Is there a generic for Dronedarone hydrochloride?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Dronedarone hydrochloride, referencing the brand MULTAQ. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Dronedarone hydrochloride?

MULTAQ (NDA 022425, SANOFI AVENTIS US) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Dronedarone hydrochloride?

The Orange Book lists 3 patents against Dronedarone hydrochloride products, with the earliest listed expiry in 2029. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Dronedarone hydrochloride are approved?

Dronedarone hydrochloride is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Dronedarone hydrochloride

Dronedarone hydrochloride: 1 brand, 1 generic; first approved Jul 01, 2009; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 1 ANDA application approved.

Earliest patent expiry Apr 16, 2029

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Apr 16, 2029

in 2 yr 7 mo

Brand (NDA) products

Originator applications

MULTAQRLDRS
SANOFI AVENTIS USNDA 0224252009
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 400MG BASE TABLET ORAL Rx —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 400MG BASE	TABLET	ORAL	Rx	—

Generic (ANDA) products (1)

Abbreviated applications

DRONEDARONE HYDROCHLORIDE
LUPINANDA 2059042024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 400MG BASE TABLET ORAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 400MG BASE	TABLET	ORAL	Discontinued	—

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8410167	Apr 16, 2029	in 2 yr 7 mo	U-1387
9107900	Apr 16, 2029	in 2 yr 7 mo	U-1728
8602215	Jun 30, 2031	in 4 yr 10 mo	U-1473

Approval history

FDA approval span

First approval

Jul 01, 2009

17 yr 6 mo ago

Most recent approval

Jan 31, 2024

2 yr 9 mo ago

Approvals span 2009–2024 across 2 FDA applications.

Brand (NDA) 150%

Generic (ANDA) 150%

Dronedarone hydrochloride: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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