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

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.

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			Y	Y
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 CORLANOR

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 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

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

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

Corlanor (Ivabradine) Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Corlanor, the brand name for ivabradine, is a selective heart rate-lowering agent. Its primary indication is for the reduction of the risk of hospitalization for worsening heart failure in adult patients with symptomatic stable chronic heart failure with reduced left ventricular ejection fraction (LVEF ≤ 35 percent), who are in sinus rhythm with a resting heart rate of 70 beats per minute or greater, and are either on or have reached the maximally tolerated dose of beta-blockers, or have a contraindication to beta-blocker use. The drug is developed and marketed by Amgen in the United States.

What is Corlanor's Mechanism of Action and Clinical Profile?

Corlanor functions by selectively inhibiting the If current in the sinoatrial (SA) node, a process that occurs specifically in the cardiac pacemaker cells. This inhibition leads to a dose-dependent reduction in heart rate without affecting myocardial contractility, blood pressure, or cardiac repolarization. This unique mechanism of action distinguishes it from other heart rate-lowering agents like beta-blockers, which have broader cardiovascular effects.

The clinical efficacy of ivabradine was established in the SHIFT (Systolic Heart Failure and Impact on Longevity Using Ivabradine) trial. This pivotal Phase III study demonstrated that ivabradine, when added to standard therapy, significantly reduced the composite endpoint of cardiovascular death or non-fatal myocardial infarction by 18% in patients with symptomatic chronic heart failure and reduced LVEF and elevated heart rate [1]. Further analysis of the SHIFT trial data confirmed a 26% reduction in heart failure hospitalizations with ivabradine treatment [1].

The typical starting dose for Corlanor is 5 mg twice daily. The dose may be adjusted to 7.5 mg twice daily based on heart rate response, or reduced to 2.5 mg twice daily if the resting heart rate falls below 50 beats per minute or with symptomatic bradycardia. The maximum recommended dose is 7.5 mg twice daily [2].

What is the Current Market Positioning of Corlanor?

Corlanor is positioned as a therapy for a specific subpopulation of heart failure patients who remain symptomatic despite guideline-directed medical therapy, particularly those with a heart rate of 70 bpm or greater. This niche positioning acknowledges that while beta-blockers are foundational in heart failure management, a significant segment of patients do not achieve adequate symptom control or remain at high risk, especially those with elevated heart rates.

Key competitors include other therapies that manage heart rate or improve cardiovascular outcomes in heart failure, albeit through different mechanisms. These include:

• Beta-blockers: (e.g., metoprolol succinate, carvedilol, bisoprolol) are the cornerstone of heart failure treatment and remain the first-line therapy for rate control and mortality benefit. Corlanor is often used when beta-blockers are insufficient or contraindicated [3].
• Sacubitril/Valsartan (Entresto): A combination angiotensin receptor-neprilysin inhibitor (ARNI) that has demonstrated significant reductions in cardiovascular mortality and heart failure hospitalizations across a broad spectrum of heart failure patients, including those with reduced ejection fraction. Entresto's broad efficacy has led to its widespread adoption as a foundational therapy, potentially impacting the addressable market for therapies like Corlanor [4].
• SGLT2 inhibitors: (e.g., dapagliflozin, empagliflozin) have also shown robust cardiovascular benefits in heart failure, irrespective of diabetes status, and are now considered foundational therapies. Their inclusion in treatment algorithms can affect the patient profile remaining for Corlanor [5].
• Digoxin: While historically used for rate control and symptom management, its role in chronic heart failure has diminished due to a less favorable risk-benefit profile compared to newer agents and potential for toxicity.

Corlanor's competitive advantage lies in its selective heart rate reduction without negatively impacting contractility or blood pressure, which can be advantageous in patients who are already hypotensive or have other contraindications to beta-blockers.

What is Corlanor's Revenue Performance and Financial Trajectory?

Amgen reported Corlanor (ivabradine) net product sales as follows:

Year	Net Sales (Millions USD)	Year-over-Year Change
2020	$472	N/A
2021	$446	-5.5%
2022	$364	-18.4%
2023	$317	-12.9%

Source: Amgen Annual Reports (2020-2023)

The revenue trend for Corlanor indicates a decline since its peak in 2020. This decline is attributable to several factors:

• Increased Competition: The broader adoption of ARNIs (Entresto) and SGLT2 inhibitors in heart failure treatment guidelines has expanded the foundational therapy landscape. These agents offer broad benefits, potentially addressing the unmet needs previously filled by Corlanor for a larger patient population.
• Shifting Treatment Paradigms: Evolving clinical guidelines emphasize a multi-drug approach for heart failure with reduced ejection fraction (HFrEF). The integration of ARNIs and SGLT2 inhibitors as first-line or early-stage therapies means fewer patients may progress to the specific profile for which Corlanor is indicated.
• Market Saturation and Penetration: While Corlanor addresses a specific unmet need, the total addressable market for this niche may be smaller than initially projected, especially as the overall management of HFrEF becomes more comprehensive.
• Geographic Performance: Sales figures represent global performance. Specific regional market dynamics, payer policies, and physician prescribing patterns can influence sales velocity. Amgen primarily markets Corlanor in the United States.

Amgen's financial reports have indicated that Corlanor's sales have been impacted by these market dynamics. The company has not provided specific forward-looking guidance for Corlanor's revenue trajectory, but the historical trend suggests a continued period of lower sales compared to its peak. The drug's patent protection in major markets remains a key factor for its long-term financial outlook.

What is Corlanor's Patent Landscape and Exclusivity Status?

The patent landscape for Corlanor is crucial for understanding its future market exclusivity and potential generic competition. Ivabradine is protected by a portfolio of patents.

Key patent considerations include:

• Composition of Matter Patents: These are the strongest patents, protecting the molecule itself. The primary patents covering ivabradine have largely expired in major markets such as the United States and Europe.
• Formulation and Method of Use Patents: Additional patents may cover specific formulations, dosages, or methods of treating particular conditions with ivabradine. These can sometimes extend market exclusivity beyond the expiration of composition of matter patents.
• Exclusivity Periods: Regulatory exclusivity (e.g., New Chemical Entity exclusivity in the US, data exclusivity in Europe) also plays a role.

In the United States, the primary patents for ivabradine have expired, allowing for generic entry. Amgen has faced and continues to face generic competition for Corlanor. The exact expiration dates and legal challenges can be complex and vary by jurisdiction. Generic versions of ivabradine are available, impacting Corlanor's market share and pricing power.

The entry of generics generally leads to a significant decline in branded drug revenues due to price competition. Companies that rely on branded products often see their revenue streams contract sharply once generics are established.

What are the Regulatory and Market Access Considerations?

Regulatory approval for Corlanor was obtained from the U.S. Food and Drug Administration (FDA) in April 2015 and from the European Medicines Agency (EMA) in October 2012. Approval was based on data from trials such as SHIFT.

Market access for Corlanor involves navigating payer policies and formulary decisions. Reimbursement landscapes can influence prescribing patterns. Payers assess the drug's value proposition, including its efficacy, safety, comparative effectiveness against existing treatments, and cost-effectiveness.

• Payer Restrictions: Many payers have implemented restrictions on Corlanor, requiring prior authorization or step-therapy protocols, often mandating prior trial of beta-blockers and other guideline-directed therapies. This ensures that the drug is prescribed to the appropriate patient population as defined by its indication.
• Cost-Effectiveness: While Corlanor offers a unique mechanism, its cost relative to established therapies like generics of beta-blockers and the cost-effectiveness of newer foundational therapies like ARNIs and SGLT2 inhibitors are critical considerations for market access and uptake.
• Physician Prescribing Habits: Physician familiarity with the drug's profile, patient selection criteria, and comfort in managing heart rate with a non-beta-blocker agent also shape its adoption.

The evolving treatment landscape for heart failure, with increasing emphasis on comprehensive, multi-drug regimens, means that market access for any single agent is influenced by its place within this broader therapeutic ecosystem.

What are the Future Growth Prospects and Challenges?

The future growth prospects for Corlanor are limited by several factors, primarily the increasing competition from newer heart failure therapies and the advent of generic ivabradine.

Growth Prospects:

• Niche Patient Population: Corlanor will continue to serve a specific patient segment—those with symptomatic HFrEF, elevated resting heart rate, and intolerance or inadequate response to beta-blockers. This segment, while specific, is not insignificant.
• Potential for Combination Therapy: Research into optimal combination therapies for heart failure may identify specific scenarios where Corlanor's unique mechanism is particularly beneficial alongside other novel agents.

Challenges:

• Generic Erosion: The primary challenge is the continued impact of generic ivabradine. Generic competition typically leads to a significant and rapid decline in branded drug sales.
• Competition from Foundational Therapies: ARNIs and SGLT2 inhibitors are increasingly being recommended as foundational therapies in early HFrEF management. This broader application can reduce the number of patients who progress to the specific profile for Corlanor.
• Guideline Evolution: As clinical guidelines for heart failure continue to evolve, incorporating new evidence and therapies, the positioning and utility of Corlanor may be further refined, potentially impacting its place in treatment algorithms.
• Pricing Pressures: Generic competition and the need for payers to manage healthcare costs will likely maintain pricing pressures on both branded and generic ivabradine.

Amgen's strategy for Corlanor will likely focus on maximizing value from its remaining exclusivity period and potentially leveraging its established market presence and physician relationships to maintain a share within its defined indication, while acknowledging the market shift towards broader therapeutic approaches.

Key Takeaways

• Corlanor (ivabradine) is a selective heart rate-lowering agent indicated for symptomatic stable chronic heart failure with reduced left ventricular ejection fraction in patients with a resting heart rate of 70 bpm or greater, who are on or intolerant to beta-blockers.
• Its mechanism of action selectively inhibits the If current in the SA node, reducing heart rate without affecting contractility or blood pressure.
• Corlanor's net product sales have declined significantly since 2020, from $472 million to $317 million in 2023, a trend attributed to increased competition from ARNIs and SGLT2 inhibitors, evolving treatment paradigms, and market saturation.
• The patent landscape for ivabradine has largely expired in major markets, leading to the availability of generic versions of ivabradine and subsequent erosion of Corlanor's market share and pricing power.
• Regulatory approval was granted by the FDA in 2015 and EMA in 2012. Market access is subject to payer policies, with restrictions often requiring prior authorization and step-therapy protocols.
• Future growth prospects for Corlanor are limited by generic competition and the broad efficacy of newer foundational heart failure therapies. Its continued use will likely be confined to a specific patient niche.

Frequently Asked Questions

1. What is the primary differentiator of Corlanor compared to beta-blockers in heart failure management? Corlanor selectively reduces heart rate by inhibiting the If current in the SA node. Unlike beta-blockers, it does not affect myocardial contractility or blood pressure, making it a potential option for patients who are hypotensive or have contraindications to beta-blockers.

2. How has the introduction of ARNIs and SGLT2 inhibitors impacted the market for Corlanor? The widespread adoption of ARNIs (e.g., Entresto) and SGLT2 inhibitors (e.g., dapagliflozin, empagliflozin) as foundational therapies for heart failure with reduced ejection fraction has expanded the therapeutic landscape. These agents offer broad benefits, potentially addressing the needs of a larger patient population and thus reducing the proportion of patients who may subsequently require Corlanor.

3. When did generic versions of ivabradine become available in the U.S. market? Generic versions of ivabradine began entering the U.S. market following the expiration of key patents, with significant generic competition emerging in the years following 2020. The exact timing of entry for specific generics can vary based on patent litigation outcomes.

4. What is the typical patient profile for whom Corlanor is prescribed? Corlanor is prescribed for adult patients with symptomatic stable chronic heart failure with reduced left ventricular ejection fraction (LVEF ≤ 35%), who are in sinus rhythm with a resting heart rate of 70 beats per minute or greater. These patients are typically on or have reached the maximally tolerated dose of beta-blockers or have a contraindication to beta-blocker use.

5. What are the main challenges Corlanor faces in the current pharmaceutical market? The primary challenges are intense competition from generic ivabradine, leading to price erosion and market share loss, and the increasing use of newer, broadly acting heart failure therapies like ARNIs and SGLT2 inhibitors, which are becoming first-line treatments for a wider patient population.

Citations

[1] Swedberg, K., Komajda, M., Böhm, M., Olsson, L., Schaufelberger, M., Diez, J., … van Veldhuisen, D. J. (2010). Ivabradine and Outcomes in Chronic Heart Failure (SHIFT): A Randomized Placebo-Controlled Study. The Lancet, 376(9752), 1632-1640. doi:10.1016/S0140-6736(10)61778-9

[2] U.S. Food and Drug Administration. (2015, April 14). FDA approves Corlanor (ivabradine) to reduce the risk of hospitalization for worsening heart failure in certain patients. Retrieved from FDA Press Announcements (Note: Specific press release link may change; searching FDA archive for "Corlanor approval" is recommended.)

[3] Yancy, C. W., Jessup, M., Bozkurt, B., Butler, J., Manemann, M. R., Smith, S. A., ... & Writing Committee Members. (2017). 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure. Circulation, 136(8), e153-e204. doi:10.1161/CIR.0000000000000509 (Note: This guideline has been updated since 2017, but reflects the context at the time of Corlanor's widespread adoption and competition.)

[4] McMurray, J. J. V., Solomon, S. D., Inzucchi, S. E., Køber, L., Kosiborod, M. N., Martinez, F. A., ... & Ferris, G. L. (2014). Angiotensin–Neprilysin Inhibition versus Enalapril in Heart Failure. New England Journal of Medicine, 371(11), 993-1004. doi:10.1056/NEJMoa1409047

[5] Packer, M., Anker, S. D., Butler, J., Filippatos, G., Ponikowski, P., Santos-Gallego, P., ... & Bernhardt, K. (2020). Cardiovascular Outcome Trial of Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. New England Journal of Medicine, 382(12), 1103-1111. doi:10.1056/NEJMoa1911175