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Last Updated: January 27, 2023

Ivabradine - Generic Drug Details


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

Ivabradine is the generic ingredient in two branded drugs marketed by Amgen Inc, Annora Pharma, and Ingenus Pharms Llc, and is included in four NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Summary for ivabradine
Recent Clinical Trials for ivabradine

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

SponsorPhase
Uniformed Services University of the Health SciencesPhase 4
The Young Investigator Group of Cardiovascular ResearchPhase 3
Vanderbilt University Medical CenterPhase 3

See all ivabradine clinical trials

Generic filers with tentative approvals for IVABRADINE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing7.5MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing5MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

US Patents and Regulatory Information for ivabradine

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 206143-001 Apr 15, 2015 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Amgen Inc CORLANOR ivabradine SOLUTION;ORAL 209964-001 Apr 22, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amgen Inc CORLANOR ivabradine SOLUTION;ORAL 209964-001 Apr 22, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Amgen Inc CORLANOR ivabradine hydrochloride TABLET;ORAL 206143-002 Apr 15, 2015 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Amgen Inc CORLANOR ivabradine SOLUTION;ORAL 209964-001 Apr 22, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Annora Pharma IVABRADINE HYDROCHLORIDE ivabradine hydrochloride TABLET;ORAL 213366-002 Oct 5, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 ivabradine

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-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., ,
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 ivabradine

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 See Plans and Pricing
Australia 2006200857 y-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it See Plans and Pricing
Saudi Arabia 2399 γ -Crystalline Form of Ivabradine Hydrochloride, a Process for its Preparation and Pharmaceutical Compositions Containing It See Plans and Pricing
World Intellectual Property Organization (WIPO) 2006092492 See Plans and Pricing
Taiwan 200640873 &bgr-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it See Plans and Pricing
France 2882555 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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