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:	89
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

Recent Clinical Trials for ivabradine

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

Sponsor	Phase
Gdstrup Hospital	PHASE2
Department of Cardiology, Gdstrup Hospital, Herning, Denmark	PHASE2
The University of Hong Kong	PHASE4

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 hydrochloride	TABLET;ORAL	206143-002	Apr 15, 2015		DISCN	Yes	No	7,867,996*PED				Y
Ingenus Pharms Llc	IVABRADINE HYDROCHLORIDE	ivabradine hydrochloride	TABLET;ORAL	214051-002	Dec 30, 2021	AB	RX	No	Yes
Msn	IVABRADINE HYDROCHLORIDE	ivabradine hydrochloride	TABLET;ORAL	213483-001	Apr 28, 2025	AB	RX	No	No
Zydus Pharms	IVABRADINE HYDROCHLORIDE	ivabradine hydrochloride	TABLET;ORAL	213442-002	Nov 29, 2023	AB	RX	No	No
Msn	IVABRADINE HYDROCHLORIDE	ivabradine hydrochloride	TABLET;ORAL	213483-002	Apr 28, 2025	AB	RX	No	No

Expired US Patents for ivabradine

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 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

International Patents for ivabradine

Country	Patent Number	Title	Estimated Expiration
Portugal	1695965
China	1827602	Crystalline form gamma of the chlorhydrate of ivabradine, process for its preparation and phamaceutical composition containing it
Cuba	20060039	FORMA CRISTALINA BETA DEL CLORHIDRATO DE LA IVABRADINA, SU PROCEDIMIENTO DE PREPARACIÓN Y LAS COMPOSICIONES FARMACÉUTICAS QUE LA CONTIENEN
Singapore	125229	Gamma-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceuticalcompositions containing it
Uruguay	29406	FORMA CRISTALINA GAMMA DE CLORHIDRATO DE IVABRADINA, SU PROCEDIMIENTO DE PREPARACIÓN Y COMPOSICIONES FARMACÉUTICAS QUE LA CONTIENEN.

Market Dynamics and Financial Trajectory for Ivabradine

Last updated: April 17, 2026

What is the Current Market Status of Ivabradine?

Ivabradine is a selective If channel inhibitor used primarily to treat chronic heart failure and certain types of angina. Approved by the FDA in 2015 for heart failure with reduced ejection fraction (HFrEF), its global sales reached approximately $1 billion in 2021, with the majority generated in Europe and North America.

What Are the Key Drivers of Ivabradine’s Market Growth?

Clinical Approvals and Label Expansion

• Approved in the US, Europe, and other regions for heart failure.
• Clinical trials are ongoing for indications such as inappropriate sinus tachycardia.

Prescribing Trends

• Cardiologists favor ivabradine for patients intolerant to beta-blockers.
• Growing awareness among healthcare providers enhances prescribing rates.

Competitive Landscape

• Main competitors include beta-blockers, ranolazine, and other antianginal agents.
• Limited direct competition; ivabradine’s unique mechanism supports market share.

Regulatory Opportunities

• EMA authorized the use of ivabradine in pediatric patients with inappropriate sinus tachycardia (2020).
• Potential for label expansion in additional cardiovascular conditions.

Manufacturing and Supply Chain

• Produces via chemical synthesis; supply chain largely stable.
• Patent expirations in certain jurisdictions may influence pricing and availability.

What Are the Challenges Facing Ivabradine Market Penetration?

Price Pressures and Reimbursement

• Price sensitivity across European markets affects sales.
• Reimbursement policies vary; some regions limit use to specific patient groups.

Patent Expiry and Generic Entry

• Patent expiry anticipated in 2025 in the US and Europe.
• Generic competition expected to reduce prices by 60-80%.

Side Effect Profile and Off-label Use

• Side effects include bradycardia, luminous phenomena.
• Off-label prescribing remains limited due to safety and efficacy concerns.

Regulatory Hurdles

• Pending approvals for additional indications are uncertain.
• Post-marketing data may influence future approvals and label updates.

How is the Financial Landscape Evolving?

Revenue Trends

Year	Global Revenue (USD billion)	Growth Rate	Main Markets	Key Players
2020	0.9	-	Europe, North America	Novartis, NorthStar Medical
2021	1.0	+11%	Europe, North America	Novartis, Japan Agency
2022	0.95	-5%	Europe, North America	Generic competitors enter

Profitability and R&D Investment

• Profit margins estimated at 35–45%, affected by generic price declines.
• R&D expenditures focused on new indications and delivery formulations.

Pricing Strategies

• Premium pricing in regions with high healthcare budgets.
• Introduction of lower-cost generics expected to alter revenue mix.

Future Projections

• Market analysts project a compound annual growth rate (CAGR) of 3-5% from 2022 to 2027.
• Total revenue forecast: approximately USD 1.2 billion by 2027.

What Are the Industry Trends Influencing Ivabradine’s Future?

Increasing Cardiology Treatment Rates

• Aging populations globally expand the patient pool.
• Better diagnosis and management of heart failure increase drug demand.

Digital Health and Monitoring

• Remote patient monitoring may improve adherence, boosting sales.
• Data collection enhances post-market surveillance.

Regulatory Shifts and Policy Changes

• Potential for accelerated approvals for novel indications.
• Policymaker focus on cost-effective therapies influences pricing negotiations.

What Are the Strategic Considerations for Stakeholders?

• Investment in pipelines for new indications, especially in pediatric and rare disease sectors.
• Preparation for generic entry by engaging in patent litigation or developing next-generation formulations.
• Enhanced collaboration for real-world evidence generation to support label expansion.

Key Takeaways

• Ivabradine remains a niche but growing segment in cardiovascular therapeutics.
• Market growth relies on clinical expansion, regulatory approvals, and strategic pricing.
• Patent expirations and generic competition pose long-term revenue risks.
• Total global sales projected to rise moderately, reaching about USD 1.2 billion in five years.
• Investors and manufacturers should monitor regulatory trends, patent timelines, and evolving treatment guidelines.

FAQs

1. What are the main indications for ivabradine?
Chronic heart failure with reduced ejection fraction and certain angina types.

2. When is patent expiry expected for ivabradine?
Around 2025 in the US and Europe.

3. What are the major competitors?
Beta-blockers, ranolazine, and other antianginal agents.

4. How does pricing impact ivabradine’s market?
Price sensitivity and reimbursement policies influence sales, particularly in Europe.

5. Are there new indications in development?
Yes, ongoing trials explore uses in inappropriate sinus tachycardia and other conditions.

References

[1] Novartis. (2022). Annual Report 2022. Retrieved from https://www.novartis.com
[2] Global Data. (2023). Cardiovascular Drugs Market Analysis.
[3] European Medicines Agency. (2020). Label update for ivabradine in pediatric patients.
[4] IQVIA. (2022). Pharmaceutical Market Data.
[5] PharmTech. (2023). Patent expiry calendar for cardiovascular drugs.