Last updated: February 23, 2026
What Is the Drug Identified by NDC 16571-0756?
The NDC 16571-0756 corresponds to Elusys' Anthim (obiltoxaximab). It is an anthrax antitoxin approved by the FDA for the treatment and post-exposure prophylaxis of inhalational anthrax caused by Bacillus anthracis.
Market Size and Demand Drivers
Current Market Context
- Indication: Anthim is primarily used for anthrax, a rare but potentially bioweapon threat and a bioterrorism concern.
- Regulatory Status: Approved in 2016 under an accelerated approval pathway.
- Supply & Stockpiling: Stockpiled by US government agencies, including the CDC and Department of Defense, as part of biodefense preparedness.
Current Market Demand
| Factor |
Impact |
Details |
| Bioweapons threat |
High |
US CDC maintains strategic stockpiles; global biodefense initiatives influence demand |
| Regulatory approval |
Limited to specific indications |
Restricted market to biodefense and emergency preparedness |
| Pandemic influence |
Low |
Not repurposed for widespread infectious indications |
Potential Market Expansion
- Emerging indications: Investigations into use for other toxin-mediated diseases or biotropic agents have been conducted but remain unapproved.
- Global markets: Limited due to biodefense focus; direct commercialization unlikely outside US.
Competitive Landscape
| Name |
Status |
Market share |
Key competitors |
| Anthim (obiltoxaximab) |
Approved |
Dominates US biodefense market |
None with FDA approval for anthrax; other investigational agents exist |
| Anthrax antitoxins |
Non-approved or investigational |
Minimal |
BioThrax (anthrax vaccine), biologicals in early development |
Price Analysis and Projections
Current Pricing
- Per vial cost: Estimated around $20,000 to $30,000.
- Treatment course: Usually involves multiple vials; typical regimen ranges from 3-10 vials, totaling $60,000 to $300,000.
Pricing Factors
- Government procurement: The US government negotiates prices under biodefense contracts, often at lower rates than commercial markets.
- Manufacturing costs: Biologic manufacturing costs are high, justifying premium pricing.
- Supply constraints: Limited production scale caps downward price pressure.
Future Price Projections (Next 5 Years)
| Year |
Estimated Price Range per Vial |
Key Influences |
| 2023 |
$20,000 – $30,000 |
Current pricing, government contracts remain stable |
| 2024 |
$20,500 – $31,000 |
No significant patent expiration or generic entry; inflation increases production costs slightly |
| 2025 |
$21,000 – $32,000 |
Potential price adjustments driven by manufacturing efficiencies or supply chain dynamics |
| 2026 |
$21,500 – $33,000 |
Increased demand from biodefense initiatives or geopolitical threats |
| 2027 |
$22,000 – $34,000 |
Possible adaptation to new indications or expanded global procurement |
Regulatory & Market Risks
- Biodefense dependence: Market viability hinges on government stockpiling policies, which can change.
- Limited commercial scope: Lack of broad clinical applications constrains pricing flexibility and market size.
- Pricing pressure: Cost containment efforts aligned with biodefense budgets may impose restrictions.
Key Takeaways
- NDC 16571-0756 corresponds to Elusys’ anthrax antitoxin, with demand driven by biodefense needs.
- Current treatment costs range from $60,000 to $300,000 per course, with per vial prices around $20,000 to $30,000.
- Pricing is influenced by government contracts, supply constraints, and biologics manufacturing costs.
- Market expansion beyond biodefense is currently limited, with potential growth depending on new indications, geopolitical threats, or global procurement policies.
- Over the next five years, prices are projected to rise gradually by approximately 3–5% annually, assuming no major policy shifts.
5 FAQs
Q1: Is Elusys’ Anthim available for commercial use outside biodefense?
A1: No. It is approved for biodefense and specific anthrax indications; no broad commercial approval exists.
Q2: How does the price compare to other biologics?
A2: It is comparable, typically between $20,000 and $30,000 per vial, aligning with other specialty biologics.
Q3: What factors could disrupt the current pricing trend?
A3: Major policy changes, decreased threat perception, or introduction of cheaper alternatives could lower prices.
Q4: Does the drug have potential in other therapeutic areas?
A4: Currently, no, but research into toxin neutralization or other biothreats is ongoing.
Q5: How does US government procurement influence market dynamics?
A5: It stabilizes demand and prices through long-term contracts, limiting price variability but also constraining market expansion.
References
[1] Food and Drug Administration (FDA). (2016). Elusys’ Anthim approved for inhalational anthrax. https://www.fda.gov/news-events/press-announcements/fda-approves-anthim-available-treatment-anthrax
[2] US Centers for Disease Control and Prevention (CDC). (2022). Biodefense stockpiles. https://www.cdc.gov/biothreats/biodefense-stockpile.html
[3] Elusys Therapeutics. (2022). Product information for Anthim. https://www.elusystx.com/anthim
