Ivabradine hydrochloride - Generic Drug Details

What are the generic drug sources for ivabradine hydrochloride and what is the scope of patent protection?

Ivabradine hydrochloride is the generic ingredient in two branded drugs marketed by Amgen Inc, Alembic, Annora Pharma, Bionpharma, Ingenus Pharms Llc, and Zydus Pharms, and is included in six NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ivabradine hydrochloride has ninety-seven patent family members in forty-two countries.

There are eight drug master file entries for ivabradine hydrochloride. Nine suppliers are listed for this compound.

Summary for ivabradine hydrochloride

International Patents:	97
US Patents:	4
Tradenames:	2
Applicants:	6
NDAs:	6
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	80
Patent Applications:	384
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ivabradine hydrochloride
DailyMed Link:	ivabradine hydrochloride at DailyMed

Recent Clinical Trials for ivabradine hydrochloride

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 hydrochloride clinical trials

Pharmacology for ivabradine hydrochloride

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 hydrochloride

C01EB	Other cardiac preparations
C01E	OTHER CARDIAC PREPARATIONS
C01	CARDIAC THERAPY
C	Cardiovascular system

Paragraph IV (Patent) Challenges for IVABRADINE HYDROCHLORIDE

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 ivabradine hydrochloride

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	213366-002	Oct 5, 2022	AB	RX	No	No
Amgen Inc	CORLANOR	ivabradine hydrochloride	TABLET;ORAL	206143-001	Apr 15, 2015	AB	RX	Yes	No	7,867,996*PED				Y
Zydus Pharms	IVABRADINE HYDROCHLORIDE	ivabradine hydrochloride	TABLET;ORAL	213442-002	Nov 29, 2023	AB	RX	No	No
Amgen Inc	CORLANOR	ivabradine hydrochloride	TABLET;ORAL	206143-002	Apr 15, 2015	AB	RX	Yes	Yes	7,867,996*PED				Y
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	7,361,650*PED				Y
Amgen Inc	CORLANOR	ivabradine hydrochloride	TABLET;ORAL	206143-001	Apr 15, 2015	AB	RX	Yes	No	7,361,649*PED				Y

International Patents for ivabradine hydrochloride

Country	Patent Number	Title	Estimated Expiration
South Korea	20060095501	beta;-CRYSTALLINE FORM OF IVABRADINE HYDROCHLORIDE, A PROCESS FOR ITS PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING IT
Japan	2006241154	beta-CRYSTAL FORM OF IVABRADINE HYDROCHLORIDE, METHOD FOR PRODUCING THE SAME AND MEDICINAL COMPOSITION CONTAINING THE SAME
China	100402502
Cuba	20060039	FORMA CRISTALINA BETA DEL CLORHIDRATO DE LA IVABRADINA, SU PROCEDIMIENTO DE PREPARACIÓN Y LAS COMPOSICIONES FARMACÉUTICAS QUE LA CONTIENEN
Germany	602006001312
Hong Kong	1096659	Crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
African Regional IP Organization (ARIPO)	1956	y-Crystalline form of Ivabradine Hydrochloride, a process for its preperation and pharmaceutical compositions containing it

Market Dynamics and Financial Trajectory of Ivabradine Hydrochloride

Introduction

Ivabradine hydrochloride, a medication primarily used to treat certain heart conditions such as angina pectoris and heart failure, has been experiencing significant growth in the pharmaceutical market. This article delves into the market dynamics, financial trajectory, and key factors influencing the ivabradine hydrochloride market.

Market Size and Growth Projections

The ivabradine hydrochloride market has seen substantial growth in recent years and is expected to continue this trend. By 2031, the market is anticipated to reach a value of several billion USD, up from its current valuation. This growth is driven by the increasing incidence of cardiovascular diseases globally[1][4].

Segmentation of the Market

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

By Type

The market is categorized into two main types: 5mg/tablet and 7.5mg/tablet. These different dosages cater to various patient needs and are prescribed based on the severity of the heart condition[1].

By Application

The primary applications include hospitals, retail pharmacies, clinics, and other healthcare settings. The demand from these segments is driven by the need for effective heart rate regulation therapies[1].

By Geography

The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East & Africa. Each region presents unique market dynamics influenced by local healthcare policies, patient demographics, and economic factors[1].

Drivers of Market Growth

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

Increasing Incidence of Cardiovascular Diseases

The global rise in cardiovascular disorders, such as angina pectoris and heart failure, has significantly increased the demand for ivabradine hydrochloride. This trend is expected to continue as the global population ages[4].

Demographic Changes

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

Clinical Efficacy and Recommendations

Strong clinical data demonstrating the efficacy of ivabradine hydrochloride in reducing cardiovascular mortality and hospitalizations has led to increased prescriptions and patient preference. Clinical recommendations and inclusion in comprehensive heart failure care methods further boost its acceptance[2][4].

Cost-Effectiveness

Ivabradine hydrochloride is considered cost-effective compared to other treatments like sacubitril-valsartan. The cost-utility analysis shows that ivabradine offers a reasonable incremental cost-utility ratio, making it a favorable option for healthcare providers[2].

Market Restraints and Challenges

Despite the growth, there are several challenges and restraints:

Adverse Events

While ivabradine hydrochloride has a favorable safety profile, it can cause adverse events such as bradycardia, atrial fibrillation, and visual abnormalities. These side effects can impact patient compliance and overall market growth[2].

Regulatory Approvals

The market is heavily influenced by regulatory approvals and drug coverage decisions. For instance, the Drug Benefit Council's recommendation for limited coverage can affect market access and penetration[2].

Competitive Landscape

The ivabradine hydrochloride market is characterized by a competitive landscape with several key players:

Major Players

Companies such as 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 are prominent in the market. These companies are involved in manufacturing and distributing ivabradine hydrochloride tablets globally[1][4].

Financial Trajectory

The financial trajectory of the ivabradine hydrochloride market is positive, with projected growth rates indicating a robust expansion from 2023 to 2031.

Revenue Forecast

The market is expected to grow from its current value to several billion USD by 2031, with a significant compound annual growth rate (CAGR) during the forecast period[1][4].

Pricing Analysis

The pricing of ivabradine hydrochloride tablets is a critical factor. The cost-effectiveness of the drug, especially when compared to other heart failure treatments, contributes to its market appeal. The incremental cost-utility ratio of ivabradine hydrochloride is estimated to be around $12,895 per quality-adjusted life-year (QALY), making it a viable option for healthcare providers[2].

Market Outlook and Trends

The market outlook for ivabradine hydrochloride is optimistic, driven by several trends:

Improvements in Heart Failure Treatment

Advancements in the treatment of heart failure have increased the need for drugs like ivabradine hydrochloride. Its inclusion in comprehensive heart failure care methods has propelled the market's overall development[4].

Pharmacological Characteristics

Ivabradine hydrochloride's unique ability to reduce heart rate without altering other cardiovascular parameters makes it a preferred therapeutic choice. This pharmacological characteristic is a significant driver of the market[4].

Patient and Healthcare Provider Preferences

Clinical recommendations and patient input have highlighted the benefits of ivabradine hydrochloride. Patients who have tried the drug report improved symptoms and exercise tolerance, further boosting its market acceptance[2].

Conclusion

The ivabradine hydrochloride market is poised for significant growth, driven by the increasing incidence of cardiovascular diseases, demographic changes, and strong clinical efficacy data. Despite some challenges, the market's financial trajectory is robust, with a projected increase in revenue and a favorable competitive landscape.

Key Takeaways

• The ivabradine hydrochloride market is expected to grow substantially from 2023 to 2031.
• The market is driven by the increasing incidence of cardiovascular diseases and demographic changes.
• Clinical efficacy and cost-effectiveness are key factors boosting market growth.
• Major players include Les Laboratoires Servier, Shandong New Time Pharmaceutical Co., Ltd., and others.
• The market faces challenges such as adverse events and regulatory approvals.

FAQs

What is ivabradine hydrochloride used for?

Ivabradine hydrochloride is used to treat certain heart conditions, including angina pectoris and heart failure, by reducing heart rate.

What are the key drivers of the ivabradine hydrochloride market?

The key drivers include the increasing incidence of cardiovascular diseases, demographic changes, clinical efficacy, and cost-effectiveness.

Who are the major players in the ivabradine hydrochloride market?

Major players 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.

What are the common side effects of ivabradine hydrochloride?

Common side effects include bradycardia, atrial fibrillation, and visual abnormalities such as phosphenes.

How does ivabradine hydrochloride compare to other heart failure treatments in terms of cost-effectiveness?

Ivabradine hydrochloride is considered cost-effective, with an estimated incremental cost-utility ratio of $12,895 per quality-adjusted life-year (QALY), making it a favorable option compared to other treatments like sacubitril-valsartan.

Sources

1. Market Research Intellect: Ivabradine Hydrochloride Market Size, Scope And Forecast Report.
2. Government of British Columbia: Ivabradine (Lancora) DDS.
3. Market Research Intellect: Isoxazoline Drugs Market.
4. Valuates Reports: Global Ivabradine Hydrochloride Tablets Market Research Report 2024.
5. Frontiers in Pharmacology: Long-Term Effects of Ivabradine on Cardiac Vagal Parasympathetic Modulation in Healthy Rats.