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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:	80
Clinical Trials:	6
Patent Applications:	1,260
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
Norway	913033
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)
Norway	996372

Supplementary Protection Certificates for MULTAQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1007030	SZ 22/2010	Austria		PRODUCT NAME: DRONEDARON ODER PHARMAZEUTISCH ANNEHMBARE SALZE HIEVON
1007030	384	Finland
1007030	C01007030/01	Switzerland		PRODUCT NAME: DRONEDARONUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 59292 16.09.2009

MULTAQ Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: MULTAQ

Introduction

Multaq, also known as dronedarone, is a brand-name oral tablet approved by the FDA to reduce the risk of hospitalization for atrial fibrillation (AFib) in certain adults. Here, we will delve into the market dynamics and financial trajectory of this drug, exploring its approval, usage, safety concerns, pricing, and financial performance.

Approval and Indications

Multaq was approved by the FDA in July 2009 for the treatment of non-permanent atrial fibrillation (AFib), specifically for patients with paroxysmal or persistent AFib who have a history of these conditions but are currently in sinus rhythm[4].

Clinical Trials and Safety Concerns

The approval of Multaq was supported by several clinical trials, including the ATHENA trial, which showed a reduction in the risk of hospitalizations for AFib in patients with non-permanent AFib. However, the PALLAS trial, which involved patients with permanent AFib, was terminated early due to a significantly higher number of cardiovascular events in the Multaq-treated group compared to the placebo group. This trial highlighted increased risks of total deaths, deaths from arrhythmia or sudden death, stroke, and hospitalization for heart failure associated with Multaq use in patients with permanent AFib[1].

Usage and Prescriptions

From its approval in July 2009 through October 2011, approximately 1.3 million Multaq prescriptions were dispensed, and about 278,000 patients received these prescriptions from U.S. outpatient retail pharmacies. Despite the safety concerns, Multaq continues to be prescribed for patients with non-permanent AFib, following the revised drug label recommendations[1].

Adverse Reactions and Safety Profile

Multaq is associated with several adverse reactions, including gastrointestinal disorders such as diarrhea, nausea, abdominal pain, vomiting, and asthenia. Other significant safety concerns include QTc interval prolongation, new onset or worsening of heart failure, and renal impairment. These factors necessitate careful patient selection and monitoring by healthcare professionals[2][5].

Pricing and Financial Assistance

The cost of Multaq can vary based on factors such as treatment plan, insurance coverage, and the pharmacy used. On average, the cost of Multaq without insurance can be around $798 per month. However, patients may benefit from savings programs, such as the Multaq Savings Card, which can reduce the copay to as low as $0 for eligible patients[4].

Financial Performance

While specific financial data for Multaq alone is not readily available, it is part of the broader pharmaceutical portfolio of Sanofi, the drug's manufacturer. Sanofi's overall performance has been strong, with significant growth in other key products. However, the financial impact of Multaq is likely influenced by its niche market and the competition within the cardiovascular drug sector. The drug's sales are not highlighted as a major contributor to Sanofi's overall revenue in recent financial reports, which focus more on blockbuster drugs like Dupixent[3].

Market Dynamics

The market for AFib treatments is competitive, with various drugs and therapies available. Multaq's position in this market is defined by its specific indications and the need for careful patient selection due to its safety profile. The drug's market dynamics are also influenced by the availability of generic alternatives for other AFib treatments and the ongoing development of new cardiovascular therapies.

Competitive Landscape

Multaq competes with other anti-arrhythmic drugs and treatments for AFib. Its unique selling point is its ability to reduce hospitalizations for AFib in patients with non-permanent AFib, but this is balanced against the risks associated with its use. The competitive landscape is further complicated by the presence of generic drugs and the evolving treatment guidelines for AFib.

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of Multaq. The FDA's safety reviews and updates to the drug label have significantly impacted how the drug is prescribed and used. Healthcare professionals must adhere to these guidelines to manage the potential serious cardiovascular risks associated with Multaq[1].

Patient Access and Support

To improve patient access, Sanofi offers various support programs, including the Multaq Savings Card, which helps reduce the financial burden on patients. These programs are essential in ensuring that eligible patients can afford the medication despite its cost[2].

Future Outlook

The future outlook for Multaq is tied to its continued use within the specified indications and the management of its safety profile. As new treatments for AFib emerge, Multaq's market position may evolve. However, its established role in reducing hospitalizations for non-permanent AFib ensures it will remain a relevant option for certain patients.

Key Takeaways

• Approval and Indications: Multaq is approved for reducing the risk of hospitalization for non-permanent AFib.
• Safety Concerns: Associated with increased cardiovascular risks in patients with permanent AFib.
• Usage and Prescriptions: Widely prescribed despite safety concerns, with careful patient selection.
• Pricing and Financial Assistance: Variable cost, with savings programs available.
• Financial Performance: Part of Sanofi's broader portfolio, with no specific standout financial data.
• Market Dynamics: Competitive market with a niche position due to specific indications and safety profile.
• Regulatory Environment: FDA guidelines significantly impact its use.
• Patient Access and Support: Support programs available to reduce financial burden.

FAQs

What is Multaq used for?

Multaq (dronedarone) is used to reduce the risk of hospitalization for atrial fibrillation (AFib) in patients with paroxysmal or persistent AFib who are currently in sinus rhythm.

What are the safety concerns associated with Multaq?

Multaq is associated with increased risks of serious cardiovascular events, including death, stroke, and heart failure, particularly in patients with permanent AFib. It also causes QTc interval prolongation, gastrointestinal disorders, and renal impairment.

How much does Multaq cost?

The cost of Multaq can vary, but on average, it is around $798 per month without insurance. Savings programs like the Multaq Savings Card can reduce the copay to as low as $0 for eligible patients.

Is Multaq still prescribed despite safety concerns?

Yes, Multaq is still prescribed for patients with non-permanent AFib, following the revised drug label recommendations and careful patient selection by healthcare professionals.

What support programs are available for Multaq patients?

Patients may benefit from the Multaq Savings Card and other financial assistance programs to reduce the cost of the medication.

How does Multaq fit into the broader market for AFib treatments?

Multaq competes in a competitive market for AFib treatments, with its unique selling point being the reduction of hospitalizations for non-permanent AFib, balanced against its safety profile and regulatory guidelines.