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Dronedarone hydrochloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for dronedarone hydrochloride?

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-two patent family members in fifty-six countries.

There are eighteen drug master file entries for dronedarone hydrochloride. Four suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for Generic Name: dronedarone hydrochloride

Tradenames:1
Patents:6
Applicants:1
NDAs:1
Drug Master File Entries: see list18
Suppliers / Packagers: see list4
Bulk Api Vendors: see list58
Clinical Trials: see list1,000
Patent Applications: see list138
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:dronedarone hydrochloride at DailyMed

Pharmacology for Ingredient: dronedarone hydrochloride

Tentative approvals for DRONEDARONE HYDROCHLORIDE

Applicant Application No. Form Dosage
► Subscribe► SubscribeTABLET;ORAL400MG
► Subscribe► SubscribeTABLET;ORAL400MG
► Subscribe► SubscribeTABLET;ORAL400MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us
MULTAQ
dronedarone hydrochloride
TABLET;ORAL022425-001Jul 1, 2009RXYesYes8,602,215► Subscribe ► Subscribe
Sanofi Aventis Us
MULTAQ
dronedarone hydrochloride
TABLET;ORAL022425-001Jul 1, 2009RXYesYes5,223,510► SubscribeYY ► Subscribe
Sanofi Aventis Us
MULTAQ
dronedarone hydrochloride
TABLET;ORAL022425-001Jul 1, 2009RXYesYes7,323,493► SubscribeY ► Subscribe
Sanofi Aventis Us
MULTAQ
dronedarone hydrochloride
TABLET;ORAL022425-001Jul 1, 2009RXYesYes8,318,800► SubscribeY ► Subscribe
Sanofi Aventis Us
MULTAQ
dronedarone hydrochloride
TABLET;ORAL022425-001Jul 1, 2009RXYesYes8,410,167► Subscribe ► 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, 20095,223,510► Subscribe
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International Patent Family for Ingredient: dronedarone hydrochloride

Country Document Number Estimated Expiration
Uruguay31768► Subscribe
CroatiaP980355► Subscribe
Slovakia284972► Subscribe
HungaryT62280► Subscribe
South Korea100542089► 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
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
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
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
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
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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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