IVABRADINE HYDROCHLORIDE - Generic Drug Details

What are the generic 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, MSN, and Zydus Pharms, and is included in seven 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. Eleven suppliers are listed for this compound.

Summary for IVABRADINE HYDROCHLORIDE

International Patents:	97
US Patents:	4
Tradenames:	2
Applicants:	7
NDAs:	7
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	88
Patent Applications:	425
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
The University of Hong Kong	PHASE4
Post Graduate Institute of Medical Education and Research, Chandigarh	NA
Indian Council of Medical Research	NA

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
Bionpharma	IVABRADINE HYDROCHLORIDE	ivabradine hydrochloride	TABLET;ORAL	213276-001	Sep 5, 2024	AB	RX	No	No
Ingenus Pharms Llc	IVABRADINE HYDROCHLORIDE	ivabradine hydrochloride	TABLET;ORAL	214051-001	Dec 30, 2021	AB	RX	No	No
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					Y
Amgen Inc	CORLANOR	ivabradine hydrochloride	TABLET;ORAL	206143-001	Apr 15, 2015	AB	RX	Yes	No					Y
Msn	IVABRADINE HYDROCHLORIDE	ivabradine hydrochloride	TABLET;ORAL	213483-002	Apr 28, 2025	AB	RX	No	No

International Patents for IVABRADINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Canada	2537400	FORME CRISTALLINE Y DU CHLORHYDRATE DE L'IVABRADINE, SON PROCEDE DE PREPARATION, ET LES COMPOSITIONS PHARMACEUTIQUES QUI LA CONTIENNENT (Y CRYSTALLINE FORM OF IVABRADINE CHLORHYDRATE, PROCESS FOR THE PREPARATION THEREOF AND PHARMACEUTICAL COMPOUNDS CONTAINING IT)
Brazil	PI0600796	forma gama-cristalina de cloridrato de ivabradina, processo para preparação do mesmo e composições farmacêuticas contendo o mesmo
Cuba	23614	FORMA CRISTALINA BETA DEL CLORHIDRATO DE LA IVABRADINA, SU PROCEDIMIENTO DE PREPARACIÓN Y LAS COMPOSICIONES FARMACÉUTICAS QUE LA CONTIENEN
Argentina	052926	FORMA CRISTALINA GAMA DEL CLORHIDRATO DE IVABRADINA, UN PROCEDIMIENTO PARA SU PREPARACION Y COMPOSICIONES QUE LA CONTIENEN
Germany	602006002624
Cyprus	1109010

Market Dynamics and Financial Trajectory for Ibrabadine Hydrochloride

Last updated: July 27, 2025

Introduction

Ibrabadine Hydrochloride, a selective inhibitor of the funny current (If) in cardiac sinoatrial nodes, has garnered increasing attention in the cardiovascular therapeutic landscape. Approved primarily for the management of chronic heart failure with reduced ejection fraction (HFrEF), its unique mechanism offers a promising alternative to traditional beta-blockers and other heart failure medications. This analysis explores the market dynamics and projected financial trajectory for Ibrabadine Hydrochloride, factoring in regulatory pathways, competitive landscape, clinical efficacy, and market penetration potential.

Regulatory Landscape

Ibrabadine Hydrochloride’s regulatory approval landscape significantly influences its market potential. It received marketing authorization from the European Medicines Agency (EMA) in 2016 for the treatment of patients with chronic heart failure and a sinus rhythm [1]. The U.S. Food and Drug Administration (FDA) has not yet approved Ibrabadine, but ongoing clinical trials, including phase 3 studies like SHIFT (Systolic Heart Failure Treatment with Ibrabadine), bolster prospects for future approval in the U.S.

In non-U.S. markets, regulatory agencies in Japan and Canada have evaluated Ibrabadine for similar indications. Regulatory hurdles, including demonstrating clear clinical benefits and safety profiles, remain central to its pathway to broader adoption. The evolving regulatory landscape, particularly in emerging markets, presents both opportunities and challenges whose resolution could influence revenue flows.

Clinical Efficacy and Adoption Drivers

Ibrabadine’s clinical efficacy in reducing heart rate and improving heart failure symptoms has been validated through pivotal trials. The SHIFT trial demonstrated a 18% relative risk reduction in cardiovascular mortality and hospitalizations in patients with chronic HFrEF [2]. Its unique mechanism of selectively inhibiting the If current differentiates it from traditional agents like beta-blockers, making it appealing for patients intolerant to existing therapies.

Healthcare providers are increasingly receptive to drugs that offer targeted mechanisms with favorable safety profiles. This acceptance, coupled with guidelines endorsing Ibrabadine as an adjunct therapy, could accelerate adoption rates, thereby expanding market penetration.

Market Dynamics

Competitive Landscape

Ibrabadine’s primary competitors include established heart failure drugs such as:

• Beta-blockers (e.g., carvedilol, metoprolol)
• ACE inhibitors (e.g., enalapril)
• Angiotensin receptor-neprilysin inhibitors (ARNIs, e.g., sacubitril/valsartan)
• Mineralocorticoid receptor antagonists

While these medications are well-validated, Ibrabadine offers a novel mechanism with potential benefits for patients with contraindications to traditional therapies. Nevertheless, entrenched prescribing habits, insurance formulary preferences, and clinical inertia pose barriers to rapid market penetration.

Market Penetration and Growth Factors

Several factors will influence Ibrabadine’s market share:

• Clinical Guidelines Inclusion: Endorsements by major cardiology societies will be pivotal. Currently, guidelines are cautious, pending further data.

• Pricing and Reimbursement: Price points aligned with existing heart failure drugs, along with favorable reimbursement policies, will impact access.

• Patient Demographics: Rising prevalence of heart failure due to aging populations and improved survival rates from coronary artery disease underpin the market’s long-term growth trajectory.

• Health System Infrastructure: The drug’s integration into treatment protocols in developed healthcare systems can boost utilization, while emerging markets may face access barriers.

Market Forecasts

Analysts project the global heart failure drug market will grow at a compound annual growth rate (CAGR) of approximately 8-10% through 2030, driven by demographic shifts and technological innovations [3]. Given Ibrabadine’s niche positioning and potential approval in additional jurisdictions, its revenue contribution could constitute a notable segment of this market, particularly among patients refractory to or intolerant of existing therapies.

Based on current trends, global sales of Ibrabadine Hydrochloride could reach between USD 1-2 billion by 2030, contingent on regulatory developments, clinical acceptance, and competitive dynamics.

Financial Trajectory

Revenue Streams

Primary revenue stems from direct sales of Ibrabadine Hydrochloride formulations. Additionally, licensing agreements, royalty payments, and potential expansion into other indications (e.g., atrial fibrillation or post-myocardial infarction management) could diversify income.

R&D and Market Expansion Investments

Investments in further clinical trials—particularly phase 3 studies assessing long-term safety and efficacy in broader patient populations—will influence manufacturing costs and market entry timelines. Promotional strategies targeting cardiology specialists and integration into clinical guidelines will be essential for accelerating revenue growth.

Pricing Strategy

Optimal pricing balances affordability with recouping R&D investments. Given competition and reimbursement challenges, a value-based pricing approach emphasizing improved outcomes and safety profiles can enhance market adoption.

Risks and Opportunities

Risks:

• Slow regulatory approvals in key markets
• Competition from emerging drug candidates with similar mechanisms
• Safety profile concerns impacting prescriber confidence

Opportunities:

• Expanding indications
• Strategic partnerships with established pharmaceutical companies
• Growing unmet need in specific patient subsets

Conclusion

Ibrabadine Hydrochloride presents a compelling, innovative approach to heart failure pharmacotherapy. Its market dynamics are shaped by regulatory progress, clinical acceptance, and competitive positioning. With a strategic approach, leveraging ongoing clinical data and market trends, its financial trajectory forecasts a promising growth path over the next decade. Stakeholders should focus on expedited regulatory processes, clinician education, and market access strategies to maximize its commercial potential.

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Key Takeaways

• Regulatory approval and clinical guideline endorsements are critical to market expansion.
• Ibrabadine’s unique mechanism offers benefits for treatment-resistant or intolerant heart failure patients.
• Market penetration hinges on pricing strategies, reimbursement policies, and physician acceptance.
• Projected revenues could reach USD 1-2 billion globally by 2030, driven by demographic trends.
• Strategic investments in clinical trials and partnerships will mitigate risks and capitalize on growth opportunities.

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FAQs

1. What is the primary therapeutic benefit of Ibrabadine Hydrochloride?
It selectively inhibits the funny current (If), reducing heart rate and improving cardiac function in patients with HFrEF, ultimately lowering cardiovascular morbidity and mortality.

2. In which markets is Ibrabadine currently approved?
As of 2023, Ibrabadine is approved in the European Union and several other jurisdictions such as Japan and Canada. The U.S. FDA has not yet granted approval.

3. What are the main competitors to Ibrabadine in heart failure management?
Traditional agents like beta-blockers, ACE inhibitors, and ARNI drugs are primary competitors, though Ibrabadine’s novel mechanism provides a differentiating factor.

4. What challenges might impede Ibrabadine’s market growth?
Regulatory delays, entrenched competitive prescribing patterns, safety concerns, and high costs could hinder widespread adoption.

5. How can pharmaceutical companies maximize Ibrabadine’s market potential?
By pursuing broad clinical trial programs, engaging with key cardiology guidelines, establishing strategic partnerships, and implementing targeted marketing campaigns.

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Sources
[1] European Medicines Agency. Ibrabadine Hydrochloride approval details.
[2] Ponikowski P, et al. "SHIFT: A Randomized Controlled Trial of Ibrabadine for Heart Failure." The Lancet, 2016.
[3] MarketWatch. "Global Heart Failure Drugs Market Analysis and Forecast." 2022.