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Last Updated: December 12, 2025

ATRACURIUM BESYLATE Drug Patent Profile


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Which patents cover Atracurium Besylate, and when can generic versions of Atracurium Besylate launch?

Atracurium Besylate is a drug 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-two NDAs.

The generic ingredient in ATRACURIUM BESYLATE is atracurium besylate. There are sixteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the atracurium besylate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Atracurium Besylate

A generic version of ATRACURIUM BESYLATE was approved as atracurium besylate by HIKMA on July 18th, 1997.

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Fayoum University HospitalNA
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Tanta UniversityN/A

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Medical Subject Heading (MeSH) Categories for ATRACURIUM BESYLATE

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
Baxter Hlthcare ATRACURIUM BESYLATE atracurium besylate INJECTABLE;INJECTION 074824-001 Sep 30, 1997 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Hospira ATRACURIUM BESYLATE PRESERVATIVE FREE atracurium besylate INJECTABLE;INJECTION 074741-001 Mar 28, 1997 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Hospira Inc ATRACURIUM BESYLATE atracurium besylate INJECTABLE;INJECTION 090761-001 Oct 18, 2012 AP RX 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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Atracurium Besylate

Last updated: July 27, 2025


Introduction

Atracurium besylate, a non-depolarizing neuromuscular blocking agent, is extensively utilized in anesthesia practice to facilitate endotracheal intubation and muscle relaxation during surgical procedures. Its unique pharmacokinetic properties, including Hofmann elimination, make it a preferred choice in specific clinical settings. This article examines the current market landscape, growth drivers, challenges, and the financial outlook for atracurium besylate, grounded in recent industry data and trends.


Market Overview and Size

The global neuromuscular blocking agents (NMBAs) market, including atracurium besylate, was valued at approximately USD 600 million in 2022 and is projected to reach USD 800 million by 2030, registering a compound annual growth rate (CAGR) of around 4.2% [1]. Atracurium’s share within this segment remains significant, owing to its considerable prevalence in both developed and emerging markets.

Key regional contributions include North America, with dominant market share driven by high procedural volumes and advanced healthcare infrastructure. Europe follows, supported by aging populations and increased surgical procedures. Asia-Pacific emerges as a substantial growth frontier, driven by expanding healthcare access, rising surgical procedures, and increasing adoption of anesthesia drugs in emerging economies such as India and China.


Market Drivers

1. Rising Surgical Volumes

Global surgeries are on the rise, notably in oncology, cardiovascular, and orthopedic procedures. According to the World Health Organization, surgical volumes increased by over 15% globally from 2015 to 2019, creating sustained demand for neuromuscular blockers such as atracurium [2].

2. Advancements in Anesthesia Techniques

Growing adoption of advanced anesthetic protocols, emphasizing safety and efficiency, bolsters the demand for reliable neuromuscular blocking agents. Atracurium’s predictable pharmacokinetic profile and minimal cardiovascular side effects make it ideal, especially in sessions requiring controlled muscle relaxation.

3. Increased Focus on Patient Safety

The safety profile of atracurium, characterized by spontaneous Hofmann elimination at physiological pH and temperature, minimizes adverse effects and metabolite accumulation. This positions it favorably amidst changing regulations emphasizing patient safety and drug efficacy.

4. Rising Healthcare Expenditure

Global healthcare spending spurs investment in surgical infrastructure, leading to higher procurement of anesthetic agents. In 2021, worldwide healthcare expenditure exceeded USD 8.3 trillion, with a persistent upward trend supporting sustained drug demand [3].


Market Challenges

1. Competition from Alternative Neuromuscular Blockers

Atracurium faces stiff competition from agents like rocuronium and vecuronium, which offer rapid onset and reversal capabilities through newer reversal agents. The development and approval of these drugs, along with their marketing, threaten atracurium's market share.

2. Patent Expiry and Generic Competition

Most formulations of atracurium besylate have lost patent protection, leading to the proliferation of generic versions that exert downward pressure on prices and profit margins.

3. Regulatory Concerns and Pricing Pressures

Governments and insurance providers are increasingly enforcing cost-containment measures, especially in cost-sensitive markets such as India and parts of Africa. This results in price erosion and challenges for branded formulations.

4. Supply Chain and Manufacturing Challenges

Complex manufacturing processes and raw material sourcing, including the need for high-quality benzyl chloride and other intermediates, pose risks related to supply chain disruptions, which could impact availability and pricing.


Key Market Players

Major pharmaceutical companies involved in manufacturing atracurium besylate include Mediolife, Hospira (Pfizer), and Teva Pharmaceutical Industries Ltd. These players are investing in manufacturing capacity expansion, regulatory approvals, and marketing to maintain or grow their market positions.

Emerging biotech firms are also exploring novel neuromuscular blockade agents with improved safety profiles, potentially disrupting traditional markets, including atracurium.


Financial Trajectory and Future Outlook

The financial landscape reflects a balanced mix of opportunities and threats. The low-cost generic manufacturing of atracurium besylate ensures steady revenue streams but limits high-margin potential in mature markets. Notably, the rise of biosimilar formulations and value-added drug delivery systems might open new revenue channels.

Projected Growth

Given the steady evolution of surgical procedures and technological advancements in anesthesia, atracurium’s market is poised for moderate CAGR growth of around 3.5-4% over the next decade. The Asian-Pacific region could witness higher growth rates, exceeding 6%, thanks to increasing healthcare infrastructure and government initiatives.

Profitability Trends

Profit margins are expected to remain constrained due to generic price competition. Companies that diversify through product innovation, such as fixed-dose combinations or targeted delivery systems, could enhance profitability. Value-added formulations with extended shelf-life or simplified administration may command premium pricing.

Moreover, emerging markets’ propensity to adopt generic drugs offers volume-driven growth that compensates for low per-unit margins.


Regulatory and Policy Impact

Regulatory bodies such as the FDA, EMA, and PMDA continue to oversee safety and efficacy standards. Recent regulatory focus has been on minimizing adverse drug reactions and ensuring transparency in manufacturing processes. Stringent regulations could marginally increase compliance costs but also serve as barriers to entry for smaller players.

Policies promoting cost-effective healthcare, like centralized procurement in public systems, will influence pricing strategies and profitability margins, especially in government-driven markets.


Strategic Opportunities

Companies can capitalize on technological advancements, such as the development of optimized formulations that reduce dosage and administration costs, to differentiate their products. Engaging in strategic collaborations for market penetration in emerging economies can bolster revenue streams.

Investments in manufacturing efficiencies and raw material sourcing, coupled with proactive regulatory engagement, will bolster supply chain resilience and market share.


Key Takeaways

  • Stability in a Mature Market: Atracurium besylate sustains a stable market with consistent demand driven by a broad surgical application base.
  • Growth in Emerging Markets: Asia-Pacific and Latin America are pivotal regions for accelerated demand growth, owing to expanding healthcare infrastructure.
  • Competitive Pressures: Price competition from generics and emerging neuromuscular blockers necessitate differentiation and innovation.
  • Regulatory Landscape: Evolving safety standards and cost-containment policies will influence future pricing and market access strategies.
  • Innovation Potential: Development of improved formulations and combination therapies offers pathways for revenue diversification.

Conclusion

Atracurium besylate maintains a vital position within anesthesia pharmacology, supported by its pharmacological advantages and ongoing surgical demand. While faced with competitive and regulatory challenges, strategic initiatives focusing on market expansion, manufacturing innovation, and value-based therapies can sustain its financial trajectory. Stakeholders poised to adapt to these dynamics will optimize growth opportunities amid a cautiously optimistic outlook for this essential neuromuscular blocking agent.


FAQs

1. How does atracurium besylate compare to other neuromuscular blocking agents?
Atracurium offers predictable pharmacokinetics with minimal cardiovascular side effects, making it preferable in patients with cardiac comorbidities. Unlike newer agents like rocuronium, it does not require reversal agents like sugammadex, which can influence its clinical choice.

2. What factors influence the pricing of atracurium besylate in different markets?
Pricing is driven by generic competition, procurement practices, regulatory policies, raw material costs, and regional healthcare expenditure. Price erosion is more pronounced in markets with intense generic competition.

3. Are there recent innovations in neuromuscular blockade that could impact atracurium’s market share?
Yes, development of rapid-onset agents with reversal capabilities, such as rocuronium with sugammadex, poses competition, particularly in settings prioritizing quick recovery.

4. What are the main markets for atracurium besylate currently?
North America and Europe are established markets, with significant growth potential in Asia-Pacific and Latin America due to expanding surgical procedures and healthcare infrastructure.

5. How might regulatory changes affect future sales of atracurium besylate?
Enhanced safety regulations and approvals for biosimilar or alternative agents could influence demand, but consistent clinical utility ensures maintained relevance, especially if compliance costs are managed effectively.


References

[1] Market Research Future. "Neuromuscular Blocking Agents Market Analysis." 2022.

[2] World Health Organization. "Surgical Procedures and Global Surgical Volume." 2020.

[3] World Bank. "Healthcare Expenditure Data." 2022.

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