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Last Updated: May 29, 2020

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CORLANOR Drug Profile


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Which patents cover Corlanor, and what generic alternatives are available?

Corlanor is a drug marketed by Amgen Inc and is included in two NDAs. There are eight patents protecting this drug.

This drug has ninety-nine patent family members in forty-three countries.

The generic ingredient in CORLANOR is ivabradine hydrochloride. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ivabradine hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Corlanor

Corlanor was eligible for patent challenges on April 15, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 22, 2026. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for CORLANOR
Drug Prices for CORLANOR

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Generic Entry Opportunity Date for CORLANOR
Generic Entry Dates for CORLANOR*:
Constraining patent/regulatory exclusivity:
INDICATED FOR THE TREATMENT OF STABLE SYMPTOMATIC HEART FAILURE DUE TO DILATED CARDIOMYOPATHY (DCM) IN PEDIATRIC PATIENTS AGED 6 MONTHS AND OLDER, WHO ARE IN SINUS RHYTHM WITH AN ELEVATED HEART RATE
NDA:
Dosage:
SOLUTION;ORAL
Generic Entry Dates for CORLANOR*:
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 CORLANOR

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

SponsorPhase
AmgenPhase 3
iRhythm Technologies, Inc.Phase 4
Phillip LevyPhase 4

See all CORLANOR clinical trials

Recent Litigation for CORLANOR

Identify potential future generic entrants

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

See all CORLANOR litigation

Synonyms for CORLANOR
(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)methylamino)propyl)-1,3,4,5-tetrahydro-7,8-dimethoxy-2H-3-benzazepin-2-one
(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
155974-00-8
185824-EP2276742A1
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-, (S)-
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)methylamino)propyl)-1,3,4,5-tetrahydro-7,8-dimethoxy-2H-3-benzazepin-2-one
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
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-[[(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
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-[[(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
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
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
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
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)
3H48L0LPZQ
7-(3-((((R)-4,5-dimethoxy-1,2-dihydrocyclobutabenzen-1-yl)methyl)(methyl)amino)propyl)-2,3-dimethoxy-8,9-dihydro-5H-benzo[7]annulen-6(7H)-one
7,8-Dimethoxy-3-(3-(((4,5-dimethoxybenzocyclobutan-1-yl)methyl)methylamino)propyl)-1,3,4,5-tetrahydro-2H-benzazepin-2-one
974I008
AB0011288
AB01566878_01
AC-543
AC-8848
ACRHBAYQBXXRTO-OAQYLSRUSA-N
AK-46411
AKOS015849582
AKOS015896494
AKOS016002249
AM20090729
AMG-998
AOB4729
API0000615
API0006402
AR-270/43507923
AX8135490
B1360
BCP05218
BCP21052
BCP9000798
BDBM50326992
C27H36N2O5
C27H37ClN2O5
CAS-148849-67-6
CHEBI:85966
CHEBI:85969
CHEMBL2145077
CHEMBL471737
CI0043
Corlanor (TN)
Corlentor
Corlentor (TN)
CS-1994
CTK8E8827
D07165
D08095
DB09083
DSSTox_CID_26913
DSSTox_GSID_46913
DSSTox_RID_82011
DTXSID2046913
DTXSID2048240
FT-0659345
FT-0697755
GS-3584
GTPL2357
HLUKNZUABFFNQS-ZMBIFBSDSA-N
HY-B0162A
I0847
Ivabradine
Ivabradine (hydrochloride)
Ivabradine (USAN/INN)
Ivabradine [INN]
Ivabradine [USAN:INN:BAN]
Ivabradine HCl
Ivabradine HCl (Procoralan)
Ivabradine hydrochloride
Ivabradine hydrochloride (JAN)
Ivabradine hydrochloride [USAN]
Ivabradine hydrochloride, >=98% (HPLC)
ivabradine monohydrochloride
ivabradine-hcl-procoralan
IvabradineHCl
Ivabrandine hydrochloride
J-008523
J-521616
KS-000004OB
LS-28023
LS-28024
MLS006010110
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
Q27158823
Q425729
RTC-070922
S 16257
S 16257-2
S-16257
S-16257-2
S-16260-2
s16257
s2086
SB12484
SB12485
SC-20079
SC-83347
SCHEMBL23470
SCHEMBL23472
SMR004701246
ST24036090
TC-070922
Tox21_112802
TP19837BZK
UNII-3H48L0LPZQ
UNII-C8ADC441ME component ACRHBAYQBXXRTO-OAQYLSRUSA-N
UNII-TP19837BZK
V0092
ZINC3805768
Paragraph IV (Patent) Challenges for CORLANOR
Tradename Dosage Ingredient NDA Submissiondate
CORLANOR TABLET;ORAL ivabradine hydrochloride 206143 2019-10-15

US Patents and Regulatory Information for CORLANOR

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 SOLUTION;ORAL 209964-001 Apr 22, 2019 RX Yes Yes   Start Trial   Start Trial Y 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 SOLUTION;ORAL 209964-001 Apr 22, 2019 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

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Serving leading biopharmaceutical companies globally:

Dow
Johnson and Johnson
McKinsey
McKesson
Colorcon
Express Scripts

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 verification 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.