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Generated: September 19, 2018

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Dronedarone hydrochloride - Generic Drug Details

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What are the generic sources for dronedarone hydrochloride and what is the scope of dronedarone hydrochloride freedom to operate?

Dronedarone hydrochloride is the generic ingredient in one branded drug marketed by Sanofi Aventis Us and is included in one NDA. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are nineteen drug master file entries for dronedarone hydrochloride. Three suppliers are listed for this compound. There are three tentative approvals for this compound.

Pharmacology for dronedarone hydrochloride
Synonyms for dronedarone hydrochloride
141625-93-6
2-n-butyl 3-[4-(3-di-n-butylamino-propoxy)benzoyl] 5-methylsulfonamido benzofuran hydrochloride
4CH-007232
AB2000517
AC-5011
AC1L55X4
AC1Q3EU3
AK-72887
AKOS005145691
AN-544
ANW-49035
BC201083
BR-72887
C31H44N2O5S.HCl
CD0187
CHEMBL1201729
CS-0712
CTK8B5527
D03914
D4689
Dronedarone HCl
Dronedarone (Hydrochloride)
Dronedarone HCl
Dronedarone HCl (Multaq)
Dronedarone hydrochloride (USAN)
Dronedarone hydrochloride [USAN]
Dronedarone Hydrochloride 1.0 mg/ml in Methanol (as free base)
Dronedarone hydrochloride, >=98% (HPLC)
Dronedarone hydrochloride, United States Pharmacopeia (USP) Reference Standard
DRONEDARONEHYDROCHLORIDE
DTXSID30161779
DWKVCQXJYURSIQ-UHFFFAOYSA-N
FA36DV299Q
FT-0667799
HY-75839
J-007525
J-520429
KB-76727
KS-00000G47
KS-1260
MCULE-2160502046
Methanesulfonamide, N-(2-butyl-3-(4-(3-(dibutylamino)propoxy)benzoyl)-5-benzofuranyl)-, monohydrochloride
MFCD00914940
MLS004774028
MLS006011986
MolPort-005-932-572
Multaq (TN)
multaq hydrochloride
N-(2-Butyl-3-(4-(3-(dibutylamino)propoxy)benzoyl)-5-benzofuranyl)methanesulfonamide monohydrochloride
N-(2-Butyl-3-(4-(3-(dibutylamino)propoxy)benzoyl)-benzofuran-5-yl)methanesulfonamide hydrochloride
N-(2-Butyl-3-(4-(3-(dibutylamino)propoxy)benzoyl)benzofuran-5-yl)methanesulfonamide hydrochloride
N-(2-Butyl-3-(4-(3-(dibutylamino)proproxy)benzoyl)benzofuran-5-yl) methanesulfonamide-, monohydrochloride
N-(2-butyl-3-{4-[3-(dibutylamino)propoxy]benzoyl}-1-benzofuran-5-yl)methanesulfonamide hydrochloride
N-[2-butyl-3-[4-(3-dibutyl-aminopropoxy) benzoyl] methanesulfonamide hydrochloride
N-[2-butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]-1-benzofuran-5-yl]methanesulfonamide hydrochloride
N-[2-butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]-1-benzofuran-5-yl]methanesulfonamide;hydrochloride
N-[2-Butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]-5-benzofuranyl]methanesulfonamide Hydrochloride
N-[2-butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]benzofuran-5-yl]methanesulfonamide hydrochloride
RL01735
RTC-070901
S-7529
s2114
SCHEMBL223035
SMR003500707
SR-33589B
SR-33598B
SR33598B
ST2413542
UNII-FA36DV299Q
W3083
Z1550675452
Tentative approvals for DRONEDARONE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up400MGTABLET;ORAL
➤ Sign Up➤ Sign Up400MGTABLET;ORAL
➤ Sign Up➤ Sign Up400MGTABLET;ORAL

US Patents and Regulatory Information for dronedarone hydrochloride

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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009 RX Yes Yes ➤ 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

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Expired US Patents for dronedarone hydrochloride

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

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Supplementary Protection Certificates for dronedarone hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
4 Finland ➤ Sign Up
00446 Netherlands ➤ Sign Up PRODUCT NAME: DRONEDARON, DESGEWENST IN DE VORM VAN EEN AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/09/591/001-004 20091126
22/2010 Austria ➤ Sign Up PRODUCT NAME: DRONEDARON ODER PHARMAZEUTISCH ANNEHMBARE SALZE HIEVON
C008/2010 Ireland ➤ Sign Up SPC008/2010: 20101015, EXPIRES: 20230616
C/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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Chinese Patent Office
Federal Trade Commission
Accenture
Harvard Business School
US Department of Justice
Daiichi Sankyo
McKesson
Julphar

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