MULTAQ Drug Patent Profile

Which patents cover Multaq, 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
American Heart Association	Phase 4
Duke Clinical Research Institute	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
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 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
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 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
Australia	728287
New Zealand	502464	Solid pharmaceutical composition containing benzofuran derivatives and a nonionic hydrophilic surfactant
El Salvador	2010003701	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

Supplementary Protection Certificates for MULTAQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1007030	SPC008/2010	Ireland		SPC008/2010: 20101015, EXPIRES: 20230616
1007030	C300446	Netherlands		PRODUCT NAME: DRONEDARON, DESGEWENST IN DE VORM VAN EEN AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/09/591/001-004 20091126
1007030	C01007030/01	Switzerland		PRODUCT NAME: DRONEDARONUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 59292 16.09.2009

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: MULTAQ

Last updated: July 27, 2025

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Introduction

MULTAQ (dronedarone) is a prescription medication developed by Sanofi, primarily used in the management of atrial fibrillation (AF) and atrial flutter, conditions characterized by irregular heart rhythms. Since its market approval, MULTAQ has presented a complex interplay of clinical efficacy, safety concerns, regulatory landscapes, and competitive pressures shaping its market dynamics and financial trajectory.

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Market Overview and Therapeutic Context

Atrial fibrillation affects an estimated 33 million globally, with prevalence expected to rise owing to aging populations and increasing cardiovascular comorbidities. The pharmacological management predominantly involves rate control, rhythm control, and anticoagulation strategies. MULTAQ operates within the rhythm control class, designed to maintain sinus rhythm and prevent AF recurrence.

Its approval by the FDA in 2010 was based on the EVALUATE (European trial) and ATHENA (American trial) studies, illustrating its efficacy in reducing hospitalization rates for cardiovascular events. Nonetheless, critical safety concerns—particularly, an increased risk of heart failure and stroke—prompted cautious positioning and limited prescribing.

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Market Dynamics

1. Regulatory Milestones and Restrictions

Initially, MULTAQ experienced a tumultuous regulatory journey. The FDA’s initial warning in 2011 regarding increased risks of heart failure and stroke led to restricted usage, primarily reserved for patients with normal or mildly impaired left ventricular function with no recent decompensation. Conversely, the European Medicines Agency (EMA) approved MULTAQ for broader indications, emphasizing its benefit-risk profile.

Subsequently, post-marketing surveillance and additional studies, such as the PALLAS trial, underscored the increased risk of adverse outcomes, leading to further restrictions in certain populations and influencing prescriber confidence.

2. Competitive Landscape

MULTAQ entered a market crowded with established anti-arrhythmic drugs, including amiodarone, flecainide, propafenone, and newer agents like Tikosyn (dofetilide) and Sotalol. The drug's safety profile and narrow indicated patient population have limited its market penetration.

The advent of direct oral anticoagulants (DOACs) and catheter ablation therapies shifted treatment paradigms, favoring procedural and anticoagulant options over rhythm control pharmacotherapy for many patients, thereby impacting MULTAQ's sales potential.

3. Clinical Adoption and Prescribing Trends

Prescribing patterns reflect clinicians' cautious approach, favoring safer, well-established therapies. Healthcare providers are highly attentive to MULTAQ's risk profile, especially its potential to precipitate heart failure, leading to conservative utilization. This cautious adoption has constrained growth and sustained existing market share.

4. Pharmacoeconomic and Reimbursement Factors

Cost considerations and reimbursement policies significantly influence drug utilization. Given the safety concerns and the availability of alternative therapies, payers have been selective, with some placing restrictions on coverage for MULTAQ, further impeding its wider adoption.

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Financial Trajectory

1. Revenue Trends and Sales Performance

Since its launch, MULTAQ's global sales have been modest relative to expectations, constrained by safety concerns, regulatory restrictions, and market saturation. According to Sanofi’s financial reports, peak sales in the early 2010s approached hundreds of millions of dollars globally, but subsequent years saw a decline due to the decline in prescriptions.

In recent reports, Sanofi indicated that MULTAQ’s revenues represent a niche segment, with annual sales declining at a compounded rate, reflecting market saturation and shifting treatment algorithms.

2. Research and Development Investment

Sanofi has largely deprioritized aggressive investment in MULTAQ’s pipeline development due to its limited growth prospects. Redirected focus towards immunology, oncology, and broad cardiovascular therapeutic areas indicates a strategic move away from disruption in the atrial fibrillation pharmaco-market.

3. Patent and Market Exclusivity

MULTAQ's patent protection originally provided exclusivity, but generic versions began entering markets once patents expired or faced challenges. Genericization tends to erode revenues, though Sanofi has maintained some market control via regulatory data exclusivity and formulation patents.

4. Market Exit or Lifecycle Management

Efforts like lifecycle management initiatives—combination products, expanded indications, or formulations—have been minimal for MULTAQ, with the primary trajectory pointing towards a gradual decline driven by market attrition and clinical caution.

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Key Drivers and Challenges

Drivers:

• Existing clinical data supporting efficacy in selected patient groups.
• Long-standing position within guidelines as an option for rhythm control.
• Ongoing need for anti-arrhythmic therapies with manageable safety profiles.

Challenges:

• Safety profile limitations restricting broader use.
• Competition from safer or more effective therapies.
• Evolving treatment paradigms favoring interventional or anticoagulant strategies.
• Regulatory restrictions dampening market expansion.

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Future Outlook and Strategic Considerations

Looking ahead, the market trajectory for MULTAQ appears subdued, with potential for further decline unless new clinical evidence demonstrates improved safety or efficacy profiles that can justify expanded indications. Lifecycle management efforts such as reformulation, combination therapies, or targeted marketing might marginally influence its continued presence but are unlikely to reverse current trends.

The increasing adoption of catheter ablation and novel agents signifies a paradigm shift, potentially relegating MULTAQ to a niche status within atrial fibrillation treatment.

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Key Market Opportunities and Threats

• Opportunities:

  • Targeted use in narrowly defined patient populations where benefits outweigh risks.
  • Combination with other therapies in precision medicine frameworks.
  • Real-world data generation to support guideline inclusion.

• Threats:

  • Rapid evolution of AF management strategies.
  • Competitive drugs with superior safety profiles.
  • Regulatory actions limiting approved indications or access.

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Summary

Market dynamics for MULTAQ are characterized by modest demand constrained by safety concerns, regulatory restrictions, and competitive alternatives. Its financial trajectory reflects a decline from peak sales, emphasizing the importance of targeted patient selection and cautious prescriber engagement. Launched amidst optimistic expectations, MULTAQ’s future appears limited unless significant clinical advancements or strategic repositioning occur.

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Key Takeaways

• Safety concerns and regulatory restrictions have significantly limited MULTAQ’s market growth since approval.
• The shifting treatment paradigm in atrial fibrillation favors procedural interventions and anticoagulants over pharmacological rhythm control, impacting MULTAQ’s market share.
• Sanofi’s strategic focus has moved away from MULTAQ, with declining sales reflecting limited growth prospects.
• Market exclusivity challenges and the advent of generics reduce revenue potential, emphasizing the importance of lifecycle management.
• Future growth hinges on evidence supporting expanded indications or identifying niche patient segments with favorable risk profiles.

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FAQs

1. What are the primary safety concerns associated with MULTAQ?
MULTAQ has been linked to increased risks of heart failure exacerbation, stroke, and hepatic toxicity, which restrict its use to specific patient populations and necessitate careful monitoring.

2. How does MULTAQ compare to other anti-arrhythmic drugs?
While effective in maintaining sinus rhythm, MULTAQ's safety profile has limited its use relative to drugs like amiodarone, which, despite its own risks, remains more widely prescribed due to familiarity and broader indications.

3. Has the regulatory environment improved for MULTAQ?
Regulatory agencies have imposed restrictions reflecting safety concerns, but ongoing post-marketing studies continue to influence its label; overall, the environment remains cautious.

4. What is the current market size for MULTAQ globally?
Estimated sales have declined from peak figures of several hundred million dollars annually to a niche market, with ongoing sales likely to decline further as newer therapies emerge.

5. Could MULTAQ’s future be revitalized with new clinical data?
Potentially, if emerging evidence demonstrates superior safety or efficacy in specific patient subsets, regulatory agencies and clinicians might revisit its positioning, but such scenarios remain uncertain.

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References

[1] Sanofi Annual Reports, 2010-2022.
[2] U.S. Food and Drug Administration. MULTAQ (dronedarone) prescribing information.
[3] European Medicines Agency. MULTAQ (dronedarone) Summary of Product Characteristics.
[4] Camm AJ, et al. "Dronedarone: Efficacy and safety in atrial fibrillation." Journal of Cardiac Failure, 2014.
[5] Gorenek B, et al. "Approach to pharmacological rhythm control in atrial fibrillation." European Heart Journal, 2015.