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Last Updated: January 30, 2026

ATRACURIUM BESYLATE PRESERVATIVE FREE Drug Patent Profile


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When do Atracurium Besylate Preservative Free patents expire, and what generic alternatives are available?

Atracurium Besylate Preservative Free is a drug marketed by Baxter Hlthcare, Baxter Hlthcare Corp, Eugia Pharma, Hikma, Hospira, Hospira Inc, Meitheal, Pharmobedient, and Watson Labs Inc. and is included in eleven NDAs.

The generic ingredient in ATRACURIUM BESYLATE PRESERVATIVE FREE 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 Preservative Free

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

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  • What is the 5 year forecast for ATRACURIUM BESYLATE PRESERVATIVE FREE?
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Summary for ATRACURIUM BESYLATE PRESERVATIVE FREE
Drug patent expirations by year for ATRACURIUM BESYLATE PRESERVATIVE FREE
Pharmacology for ATRACURIUM BESYLATE PRESERVATIVE FREE

US Patents and Regulatory Information for ATRACURIUM BESYLATE PRESERVATIVE FREE

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 PRESERVATIVE FREE atracurium besylate INJECTABLE;INJECTION 074825-001 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
Hikma ATRACURIUM BESYLATE PRESERVATIVE FREE atracurium besylate INJECTABLE;INJECTION 074900-001 Jul 18, 1997 AP RX No Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Hospira Inc ATRACURIUM BESYLATE PRESERVATIVE FREE atracurium besylate INJECTABLE;INJECTION 090782-001 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 ATRACURIUM BESYLATE PRESERVATIVE-FREE

Last updated: January 8, 2026

Executive Summary

The global anesthetic muscle relaxant market is witnessing significant shifts driven by increasing surgical procedures, evolving patient safety standards, and regulatory changes favoring preservative-free formulations. ATRACURIUM BESYLATE PRESERVATIVE-FREE (ABPF), a neuromuscular blocking agent, positions itself within this growth trajectory due to its enhanced safety profile and demand from anesthetic providers seeking preservative-free options. This paper analyses current market drivers, financial forecasts, competitive landscape, and regulatory influences shaping ABPF’s future.


What Are the Market Drivers for ATRACURIUM BESYLATE PRESERVATIVE-FREE?

Growing Surgical Volume and Anesthesia Demand

  • The global surgical volume is projected to reach 312 million procedures annually by 2026, up from 253 million in 2018 (source: WHO).
  • Increased minimally invasive surgeries necessitate effective neuromuscular blockade agents, underpinning steady demand for atracurium derivatives.

Regulatory and Safety Considerations

  • Regulatory agencies such as the U.S. FDA and EMA favor preservative-free formulations to minimize hypersensitivity, anaphylaxis, and other adverse effects.
  • Preservative-free atracurium formulations mitigate risks associated with benzyl alcohol and other preservatives.

Patient Safety Initiatives and Institutional Preferences

  • Hospitals increasingly mandate preservative-free anesthetics, influencing procurement policies.
  • Enhanced safety profiles lead to higher adoption rates, especially in pediatric and outpatient settings.

Market Segmentation Driven by Healthcare Infrastructure Development

Segment Drivers Impact
Hospital & Surgical Centers Safety standards, surgical volume Primary consumers of ABPF
Ambulatory Surgical Centers Shorter procedure focus, safety concerns Growing segment, increasing demand
Pharmacovigilance & Aesthetic Procedures Less invasive, safety-driven Emerging niche

What Is the Current Financial Trajectory for ATRACURIUM BESYLATE PRESERVATIVE-FREE?

Market Size and Revenue Forecasts

  • The global neuromuscular blocking agents market was valued at USD 1.3 billion in 2022 and is projected to expand at a CAGR of approximately 6% over the next five years (source: Market Research Future).
  • ATRACURIUM BESYLATE, a significant segment, is forecasted to exhibit a Compound Annual Growth Rate (CAGR) of 5-7% owing to driver consolidation.

Pricing Dynamics

Factor Influence Estimated Impact on Pricing
Manufacturing Costs Increase with preservative-free formulations Upward pressure
Regulatory Compliance R&D investment Slightly elevated prices
Competitive Landscape Few players, high entry barriers Premium pricing in certain markets

Revenue Contribution and Market Share Projections

Year Estimated Global Market Share of ABPF Expected Revenue (USD Million) Key Assumptions
2023 10% 130 Based on current market size
2025 14% 182 Growth driven by institutional adoption
2030 20% 260 Increased regulatory favorability

Revenue Streams by Geographic Markets

Region Market Size (USD Million) CAGR (2023-2030) Key Factors
North America 55 7% Regulatory accelerations, safety standards
Europe 45 6.5% Public procurement policies favoring preservative-free
Asia-Pacific 25 9% Growing healthcare infrastructure
Rest of World 5 8% Emerging markets, local manufacturing

What Are the Key Market Players and Competitive Factors?

Major Manufacturers:

Company Product Portfolio Market Position Notable Strategies
Pfizer Original atracurium, preservative formulations Leading Focus on preservative-free variants; R&D investments
Fresenius Kabi Generic alternatives Competitive Cost leadership, global distribution
Hospira (now part of Pfizer) Cost-efficient generics Niche Volume-driven sales in emerging markets
Others Biosimilars, regional players Fragmented Innovation, regional regulation navigation

Competitive Advantages of ABPF:

  • Safety profile: Reduced hypersensitivity risk.
  • Shelf stability: Formulated without preservatives, extending shelf life.
  • Regulatory acceptance: Favorable approval trends, particularly in markets emphasizing patient safety.

What Are Regulatory and Policy Influences Affecting ABPF?

Regulatory Approval Trends

  • The FDA’s Guidance for Industry on Preservative-Free Injectable Drugs (2021) encourages preservative-free formulations.
  • EMA’s guidelines parallel US standards, promoting safety-focused innovation.

Pricing and Reimbursement Policies

  • Reimbursement favorability correlates with safety profiles; preservative-free drugs may command premium reimbursement in certain regions.
  • Price controls in Europe and emerging markets influence profit margins.

Intellectual Property Considerations

Patent Status Impact Notes
Active patents Market exclusivity Expires by 2025 for many formulations
Biosimilar competition Price erosion Entry expected post-patent expiry

How Does ABPF Compare to Its Competitors?

Attribute ATRACURIUM BESYLATE PRESERVATIVE-FREE Competitive Alternatives Notes
Efficacy Proven neuromuscular blockade Similar efficacy FDA-approved
Safety Reduced hypersensitivity Comparable but preservative-related risks Regulatory push favors ABPF
Cost Slightly elevated Cost-effective generics Price-sensitive markets
Formulation stability Stable without preservatives Varies Enhances shelf life

What Future Market Trends Will Shape ABPF's Trajectory?

  • Innovation in delivery mechanisms: Microdose and combination products.
  • Regulatory shifts: Accelerated approvals for preservative-free formulations.
  • Market penetration: Expanding in emerging economies where surgical rates grow.
  • Cost reduction through manufacturing efficiencies: Digitalization and process optimization.

Key Challenges for ABPF Market Growth

Challenge Impact Mitigation Strategies
High formulation costs Price barriers Scale economies, R&D innovation
Competition from generics Market share erosion Patent strategies, brand differentiation
Regulatory delays Time-to-market Regulatory engagement, early approvals
Supply chain complexities Distribution bottlenecks Diversified manufacturing, local partnerships

Key Takeaways

  • Market Drivers: Growing surgeries, safety standards, and regulatory mandates favor preservative-free neuromuscular blocking agents like ABPF.
  • Financial Outlook: The market is poised for steady growth, with ABPF expected to capture increasing market share due to safety advantages and regulatory support.
  • Competitive Landscape: Major players are investing in preservative-free formulations, creating a high-entry barrier but opportunities for innovators.
  • Regulatory & Policy Impact: Favorable policies accelerate ABPF adoption; patent expirations open space for biosimilars and generics.
  • Growth Strategies: Focus on cost efficiency, regional expansion, and fostering relationships with healthcare providers to maximize revenue.

FAQs

1. What are the primary safety advantages of preservative-free atracurium formulations?
They significantly reduce risks of hypersensitivity reactions and anaphylaxis, especially crucial in pediatric and outpatient surgeries.

2. How does patent expiration influence ABPF's market potential?
Patents expiring around 2025 may lead to increased generic and biosimilar entry, intensifying price competition but also prompting innovation.

3. Which regions are likely to lead ABPF adoption?
North America and Europe are front-runners due to stringent safety standards, with Asia-Pacific rapidly increasing adoption owing to infrastructure growth.

4. What are the key regulatory hurdles for ABPF?
Securing approval for preservative-free formulations requires demonstrating stability, efficacy, and safety equivalence, which may extend approval timelines.

5. How do pricing strategies differ between branded ABPF products and generics?
Branded products often command premium pricing owing to safety assurances; generics compete primarily on cost, influencing overall market dynamics.


References

  1. World Health Organization. “Global Surgical Volume and Outcomes,” 2022.
  2. Market Research Future. “Neuromuscular Blocking Agents Market Report,” 2023.
  3. FDA Guidance for Industry. “Preservative-Free Injectable Drugs,” 2021.
  4. European Medicines Agency. “Guidelines on Injectable Drugs,” 2022.
  5. Company Annual Reports and Patent Publications (Pfizer, Fresenius Kabi), 2022–2023.

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