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, and Mylan Institutional, 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:	4
NDAs:	5
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	1
Patent Applications:	858
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
Abbott Medical Devices	N/A
Ball Memorial Hospital	N/A
St. Jude Medical	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
Mylan Institutional	IBUTILIDE FUMARATE	ibutilide fumarate	INJECTABLE;INJECTION	090643-001	Jan 11, 2010	AP	RX	No	No
Mylan Institutional	IBUTILIDE FUMARATE	ibutilide fumarate	INJECTABLE;INJECTION	090924-001	Jan 11, 2010		DISCN	No	No
Pfizer	CORVERT	ibutilide fumarate	INJECTABLE;INJECTION	020491-001	Dec 28, 1995	AP	RX	Yes	Yes
Luitpold	IBUTILIDE FUMARATE	ibutilide fumarate	INJECTABLE;INJECTION	090240-001	Jan 11, 2010		DISCN	No	No
Avet Lifesciences	IBUTILIDE FUMARATE	ibutilide fumarate	INJECTABLE;INJECTION	204146-001	Apr 1, 2024	AP	RX	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

IBUTILIDE FUMARATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Ibutilide Fumarate

Introduction

Ibutilide fumarate, a class III antiarrhythmic agent, has been a significant player in the treatment of atrial flutter and atrial fibrillation. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Size and Growth

The global ibutilide fumarate market has been experiencing substantial growth. As of 2023, the market size was valued at approximately USD 1.2 billion. Projections indicate that this market is expected to expand significantly, reaching USD 2.3 billion by 2032[4].

Market Drivers

Several factors are driving the growth of the ibutilide fumarate market:

• Increasing Prevalence of Atrial Arrhythmias: The rising incidence of atrial flutter and atrial fibrillation, particularly among the aging population, is a key driver.
• Efficacy and Safety Profile: Ibutilide fumarate has demonstrated high efficacy in converting atrial arrhythmias to normal sinus rhythm, with conversion rates significantly higher than those of placebo and other antiarrhythmic agents[2][5].
• Clinical Trials and Approvals: Positive outcomes from clinical trials and regulatory approvals have bolstered the market's confidence in ibutilide fumarate.

Competitive Landscape

The market for ibutilide fumarate is competitive, with several manufacturers involved:

• Pharmacia and Upjohn Company LLC: One of the primary manufacturers, known for the brand name Corvert[5].
• Bioniche Pharma USA LLC: Another significant player in the market[3].
• Generamedix Inc. and Paddock Laboratories, Inc.: These companies also produce and distribute ibutilide fumarate[3].

Pharmacokinetics and Pharmacodynamics

Understanding the pharmacokinetics and pharmacodynamics of ibutilide fumarate is crucial for its market positioning:

• Rapid Absorption and Distribution: Ibutilide fumarate is rapidly absorbed after intravenous administration, with a high systemic plasma clearance and a large volume of distribution[3][5].
• Mechanism of Action: It prolongs cardiac repolarization by activating a slow inward sodium current, making it a 'pure' class III antiarrhythmic agent[2][3].

Clinical Efficacy

Clinical trials have shown that ibutilide fumarate is highly effective:

• Conversion Rates: In patients with atrial flutter, conversion rates ranged from 56% to 78% depending on the dose, significantly higher than placebo. For atrial fibrillation, conversion rates were between 28% and 44%[5].
• Comparison with Other Agents: Ibutilide fumarate has been shown to be more effective than sotalol and procainamide in converting atrial arrhythmias[2].

Adverse Effects and Safety

While ibutilide fumarate is generally well-tolerated, it does come with some adverse effects:

• Common Adverse Effects: Nausea is the most common non-cardiac adverse effect. Cardiac adverse effects include nonsustained and sustained polymorphic ventricular tachycardia[2][3].
• Toxicity: Acute overdose can result in CNS toxicity, but the therapeutic dose is much lower than the toxic dose[3].

Market Segmentation

The market for ibutilide fumarate can be segmented based on several factors:

• Geographical Segmentation: The market is global, with significant demand in regions with high prevalence of atrial arrhythmias.
• End-User Segmentation: Hospitals, cardiac care units, and emergency departments are primary end-users.

Financial Performance

The financial performance of ibutilide fumarate is robust:

• Revenue Growth: The market is projected to grow from USD 1.2 billion in 2023 to USD 2.3 billion by 2032, indicating a strong revenue growth trajectory[4].
• Pricing: The cost of ibutilide fumarate varies by manufacturer and region, but it generally falls in the range of USD 33.6 to USD 54.27 per milliliter[3].

Future Outlook

The future outlook for the ibutilide fumarate market is promising:

• Increasing Demand: The growing incidence of atrial arrhythmias and the aging population will continue to drive demand.
• Research and Development: Ongoing research may lead to new formulations or improved delivery methods, further enhancing market growth.

Key Takeaways

• The global ibutilide fumarate market is expected to grow significantly, reaching USD 2.3 billion by 2032.
• Ibutilide fumarate's efficacy in converting atrial arrhythmias to normal sinus rhythm is a key market driver.
• The drug is available from multiple manufacturers, contributing to a competitive market.
• Clinical trials have demonstrated its superiority over other antiarrhythmic agents.
• While it has some adverse effects, the therapeutic benefits outweigh the risks.

Frequently Asked Questions (FAQs)

Q: What is ibutilide fumarate used for? A: Ibutilide fumarate is used for the conversion of acute atrial flutter and recent onset atrial fibrillation to normal sinus rhythm[2][3].

Q: How effective is ibutilide fumarate in converting atrial arrhythmias? A: Ibutilide fumarate has shown high efficacy, with conversion rates ranging from 56% to 78% for atrial flutter and 28% to 44% for atrial fibrillation, depending on the dose[5].

Q: What are the common adverse effects of ibutilide fumarate? A: Common adverse effects include nausea and cardiac effects such as nonsustained and sustained polymorphic ventricular tachycardia[2][3].

Q: How is ibutilide fumarate administered? A: Ibutilide fumarate is administered intravenously, typically through a 10-minute infusion[2][5].

Q: What is the projected market size of ibutilide fumarate by 2032? A: The global ibutilide fumarate market is projected to reach USD 2.3 billion by 2032[4].

Cited Sources:

1. Market Research Intellect - Ibutilide Fumarate Market Size, Scope And Forecast Report
2. PubMed - Ibutilide: a new class III antiarrhythmic agent
3. DrugBank - Ibutilide: Uses, Interactions, Mechanism of Action
4. Dataintelo - Ibutilide Fumarate Market Research Report 2032
5. Pfizer - Corvert® (ibutilide fumarate) injection