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Last Updated: March 19, 2024

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 two branded drugs marketed by Lupin and Sanofi Aventis Us, and is included in two NDAs. 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-seven patent family members in twenty-eight countries.

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

Recent Clinical Trials for dronedarone hydrochloride

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

SponsorPhase
Shanghai East HospitalPhase 4
Stony Brook UniversityPhase 3
China National Center for Cardiovascular DiseasesPhase 4

See all dronedarone hydrochloride clinical trials

Generic filers with tentative approvals for DRONEDARONE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial400MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial400MGTABLET;ORAL
⤷  Try a Trial⤷  Try a 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 Strength NDA ANDAs Submitted Submissiondate
MULTAQ Tablets dronedarone hydrochloride 400 mg 022425 7 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 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lupin DRONEDARONE HYDROCHLORIDE dronedarone hydrochloride TABLET;ORAL 205904-001 Jan 31, 2024 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for dronedarone hydrochloride

Country Patent Number Title Estimated Expiration
Malaysia 153608 USE OF DRONEDARONE FOR THE PREPARATION OF MEDICAMENT FOR USE IN THE PREVENTION OF CARDIOVASCULAR HOSPITALIZATION OR OF MORTALITY ⤷  Try a Trial
European Patent Office 3195862 UTILISATION DE LA DRONEDARONE DANS LA PREPARATION D'UN MEDICAMENT UTILISE POUR PREVENIR UN EPISODE CARDIOVASCULAIRE MENANT A L'HOSPITALISATION OU PREVENIR LA FIBRILLATION AURICULAIRE (USE OF DRONEDARONE FOR THE PREPARATION OF A MEDICAMENT FOR USE IN THE PREVENTION OF CARDIOVASCULAR HOSPITALIZATION OR IN THE PREVENTION OF ATRIAL FIBRILLATION) ⤷  Try a Trial
Tunisia 2010000454 USE OF DRONEDARONE FOR THE PREPARATION OF A MEDICAMENT FOR USE IN THE PREVENTION OF CARDIOVASCULAR HOSPITALISATION OR OF MORTATILY ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for dronedarone hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1007030 10C0031 France ⤷  Try a 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 ⤷  Try a 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
1007030 SPC/GB10/029 United Kingdom ⤷  Try a 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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