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Last Updated: April 1, 2026

Drug Price Trends for NDC 64380-0833


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Best Wholesale Price for NDC 64380-0833

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions
Drug Name Vendor NDC Count Price ($) Price/Unit ($) Dates Price Type
>Drug Name >Vendor >NDC >Count >Price ($) >Price/Unit ($) >Dates >Price Type
Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Market Analysis and Price Projections for NDC 64380-0833

Last updated: February 24, 2026

What is the drug associated with NDC 64380-0833?

The National Drug Code (NDC) 64380-0833 refers to a specific formulation of valoctocogene roxaparvovec, marketed under the brand name Roctavian. It is an adeno-associated virus (AAV)-based gene therapy approved by the FDA in August 2022 for treating adults with severe hemophilia A.

Market Overview

Market Size and Patient Population

  • Hemophilia A prevalence: Approximately 15,000–20,000 U.S. patients with severe hemophilia A.
  • Target population for Roctavian: Estimated at 5,000–8,000 eligible adult patients with severe forms in the U.S.
  • Global market potential: Europe and Japan account for an additional 10,000–12,000 patients.

Competitive Landscape

  • Existing treatments: Hemophilia A managed via recombinant factor VIII infusions, with annual costs typically $200,000–$300,000 per patient.
  • Gene therapies: Roctavian is among the first approved gene therapies in hemophilia A, competing with other candidates like BioMarin’s valoctocogene roxaparvovec (not FDA-approved) and Bioverativ’s hemophilia gene therapies under development.

Price Points and Reimbursement Landscape

List Price and Pricing Strategy

  • Initial list price: $2.5 million per treatment dose.
  • The pricing aligns with other high-cost gene therapies such as Zynteglo for beta-thalassemia ($1.8 million) and Luxturna for inherited retinal disease ($850,000).
  • Payment models: Pay-for-performance agreements are anticipated, with insurers potentially negotiating outcomes-based payment contracts.

Reimbursement Considerations

  • High upfront costs place heavy burden on payers.
  • Efficacy data showing durable bleed reduction will influence reimbursement negotiations.
  • Access programs and managed entry agreements are likely being employed to facilitate coverage.

Projected Sales and Revenue

Short-term Revenue (2023–2025)

  • 2023: Initial launches expected to generate sales of approximately $50–$100 million.
  • 2024: Sales could reach $300–$500 million as awareness increases and reimbursement pathways are established.
  • 2025: Potential sales of $800 million to $1 billion if market penetration expands and long-term efficacy is confirmed.

Long-term Revenue forecasts (2026+)

  • If efficacy sustains over a decade, peak sales could range from $1.5 billion to $2 billion annually in the U.S. alone.
  • Global uptake will contribute an additional 10–20% to revenues.

Market Entry Risks and Barriers

  • Reimbursement delays due to high upfront costs.
  • Long-term safety profile uncertainties.
  • Competition from emerging gene therapy offerings and improved conventional therapies.
  • Manufacturing scalability and supply chain logistics.

Price Projections (Next 5 Years)

Year Expected Price per Dose Notes
2023 $2.5 million Launch price set at initial approval.
2024 $2.3 – $2.5 million Potential discounts or outcome-based agreements.
2025 $2.2 – $2.4 million Continued negotiations and wound-down launch phase.
2026 $2.0 – $2.3 million Market stabilization and biosimilar considerations.
2027 $2.0 million or lower Competitive pressure or biosimilar entry.

Key Market Dynamics

  • Durability of Effect: Proven long-term efficacy diminishes the need for chronic treatment, supporting premium pricing.
  • Patient Access: High costs limit widespread adoption pending favorable reimbursement.
  • Innovator Strategies: Expansion into pediatric populations and combination therapies could alter market dynamics.

Key Takeaways

  • NDC 64380-0833 corresponds to Roctavian, a gene therapy for severe hemophilia A.
  • Launch price is approximately $2.5 million per dose.
  • Short-term sales are projected to reach $100 million in 2023, expanding to over $1 billion by 2025.
  • Long-term revenues depend on long-term efficacy, reimbursement success, and competitive pressures.
  • Price reductions may occur as biosimilars or alternative therapies emerge, but current valuations support premium pricing.

FAQs

  1. What factors influence the price of Roctavian?
    Efficacy, durability of treatment response, manufacturing costs, reimbursement negotiations, and competitive landscape.

  2. How does Roctavian compare with traditional hemophilia A treatments cost-wise?
    While traditional treatments cost $200,000–$300,000 annually, Roctavian’s upfront price is higher, but expected to reduce long-term treatment costs for eligible patients.

  3. What are potential barriers to market penetration?
    Reimbursement hurdles, safety data accumulation, manufacturing capacity, and physician adoption rate.

  4. Are there risks associated with the high upfront pricing?
    Yes, payers may be hesitant to cover the full cost without confirmed long-term durability, possibly requiring outcome-based agreements.

  5. What is the outlook for global adoption?
    Pending regulatory approval in Europe and Japan, global sales could add 10–20% to U.S. revenues, with access barriers similar to those in the U.S.


References

[1] U.S. Food and Drug Administration. (2022). FDA Approves Roctavian for Hemophilia A. Retrieved from https://www.fda.gov

[2] IQVIA. (2022). Hemophilia market data. IQVIA Institute for Human Data Science.

[3] EvaluatePharma. (2023). Global Hemophilia Market Outlook. Evaluate Pharma Report.

[4] World Federation of Hemophilia. (2022). Annual Global Hemophilia Report.

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