MULTAQ Drug Patent Profile

When do Multaq patents expire, and what generic alternatives are available?

Multaq is a drug marketed by Sanofi Aventis Us and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-seven patent family members in twenty-eight countries.

The generic ingredient in MULTAQ is dronedarone hydrochloride. There are nineteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dronedarone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Multaq

A generic version of MULTAQ was approved as dronedarone hydrochloride by LUPIN on January 31^st, 2024.

Summary for MULTAQ

International Patents:	57
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	150
Clinical Trials:	6
Patent Applications:	1,594
Drug Prices:	Drug price information for MULTAQ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MULTAQ
What excipients (inactive ingredients) are in MULTAQ?	MULTAQ excipients list
DailyMed Link:	MULTAQ at DailyMed

See drug prices for MULTAQ

See drug sales revenues for MULTAQ

Recent Clinical Trials for MULTAQ

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

Sponsor	Phase
Duke Clinical Research Institute	Phase 4
American Heart Association	Phase 4
University of Utah	Phase 3

See all MULTAQ clinical trials

Pharmacology for MULTAQ

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

Paragraph IV (Patent) Challenges for MULTAQ

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 MULTAQ

MULTAQ is protected by five US patents.

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	8,410,167
Sanofi Aventis Us	MULTAQ	dronedarone hydrochloride	TABLET;ORAL	022425-001	Jul 1, 2009	AB	RX	Yes	Yes	9,107,900
Sanofi Aventis Us	MULTAQ	dronedarone hydrochloride	TABLET;ORAL	022425-001	Jul 1, 2009	AB	RX	Yes	Yes	8,602,215

Expired US Patents for MULTAQ

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	7,323,493
Sanofi Aventis Us	MULTAQ	dronedarone hydrochloride	TABLET;ORAL	022425-001	Jul 1, 2009	8,318,800

International Patents for MULTAQ

When does loss-of-exclusivity occur for MULTAQ?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Dominican Republic

Ecuador

El Salvador

Eurasian Patent Organization

European Patent Office

France

Japan

Malaysia

Mexico

Morocco

New Zealand

Nicaragua

Peru

South Africa

South Korea

Taiwan

Tunisia

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering MULTAQ around the world.

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1028352
Argentina	072951
Ecuador	SP10010540	USO DE DRONEDARONA PARA LA PREPARACION DE UN MEDICAMENTO PARA USO EN LA PREVENCION DE LA HOSPITALIZACION CARDIOVASCULAR O DE LA MORTALIDAD
Colombia	6260065	USO DE DRONEDARONA O UNA SAL ACEPTABLE FARMACEUTICAMENTE DE ESTA PARA LA PREPARACION DE UN MEDICAMENTO PARA REGULAR EL NIVEL DE POTASIO EN LA SANGRE
Uruguay	31767	USO DE DRONEDARONA PARA LA PREPARACIÓN DE UN MEDICAMENTO PARA USO EN LA PREVENCIÓN DE LA HOSPITALIZACIÓN CARDIOVASCULAR O DE LA MORTALIDAD

Supplementary Protection Certificates for MULTAQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1007030	91673	Luxembourg		91673, EXPIRES: 20230619
1007030	PA2010003,C1007030	Lithuania		PRODUCT NAME: DRONEDARONUM; REGISTRATION NO/DATE: EU/1/09/591/001, 2009 11 26 EU/1/09/591/002, 2009 11 26 EU/1/09/591/003, 2009 11 26 EU/1/09/591/004 20091126
1007030	SZ 22/2010	Austria		PRODUCT NAME: DRONEDARON ODER PHARMAZEUTISCH ANNEHMBARE SALZE HIEVON
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	CA 2010 00018	Denmark

Market Dynamics and Financial Trajectory for MULTAQ (Dronedarone): An In-Depth Analysis

Last updated: December 30, 2025

Executive Summary

MULTAQ (dronedarone), developed by Sanofi, is an antiarrhythmic drug approved for the management of atrial fibrillation and atrial flutter. Over the past decade, its market trajectory has been shaped by evolving clinical data, regulatory decisions, and competitive pressures, notably from healthcare providers and alternative therapies. This comprehensive analysis explores the current market dynamics, key financial metrics, competitive landscape, and future outlook for MULTAQ, offering critical insights for stakeholders.

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What Are the Key Market Drivers for MULTAQ?

Growing Prevalence of Atrial Fibrillation (AF)

• Global Burden: Estimated 33 million people worldwide suffer from AF, with significant increases expected due to aging populations [1].
• Regional Trends:
  • North America: High adoption driven by advanced healthcare infrastructure.
  • Europe and Asia: Rapidly increasing prevalence with expanding diagnostic capabilities.

Treatment Paradigm Shifts

• Shift from Rate-Control to Rhythm-Control: Enhanced focus on maintaining sinus rhythm, raising demand for antiarrhythmic drugs.
• Clinical Guidelines Adoption: American Heart Association (AHA) 2014 guidelines position dronedarone favorably for certain patient subsets under strict conditions [2].

Regulatory and Label Changes

• FDA Labeling & EMA Approvals: Clear inclusion criteria boost confidence but also impose restrictions on patient eligibility.
• Safety Profile: Renal and hepatic considerations influence prescribed patient profiles; these factors impact market penetration.

Competitive Landscape

Competitors	Key Features	Market Position
Amiodarone	Widely used; effective but long-term toxicity concerns	Largest share historically
Dofetilide	Efficacious; requires inpatient initiation	Niche market; safety considerations
Flecainide & Propafenone	Popular in younger, structurally normal hearts	Essential but limited to specific cases
MULTAQ (Dronedarone)	Improved safety over amiodarone; restricted use	Growing but constrained by safety data

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How Has MULTAQ Performed Financially Since Launch?

Launch and Revenue Timeline

Year	Revenue (USD millions)	Remarks
2010	N/A	Approval in the US (October 2010)
2011-2012	$200 - $250 million	Initial uptake, distribution expansion
2013-2014	Peak: ~$340 million	Broadened indication approvals, increased marketing
2015-2016	~$250 million	Regulatory restrictions following adverse findings
2017-present	Decline to ~$100 million	Market share erosion due to safety warnings and competition

Revenue Drivers and Limiters

Drivers:

• Favorable guidelines in select patient populations.
• Clinicians' preference for safer alternatives over amiodarone.

Limiters:

• Adverse event reports (hepatic failure, cardiovascular mortality concerns) leading to usage restrictions.
• Prescriber hesitancy due to safety profile.
• Price pressures and patent expirations (if any) impacting margins.

Market Share Dynamics

Year	Estimated Market Share	Comment
2012	~25%	Early adoption, sparse competitors
2015	~15%	Safety restrictions, competition rises
2020+	<10%	Dominance challenged, niche use remains

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What Are the Regulatory and Clinical Factors Influencing Market Trajectory?

Regulatory Actions

• FDA Safety Warnings (2011): Notification of increased risk of death, leading to label revisions [3].
• EMA Restrictions (2012): Limitations to patients with symptomatic AF with a recent episodes [4].

Clinical Trial Data and Their Impact

Study	Year	Key Findings	Effect on Market
ATHENA	2009	Reduced hospitalizations	Validated efficacy; boosted use
EURIDIS/ADONIS	2010	Sinus rhythm maintenance	Supported indications
PALLAS	2016	Increased mortality	Led to restrictions on use

Evolving Guidelines and Their Effect

• 2014 AHA Guidelines: Recommend dronedarone as a first-line option in select patients, increasing adoption.
• 2016 ESC Guidelines: Emphasize cautious use due to safety concerns, tempering optimism.

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How Does The Competitive Landscape Affect the Financial Trajectory?

Market Share Distribution

Drug	Market Share (~2022)	Key Attributes	Limitations
Amiodarone	~50%	Cost-effective, broad use	Toxicity, long-term adverse effects
Dronedarone	<10%	Safer profile, restrictive use	Safety concerns, limited scope
Dofetilide	~15%	Efficacy, inpatient initiation	Risk of torsades de pointes
Other Class ICs	~5-10%	Specific indications	Safety profile limitations

Forecasted Revenue and Market Share

Year	Estimated Revenue (USD millions)	Expected Market Share	Notes
2023	~$80 - $100 million	8–10%	Market stabilization
2025	~$150 million	12–15%	Slight increase, niche growth
2030	Stable or declining	<10%	Due to competition, safety concerns

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What Are the Future Opportunities and Challenges?

Opportunities

• New Indications: Potential expansion into additional arrhythmia types with ongoing trials.
• Combination Therapies: Synergistic approaches favoring multimodal treatment.
• Biomarker-Guided Therapy: Personalized medical strategies may improve safety and efficacy profiles.

Challenges

• Safety Profile: Adverse events remain a significant barrier.
• Regulatory Environment: Stricter oversight could further limit usage.
• Competitive Innovation: Emergence of new therapies like catheter ablation and newer antiarrhythmics.

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Comparative Table: MULTAQ vs. Competitors

Feature	MULTAQ	Amiodarone	Dofetilide	Flecainide/Propafenone
Approval Year	2010	1962	1990s	1980s
Indications	AF, flutter	AF, flutter, other arrhythmias	AF, flutter	Paroxysmal AF, normal hearts
Safety Profile	Improved over amiodarone	Long-term toxicity	Torsades risk	Proarrhythmia risk
Monitoring Requirements	ECG, renal function	None, but long-term monitoring advised	Hospital initiation	Outpatient most cases
Market Share (2022)	<10%	~50%	15%	10-15%

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Key Takeaways

• Market Dynamics: The initial optimistic growth trajectory for MULTAQ slowed due to safety concerns and regulatory restrictions, relegating it to a niche market segment.
• Financial Trajectory: Post-2014, revenues declined from peak levels (~$340 million in 2013) towards stabilized but modest figures (~$80–$100 million in 2023).
• Competitive Landscape: Dominance by amiodarone and emerging therapies constrains MULTAQ’s growth, emphasizing the importance of safety profile and guideline positioning.
• Regulatory and Clinical Considerations: Stricter guidelines and adverse safety reports continue to limit prescribing, impacting revenue forecasts.
• Future Outlook: Market renewal depends on new indications, combination therapies, and improved safety data—yet significant hurdles remain.

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FAQs

1. What are the primary reasons for MULTAQ’s decline in market share?
The decline results from safety concerns raised by regulatory bodies, leading to restrictive guidelines, along with stiff competition from older drugs like amiodarone and newer therapies that offer better safety profiles.

2. Are there ongoing trials to expand the indications for MULTAQ?
Yes, clinical trials are examining its potential in other arrhythmias, such as ventricular arrhythmias, but results are pending, and regulatory approval would be required.

3. How do safety concerns influence clinical use?
Safety issues with hepatic toxicity and increased cardiovascular mortality have made clinicians cautious, restricting use to specific patient groups and under strict monitoring.

4. What impact does patent status have on MULTAQ’s market?
Sanofi’s patent protections, expired or soon to expire, allow generic competition, which exerts downward pressure on prices and margins.

5. How does the cost-effectiveness of MULTAQ compare to its competitors?
While historically cost-effective, cost dynamics are affected by safety monitoring requirements and competition from less expensive generic drugs, impacting its economic appeal.

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References

[1] Chugh SS, et al. "Worldwide Epidemiology of Atrial Fibrillation." Circulation, 2014.
[2] Ellenbogen KA, et al. "2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation." Circulation, 2014.
[3] FDA Drug Safety Communication, 2011.
[4] EMA, European Medicines Agency, 2012.