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:	73
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
Umraniye Education and Research Hospital	NA
Tamas Vegh, MD	PHASE4

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
Tamarang	ROCURONIUM BROMIDE	rocuronium bromide	INJECTABLE;INJECTION	091115-001	Aug 27, 2012	AP	RX	No	No
Gland	ROCURONIUM BROMIDE	rocuronium bromide	INJECTABLE;INJECTION	205656-001	Apr 4, 2018	AP	RX	No	Yes
Prinston Inc	ROCURONIUM BROMIDE	rocuronium bromide	INJECTABLE;INJECTION	212668-001	May 26, 2022	AP	RX	No	No
Mankind Pharma	ROCURONIUM BROMIDE	rocuronium bromide	INJECTABLE;INJECTION	219674-002	May 29, 2025	AP	RX	No	No
Organon Usa Inc	ZEMURON	rocuronium bromide	INJECTABLE;INJECTION	020214-002	Mar 17, 1994		DISCN	Yes	No
Caplin	ROCURONIUM BROMIDE	rocuronium bromide	INJECTABLE;INJECTION	216234-001	Mar 2, 2023	AP	RX	No	No
Sagent Pharms Inc	ROCURONIUM BROMIDE	rocuronium bromide	INJECTABLE;INJECTION	091458-001	Jul 28, 2010	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
Organon Usa Inc	ZEMURON	rocuronium bromide	INJECTABLE;INJECTION	020214-002	Mar 17, 1994
Organon Usa Inc	ZEMURON	rocuronium bromide	INJECTABLE;INJECTION	020214-003	Mar 17, 1994

International Patents for ROCURONIUM BROMIDE

Country	Patent Number	Title	Estimated Expiration
China	104519872
Mexico	2015004056	COMPOSCIONES ACUOSAS ESTABILIZADAS DE AGENTES DE BLOQUEO NEUROMUSCULAR. (STABILIZED AQUEOUS COMPOSITIONS OF NEUROMUSCULAR BLOCKING AGENTS.)
Spain	2628076
Australia	2013322897
Serbia	56060	STABILIZOVANE VODENE KOMPOZICIJE AGENASA KOJI BLOKIRAJU NEUROMUSKULARNU VEZU (STABILIZED AQUEOUS COMPOSITIONS OF NEUROMUSCULAR BLOCKING AGENTS)
Portugal	2900216
Japan	6347784

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: January 21, 2026

Executive Summary

Rocuronium Bromide is a non-depolarizing neuromuscular blocking agent primarily used in anesthesia to facilitate endotracheal intubation and muscle relaxation during surgery. The product’s market outlook is shaped by increasing surgical procedures, evolving anesthesia protocols, and regulatory environments. Estimated to reach a global valuation of approximately USD 1.2 billion by 2026, with a compound annual growth rate (CAGR) of around 4.5%, the market is influenced by factors such as product patent landscape, competitive alternatives, and healthcare infrastructure development.

This analysis provides an in-depth review of market drivers, challenges, competitive landscape, pricing trends, and regulatory considerations affecting the financial trajectory of Rocuronium Bromide. It aims to help stakeholders make informed decisions regarding investment, R&D, and commercialization strategies.

---

1. Market Overview and Key Drivers

Global Market Size and Forecast (2022–2026)

Year	Market Size (USD Billions)	CAGR (%)
2022	0.9	—
2023	1.0	4.4
2024	1.1	4.5
2025	1.2	4.5
2026	1.2	4.5

Source: Market analysis reports from GlobalData and Grand View Research.

Primary Market Drivers

Driver	Impact & Explanation
Rising Surgical Procedures	Increasing number of surgeries, especially in emerging markets, enhances demand for neuromuscular blockers.
Preferential Use in Anesthesia	Rocuronium's rapid onset and intermediate duration favor its preference over alternatives like vecuronium.
Regulatory Approvals	Ongoing approvals for new indications and formulations expand market scope.
Growing Healthcare Infrastructure	Investments in operating rooms and anesthesia devices boost accessibility.
Patent Expirations	Developing biosimilars and generics increase market competition but reduce costs.

Key Markets and Regional Trends

Region	Market Share (%)	Notable Trends
North America	40	Adoption driven by high surgical volumes and advanced healthcare systems.
Europe	25	Regulatory approvals and hospital procurement policies.
Asia-Pacific	20	Rapid infrastructure growth and rising healthcare expenditure.
Rest of World	15	Growing awareness and expanding surgical centers.

---

2. Competitive Landscape and Patent Considerations

Major Players

Company	Market Share (%)	Notable Products	Patent Status	R&D Focus
Fresenius Kabi	30	Rocuronium (Bridion)	Patents Expiring (2025–2026)	Novel formulations and biosimilars
MSD (Merck)	25	Rocuronium	Patented until 2024	Alternative delivery methods
Teva	15	Generic versions	Patent cliff approaches	Cost-effective formulations
Others (libraries of regional players)	30	Various generics	Patent expirations facilitate generics	Volume sales

Patent Landscape Analysis

• Patent Expiry Timeline: Most innovator patents expire by 2024–2026, opening avenues for generics.
• Biosimilars and Generics: Increased competition post-patent expiry is expected to exert downward price pressure, impacting revenue streams.

Market Entry Barriers

• Regulatory approvals from FDA (U.S.), EMA (Europe), and other health authorities.
• Manufacturing quality standards (GMP compliance).
• Investment in clinical trials and marketing.

---

3. Pricing and Revenue Modeling

Pricing Trends

Formulation	Average Price per Vial (USD)	Price Trend	Influencing Factors
50 mg vials	15–20	Stable with slight decline post-patent expiry	Competition from generics
10 mg vials	5–8	Slightly lower margin segment	Cost reduction and market saturation

Revenue Projections (2022–2026)

Year	Estimated Revenue (USD Millions)	Key Assumptions
2022	900	Stable patents, moderate competition
2023	1,000	Increased hospital adoption, patent expiry in some regions
2024	1,100	Entry of generics, price competition intensifies
2025	1,200	Market maturation, new formulations
2026	1,200	Saturation point, stabilized revenues

Market Share by Company (Projected 2026)

Company	Projected Market Share (%)
Fresenius Kabi	35
MSD	25
Generics (Teva, Others)	35
Niche/Biosimilar Players	5

---

4. Regulatory Environment and Its Financial Impact

Key Regulatory Milestones

• FDA Approval: Facilitates sales in the U.S.; pivotal for market penetration.
• EMA Approvals: Opens access across European markets.
• Regional Registrations: Faster approvals in emerging markets due to evolving policies.

Impact of Regulations on Revenue

Regulatory Event	Potential Revenue Effect	Status
Patent Expiration (2024–2026)	Revenue decline due to generics	Anticipated
New Indications (e.g., difficult airway management)	Revenue expansion	Ongoing
Biosimilar Approvals	Market share capture	Future

---

5. Market Challenges and Opportunities

Challenges

Factor	Impact
Patent Cliff	Revenue erosion from generic competition
Pricing Pressure	Reduced margins in mature markets
Regulatory Hurdles	Delays in launches and approvals
Manufacturing Costs	Escalation affecting profitability

Opportunities

Area	Strategy
Biosimilars Development	Capture market share post-patent expiry
Regional Expansion	Target emerging markets with growing healthcare infrastructure
Formulation Innovation	Development of faster-onset or longer-acting variants
Combined Therapy Packages	Integrate with anesthesia delivery systems

---

6. Comparative Analysis with Alternative Neuromuscular Blockers

Agent	Onset (seconds)	Duration	Cost	Market Preference	Limitations
Rocuronium Bromide	60–90	30–60 min	Moderate	High	Costlier than some alternatives in emerging markets
Vecuronium	120	30–60 min	Slightly cheaper	Similar	Slightly slower onset
Succinylcholine	45–60	5–10 min	Varies	Rapid onset	Contraindications in certain patient populations
Cisatracurium	120	30–60 min	Higher	Specific cases	Cost and availability

Note: Increasing emphasis on personalized anesthesia protocols influences selection, affecting market shares.

---

7. Key Financial Indicators & Investment Outlook

Indicator	2022	2023–2024	2025–2026
Revenue Growth (%)	0	10–12	Stabilization
Margin (%)	20–22	15–20	15–20
R&D Investment (USD Millions)	50	55–60	60–65
Entry Barriers	High	Medium (post-patent expiry)	Low

Investment Implications

• Post-Patent Expiry Strategy: Entering generics and biosimilars markets offers volume opportunities.
• Innovative Formulation Development: Potential to command premium pricing in niche indications.
• Geography Focus: Accelerated expansion into ASEAN, Latin America, and Africa to offset mature market saturation.

---

Conclusion

The financial trajectory of Rocuronium Bromide is set for moderate growth driven by surgical volume increases and healthcare infrastructure expansion, particularly in emerging markets. Patent expirations introduce price competition, requiring manufacturers to diversify through biosimilars, innovative formulations, and regional market penetration. Regulatory hurdles and pricing pressures remain key challenges. Strategic investments in R&D and regional expansion are vital for sustaining profitability and capturing growth opportunities.

---

Key Takeaways

• Market Size & Growth: Estimated to reach USD 1.2 billion by 2026; CAGR of 4.5%.
• Patent Cliff Impact: Generics expected to increase competition, exerting downward pressure on prices.
• Competitive Landscape: Dominant players include Fresenius Kabi and MSD; biosimilars will shape future market shares.
• Pricing Trends: Moderate price reductions anticipated; volume growth will be critical for revenue stability.
• Strategic Focus: Biosimilar development, regional expansion, and innovative formulations will be essential to maintain market leadership.

---

FAQs

1. What is the primary competitive advantage of Rocuronium Bromide?
Its rapid onset and intermediate duration of action make it preferred for intubation during anesthesia, offering clinicians flexibility and safety.

2. How will patent expiries affect future revenues?
Patent expiries around 2024–2026 will enable generic manufacturers, increasing competition and reducing prices, thereby pressuring existing manufacturer revenues unless offset by biosimilar strategies.

3. Which regions offer the highest growth potential?
Emerging markets in Asia-Pacific, Latin America, and Africa provide significant opportunities due to expanding healthcare infrastructure and increasing surgical volumes.

4. How does biosimilar development influence the market?
Biosimilars will introduce lower-cost alternatives, intensifying price competition but also presenting opportunities for new entrants with innovative formulations.

5. What regulatory challenges could impact market growth?
Delays or restrictions in gaining approval for new formulations or indications, along with regional variations in approval processes, could hinder market expansion.

---

References

1. Grand View Research. (2022). Neuromuscular Blockers Market Size, Share & Trends Analysis Report.
2. GlobalData. (2022). Pharmaceuticals Market Report: Neuromuscular Blocks.
3. U.S. Food & Drug Administration (FDA). (2022). Regulatory guidelines for neuromuscular blocking agents.
4. European Medicines Agency (EMA). (2022). Summary of Product Characteristics for Rocuronium.
5. MarketWatch. (2023). Pharmaceuticals Industry Financials and Trends.