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, Annora Pharma, Bionpharma, Ingenus Pharms Llc, and Zydus Pharms, and is included in six 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:	5
NDAs:	6
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	45
Clinical Trials:	80
Patent Applications:	1,574
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ivabradine

Constraining patent/regulatory exclusivity:

7,867,996

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 ivabradine

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

Sponsor	Phase
Second Affiliated Hospital of Guangzhou Medical University	Phase 4
Uniformed Services University of the Health Sciences	Phase 4
The Young Investigator Group of Cardiovascular Research	Phase 3

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
Annora Pharma	IVABRADINE HYDROCHLORIDE	ivabradine hydrochloride	TABLET;ORAL	213366-001	Oct 5, 2022	AB	RX	No	No
Amgen Inc	CORLANOR	ivabradine hydrochloride	TABLET;ORAL	206143-002	Apr 15, 2015	AB	RX	Yes	Yes	7,361,649*PED				Y
Amgen Inc	CORLANOR	ivabradine	SOLUTION;ORAL	209964-001	Apr 22, 2019		RX	Yes	Yes	7,879,842		Y	Y
Zydus Pharms	IVABRADINE HYDROCHLORIDE	ivabradine hydrochloride	TABLET;ORAL	213442-001	Nov 29, 2023	AB	RX	No	No
Amgen Inc	CORLANOR	ivabradine hydrochloride	TABLET;ORAL	206143-002	Apr 15, 2015	AB	RX	Yes	Yes	7,361,650*PED				Y
Bionpharma	IVABRADINE HYDROCHLORIDE	ivabradine hydrochloride	TABLET;ORAL	213276-002	Sep 5, 2024	AB	RX	No	No

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/004241 Symptomatic 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/004117 Symptomatic 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/000598 Symptomatic 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/000597 Symptomatic 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/004187 Symptomatic 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
JensonR+ Limited	Ivabradine JensonR	ivabradine	EMEA/H/C/004217 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 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.,	Withdrawn	yes	no	no	2016-11-11

International Patents for ivabradine

Country	Patent Number	Title	Estimated Expiration
Germany	602006002624
Slovenia	1707562
Montenegro	02747	KRISTALNI OBLIK GAMA IVABRADIN HLORHIDRATA, POSTUPAK NJEGOVE IZRADE I FARMACEUTSKE SMEŠE KOJE GA SADRŽE (CRYSTALLINE FORM GAMMA OF THE CHLORHYDRATE OF IVABRADINE, PROCESS FOR ITS PREPARATION AND PHARAMCETUICAL COMPOSITION CONTAINING IT)
Germany	602006001312
China	1827602	Crystalline form gamma of the chlorhydrate of ivabradine, process for its preparation and phamaceutical composition containing it
Saudi Arabia	06270040	الصورة المتبلرة - γ لهيدروكلوريد إيڤابرادين، وعملية لتحضيرها، وتركيبات صيدلانية تحتوي عليها، (γ -Crystalline Form of Ivabradine Hydrochloride, a Process for its Preparation and Pharmaceutical Compositions Containing It)

Ivabradine Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Ivabradine

Introduction to Ivabradine

Ivabradine is a heart rate reducer that works by inhibiting the If current in the sinoatrial node, making it a crucial therapeutic option for patients with certain cardiovascular conditions, such as heart failure and angina pectoris. Here, we delve into the market dynamics and financial trajectory of ivabradine, highlighting its current status, growth drivers, and future projections.

Market Size and Growth Projections

The ivabradine hydrochloride market has experienced significant growth in recent years and is anticipated to continue this trend. By 2023, the market had reached a substantial value, and it is projected to attain even higher values by 2031, driven by increasing demand for effective cardiovascular treatments[1][4].

Segmentation of the Market

The ivabradine hydrochloride market is segmented based on several key factors:

• Type: The market is categorized into 5mg/tablet and 7.5mg/tablet formulations.
• Application: The primary applications include hospitals, retail pharmacies, clinics, and other healthcare settings.
• Geography: The market is analyzed across regions such as North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa[1][4].

Growth Drivers

Several factors are driving the growth of the ivabradine hydrochloride market:

Increasing Prevalence of Cardiovascular Diseases

The global incidence of cardiovascular disorders, including heart failure and angina pectoris, is on the rise. This has led to a higher demand for effective treatments like ivabradine hydrochloride[4].

Demographic Changes

Global population aging is a significant driver, as cardiovascular diseases are often exacerbated by aging. The growing number of elderly individuals has increased the need for drugs like ivabradine[4].

Clinical Efficacy and Recommendations

Strong clinical data demonstrating the efficacy of ivabradine in alleviating symptoms, improving exercise tolerance, and reducing hospitalization rates for cardiovascular diseases have contributed to its market expansion. Clinical recommendations and inclusion in comprehensive heart failure care methods further boost its acceptance[4][5].

Market Dynamics: Drivers, Restraints, Opportunities, and Challenges

Drivers

• Effective Heart Rate Control: Ivabradine's unique pharmacological characteristics, which reduce heart rate without altering other cardiovascular parameters, make it a preferred choice for heart rate modulation[5].
• Advancements in Heart Failure Treatments: Improvements in heart failure treatments and the inclusion of ivabradine in these treatment protocols have increased its demand[4].

Restraints

• Side Effects and Safety Concerns: While ivabradine has shown significant benefits, it can cause side effects such as atrial fibrillation and must be used cautiously, which can act as a restraint[2].
• Regulatory Approvals: The need for continuous regulatory approvals and monitoring can slow down market growth.

Opportunities

• Expanding Indications: Potential expansion of indications for ivabradine, such as its use in postural orthostatic tachycardia syndrome and inappropriate sinus tachycardia, offers new market opportunities[2].
• Emerging Markets: Growing healthcare needs in emerging economies present opportunities for market expansion.

Challenges

• Competitive Landscape: The heart failure drugs market is highly competitive, with other drugs like empagliflozin gaining approvals and market share[3].
• Economic Factors: Economic fluctuations and healthcare budget constraints can impact market growth.

Financial Trajectory

Revenue Forecast

The ivabradine hydrochloride market is expected to see robust revenue growth from 2023 to 2031. The market size is projected to increase significantly, driven by the factors mentioned above[1][4].

Key Players

Prominent companies in the ivabradine hydrochloride market include Les Laboratoires Servier, Shandong New Time Pharmaceutical Co. Ltd., Chongqing Southwest NO.2 Pharmaceutical FACTORY Co. Ltd., Beijing Baiao Pharmaceuticals Co. Ltd., and Cadiasun Pharma GmbH. These companies play a crucial role in the production, distribution, and marketing of ivabradine hydrochloride tablets[1][4].

Regional Analysis

The market is geographically diverse, with significant growth anticipated in regions such as Europe and Asia-Pacific. Europe, in particular, is expected to register a robust market CAGR due to advancements in heart failure treatments and favorable regulatory environments[1][3].

Competitive Landscape

The heart failure drugs market, which includes ivabradine, is highly competitive. Other drugs, such as empagliflozin, have gained significant market share due to their efficacy and expanded indications. The competitive landscape is characterized by ongoing research, new product developments, and strategic partnerships among pharmaceutical companies[3].

Clinical Implications and Market Impact

Ivabradine's clinical implications are significant, particularly in heart failure with reduced ejection fraction. The SHIFT trial and other studies have demonstrated its efficacy in reducing mortality and morbidity by optimizing heart rate control and allowing for the up-titration of other heart failure medications[5].

"Ivabradine, when compared to a placebo, yielded a notable increase in freedom from death or heart-failure recurrence among patients with HFrEF," as highlighted in the SHIFT trial[5].

Key Takeaways

• Growing Demand: The ivabradine hydrochloride market is driven by the increasing prevalence of cardiovascular diseases and demographic changes.
• Clinical Efficacy: Strong clinical data supports the use of ivabradine, contributing to its market expansion.
• Geographical Growth: Europe and Asia-Pacific are expected to be key regions for market growth.
• Competitive Landscape: The market is competitive, with other heart failure drugs also gaining traction.
• Financial Projections: The market is anticipated to see significant revenue growth from 2023 to 2031.

FAQs

What is the primary mechanism of action of ivabradine?

Ivabradine works by inhibiting the If current in the sinoatrial node, reducing heart rate without altering other cardiovascular parameters[5].

Which regions are expected to drive the growth of the ivabradine hydrochloride market?

Europe and Asia-Pacific are anticipated to be key regions driving the growth of the ivabradine hydrochloride market[1][3].

What are the main applications of ivabradine hydrochloride?

The main applications include hospitals, retail pharmacies, clinics, and other healthcare settings[1].

How does ivabradine impact heart failure patients?

Ivabradine improves clinical outcomes in heart failure patients by optimizing heart rate control, allowing for the up-titration of other heart failure medications, and reducing mortality and morbidity[5].

What are the potential side effects of ivabradine?

Ivabradine can cause side effects such as atrial fibrillation and must be used cautiously, especially in patients with certain heart conditions[2].

Sources

1. Market Research Intellect, "Ivabradine Hydrochloride Market Size, Scope And Forecast Report," December 2024.
2. Frontiers in Pharmacology, "Long-Term Effects of Ivabradine on Cardiac Vagal Parasympathetic Modulation in Healthy Rats," April 8, 2021.
3. Emergen Research, "Heart Failure Drugs Market Size, Trend, Demand Analysis Till 2032."
4. Valuates Reports, "Ivabradine Hydrochloride Tablets Market Research Report 2024."
5. MDPI, "Clinical Implications of Ivabradine in the Contemporary Era," 2023.