ivabradine Oral Tablet

Brand(s)
Corlanor
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Amgen Inc (2015-04-28)
Oldest Current Product
2015-04-20
License(s)
NDA
RxNORM
ORAL TABLET\IVABRADINE
FDAOB
ORAL\TABLET\IVABRADINE HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED\IVABRADINE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED\IVABRADINE

product(s) by strength(s)

ivabradine 5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1555130800CorlanorNDAAmgen Inc2015-04-20IVABRADINE HYDROCHLORIDEORALTABLET, FILM COATEDNDA20614392018a65-38f6-45f7-91d4-a34921b81d0d

ivabradine 7.5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1555130810CorlanorNDAAmgen Inc2015-04-20IVABRADINE HYDROCHLORIDEORALTABLET, FILM COATEDNDA20614392018a65-38f6-45f7-91d4-a34921b81d0d

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA206143CORLANORAMGEN INC2015-04-15p7361649, A METHOD FOR TREATING HEART FAILURE IN A HUMAN USING A CRYSTALLINE FORM OF IVABRADINE HYDROCHLORIDE, SUBSTANCE
p7867996, A METHOD FOR TREATING HEART FAILURE IN A HUMAN USING A CRYSTALLINE FORM OF IVABRADINE HYDROCHLORIDE, SUBSTANCE
p7361650, A METHOD FOR TREATING HEART FAILURE IN A HUMAN USING A CRYSTALLINE FORM OF IVABRADINE HYDROCHLORIDE, SUBSTANCE
p7879842, A METHOD FOR TREATING HEART FAILURE IN A HUMAN USING A CRYSTALLINE FORM OF IVABRADINE HYDROCHLORIDE, SUBSTANCE
NEW CHEMICAL ENTITY [2020-04-15]NDA206143_001, NDA206143_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA206143_001RXIVABRADINE HYDROCHLORIDE (EQ 5MG BASE)ORALTABLETFalse2015-04-15CORLANOR
2NDA206143_002RXIVABRADINE HYDROCHLORIDE (EQ 7.5MG BASE)ORALTABLETTrue2015-04-15CORLANOR

patent(s)

#idexpiration dateapplication(s)
1p7361649 (view patent)2026-04-17NDA206143
2p7361650 (view patent)2026-04-14NDA206143
3p7867996 (view patent)2026-02-22NDA206143
4p7879842 (view patent)2026-02-22NDA206143

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
192018a65-38f6-45f7-91d4-a34921b81d0d (view SPL)These highlights do not include all the information needed to use CORLANOR safely and effectively. See full prescribing information for CORLANOR . CORLANOR (ivabradine) t ablets , for oral use Initial U.S. Approval: 2015prescriptionHuman PrescriptionAmgen Inc2015-04-284555130800, 555130810

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII