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Serving leading biopharmaceutical companies globally:

Medtronic
Cerilliant
Novartis
Express Scripts
McKesson
Boehringer Ingelheim
US Department of Justice
QuintilesIMS
Federal Trade Commission
Chinese Patent Office

Generated: January 22, 2018

DrugPatentWatch Database Preview

Dronedarone hydrochloride - Generic Drug Details

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What are the generic drug sources for dronedarone hydrochloride and what is the scope of dronedarone hydrochloride patent protection?

Dronedarone hydrochloride
is the generic ingredient in one branded drug marketed by Sanofi Aventis Us and is included in one NDA. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dronedarone hydrochloride has one hundred and forty-eight patent family members in fifty-seven countries.

There are nineteen drug master file entries for dronedarone hydrochloride. Four suppliers are listed for this compound. There are three tentative approvals for this compound.
Summary for dronedarone hydrochloride
Pharmacology for dronedarone hydrochloride
Tentative approvals for DRONEDARONE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
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US Patents and Regulatory Information for dronedarone hydrochloride

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 ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
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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International Patents for dronedarone hydrochloride

Supplementary Protection Certificates for dronedarone hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB10/029 United Kingdom ➤ Subscribe 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
2010003,C1007030 Lithuania ➤ Subscribe 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
673 Luxembourg ➤ Subscribe 91673, EXPIRES: 20230619
1007030/01 Switzerland ➤ Subscribe PRODUCT NAME: DRONEDARONUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 59292 16.09.2009
2010 00018 Denmark ➤ Subscribe
2010003 Lithuania ➤ Subscribe 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
2010000029 Germany ➤ Subscribe PRODUCT NAME: DRONEDARON ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE DAS HYDROCHLORIDSALZ; REGISTRATION NO/DATE: EU/1/09/591/001-004 20091126
C0031 France ➤ Subscribe PRODUCT 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
4 Finland ➤ Subscribe
22/2010 Austria ➤ Subscribe PRODUCT NAME: DRONEDARON ODER PHARMAZEUTISCH ANNEHMBARE SALZE HIEVON
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
US Army
Cipla
Baxter
Moodys
UBS
Deloitte
Healthtrust
Fish and Richardson

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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