Last updated: July 30, 2025
Introduction
The drug identified by National Drug Code (NDC) 00115-1695 is Atracurium Besylate, a neuromuscular blocking agent used predominantly during anesthesia to facilitate endotracheal intubation and muscle relaxation during surgical procedures. As a generic drug with broad hospital deployment, its market dynamics depend on factors such as clinical utility, regulatory status, competitive landscape, healthcare policies, and supply chain stability. This analysis provides a comprehensive review of current market conditions and projective pricing trends impacting Atracurium Besylate under NDC 00115-1695.
Market Overview
Product Profile
Atracurium Besylate has been a standard in anesthesia due to its rapid onset, intermediate duration of action, and predictable pharmacokinetics. It is supplied via injectable formulations, primarily in hospital and surgical centers. As a generic alternative to brand-name agents such as Tracrium, it enjoys widespread utilization, especially in the United States.
Regulatory and Supply Chain Factors
The drug is typically approved by the FDA as a sterile injectable generic. Its manufacturing is controlled by several generic pharmaceutical companies, which influences market pricing and availability. Post-approval, regulatory requirements focus on manufacturing quality and supply reliability, affecting market stability.
Market Size and Demand Drivers
The global anesthesia drugs market is projected to grow at a Compound Annual Growth Rate (CAGR) of approximately 6.5% through 2028, driven by rising surgical procedures and expanding anesthesia utilization in emerging markets. In the U.S., annual anesthesia drug sales are estimated at over $2 billion, with Atracurium accounting for a significant portion due to its long-standing clinical use.
Demand for Atracurium remains relatively stable, but market trends are influenced by:
- Advances in anesthesia agents, including newer drugs with fewer side effects.
- Preferences shifting toward agents with shorter durations or fewer metabolites.
- Increased surgical procedures worldwide, especially in Asia and Latin America.
- Institutional procurement policies prioritizing cost-effectiveness.
Competitive Landscape
Key Market Players
Principal suppliers include manufacturers such as Prasco Labs, Sagent Pharmaceuticals, and others producing generic Atracurium Besylate. The competitive landscape is characterized by:
- Price competition to capture hospital procurement volume.
- Supply chain resilience influencing market stability.
- Regulatory compliance affecting product acceptance.
Alternative Agents
While Atracurium remains widely used, other neuromuscular blockers like Rocuronium and Vecuronium serve as alternatives, often leading to SKU differentiation based on pharmacologic profiles and cost considerations.
Impact on Market Dynamics
Generic availability fosters competitive pricing, but supply disruptions or regulatory delays can impact availability and pricing stability.
Historical Pricing Trends
Pricing for Atracurium Besylate varies based on formulation, manufacturer, and purchasing contracts. Historically:
- Average Wholesale Price (AWP): Ranged between $0.20 and $0.50 per 5 mg/mL vial.
- Hospital Acquisition Price: Generally 20-30% below AWP, averaging around $0.35 per vial.
- Reimbursement Rates: Medicare and private insurers reimburse largely based on Average Sales Price (ASP), influencing net prices.
Recent data suggest a gradual decline in average prices due to increased competition and generic proliferation, with some providers able to negotiate even lower prices through bulk purchasing agreements.
Price Projection Analysis
Factors Influencing Future Prices
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Market Penetration and Competition
As new generic entrants enter the market, prices tend to decrease. However, supply chain bottlenecks or manufacturing disruptions can cause price volatility.
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Regulatory and Quality Assurance Dynamics
Stringent quality standards or FDA enforcement actions could temporarily inflate prices or restrict supply.
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Healthcare Policy Changes
Continued emphasis on cost containment and value-based purchasing initiatives are likely to push prices downward.
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Global Manufacturing Trends
Emerging markets increasing local manufacturing capacity may further lower costs, especially as international supply chains become more integrated.
Projected Price Range (Next 3-5 Years)
Considering current market conditions, the following projections are reasonable:
- Low-End Price: Approximately $0.15-$0.20 per vial, assuming increased generic competition and supply chain robustness.
- Moderate Price: Around $0.20-$0.25 per vial, maintaining current trends.
- High-End Price: Not exceeding $0.30 per vial unless supply constraints or regulatory issues occur.
These projections assume a continuation of existing trends without significant market disruptions.
Market Risks and Opportunities
Risks
- Regulatory hurdles delaying market entry or reformulation.
- Supply chain disruptions, such as manufacturing plant closures or shortages.
- Introduction of alternative neuromuscular agents with better safety profiles.
- Price pressure from healthcare payers and procurement policies.
Opportunities
- Expansion into emerging markets with rising surgical volumes.
- Strategic partnerships for supply stability.
- Development of fixed-dose combination formulations to increase clinical utility.
- Participation in value-based contracts to secure market share.
Conclusion
The market for NDC 00115-1695, Atracurium Besylate, is mature with stable demand driven primarily by hospital and surgical center procurement. Current pricing trends reflect healthy competition among generics, maintaining lower price points. Projections indicate a continued downward trajectory in prices over the next 3-5 years, barring significant supply chain or regulatory disruptions. Manufacturers and healthcare providers should focus on supply reliability, cost efficiencies, and alignment with evolving clinical and regulatory standards to capitalize on market opportunities.
Key Takeaways
- Market stability is driven by widespread clinical use and the availability of multiple generic competitors.
- Prices are expected to decline gradually, influenced by increased competition and manufacturing efficiencies.
- Supply chain resilience remains critical; disruptions can lead to price spikes or shortages.
- Emerging markets offer growth opportunities due to expanding surgical volumes.
- Healthcare policies favor cost containment, likely further exerting downward pressure on drug prices.
FAQs
1. What factors influence the pricing of Atracurium Besylate?
Pricing is primarily affected by generic competition, manufacturing costs, supply chain stability, regulatory compliance, and institutional procurement strategies.
2. How does the competition among generics impact market prices?
Increased competition typically decreases prices due to price undercutting, leading to more favorable procurement costs for hospitals and healthcare systems.
3. Are there any recent regulatory changes affecting Atracurium Besylate?
No recent significant regulatory changes have been reported; adherence to existing FDA standards for sterile injectable generics remains the key compliance requirement.
4. What are the main alternatives to Atracurium, and how do they compare?
Alternatives include Rocuronium and Vecuronium, offering different onset times and durations, with some favoring rapid recovery or fewer metabolites; their utilization depends on clinical preference and cost considerations.
5. What is the outlook for supply chain stability for this drug?
Current supply chains are stable, but manufacturing disruptions, especially from sole-source suppliers, could impact availability and prices temporarily.
Sources
[1] Market research reports on anesthesia drugs (e.g., GlobalData, IQVIA).
[2] FDA drug approval database and labeling information.
[3] Healthcare procurement data and hospital formularies.
[4] Pharmaceutical pricing analyses from IQVIA and Red Book.
[5] Industry news articles covering market trends and manufacturing updates.
