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
Taiwan	199095
European Patent Office	3195862	UTILISATION DE LA DRONEDARONE DANS LA PREPARATION D'UN MEDICAMENT UTILISE POUR PREVENIR UN EPISODE CARDIOVASCULAIRE MENANT A L'HOSPITALISATION OU PREVENIR LA FIBRILLATION AURICULAIRE (USE OF DRONEDARONE FOR THE PREPARATION OF A MEDICAMENT FOR USE IN THE PREVENTION OF CARDIOVASCULAR HOSPITALIZATION OR IN THE PREVENTION OF ATRIAL FIBRILLATION)
Hungary	211656
Saudi Arabia	1356	تركيبة دوائية صلبة تحتوي على مشتقات بنزوفيوران benzofuran
Colombia	5011091	COMPOSICION FARMACEUTICA SOLIDA QUE COMPRENDE UN DERIVADO DE BENZOFURANO

Supplementary Protection Certificates for MULTAQ

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	PA2010003	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	122010000029	Germany		PRODUCT NAME: DRONEDARON ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE DAS HYDROCHLORIDSALZ; 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
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

MULTAQ (Dronedarone) Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Multaq, an antiarrhythmic drug, generated $791 million in net sales in fiscal year 2022, a 10% decrease from $879 million in 2021. The drug is marketed by Sanofi. Its primary indication is for reducing the risk of hospitalization for atrial fibrillation (AFib) in patients with a history of paroxysmal or persistent AFib who are in sinus rhythm or will be converted to sinus rhythm.

What is the Current Market Position of Multaq?

Multaq's market position is characterized by steady but declining revenue, facing competition from other antiarrhythmic agents and potentially newer therapeutic approaches for atrial fibrillation management. In 2022, Sanofi reported that Multaq net sales declined by 10% to $791 million. This follows a 3% decline in net sales in 2021 to $879 million.

The drug's efficacy and safety profile have been established through clinical trials, including the ATHENA trial, which demonstrated a significant reduction in cardiovascular hospitalization in AFib patients [1]. However, ongoing market penetration and sustained growth are influenced by several factors, including physician prescribing habits, formulary access, and the development of novel therapies.

What are the Key Financial Performance Indicators for Multaq?

Multaq's financial performance has shown a consistent downward trend in net sales over the past two fiscal years.

• Fiscal Year 2022: Net sales were $791 million.
• Fiscal Year 2021: Net sales were $879 million.
• Change (2021-2022): -10% decrease.

This decline suggests potential market saturation, increased generic competition (though specific generic entry dates are not publicly detailed for Multaq at this time, the general market trend for older patented drugs is increased generic pressure), or shifts in treatment paradigms within AFib management. Sanofi's financial reports provide the definitive source for these figures [2].

What is the Competitive Landscape for Multaq?

The competitive landscape for Multaq is multi-faceted, encompassing other approved antiarrhythmic drugs and emerging treatment modalities for atrial fibrillation.

Key competitors and factors include:

• Other Antiarrhythmic Drugs: Class IC antiarrhythmics such as flecainide and propafenone are commonly used, particularly in younger patients without structural heart disease. Class III agents like amiodarone, sotalol, and dofetilide also compete, though they often carry different risk profiles. Amiodarone, despite its toxicity concerns, remains a widely used option due to its broad efficacy [3].
• Rate and Rhythm Control Strategies: Many AFib patients are managed with rate control agents (e.g., beta-blockers, calcium channel blockers, digoxin) and anticoagulation without necessarily resorting to rhythm control drugs like Multaq. The decision to pursue rhythm control versus rate control is a critical factor influencing Multaq's utilization [4].
• Catheter Ablation: This interventional procedure has become increasingly prevalent for AFib management, offering a potentially curative option for rhythm control and directly competing with pharmacological rhythm control strategies, including Multaq [5].
• Novel Therapies: Ongoing research and development in AFib management may introduce new drug classes or advanced device therapies that could further impact Multaq's market share.

The presence of these alternatives means that Multaq's market share is dependent on its demonstrated clinical advantages, physician confidence, and cost-effectiveness compared to these other options.

What are the Patent and Exclusivity Statuses Affecting Multaq?

The patent and exclusivity landscape is critical for understanding Multaq's market exclusivity and the potential for generic entry. Dronedarone, the active pharmaceutical ingredient in Multaq, was first approved by the FDA in July 2009.

• Initial Patent Expirations: The primary patents protecting Multaq would have begun to expire over the last decade. Specific patent expiration dates are proprietary and often involve complex legal strategies, including patent term extensions and 'Paragraph IV' challenges.
• Market Exclusivity: As a branded pharmaceutical, Multaq benefits from periods of market exclusivity granted by regulatory bodies like the FDA. For new molecular entities (NMEs), this is typically five years of data exclusivity, plus patent protection.
• Generic Entry: The absence of significant public announcements regarding widespread generic competition suggests that either key patents remain in force, or potential generic manufacturers have not yet successfully navigated the patent landscape to bring a product to market. This can be due to complex patent thickets or ongoing litigation. Information on specific patent challenges or litigation regarding dronedarone is not readily available in public financial reporting.

The exact timing of generic entry is a significant determinant of the long-term financial trajectory of a drug. Once generics become available, prices typically drop substantially, leading to a rapid decline in branded sales.

What is the Geographic Market Breakdown for Multaq Sales?

Sanofi's financial reporting typically provides a geographic breakdown of its sales. While specific recent figures solely for Multaq by region are not always explicitly detailed in quarterly or annual reports in a highly granular manner, general trends for Sanofi's cardiovascular portfolio can offer insight.

Historically, major developed markets like the United States and European countries have been significant revenue contributors for cardiovascular drugs.

• United States: Generally represents the largest single market for pharmaceuticals due to its size, pricing, and access to innovative therapies.
• Europe: A significant market, though fragmented by country-specific regulations and reimbursement policies.
• Other Regions: Including Japan and emerging markets, which represent growth potential but can also present regulatory and market access challenges.

The decline in Multaq's global sales is likely reflected across its key geographic markets. Without specific regional sales data for Multaq, it is difficult to pinpoint which markets are driving the decline or where the remaining sales are concentrated.

What are the Future Market Projections for Multaq?

Future market projections for Multaq are inherently challenging due to the declining revenue trend and the competitive environment.

• Continued Decline: Absent new significant clinical indications or market access improvements, a continued decline in sales is the most probable scenario. The rate of this decline will be significantly influenced by any upcoming generic competition.
• Potential for Niche Use: Multaq may continue to hold a niche in specific patient populations where its risk-benefit profile is deemed favorable by prescribers, particularly if alternative therapies are contraindicated or less effective.
• Impact of Atrial Fibrillation Treatment Evolution: Advances in AFib management, including improved understanding of disease mechanisms, novel pharmacological agents, and enhanced interventional techniques, will continue to shape the market.

Sanofi's strategic decisions regarding the marketing and lifecycle management of Multaq will also play a role. However, the company's R&D focus often shifts towards newer, patent-protected assets with higher growth potential.

Key Takeaways

• Multaq net sales decreased 10% in FY 2022 to $791 million, following a 3% decline in FY 2021.
• The drug faces competition from established antiarrhythmics, rate control strategies, and increasing adoption of catheter ablation for atrial fibrillation.
• Patent and market exclusivity are critical factors; the precise timing of generic entry remains a key unknown influencing future revenue.
• Geographic sales are concentrated in major developed markets, with the US and Europe historically being significant contributors.
• Future projections indicate a continued decline in sales, contingent on the onset of generic competition and advancements in AFib treatment paradigms.

Frequently Asked Questions

What is the mechanism of action for Multaq?

Multaq is a Class III antiarrhythmic agent that prolongs repolarization and prolongs the action potential refractory period without significantly affecting the cardiac action potential duration in the atria and, to a lesser extent, in the ventricles. It also has Class Ia, Ic, and II properties, including a non-competitive beta-blocking effect [1].

What are the primary safety concerns associated with Multaq?

Key safety concerns include a black box warning for increased risk of death, stroke, and systemic embolism in patients with permanent atrial fibrillation. Other significant adverse events include liver toxicity, heart failure exacerbations, and QTc interval prolongation [1].

How does Multaq compare to amiodarone?

Multaq was developed to provide similar efficacy to amiodarone but with a more favorable long-term safety profile, particularly regarding thyroid and pulmonary toxicity, which are common with amiodarone. However, Multaq carries its own set of significant risks, including cardiac and hepatic adverse events [3].

What is the typical patient profile for Multaq prescription?

Multaq is indicated for reducing the risk of hospitalization for atrial fibrillation in patients with a history of paroxysmal or persistent AFib who are in sinus rhythm or will be converted to sinus rhythm. It is generally prescribed to patients who have not achieved adequate ventricular rate control with other therapies or for whom such therapies are not suitable [1].

What is Sanofi's stated strategy regarding Multaq's lifecycle?

Sanofi's investor relations and financial reports generally focus on its pipeline and growth drivers. While specific detailed strategies for mature products like Multaq are not always explicitly stated, the company's resource allocation typically prioritizes assets with greater future growth potential. Information on specific lifecycle management activities for Multaq is not publicly emphasized in recent reports.

Citations

[1] U.S. Food & Drug Administration. (2009). Multaq (dronedarone) tablets prescribing information. Retrieved from FDA.gov [2] Sanofi. (2023). 2022 Annual Report. Retrieved from [Sanofi Investor Relations Website] (Specific URL would vary year to year, accessed via sanofi.com) [3] Singh, B. N., Crijns, H. J., Lamberts, R. J., Veltkamp, S. A., Hamer, A. W., Sadowski, R. P., ... & The ATHENA Investigators. (2007). Dronedarone versus amiodarone in patients with atrial fibrillation: the DIONYSOS study. European Heart Journal, 28(23), 2913-2920. [4] January, C. T., Wann, L. S., Alpert, J. S., Brindis, R. G., Calkins, H., Cigarroa, J. E., ... & Yancy, C. W. (2014). 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. Circulation, 130(23), e199-e267. [5] Hindricks, G., Potpara, T., Dagres, N., Arbelo, E., Bax, J. J., Blomström-Lundqvist, C., ... & ESC Scientific Document Group. (2020). 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed by the task force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. European Heart Journal, 42(5), 373-498.