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Last Updated: January 27, 2023

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 four tentative approvals for this compound.

Recent Clinical Trials for dronedarone hydrochloride

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

SponsorPhase
Stony Brook UniversityPhase 3
China National Center for Cardiovascular DiseasesPhase 4
Chinese Academy of Medical Sciences, Fuwai HospitalPhase 4

See all dronedarone hydrochloride clinical trials

Generic filers with tentative approvals for DRONEDARONE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing400MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing400MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing400MGTABLET;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 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009 See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for dronedarone hydrochloride

Country Patent Number Title Estimated Expiration
European Patent Office 2684564 Utilisation de dronédarone dans un médicament utilisé pour prévenir un épisode cardiovasculaire menant à l’hospitalisation ou prévenir 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) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2009144550 See Plans and Pricing
El Salvador 2010003701 USO DE DRONEDARONA O UNA SAL ACEPTABLE FARMACEUTICAMENTE DE ESTA, PARA LA PREPARACION DE UN MEDICAMENTO PARA REGULAR EL NIVEL DE POTASIO EN LA SANGRE See Plans and Pricing
Israel 208752 See Plans and Pricing
Uruguay 31767 USO DE DRONEDARONA PARA LA PREPARACIÓN DE UN MEDICAMENTO PARA USO EN LA PREVENCIÓN DE LA HOSPITALIZACIÓN CARDIOVASCULAR O DE LA MORTALIDAD See Plans and Pricing
>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 See Plans and Pricing 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 See Plans and Pricing 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 See Plans and Pricing 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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