BRETYLIUM TOSYLATE IN DEXTROSE 5% Drug Patent Profile

When do Bretylium Tosylate In Dextrose 5% patents expire, and what generic alternatives are available?

Bretylium Tosylate In Dextrose 5% is a drug marketed by Abbott, B Braun, Baxter Hlthcare, and Hospira Inc. and is included in four NDAs.

The generic ingredient in BRETYLIUM TOSYLATE IN DEXTROSE 5% is bretylium tosylate. There are three drug master file entries for this compound. Additional details are available on the bretylium tosylate profile page.

Summary for BRETYLIUM TOSYLATE IN DEXTROSE 5%

US Patents:	0
Applicants:	4
NDAs:	4
Raw Ingredient (Bulk) Api Vendors:	41
DailyMed Link:	BRETYLIUM TOSYLATE IN DEXTROSE 5% at DailyMed

US Patents and Regulatory Information for BRETYLIUM TOSYLATE IN DEXTROSE 5%

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbott	BRETYLIUM TOSYLATE IN DEXTROSE 5%	bretylium tosylate	INJECTABLE;INJECTION	019005-002	Apr 29, 1986		DISCN	No	No
Baxter Hlthcare	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	bretylium tosylate	INJECTABLE;INJECTION	019837-002	Apr 12, 1989		DISCN	No	No
B Braun	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	bretylium tosylate	INJECTABLE;INJECTION	019121-001	Apr 29, 1986		DISCN	No	No
Baxter Hlthcare	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	bretylium tosylate	INJECTABLE;INJECTION	019837-001	Apr 12, 1989		DISCN	No	No

BRETYLIUM TOSYLATE IN DEXTROSE 5% Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Bretylium Tosylate in Dextrose 5%

Introduction

Bretylium tosylate, often administered in a solution with dextrose 5%, is a critical antiarrhythmic drug used to manage and suppress ventricular arrhythmias, including ventricular fibrillation and ventricular tachycardia. Understanding the market dynamics and financial trajectory of this drug is essential for pharmaceutical companies, investors, and healthcare providers.

Market Overview

Bretylium tosylate has been approved for parenteral use against resistant ventricular arrhythmias, a condition that poses significant risks to patients and requires immediate and effective treatment[5].

Target Market

The primary target market for bretylium tosylate includes patients suffering from life-threatening ventricular arrhythmias, particularly those who have not responded to other antiarrhythmic treatments. This market segment is critical due to the high mortality rate associated with untreated ventricular fibrillation and tachycardia.

Competitive Landscape

The antiarrhythmic drug market is competitive, with various drugs available for different types of arrhythmias. However, bretylium tosylate stands out due to its unique mechanism of action and effectiveness in treating resistant ventricular arrhythmias.

Unique Selling Points

• Mechanism of Action: Bretylium tosylate selectively accumulates in sympathetic ganglia and postganglionic adrenergic neurons, inhibiting norepinephrine release and suppressing ventricular fibrillation and tachycardia without depressing myocardial contractility[1][4][5].
• Clinical Efficacy: It has been shown to be effective in clinical studies, particularly in cases of recurrent, drug-resistant ventricular tachycardia or ventricular fibrillation[5].

Regulatory Environment

Bretylium tosylate is regulated by various health authorities, including the FDA. The drug has been approved for parenteral use, and its administration is subject to specific guidelines and warnings.

Approval and Compliance

• FDA Approval: Bretylium tosylate has been approved for use in treating ventricular arrhythmias, with specific dosing and administration guidelines[5].
• Safety and Efficacy: Regulatory bodies closely monitor the safety and efficacy of bretylium tosylate, ensuring that it meets stringent standards for patient safety.

Financial Trajectory

The financial performance of bretylium tosylate is influenced by several factors, including market demand, competition, and regulatory compliance.

Revenue Streams

• Hospital and Clinical Use: The primary revenue stream for bretylium tosylate comes from its use in hospitals and clinical settings for the treatment of acute ventricular arrhythmias.
• Emergency Services: It is also used in emergency medical services, contributing to its revenue.

Cost and Pricing

• Dosage and Administration: The cost of bretylium tosylate is influenced by its dosage and administration protocols. It is typically administered intravenously or intramuscularly, with specific dosing schedules[1][2].
• Market Pricing: The pricing of bretylium tosylate is competitive within the antiarrhythmic drug market, balancing between profitability and patient affordability.

Challenges and Opportunities

Despite its clinical efficacy, bretylium tosylate faces several challenges and opportunities in the market.

Challenges

• Side Effects and Interactions: The drug can cause side effects such as orthostatic hypotension, nausea, and vomiting, especially with rapid infusion. It also interacts with other medications like digitalis glycosides and catecholamines[2].
• Geriatric Use: Special caution is required when administering bretylium tosylate to elderly patients due to potential renal function impairment and increased risk of orthostatic hypotension[1][2].

Opportunities

• Growing Demand: The increasing incidence of cardiovascular diseases and the need for effective antiarrhythmic treatments present a growing demand for bretylium tosylate.
• Research and Development: Continued research into the mechanisms of action and potential new indications could expand the market for bretylium tosylate.

Market Trends

Several trends influence the market dynamics of bretylium tosylate.

Advancements in Cardiac Care

• Technological Advancements: Improvements in cardiac monitoring and treatment technologies can enhance the use and effectiveness of bretylium tosylate.
• Personalized Medicine: The trend towards personalized medicine could lead to more targeted and effective use of bretylium tosylate based on individual patient profiles.

Global Health Initiatives

• Access to Healthcare: Global health initiatives aimed at improving access to healthcare can increase the demand for bretylium tosylate in emerging markets.

Key Takeaways

• Unique Mechanism: Bretylium tosylate's unique mechanism of action sets it apart in the antiarrhythmic drug market.
• Clinical Efficacy: It is highly effective in treating resistant ventricular arrhythmias.
• Regulatory Compliance: Strict adherence to regulatory guidelines is crucial for its use.
• Financial Performance: Revenue is driven by hospital and clinical use, with challenges and opportunities influencing its financial trajectory.
• Market Trends: Advancements in cardiac care and global health initiatives impact market dynamics.

FAQs

1. What is the primary use of bretylium tosylate?

   • Bretylium tosylate is primarily used to treat and suppress ventricular arrhythmias, including ventricular fibrillation and ventricular tachycardia.

2. How does bretylium tosylate work?

   • Bretylium tosylate selectively accumulates in sympathetic ganglia and postganglionic adrenergic neurons, inhibiting norepinephrine release and suppressing ventricular fibrillation and tachycardia.

3. What are the common side effects of bretylium tosylate?

   • Common side effects include orthostatic hypotension, nausea, and vomiting, especially with rapid infusion.

4. Can bretylium tosylate be used in elderly patients?

   • Yes, but with caution. Elderly patients may require dose adjustments due to potential renal function impairment and increased risk of orthostatic hypotension.

5. Is bretylium tosylate approved for pediatric use?

   • No, the safety and effectiveness of bretylium tosylate have not been established in pediatric patients.

Cited Sources

1. Drugs.com: Bretylium Injection: Package Insert / Prescribing Info.
2. RxList: Bretylium (Bretylium Tosylate Injection): Side Effects, Uses.
3. PubChem: Bretylium Tosylate | C18H24BrNO3S | CID 6100.
4. DrugBank: Bretylium: Uses, Interactions, Mechanism of Action.
5. PubMed: Bretylium tosylate: a newly available antiarrhythmic drug.