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Last Updated: March 18, 2024

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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-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.

Drug patent expirations by year for MULTAQ
Drug Prices for MULTAQ

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Drug Sales Revenue Trends for MULTAQ

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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.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: MANAGEMENT OF RISK OF DRONEDARONE/BETA-BLOCKER INTERACTION IN PATIENTS IN SINUS RHYTHM 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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009 ⤷  Try a Trial ⤷  Try a Trial
>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: ⤷  Try a Trial

Patent: 2951
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 09252897
Estimated Expiration: ⤷  Try a Trial

Patent: 09252898
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0910631
Estimated Expiration: ⤷  Try a Trial

Patent: 0911198
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 21489
Estimated Expiration: ⤷  Try a Trial

Patent: 21491
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 09000919
Estimated Expiration: ⤷  Try a Trial

Patent: 09000920
Estimated Expiration: ⤷  Try a Trial

China

Patent: 2065855
Estimated Expiration: ⤷  Try a Trial

Patent: 2065857
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 60064
Estimated Expiration: ⤷  Try a Trial

Patent: 60065
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 721
Estimated Expiration: ⤷  Try a Trial

Patent: 734
Estimated Expiration: ⤷  Try a Trial

Dominican Republic

Patent: 010000299
Estimated Expiration: ⤷  Try a Trial

Patent: 010000300
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 10010540
Estimated Expiration: ⤷  Try a Trial

Patent: 10010553
Estimated Expiration: ⤷  Try a Trial

El Salvador

Patent: 10003700
Estimated Expiration: ⤷  Try a Trial

Patent: 10003701
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 5017
Estimated Expiration: ⤷  Try a Trial

Patent: 1071204
Estimated Expiration: ⤷  Try a Trial

Patent: 1071209
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 80701
Estimated Expiration: ⤷  Try a Trial

Patent: 80702
Estimated Expiration: ⤷  Try a Trial

Patent: 84564
Estimated Expiration: ⤷  Try a Trial

Patent: 95862
Estimated Expiration: ⤷  Try a Trial

France

Patent: 30148
Estimated Expiration: ⤷  Try a Trial

Patent: 30150
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 11518147
Estimated Expiration: ⤷  Try a Trial

Patent: 11518785
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 3608
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 10011400
Estimated Expiration: ⤷  Try a Trial

Patent: 10011414
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 354
Estimated Expiration: ⤷  Try a Trial

Patent: 356
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 8623
Estimated Expiration: ⤷  Try a Trial

Nicaragua

Patent: 1000172
Estimated Expiration: ⤷  Try a Trial

Patent: 1000173
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 091777
Estimated Expiration: ⤷  Try a Trial

Patent: 091809
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1007248
Estimated Expiration: ⤷  Try a Trial

Patent: 1007391
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 100135814
Estimated Expiration: ⤷  Try a Trial

Patent: 100135909
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 19298
Estimated Expiration: ⤷  Try a Trial

Patent: 0946108
Estimated Expiration: ⤷  Try a Trial

Patent: 0948354
Estimated Expiration: ⤷  Try a Trial

Patent: 1529068
Estimated Expiration: ⤷  Try a Trial

Tunisia

Patent: 10000454
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 8980
Estimated Expiration: ⤷  Try a Trial

Uruguay

Patent: 767
Estimated Expiration: ⤷  Try a Trial

Patent: 768
Estimated Expiration: ⤷  Try a Trial

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
South Korea 20100135909 USE OF DRONEDARONE FOR THE PREPARATION OF A MEDICAMENT FOR USE IN THE PREVENTION OF CARDIOVASCULAR HOSPITALIZATION OR OF MORTALITY ⤷  Try a Trial
France 2665444 DERIVES D'AMINO-BENZOFURANNE, BENZOTHIOPHENE OU INDOLE, LEUR PROCEDE DE PREPARATION AINSI QUE LES COMPOSITIONS LES CONTENANT. ⤷  Try a Trial
Taiwan 548108 ⤷  Try a Trial
Brazil 9810320 ⤷  Try a Trial
>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 ⤷  Try a Trial
1007030 122010000029 Germany ⤷  Try a Trial PRODUCT NAME: DRONEDARON ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE DAS HYDROCHLORIDSALZ; REGISTRATION NO/DATE: EU/1/09/591/001-004 20091126
1007030 CA 2010 00018 Denmark ⤷  Try a Trial
1007030 10C0031 France ⤷  Try a Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.