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.

Summary for DRONEDARONE HYDROCHLORIDE

International Patents:	57
US Patents:	3
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	112
Clinical Trials:	34
Patent Applications:	187
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DRONEDARONE HYDROCHLORIDE
DailyMed Link:	DRONEDARONE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for DRONEDARONE HYDROCHLORIDE

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

Sponsor	Phase
Shanghai East Hospital	Phase 4
Stony Brook University	Phase 3
China National Center for Cardiovascular Diseases	Phase 4

See all DRONEDARONE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for DRONEDARONE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	400MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	400MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	400MG	TABLET;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

Drug Class	Antiarrhythmic
Mechanism of Action	Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for DRONEDARONE HYDROCHLORIDE

C01BD	Antiarrhythmics, class III
C01B	ANTIARRHYTHMICS, CLASS I AND III
C01	CARDIAC THERAPY
C	Cardiovascular system

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

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sanofi Aventis Us	MULTAQ	dronedarone hydrochloride	TABLET;ORAL	022425-001	Jul 1, 2009	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sanofi Aventis Us	MULTAQ	dronedarone hydrochloride	TABLET;ORAL	022425-001	Jul 1, 2009	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lupin	DRONEDARONE HYDROCHLORIDE	dronedarone hydrochloride	TABLET;ORAL	205904-001	Jan 31, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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

International Patents for DRONEDARONE HYDROCHLORIDE

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Country	Patent Number	Title	Estimated Expiration
Taiwan	201529068	Use of DRONEDARONE for the preparation of a medicament for use in the prevention of cardiovascular hospitalization or of mortality	⤷ Sign Up
Ecuador	SP10010553	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	⤷ Sign Up
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)	⤷ Sign Up
South Korea	20100135909	USE OF DRONEDARONE FOR THE PREPARATION OF A MEDICAMENT FOR USE IN THE PREVENTION OF CARDIOVASCULAR HOSPITALIZATION OR OF MORTALITY	⤷ Sign Up
Taiwan	I519298		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for DRONEDARONE HYDROCHLORIDE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1007030	SPC/GB10/029	United Kingdom	⤷ Sign Up	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	⤷ Sign Up	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	⤷ Sign Up	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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