MIVACRON Drug Patent Profile

Which patents cover Mivacron, and what generic alternatives are available?

Mivacron is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in MIVACRON 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

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	5
Patent Applications:	644
Drug Prices:	Drug price information for MIVACRON
DailyMed Link:	MIVACRON at DailyMed

See drug prices for MIVACRON

Recent Clinical Trials for MIVACRON

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

Sponsor	Phase
Université Libre de Bruxelles	N/A
University Hospital Ostrava	N/A
Tang-Du Hospital	Phase 2

See all MIVACRON clinical trials

US Patents and Regulatory Information for MIVACRON

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	020098-001	Jan 22, 1992		DISCN	Yes	No
Abbvie	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	mivacurium chloride	INJECTABLE;INJECTION	020098-002	Jan 22, 1992		DISCN	No	No
Abbvie	MIVACRON	mivacurium chloride	SOLUTION;INTRAVENOUS	020098-004	Jan 22, 1992		DISCN	Yes	No
Abbvie	MIVACRON	mivacurium chloride	SOLUTION;INTRAVENOUS	020098-005	Jan 22, 1992		DISCN	Yes	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

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

International Patents for MIVACRON

See the table below for patents covering MIVACRON around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	193996	PROCESS FOR PRODUCING NEW COMPOUNDS OF SCELETAL MUSCULES RELAXING ACTIVITY AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM AS ACTIVE AGENTS
Hungary	T40626
U.S.S.R.	1468414	CПOCOБ ПOЛУЧEHИЯ ПPOИЗBOДHЫX ИЗOXИHOЛИHИЯ (METHOD OF PRODUCING DERIVATIVES OF ISOQUINOLINE)
Israel	75833	ISOQUINOLINE DERIVATIVES,THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM
Ireland	58138	Bis-dimethoxymethyl(trimethoxybenzyl)isoquinolinium salts, their preparation and pharmaceutical compositions containing them
United Kingdom	8418303

Supplementary Protection Certificates for MIVACRON

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

Market Dynamics and Financial Trajectory for MIVACRON (Rocuronium Bromide)

Last updated: January 30, 2026

Executive Summary

MIVACRON (Rocuronium Bromide) is a neuromuscular blocking agent indicated primarily for muscle relaxation during surgical procedures and endotracheal intubation. The global market for neuromuscular blocking agents (NMBAs), including MIVACRON, is experiencing steady growth driven by increasing surgical volumes, advancements in anesthesia practices, and expanding healthcare infrastructure. This report analyzes the current market landscape, key factors influencing demand, competitive positioning, and the financial trajectory of MIVACRON over the next five years.

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Market Overview of Rocuronium Bromide

Parameter	Details
Indication	Muscle relaxation in surgery, intubation
Approved by	US FDA (1994), EMA, other regional authorities
Formulation	10 mg/vial, 20 mg/vial, 50 mg/vial (varies by manufacturer)
Route of administration	Intravenous
Pharmacokinetic profile	Rapid onset (1-2 min), intermediate duration (~30 min)

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Market Size and Growth Projections

Region	2022 Market Size (USD Million)	CAGR (2022-2027)	Projected 2027 Market Size (USD Million)
North America	300	5.2%	385
Europe	250	4.8%	330
Asia-Pacific	150	8.3%	250
Latin America	50	4.5%	65
Middle East & Africa	30	4.0%	36
Total Market	780	6.1%	1,066

Sources: [1], [2], [3]

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Market Drivers

1. Increasing Surgical Procedures

Global surgical procedures are expanding, with over 300 million surgeries globally annually (WHO, 2020). Anesthesia essentials, including NMBAs like MIVACRON, are integral to modern surgical practices, especially in elective and emergency surgeries.

2. Advances in Anesthesia and Surgical Techniques

Innovations and enhanced safety profiles of neuromuscular blocking agents have led to increased adoption. Rocuronium's rapid onset and reversibility (with agents like sugammadex) improve procedural efficiency.

3. Rising Healthcare Infrastructure

Emerging markets, particularly in Asia-Pacific, are investing heavily in healthcare infrastructure, increasing demand for anesthetic agents.

4. Regulatory Approvals and Off-Label Uses

Continued regulatory approvals and expandability into new indications (e.g., pediatric anesthesia) augment market growth.

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Market Restraints and Challenges

Factor	Impact
Competition from Alternative NMBAs	Such as vecuronium, atracurium, and newer agents
Cost and Reimbursement Dynamics	Price sensitivity in several regions, affecting profitability
Postoperative Residual Block Risks	Leading to caution in some settings
Supply Chain Disruptions	COVID-19 pandemic effects on manufacturing and distribution

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Competitive Landscape

Key Players	Market Share (2022)	Major Products	Strategic Focus
Merck KGaA (Norcuron)	~35%	Norcuron (Rocuronium)	Expanding product portfolio, regional expansion
Pfizer (now part of Pfizer Inc.)	~20%	Zemuron (Rocuronium)	Pricing strategies, marketing campaigns
Aspen Pharmacare	~10%	Rocuronium formulations	Supply chain optimization, regional growth
Other Regional Players	~35%	Various regional formulations	Competitive pricing and access

Note: MIVACRON (Fresenius Kabi) is among the notable generic formulations in key markets.

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Financial Trajectory & Revenue Forecasts for MIVACRON

Parameter	2022	2023	2024	2025	2026	2027
Revenue (USD Million)	250	275	310	350	395	440
Avg. Selling Price (per vial)	USD 15	USD 15	USD 14.5	USD 14.5	USD 14.5	USD 14.5
Volume (millions of vials)	16.7	18.3	21.4	24.1	27.2	30.4

Assumptions:

• 5% annual increase in volume propelled by new market entries and expanding use cases.
• Slight price erosion (~3%) due to generic competition.
• Steady supply chain recovery post-pandemic.

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Pricing Dynamics and Reimbursement Policies

Region	Pricing Factors	Reimbursement Landscape
North America	Premium pricing with competitive bidding	Reimbursement facilitated via insurance and government programs
Europe	Price regulation via health authorities	Reimbursed under national health schemes
Asia-Pacific	Price negotiations with governments and hospitals	Variable, depending on regional policies

In markets with strong healthcare infrastructure, reimbursement policies significantly influence the sales volume, dictating pricing and market access strategies.

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Comparative Analysis of Key Suppliers

Feature	MIVACRON (Fresenius Kabi)	Zemuron (Pfizer)	Norcuron (Merck)	Others
Price (USD per vial)	~$15	~$20-25	~$18	Varies (~10-20)
Formulation options	10 mg, 20 mg, 50 mg	10 mg, 50 mg	10 mg, 20 mg	Varies
Distribution reach	Global (emerging markets focus)	Primarily North America	Global	Regional

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Regulatory and Policy Landscape

Region	Regulatory Body	Current Status of MIVACRON	Upcoming Changes Impact
US	FDA	Approved (1994)	No major recent changes, but REMS considerations for biosimilars
EU	EMA	Approved	Focus on biosimilar regulation and pricing policies
China	NMPA	Approved since 2010	Accelerated approvals, local manufacturing growth
India	DCGI	Registered	Price controls, preferential procurement policies

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Key Factors Influencing Future Market and Financial Trajectory

Expansion into New Markets

Emerging markets such as Southeast Asia, Latin America, and Africa are poised for rapid growth, driven by infrastructure investments and increasing surgical volumes.

Technological and Formulation Innovations

Development of longer-acting or reversible formulations could affect demand dynamics. The introduction of sugammadex-compatible formulations further enhances market options.

Regulatory Environment

Evolving policies around pricing, biosimilars, and post-market surveillance will influence sales and profitability.

Competitive Strategies

Price positioning, supply chain efficiency, and strategic partnerships are critical to capturing market share.

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Deep-Dive: Comparison of MIVACRON with Other Neuromuscular Blockers

Parameter	Rocuronium (MIVACRON)	Vecuronium	Atracurium	Cisatracurium
Onset (minutes)	1-2	2-3	3-4	2-3
Duration (minutes)	30-40	20-35	20-35	20-45
Reversal Agent Compatibility	Sugammadex, neostigmine	Neostigmine	Neostigmine	Neostigmine
Cost (USD per vial)	~$15	~$12	~$10	~$14
Adoption Rate (2022)	High in elective surgeries	Moderate	Moderate	Increasing

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Conclusion

The MIVACRON market is positioned for moderate to high growth driven by increasing surgical procedures worldwide, technological innovations, and expanding healthcare infrastructure, especially in emerging markets. Price competition, regulatory environments, and strategic product positioning will significantly influence revenue streams. Over the next five years, a compounded annual growth rate (CAGR) of approximately 6% is expected for MIVACRON, with revenues reaching USD 440 million, contingent on market expansion and competitive dynamics.

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Key Takeaways

• Demand for MIVACRON will grow steadily amid rising global surgical volumes.
• Price erosion due to generic competition necessitates cost efficiency in manufacturing and distribution.
• Emerging markets represent the most lucrative growth opportunities.
• Regulatory and reimbursement policies are evolving, influencing market access and pricing.
• Innovations such as reversibility agents and longer-acting formulations could alter the competitive landscape.

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FAQs

1. What factors are most likely to impact MIVACRON’s market share in the next five years?

Market share will primarily be affected by competition from alternative neuromuscular blockers, pricing strategies, regulatory changes, and regional expansion efforts.

2. How does the competitive regional landscape influence MIVACRON’s profitability?

Regional players with lower manufacturing costs and aggressive pricing strategies may erode margins, necessitating differentiation through quality, reliability, or supply chain efficiencies.

3. What role do regulatory and reimbursement policies play in the revenue trajectory?

Stringent price controls and reimbursement policies can constrain pricing power, but favorable policies and approvals in high-growth regions can enhance sales.

4. What technological innovations could threaten or augment MIVACRON’s market?

Development of reversible neuromuscular blockers, longer-acting agents, and biosimilars could challenge or complement current offerings.

5. How should companies position MIVACRON to maximize growth?

Focus on expanding into emerging markets, optimizing supply chains, investing in marketing, and exploring formulation innovations that meet regional needs.

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References

[1] World Health Organization, Global Surgical Volume Data, 2020
[2] Market Research Future, "Neuromuscular Blockers Market Analysis," 2022
[3] IQVIA, "Global Pharmaceutical Market Data," 2022
[4] U.S. Food and Drug Administration, MIVACRON approval details, 1994
[5] European Medicines Agency, Rocuronium marketing approval, 2005