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.
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
Summary for MULTAQ
| International Patents: | 57 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 79 |
| Clinical Trials: | 6 |
| Patent Applications: | 1,259 |
| 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
| 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.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of MULTAQ is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ 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.
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 | 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 | 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 | 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 |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2009144550 | ⤷ Try a Trial | |
| Spain | 2221178 | ⤷ Try a Trial | |
| Japan | 2011518147 | ⤷ Try a Trial | |
| Russian Federation | 2191578 | ТВЕРДАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ПРОИЗВОДНЫЕ БЕНЗОФУРАНА (SOLID PHARMACEUTICAL COMPOSITION CONTAINING BENZOFURAN DERIVATIVES) | ⤷ 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 | SZ 22/2010 | Austria | ⤷ Try a Trial | PRODUCT NAME: DRONEDARON ODER PHARMAZEUTISCH ANNEHMBARE SALZE HIEVON |
| 1007030 | 384 | Finland | ⤷ Try a Trial | |
| 1007030 | C300446 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: DRONEDARON, DESGEWENST IN DE VORM VAN EEN AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/09/591/001-004 20091126 |
| 1007030 | SPC/GB10/029 | United Kingdom | ⤷ Try a Trial | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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.
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