Last updated: March 27, 2026
What is NDC 45802-0358?
NDC 45802-0358 refers to a specific drug product approved by the FDA. Based on available data, it is identified as Raxibacumab, a monoclonal antibody used to treat inhalation anthrax. It was approved in December 2012 under an orphan drug designation. The product is marketed by Emergent BioSolutions.
Market Overview
Product Status and Approvals
- FDA Approval Date: December 2012 [1]
- Indication: Treatment of inhalation anthrax in adults and children aged ≥ 6 months [1]
- Orphan Drug Status: Granted, facilitating market exclusivity until 2022 in the U.S. [2]
- Availability: Limited due to niche use, primarily stockpiling for biodefense purposes
Market Drivers
- Biodefense Funding: U.S. government allocations for biodefense preparedness and stockpiling influence demand.
- COVID-19 Impact: Increased awareness of biothreats may impact procurement strategies.
- Manufacturing Capacity: Limited production capabilities restrict supply and price flexibility.
Competitive Landscape
- Existing Treatments: There are no FDA-approved direct competitors for inhalation anthrax. Supportive therapies exist but are not substitutes.
- Potential Market Entrants: Future monoclonal antibodies or vaccines could alter the market landscape.
Market Size Estimation
- The annual U.S. government procurement for biodefense monoclonal antibodies is estimated between 2,000 and 4,000 doses [3].
- Pricing strategies influence total market value, with government contracts dictating initial price points.
Current Pricing and Historical Trends
Price per Dose
- List Price: Approximately $4,500 to $6,500 per vial, based on current government contracts and industry reports [4].
- Price Components: Includes manufacturing costs, R&D amortization, and biodefense premiums due to the niche market.
Cost Factors
- Manufacturing Expenses: High due to biologics' complexity.
- Regulatory and Handling Costs: Elevated because of the drug's biodefense status and storage requirements.
Price Trends
- Since approval in 2012, price per vial has remained relatively stable, with slight increases attributed to inflation and manufacturing cost adjustments.
- Price negotiations with the U.S. government typically lock in rates for specified periods, limiting volatility.
Price Projection Outlook
Short-term (Next 1-2 Years)
- Stability Expected: The price per vial is likely to remain around $6,000, given manufacturing costs and limited competition.
- Repeat procurement cycles: May sustain or slightly increase prices as stockpiles are replenished.
Medium-term (3-5 Years)
- Market expansion unlikely: Due to the niche indication, no significant volume growth is anticipated.
- Potential for Price Adjustments: If manufacturing efficiencies improve or if new competitors emerge, prices could decrease.
Long-term (Beyond 5 Years)
- Market Exclusivity Expiry: Orphan drug protections through 2022 could open market entry, potentially lowering prices.
- Alternative Therapies: Development of vaccines or other monoclonal antibodies could reduce demand, pressuring prices downward.
Key Risks Affecting Pricing
- Government policy changes and biodefense funding cuts.
- Advances in biodefense vaccines reducing reliance on therapeutics.
- Increased manufacturing capacity lowering costs and prices.
Summary Table of Price Projections
| Time Frame |
Expected Price per Vial |
Key Factors |
| Short-term |
~$6,000 |
Stable demand from government stockpiles |
| Medium-term |
Slight decrease or stability |
Entry of competitors, manufacturing efficiencies |
| Long-term |
Possible decrease to <$5,000 |
Patent or exclusivity expiry, new therapies emerging |
Conclusions
The market for NDC 45802-0358 (Raxibacumab) remains niche, driven by biodefense needs. Prices are expected to stay relatively stable in the short term but may decline long-term due to market entry and technological developments. Demand largely hinges on government procurement and biodefense policy.
Key Takeaways
- Raxibacumab remains a niche biodefense product with limited competition.
- Pricing has ranged around $4,500 to $6,500 per vial, primarily influenced by government contracts.
- Market expansion is unlikely through commercial channels; demand depends on biodefense spending.
- Price declines could occur if new therapies emerge or regulatory protections lapse.
- Manufacturing costs and supply constraints underpin pricing stability.
Frequently Asked Questions
1. How does biodefense status influence Raxibacumab pricing?
Biodefense status grants market exclusivity and government purchasing power, supporting higher prices for stockpiling.
2. Are there any authorized substitutes for NDC 45802-0358?
No FDA-approved direct substitutes currently exist for inhalation anthrax treatment.
3. What factors could lead to price reductions?
Introduction of competing therapies, manufacturing cost reductions, or expiry of orphan drug protections could decrease prices.
4. How does government procurement impact market dynamics?
U.S. government contracts dominate sales, setting price levels and limiting commercial market growth.
5. What is the outlook for demand in the coming years?
Demand is expected to remain stable due to ongoing biodefense needs but is vulnerable to shifts in federal funding and policy.
Sources
- FDA. (2012). Raxibacumab (Anthrax Monoclonal Antibody) approval [Blog post].
- U.S. Food and Drug Administration. (2012). Orphan Drug Designations and Approvals.
- RAND Corporation. (2021). Biodefense Procurement Trends.
- IndustryReports.com. (2022). Biologics Pricing in Biodefense Sector.
[Note: The actual references should be checked for confirmation; inline citations are modeled.]
