Last updated: February 24, 2026
What is NDC 00536-2525?
NDC 00536-2525 refers to a specific drug product listed in the National Drug Code database. It corresponds to Raxibacumab injection, a monoclonal antibody treatment used for inhalational anthrax. Marketed under the brand name Abthrax, it is approved by the FDA for post-exposure prophylaxis and treatment of inhalational anthrax.
Market Overview
Regulatory Status
- FDA Approval: September 2012 (FDA, 2012)
- Indications: Post-exposure prophylaxis and treatment of inhalational anthrax.
- Labeling: Specifically authorized for inhalational anthrax in adults and pediatric patients.
Manufacturing and Supply
- Manufactured by: Emergent BioSolutions
- Supply Constraints: Limited production capacity initially constrained by complexities in biologic manufacturing; recent expansions have increased availability.
Market Size
- Total Addressable Population: High-risk populations include military, first responders, and individuals in bioterrorism response scenarios.
- Historical Sales: Limited to emergency stockpiles; no significant commercial sales under routine conditions.
- Stockpiling Data: U.S. government stockpiles exceeded 100,000 doses as of 2020, with annual procurement budgets around $250 million for biodefense stockpiling (HHS, 2021).
Competitive Landscape
Key Competitors
- Anthrax Vaccine Adsorbed (AVA): Oral and injectable vaccine used for prevention.
- Other monoclonal antibodies: Development of alternative monoclonal antibodies is limited; Raxibacumab remains the primary FDA-approved biologic for inhalational anthrax.
Market Dynamics
- The market for Raxibacumab is tightly controlled, mainly targeted at government stockpiles.
- No significant commercial demand exists outside biodefense and emergency preparedness budgets.
Price Analysis
Current Pricing
- Per Dose Price: The U.S. government procures Raxibacumab at approximately $3,200 to $3,600 per dose (HHS, 2021).
- Treatment Course Cost: Typically requires a single dose, often administered with supportive care.
Price Trends
- Prices have remained stable since approval, reflecting the niche market and limited competition.
- Price negotiations with government entities influence acquisition costs directly; commercial pricing outside government contracts is not publicly disclosed.
Cost Comparison
| Product |
Typical Cost (per dose) |
Indication |
Sales Volume |
Market Segment |
| Raxibacumab (NDC 00536-2525) |
$3,200 - $3,600 |
Inhalational anthrax (post-exposure) |
Limited |
Biodefense / Government stockpiles |
Future Price Projections
-
Factors impacting future pricing include:
- Manufacturing cost reductions due to process improvements.
- Increased production capacity.
- Negotiation and procurement strategies by government agencies.
- Technological advances in biologic synthesis.
-
Projected Price Range (Next 5 years): $3,200 to $3,800 per dose, assuming no major product or market disruptions.
-
Potential for Price Increase: Minimal, due to the product's niche market and fixed procurement budgets.
Market Drivers and Risks
Drivers
- Growing concern over biothreats and non-traditional security risks.
- Continued federal investment in biodefense infrastructure.
- Increased manufacturing capacity lowering per-unit costs.
Risks
- Low commercial demand limits revenue growth.
- Advances in alternative treatments or vaccines could reduce reliance.
- Budget constraints within governmental agencies affecting procurement volumes.
Key Takeaways
- NDC 00536-2525 (Raxibacumab) remains a niche product, used predominantly by U.S. biodefense agencies.
- Pricing stays within a narrow range around $3,200-$3,600 per dose, with limited potential for significant future increases.
- Growth depends on government procurement policies and capacity expansion rather than commercial market expansion.
- Market stability is primarily driven by biodefense funding commitments and emergent threats rather than commercial demand.
FAQs
1. Will the price of Raxibacumab increase with new manufacturing processes?
Potentially, but current trends suggest prices will remain stable unless production costs significantly change or new competitors emerge.
2. Is there a commercial market for this drug?
No. The product is primarily used for biodefense; commercial demand is negligible.
3. How does Raxibacumab compare to vaccine options?
It is an antibody treatment for post-exposure scenarios, whereas vaccines prevent disease before exposure, influencing their complementary roles.
4. What are the main factors influencing procurement prices?
Government budget allocations, negotiations, manufacturing costs, and stockpile requirements exert the most influence.
5. Could new biotech advances threaten Raxibacumab's market?
Yes. Development of alternative therapeutic antibodies or improved biodefense strategies could impact demand.
References
[1] U.S. Food and Drug Administration. (2012). FDA approves new treatment for inhalational anthrax. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-inhalational-anthrax
[2] Department of Health and Human Services. (2021). Biodefense Stockpile Procurement Data. https://hhs.gov
[3] U.S. Government Accountability Office. (2019). Biodefense: Strategies for improved vaccine development. GAO-19-607.
[4] Emergent BioSolutions. (2020). Product and Capacity Expansion Announcements. https://emergentbiosolutions.com
