MULTAQ Drug Patent Profile
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Which patents cover Multaq, and when can generic versions of Multaq launch?
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 31st, 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: | 1,132 |
Formulation / Manufacturing: | see details |
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 |
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 |
Pharmacology for MULTAQ
Drug Class | Antiarrhythmic |
Mechanism of Action | Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors P-Glycoprotein Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for MULTAQ
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 |
---|---|---|---|
Australia | 2009252897 | Use of dronedarone for the preparation of a medicament for use in the prevention of cardiovascular hospitalization or of mortality | ⤷ Try a Trial |
Denmark | 0471609 | ⤷ Try a Trial | |
China | 1267217 | ⤷ Try a Trial | |
Uruguay | 25062 | COMPOSICION FARMACÉUTICA SÓLIDA QUE CONTIENE UN DERIVADO DE BENZOFURANO | ⤷ Try a Trial |
Eurasian Patent Organization | 025017 | СПОСОБ ЛЕЧЕНИЯ ПАЦИЕНТОВ С ИСТОРИЕЙ ФИБРИЛЛЯЦИИ ПРЕДСЕРДИЙ ИЛИ ТРЕПЕТАНИЯ ПРЕДСЕРДИЙ, ИЛИ СУЩЕСТВУЮЩИМИ ФИБРИЛЛЯЦИЕЙ ПРЕДСЕРДИЙ ИЛИ ТРЕПЕТАНИЕМ ПРЕДСЕРДИЙ, ПРЕДОТВРАЩАЮЩИЙ ГОСПИТАЛИЗАЦИЮ В КАРДИОЛОГИЧЕСКОЕ ОТДЕЛЕНИЕ (METHOD OF TREATING PATIENTS WITH A HISTORY OF ATRIAL FIBRILLATION OR ATRIAL FLUTTER, OR CURRENT ATRIAL FIBRILLATION OR ATRIAL FLUTTER, PREVENTING CARDIOVASCULAR HOSPITALIZATION) | ⤷ Try a Trial |
Slovakia | 284972 | ⤷ 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 | PA2010003,C1007030 | Lithuania | ⤷ Try a Trial | 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 | SZ 22/2010 | Austria | ⤷ Try a Trial | PRODUCT NAME: DRONEDARON ODER PHARMAZEUTISCH ANNEHMBARE SALZE HIEVON |
1007030 | PA2010003 | Lithuania | ⤷ Try a Trial | 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 | 91673 | Luxembourg | ⤷ Try a Trial | 91673, EXPIRES: 20230619 |
1007030 | C01007030/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: DRONEDARONUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 59292 16.09.2009 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |