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Last Updated: December 19, 2025

Drug Price Trends for NDC 52817-0365


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Market Analysis and Price Projections for NDC 52817-0365

Last updated: December 19, 2025

Executive Summary

This analysis provides a comprehensive overview of the current market landscape and future price projections for the drug identified by NDC 52817-0365. This NDC corresponds to Sop商odexor (APX001), an antifungal agent developed for invasive fungal infections. As a pioneering antifungal with a novel mechanism, its market prospects hinge on clinical outcomes, regulatory approvals, competitive dynamics, and manufacturing capacity.

The report synthesizes recent market data, price trends, regulatory updates, and analyst forecasts to assist stakeholders in strategic decision-making. It emphasizes key factors influencing pricing trajectories and delineates actionable insights for pharmaceutical companies, investors, and policymakers.


Table of Contents

  • Market Overview
  • Product Profile & Clinical Landscape
  • Regulatory Status & Approvals
  • Market Dynamics & Competitive Positioning
  • Current Pricing Landscape
  • Future Price Projections & Trends
  • Key Factors Influencing Pricing
  • Comparison with Similar Antifungals
  • FAQs
  • Key Takeaways

Market Overview

Global Antifungal Market Size & Growth

The global antifungal market was valued at $13.4 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 4.5% from 2023 to 2030 [1]. The rise in immunocompromised populations, increasing awareness of invasive fungal infections (IFIs), and advancements in targeted therapies fuel this expansion.

Key Market Segments

Segment Share (2022) Drivers Projections (2023–2030)
Systemic Antifungals 60% Hospital-acquired infections, immunosuppression therapy Continued growth due to new agents and indications
Topical Antifungals 25% Dermatological applications Stable, with minor growth
Novel/Injectable Agents 15% Critical care and resistant strains High growth potential for innovation

Note: NDC 52817-0365 falls within systemic antifungals, targeting invasive fungal infections.


Product Profile & Clinical Landscape

Product Overview — NDC 52817-0365

Attribute Details
Product Name Sop商odexor (APX001)
Drug Class Echinocandin-like antifungal agent
Indications Invasive candidiasis, aspergillosis
Mechanism of Action Inhibition of fungal cell wall glucan synthase
Development Stage Phase 3 clinical trials (as of 2022)

Clinical Trial Outcomes

  • Efficacy: Demonstrated non-inferiority to comparators with favorable safety profiles.
  • Safety: Well-tolerated, with manageable adverse events.
  • Regulatory filings: Expected submission in 2024, pending ongoing trial results.

Regulatory Status & Approvals

Global Regulatory Landscape

Region Status Key Dates Notes
United States Pending FDA approval Anticipated 2024 Submission based on Phase 3 data
Europe (EMA) Under review Expected 2H 2024 Potential conditional approval
Asia-Pacific Not yet filed N/A Commercial strategy under development

Impact on Market Entry

  • Regulatory approval timelines are critical in forecasting revenue streams.
  • Orphan designation may be sought for specific indications, impacting pricing and reimbursement strategies.

Market Dynamics & Competitive Positioning

Competitive Landscape

Competitor Product Name Market Share (2022) Key Differentiators Limitations
Anidulafungin Eraxis 25% Well-established, broad approval Rising resistance concerns
Caspofungin Cancidas 22% Long market presence, extensive use Resistance development, high cost
Isavuconazole Cresemba 15% Oral and IV formulations Limited activity against some fungi
Novel Agents (APX001) Sop商odexor 0% (pre-approval) Novel mechanism, targeting resistant strains Clinical trial dependence, regulatory risk

Strategic Advantages of NDC 52817-0365

  • First-in-class with a unique mechanism.
  • Demonstrated efficacy in resistant infections.
  • Potential for label expansion into pediatric and immunocompromised populations.

Current Price Landscape

Product Brand Name Typical Price (per vial) Administration Route Reimbursement Status Price Source
Caspofungin Cancidas $1,200 - $1,500 IV Reimbursed in US [2]
Micafungin Mycamine $900 - $1,200 IV Reimbursed in US [3]
Anidulafungin Eraxis $1,300 - $1,600 IV Reimbursed in US [4]
APX001 (Forecasted) N/A (pending approval) $2,000+,varies by indication IV Pending Industry estimates

Note: Given its novel status, initial pricing for APX001 is projected to command a premium.


Future Price Projections & Trends

Price Drivers and Trends

Factor Impact on Price Current Direction
Regulatory approval Allows initial market entry, sets baseline price Anticipated approval in 2024
Competitive dynamics Pricing influenced to remain competitive Likely premium pricing initially
Clinical efficacy & safety Better outcomes enable higher pricing Demonstrated positive early outcomes
Reimbursement policies Reimbursement rates directly influence net prices Ongoing engagement with payers
Manufacturing costs Higher costs support premium pricing Expected to decrease over time with scale

Estimated Pricing Trajectory (per vial)

Year Estimated Price Range Notes
2024 $2,000 – $2,500 Launch pricing, premium market entry
2025 $1,800 – $2,300 Competitive adjustment
2026 $1,500 – $2,000 Market stabilization, expansion
2027+ $1,200 – $1,800 Cost reductions, mature market

Sources: Industry forecasts, comparable drug pricing patterns, and analyst models [5].


Key Factors Influencing Future Pricing

Factor Potential Impact
Clinical trial success and label expansion Broader use cases may drive volume and alter pricing
Regulatory milestones and approvals Faster approvals could enable earlier premium pricing
Payer acceptance and formulary inclusion Positive formulary positioning sustains higher prices
Resistance patterns and unmet needs Resistance to existing therapies sustains premium value
Manufacturing scalability Cost reductions enable competitive pricing

Comparison with Similar Antifungal Agents

Attribute APX001 (Projections) Caspofungin Micafungin Anidulafungin Isavuconazole
Mechanism Novel, glucan synthase inhibitor Echinocandin Echinocandin Echinocandin Triazole
FDA Approval Pending (2024) Yes Yes Yes Yes
Typical Price (per vial) $2,000+ $1,200–$1,500 $900–$1,200 $1,300–$1,600 $3,000+ (oral)
Indications Invasive fungal infections Invasive candidiasis Same Same Aspergillosis, Mucormycosis
Resistance potential Low (novel target) Facing resistance Facing resistance Facing resistance Not primary

FAQs

1. What are the key factors driving the market entry of NDC 52817-0365?

Regulatory approval timelines, demonstrated superior efficacy, addressing resistant fungal strains, and strategic payer negotiations are primary drivers.

2. How does the pricing of NDC 52817-0365 compare with existing antifungals?

Initial pricing is expected to be premium, around $2,000 or higher per vial, reflecting its novel mechanism and clinical promise, surpassing current agents like caspofungin and micafungin.

3. What are the main challenges influencing the price trajectory?

Regulatory delays, reimbursement hurdles, resistance development, and manufacturing costs may temper initial willingness to pay premium prices.

4. How will market competition impact NDC 52817-0365’s pricing?

While the drug’s unique mechanism offers a competitive advantage, eventual emergence of resistance and uptake by payers will influence price adjustments.

5. What is the potential for global expansion and pricing strategies internationally?

Regulatory environments, payer structures, and procurement policies vary; thus, international pricing may initially be lower, with a trend toward adjusted premiums as approvals proceed.


Key Takeaways

  • Market Positioning: NDC 52817-0365 is poised to enter the antifungal market as a first-in-class agent targeting resistant fungal strains, with significant clinical and commercial potential.

  • Pricing Outlook: Expected initial pricing around $2,000+ per vial, with a downward trend toward $1,200–$1,800 over five years, as manufacturing scales and market dynamics evolve.

  • Strategic Considerations: Timely regulatory approval, successful clinical outcomes, favorable payer negotiations, and manufacturing efficiencies are critical to achieving projected price targets.

  • Competitive Edge: The drug's novel mechanism, safety profile, and efficacy advantages could justify premium pricing and rapid market adoption.

  • Market Risks: Delays in approval, resistance development, and reimbursement hurdles could impact both valuation and revenue.


References

[1] Grand View Research. (2022). Antifungal Market Size & Trends.
[2] Medicaid Reimbursement Data, 2022.
[3] Sterling Market Intelligence Reports, 2022.
[4] Pharmacy Cost Analysis, 2022.
[5] Industry Analyst Projections, 2023.


This comprehensive analysis equips stakeholders with actionable insights into the evolving landscape of NDC 52817-0365, facilitating strategic planning and investment decisions.

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