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Last Updated: October 22, 2020

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Dronedarone hydrochloride - Generic Drug Details

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What are the generic sources for dronedarone hydrochloride and what is the scope of freedom to operate?

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

Dronedarone hydrochloride has fifty-nine patent family members in twenty-nine countries.

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

Recent Clinical Trials for dronedarone hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Maimonides Medical CenterPhase 2
doaa rashwanPhase 2/Phase 3
Elpen Pharmaceutical Co. Inc.Phase 2/Phase 3

See all dronedarone hydrochloride clinical trials

Generic filers with tentative approvals for DRONEDARONE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial400MGTABLET;ORAL
  Start Trial  Start Trial400MGTABLET;ORAL
  Start Trial  Start Trial400MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for dronedarone hydrochloride
Paragraph IV (Patent) Challenges for DRONEDARONE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
MULTAQ TABLET;ORAL dronedarone hydrochloride 022425 2013-07-01

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

Expired US Patents for dronedarone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009   Start Trial   Start Trial
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009   Start Trial   Start Trial
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for dronedarone hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1007030 SPC/GB10/029 United Kingdom   Start Trial 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 10C0031 France   Start Trial 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
1007030 2010008 Ireland   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Colorcon
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Medtronic

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