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Serving leading biopharmaceutical companies globally:

Fuji
Medtronic
QuintilesIMS
US Army
Colorcon
Novartis
Argus Health
Boehringer Ingelheim
Daiichi Sankyo
Teva

Generated: October 21, 2017

DrugPatentWatch Database Preview

MULTAQ Drug Profile

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What is the patent landscape for Multaq, and what generic Multaq alternatives are available?

Multaq is a drug marketed by Sanofi Aventis Us and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and forty-eight patent family members in fifty-seven countries and thirteen supplementary protection certificates in eleven countries.

The generic ingredient in MULTAQ is dronedarone hydrochloride. There are nineteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dronedarone hydrochloride profile page.

Summary for Tradename: MULTAQ

US Patents:6
Applicants:1
NDAs:1
Suppliers / Packagers: see list4
Bulk Api Vendors: see list37
Clinical Trials: see list5
Patent Applications: see list79
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:MULTAQ at DailyMed
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;ORAL022425-001Jul 1, 2009RXYesYes► Subscribe► SubscribeYY ► Subscribe
Sanofi Aventis Us
MULTAQ
dronedarone hydrochloride
TABLET;ORAL022425-001Jul 1, 2009RXYesYes► Subscribe► SubscribeY ► Subscribe
Sanofi Aventis Us
MULTAQ
dronedarone hydrochloride
TABLET;ORAL022425-001Jul 1, 2009RXYesYes► Subscribe► Subscribe ► Subscribe
Sanofi Aventis Us
MULTAQ
dronedarone hydrochloride
TABLET;ORAL022425-001Jul 1, 2009RXYesYes► Subscribe► Subscribe ► Subscribe
Sanofi Aventis Us
MULTAQ
dronedarone hydrochloride
TABLET;ORAL022425-001Jul 1, 2009RXYesYes► Subscribe► Subscribe ► Subscribe
Sanofi Aventis Us
MULTAQ
dronedarone hydrochloride
TABLET;ORAL022425-001Jul 1, 2009RXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Tradename: MULTAQ

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
MULTAQ
dronedarone hydrochloride
TABLET;ORAL022425-001Jul 1, 2009► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for MULTAQ

Drugname Dosage Strength RLD Submissiondate
dronedarone hydrochlorideTablets400 mgMultaq7/1/2013

International Patent Family for Tradename: MULTAQ

Country Document Number Estimated Expiration
Indonesia23872► Subscribe
Iceland2340► Subscribe
Taiwan201529068► Subscribe
El Salvador2010003701► Subscribe
Norway2010009► Subscribe
South Korea20010014098► Subscribe
Australia8142891► Subscribe
France2930150► Subscribe
TunisiaSN91070► Subscribe
Hungary0100412► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: MULTAQ

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
673Luxembourg► Subscribe91673, EXPIRES: 20230619
00446Netherlands► SubscribePRODUCT 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
C008/2010Ireland► SubscribeSPC008/2010: 20101015, EXPIRES: 20230616
10008Ireland► SubscribeTHE CORRECT SPC EXTENSION DATE IS 20230618 (NOT 20230616); PRODUCT NAME: DRONEDARONE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1/09/591/001-004 20091126
2010003Lithuania► SubscribePRODUCT 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
1007030/01Switzerland► SubscribePRODUCT NAME: DRONEDARONUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 59292 16.09.2009
C0031France► SubscribePRODUCT 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
2010000029Germany► SubscribePRODUCT NAME: DRONEDARON ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE DAS HYDROCHLORIDSALZ; REGISTRATION NO/DATE: EU/1/09/591/001-004 20091126
C/GB10/029United Kingdom► SubscribePRODUCT 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
2010003,C1007030Lithuania► SubscribePRODUCT 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
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Merck
Federal Trade Commission
McKinsey
Accenture
Farmers Insurance
Teva
Queensland Health
Express Scripts
Daiichi Sankyo
Deloitte

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 verifification 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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