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Last Updated: December 12, 2025

MIVACURIUM CHLORIDE - Generic Drug Details


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What are the generic drug sources for mivacurium chloride and what is the scope of patent protection?

Mivacurium chloride is the generic ingredient in three branded drugs marketed by Abbvie, Rising, and Woodward, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for mivacurium chloride.

Summary for MIVACURIUM CHLORIDE
Recent Clinical Trials for MIVACURIUM CHLORIDE

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

SponsorPhase
Peng LiangNA
Tang-Du HospitalPhase 2
Jiangsu Nhwa Pharmaceutical Co., Ltd.Phase 2

See all MIVACURIUM CHLORIDE clinical trials

US Patents and Regulatory Information for MIVACURIUM CHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie MIVACRON mivacurium chloride SOLUTION;INTRAVENOUS 020098-005 Jan 22, 1992 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Abbvie MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER mivacurium chloride INJECTABLE;INJECTION 020098-003 Jan 22, 1992 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Rising MIVACURIUM CHLORIDE mivacurium chloride INJECTABLE;INJECTION 078562-001 Apr 30, 2009 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for MIVACURIUM CHLORIDE

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 4,761,418 ⤷  Get Started Free
Abbvie MIVACRON mivacurium chloride SOLUTION;INTRAVENOUS 020098-001 Jan 22, 1992 4,761,418 ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Market Dynamics and Financial Trajectory for MIVACURIUM CHLORIDE

Last updated: July 30, 2025

Introduction

Mivacurium chloride, a non-depolarizing neuromuscular blocking agent, plays a critical role in anesthesia practices globally. Its unique pharmacokinetics, safety profile, and functional attributes position it distinctly within both conventional and specialized clinical settings. Understanding the market dynamics and financial trajectory surrounding this drug involves examining product characteristics, competitive landscape, regulatory environment, emerging trends, and economic factors shaping its adoption and profitability.

Pharmacological Profile and Clinical Utility

Mivacurium chloride is characterized by rapid onset and short duration of action, making it ideal for outpatient procedures and short surgical interventions. Its rapid metabolism via plasma cholinesterases results in a predictable recovery, reducing the need for prolonged ventilatory support. These features align closely with contemporary anesthetic protocols emphasizing efficiency and safety, which bolster the drug’s clinical demand.

Market Landscape

The global neuromuscular blocking agents (NMBA) market, valued at approximately USD 4.2 billion in 2022, is projected to grow at a CAGR of about 6% through 2030 [1]. Mivacurium chloride’s market share remains niche relative to dominant competitors such as rocuronium and vecuronium but retains importance in specific surgical contexts. Its application is particularly relevant in regions with resource-limited settings due to its shorter duration and reversal profile, which could be strategically leveraged.

Key Market Drivers

  • Rising Surgical Volumes: Increasing global surgical procedures, notably minimally invasive and outpatient interventions, drive demand.
  • Preference for Short-Acting NMBAs: Surgeons and anesthesiologists favor agents like mivacurium for quick turnaround procedures.
  • Advances in Anesthesia Monitoring: Enhanced neuromuscular monitoring systems improve safety, encouraging the use of agents with predictable profiles.
  • Regional Expansion: Growth in emerging economies unserved by a broad portfolio of neuromuscular blockers creates markets for niche agents like mivacurium.

Market Challenges

  • Limited Patent Protection: As a generic, mivacurium faces pricing pressures and limited profitability.
  • Competition from Alternatives: Preferential use of newer agents with better safety profiles or cost advantages can erode market share.
  • Regulatory Barriers: Variability in regulatory approvals and clinical guidelines impacts market penetration.
  • Supply Chain Constraints: Dependence on specific manufacturing processes and plasma cholinesterase activity can limit consistent supply.

Regulatory and Patent Landscape

Mivacurium chloride was initially approved in the 1980s; however, its patent life expired in many jurisdictions, classifying it largely as a generic compound today [2]. This status influences market dynamics by focusing competition on manufacturing efficiency and distribution rather than innovation. Regulatory approvals vary, with some nations requiring extensive clinical data, influencing price and accessibility strategies.

Competitive Dynamics

The competitive landscape features both branded and generic manufacturers. Key competitors include:

  • Rocuronium and Vecuronium: Longer-acting agents with established safety profiles and greater marketing presence, often preferred in complex surgeries.
  • Atracurium and Cisatracurium: Offering advantages in particular patient populations due to less cardiovascular impact.
  • Emerging Agents: Sugammadex, a reversal agent, enhances the utility of certain NMBA agents, indirectly influencing mivacurium use.

Manufacturers’ strategic focus lies in emphasizing the unique pharmacokinetic properties of mivacurium, especially its rapid onset and recovery, to maintain niche demand.

Technological and Innovation Trends

Advancements in anesthesia delivery include improved neuromuscular monitoring, which enhances safety and precision. This technology supports the use of short-acting agents like mivacurium. Furthermore, biotechnological innovations could optimize manufacturing processes, reduce costs, or enable combination therapies, broadening the drug’s application. However, mivacurium’s prospects depend heavily on clinician familiarity and established protocols.

Economic Factors Influencing Financial Trajectory

Pricing and Reimbursement

As a generic, mivacurium’s pricing remains competitive. Reimbursement policies significantly influence uptake in various regions, with government and private payers increasingly favoring cost-effective agents.

Manufacturing Costs

Manufacturers’ ability to optimize synthesis and formulation processes will directly impact margins. Economies of scale are limited due to relatively niche demand.

Market Penetration Strategies

Targeting hospitals with high surgical volumes, especially outpatient centers and regions with limited access to newer agents, can spur growth. Additionally, strategic partnerships with healthcare providers enhance distribution channels.

Supply Chain and Distribution

Ensuring consistent supply is critical for maintaining market confidence. Global disruptions, such as those observed during the COVID-19 pandemic, exposed vulnerabilities in pharmaceutical distribution that must be managed proactively.

Future Financial Trajectory

The outlook for mivacurium chloride suggests modest growth driven by niche applications and regional expansion. Its continued relevance hinges on:

  • Regulatory Approvals: Expanding approvals can open new markets.
  • Market Education: Increasing clinician familiarity through education campaigns.
  • Innovation: Potential formulation improvements or combination products with reversal agents could renew interest.
  • Regional Focus: Exploiting emerging markets with growing surgical capacities.

Projected revenue streams are expected to remain stable within existing niches, with incremental increases as procedural volumes expand and procedural protocols evolve.

Impact of Market Trends on Investment and Business Strategies

Investors and pharmaceutical companies must weigh the limited scope of growth against the costs and risks associated with maintaining manufacturing capacity for a generic drug. Diversifying portfolios with innovative neuromuscular agents or developing combination therapies may be necessary to sustain profitability.

Key Takeaways

  • Niche yet Stable: Mivacurium chloride remains relevant for short-duration surgeries, offering predictable recovery times.
  • Market Growth Driven by Surgical Volume Increase: Surge in outpatient procedures globally supports consistent demand.
  • Competitive Challenges: Facing stiff competition from longer-acting agents and newer pharmacological innovations.
  • Regulatory and Pricing Pressures: Generic status exerts downward pressure on margins; strategic positioning is essential.
  • Regional Expansion Opportunities: Emerging markets present growth avenues with relatively less competition.

FAQs

  1. What are the primary clinical advantages of mivacurium chloride?
    Its rapid onset and short duration of action facilitate quick, efficient surgeries, and predictable recovery minimize the need for prolonged ventilation, making it ideal for outpatient procedures.

  2. How does the patent status influence mivacurium’s market potential?
    As a generic drug with expired patents, mivacurium faces intense price competition but benefits from established clinical familiarity and safety profiles.

  3. What regions offer the most growth opportunities for mivacurium chloride?
    Emerging economies with expanding surgical infrastructure and limited access to newer agents represent significant growth opportunities.

  4. What factors could inhibit mivacurium’s market growth?
    Competition from longer-acting neuromuscular blockers, newer agents with improved safety profiles, regulatory hurdles, and supply chain issues may constrain growth.

  5. Could innovations or formulation improvements impact mivacurium’s marketability?
    Yes, innovations that enhance stability, administration convenience, or efficacy could rejuvenate interest and expand its application scope.

References

  1. [MarketResearch.com] - Global neuromuscular blockade agents market report, 2022-2030.

  2. [Pharmacological Reviews] - Historical patent and regulatory analysis of mivacurium chloride.


Note: Data based on industry reports, market analyses, and regulatory sources as of 2023.

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