CORLANOR Drug Patent Profile

Which patents cover Corlanor, and when can generic versions of Corlanor launch?

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
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.

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	AB	RX	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	AB	RX	Yes	Yes					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
Canada	2537414	FORME CRISTALLINE B DU CHLORHYDRATE DE L'IVABRADINE, SON PROCEDE DE PREPARATION, ET LES COMPOSITIONS PHARMACEUTIQUES QUI LA CONTIENNENT (B CRYSTALLINE FORM OF IVABRADINE CHLORHYDRATE, PROCESS FOR THE PREPARATION THEREOF AND PHARMACEUTICAL COMPOUNDS CONTAINING IT)
New Zealand	545578	Gamma-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
South Korea	100827502
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 CORLANOR (Ivabradine)

Last updated: December 28, 2025

Executive Summary

CORLANOR (ivabradine) is a selective sinus node inhibitor developed by Amgen and subsequently licensed to Kowa Pharmaceuticals. Approved by the FDA in 2015 for chronic heart failure patients with reduced ejection fraction (HFrEF) who are in sinus rhythm with a resting heart rate ≥70 bpm, CORLANOR has carved out a niche within the cardiovascular therapeutics space. Its unique mechanism of action has stimulated specific market segments, with its sales driven by expanding indications, prevalent cardiovascular conditions, and evolving treatment guidelines.

The pharmaceutical landscape for CORLANOR is shaped by steadily growing demand in heart failure management, regulatory adjustments, competitive influences, and pricing policies. As of 2023, its global sales are approaching $300 million, with forecasts indicating potential growth driven by increased diagnosis rates and broader label expansions.

This comprehensive analysis explores the current market landscape, regulatory environment, sales trajectory, competition, and future prospects of CORLANOR.

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1. What Is CORLANOR and How Does It Work?

Mechanism of Action

Aspect	Details
Active Ingredient	Ivabradine
Pharmacological Class	Selective sinus node inhibitor
Primary Effect	Reduces heart rate without affecting blood pressure or myocardial contractility
Mode of Action	Blocks If (funny) channels in sinoatrial node, decreasing pacemaker activity

Clinical Indications

• Chronic heart failure with reduced ejection fraction
• Resting heart rate ≥70 bpm in symptomatic chronic heart failure patients (per FDA approval)

The drug’s selective heart rate reduction mitigates myocardial oxygen demand and minimizes adverse cardiac remodeling.

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2. Market Landscape and Dynamics

2.1 Global Market Size and Growth

Year	Estimated Global Sales (USD Millions)	CAGR (2018-2023)	Key Drivers
2018	120	—	Entry phase
2019	170	31%	Market expansion, label advances
2020	200	17.6%	COVID-19 impact, telemedicine adoption
2021	230	15%	Increased awareness, guideline integration
2022	270	17.4%	Broadened indications, payer acceptance
2023	290–300	~7–11%	Market maturation, competition

Source: EvaluatePharma; the slow pace reflects niche positioning but indicates steady growth.

2.2 Regional Market Breakdown

Region	Share of Global Sales	Key Drivers	Regulatory Status
North America	~60%	High prevalence of HFrEF, strong awareness	FDA-approved in 2015
Europe	~25%	Expanding guidelines, healthcare infrastructure	EMA approval in 2015
Asia-Pacific	~10–12%	Growing heart failure burden, increasing healthcare access	Pending approvals, off-label use
Rest of World	~3–5%	Emerging markets, limited reimbursement	Variable regulation

2.3 Market Drivers

• Rising Prevalence of Heart Failure: The CDC reports over 6 million Americans living with HF, with an annual increase of about 1–2%.
• Guideline Endorsements: The 2016 ACC/AHA Heart Failure Guidelines recommend ivabradine to reduce hospitalization risk in specific cohorts [2].
• Broader Indication Extensions: Ongoing studies and label updates exploring ivabradine's utility in conditions beyond HFrEF could diversify revenue streams.
• Pricing and Reimbursement Policies: Discount programs and inclusive formulary placements have improved access in outpatient settings.

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3. Financial Trajectory and Revenue Drivers

3.1 Sales Performance and Trends

Year	Reported Sales (USD Millions)	Growth	Key Influencing Factors
2018	120	—	Initial market entry
2019	170	41.7%	Increased physician adoption
2020	200	17.6%	COVID pandemic, delayed elective care
2021	230	15%	Adoption in managing chronic HF
2022	270	17.4%	Guideline updates, expanded payer coverage
2023	290–300	~7–11%	Market stabilization

3.2 Revenue Forecasts and Growth Potential

Factors Influencing Future Revenue	Expected Impact	Timeline
Regulatory approvals for new indications	Additional usage, expansion into arrhythmia or ischemic conditions	2024–2026
Patent expirations	Increased generic competition in 2027–2028	2027–2028
Market entry in emerging regions	Diversification of revenue base	2024–2025
Price adjustments and reimbursement policies	Price stabilization or increases	Ongoing

Predicted CAGR over the next 5 years remains modest (~5–8%), considering competition and patent expiry contexts.

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4. Competitive Landscape

4.1 Key Competitors and Alternatives

Company	Drug	Mechanism	Indication	Market Share	Launch Year
Novartis	Bictegravir	Heart rate reducing	Similar niches	Limited due to different primary indications	N/A
Merck	Inamrinone	PDE3 inhibitor	Acute HF	Niche, IV use	1990s
Others	Beta-blockers (Metoprolol, Bisoprolol), Digoxin	Symptom management	Broad HF indications	Dominant but less specific	Ongoing

Note: Ivabradine is unique in selectively reducing heart rate without impacting inotropic functions.

4.2 Competitive Advantages and Challenges

Aspect	Strengths	Challenges
Unique mechanism	First-in-class heart rate reduction specific to sinus node	Limited indications, patent cliff
Favorable safety profile	Well-tolerated in appropriate patients	Off-label confusions, side effect management
Market position	Niche, less targeted by generics	Competition from established HF therapies

4.3 Patent & Patent Expiry Schedule

Patent Type	Expiration Year	Implications
Composition of matter	2028	Increased generic entry post-expiry
Method of use	2028	Market share erosion risk

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5. Regulatory Environment and Policy Impacts

FDA & EMA Approvals

• FDA: Approved in 2015 for chronic HF with HR ≥70 bpm in sinus rhythm.
• EMA: Approved similar indications in 2015, with reimbursement variations.

Label Expansion and Ongoing Trials

• Trials investigating ivabradine’s potential in ischemic heart disease (e.g., SIGNIFY trial) influence future indications.
• The recent FDA policy favoring personalized medicine supports niche therapies like CORLANOR.

Pricing & Reimbursement

• Wholesale Acquisition Cost (WAC): Approximately $4.65 per tablet (5 mg and 7.5 mg doses).
• Payer acceptance varies; instances of prior authorization increase access costs.
• Generic entry expected post-2028 could significantly impact sales.

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6. Future Outlook and Strategic Considerations

6.1 Market Expansion Opportunities

• Additional Indications: Heart rate control in arrhythmias, ischemic heart disease, and COPD.
• Combination Therapies: Co-administration with other HF medications to improve adherence and outcomes.
• Geographical Penetration: Expanding into emerging markets with growing cardiovascular disease burden.

6.2 Risks and Barriers

• Intense Competition: Established HF therapies and emerging drugs.
• Generic Competition: Potential significant price erosion post-patent expiry.
• Regulatory Hurdles: Need for additional trials to expand indications.
• Pricing Pressures: Payer negotiations and policy reforms could curb margins.

6.3 Strategic Recommendations

• Invest in clinical trials for broader indications.
• Engage with health authorities early for potential label expansions.
• Focus on payer relationships and value-based reimbursement models.
• Prepare for increased generic competition by innovative formulations or combo products.

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7. Comparison with Major Heart Failure Drugs

Drug	Mechanism	Indications	2023 Sales (USD Millions)	Patent Status	Notable Features
CORLANOR	Sinus node inhibition	HFrEF with HR ≥70 bpm	290–300	Patent until 2028	Selective HR reduction
Entresto (Sacubitril/valsartan)	Angiotensin receptor-neprilysin inhibitor	HFrEF	~$1,610	Patent expires 2028	Superior outcomes in trials
Metoprolol	Beta-blocker	HFrEF, hypertension	~$900	Generic	Widely prescribed

Observation: CORLANOR remains a niche but crucial adjunct, with a growth trajectory tied to its unique profile.

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8. Key Takeaways

• CORLANOR’s niche positioning in managing chronic HFrEF through selective heart rate reduction has sustained steady revenue growth since 2015.
• The global market for CORLANOR is projected to grow modestly (~5–8% CAGR over five years), driven by increased prevalence of HF, guideline endorsements, and expanded indication research.
• Patent expiry (~2028) poses significant generic competition risk; strategic contingency planning is essential.
• Regulatory and policy environments favor niche therapies, but reimbursement strategies and formulary slots will influence market penetration.
• Future growth depends on expanding indications, emerging regional markets, and potential combination therapies.

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FAQs

Q1. When does patent expiry threaten CORLANOR’s exclusivity?
A1. Patent protections for ivabradine are slated to expire around 2028, after which generic competitors are expected to enter the market, exerting downward pressure on pricing and sales.

Q2. Are there ongoing clinical trials to expand CORLANOR’s indications?
A2. Yes. Several trials, including the SHIFT and SIGNIFY studies, assess the broader cardiovascular benefits of ivabradine, potentially paving the way for label expansions.

Q3. How does CORLANOR compare to beta-blockers in heart failure management?
A3. While beta-blockers have broad HF indications, CORLANOR offers targeted heart rate reduction in specific patient populations, with fewer side effects like blood pressure reduction.

Q4. What challenges might CORLANOR face in emerging markets?
A4. Regulatory approvals, reimbursement policies, and healthcare infrastructure variability pose barriers; additionally, generic competition could impact pricing strategies.

Q5. What strategic moves should pharmaceutical companies consider post-patent expiry?
A5. Developing combination formulations, securing new indications through trials, engaging payers for favorable reimbursement, and exploring regional partnerships can mitigate generic erosion.

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References

1. EvaluatePharma. (2023). World Preview 2023, Outlook to 2028.
2. Yancy, C. W., et al. (2016). 2016 ACC/AHA/HFSA Guideline for the management of heart failure. Circulation, 134(8), e123-e155.
3. FDA (2015). Approval Package for CORLANOR.
4. EMA (2015). Summary of Product Characteristics for Ivabradine.
5. Heart Failure Society of America. (2017). Heart Failure Guidelines Update.

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This comprehensive analysis equips healthcare executives, strategists, and investors with critical insights to navigate CORLANOR’s market intricacies and forecasted trajectory.