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Last Updated: September 30, 2022

MULTAQ Drug Patent Profile


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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-nine patent family members in twenty-nine 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® Generic Entry Outlook for Multaq

Multaq was eligible for patent challenges on July 1, 2013.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 16, 2029. This may change due to patent challenges or generic licensing.

There have been twenty patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are four tentative approvals for the generic drug (dronedarone hydrochloride), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for MULTAQ
Drug Prices for MULTAQ

See drug prices for MULTAQ

Drug Sales Revenue Trends for MULTAQ

See drug sales revenues for MULTAQ

DrugPatentWatch® Estimated Generic Entry Opportunity Date for MULTAQ
Generic Entry Date for MULTAQ*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for MULTAQ

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

SponsorPhase
American Heart AssociationPhase 4
Duke Clinical Research InstitutePhase 4
University of UtahPhase 3

See all MULTAQ clinical trials

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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of MULTAQ is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Patents protecting MULTAQ

Use of dronedarone for the preparation of a medicament for use in the prevention of cardiovascular hospitalization or of mortality
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION IN RISK OF HOSPITALIZATION IN PATIENTS WITH A HISTORY OF PAROXYSMAL OR PERSISTENT AF WITHOUT SEVERE HEART FAILURE AND WITH ONE OR MORE RISK FACTORS BY ADMINISTRATION TWICE A DAY WITH MORNING AND EVENING MEALS

Use of dronedarone for the preparation of a medicament for use in the prevention of cardiovascular hospitalization or of mortality
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PATIENTS WITH A HISTORY OF PAROXYSMAL OR PERSISTENT AF WITHOUT SEVERE HEART FAILURE AND WITH ONE OR MORE RISK FACTORS BY ADMINISTRATION TWICE A DAY WITH MORNING AND EVENING MEALS

Methods for reducing the risk of an adverse dronedarone/beta-blockers interaction in a patient suffering from atrial fibrillation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF RISK OF DRONEDARONE/BETA-BLOCKER INTERACTION IN PATIENTS IN SINUS RYTHM WITH A HISTORY OF PAROXYSMAL OR PERSISTENT AF

Use of dronedarone for the preparation of a medicament for use in the prevention of cardiovascular hospitalization or of morality
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION IN RISK OF HOSPITALIZATION IN PATIENTS WITH STABLE NYHA CLASS III HEART FAILURE AND A HISTORY OF PAROXYSMAL OR PERSISTENT AF AND WITH ONE OR MORE RISK FACTORS BY ADMINISTRATION TWICE A DAY WITH MORNING AND EVENING MEALS

Use of dronedarone for the preparation of a medicament for use in the prevention of cardiovascular hospitalization or of morality
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION IN RISK OF HOSPITALIZATION IN PATIENTS WITH CORONARY HEART DISEASE AND A HISTORY OF PAROXYSMAL OR PERSISTENT AF AND WITH ONE OR MORE RISK FACTORS BY ADMINISTRATION TWICE A DAY WITH MORNING AND EVENING MEALS

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 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009 See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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

Patent: 2950
Estimated Expiration: See Plans and Pricing

Patent: 2951
Estimated Expiration: See Plans and Pricing

Australia

Patent: 09252897
Estimated Expiration: See Plans and Pricing

Patent: 09252898
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0910631
Estimated Expiration: See Plans and Pricing

Patent: 0911198
Estimated Expiration: See Plans and Pricing

Canada

Patent: 21489
Estimated Expiration: See Plans and Pricing

Patent: 21491
Estimated Expiration: See Plans and Pricing

Chile

Patent: 09000919
Estimated Expiration: See Plans and Pricing

Patent: 09000920
Estimated Expiration: See Plans and Pricing

China

Patent: 2065855
Estimated Expiration: See Plans and Pricing

Patent: 2065857
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 60064
Estimated Expiration: See Plans and Pricing

Patent: 60065
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 721
Estimated Expiration: See Plans and Pricing

Patent: 734
Estimated Expiration: See Plans and Pricing

Dominican Republic

Patent: 010000299
Estimated Expiration: See Plans and Pricing

Patent: 010000300
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 10010540
Estimated Expiration: See Plans and Pricing

Patent: 10010553
Estimated Expiration: See Plans and Pricing

El Salvador

Patent: 10003700
Estimated Expiration: See Plans and Pricing

Patent: 10003701
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 5017
Estimated Expiration: See Plans and Pricing

Patent: 1071204
Estimated Expiration: See Plans and Pricing

Patent: 1071209
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 80701
Estimated Expiration: See Plans and Pricing

Patent: 80702
Estimated Expiration: See Plans and Pricing

Patent: 84564
Estimated Expiration: See Plans and Pricing

Patent: 95862
Estimated Expiration: See Plans and Pricing

France

Patent: 30148
Estimated Expiration: See Plans and Pricing

Patent: 30150
Estimated Expiration: See Plans and Pricing

Israel

Patent: 8751
Estimated Expiration: See Plans and Pricing

Patent: 8752
Estimated Expiration: See Plans and Pricing

Japan

Patent: 11518147
Estimated Expiration: See Plans and Pricing

Patent: 11518785
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 3608
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 10011400
Estimated Expiration: See Plans and Pricing

Patent: 10011414
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 354
Estimated Expiration: See Plans and Pricing

Patent: 356
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 8623
Estimated Expiration: See Plans and Pricing

Nicaragua

Patent: 1000172
Estimated Expiration: See Plans and Pricing

Patent: 1000173
Estimated Expiration: See Plans and Pricing

Peru

Patent: 091777
Estimated Expiration: See Plans and Pricing

Patent: 091809
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1007248
Estimated Expiration: See Plans and Pricing

Patent: 1007391
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 100135814
Estimated Expiration: See Plans and Pricing

Patent: 100135909
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 19298
Estimated Expiration: See Plans and Pricing

Patent: 0946108
Estimated Expiration: See Plans and Pricing

Patent: 0948354
Estimated Expiration: See Plans and Pricing

Patent: 1529068
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 10000454
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 8980
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 767
Estimated Expiration: See Plans and Pricing

Patent: 768
Estimated Expiration: See Plans and Pricing

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
Israel 98991 Derivatives of benzofuran benzothiophene indole and indolizine their preparation and pharmaceutical compositions containing them See Plans and Pricing
Malaysia 153608 USE OF DRONEDARONE FOR THE PREPARATION OF MEDICAMENT FOR USE IN THE PREVENTION OF CARDIOVASCULAR HOSPITALIZATION OR OF MORTALITY See Plans and Pricing
Taiwan 200948354 Use of dronedarone for the preparation of a medicament for use in the prevention of cardiovascular hospitalization or of mortality See Plans and Pricing
Denmark 0471609 See Plans and Pricing
Luxembourg 91673 See Plans and Pricing
Nicaragua 201000173 USO DE DRONEDARONA O UNA SAL ACEPTABLE FARMACÉUTICAMENTE DE ÉSTA, PARA LA PREPARACIÓN DE UN MEDICAMENTO PARA REGULAR EL NIVEL DE POTASIO EN LA SANGRE. See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for MULTAQ

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1007030 384 Finland See Plans and Pricing
1007030 10C0031 France See Plans and Pricing 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 C01007030/01 Switzerland See Plans and Pricing PRODUCT NAME: DRONEDARONUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 59292 16.09.2009
1007030 PA2010003 Lithuania See Plans and Pricing 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 SPC/GB10/029 United Kingdom See Plans and Pricing 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
1007030 PA2010003,C1007030 Lithuania See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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McKinsey
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Medtronic
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.