CORLANOR Drug Patent Profile

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. Eleven 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 INGENUS PHARMS LLC on December 30^th, 2021.

Summary for CORLANOR

International Patents:	97
US Patents:	8
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	6
Patent Applications:	243
Drug Prices:	Drug price information for CORLANOR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CORLANOR
What excipients (inactive ingredients) are in CORLANOR?	CORLANOR excipients list
DailyMed Link:	CORLANOR at DailyMed

See drug prices for CORLANOR

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

Constraining patent/regulatory exclusivity:

7,867,996

NDA:

209964

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

Sponsor	Phase
Amgen	Phase 3
Phillip Levy	Phase 4
iRhythm Technologies, Inc.	Phase 4

See all CORLANOR clinical trials

Pharmacology for CORLANOR

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

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.

This potential generic entry date is based on patent 7,867,996.

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

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	7,867,996		Y	Y
Amgen Inc	CORLANOR	ivabradine hydrochloride	TABLET;ORAL	206143-001	Apr 15, 2015	AB	RX	Yes	No	7,879,842*PED				Y
Amgen Inc	CORLANOR	ivabradine	SOLUTION;ORAL	209964-001	Apr 22, 2019		RX	Yes	Yes	7,879,842		Y	Y
Amgen Inc	CORLANOR	ivabradine hydrochloride	TABLET;ORAL	206143-002	Apr 15, 2015	AB	RX	Yes	Yes	7,867,996*PED				Y

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/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

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)

Argentina

Canada

Malaysia

Singapore

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
Morocco	28134	FORME CRISTALLINE GAMMA DU CHLORHYDRATE DE L'IVABRADINE, SON PROCEDE DE PREPARATION, ET LES COMPOSITIONS PHARMACEUTIQUES QUI LA CONTIENNENT.
South Korea	20060095501	beta;-CRYSTALLINE FORM OF IVABRADINE HYDROCHLORIDE, A PROCESS FOR ITS PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING IT
Japan	4628974
Australia	2006200856	beta-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it

Market Dynamics and Financial Trajectory for CORLANOR (Ivabradine)

Last updated: July 27, 2025

Introduction

CORLANOR (ivabradine) stands as a distinctive pharmaceutical agent in the treatment of chronic heart failure and other cardiovascular conditions. Its unique mechanism—selective inhibition of the funny current (I_f) in the sinoatrial node—differentiates it from beta-blockers and other standard heart failure therapies. As the cardiovascular drug market evolves, understanding CORLANOR’s market dynamics and financial trajectory is critical for stakeholders aiming to gauge its growth potential and competitive standing.

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Market Overview of CORLANOR

Introduced by Amgen in 2015 following acquisition of the rights from Servier, CORLANOR addressed unmet needs in heart failure management, particularly in patients with reduced ejection fraction who remained symptomatic despite standard therapy. Its approval was primarily granted in North America and Europe, with subsequent expansion into other regions, including Asia-Pacific.

The global heart failure market, projected to reach USD 6.7 billion by 2027 (CAGR ~8%), provides a substantial backdrop against which CORLANOR operates (1). Within this landscape, ivabradine’s niche emphasis on heart rate reduction in specific patient populations offers both opportunities and constraints.

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Key Market Drivers

1. Epidemiological Shifts: Rapid aging populations across North America, Europe, and Asia-Pacific increase the prevalence of chronic heart failure—an age-related condition affecting over 64 million globally (2). This expanding patient base directly impacts demand for innovative therapies like CORLANOR.

2. Clinical Evidence and Guidelines: The SHIFT trial (Systolic Heart failure treatment with the I_f inhibitor ivabradine) demonstrated significant reductions in cardiovascular death and hospitalizations (3). The incorporation of ivabradine into guidelines by the American College of Cardiology/American Heart Association (ACC/AHA) and European Society of Cardiology (ESC) has reinforced its credibility, bolstering physician adoption.

3. Regulatory Approvals and Expansions: Regulatory bodies have approved ivabradine for specific indications, including chronic heart failure with reduced ejection fraction (HFrEF) and residual angina in ischemic heart disease. Ongoing discussions around broader indications and additional formulations could foster new revenue streams.

4. Competitive Landscape: CORLANOR faces competition from traditional therapies such as beta-blockers, ACE inhibitors, and aldosterone antagonists. Its niche positioning relies on use in patients intolerant to or inadequately managed by existing drugs. Upcoming generics or biosimilars in the cardiovascular space could threaten pricing power.

5. Pricing and Reimbursement: Reimbursement policies significantly influence market penetration. While CORLANOR’s premium positioning reflects its specialized use, price sensitivity and payer restrictions in certain markets may limit widespread adoption.

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Market Challenges

• Limited Indications: Currently approved primarily for heart failure with reduced ejection fraction. This narrow scope constrains revenue potential compared to multi-indication blockbusters.
• Physician and Patient Awareness: Adoption depends on clinician familiarity and patient compliance, especially since ivabradine’s benefits are highly specific.
• Safety Profile and Side Effects: Bradycardia and luminous phenomena have been noted as adverse effects (4). These may impact prescribing patterns.
• Pricing Pressures: Increasing scrutiny of drug prices globally could impact margins, necessitating strategies for value demonstration.

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Financial Trajectory and Revenue Outlook

In its initial years, CORLANOR demonstrated promising sales growth. According to Amgen’s filings, sales reached approximately USD 300 million in 2021, reflecting a compound annual growth rate (CAGR) of about 15% since launch (5). However, growth momentum has tempered somewhat due to market saturation, competition, and reimbursement challenges.

Forecasts indicate:

• Short-Term (Next 2-3 Years): Moderate growth driven by expanding indications, increased penetration into established markets, and ongoing clinical trials supporting broader use.

• Medium-Term (3-5 Years): Potential ramp-up in sales with new formulations, combination therapies, and off-label uses if supported by evidence. Nonetheless, the emergence of generics or biosimilars could exert downward pressure.

• Long-Term (5+ Years): Revenue stability hinges on the successful approval of additional indications and geographic expansion. Price negotiations and evolving reimbursement policies may influence net profitability.

Risks and Opportunities

• Pipeline and Research: Trials investigating ivabradine in atrial fibrillation, angina, and other arrhythmias could unlock new markets (6).
• Market Penetration Strategies: Targeted marketing and physician education could accelerate adoption, especially in regions with high heart failure burdens.
• Cost-Effectiveness Assessments: Demonstrating economic benefits—such as reduced hospitalizations—can support favorable reimbursement terms.

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Impact of Market Trends on CORLANOR

The cardiovascular drug market is increasingly influenced by personalized medicine, digital health integration, and value-based care models. For CORLANOR, these trends translate into opportunities for precision targeting of appropriate patient subsets and technological integration to monitor outcomes.

Emerging therapies and innovations, such as gene therapy and novel device-based interventions, continue to shape the competitive landscape. While they may challenge ivabradine’s positioning, they also highlight the importance of continued clinical research and strategic adaptation.

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Key Takeaways

• Growing Market Backdrop: An aging population and rising heart failure prevalence underpin sustained demand for drugs like CORLANOR.
• Clinical Validation: Evidence from landmark trials and guideline endorsements bolster its physician adoption, supporting sales growth.
• Strategic Expansion Needed: Broader indications, geographic penetration, and partnership development remain critical to maximizing revenue potential.
• Pricing and Patent Dynamics: Patent expirations and generics pose risks, necessitating innovative marketing and value demonstration.
• Emerging Opportunities: Investigating additional indications and combination therapies could significantly enhance CORLANOR’s financial trajectory.

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Frequently Asked Questions

1. What are the primary drivers of CORLANOR’s market growth?
Epidemiological increases in heart failure, positive clinical evidence, guideline inclusion, and regional approvals are the main growth drivers.

2. How does CORLANOR compare to traditional heart failure therapies?
It offers a unique mechanism by selectively lowering heart rate, beneficial for patients intolerant to beta-blockers, but is limited by its narrower indication and higher cost.

3. What are the major market challenges facing CORLANOR?
Limited approved indications, competitive pressure from generics, safety concerns, and reimbursement hurdles hinder broader market penetration.

4. What potential future developments could impact CORLANOR’s revenue?
New clinical trial results, expanded indications, geographic expansion, and strategic partnerships could significantly influence its financial trajectory.

5. How might pricing and reimbursement trends affect CORLANOR?
Global shifts toward value-based reimbursement and price transparency may pressure margins; demonstrating cost-effectiveness remains pivotal.

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References

1. Grand View Research. Heart Failure Drugs Market Analysis, 2022.
2. Ponikowski P, et al. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2016.
3. Swedberg K, et al. Ivabradine and Outcomes in Chronic Heart Failure (SHIFT). Lancet. 2010.
4. Amgen. CORLANOR (Ivabradine) Prescribing Information. 2022.
5. Amgen. 2021 Annual Report.
6. FDA. Investigational Trials on Ivabradine’s Broader Indications.

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Conclusion

CORLANOR’s market dynamics are shaped by its targeted clinical profile amidst a burgeoning cardiovascular market, promising long-term growth prospects rooted in clinical evidence and expanding indications. However, competitive pressures, pricing considerations, and regulatory landscapes necessitate strategic agility. Stakeholders must monitor emerging data, market trends, and policy shifts to optimize its financial trajectory.