These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions
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
What factors influence the price of Roctavian?
Efficacy, durability of treatment response, manufacturing costs, reimbursement negotiations, and competitive landscape.
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.
What are potential barriers to market penetration?
Reimbursement hurdles, safety data accumulation, manufacturing capacity, and physician adoption rate.
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.
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.
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.
Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data.
The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free.
We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models.
By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice.
thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user.
Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
Alerts Available With Subscription
Alerts are available for users with active subscriptions.