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:	88
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
The University of Hong Kong	PHASE4
Post Graduate Institute of Medical Education and Research, Chandigarh	NA
Indian Council of Medical Research	NA

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
Amgen Inc	CORLANOR	ivabradine	SOLUTION;ORAL	209964-001	Apr 22, 2019		RX	Yes	Yes
Zydus Pharms	IVABRADINE HYDROCHLORIDE	ivabradine hydrochloride	TABLET;ORAL	213442-002	Nov 29, 2023	AB	RX	No	No
Alembic	IVABRADINE HYDROCHLORIDE	ivabradine hydrochloride	TABLET;ORAL	215238-001	Nov 8, 2024	AB	RX	No	No
Amgen Inc	CORLANOR	ivabradine hydrochloride	TABLET;ORAL	206143-002	Apr 15, 2015	AB	RX	Yes	Yes					Y
Amgen Inc	CORLANOR	ivabradine hydrochloride	TABLET;ORAL	206143-002	Apr 15, 2015	AB	RX	Yes	Yes					Y
Msn	IVABRADINE HYDROCHLORIDE	ivabradine hydrochloride	TABLET;ORAL	213483-002	Apr 28, 2025	AB	RX	No	No

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
JensonR+ Limited	Ivabradine JensonR	ivabradine	EMEA/H/C/004217Symptomatic 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

International Patents for ivabradine

Country	Patent Number	Title	Estimated Expiration
Portugal	1695965
Eurasian Patent Organization	200600320	γ-КРИСТАЛЛИЧЕСКАЯ ФОРМА ГИДРОХЛОРИДА ИВАБРАДИНА, СПОСОБ ЕЁ ПОЛУЧЕНИЯ И ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, КОТОРЫЕ ЕЁ СОДЕРЖАТ
Saudi Arabia	06270040	الصورة المتبلرة - γ لهيدروكلوريد إيڤابرادين، وعملية لتحضيرها، وتركيبات صيدلانية تحتوي عليها، (γ -Crystalline Form of Ivabradine Hydrochloride, a Process for its Preparation and Pharmaceutical Compositions Containing It)
World Intellectual Property Organization (WIPO)	2006092493
Brazil	PI0600623	forma beta-cristalina de cloridrato de ivabradina, processo para preparação do mesmo e composições farmacêuticas contendo o mesmo
Argentina	052926	FORMA CRISTALINA GAMA DEL CLORHIDRATO DE IVABRADINA, UN PROCEDIMIENTO PARA SU PREPARACION Y COMPOSICIONES QUE LA CONTIENEN

Market Dynamics and Financial Trajectory for Ivabradine

Last updated: July 27, 2025

Introduction

Ivabradine, marketed primarily under the brand name Corlanor, represents a pivotal class of heart rate-reducing agents used in managing chronic heart failure and certain arrhythmias. Since its regulatory approval, ivabradine’s market trajectory is shaped by evolving clinical guidelines, patent landscapes, competitive pressures, and emerging therapeutic applications, positioning it as a significant player within cardiovascular pharmacotherapy. This report analyzes the current market dynamics and forecasts the financial trajectory for ivabradine, providing strategic insights for stakeholders.

Regulatory and Clinical Landscape

Regulatory Approvals and Indications

Ivabradine received FDA approval in 2015 for reducing hospitalization risk in chronic heart failure patients with reduced ejection fraction (HFrEF) who are in sinus rhythm with a heart rate of 70 bpm or higher, despite guideline-directed medical therapy [1]. Its European approval predates this, originally granted in 2005, reflecting early recognition of its benefits in stable angina and heart failure [2].

The incremental indication expansion, notably in Europe, to cover broader heart failure populations, has bolstered its prescription volume. However, regulatory differences limit rapid global adoption, with certain markets still awaiting approval or clinical guideline integration.

Clinical Evidence and Practice Adoption

Robust clinical trials — notably the SHIFT trial — underpin ivabradine’s role in reducing hospitalizations and mortality in chronic heart failure [3]. Nonetheless, adoption varies geographically, influenced by clinicians’ familiarity with guidelines, competing therapies, and perceived safety profiles. The drug's contraindications, such as in patients with hypotension, sick sinus syndrome, or certain tachyarrhythmias, influence prescribing patterns.

Market Drivers

Growing Prevalence of Heart Failure

The global burden of heart failure continues to escalate, driven by aging populations, hypertension, ischemic heart disease, and lifestyle factors [4]. The American Heart Association estimates over 6.2 million Americans suffer from heart failure, a figure projected to increase by 46% by 2030 [5]. This expanding prevalence enhances the demand for effective therapeutics like ivabradine.

Evolving Treatment Guidelines

Major cardiology societies, including the European Society of Cardiology (ESC) and American College of Cardiology (ACC), endorse ivabradine as part of comprehensive heart failure management in suitable subsets. Clinical guidelines’ endorsement significantly influences physician prescribing behavior, securing ivabradine’s place in standard-of-care protocols.

Patent Status and Generic Competition

The original patent for ivabradine has expired in several jurisdictions, notably in Europe and the US, precipitating generic entrants that exert downward pressure on prices and margins. For example, the first generic versions launched in Europe around 2018, increasing market competition [6].

Despite this, branded formulations retain a premium in some markets due to brand recognition, formulary preferences, and supply chain considerations. The patent landscape remains complex, with some formulations covered by secondary patents or formulation-specific exclusivities delaying genericization.

Market Penetration and Reimbursement Policies

In developed markets, reimbursement frameworks largely support ivabradine use, mitigating cost barriers. Conversely, in emerging markets, reimbursement limitations and cost-awareness constrain widespread adoption, although expanding cardiovascular disease burden presents growth opportunities.

Competitive Landscape

Primary Competitors

• Beta-blockers: Widely used as first-line agents in heart failure management, often viewed as competitors or complementary agents.
• Other heart rate modulators: For specific arrhythmias, class IC and III antiarrhythmics compete based on clinical context.
• Emerging therapies: Novel agents targeting neurohormonal pathways or directly optimizing cardiac function threaten to encroach upon ivabradine’s niche.

Market Positioning

Ivabradine’s unique mechanism—inhibition of the funny current (I_f)—renders it distinct, particularly in patients intolerant to beta-blockers. Its positioning as a targeted therapy for a specific subset underpins sustained demand, especially where evidence-based guidelines favor its use.

Financial Trajectory

Historical Performance

Pfizer and Servier, the key developers of ivabradine, reported incremental sales increases post-approval, with peak revenues reaching approximately $700 million globally in the early 2010s [7]. Post-patent expiry, sales declined in certain markets due to generics but remained resilient in others because of brand loyalty and clinical uptake.

Forecasted Growth Trends

The forecast anticipates modest but steady growth driven primarily by:

• Expansion into emerging markets.
• Increased awareness and guideline adoption.
• Ongoing clinical trials exploring additional indications, such as post-acute myocardial infarction heart failure.

Analysts project a compound annual growth rate (CAGR) of approximately 2-3% over the next five years, chiefly in regions where patent protections or purchase agreements sustain revenues. In markets with robust generic competition, revenue erosion is expected, but volume gains may offset price declines.

Emerging Opportunities and Risks

• New indications: Trials investigating ivabradine’s role in conditions like atrial fibrillation could unlock new revenue streams.
• Combination therapies: Synergistic regimens with other heart failure agents may expand usage.
• Generic competition: Will likely constrain margins but could boost volume and market penetration.

Strategic partnerships, licensing arrangements, and pricing strategies will be crucial for maintaining profitability amid increasing commoditization.

Market Challenges

• Safety perceptions: Concerns over visual phenomena (phosphenes) and bradycardia influence prescribing.
• Competitive therapies: Advances in device therapy and emerging pharmacologics could diminish role.
• Regulatory hurdles: Delays or denials in new markets may impede expansion.

Conclusion

Ivabradine’s market dynamics are intricately linked to demographic trends, clinical guideline endorsements, patent landscapes, and competitive forces. While mature in certain regions, its long-term financial trajectory hinges on strategic positioning, ongoing clinical evidence, and geographic expansion. The outlook remains cautiously optimistic, with incremental growth expected amid a backdrop of competitive pressures and patent expirations.

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Key Takeaways

• Demographic trends, notably aging populations and rising heart failure incidence, are primary growth drivers.
• Guideline integration remains vital; widespread physician acceptance sustains demand.
• Patent expirations and generics exert pricing pressure, but brand loyalty and clinical positioning mitigate revenue decline.
• Emerging indications and combination therapies present new revenue opportunities.
• Market expansion efforts into emerging economies can offset stagnation in mature markets.

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FAQs

1. What are the main therapeutic uses of ivabradine?
Ivabradine primarily reduces heart rate in patients with chronic heart failure with reduced ejection fraction and stable angina, as recommended by major cardiology guidelines.

2. How does patent expiry affect ivabradine’s market?
Patent loss enables generic manufacturers to enter the market, leading to price competition and potential revenue decline for the original branded product.

3. Are there notable side effects associated with ivabradine?
Common side effects include luminous phenomena (phosphenes), bradycardia, and atrial fibrillation, influencing prescribing decisions.

4. What emerging indications could expand ivabradine’s market?
Research exploring its utility in post-MI heart failure and arrhythmia management holds potential for expanded indications.

5. How does geographic variation influence ivabradine’s market?
Regulatory approvals, reimbursement frameworks, and clinical guidelines vary globally, impacting adoption rates and sales performance across regions.

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References

[1] FDA. (2015). Ivabradine (Corlanor) for Heart Failure. US Food and Drug Administration.
[2] European Medicines Agency. (2005). Approval of Corlentor (ivabradine) for angina.
[3] Swedberg, K., et al. (2010). The SHIFT Trial: Heart Failure and Ivabradine. Lancet.
[4] Mozaffarian, D., et al. (2016). Heart Disease and Stroke Statistics. Circulation.
[5] American Heart Association. (2019). Heart Failure Statistics.
[6] European Patent Office. (2018). Patent expiration and generic entry for ivabradine.
[7] Pfizer. (2014). Annual Report: Cardiovascular Business.