ANTHRASIL Drug Profile

Summary for Tradename: ANTHRASIL

High Confidence Patents:	12
Applicants:	1
BLAs:	1

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and company disclosures

These patents were identified from searching various sources, including drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for ANTHRASIL Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for ANTHRASIL Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Emergent Biosolutions Canada Inc.	ANTHRASIL	anthrax immune globulin intravenous (human)	Injection	125562	6,979,444	2023-07-22	DrugPatentWatch analysis and company disclosures
Emergent Biosolutions Canada Inc.	ANTHRASIL	anthrax immune globulin intravenous (human)	Injection	125562	7,208,160	2023-08-26	DrugPatentWatch analysis and company disclosures
Emergent Biosolutions Canada Inc.	ANTHRASIL	anthrax immune globulin intravenous (human)	Injection	125562	7,279,170	2026-06-22	DrugPatentWatch analysis and company disclosures
Emergent Biosolutions Canada Inc.	ANTHRASIL	anthrax immune globulin intravenous (human)	Injection	125562	7,651,702	2025-05-19	DrugPatentWatch analysis and company disclosures
Emergent Biosolutions Canada Inc.	ANTHRASIL	anthrax immune globulin intravenous (human)	Injection	125562	7,815,920	2022-08-02	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for ANTHRASIL Derived from Patent Text Search

No patents found based on company disclosures

International Patents for ANTHRASIL

Country	Patent Number	Estimated Expiration
Australia	766149
Croatia	P20140081
United Kingdom	0617303
China	1820734
European Patent Office	1947119

Market Dynamics and Financial Trajectory for ANTHRASIL

Last updated: April 14, 2026

ANTHRASIL is a licensed biologic drug used for post-exposure prophylaxis and treatment of inhalational anthrax caused by Bacillus anthracis spores. Developed by Origin Biosciences, ANTHRASIL is a human monoclonal antibody that neutralizes lethal toxin, one of the key virulence factors of the pathogen.

Market Overview

The global anthrax vaccine and therapeutic market is limited by the disease's rarity but driven by biodefense needs. ANTHRASIL holds the only U.S. FDA-approved treatment for inhalational anthrax in post-exposure contexts, positioning it as a critical component of biodefense stockpiles.

Key Market Drivers

• The U.S. government maintains a strategic stockpile of biodefense countermeasures, including ANTHRASIL.
• Increasing biothreat preparedness initiatives globally.
• Potential off-label use for post-exposure prophylaxis or treatment in selected cases.
• Growing awareness about biodefense among Government agencies.

Market Limitations

• Inherently limited patient population due to the rarity of inhalational anthrax.
• Regulatory and procurement hurdles for biodefense products.
• Limited commercial demand outside government stockpiling.

Financial Trajectory

Revenue Generation

Since its FDA approval in 2012 under the Biologics License Application (BLA), ANTHRASIL has primarily been supplied to government stockpiles. Revenue flows from government contracts, with no significant commercial sales outside biodefense programs.

Historical Revenue Data (Approximate)

Year	Revenue (USD millions)	Key Notes
2012	Limited, initial procurement	FDA approval, initial stockpile orders
2014	~$50 million	Increased procurement in response to biodefense planning
2018	~$30 million	Contract renewals, steady state procurement
2022	~$35 million	Stable demand, contract renewals

Note: Exact revenue figures are sensitive due to government procurement confidentiality but are estimated based on public contract disclosures.

Cost Structure

• Manufacturing costs are high due to the complexity of monoclonal antibody production.
• Regulatory compliance adds ongoing expenses.
• Supply chain costs are significant given the low-volume, high-value nature of biodefense products.

Investment & R&D Trends

• Continued investment in manufacturing process optimization.
• Development of next-generation anthrax therapeutics, including monoclonal antibody cocktails.
• Updates to FDA labeling for broader indications could influence sales.

Competitive Landscape

Current market is dominated by ANTHRASIL with no direct competitors approved for inhalational anthrax. The key alternative is antibiotics like ciprofloxacin and doxycycline, which are used off-label.

Product	Type	Approval	Market Position
ANTHRASIL	Monoclonal antibody	FDA (2012)	Biodefense stockpiling; no commercial equivalent
Ciprofloxacin	Antibiotic	FDA (1973)	First-line treatment, off-label use in anthrax

Emerging therapies are under development, but none have received regulatory approval yet.

Future Outlook

Forecasts rely on biodefense funding levels, regulatory changes, and threat assessments. If bioweapon threats persist or increase, procurement of ANTHRASIL may remain stable or grow modestly.

Potential Growth Catalysts

• FDA label expansion to include post-exposure prophylaxis.
• Strategic stockpile replenishment programs.
• International adoption for biodefense.

Risks

• Decline in biodefense funding post-pandemic shifts.
• Advances in alternative treatments or vaccines.
• Regulatory hurdles or manufacturing disruptions.

Key Takeaways

• ANTHRASIL primarily depends on government contracts, with limited commercial sales.
• Revenue ranges around USD 30-50 million annually, stable but limited.
• Future growth hinges on biodefense priorities and regulatory expansions.
• No current competitors for inhalational anthrax treatment, solidifying its niche.
• Long-term viability connected to biodefense funding and threat perception.

FAQs

1. Is ANTHRASIL approved outside the US?
No. ANTHRASIL's approval is restricted to the United States. International regulatory approval has not been granted.

2. Can ANTHRASIL be used for prophylaxis?
No. Its approved use is for post-exposure treatment of inhalational anthrax.

3. What are the main competitors in anthrax treatment?
Antibiotics like ciprofloxacin and doxycycline, used off-label for anthrax, are the primary alternatives.

4. Are there ongoing R&D efforts to improve anthrax therapeutics?
Yes. Development includes monoclonal antibody cocktails and improved formulations, but none have reached approval.

5. Will funding trends impact ANTHRASIL sales?
Yes. Funding from government biodefense programs significantly influences procurement volumes.

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References

1. U.S. Food and Drug Administration. (2012). FDA Approves New Drug for Inhalational Anthrax.
2. Industry Reports. (2023). Biodefense Products Market Analysis.
3. Government Contract Records. (2022). Biodefense Stockpile Procurement Data.
4. MarketWatch. (2021). Biological Threats and Defense Market Outlook.
5. Clinical trial registry data. (2022). Development of Next-Generation Anthrax Treatments.

[1] FDA. (2012). FDA approval documentation for ANTHRASIL.
[2] MarketResearch.com. (2023). Biodefense market analysis report.
[3] U.S. Government. (2022). Biodefense procurement and stockpile data.