Ivabradine - Generic Drug Details

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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.

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
Bionpharma	IVABRADINE HYDROCHLORIDE	ivabradine hydrochloride	TABLET;ORAL	213276-002	Sep 5, 2024	AB	RX	No	No
Amgen Inc	CORLANOR	ivabradine hydrochloride	TABLET;ORAL	206143-001	Apr 15, 2015		DISCN	Yes	No					Y
Annora Pharma	IVABRADINE HYDROCHLORIDE	ivabradine hydrochloride	TABLET;ORAL	213366-001	Oct 5, 2022	AB	RX	No	No
Ingenus Pharms Llc	IVABRADINE HYDROCHLORIDE	ivabradine hydrochloride	TABLET;ORAL	214051-002	Dec 30, 2021	AB	RX	No	Yes
Amgen Inc	CORLANOR	ivabradine	SOLUTION;ORAL	209964-001	Apr 22, 2019		DISCN	Yes	No			Y	Y

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
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 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
African Regional IP Organization (ARIPO)	1907	Beta-crystalline form of ivabradine hydrochloride,a process for its preparation and pharmaceutical compositions containing it
Argentina	053147	FORMA CRISTALINA DEL CLORHIDRATO DE IVABRADINA, UN PROCEDIMIENTO PARA SU PREPARACION Y COMPOSICIONES FARMACEUTICAS QUE LA CONTIENEN
Austria	E407926
Australia	2006200856	beta-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
Brazil	PI0600623	forma beta-cristalina de cloridrato de ivabradina, processo para preparação do mesmo e composições farmacêuticas contendo o mesmo

Ivabradine Market Dynamics, Patent Exposure, Generic Competition, and Financial Trajectory

Last updated: November 3, 2026

Ivabradine is a mature cardiovascular medicine with declining branded exclusivity, broad international generic availability, and continuing clinical relevance in heart failure and selected tachycardia indications. Servier owns the originator franchise outside the United States under Procoralan and related brands. Amgen commercialized Corlanor in the United States under a collaboration with Servier. The commercial opportunity has shifted from premium branded growth to volume retention, geographic expansion, and lifecycle management.

Public company filings do not separately disclose global ivabradine revenue. Financial analysis therefore depends on company-level reporting, prescription data, regulatory milestones, and the timing of generic entry.

What is ivabradine and how is the drug used?

Ivabradine is an oral selective inhibitor of the cardiac funny-current, or If current, in the sinoatrial node. It lowers heart rate without the negative inotropic effects associated with many beta blockers and calcium-channel blockers.

Attribute	Ivabradine
Active ingredient	Ivabradine hydrochloride
Originator brands	Procoralan, Corlanor, Corlentor and regional brands
Primary developers	Servier; Amgen for U.S. commercialization
U.S. approval	April 2015
U.S. indication	Stable symptomatic chronic heart failure with reduced ejection fraction in specified patients
Pediatric use	FDA approval includes selected patients from 6 months of age
Dosage forms	Immediate-release tablets; oral solution in selected markets
Typical strengths	5 mg and 7.5 mg tablets
Main therapeutic target	Heart-rate reduction in sinus rhythm
Key commercial markets	United States, Europe, China, India, Latin America and selected emerging markets

The U.S. label covers patients with stable symptomatic chronic heart failure, left ventricular ejection fraction of 35% or less, sinus rhythm, and resting heart rate of at least 70 beats per minute who are receiving maximally tolerated beta-blocker therapy or have a contraindication to beta-blockers. The label also covers certain pediatric heart-failure patients with dilated cardiomyopathy.[1]

European use is broader in commercial terms. Procoralan has been used for chronic stable angina and chronic heart failure, subject to national and European labeling requirements.[2]

How large is the ivabradine market?

Ivabradine is a global multi-source market, but its value is concentrated in a smaller number of branded markets and higher-income cardiovascular systems.

The market has four structural characteristics:

1. The addressable patient population is large because chronic heart failure and coronary artery disease are prevalent.
2. The eligible ivabradine population is narrower because treatment generally requires sinus rhythm, elevated heart rate, and specific clinical circumstances.
3. Generic competition has reduced unit prices in Europe and other mature markets.
4. Demand remains durable because heart failure treatment is chronic and ivabradine occupies a defined treatment niche.

The U.S. market is commercially important because Corlanor carries a higher price than many international generic products. Its growth was supported by the 2015 FDA approval and by pediatric labeling. European markets have greater prescription volume but lower average selling prices after generic entry.

What drives demand for ivabradine?

Demand is determined by:

• Heart-failure prevalence and diagnosis rates.
• Use of guideline-directed medical therapy.
• The number of patients unable to tolerate target beta-blocker doses.
• The prevalence of sinus rhythm among heart-failure patients.
• Physician preference for heart-rate reduction without additional blood-pressure reduction.
• Pediatric cardiology adoption.
• Reimbursement rules and generic substitution.
• Availability of competing therapies, especially beta blockers and newer heart-failure drugs.

Ivabradine is not a broad replacement for beta blockers. It is generally used as an add-on or alternative option in a narrower clinical population.

What is the financial trajectory for ivabradine?

Ivabradine has moved from an originator-growth product to a mature, partly genericized franchise.

Servier financial exposure

Servier reports total group revenue and therapeutic-area performance but does not publish a consistent standalone revenue line for Procoralan. The company reported total revenue of approximately €5.4 billion for fiscal 2023-2024, with cardiovascular and immuno-inflammatory medicines among its major therapeutic areas.[3]

Ivabradine remains strategically relevant to Servier because:

• The product has global brand recognition.
• It has long-term chronic-use demand.
• Regulatory approvals cover multiple age groups and markets.
• It can be manufactured and distributed through established cardiovascular channels.
• It provides cash generation after the recovery of development and launch costs.

Its financial trajectory is likely characterized by lower price and volume pressure in Europe, stable or declining branded demand in mature markets, and continued contribution from emerging markets where branded products retain greater share.

Amgen financial exposure

Amgen commercialized Corlanor in the United States through its agreement with Servier. Amgen's annual reports disclose company-wide revenue but do not consistently provide a standalone Corlanor revenue figure in recent reporting periods.[4]

Corlanor is economically smaller than Amgen's major products, including oncology, inflammation, bone-health and cardiovascular franchises. The drug remains relevant as a recurring-product asset but is unlikely to materially influence Amgen's consolidated growth rate.

The main U.S. financial risks are:

• Generic entry after loss of core patent protection.
• Reimbursement pressure from commercial and government payers.
• Higher patient copay exposure.
• Limited indication expansion.
• Substitution by broader heart-failure regimens.

Financial trajectory by phase

Period	Commercial position	Financial effect
2005-2014	European originator expansion	Premium pricing and indication development
2015-2019	U.S. launch and adoption	Higher global visibility and branded revenue growth
2020-2022	Mature branded product	Slower growth and increasing price pressure
2023 onward	Genericized or patent-exposed market	Lower average selling prices and share erosion
Long term	Established chronic cardiovascular medicine	Volume-based revenue with regional brand persistence

No reliable public source supports a standalone global revenue estimate for ivabradine across all manufacturers. Market-value estimates that combine branded sales, generic sales, hospital purchasing and retail prescriptions should be treated cautiously because reporting conventions differ by country.

When does ivabradine lose exclusivity?

Ivabradine's exclusivity has already eroded in several major markets. The exact timing differs by jurisdiction because patent terms, supplementary protection certificates, regulatory exclusivities and settlement agreements are country-specific.

United States

Corlanor received FDA approval in 2015. FDA regulatory exclusivity protected the approved product during the initial post-approval period, while patent protection controlled the longer commercial exclusivity period.[1]

The U.S. risk profile includes:

• Expiration or invalidation of composition and formulation patents.
• Paragraph IV certifications against Orange Book-listed patents.
• Potential 30-month stays following patent litigation.
• Pediatric exclusivity attached to qualifying labeling, where applicable.
• Generic approval based on bioequivalence to the tablet dosage form.

The commercial effect of U.S. generic entry depends on whether an approved generic launches at risk, enters under a settlement date, or waits until all relevant patent barriers expire.

Europe

European exclusivity has eroded earlier than in the United States in many countries. National generic launches are governed by local implementation of European pharmaceutical law, national reimbursement systems and country-specific patent or SPC outcomes.

Because generic substitution is stronger in many European systems, price erosion can be rapid even when the originator retains meaningful prescription volume.

Emerging markets

India, China, Latin America and other emerging markets have a mixed structure. Local ivabradine products may be available under national brands, while Servier retains physician recognition and distribution advantages. Price competition is generally stronger, but local manufacturing and registration requirements can limit immediate market fragmentation.

What patents protect ivabradine products?

Ivabradine protection has historically included several layers:

Protection layer	Commercial purpose	Current risk
Active-ingredient or composition patents	Protect the molecule and pharmaceutical salts	Generally expired or heavily exposed in major markets
Formulation patents	Protect tablet composition, release characteristics or stability	Narrower scope and easier design-around risk
Method-of-use patents	Protect treatment of heart failure, angina or specified patient groups	Vulnerable to skinny-label or non-infringing use strategies
Pediatric exclusivity	Protects qualifying pediatric labeling for a limited period	Temporary regulatory protection
Manufacturing patents	Protect synthesis, intermediates or process controls	Relevant mainly to supply and cost structure

The strongest historical barrier was the core active-ingredient protection. Once that layer weakened, formulation and method-of-use claims became less effective at preventing competition because generic applicants can often pursue a narrower label or design around nonessential formulation elements.

Patent strength is therefore moderate to weak as a barrier to broad generic substitution. It is stronger for particular dosage forms, pediatric uses or manufacturing routes where claim scope remains enforceable.

What is the Orange Book status of Corlanor?

Corlanor is an FDA-approved ivabradine product with Orange Book-listed patent exposure determined by the patents submitted by the reference-product sponsor and accepted for listing by FDA.[5]

Orange Book risk analysis should distinguish:

• Patent expiry from regulatory exclusivity.
• Listed patents from enforceable patent claims.
• Tablet approval from oral-solution approval.
• Product-level patents from method-of-use claims.
• A Paragraph IV challenge from an actual commercial launch.

A generic applicant may file an abbreviated new drug application with Paragraph IV certifications alleging that listed patents are invalid, unenforceable or not infringed. The reference sponsor can file litigation within the statutory period, potentially triggering a 30-month stay under the Hatch-Waxman framework.[6]

The existence of a Paragraph IV filing does not establish that generic entry will occur on the filing date. Litigation outcome, settlement terms and regulatory approval timing control the actual launch risk.

Which companies are challenging or competing with ivabradine?

Competition comes from both generic ivabradine manufacturers and therapeutic substitutes.

Generic manufacturers

Generic competition is fragmented by country. Companies that have marketed or sought approval for ivabradine products include regional and multinational manufacturers such as:

• Teva and other European generic suppliers.
• Zydus Lifesciences and other Indian manufacturers.
• National generic companies in China and Latin America.
• Local manufacturers operating under country-specific cardiovascular brands.

The competitive set changes by jurisdiction and should not be treated as a single global list.

Therapeutic competitors

Competitor class	Examples	Competitive effect
Beta blockers	Carvedilol, metoprolol, bisoprolol	First-line heart-rate and heart-failure therapy
ARNI therapy	Sacubitril/valsartan	Reduces hospitalization and mortality in selected HFrEF patients
SGLT2 inhibitors	Dapagliflozin, empagliflozin	Broad heart-failure benefits across ejection-fraction categories
Digoxin	Generic digoxin	Low-cost rate and symptom control in selected patients
Cardiac devices	ICDs, CRT devices	Address structural and rhythm-related risk
Ablation procedures	Catheter ablation	Competes in selected tachyarrhythmia populations

Ivabradine's clinical differentiation is heart-rate reduction without direct reduction of myocardial contractility. Its commercial limitation is the need for a narrower patient phenotype.

What generic entry risks exist for Corlanor?

The principal generic-entry risks are price erosion, formulary substitution and loss of brand loyalty.

Base-case scenario

The base case is a gradual decline in branded volume as payers require generic substitution. Corlanor retains a share among physicians who prefer the branded product, pediatric specialists, and patients with stable reimbursement coverage.

Accelerated-entry scenario

An accelerated scenario occurs if a generic manufacturer launches after a successful Paragraph IV challenge or a settlement that permits early entry. Brand sales could fall sharply because tablet ivabradine is relatively simple to manufacture and does not require a complex delivery device.

Delayed-entry scenario

A delayed scenario occurs if listed patents withstand challenge, litigation extends beyond the expected expiry period, or a generic applicant receives approval but remains subject to a settlement restriction.

The main manufacturing barrier is modest. Ivabradine is a small-molecule oral product, not a biologic or complex injectable. Manufacturing know-how, API sourcing, stability validation and regulatory compliance matter, but they do not create the same barrier as monoclonal-antibody production or device-integrated delivery systems.

How does ivabradine compare with competing heart-failure drugs?

Ivabradine has a narrower indication but a lower development and manufacturing burden than newer specialty cardiovascular therapies.

Factor	Ivabradine	Sacubitril/valsartan	SGLT2 inhibitors
Primary value proposition	Heart-rate reduction	Neurohormonal modulation	Broad heart-failure outcome benefits
Patient selection	Narrow	Broader HFrEF use	Broad across EF categories
Generic exposure	High	Increasing after patent expiry	Varies by product and market
Manufacturing complexity	Low	Low to moderate	Low
Pricing power	Limited	Historically higher	Historically higher
Growth outlook	Mature or declining	Mature with generic pressure	Stronger historical expansion
Commercial differentiation	Physiologic niche	Outcome and guideline position	Broad outcome evidence

Ivabradine remains clinically useful, but its commercial growth prospects are weaker than those of drugs with broad heart-failure indications and stronger mortality or hospitalization data.

What litigation and settlement issues affect ivabradine?

Ivabradine litigation risk is concentrated in the United States and relates primarily to Hatch-Waxman patent challenges. Relevant legal questions include:

• Whether the generic label induces infringement of method-of-use claims.
• Whether formulation claims cover the approved generic product.
• Whether a patent is valid after prior-art review.
• Whether a settlement permits a fixed generic-entry date.
• Whether pediatric labeling creates a separate commercial barrier.
• Whether an authorized generic is launched after settlement.

Publicly reported litigation and settlement terms should be evaluated patent by patent. A generic applicant may obtain approval while remaining contractually barred from launch. Conversely, a patent may remain listed while offering limited practical protection if its claims are narrow or vulnerable.

What is the regulatory outlook for ivabradine?

The regulatory outlook is stable rather than expansionary.

Key regulatory dynamics are:

• Continued generic approvals for tablets.
• Potential competition in oral solution or pediatric formulations.
• Label maintenance for heart failure and pediatric use.
• Pharmacovigilance involving bradycardia, atrial fibrillation, visual phenomena and conduction effects.
• Reimbursement scrutiny for branded products.
• Country-level substitution policies.

FDA and EMA labeling emphasize contraindications and monitoring for bradycardia, conduction abnormalities and atrial fibrillation.[1,2] Regulatory risk is lower than for a newly approved drug because the safety profile is established, but the narrow therapeutic window for heart-rate reduction limits broad off-label expansion.

What is the investment outlook for ivabradine?

Ivabradine is a cash-generation and portfolio-defense asset rather than a high-growth pharmaceutical franchise.

The principal investment conclusions are:

• Revenue is likely to decline in markets with active generic substitution.
• Brand value persists where Servier or Amgen controls reimbursement access and physician familiarity.
• U.S. revenue exposure is more financially visible than European revenue because branded pricing is higher.
• The molecule has low manufacturing complexity and limited supply-chain defensibility.
• Patent protection is less important than formulary position, contracting and distribution.
• Pediatric and oral-solution niches may preserve higher margins than standard adult tablets.
• The product has limited upside without new outcomes data, expanded indications or a differentiated formulation.

Key Takeaways

• Ivabradine is a mature, globally marketed cardiovascular drug with durable but narrow clinical demand.
• Servier retains the core originator franchise outside the United States; Amgen commercialized Corlanor in the United States.
• Neither company consistently reports standalone global ivabradine revenue.
• Generic exposure is the central commercial risk, particularly for standard-strength tablets.
• Patent protection has shifted from broad molecule-level exclusivity toward narrower formulation, method-of-use and jurisdiction-specific rights.
• The U.S. market has greater branded pricing potential, while Europe has greater generic substitution pressure.
• Ivabradine's long-term value is volume-based and regional, not driven by broad market expansion.
• The strongest competitive threats are generic ivabradine, beta blockers, SGLT2 inhibitors and sacubitril/valsartan.

FAQs

Is ivabradine still under patent protection?

Patent protection is jurisdiction-specific and has substantially weakened in major markets. Remaining rights may cover formulations, methods of use or pediatric applications rather than the broad active ingredient.

Does ivabradine have biosimilar competition?

No. Ivabradine is a small-molecule drug, so competition comes through generic-drug pathways rather than biosimilar approval pathways.

Can generic ivabradine use the same heart-failure indication?

A generic applicant may seek approval for all or part of the reference product's labeling. Patent-protected methods of use can lead to a narrower label or a so-called skinny-label strategy.

Which company owns Corlanor?

Amgen commercialized Corlanor in the United States under an agreement with Servier. Servier developed ivabradine and markets Procoralan and related brands internationally.

Is ivabradine a growth drug for pharmaceutical investors?

Generally no. It is better classified as a mature cardiovascular cash-flow product with regional brand value, generic-entry risk and limited standalone growth potential.

References

1. U.S. Food and Drug Administration. (2024). Corlanor (ivabradine) prescribing information.
2. European Medicines Agency. (2024). Procoralan: European public assessment report and product information.
3. Servier. (2024). Annual report 2023-2024.
4. Amgen Inc. (2024). 2023 annual report and Form 10-K.
5. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations.
6. U.S. Congress. (1984). Drug Price Competition and Patent Term Restoration Act of 1984, 21 U.S.C. § 355.