MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER Drug Patent Profile

When do Mivacron In Dextrose 5% In Plastic Container patents expire, and what generic alternatives are available?

Mivacron In Dextrose 5% In Plastic Container is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER is mivacurium chloride. There are two drug master file entries for this compound. Additional details are available on the mivacurium chloride profile page.

Summary for MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	21
Clinical Trials:	5
DailyMed Link:	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER

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

Sponsor	Phase
Université Libre de Bruxelles	N/A
University Hospital Ostrava	N/A
Jiangsu Nhwa Pharmaceutical Co., Ltd.	Phase 2

See all MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER clinical trials

US Patents and Regulatory Information for MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	mivacurium chloride	INJECTABLE;INJECTION	020098-002	Jan 22, 1992		DISCN	No	No
Abbvie	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	mivacurium chloride	INJECTABLE;INJECTION	020098-003	Jan 22, 1992		DISCN	No	No

Expired US Patents for MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	mivacurium chloride	INJECTABLE;INJECTION	020098-002	Jan 22, 1992

International Patents for MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER

See the table below for patents covering MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER around the world.

Country	Patent Number	Title	Estimated Expiration
Latvia	5483	Izohinolinija atvasinajumu iegusanas panemiens
Netherlands	940023
Ireland	851791
Japan	S6187666	NOVEL COMPOUND, PREPARATION AND USE AS MUSCLE RELAXANT

Supplementary Protection Certificates for MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0181055	96C0001	Belgium		PRODUCT NAME: MIVACURIUM CHLORID.= MIVACURIUM (+5% OVERDOSERING); NAT REG.: 251 IS 152 F 12 19951114; FIRST REG.: GB 0003/0325 19921208
0181055	SPC/GB93/031	United Kingdom		SPC/GB93/031:, EXPIRES: 20071207

MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for MIVACRON in Dextrose 5% in Plastic Container

Introduction

MIVACRON, a neuromuscular blocking agent, is used in surgical procedures to facilitate tracheal intubation and provide skeletal muscle relaxation. When administered in a solution of dextrose 5%, it is crucial to understand the market dynamics and financial trajectory of this formulation.

Market Overview

The market for neuromuscular blocking drugs (NMBDs) is diverse, with various agents competing for market share. MIVACRON, specifically, is a short- to intermediate-acting NMBD, which positions it uniquely in the market.

Market Share and Competition

In the NMBD market, MIVACRON competes with other agents such as rocuronium, vecuronium, and atracurium. While rocuronium has a significant market share and is associated with a higher rate of anaphylaxis, MIVACRON's profile as a shorter-acting agent with fewer severe side effects can be a competitive advantage[4].

Clinical Use and Demand

MIVACRON is used in a variety of surgical settings, particularly where short to intermediate neuromuscular blockade is required. Its use is facilitated by its rapid onset and relatively short duration of action, making it suitable for procedures that do not require prolonged muscle relaxation[2].

Financial Trajectory

Revenue Streams

The revenue generated by MIVACRON is influenced by several factors, including the volume of sales, pricing strategies, and the cost of production. Given its niche as a short- to intermediate-acting NMBD, MIVACRON can command a premium price due to its specific clinical benefits.

Pricing and Cost Considerations

The pricing of MIVACRON is affected by the costs associated with its production, including the cost of the active ingredient, the dextrose solution, and the plastic container. The use of a plastic container, such as the AVIVA system, adds to the overall cost but also provides advantages in terms of compatibility and safety[3].

Market Trends

The market trend for NMBDs shows a shift towards agents with fewer side effects and more precise control over the duration of action. MIVACRON, with its shorter duration and lower incidence of severe side effects compared to some other agents, is well-positioned to benefit from this trend[4].

Clinical and Economic Benefits

Clinical Benefits

MIVACRON offers several clinical benefits, including a rapid onset of action and a shorter duration of neuromuscular blockade, which can reduce the overall time spent in the operating room and recovery. This efficiency can lead to cost savings for healthcare providers[2].

Economic Benefits

The economic benefits of using MIVACRON include reduced hospital stay times and lower costs associated with post-operative care. Additionally, the precision in dosing and the predictable recovery profile can minimize the need for additional medications and interventions, further reducing costs.

Cost-Effectiveness

Studies on personalized medicine and pharmacogenomics highlight the potential for cost savings through targeted drug use. While MIVACRON does not fall under personalized medicine, its precise dosing and predictable effects contribute to a cost-effective approach in surgical care[5].

Regulatory and Safety Considerations

Regulatory Environment

MIVACRON must comply with stringent regulatory requirements, including those related to the safety and efficacy of the drug and the dextrose solution, as well as the materials used in the plastic container. Compliance with these regulations can impact the financial trajectory by affecting production costs and market access[1][3].

Safety Profile

The safety profile of MIVACRON is a critical factor in its market dynamics. While it is generally well-tolerated, it can cause transient decreases in mean arterial blood pressure and increases in heart rate in some patients. These effects are typically manageable and do not significantly impact its market position[1].

Market Growth and Projections

Market Growth

The demand for NMBDs is expected to grow with the increasing number of surgical procedures. MIVACRON, with its unique profile, is likely to see steady growth as healthcare providers seek agents that offer both efficacy and safety.

Projections

Given the trends in the NMBD market and the clinical benefits of MIVACRON, projections indicate a stable to increasing market share for this drug. The financial trajectory is expected to be positive, driven by consistent demand and the potential for premium pricing due to its specific clinical advantages.

Conclusion

MIVACRON in dextrose 5% in a plastic container is a valuable asset in the neuromuscular blocking agent market. Its unique clinical profile, combined with the safety and compatibility of the AVIVA plastic container system, positions it for continued market success. The financial trajectory for this formulation is expected to be positive, driven by its clinical benefits, cost-effectiveness, and compliance with regulatory requirements.

Key Takeaways

• Market Position: MIVACRON competes in the NMBD market with a unique short- to intermediate-acting profile.
• Clinical Benefits: Rapid onset and predictable recovery profile contribute to efficiency and cost savings.
• Economic Benefits: Reduced hospital stay times and lower post-operative care costs.
• Regulatory Compliance: Strict adherence to safety and efficacy regulations.
• Safety Profile: Generally well-tolerated with manageable side effects.
• Market Growth: Expected steady growth driven by increasing surgical procedures.

FAQs

Q1: What is the typical duration of action for MIVACRON?

The clinically effective duration of action for MIVACRON is approximately 15 to 20 minutes, with spontaneous recovery expected to be 95% complete in 25 to 30 minutes[2].

Q2: How does the use of dextrose 5% in the formulation affect MIVACRON?

The dextrose 5% solution serves as a vehicle for MIVACRON, providing a sterile and nonpyrogenic medium for intravenous administration. It does not alter the pharmacological properties of MIVACRON but ensures compatibility and safety[3].

Q3: What are the potential side effects of MIVACRON?

MIVACRON can cause transient decreases in mean arterial blood pressure and increases in heart rate in some patients. These effects are usually maximal within 1 to 3 minutes and resolve without treatment[1].

Q4: How does MIVACRON compare to other NMBDs in terms of anaphylaxis risk?

MIVACRON has a lower incidence of anaphylaxis compared to some other NMBDs like rocuronium. This makes it a safer option for patients with a history of allergic reactions to neuromuscular blocking agents[4].

Q5: What is the impact of volatile anesthetics on MIVACRON dosing?

Volatile anesthetics such as isoflurane and enflurane can decrease the dosing requirement for MIVACRON and prolong its duration of action. This effect is more pronounced with higher concentrations of these anesthetics[1][2].

Sources

1. MIVACRON® Injection (mivacurium chloride) - accessdata.fda.gov
2. Mivacron Dosage Guide - Drugs.com
3. 5% Dextrose Injection, USP - Baxter
4. Anaphylaxis to neuromuscular blocking drugs: incidence and cross-reactivity - Oxford Academic
5. THE PERSONALIZED MEDICINE REPORT - Personalized Medicine Coalition