.

Make Better Decisions

  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents
  • Obtain formulation and manufacturing information

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Julphar
Harvard Business School
Cerilliant
Accenture
Citi
Cantor Fitzgerald
Healthtrust
US Army
Covington
Medtronic

Generated: December 12, 2017

DrugPatentWatch Database Preview

MULTAQ Drug Profile

« Back to Dashboard

When do Multaq patents expire, and what generic 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.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis UsMULTAQdronedarone hydrochlorideTABLET;ORAL022425-001Jul 1, 2009RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Sanofi Aventis UsMULTAQdronedarone hydrochlorideTABLET;ORAL022425-001Jul 1, 2009RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Sanofi Aventis UsMULTAQdronedarone hydrochlorideTABLET;ORAL022425-001Jul 1, 2009RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Sanofi Aventis UsMULTAQdronedarone hydrochlorideTABLET;ORAL022425-001Jul 1, 2009RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Sanofi Aventis UsMULTAQdronedarone hydrochlorideTABLET;ORAL022425-001Jul 1, 2009RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Sanofi Aventis UsMULTAQdronedarone hydrochlorideTABLET;ORAL022425-001Jul 1, 2009RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
China1267217► Subscribe
Australia728287► Subscribe
Australia2009252898► Subscribe
Denmark0471609► Subscribe
Taiwan548108► Subscribe
Taiwan199095► Subscribe
China102065857► Subscribe
Israel133605► Subscribe
Czech Republic295191► Subscribe
Australia2009252897► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: MULTAQ

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C008/2010Ireland► SubscribeSPC008/2010: 20101015, EXPIRES: 20230616
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
1007030/01Switzerland► SubscribePRODUCT NAME: DRONEDARONUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 59292 16.09.2009
673Luxembourg► Subscribe91673, EXPIRES: 20230619
2010000029Germany► SubscribePRODUCT NAME: DRONEDARON ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE DAS HYDROCHLORIDSALZ; REGISTRATION NO/DATE: EU/1/09/591/001-004 20091126
22/2010Austria► SubscribePRODUCT NAME: DRONEDARON ODER PHARMAZEUTISCH ANNEHMBARE SALZE HIEVON
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
2010 00018Denmark► Subscribe
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
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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Daiichi Sankyo
Farmers Insurance
Federal Trade Commission
Accenture
Dow
Johnson and Johnson
Mallinckrodt
Chinese Patent Office
Moodys

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot