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

Recent Clinical Trials for CORLANOR

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

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

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		DISCN	Yes	No	7,867,996		Y	Y
Amgen Inc	CORLANOR	ivabradine hydrochloride	TABLET;ORAL	206143-001	Apr 15, 2015		DISCN	Yes	No	7,879,842*PED				Y
Amgen Inc	CORLANOR	ivabradine	SOLUTION;ORAL	209964-001	Apr 22, 2019		DISCN	Yes	No	7,879,842		Y	Y
Amgen Inc	CORLANOR	ivabradine hydrochloride	TABLET;ORAL	206143-002	Apr 15, 2015		DISCN	Yes	No	7,867,996*PED				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	7,879,842
Amgen Inc	CORLANOR	ivabradine	SOLUTION;ORAL	209964-001	Apr 22, 2019	7,361,649
Amgen Inc	CORLANOR	ivabradine	SOLUTION;ORAL	209964-001	Apr 22, 2019	7,361,650

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
Ukraine	86595	ГАММА-КРИСТАЛЛИЧЕСКАЯ ФОРМА ГИДРОХЛОРИДА ИВАБРАДИНА, СПОСОБ ЕЕ ПОЛУЧЕНИЯ И ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, КОТОРАЯ ЕЕ СОДЕРЖИТ;ГАММА-КРИСТАЛІЧНА ФОРМА ГІДРОХЛОРИДУ ІВАБРАДИНУ, СПОСІБ ЇЇ ОДЕРЖАННЯ І ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ, ЯКА ЇЇ МІСТИТЬ (GAMMA-CRYSTALLINE FORM OF THE CHLOROHYDRATE OF IVABRADINE, PROCESS FOR ITS PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING IT)
Cuba	23616	FORMA CRISTALINA GAMMA DEL CLORHIDRATO DE LA IVABRADINA, SU PROCEDIMIENTO DE PREPARACIÓN Y LAS COMPOSICIONES FARMACÉUTICAS QUE LAS CONTIENEN
Saudi Arabia	06270038	الصورة المتبلرة- β لهيدروكلوريد إيفابرادين ، وعملية لتحضيرها، (�-Crystalline Form of Ivabradine Hydrochloride, a Process for its Preparation and Pharmaceutical Compositions Containing It)
Norway	338481

Market Dynamics and Financial Trajectory for CORLANOR (ivabradine)

Last updated: April 17, 2026

What is CORLANOR?

CORLANOR (ivabradine) is a selective sinus node inhibitor approved for reducing hospitalization risk in chronic heart failure with reduced ejection fraction (HFrEF), alongside standard therapy. It is marketed by Amgen and Servier. Approved by the FDA in 2015, the drug primarily targets patients with symptomatic heart failure who are in sinus rhythm with a resting heart rate ≥70 bpm.

Industry Landscape and Market Size

The HFrEF market exceeds $10 billion globally, driven by increasing prevalence and improved diagnostic capabilities. The US accounted for nearly 50% of this market in 2022. Ivabradine’s contribution, including CORLANOR specifically, is confined to niche segments, with global sales estimated at approximately $210 million in 2022.

Competitive Environment

The primary competitor is beta-blockers, which are first-line treatments for HFrEF. Ivabradine acts as an adjunct, suited for patients intolerant or insufficiently responsive to beta-blockers. Other therapies, such as sacubitril/valsartan, have gained market share but target broader indications.

Market Penetration and Adoption

Corlanor's adoption remains moderate, with prescription volumes influenced by physician familiarity, insurance coverage, and patient eligibility criteria. Its utilization is constrained by strict eligibility for heart rate threshold and sinus rhythm requirement.

Revenue and Financial Trends

Historical Revenue Data

Year	Global Sales (USD millions)	Market Share (%)	Key Growth Drivers
2015	N/A	N/A	Market entry, initial adoption
2018	~$125	~1.2	Increasing adoption, expanded indications
2020	~$180	~1.8	Prescriber uptake, expanded payor coverage
2022	~$210	~2.0	Growth in heart failure diagnoses

Revenue Drivers

• Increased diagnosis of HFrEF: Rising prevalence in aging populations.
• Guideline updates: American and European guidelines include ivabradine, expanding potential patient pool.
• Expanded label: Approval for additional indications could boost sales, though current labels remain narrow.

Pricing and Reimbursement

Average wholesale price (AWP) in the US stands around $328 per month per patient. Reimbursement varies with payer policies; coverage has improved with increased awareness and clinical evidence.

Regulatory and Clinical Pipeline Impact

• Additional approvals: Regulatory submissions for heart failure with preserved ejection fraction (HFpEF) and cardiac arrhythmias are underway.
• Clinical trials: Ongoing studies intend to evaluate long-term safety and broader indications, potentially impacting market size.

Challenges and Risks

• Limited patient eligibility: Strict criteria limit market size.
• Competitive therapies: Beta-blockers and emerging drugs could diminish incremental market share.
• Cost-effectiveness: Payers scrutinize incremental benefits over established therapies.

Market Expansion Opportunities

• Additional indications: Heart failure subtypes, arrhythmias.
• Geographic expansion: Emerging markets with increasing healthcare infrastructure.
• Combination therapies: Co-prescription with drugs addressing other HFrEF pathways.

Investment Outlook

While CORLANOR's current revenue remains modest relative to broader heart failure treatments, ongoing clinical development, expanded guidelines, and demographic trends support slow but steady growth. Strategic focus on expanding indications, geographic reach, and payer acceptance could improve financial performance over the next five years.

Key Takeaways

• CORLANOR (ivabradine) operates within a narrow niche for HFrEF, with approximately $210 million in global sales as of 2022.
• Market growth is driven by an aging population, increased heart failure prevalence, and guideline recognition.
• The drug faces competition from first-line therapies and strict patient eligibility constraints.
• Future revenue depends heavily on approval for new indications and expanded geographic and payer coverage.

FAQs

1. What is the primary indication for CORLANOR?
It is approved for reducing hospitalization in chronic HFrEF patients with an elevated heart rate of ≥70 bpm in sinus rhythm.

2. How does CORLANOR compare to beta-blockers in heart failure management?
It is used as an adjunct for patients who cannot tolerate beta-blockers or do not respond sufficiently, owing to its distinct mechanism targeting the sinoatrial node.

3. What are the key drivers of CORLANOR’s sales growth?
Increased heart failure prevalence, guideline inclusion, and expanding clinical evidence.

4. What are the main barriers to market expansion?
Strict eligibility criteria, competition, and reimbursement challenges.

5. What future developments could impact the market for CORLANOR?
New indications, clinical trial results, and broader geographic approvals.

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References

[1] Amgen Inc. (2022). CORLANOR (ivabradine) prescribing information.
[2] American Heart Association. (2022). Heart Failure Statistics.
[3] IQVIA. (2022). Pharmaceutical Market Data.
[4] European Medicines Agency. (2022). IVABRADINE Marketing Authorization.
[5] U.S. Food and Drug Administration. (2015). Corlanor approval announcement.