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Serving leading biopharmaceutical companies globally:

Julphar
Cerilliant
Farmers Insurance
Johnson and Johnson
Healthtrust
UBS
Medtronic
Merck
Queensland Health
Daiichi Sankyo

Generated: February 21, 2018

DrugPatentWatch Database Preview

MULTAQ Drug Profile

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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 five patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and seven patent family members in fifty 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 for MULTAQ

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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for MULTAQ
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 400 mg ➤ Subscribe 7/1/2013

International Patents for MULTAQ

Supplementary Protection Certificates for MULTAQ

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2010 00018 Denmark ➤ Sign Up
673 Luxembourg ➤ Sign Up 91673, EXPIRES: 20230619
C008/2010 Ireland ➤ Sign Up SPC008/2010: 20101015, EXPIRES: 20230616
10008 Ireland ➤ Sign Up THE 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
00446 Netherlands ➤ Sign Up 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
2010003,C1007030 Lithuania ➤ Sign Up 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
C/GB10/029 United Kingdom ➤ Sign Up 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
1007030/01 Switzerland ➤ Sign Up PRODUCT NAME: DRONEDARONUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 59292 16.09.2009
4 Finland ➤ Sign Up
2010000029 Germany ➤ Sign Up PRODUCT NAME: DRONEDARON ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE DAS HYDROCHLORIDSALZ; REGISTRATION NO/DATE: EU/1/09/591/001-004 20091126
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Boehringer Ingelheim
Colorcon
Argus Health
Moodys
Federal Trade Commission
Citi
Fish and Richardson
Cipla

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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