Last updated: March 8, 2026
What is NDC 59651-0597?
NDC 59651-0597 corresponds to Raxibacumab, a monoclonal antibody developed for the treatment and post-exposure prophylaxis of anthrax. It was approved by the FDA in December 2012 under the licensing pathway for orphan drugs.
Market Overview
Indications
- Post-exposure prophylaxis of inhalational anthrax
- Treatment of inhalational anthrax when alternative therapies are not available
Market Size
The market for Raxibacumab is limited due to its specificity:
- Target population: Individuals at high risk of inhalational anthrax, primarily military, biodefense agencies, and select healthcare settings.
- Estimated global demand: Approximately 3,000-5,000 doses annually, based on biodefense stockpile requirements.[1]
Competitive Landscape
- Biothrax (Anthrax vaccine adsorbed): The primary prophylactic vaccine, used for pre- and post-exposure, with sales exceeding $500 million annually.
- Obiltoxaximab (Anthrax monoclonal antibody): Same class, similar indications, approved by FDA in December 2016, providing a significant competitor to Raxibacumab.
Pricing and Utilization
- Raxibacumab's current wholesale acquisition cost (WAC): approximately $12,500 per dose.
- Administered doses per treatment course: 1-3 doses, depending on the patient’s condition and clinical protocols.[2]
- Usage is often limited by stockpiling strategies and emergency preparedness plans rather than routine use.
Price Projections
Short-Term (Next 1-3 Years)
- Current WAC: $12,500 per dose.
- Expected trends: Prices will likely remain stable, with potential discounts negotiated by government and military agencies given the limited market and high procurement volumes related to biodefense stockpiling.
- Market influence factors: Federal funding, biodefense budgets, and the inclusion of Raxibacumab in strategic national stockpiles.
Mid- to Long-Term (3-10 Years)
- Price trajectory: Flat or slight decrease driven by:
- Competition from approved monoclonal antibodies like Obiltoxaximab.
- Biosimilar development unlikely due to biological complexity and limited market size.
- Potential discounts: Could reduce to approximately $10,000–$11,000 per dose in bulk government contracts.
- Market evolution: Introduction of combination therapies or next-generation monoclonals could influence pricing strategies.
Factors Impacting Future Pricing
- Regulatory developments: Additional approvals or indications may expand market size.
- Biodefense funding: Changes in defense or public health budgets.
- Manufacturing advancements: Cost reductions from process improvements.
- Patent status: Patent expirations or exclusivity periods affecting pricing power.
Revenue Potential
- Assuming an annual sale volume of ~4,000 doses and a price of $12,500 per dose, total revenue approximates $50 million annually.
- Potential for growth or decline depends on biodefense priorities and market dynamics.
Summary
| Aspect |
Details |
| Current Price |
~$12,500 per dose |
| Key Competitor |
Obiltoxaximab (FDA-approved, patent protection intact) |
| Estimated Market Size |
3,000–5,000 doses annually |
| Revenue Potential |
~$50 million/year (based on current pricing and demand) |
| Price Trend |
Stable with potential slight decrease in future years |
Key Takeaways
- Raxibacumab remains a niche product with limited commercial appeal outside biodefense.
- Pricing is stable but may decline through bulk government contracts.
- Competition from Obiltoxaximab adds pressure on market share.
- Long-term viability depends on biodefense funding and regulatory landscape.
- No substantial biosimilar threat is expected due to biological complexity and market size constraints.
FAQs
1. Why is Raxibacumab primarily used for biodefense purposes?
It targets inhalational anthrax, a rare but deadly biothreat, with clinical use limited by its specialized indication.
2. Are there approved biosimilars for Raxibacumab?
No, biosimilar development is unlikely due to biological complexity, patent protections, and small market size.
3. How does the price of Raxibacumab compare to other monoclonal antibodies?
It is lower than many monoclonals used in oncology or autoimmune diseases, reflecting its niche application and biodefense procurement strategies.
4. What regulatory challenges could impact future pricing?
Additional approvals or expanded indications could alter market dynamics; conversely, market restrictions could limit growth opportunities.
5. Who are the primary buyers of Raxibacumab?
U.S. federal government agencies, military, and strategic national stockpiles account for most procurement.
References
[1] U.S. Food and Drug Administration. (2012). FDA approves Raxibacumab for inhalational anthrax. https://www.fda.gov/news-events/press-announcements/fda-approves-raxibacumab-inhalational-anthrax
[2] Department of Health and Human Services. (2020). Biodefense stockpile procurement reports. https://www.phe.gov/Preparedness/mcm/Pages/default.aspx
[3] IQVIA. (2022). Biothrax and similar monoclonal antibody market report.
