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Serving leading biopharmaceutical companies globally:

Moodys
Johnson and Johnson
Queensland Health
Mallinckrodt
Accenture
Daiichi Sankyo
Express Scripts
McKesson
US Department of Justice
Chubb

Generated: November 18, 2017

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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 and thirteen supplementary protection certificates in eleven 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.

Pharmacology for dronedarone hydrochloride

Tentative approvals for DRONEDARONE HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
u► Subscribe400MGTABLET;ORAL
u► Subscribe400MGTABLET;ORAL
u► Subscribe400MGTABLET;ORAL
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► 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
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► SubscribeYY ► Subscribe
Sanofi Aventis Us
MULTAQ
dronedarone hydrochloride
TABLET;ORAL022425-001Jul 1, 2009RXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: dronedarone hydrochloride

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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International Patent Family for Ingredient: dronedarone hydrochloride

Country Document Number Estimated Expiration
China1091593► Subscribe
Ireland912595► Subscribe
Japan2002506442► Subscribe
European Patent Office2280702► Subscribe
Canada2721489► Subscribe
Hong Kong1028352► Subscribe
HungaryT62280► Subscribe
Israel208752► Subscribe
Czech Republic9904666► Subscribe
Australia648569► 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: DRONEDARONE HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
673Luxembourg► Subscribe91673, EXPIRES: 20230619
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
1007030/01Switzerland► SubscribePRODUCT NAME: DRONEDARONUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 59292 16.09.2009
22/2010Austria► SubscribePRODUCT NAME: DRONEDARON ODER PHARMAZEUTISCH ANNEHMBARE SALZE HIEVON
2010 00018Denmark► Subscribe
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
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
4Finland► Subscribe
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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Farmers Insurance
QuintilesIMS
Argus Health
Covington
Fish and Richardson
Johnson and Johnson
Cipla
Baxter
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.

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