ROCURONIUM BROMIDE - Generic Drug Details

What are the generic sources for rocuronium bromide and what is the scope of patent protection?

Rocuronium bromide is the generic ingredient in two branded drugs marketed by Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Hospira, Mankind Pharma, Meitheal, Mylan Institutional, Piramal Critical, Prinston Inc, Rising, Sagent Pharms Inc, Sandoz, Shandong, Steriscience, Tamarang, Teva Pharms, West Ward Pharm Corp, Organon Usa Inc, and Sterinova Inc, and is included in twenty-two NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Rocuronium bromide has twenty-five patent family members in nineteen countries.

There are eleven drug master file entries for rocuronium bromide. Twenty-four suppliers are listed for this compound.

Summary for ROCURONIUM BROMIDE

International Patents:	25
US Patents:	1
Tradenames:	2
Applicants:	21
NDAs:	22
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	72
Patent Applications:	1,097
What excipients (inactive ingredients) are in ROCURONIUM BROMIDE?	ROCURONIUM BROMIDE excipients list
DailyMed Link:	ROCURONIUM BROMIDE at DailyMed

Recent Clinical Trials for ROCURONIUM BROMIDE

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

Sponsor	Phase
Ataturk University	NA
Tamas Vegh, MD	PHASE4
The Second People's Hospital of Huai'an	PHASE1

See all ROCURONIUM BROMIDE clinical trials

Pharmacology for ROCURONIUM BROMIDE

Drug Class	Nondepolarizing Neuromuscular Blocker
Physiological Effect	Neuromuscular Nondepolarizing Blockade

Anatomical Therapeutic Chemical (ATC) Classes for ROCURONIUM BROMIDE

M03AC	Other quaternary ammonium compounds
M03A	MUSCLE RELAXANTS, PERIPHERALLY ACTING AGENTS
M03	MUSCLE RELAXANTS
M	Musculo-skeletal system

US Patents and Regulatory Information for ROCURONIUM BROMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Prinston Inc	ROCURONIUM BROMIDE	rocuronium bromide	INJECTABLE;INJECTION	212668-001	May 26, 2022	AP	RX	No	No
West Ward Pharm Corp	ROCURONIUM BROMIDE	rocuronium bromide	INJECTABLE;INJECTION	204679-001	Feb 28, 2017	AP	RX	No	No
Steriscience	ROCURONIUM BROMIDE	rocuronium bromide	INJECTABLE;INJECTION	217092-001	Jul 22, 2024	AP	RX	No	No
Mylan Institutional	ROCURONIUM BROMIDE	rocuronium bromide	INJECTABLE;INJECTION	079199-002	Nov 26, 2008	AP	RX	No	No
Sandoz	ROCURONIUM BROMIDE	rocuronium bromide	INJECTABLE;INJECTION	079195-001	Dec 5, 2008	AP	RX	No	No
Caplin	ROCURONIUM BROMIDE	rocuronium bromide	INJECTABLE;INJECTION	216234-001	Mar 2, 2023	AP	RX	No	No
Shandong	ROCURONIUM BROMIDE	rocuronium bromide	INJECTABLE;INJECTION	215684-001	Jul 12, 2024	AP	RX	No	No

Expired US Patents for ROCURONIUM BROMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Usa Inc	ZEMURON	rocuronium bromide	INJECTABLE;INJECTION	020214-001	Mar 17, 1994	4,894,369*PED
Organon Usa Inc	ZEMURON	rocuronium bromide	INJECTABLE;INJECTION	020214-003	Mar 17, 1994	4,894,369*PED
Organon Usa Inc	ZEMURON	rocuronium bromide	INJECTABLE;INJECTION	020214-002	Mar 17, 1994	4,894,369*PED

International Patents for ROCURONIUM BROMIDE

Country	Patent Number	Title	Estimated Expiration
Mexico	2015004056	COMPOSCIONES ACUOSAS ESTABILIZADAS DE AGENTES DE BLOQUEO NEUROMUSCULAR. (STABILIZED AQUEOUS COMPOSITIONS OF NEUROMUSCULAR BLOCKING AGENTS.)
South Africa	201408945	STABILIZED AQUEOUS COMPOSITIONS OF NEUROMUSCULAR BLOCKING AGENTS
Japan	6347784
Russian Federation	2695226	СТАБИЛИЗИРОВАННЫЕ ВОДНЫЕ КОМПОЗИЦИИ НЕЙРОМЫШЕЧНЫХ БЛОКАТОРОВ (STABILIZED LIQUID COMPOSITIONS OF NEUROMUSCULAR BLOCKERS)
Australia	2013322897
Taiwan	I595876
European Patent Office	2712611	Compositions aqueuses stabilisées d'agents de blocage neuromusculaire (Stabilized aqueous compositions of neuromuscular blocking agents)

Supplementary Protection Certificates for ROCURONIUM BROMIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0287150	96C0038	Belgium		PRODUCT NAME: ROCURONIUMBROMIDE; NAT. REGISTRATION NO/DATE: 63 IS 9 F 12 19960709; FIRST REGISTRATION: NL RVG 16946 19940406

Market Dynamics and Financial Trajectory for Rocuronium Bromide

Last updated: July 27, 2025

Introduction

Rocuronium bromide, a non-depolarizing neuromuscular blocking agent, has cemented its position in anesthesia practice due to its rapid onset and intermediate duration of action. Its pivotal role in facilitating intubation and muscle relaxation during surgery sustains significant demand within the global pharmaceutical landscape. As the healthcare sector evolves, understanding the market dynamics and financial trajectory of rocuronium bromide becomes essential for stakeholders, encompassing pharmaceutical manufacturers, healthcare providers, and investors.

Market Overview

Global Market Size and Growth Trends

The global neuromuscular blocking agents (NMBAs) market was valued at approximately USD 1.2 billion in 2022, with rocuronium bromide comprising a substantial segment, reflecting its widespread clinical adoption [[1]](). The compound's market is anticipated to grow at a compound annual growth rate (CAGR) of around 6-8% during 2023–2028, driven by increasing surgical procedures, rising anesthesia use, and expanding healthcare infrastructure in emerging markets.

Key Market Drivers

• Rising Surgical Volume: The global rise in elective and emergency surgeries increases demand for muscle relaxants like rocuronium bromide. The American Society of Anesthesiologists reports a steady yearly increase in surgical procedures, especially in minimally invasive surgeries where rapid intubation is critical [[2]]().
• Advancements in Anesthesia Protocols: The transition toward faster-acting agents with fewer side effects promotes the preference for rocuronium bromide over older agents like pancuronium.
• Emerging Markets: Rapid expansion of healthcare infrastructure in Asia-Pacific and Latin America presents new opportunities, with a significant uptick in surgical cases and demand for modern anesthetic agents.
• Competitiveness and Product Innovations: Continuous formulation improvements and the introduction of generic versions bolster market accessibility and affordability.

Market Challenges

• Generic Competition: The patent expiration of brand-name formulations has increased generic penetration, exerting price pressures.
• Regulatory Hurdles: Stringent approval processes and evolving safety standards can delay product launches in certain markets.
• Supply Chain Disruptions: Factors such as geopolitical issues, pandemics (notably COVID-19), and raw material shortages impact production capacity.
• Adverse Event Concerns: Rare but serious side effects, such as anaphylaxis, necessitate cautious use, potentially affecting market growth.

Competitive Landscape

The market landscape is characterized by the dominance of several key players, including:

• Merck KGaA (EMEND)
• Pfizer Inc.
• Fresenius Kabi
• Bridion (sugammadex) competitors (which, while not direct competitors, influence market dynamics)
• Regional generic manufacturers emerging in Asia and Eastern Europe

Patent expirations, notably Pfizer’s patent for Rochcuronium bromide, have catalyzed generics' availability, significantly impacting pricing and market share distribution.

Financial Trajectory

Revenue Trends

Pharmaceutical companies engaged in rochetium bromide production have experienced steady revenue streams. For instance, Pfizer's sales from their rocuronium bromide formulations increased initially post-launch, with margins impacted by generic competition thereafter. The global revenues are projected to maintain an upward trajectory, with hybrids of branded and generic products balancing profitability and market penetration.

Pricing Dynamics

Pricing has seen downward pressure due to generic proliferation. While branded formulations previously commanded premiums, a shift towards cost-effective generics has redefined revenue potential:

• Brand-name formulations still hold premium pricing in developed regions.
• Generics offer volume-driven revenues in emerging markets, fostering profitability through scale.

Profitability and Investment

Investments in process innovation, such as improved synthesis and formulation to extend shelf life and reduce costs, have been pivotal. Additionally, strategic partnerships with regional manufacturers boost market access and minimize distribution costs.

Market Risks and Opportunities

• The potential for biosimilar development in neuromuscular blockade agents could diversify technological opportunities.
• Increasing prevalence of anesthesia-related adverse events necessitates R&D investments into safer formulations, creating new revenue streams.
• Regulatory uncertainties, especially in markets with evolving standards, pose financial risks but also encourage strategic positioning.

Future Outlook

The financial outlook for rocuronium bromide remains promising, supported by ongoing surgical demand and technological advancements. Industry forecasts predict steady revenue growth, especially as newer formulations and combination therapies emerge. However, price competition and regulatory landscapes will continue to influence profitability margins.

Regulatory and Patent Landscape

Patent expirations and biosimilar transitions are expected to reshape the market dynamics significantly around 2025–2027, emphasizing the importance of intellectual property management and strategic R&D for sustaining competitive advantage [[3]](). Countries' regulatory pathways for generics and biosimilars influence market access and, consequently, the financial trajectory.

Concluding Remarks

The market for rocuronium bromide is poised for steady growth, primarily driven by surgical volume increases and healthcare infrastructure expansion across high-growth regions. While challenges such as price competition and regulatory hurdles are prevalent, innovation, strategic partnerships, and regional market penetration will underpin the financial trajectory of key industry players.

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Key Takeaways

• The global rocuronium bromide market is projected to grow at a CAGR of 6-8% through 2028, driven by rising surgical procedures and healthcare expansion.
• Generic competition has significantly impacted pricing strategies, necessitating innovation and cost optimization for sustained profitability.
• Emerging markets represent vital growth opportunities, with healthcare infrastructure development facilitating increased demand.
• Strategic patent management and investments in formulation improvements are crucial for maintaining market share and revenue streams.
• Regulatory evolutions and biosimilar developments will influence future market shares and profitability.

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FAQs

1. How does patent expiration affect the financial trajectory of rocuronium bromide?
Patent expiration facilitates the entry of generic manufacturers, increasing market competition and reducing prices. While this may lower revenues for brand-name producers, it expands overall market volume and access, creating opportunities in emerging markets.

2. What are the primary factors influencing pricing strategies for rocuronium bromide?
Pricing is influenced by patent status, generic availability, regional regulatory requirements, manufacturing costs, and market competition. Cost-efficiency and strategic partnerships help maintain profitability amid price pressures.

3. Which regions offer the most growth potential for rocuronium bromide?
Emerging markets in Asia-Pacific, Latin America, and parts of Eastern Europe present significant growth potential due to expanding healthcare infrastructure and increasing surgical procedures.

4. How do regulatory challenges impact the market dynamics?
Variable approval processes and evolving safety standards can delay product launches, affect pricing, and require companies to invest in compliance and clinical studies, impacting financial outcomes.

5. What technological or formulation innovations could shape the future financial outlook?
Formulation improvements that enhance safety, efficacy, or shelf life, as well as development of biosimilars, could open new revenue streams and improve profitability in an increasingly competitive landscape.

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Sources

1. Market Research Future, 2022
2. American Society of Anesthesiologists, 2021
3. Pharmaceutical Regulatory Affairs, 2022