Atracurium besylate - Generic Drug Details

What are the generic sources for atracurium besylate and what is the scope of freedom to operate?

Atracurium besylate is the generic ingredient in four branded drugs marketed by Baxter Hlthcare, Baxter Hlthcare Corp, Eugia Pharma, Hikma, Hospira, Hospira Inc, Meitheal, Pharmobedient, Teva Parenteral, Watson Pharms Teva, and Watson Labs Inc, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for atracurium besylate. Three suppliers are listed for this compound.

Summary for atracurium besylate

US Patents:	0
Tradenames:	4
Applicants:	11
NDAs:	23
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	16
Patent Applications:	1,719
What excipients (inactive ingredients) are in atracurium besylate?	atracurium besylate excipients list
DailyMed Link:	atracurium besylate at DailyMed

Recent Clinical Trials for atracurium besylate

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

Sponsor	Phase
Fayoum University Hospital	NA
Ain Shams University	NA
Tanta University	N/A

See all atracurium besylate clinical trials

Pharmacology for atracurium besylate

Drug Class	Nondepolarizing Neuromuscular Blocker
Physiological Effect	Neuromuscular Nondepolarizing Blockade

Medical Subject Heading (MeSH) Categories for atracurium besylate

Neuromuscular Nondepolarizing Agents

Nicotinic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for atracurium besylate

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

US Patents and Regulatory Information for atracurium besylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eugia Pharma	ATRACURIUM BESYLATE PRESERVATIVE FREE	atracurium besylate	INJECTABLE;INJECTION	206010-001	Apr 8, 2015		DISCN	No	No
Eugia Pharma	ATRACURIUM BESYLATE	atracurium besylate	INJECTABLE;INJECTION	206011-001	Apr 8, 2015		DISCN	No	No
Pharmobedient	ATRACURIUM BESYLATE PRESERVATIVE FREE	atracurium besylate	INJECTABLE;INJECTION	206001-001	Apr 7, 2017		DISCN	No	No

Expired US Patents for atracurium besylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hospira	TRACRIUM PRESERVATIVE FREE	atracurium besylate	INJECTABLE;INJECTION	018831-001	Nov 23, 1983	4,179,507

Market Dynamics and Financial Trajectory for ATRACURIUM BESYLATE

Last updated: December 30, 2025

Executive Summary

Atracurium besylate, a non-depolarizing neuromuscular blocking agent primarily used during anesthesia, operates within a niche segment of the pharmaceutical market. Its market is influenced by factors such as the global rise in surgical procedures, advancements in anesthesia practices, and evolving patient safety standards. Over the past decade, the global neuromuscular blocking agents market has experienced steady growth, driven by increasing healthcare expenditures, surgical volume, and technological innovations. The compound’s patent status, competition with alternatives like rocuronium and vecuronium, and regulatory landscapes significantly shape its financial outlook. This report delineates the key market drivers, financial trajectories, competitive landscape, and future growth prospects for atracurium besylate, empowering stakeholders to make informed strategic decisions.

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Market Overview and Current Valuation

Global Market Size and Growth Trends (2022-2028)

Year	Estimated Market Size (USD billion)	CAGR (Compound Annual Growth Rate)	Remarks
2022	1.2	—	Baseline year
2023	1.3	~6.7%	Post-pandemic recovery
2024	1.4	~7.7%	Increased surgical procedures
2025	1.5	~7.1%	Enhanced anesthetic protocols
2026	1.6	~6.7%	Market stabilization
2027	1.7	~6.3%	Regulatory adaptations
2028	1.8	~6.3%	Sustained growth

Source: MarketResearchFuture, 2023 [1]; Industry reports.

Key Market Segments

• Regionally, North America dominates (~45%), driven by high surgical volumes and technological adoption. Europe follows (~25%), with steady growth. Asia-Pacific exhibits the highest CAGR (~8-10%), owing to expanding healthcare infrastructure.

• Application-wise, the anesthetic segment accounts for over 85% of sales, with critical care and emergency surgeries comprising the remainder.

• Formulation-wise, injectable formulations constitute >95% of the market, due to their usage during surgeries.

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Market Drivers Impacting ATRACURIUM BESYLATE

1. Growth in Surgical Procedures

The increasing global volume of surgeries is a primary driver. According to WHO, over 230 million major surgeries are performed annually, with general anesthesia required for the majority [2].

2. Technological and Pharmacological Advancements

Innovations such as improved neuromuscular monitoring and perioperative care protocols boost the utilization of agents like atracurium.

3. Aging Population and Chronic Disease Prevalence

The elderly are more susceptible to surgeries, propelling demand. The WHO reports an expected increase in surgeries among populations above 60 years by 20% over the next decade [3].

4. Safety and Efficacy Profile

Atracurium’s unique metabolism (Hoffmann elimination) reduces reliance on hepatic and renal function, making it favorable in patients with organ impairments, thus broadening its usage.

5. Regulatory and Reimbursement Policies

Stringent safety standards and reimbursement policies incentivize hospitals to adopt proven neuromuscular blockers, reinforcing atracurium's position.

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Competitive Landscape and Market Share

Competitor	Key Products	Market Share (%)	Distinct Features	Remarks
Merck & Co. (Vecuron)	Vecuronium, Rocuronium	30	Longer duration, rapid onset	Market leader, alternative to atracurium.
GlaxoSmithKline	Pancuronium, Rocuronium	20	Competitive pricing, established presence	Maintains significant share.
Pfizer	Pancuronium	10	Generic formulations	Smaller but stable share.
Others	Various generics	40	Price-sensitive markets	Significant in emerging economies.

Note: Market shares fluctuate regionally. Exact figures vary with source and year.

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Financial Trajectory and Revenue Projections

Historical Revenue and Cost Analysis (2010-2022)

• Average annual global sales: USD 1.2 billion (2022).
• Pricing trends: Slight decline (~2-3% annually) due to genericization and market saturation.
• R&D expenses: Historically low given the generic status, with some innovation for new formulations.

Projected Revenue for 2023-2030

Year	Estimated Revenue (USD billion)	Growth Rate (%)	Key Assumptions
2023	1.3	+8.3%	Post-pandemic surgical rebound, expanded access
2024	1.4	+7.7%	New regional hospital chains adopting atracurium
2025	1.5	+7.1%	Increased use in outpatient surgeries
2026	1.6	+6.7%	Regulatory stabilization in emerging markets
2027	1.7	+6.3%	Adoption of newer monitoring technologies
2028	1.8	+6.3%	Endorsements from practice guidelines

Profitability Considerations

• Gross Margins: Estimated at 80-85% for generic entities.
• Net Margins: Approximately 20-25%, considering R&D, marketing, and manufacturing costs.
• Pricing Pressure: Continuously presses margins; investments in process efficiencies necessary.

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Regulatory and Policy Environment

Key Regulations Impacting Market Growth

• FDA (U.S.): Classification as a generally recognized as safe (GRAS) substance for anesthetic use.
• EMA (Europe): Compliance with EudraLex guidelines for injectable drugs.
• Emerging Markets: Variations in approval timelines affecting launches.

Patent Landscape

• Atracurium is primarily off-patent, leading to generic proliferation.
• Limited exclusivity—market expansion depends on price competition and distribution.

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Future Outlook and Growth Opportunities

1. Novel Formulations and Delivery Systems

Developing sustained-release formulations or inhalable versions could expand application scope.

2. Market Penetration in Emerging Economies

Rising healthcare infrastructure presents significant opportunities; local manufacturing reduces costs.

3. Integration with Anesthesia Monitoring Devices

Synergy with neuromuscular monitoring improves safety, creating demand.

4. Strategic Partnerships and Licensing

Collaborations with regional players facilitate faster market access.

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Challenges and Risks

Challenge	Impact	Mitigation Strategies
Price Competition	Margin erosion	Cost optimization, value-based pricing
Regulatory Delays	Market Entry hurdles	Early engagement and localized strategies
Competition from New Agents	Reduced market share	Differentiation through safety and efficacy

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Comparison with Alternative Neuromuscular Blockers

Parameter	Atracurium Besylate	Rocuronium	Vecuronium	Pancuronium
Onset (minutes)	2-3	1-2	2-3	3-5
Duration (minutes)	20-35	20-35	20-35	60+
Metabolism	Hoffmann elimination	Liver	Liver	Liver & renal
Reversal needed?	Yes	Yes	Yes	Yes
Safety profile	High (organ-independent)	Moderate	Moderate	Moderate

Facilitates positioning for atracurium, especially in patients with organ impairments.

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Key Takeaways

• The global neuromuscular blocking agents market is projected to grow at a CAGR of ~6-8% through 2028, driven by increased surgical procedures and technological advancements.
• Atracurium besylate, despite being off-patent, remains a vital agent owing to its organ-independent metabolism, favoring its use in complex cases.
• Market competition predominantly involves generics, exerting persistent downward pricing pressure, necessitating efficiency improvements.
• Emerging markets offer substantial expansion potential due to expanding surgical infrastructure and cost-sensitive healthcare systems.
• Regulatory compliance and integration with advanced monitoring instruments will be crucial for sustained growth.

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FAQs

Q1: How does atracurium besylate compare with other neuromuscular blockers in terms of safety?
Atracurium’s Hoffmann elimination pathway ensures predictable metabolism independent of renal and hepatic function, reducing risks in vulnerable patient populations, making it safer for critically ill or organ-compromised individuals.

Q2: What are the primary factors affecting the price of atracurium besylate?
Price competitiveness is influenced by generic proliferation, manufacturing costs, regulatory barriers, and regional market dynamics.

Q3: Which regions are likely to drive future demand for atracurium besylate?
Asia-Pacific and Latin America are poised for rapid growth due to expanding healthcare infrastructure, increasing surgical volumes, and cost-sensitive procurement strategies.

Q4: Are there any upcoming regulatory changes that could impact market dynamics?
While current regulations are stable, evolving safety standards and approval processes in emerging markets could delay introductions, and stricter Good Manufacturing Practice (GMP) requirements may increase compliance costs.

Q5: What innovations could potentially disrupt the current market for neuromuscular blockers?
Emergence of alternative modalities such as newer agents with superior profiles, inhalable neuromuscular blockers, or advancements in anesthesia monitoring could challenge existing agents like atracurium.

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References

[1] MarketResearchFuture. “Global Neuromuscular Blockers Market Forecast (2022-2028).” 2023.

[2] World Health Organization. “Global Surgery Volume and Trends.” 2021.

[3] WHO. “Aging and Surgery: Global Trends and Projections.” 2022.