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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

6 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
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. 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. 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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Multaq (2023)

Total Spending

$409.3M

Total Claims

310,873

Beneficiaries

71,895

Avg Cost/Unit

$13.08

Spending Trend

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

YoY Change:+5.5%

5yr CAGR:+4.5%

Source: CMS Medicare Part D Spending by Drug (2023). 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)

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