Region	Estimated 2022 Sales	Market Share	Notes
US	$100-$130 million	50-55%	FDA approval in 2010; reimbursement covers most insurance plans
Europe	$70-$90 million	30-35%	EMA approval in 2010; variable country-specific reimbursement
Japan	$15-$30 million	10-15%	Approved in 2011; slower adoption due to clinical guidelines

Competitive Landscape and Market Challenges

Dronedarone faces competition primarily from amiodarone, which remains the most prescribed antiarrhythmic drug due to its established efficacy. Other competitors include newer agents like dofetilide and class IC drugs such as flecainide.

Major challenges impacting financial growth:

• Safety concerns: Increased risks, including heart failure and liver toxicity, limit broad use.
• Market saturation: Many patients eligible for antiarrhythmic therapy already prescribed alternative agents.
• Limited indication scope: Primarily approved for atrial fibrillation/flutter, constraining market size.
• Generic entry: No generic versions exist as of 2023, which sustains current pricing.

Regulatory and Patent Status

Sanofi holds orphan drug status in certain regions, providing market exclusivity until at least 2025. Patent expiration across key markets is imminent post-2025, which could lead to price erosion and increased competition from generics.

Financial Trends and Future Outlook

Projected revenues are flat or slightly declining due to the stagnation of market penetration and safety issues. The drug’s off-label use and potential label expansions for specific patient subgroups could influence future financial performance.

In publicly available filings, Sanofi’s antiarrhythmic segment—of which dronedarone is a part—has seen modest year-over-year revenue growth, indicating a limited contribution from dronedarone relative to other products.

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Summary of Market Factors

• Market size: $200-$250 million globally in 2022.
• Growth projections: Low, with potential decline due to safety concerns and patent expiry.
• Key markets: US leads, with significant but slower growth in Europe and Japan.
• Competitive threats: High from amiodarone and emerging agents.
• Regulatory terrain: Regulatory restrictions and label limitations affect market access.

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Key Takeaways

1. Dronedarone's market remains niche, constrained by safety profile and competition.
2. Revenue is under pressure from patent expirations and generics.
3. Adoption depends heavily on clinical trial outcomes and guideline updates.
4. Overall market growth prospects are limited; the drug's revenues are unlikely to expand significantly.
5. Companies exploring next-generation antiarrhythmics may influence future dynamics.

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FAQs

1. How does dronedarone compare to amiodarone in efficacy?
Dronedarone demonstrates comparable efficacy to amiodarone in maintaining sinus rhythm but with a different safety profile. Its safety concerns have limited widespread adoption.

2. What are primary safety issues associated with dronedarone?
Increased risks include heart failure, hepatic toxicity, and stroke, especially in high-risk populations, affecting its use in certain patient groups.

3. How might patent expirations impact future revenues?
Generic entry post-2025 could lead to price erosion and market share loss, reducing revenue significantly unless new formulations or indications emerge.

4. Are there ongoing clinical trials that could expand dronedarone’s indications?
Some studies explore its use in other arrhythmias or as part of combination therapies, but no major trials currently aim for broad label expansion.

5. What strategies could improve market penetration?
Optimizing patient selection, demonstrating superior safety in specific subpopulations, and updating clinical guidelines may enhance its utilization.

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References

1. Sanofi. "Multaq (dronedarone) Prescribing Information," 2011.
2. Camm AJ, et al. “Efficacy and Safety of Dronedarone in Atrial Fibrillation,” New England Journal of Medicine, 2009.
3. European Medicines Agency. “Dronedarone Summary of Product Characteristics,” 2010.
4. MarketWatch. “Antiarrhythmic Drugs Market Report,” 2022.
5. Sanofi Annual Report 2022.