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Last Updated: November 12, 2019

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Dronedarone hydrochloride - Generic Drug Details

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What are the generic drug sources for dronedarone hydrochloride and what is the scope of patent protection?

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

Dronedarone hydrochloride has fifty-five patent family members in twenty-seven countries.

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

Recent Clinical Trials for dronedarone hydrochloride

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

SponsorPhase
doaa rashwanPhase 2/Phase 3
Elpen Pharmaceutical Co. Inc.Phase 2/Phase 3
Oregon Health and Science UniversityPhase 2

See all dronedarone hydrochloride clinical trials

Recent Litigation for dronedarone hydrochloride

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 dronedarone hydrochloride litigation

Generic filers with tentative approvals for DRONEDARONE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial400MGTABLET;ORAL
  Start Trial  Start Trial400MGTABLET;ORAL
  Start Trial  Start Trial400MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
BCP22474
BR-72887
C31H44N2O5S.HCl
CD0187
CHEMBL1201729
CS-0712
CTK8B5527
D03914
D4689
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
Dronedarone, HCl
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
Methanesulfonamide, N-[2-butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]-5-benzofuranyl]-, hydrochloride (1:1)
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
SW219413-1
UNII-FA36DV299Q
W3083
Z1550675452
Paragraph IV (Patent) Challenges for DRONEDARONE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
MULTAQ TABLET;ORAL dronedarone hydrochloride 022425 2013-07-01

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   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 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   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

Supplementary Protection Certificates for dronedarone hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Boehringer Ingelheim
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Medtronic
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Express Scripts
AstraZeneca

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