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Last Updated: October 20, 2019

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MULTAQ Drug Profile

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When do Multaq patents expire, and what generic alternatives are available?

Multaq is a drug marketed by Sanofi Aventis Us and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-five patent family members in twenty-seven countries.

The generic ingredient in MULTAQ is dronedarone hydrochloride. There are nineteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dronedarone hydrochloride profile page.

Drug patent expirations by year for MULTAQ
Drug Prices for MULTAQ

See drug prices for MULTAQ

Drug Sales Revenue Trends for MULTAQ

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Generic Entry Opportunity Date for MULTAQ
Generic Entry Date for MULTAQ*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for MULTAQ

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

SponsorPhase
University of UtahPhase 3
SanofiPhase 3
Eastbourne General HospitalPhase 4

See all MULTAQ clinical trials

Recent Litigation for MULTAQ

Identify potential future generic entrants

District Court Litigation
Case NameDate
SUMITOMO DAINIPPON PHARMA CO., LTD. v. EMCURE PHARMACEUTICALS LTD2018-02-13
Sanofi v. Watson Laboratories, Inc.2015-12-23
Sanofi v. Glenmark Pharmaceuticals Inc. USA2015-12-23

See all MULTAQ litigation

Synonyms for MULTAQ
141626-36-0
626D360
A3374
A807786
AB0022262
AB01566893_01
AC-5012
AC1L4LKA
AKOS005145680
AN-5339
BCP21326
BDBM50151864
C31H44N2O5S
CAS-141626-36-0
CHEBI:50659
CHEMBL184412
CS-0384
D02537
DB04855
Dronedarone
Dronedarone (INN)
Dronedarone [INN:BAN]
Dronedarone [INN]
DRONEDARONE BASE
DSSTox_CID_28579
DSSTox_GSID_48653
DSSTox_RID_82850
DTXSID3048653
FT-0651916
GTPL7465
HSDB 7928
HY-A0016
I06-2091
J-520428
JQZ1L091Y2
KS-00000XIH
L001445
LS-90090
MCULE-5052395136
MET037
Methanesulfonamide, N-(2-butyl-3-(4-(3-(dibutylamino)propoxy)benzoyl)-5-benzofuranyl)-
Methanesulfonamide, N-[2-butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]-5-benzofuranyl]-
MolPort-006-170-000
N-(2-butyl-3-(4-(3-(dibutylamino)propoxy)benzoyl)-5-benzofuranyl)-methanesulfonamide
N-(2-butyl-3-(4-(3-(dibutylamino)propoxy)benzoyl)benzofuran-5-yl) methanesulfonamide
N-(2-Butyl-3-(p-(3-(dibutylamino)propoxy)benzoyl)-5-benzofuranyl)methanesulfonamide
N-(2-butyl-3-{4-[3-(dibutylamino)propoxy]benzoyl}-1-benzofuran-5-yl)methanesulfonamide
n-[2-butyl-3-({4-[3-(dibutylamino)propoxy]phenyl}carbonyl)-1-benzofuran-5-yl]methanesulfonamide
N-[2-butyl-3-(p-{3-(dibutylamino)propoxy} benzoyl)-5-benzofuranyl]methanesulfonamide
N-[2-butyl-3-[[4-[3-(dibutylamino)propoxy]phenyl]-oxomethyl]-5-benzofuranyl]methanesulfonamide
N-[2-butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]-1-benzofuran-5-yl]methanesulfonamide
N-[2-butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]benzofuran-5-yl]methanesulfonamide
N-[2-butyl-3-[4-[3-(dibutylamino)propoxy]phenyl]carbonyl-1-benzofuran-5-yl]methanesulfonamide
N-[2-butyl-3-{4-[3-(dibutylamino)propoxy]benzoyl}-1-benzofuran-5-yl]methanesulfonamide
NCGC00188863-01
NCGC00188863-02
NCGC00188863-10
RL01736
SC-20704
SCHEMBL110363
SR 33589
SR 33589B
SR-33598B
SR33589
STL451011
Tox21_113008
Tox21_113008_1
UNII-JQZ1L091Y2
W-5212
W3084
ZINC49933061
ZQTNQVWKHCQYLQ-UHFFFAOYSA-N

US Patents and Regulatory Information for MULTAQ

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   Start Trial   Start Trial   Start Trial
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009 RX Yes Yes   Start Trial   Start Trial   Start Trial
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009 RX Yes Yes   Start Trial   Start Trial   Start Trial
>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 MULTAQ

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   Start Trial   Start Trial
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009   Start Trial   Start Trial
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for MULTAQ
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 400 mg ➤ Subscribe   Start Trial

Supplementary Protection Certificates for MULTAQ

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1007030 2010008 Ireland   Start Trial 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   Start Trial 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   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Harvard Business School
Colorcon
Medtronic
Boehringer Ingelheim
Mallinckrodt

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