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MULTAQ

NDA

DRONEDARONE HYDROCHLORIDE | N022425 | SANOFI AVENTIS US LLC

1 strength3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)Today

2027

2028

2029

2030

2031

Today

8410167

Apr. 16, 2029

8602215

Jun. 30, 2031

9107900

Apr. 16, 2029

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

7 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Sanofi et al v. Aurobindo Pharma USA, Inc. 1:2017cv01247	D. Del.	2017-08-31	Terminated 2018-01-24	—
Sanofi et al v. First Time US Generics LLC 1:2015cv01205 3 patentsANDA 205745dronedarone	D. Del.	2015-12-23	Terminated 2016-04-14	—
Sanofi et al v. Glenmark Pharmaceuticals Inc. USA et al 1:2015cv01206 1 patentANDA 205903dronedarone	D. Del.	2015-12-23	Terminated 2017-11-07	—
Sanofi et al v. Alkem Laboratories Ltd 1:2015cv01200 4 patentsANDA 205895Dronedarone	D. Del.	2015-12-23	Terminated 2017-11-07	—
Sanofi et al v. Sun Pharma Global FZE et al 1:2015cv01208 1 patentANDA 205963Dronedarone	D. Del.	2015-12-23	Terminated 2017-11-07	—
Sanofi et al v. Alkem Laboratories, Ltd. et al 1:2014cv01957 4 patentsANDA 205895Dronedarone Hydrochloride	N.D. Ill.	2014-03-19	Terminated 2014-05-15	—
Sanofi et al v. Sun Pharma Global FZE et al 1:2014cv01844 4 patentsANDA 205963dronedarone	N.D. Ill.	2014-03-14	Terminated 2014-05-02	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

24 trials from ClinicalTrials.gov, 13 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Drug Interaction Study With Dabigatran Etexilate and Dronedarone in Healthy Subjects NCT01306162	Phase 1	Completed	Boehringer Ingelheim	36	2011-02
Effect of Addition of Dronedarone to Standard Rate Control Therapy on Ventricular Rate During Persistent Atrial Fibrillation (AFRODITE)NCT01047566	Phase 4	Completed	Sanofi	183	2010-04 → 2011-09
A Trial With Dronedarone to Prevent Hospitalization or Death in Patients With Atrial Fibrillation NCT00174785	Phase 3	Completed	Sanofi	4,628	2005-06 → 2008-03
EURopean Trial In Atrial Fibrillation(AF) or Flutter (AFL) Patients Receiving Dronedarone for the maIntenance of Sinus Rhythm (EURIDIS)NCT00259428	Phase 3	Completed	Sanofi	615	2001-11 → 2003-08
Dose Ranging Study of Dronedarone for the Control of Ventricular Rate in Japanese Patients With Permanent Atrial Fibrillation NCT01213368	Phase 2	Completed	Sanofi	181	2010-09 → 2011-04
European Study of Dronedarone in Atrial Fibrillation NCT00697086	Phase 3	Completed	Sanofi	174	2002-08 → 2004-06
American-Australian-African Trial With Dronedarone in Patients With Atrial Fibrillation or Atrial Flutter for the Maintenance of Sinus Rhythm NCT00259376	Phase 3	Completed	Sanofi	629	2001-11 → 2003-09
Study to Evaluate the Effect of Ranolazine and Dronedarone When Given Alone and in Combination in Patients With Paroxysmal Atrial Fibrillation NCT01522651	Phase 2	Completed	Gilead Sciences	134	2012-01-24 → 2014-03-10
Optimal Timing of Dronedarone Initiation After Conversion in Patients With Persistent Atrial Fibrillation NCT01140581	Phase 4	Completed	Sanofi	402	2010-09 → 2011-12
Efficacy of Propafenone Versus Dronedarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation NCT01991119	N/A	Completed	Samsung Medical Center	98	2011-05 → 2013-10

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$13.19

per ea

Lowest NADAC/Unit

$13.19

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00024414260MULTAQ 400 MG TABLET	$13.19	EA	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$591.64

Highest Price

$675.66

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00024-4142-60MULTAQ 400MG TAB	$675.66	FSS	Sanofi Aventis U.S. LLC	05/31/2028
00024-4142-60MULTAQ 400MG TAB	$591.64	Big4	Sanofi Aventis U.S. LLC	05/31/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Multaq (2024)

Total Spending

$414.8M

Total Claims

318,776

Beneficiaries

72,761

Avg Cost/Unit

$12.87

Spending Trend

$334.4M(2019)→$342.2M(2020)→$356.7M(2021)→$386.7M(2022)→$409.3M(2023)→$414.8M(2024)

YoY Change:-1.6%

5yr CAGR:+4.0%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain19 active DMFs3 inactive

17 active API suppliers hold Drug Master Files for this ingredient.

SANOFI WINTHROP INDUSTRIEDRONEDARONE HYDROCHLORIDE

DMF 184092005

UNIMARK REMEDIES LTDDRONEDARONE HYDROCHLORIDE

DMF 256692012

ALIVUS LIFE SCIENCES LTDDRONEDARONE HYDROCHLORIDE USP

DMF 260852012

CHEMWERTH INCDRONEDARONE HYDROCHLORIDE NON-STERILE BULK DRUG

DMF 264792013

WISDOM PHARMACEUTICAL CO LTDDRONEDARONE HYDROCHLORIDE

DMF 265932012

ALKEM LABORATORIES LTDDRONEDARONE HYDROCHLORIDE

DMF 269012013

MSN LABORATORIES PRIVATE LTDDRONEDARONE HYDROCHLORIDE USP [ROUTE CODE-DD]

DMF 269562013

LUPIN MANUFACTURING SOLUTIONS LTDDRONEDARONE HYDROCHLORIDE USP

DMF 269632013

ALEMBIC PHARMACEUTICALS LTDDRONEDARONE HYDROCHLORIDE USP

DMF 269762013

SUN PHARMACEUTICAL INDUSTRIES LTDDRONEDARONE HYDROCHLORIDE

DMF 271022013

RAKS PHARMA PVT LTDDRONEDARONE HYDROCHLORIDE USP

DMF 271612013

EMCURE PHARMACEUTICALS LTDDRONEDARONE HYDROCHLORIDE

DMF 272232013

ALP PHARM BEIJING CO LTDDRONEDARONE HYDROCHLORIDE

DMF 282002014

SYMED LABS LTDDRONEDARONE HYDROCHLORIDE

DMF 302292016

APITORIA PHARMA PRIVATE LTDDRONEDARONE HYDROCHLORIDE USP

DMF 312652016

PIRAMAL PHARMA LTDDRONEDARONE HYDROCHLORIDE

DMF 314862017

AURORE LIFE SCIENCES PRIVATE LTDDRONEDARONE HYDROCHLORIDE USP

DMF 359132021

MSN LABORATORIES PRIVATE LTDDRONEDARONE HYDROCHLORIDE USP

DMF 369312022

WISDOM PHARMACEUTICAL CO LTDDRONEDARONE HYDROCHLORIDE

DMF 372472022

MYLAN LABORATORIES LTDInactiveDRONEDARONE HYDROCHLORIDE

DMF 260232012

APOTEX PHARMACHEM INDIA PVT LTDInactiveDRONEDARONE HYDROCHLORIDE

DMF 270882013

SINOPEP JIANGSU INCInactiveDRONEDARONE HYDROCHLORIDE

DMF 275912013

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

22 letters from Drugs@FDA

Date	Submission	Document
Oct 24, 2023	SUPPL -30	View Letter (PDF)
Oct 24, 2023	SUPPL -28	View Letter (PDF)
Nov 17, 2020	SUPPL -29	View Letter (PDF)
Feb 16, 2016	SUPPL -27	View Letter (PDF)
Apr 3, 2014	SUPPL -25	View Letter (PDF)
Mar 20, 2014	SUPPL -22	View Letter (PDF)
Feb 4, 2014	SUPPL -23	View Letter (PDF)
Mar 29, 2013	SUPPL -21	View Letter (PDF)
Sep 10, 2012	SUPPL -17	View Letter (PDF)
Sep 10, 2012	SUPPL -16	View Letter (PDF)
Sep 10, 2012	SUPPL -18	View Letter (PDF)
Jun 15, 2012	SUPPL -14	View Letter (PDF)
Jan 30, 2012	SUPPL -2	View Letter (PDF)
Dec 21, 2011	SUPPL -13	View Letter (PDF)
Sep 6, 2011	SUPPL -12	View Letter (PDF)
Aug 11, 2011	SUPPL -6	View Letter (PDF)
Jun 27, 2011	SUPPL -10	View Letter (PDF)
Mar 14, 2011	SUPPL -7	View Letter (PDF)
Feb 15, 2011	SUPPL -1	View Letter (PDF)
Feb 15, 2011	SUPPL -5	View Letter (PDF)
Feb 4, 2011	SUPPL -4	View Letter (PDF)
Jul 30, 2009	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 400MG BASE

RLD

3 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 1, 2009

Patents (3) · 5 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
8410167	Apr 16, 2029	—	—	—	—
8602215	Jun 30, 2031	—	—	—	—
9107900	Apr 16, 2029	—	—	—	—