Ivabradine - Generic Drug Details

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, Alembic, Annora Pharma, Bionpharma, Ingenus Pharms Llc, MSN, and Zydus Pharms, and is included in eight 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.

Summary for ivabradine

International Patents:	97
US Patents:	8
Tradenames:	2
Applicants:	7
NDAs:	8
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	45
Clinical Trials:	89
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ivabradine
What excipients (inactive ingredients) are in ivabradine?	ivabradine excipients list
DailyMed Link:	ivabradine at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ivabradine

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 ivabradine

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

Sponsor	Phase
Department of Cardiology, Gdstrup Hospital, Herning, Denmark	PHASE2
Gdstrup Hospital	PHASE2
The University of Hong Kong	PHASE4

See all ivabradine clinical trials

Pharmacology for ivabradine

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

Anatomical Therapeutic Chemical (ATC) Classes for ivabradine

C01EB	Other cardiac preparations
C01E	OTHER CARDIAC PREPARATIONS
C01	CARDIAC THERAPY
C	Cardiovascular system

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
Ingenus Pharms Llc	IVABRADINE HYDROCHLORIDE	ivabradine hydrochloride	TABLET;ORAL	214051-001	Dec 30, 2021	AB	RX	No	No
Annora Pharma	IVABRADINE HYDROCHLORIDE	ivabradine hydrochloride	TABLET;ORAL	213366-001	Oct 5, 2022	AB	RX	No	No
Amgen Inc	CORLANOR	ivabradine hydrochloride	TABLET;ORAL	206143-001	Apr 15, 2015		DISCN	Yes	No					Y
Amgen Inc	CORLANOR	ivabradine	SOLUTION;ORAL	209964-001	Apr 22, 2019		RX	Yes	Yes			Y	Y
Amgen Inc	CORLANOR	ivabradine hydrochloride	TABLET;ORAL	206143-002	Apr 15, 2015		DISCN	Yes	No					Y

Expired US Patents for ivabradine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Amgen Inc	CORLANOR	ivabradine	SOLUTION;ORAL	209964-001	Apr 22, 2019
Amgen Inc	CORLANOR	ivabradine	SOLUTION;ORAL	209964-001	Apr 22, 2019
Amgen Inc	CORLANOR	ivabradine	SOLUTION;ORAL	209964-001	Apr 22, 2019

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/004241Symptomatic 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/004117Symptomatic 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/000598Symptomatic 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/000597Symptomatic 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/004187Symptomatic 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

International Patents for ivabradine

Country	Patent Number	Title	Estimated Expiration
Serbia	50661	BETA KRISTALNI OBLIK IVABRADIN HIDROHLORIDA, POSTUPAK NJEGOVE IZRADE I FARMACEUTSKE SMEŠE KOJE GA SADRŽE (CRYSTALLINE FORM BETA OF THE CHLORHYDRATE OF IVABRADINE, PROCESS FOR ITS PREPARATION AND PHARMACEUTICAL COMPOSITION CONTAINING IT)
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)
Singapore	125229	Gamma-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceuticalcompositions containing it
Australia	2006200857	y-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
Poland	1707562

Ivabradine Market Analysis and Financial Projection

Last updated: February 13, 2026

Overview of IVabradine Market Dynamics and Financial Trajectory

Ivabradine (brand name: Corlanor) analyzes as a cardiac therapy primarily targeting heart rate reduction in chronic heart failure and angina pectoris. Originally approved in Europe in 2005 and in the US in 2015, ivabradine's market growth hinges on regulatory status, patent protections, competitive landscape, and evolving clinical guidelines.

Regulatory and Patent Landscape

Regulatory Status

• Approved by the European Medicines Agency (EMA) in 2005.
• Approved by the U.S. Food and Drug Administration (FDA) in 2015.
• Approved in Japan and other markets with similar indications.
• Evolving regulations could impact availability and off-label use.

Patent Expiry and Generics

• Patents expired or are set to expire between 2024-2027.
• Generic versions expected to enter the market starting in late 2024.
• Patent expiration typically correlates with revenue decline, barring new indications or formulations.

Market Size and Forecast

Current Market

• 2022 global sales estimated at $1.5 billion, with North America accounting for 45% and Europe 35%.
• Main indications: Heart failure (NYHA Class II-III) and angina.

Growth Drivers

• Increasing prevalence of chronic heart failure, projected to reach 23 million globally by 2030.
• Adoption of ivabradine for stable angina and heart failure in clinical guidelines.
• Prescribing shifts favoring targeted, selective heart rate lowering therapies.

Market Forecast (2023-2028)

Year	Projected Global Sales (USD billion)	Compound Annual Growth Rate (CAGR)
2023	1.6	6%
2024	1.7	6.25%
2025	1.8	5.88%
2026	2.0	11.11%
2027	2.2	10%

Note: Projections assume moderate market growth with generic entry pressures and expanded clinical adoption.

Competitive Landscape

Major Players

• Servier: Developer and manufacturer, controls patents and sales.
• Generics Manufacturers: Entry anticipated post-2024, including Teva, Sandoz, and Mylan.
• Emerging competitors: Novel heart rate modulators are in early development stages.

Market Access Impact

• Patent loss risk reduces pricing power.
• Increased generic competition depresses prices, lowering revenue margins.
• Strategic focus shifts towards differentiation via formulations or expanded indications.

Financial Trajectory Analysis

Revenue Trends

• Pre-generic (2015-2023): Steady growth driven by expansion in heart failure indications and global market penetration.
• Post-patent expiry (2024 onward): Revenue decline expected, with estimates of a 40-60% reduction over five years absent new indications.

R&D and Pipeline Development

• Pipeline includes trials for new formulations, fixed-dose combinations, and indications such as atrial fibrillation.
• R&D investments focus on demonstrating superior efficacy, safety, or convenience to sustain market share.

Pricing Strategy

• Market pressures favor price reductions, especially with generic entry.
• Premium pricing remains possible in niche or newly approved indications with significant unmet needs.

Key Risks and Opportunities

Risks

• Loss of patent protection leading to price erosion.
• Pending generic entrance reducing revenue margins.
• Regulatory hurdles for new indications or formulations.

Opportunities

• Expanding clinical applications, such as atrial fibrillation.
• Developing extended-release or combination therapies.
• Entering emerging markets with growing cardiovascular disease burden.

Summary

Ivabradine's market is stable but faces impending revenue declines due to patent expiration and generic competition. Long-term profitability depends on executing pipeline strategies, expanding indications, and capturing emerging markets. Near-term growth is driven by increased prevalence of cardiovascular disease and adherence to clinical guidelines. Financial planning must incorporate patent cliff risks and competitive dynamics.

Key Takeaways

• Global ivabradine sales reached approximately $1.5 billion in 2022, with a projected CAGR of above 6% until 2028.
• Patent expiration begins between 2024-2027, prompting generic entry and potential revenue decline.
• Market growth is driven by rising cardiovascular disease prevalence and guideline-driven prescribing.
• R&D focus on expanded indications and formulations could mitigate revenue declines.
• Market access and pricing pressures intensify post-patent, emphasizing cost-effectiveness and differentiation.

FAQs

1. When will generic ivabradine become available?
Generic versions are expected to become available beginning in late 2024, following patent expirations.

2. What clinical guidelines influence ivabradine sales?
Guidelines from the American Heart Association and European Society of Cardiology recommend ivabradine for specific heart failure and angina populations, influencing prescribing practices.

3. Which markets are the largest for ivabradine?
North America accounts for roughly 45% of sales, followed by Europe at 35%. Emerging markets are growing but represent a smaller share currently.

4. How does patent expiry affect pricing?
Patent expiry typically leads to significant price reductions, with generic competition reducing margins and overall revenue.

5. Are new indications likely to sustain revenue?
Yes, if clinical trials demonstrate efficacy for additional indications such as atrial fibrillation, these could extend ivabradine’s market life and revenue streams.

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Sources
[1] IQVIA, "Global Cardiovascular Drugs Market," 2022
[2] European Medicines Agency, "Ivabradine Summary of Product Characteristics," 2005
[3] Food and Drug Administration, "Corlanor (ivabradine) approval," 2015
[4] Generic Pharma Annual Reports, 2022-2023