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Last Updated: February 24, 2020

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Ivabradine hydrochloride - Generic Drug Details

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

Ivabradine hydrochloride is the generic ingredient in one branded drug marketed by Amgen Inc and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ivabradine hydrochloride has ninety-nine patent family members in forty-three countries.

There are nine drug master file entries for ivabradine hydrochloride. One supplier is listed for this compound.

Recent Clinical Trials for ivabradine hydrochloride

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SponsorPhase
Dysautonomia InternationalPhase 2
University of CalgaryPhase 2
Alexandria UniversityN/A

See all ivabradine hydrochloride clinical trials

Recent Litigation for ivabradine hydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
AMGEN INC. v. ZYDUS PHARMACEUTICALS (USA) INC.2020-01-21

See all ivabradine hydrochloride litigation

Synonyms for ivabradine hydrochloride
(7,8-Dimethoxy 3-(3-(((1S)-(4,5-dimethoxybenzocyclobutan-1-yl)methyl)methylamino)propyl)-1,3,4,5-tetrahydro-2H-benzazepin-2-one hydrochloride
(S)-3-(3-(((3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl)methyl)(methyl)amino)propyl)-7,8-dimethoxy-1,3,4,5-tetrahydro-2H-benzo[d]azepin-2-one hydrochloride
(S)-3-(3-(((3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl)methyl)(methyl)amino)propyl)-7,8-dimethoxy-4,5-dihydro-1H-benzo[d]azepin-2(3H)-one hydrochloride
148849-67-6
2H-3-Benzazepin-2-one, 3-(3-((((7S)-3,4-dimethoxybicyclo(4.2.0)octa-1,3,5-trien-7-yl)methyl)methylamino)propyl)-1,3,4,5-tetrahydro-7,8-dimethoxy-, monohydrochloride
2H-3-Benzazepin-2-one, 3-(3-(((3,4-dimethoxybicyclo(4.2.0)octa-1,3,5-trien-7-yl)methyl)methylamino)propyl)-1,3,4,5-tetrahydro-7,8-dimethoxy-, monohydrochloride, (S)-
2H-3-Benzazepin-2-one, 3-[3-[[[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl]methylamino]propyl]-1,3,4,5-tetrahydro-7,8-dimethoxy-, hydrochloride (1:1)
3-[3-({[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl}(methyl)amino)propyl]-7,8-dimethoxy-2,3,4,5-tetrahydro-1H-3-benzazepin-2-one hydrochloride
3-[3-[[(7S)-3,4-dimethoxy-7-bicyclo[4.2.0]octa-1,3,5-trienyl]methyl-methyl-amino]propyl]-7,8-dimethoxy-2,5-dihydro-1H-3-benzazepin-4-one hydrochloride
3-[3-[[(7S)-3,4-dimethoxy-7-bicyclo[4.2.0]octa-1,3,5-trienyl]methyl-methylamino]propyl]-7,8-dimethoxy-2,5-dihydro-1H-3-benzazepin-4-one hydrochloride
3-[3-[[(8S)-3,4-Dimethoxy-8-bicyclo[4.2.0]octa-1,3,5-trienyl]methyl-methylamino]propyl]-7,8-dimethoxy-2,5-dihydro-1H-3-benzazepin-4-one hydrochloride
3-[3-[[(8S)-3,4-dimethoxy-8-bicyclo[4.2.0]octa-1,3,5-trienyl]methyl-methylamino]propyl]-7,8-dimethoxy-2,5-dihydro-1H-3-benzazepin-4-one hydrochloride3-[3-[[(8S)-3,4-dimethoxy-8-bicyclo[4.2.0]octa-1,3,
3-[3-[[[(7S)-3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl]methylamino]propyl]-1,3,4,5-tetrahydro-7,8-dimethoxy-2H-3-benzazepin-2-one Hydrochloride
3-{3-[{[(7S)-3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]-methyl}(methyl)amino]propyl}-7,8-dimethoxy-1,3,4,5-tetrahydro-2H-3-benzazepin-2-one hydrochloride
3-{3-[{[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl}(methyl)amino]propyl}-7,8-dimethoxy-1,3,4,5-tetrahydro-2H-3-benzazepin-2-one--hydrogen chloride (1/1)
974I008
AB0011288
AC-543
AC1MIILZ
AK-46411
AKOS015849582
AKOS016002249
AM20090729
AMG-998
AN-618
AOB4729
API0000615
AX8135490
B1360
BC226246
BCP05218
BCP9000798
C27H37ClN2O5
CAS-148849-67-6
CHEBI:85969
CHEMBL2145077
CI0043
Coralan
Corlanor
Corlanor (TN)
Corlentor
Corlentor (TN)
CS-1994
CTK8E8827
D08095
DSSTox_CID_26913
DSSTox_GSID_46913
DSSTox_RID_82011
DTXSID2046913
FT-0659345
GS-3584
HLUKNZUABFFNQS-ZMBIFBSDSA-N
HY-B0162A
I0847
Ivabradine (hydrochloride)
Ivabradine HCl
Ivabradine HCl (Procoralan)
Ivabradine hydrochloride (JAN)
Ivabradine hydrochloride [USAN]
Ivabradine hydrochloride, >=98% (HPLC)
ivabradine monohydrochloride
IvabradineHCl
Ivabrandine hydrochloride
J-008523
J-521616
KS-000004OB
LS-28024
MLS006010110
MolPort-005-943-399
N-{[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl}-3-(7,8-dimethoxy-2-oxo-1,2,4,5-tetrahydro-3H-3-benzazepin-3-yl)-N-methylpropan-1-aminium chloride
NCGC00181343-01
Procoralan
RL01883
RTC-070922
S-16257
S-16260-2
s16257
s2086
SB12485
SC-20079
SCHEMBL23470
SMR004701246
ST24036090
TC-070922
Tox21_112802
TP19837BZK
UNII-TP19837BZK
Paragraph IV (Patent) Challenges for IVABRADINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
CORLANOR TABLET;ORAL ivabradine hydrochloride 206143 2019-10-15

US Patents and Regulatory Information for ivabradine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amgen Inc CORLANOR ivabradine hydrochloride TABLET;ORAL 206143-002 Apr 15, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Amgen Inc CORLANOR ivabradine hydrochloride TABLET;ORAL 206143-001 Apr 15, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Amgen Inc CORLANOR ivabradine hydrochloride TABLET;ORAL 206143-002 Apr 15, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Amgen Inc CORLANOR ivabradine hydrochloride TABLET;ORAL 206143-001 Apr 15, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
Amgen Inc CORLANOR ivabradine hydrochloride TABLET;ORAL 206143-002 Apr 15, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Amgen Inc CORLANOR ivabradine hydrochloride TABLET;ORAL 206143-002 Apr 15, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Amgen Inc CORLANOR ivabradine hydrochloride TABLET;ORAL 206143-001 Apr 15, 2015 RX Yes No   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

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Moodys
Merck
Medtronic
AstraZeneca
Colorcon

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.