IBUTILIDE FUMARATE - Generic Drug Details

What are the generic sources for ibutilide fumarate and what is the scope of patent protection?

Ibutilide fumarate is the generic ingredient in two branded drugs marketed by Pfizer, Avet Lifesciences, Luitpold, Mylan Institutional, and Pharmobedient, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for ibutilide fumarate. Three suppliers are listed for this compound.

Summary for IBUTILIDE FUMARATE

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Patent Applications:	1,103
What excipients (inactive ingredients) are in IBUTILIDE FUMARATE?	IBUTILIDE FUMARATE excipients list
DailyMed Link:	IBUTILIDE FUMARATE at DailyMed

Recent Clinical Trials for IBUTILIDE FUMARATE

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

Sponsor	Phase
Ball Memorial Hospital	N/A
St. Jude Medical	N/A
Abbott Medical Devices	N/A

See all IBUTILIDE FUMARATE clinical trials

Pharmacology for IBUTILIDE FUMARATE

Drug Class

Antiarrhythmic

Anatomical Therapeutic Chemical (ATC) Classes for IBUTILIDE FUMARATE

C01BD	Antiarrhythmics, class III
C01B	ANTIARRHYTHMICS, CLASS I AND III
C01	CARDIAC THERAPY
C	Cardiovascular system

US Patents and Regulatory Information for IBUTILIDE FUMARATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmobedient	IBUTILIDE FUMARATE	ibutilide fumarate	INJECTABLE;INJECTION	090643-001	Jan 11, 2010	AP	RX	No	No
Avet Lifesciences	IBUTILIDE FUMARATE	ibutilide fumarate	INJECTABLE;INJECTION	204146-001	Apr 1, 2024	AP	RX	No	No
Luitpold	IBUTILIDE FUMARATE	ibutilide fumarate	INJECTABLE;INJECTION	090240-001	Jan 11, 2010		DISCN	No	No
Pfizer	CORVERT	ibutilide fumarate	INJECTABLE;INJECTION	020491-001	Dec 28, 1995	AP	RX	Yes	Yes
Mylan Institutional	IBUTILIDE FUMARATE	ibutilide fumarate	INJECTABLE;INJECTION	090924-001	Jan 11, 2010		DISCN	No	No

Expired US Patents for IBUTILIDE FUMARATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	CORVERT	ibutilide fumarate	INJECTABLE;INJECTION	020491-001	Dec 28, 1995	5,155,268

Market Dynamics and Financial Trajectory for Ibutilide Fumarate

Last updated: July 30, 2025

Introduction

Ibutilide fumarate is an antiarrhythmic agent primarily used to treat acute atrial fibrillation and atrial flutter. As a class III antiarrhythmic, it modulates cardiac ion channels to restore and maintain normal rhythm. Given its specific therapeutic role and recent developments in cardiac arrhythmia treatment, understanding the market dynamics and financial trajectory of ibutilide fumarate offers valuable insights for pharmaceutical stakeholders, including developers, investors, and healthcare providers.

This analysis explores the evolving landscape for ibutilide fumarate, considering regulatory, clinical, competitive, and economic factors shaping its market trajectory.

Regulatory and Clinical Landscape

Regulatory Approval and Status

Ibutilide fumarate has attained regulatory approval in multiple jurisdictions, including the United States, where it is marketed under the brand name Corvert by Hospira (a Pfizer subsidiary). The drug’s approval hinges on favorable safety and efficacy profiles demonstrated in clinical trials for acute atrial arrhythmias [1].

However, its widespread adoption faces hurdles due to safety concerns, particularly its proarrhythmic potential, which limits usage to hospital settings under monitored conditions. Regulatory agencies have mandated strict contraindications and monitoring protocols, potentially impacting market penetration.

Clinical Adoption and Efficacy

Clinicians consider ibutilide fumarate a reliable option in controlled environments for rapid cardioversion. Its efficacy in converting atrial fibrillation/flutter is documented at approximately 60-80%, with notable safety considerations. The requirement for continuous cardiac rhythm monitoring restricts outpatient use, constraining its market to inpatient settings [2].

Recent clinical studies focus on refining safety protocols and identifying patient subsets that benefit most, with emerging evidence supporting its use in specific acute care scenarios. Nevertheless, newer antiarrhythmic drugs with improved safety profiles are emerging, influencing clinical preference.

Market Drivers

Growing Prevalence of Cardiac Arrhythmias

A significant driver for ibutilide fumarate demand is the rising prevalence of atrial fibrillation (AF), projected to affect over 33 million globally by 2060 [3]. Ageing populations and increasing comorbidities contribute to this trend, elevating demand for effective acute management solutions.

Advancements in Hospital Cardiology Departments

Enhanced capabilities of modern healthcare facilities, including better emergency response systems and monitoring technologies, facilitate efficacious utilization of ibutilide fumarate. Growing investments in cardiology infrastructure support its administration.

Limited Competition in Specific Therapeutic Niches

While drugs like amiodarone and flecainide are also used for arrhythmia management, their differing safety profiles and administration routes offer niche opportunities for ibutilide fumarate, particularly in acute hospital settings.

Market Challenges

Safety and Tolerability Concerns

The primary challenge remains the drug’s proarrhythmic risk, especially Torsades de Pointes, which necessitates careful patient selection and monitoring. These safety concerns diminish its attractiveness compared to newer agents or alternative therapies with better safety margins.

Limited Outpatient and Long-term Use

Given its administration mainly in acute care settings, ibutilide fumarate’s market scope is inherently constrained. Its limited role in outpatient management or chronic therapy reduces its overall market volume.

Patent and Pricing Dynamics

As a drug with established formulations, ibutilide fumarate faces generic competition, compressing pricing and profit margins. Market entry of biosimilars or generics could pressure revenue streams.

Regulatory and Reimbursement Policies

Stringent monitoring requirements and associated healthcare costs could influence reimbursement policies, impacting profitability. In some regions, insurance coverage may restrict use to specific indications or hospital settings.

Financial Trajectory and Market Forecast

Market Size and Revenue Projections

The global market for inpatient antiarrhythmics, including ibutilide fumarate, is projected to grow at a compound annual growth rate (CAGR) of approximately 4-6% over the next five years, driven by increasing arrhythmia cases and expanding healthcare infrastructure [4].

In North America, where healthcare systems emphasize precise arrhythmia management, ibutilide fumarate's revenue contribution remains significant despite competition. The Asia-Pacific region could witness accelerated growth due to rising cardiovascular disease prevalence and expanding hospital capacities.

Impact of Competition and Innovation

Emergence of novel therapies, such as catheter ablation and newer antiarrhythmic drugs with better safety profiles, could limit ibutilide fumarate’s market share. The development of oral or more tolerable formulations might expand its use beyond inpatient settings, positively influencing revenues.

Strategic Opportunities

Partnerships with hospitals and cardiology centers to optimize protocols for safe administration can enhance market penetration. Additionally, formulations with improved safety profiles or combination therapies could extend the financial trajectory.

Future Outlook

While the overall market for ibutilide fumarate is steadier due to its clinical niche, its growth is likely to be incremental rather than explosive. Continued emphasis on safety, targeted clinical applications, and strategic marketing will determine its financial trajectory.

Conclusion

Ibutilide fumarate occupies a specialized position within acute arrhythmia management; its market dynamics are shaped by clinical efficacy, safety profiles, and healthcare infrastructure. While face challenges related to safety and limited outpatient use, demographic shifts toward higher atrial fibrillation prevalence sustain demand. The financial outlook suggests moderate growth, contingent on safety improvements, innovative formulations, and evolving clinical practices.

Effective stakeholders will leverage targeted supplementation of hospital-based cardiology services, focus on safety protocols, and explore novel delivery methods to optimize the drug's market potential.

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Key Takeaways

• Niche Market Role: Ibutilide fumarate primarily serves hospital-based cardiology departments for acute atrial arrhythmia treatment, limiting its market size.

• Safety Profile as a Critical Factor: Its proarrhythmic risks constrain widespread adoption; safety improvements or safer alternatives may threaten its market share.

• Growing Disease Burden: The rising prevalence of atrial fibrillation supports sustained demand in inpatient management.

• Competitive and Regulatory Landscape: Genomic competition and strict monitoring requirements influence revenue and expansion strategies.

• Strategic Development: Innovation in formulations and clinical protocols can enhance profitability and extend its market relevance.

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FAQs

1. How does ibutilide fumarate compare to other antiarrhythmic agents in efficacy?
Ibutilide fumarate exhibits high efficacy in converting atrial fibrillation/flutter episodes within hospital settings, with conversion rates around 60-80%. However, its safety concerns restrict its use compared to drugs like amiodarone, which, while less potent in some cases, have broader safety profiles.

2. What are the primary safety concerns associated with ibutilide fumarate?
The main safety issue is its potential to induce Torsades de Pointes due to QT interval prolongation. This necessitates continuous cardiac monitoring during and after administration, limiting outpatient applicability.

3. Is ibutilide fumarate suitable for outpatient use?
Currently, no. Its safety profile and monitoring requirements restrict its use to inpatient hospital settings where cardiac rhythm and QT intervals can be closely observed.

4. What future developments could influence ibutilide fumarate’s market growth?
Advances in safety protocols, development of oral formulations, combinations with other agents, or innovations decreasing proarrhythmic risks could broaden its applications and improve market prospects.

5. How does the global prevalence of atrial fibrillation impact the demand for ibutilide fumarate?
The increasing burden of atrial fibrillation globally, projected to affect over 33 million individuals by 2060, sustains the demand for effective acute interventions like ibutilide fumarate, especially in hospital settings.

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Sources:

[1] U.S. Food & Drug Administration. Corvert (ibutilide) approval details.
[2] Camm AJ, et al. "The Role of Antiarrhythmic Drugs in the Management of Atrial Fibrillation." The New England Journal of Medicine, 2010.
[3] Chugh SS, et al. "Worldwide Epidemiology of Atrial Fibrillation." Circulation, 2014.
[4] MarketWatch. "Global Antiarrhythmic Drugs Market Forecast 2023-2028."