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CORLANOR Drug Profile

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When do Corlanor patents expire, 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

Start Trial

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

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

Summary for CORLANOR

International Patents:	99
US Patents:	8
Applicants:	1
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	109
Clinical Trials:	5
Patent Applications:	363
Drug Prices:	Drug price information for CORLANOR
DailyMed Link:	CORLANOR at DailyMed

Drug patent expirations by year for CORLANOR

Generic Entry Opportunity Date for CORLANOR

Generic Entry Dates for CORLANOR^: Start Trial* 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: 209964 Dosage: SOLUTION;ORAL
Generic Entry Dates for CORLANOR^: Start Trial* Constraining patent/regulatory exclusivity: Start Trial NDA: 206143 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

Sponsor	Phase
Amgen	Phase 3
iRhythm Technologies, Inc.	Phase 4
Phillip Levy	Phase 4

See all CORLANOR clinical trials

Pharmacology for CORLANOR

Drug Class	Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker
Mechanism of Action	Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists

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
148870-61-5
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-[[(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
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
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
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
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
AC1L31ZF
AC1MIILZ
ACRHBAYQBXXRTO-OAQYLSRUSA-N
AJ-45658
AK-46411
AKOS015849582
AKOS015896494
AKOS016002249
AM20090729
AMG-998
AN-5299
AN-618
AOB4729
API0000615
API0006402
AX8135490
B1360
BC226246
BCP05218
BCP21052
BCP9000798
BDBM50326992
C27H36N2O5
C27H37ClN2O5
CAS-148849-67-6
CHEBI:85966
CHEBI:85969
CHEMBL2145077
CHEMBL471737
CI0043
Coralan
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
Ivabradin
Ivabradina
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
IvabradineHCl
Ivabradinum
Ivabrandine hydrochloride
J-008523
J-521616
KS-000004OB
LS-28023
LS-28024
MLS006010110
MolPort-003-986-484
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 16257-2
S-16257
S-16257-2
S-16260-2
s16257
s2086
SB12484
SB12485
SC-20079
SC-83347
SCHEMBL23470
SCHEMBL23472
SMR004701246
ST24036090
TC-070922
TL8001175
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

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Glossary

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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
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	206143-001	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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for CORLANOR

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Country	Patent Number	Estimated Expiration
South Africa	200601764	Start Trial
Ecuador	SP066373	Start Trial
Israel	173959	Start Trial
Taiwan	I314143	Start Trial
Hong Kong	1096659	Start Trial
Guatemala	200600084	Start Trial
>Country	>Patent Number	>Estimated Expiration