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MULTAQ Drug Profile

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Multaq is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from four suppliers. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and forty-one patent family members in fifty-six countries.

The generic ingredient in MULTAQ is dronedarone hydrochloride. There are seventeen drug master file entries for this compound. Four suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the dronedarone hydrochloride profile page.

Summary for Tradename: MULTAQ

Patents:6
Applicants:1
NDAs:1
Suppliers / Packagers: see list4
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us
MULTAQ
dronedarone hydrochloride
TABLET;ORAL022425-001Jul 1, 2009RXYes5,223,510► subscribeYY ► subscribe
Sanofi Aventis Us
MULTAQ
dronedarone hydrochloride
TABLET;ORAL022425-001Jul 1, 2009RXYes8,318,800► subscribeY ► subscribe
Sanofi Aventis Us
MULTAQ
dronedarone hydrochloride
TABLET;ORAL022425-001Jul 1, 2009RXYes8,410,167► subscribe ► subscribe
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Expired Patents for Tradename: MULTAQ

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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Paragraph IV activity for: MULTAQ

Drugname Dosage Strength RLD Submissiondate
dronedarone hydrochlorideTablets400 mgMultaq7/1/2013

International Patent Family for Tradename: MULTAQ

Country Document Number Estimated Expiration
Colombia6260065► subscribe
Poland190127► subscribe
South Korea20100135814► 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: MULTAQ

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
C008/2010Ireland► subscribeSPC008/2010: 20101015, EXPIRES: 20230616
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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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