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Last Updated: May 25, 2024

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CORLANOR Drug Patent 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 and one Paragraph IV challenge.

This drug has ninety-seven patent family members in forty-two countries.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Corlanor

A generic version of CORLANOR was approved as ivabradine hydrochloride by ANNORA PHARMA on October 5th, 2022.

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Drug patent expirations by year for CORLANOR
Drug Prices for CORLANOR

See drug prices for CORLANOR

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for CORLANOR
Generic Entry Date for CORLANOR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;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
Phillip LevyPhase 4
iRhythm Technologies, Inc.Phase 4

See all CORLANOR clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for CORLANOR
Paragraph IV (Patent) Challenges for CORLANOR
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
CORLANOR Tablets ivabradine hydrochloride 5 mg and 7.5 mg 206143 6 2019-10-15

US Patents and Regulatory Information for CORLANOR

CORLANOR is protected by eight US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of CORLANOR is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting CORLANOR

.beta.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: A METHOD FOR TREATING HEART FAILURE IN A HUMAN USING A CRYSTALLINE FORM OF IVABRADINE HYDROCHLORIDE

.beta.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

.gamma.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: A METHOD FOR TREATING HEART FAILURE IN A HUMAN USING A CRYSTALLINE FORM OF IVABRADINE HYDROCHLORIDE

.gamma.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

.gamma.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: A METHOD FOR TREATING HEART FAILURE IN A HUMAN USING A CRYSTALLINE FORM OF IVABRADINE HYDROCHLORIDE

.gamma.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Beta-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: A METHOD FOR TREATING HEART FAILURE IN A HUMAN USING A CRYSTALLINE FORM OF IVABRADINE HYDROCHLORIDE

Beta-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting CORLANOR

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
Exclusivity Expiration: ⤷  Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Amgen Inc CORLANOR ivabradine hydrochloride TABLET;ORAL 206143-001 Apr 15, 2015 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Amgen Inc CORLANOR ivabradine SOLUTION;ORAL 209964-001 Apr 22, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Amgen Inc CORLANOR ivabradine hydrochloride TABLET;ORAL 206143-002 Apr 15, 2015 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Amgen Inc CORLANOR ivabradine hydrochloride TABLET;ORAL 206143-001 Apr 15, 2015 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Amgen Inc CORLANOR ivabradine hydrochloride TABLET;ORAL 206143-002 Apr 15, 2015 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for CORLANOR

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Accord Healthcare S.L.U. Ivabradine Accord ivabradine EMEA/H/C/004241
Symptomatic treatment of chronic stable angina pectorisIvabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm.Ivabradine is indicated :- in adults unable to tolerate or with a contra-indication to the use of beta-blockers- or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose.Treatment of chronic heart failureIvabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated. (see section 5.1)
Authorised yes no no 2017-05-22
Zentiva, k.s. Ivabradine Zentiva ivabradine EMEA/H/C/004117
Symptomatic treatment of chronic stable angina pectoris Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm. Ivabradine is indicated:in adults unable to tolerate or with a contra-indication to the use of beta-blockersorin combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose. Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.
Authorised yes no no 2016-11-11
Les Laboratoires Servier Corlentor ivabradine EMEA/H/C/000598
Symptomatic treatment of chronic stable angina pectorisIvabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm. Ivabradine is indicated:in adults unable to tolerate or with a contraindication to the use of beta-blockersor in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose.Treatment of chronic heart failureIvabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.
Authorised no no no 2005-10-25
Les Laboratoires Servier Procoralan ivabradine EMEA/H/C/000597
Symptomatic treatment of chronic stable angina pectoris Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm. Ivabradine is indicated :in adults unable to tolerate or with a contraindication to the use of beta-blockersor in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose.Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.
Authorised no no no 2005-10-25
"Anpharm" Przedsiębiorstwo Farmaceutyczne S.A. Ivabradine Anpharm ivabradine EMEA/H/C/004187
Symptomatic treatment of chronic stable angina pectorisIvabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm. Ivabradine is indicated:in adults unable to tolerate or with a contra-indication to the use of beta-blockersor in combination with beta-blockers in patients inadequately controlled with an optimal betablocker dose.Treatment of chronic heart failureIvabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.
Authorised no no no 2015-09-08
JensonR+ Limited Ivabradine JensonR ivabradine EMEA/H/C/004217
Symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm. Ivabradine is indicated: - in adults unable to tolerate or with a contra-indication to the use of beta-blockers - or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose. Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.,
Withdrawn yes no no 2016-11-11
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for CORLANOR

When does loss-of-exclusivity occur for CORLANOR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Patent: 07
Estimated Expiration: ⤷  Sign Up

Patent: 56
Estimated Expiration: ⤷  Sign Up

Argentina

Patent: 2926
Estimated Expiration: ⤷  Sign Up

Patent: 3147
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 06200856
Estimated Expiration: ⤷  Sign Up

Patent: 06200857
Estimated Expiration: ⤷  Sign Up

Austria

Patent: 96974
Estimated Expiration: ⤷  Sign Up

Patent: 07926
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0600623
Estimated Expiration: ⤷  Sign Up

Patent: 0600796
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 37400
Estimated Expiration: ⤷  Sign Up

Patent: 37414
Estimated Expiration: ⤷  Sign Up

China

Patent: 27600
Estimated Expiration: ⤷  Sign Up

Patent: 27602
Estimated Expiration: ⤷  Sign Up

Patent: 0402502
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 70096
Estimated Expiration: ⤷  Sign Up

Patent: 70097
Estimated Expiration: ⤷  Sign Up

Costa Rica

Patent: 48
Estimated Expiration: ⤷  Sign Up

Patent: 49
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0080406
Estimated Expiration: ⤷  Sign Up

Patent: 0080520
Estimated Expiration: ⤷  Sign Up

Cuba

Patent: 614
Estimated Expiration: ⤷  Sign Up

Patent: 616
Estimated Expiration: ⤷  Sign Up

Patent: 060037
Estimated Expiration: ⤷  Sign Up

Patent: 060039
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 09010
Estimated Expiration: ⤷  Sign Up

Patent: 09072
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 95965
Estimated Expiration: ⤷  Sign Up

Patent: 07562
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 066373
Estimated Expiration: ⤷  Sign Up

Patent: 066375
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 8464
Estimated Expiration: ⤷  Sign Up

Patent: 8465
Estimated Expiration: ⤷  Sign Up

Patent: 0600320
Estimated Expiration: ⤷  Sign Up

Patent: 0600322
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 95965
Estimated Expiration: ⤷  Sign Up

Patent: 07562
Estimated Expiration: ⤷  Sign Up

France

Patent: 82553
Estimated Expiration: ⤷  Sign Up

Patent: 82555
Estimated Expiration: ⤷  Sign Up

Georgia, Republic of

Patent: 0084465
Estimated Expiration: ⤷  Sign Up

Patent: 0084467
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Germany

Patent: 2006001312
Estimated Expiration: ⤷  Sign Up

Patent: 2006002624
Estimated Expiration: ⤷  Sign Up

Guatemala

Patent: 0600084
Estimated Expiration: ⤷  Sign Up

Patent: 0600088
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Hong Kong

Patent: 96387
Estimated Expiration: ⤷  Sign Up

Patent: 96659
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Japan

Patent: 25776
Estimated Expiration: ⤷  Sign Up

Patent: 28974
Estimated Expiration: ⤷  Sign Up

Patent: 06241154
Estimated Expiration: ⤷  Sign Up

Patent: 06241156
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Jordan

Patent: 15
Estimated Expiration: ⤷  Sign Up

Patent: 48
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 8128
Estimated Expiration: ⤷  Sign Up

Patent: 8129
Estimated Expiration: ⤷  Sign Up

Montenegro

Patent: 408
Estimated Expiration: ⤷  Sign Up

Patent: 747
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 131
Estimated Expiration: ⤷  Sign Up

Patent: 134
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New Zealand

Patent: 5576
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Patent: 5578
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Norway

Patent: 8370
Estimated Expiration: ⤷  Sign Up

Patent: 8481
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Patent: 060946
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Patent: 060948
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Peru

Patent: 061009
Estimated Expiration: ⤷  Sign Up

Patent: 061142
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Poland

Patent: 95965
Estimated Expiration: ⤷  Sign Up

Patent: 07562
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Portugal

Patent: 95965
Estimated Expiration: ⤷  Sign Up

Patent: 07562
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Saudi Arabia

Patent: 270038
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Patent: 270040
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Serbia

Patent: 598
Estimated Expiration: ⤷  Sign Up

Patent: 661
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 5228
Estimated Expiration: ⤷  Sign Up

Patent: 5229
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Slovenia

Patent: 95965
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Patent: 07562
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South Africa

Patent: 0601762
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Patent: 0601764
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South Korea

Patent: 0827502
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Patent: 0835447
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Patent: 060095499
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Patent: 060095501
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Spain

Patent: 08689
Estimated Expiration: ⤷  Sign Up

Patent: 13581
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 14143
Estimated Expiration: ⤷  Sign Up

Patent: 14144
Estimated Expiration: ⤷  Sign Up

Patent: 0640872
Estimated Expiration: ⤷  Sign Up

Patent: 0640873
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Ukraine

Patent: 904
Estimated Expiration: ⤷  Sign Up

Patent: 595
Estimated Expiration: ⤷  Sign Up

Uruguay

Patent: 405
Estimated Expiration: ⤷  Sign Up

Patent: 406
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering CORLANOR around the world.

Country Patent Number Title Estimated Expiration
Georgia, Republic of P20084465 BETA-CRYSTALLINE FORM OF IVABRADINE HYDROCHLORIDE, PROCESS FOR ITS PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING IT ⤷  Sign Up
Eurasian Patent Organization 200600322 β-КРИСТАЛЛИЧЕСКАЯ ФОРМА ГИДРОХЛОРИДА ИВАБРАДИНА, СПОСОБ ЕЁ ПОЛУЧЕНИЯ И ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, КОТОРЫЕ ЕЁ СОДЕРЖАТ ⤷  Sign Up
Australia 2006200856 beta-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it ⤷  Sign Up
European Patent Office 1695965 Forme cristalline beta du chlorhydrate de l'ivabradine, son procédé de préparation, et les compositions pharmaceutiques qui la contiennent (Crystalline form beta of the chlorhydrate of ivabradine, process for its preparation and pharamcetuical composition containing it) ⤷  Sign Up
Cyprus 1109010 ⤷  Sign Up
Norway 338481 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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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.