Anthrax vaccine adsorbed - Biologic Drug Details

Summary for anthrax vaccine adsorbed

Tradenames:	1
High Confidence Patents:	0
Applicants:	2
BLAs:	2
Suppliers: see list	2
Recent Clinical Trials:	See clinical trials for anthrax vaccine adsorbed

Recent Clinical Trials for anthrax vaccine adsorbed

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Biomedical Advanced Research and Development Authority	Phase 2
Rho, Inc.	Phase 2
Emergent BioSolutions	Phase 4

See all anthrax vaccine adsorbed clinical trials

Pharmacology for anthrax vaccine adsorbed

Ingredient-type	Anthrax Vaccines Vaccines, Attenuated
Physiological Effect	Actively Acquired Immunity
Established Pharmacologic Class	Live Attenuated Bacillus Anthracis Vaccine

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 brand-side disclosures

These patents were identified from searching 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 anthrax vaccine adsorbed Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for anthrax vaccine adsorbed 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 Product Development Gaithersburg, Inc.	CYFENDUS	anthrax vaccine adsorbed, adjuvanted	Injection	125761	10,357,559	2034-12-23	DrugPatentWatch analysis and company disclosures
Emergent Product Development Gaithersburg, Inc.	CYFENDUS	anthrax vaccine adsorbed, adjuvanted	Injection	125761	10,456,463	2031-05-27	DrugPatentWatch analysis and company disclosures
Emergent Product Development Gaithersburg, Inc.	CYFENDUS	anthrax vaccine adsorbed, adjuvanted	Injection	125761	6,207,646	2016-10-30	DrugPatentWatch analysis and company disclosures
Emergent Product Development Gaithersburg, Inc.	CYFENDUS	anthrax vaccine adsorbed, adjuvanted	Injection	125761	6,406,705	2019-06-03	DrugPatentWatch analysis and company disclosures
Emergent Product Development Gaithersburg, Inc.	CYFENDUS	anthrax vaccine adsorbed, adjuvanted	Injection	125761	8,552,165	2029-12-08	DrugPatentWatch analysis and company disclosures
Emergent Product Development Gaithersburg, Inc.	CYFENDUS	anthrax vaccine adsorbed, adjuvanted	Injection	125761	8,778,359	2029-07-30	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for anthrax vaccine adsorbed Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Emergent Biodefense Operations Lansing Llc	BIOTHRAX	anthrax vaccine adsorbed	Injection	103821	10,011,843	2037-06-09	Patent claims search
Emergent Biodefense Operations Lansing Llc	BIOTHRAX	anthrax vaccine adsorbed	Injection	103821	10,022,424	2025-05-12	Patent claims search
Emergent Biodefense Operations Lansing Llc	BIOTHRAX	anthrax vaccine adsorbed	Injection	103821	10,028,935	2037-01-31	Patent claims search
Emergent Biodefense Operations Lansing Llc	BIOTHRAX	anthrax vaccine adsorbed	Injection	103821	10,036,054	2037-02-14	Patent claims search
Emergent Biodefense Operations Lansing Llc	BIOTHRAX	anthrax vaccine adsorbed	Injection	103821	10,039,758	2035-10-23	Patent claims search
Emergent Biodefense Operations Lansing Llc	BIOTHRAX	anthrax vaccine adsorbed	Injection	103821	10,058,600	2034-10-27	Patent claims search

Market Dynamics and Financial Trajectory for the Biologic Drug: Anthrax Vaccine Adsorbed

Last updated: February 17, 2026

Market Overview

Anthrax Vaccine Adsorbed (AVA), developed by Emergent BioSolutions, is the only FDA-approved anthrax vaccine for human use in the United States. It is used both for pre-exposure prophylaxis in at-risk populations and post-exposure prophylaxis when combined with antibiotics.

Regulatory Status and Manufacturing

• FDA Approval: AVA received full approval from the U.S. Food and Drug Administration in 2015, after initially being licensed in 1970 as an investigational new drug and gaining licensure in 1972.
• Manufacturing Capacity: Emergent operates two licensed manufacturing facilities in the U.S., capable of producing millions of doses annually, aligning with strategic stockpile requirements.

Market Size and Key Drivers

• Market Size: The global biodefense market was valued at approximately $21 billion in 2022, with vaccines accounting for around 25%. The AVA segment is a niche within this, driven by government contracts, primarily in the U.S. and select international partners.

• Key Drivers:

  • Government Stockpiling: The U.S. government maintains a strategic reserve of over 7 million doses. The Department of Health and Human Services (HHS) allocates tens of millions USD annually to maintain and diversify biodefense stockpiles.

  • Biodefense Budget: Consistent government investment in biodefense, with the U.S. budget exceeding $8 billion in 2022 for biodefense research and procurement [1].

  • Pandemic Preparedness: Increased interest in countermeasures for bioterror threats and pandemics influences procurement contracts.

  • International Procurement: Limited, as AVA is primarily contracted by the U.S. government, with collaborations in select countries like Canada and Australia.

  • Public Perception and Policy: Mandatory vaccination policies for military and certain civilian populations sustain demand.

Market Challenges

• Limited Commercial Demand: The vaccine’s niche application limits commercial sales outside government contracts.
• Vaccine Efficacy and Dosing: Typically requires multiple doses and booster shots, which could impact compliance and uptake.
• Emerging Alternatives: Development of new anthrax vaccine candidates with improved efficacy or ease of administration could threaten AVA’s market dominance.
• Biodefense Spending Fluctuations: Budget reallocations or political shifts may influence procurement levels.

Financial Trajectory

• Revenue Streams:

  • Primarily generated via U.S. government contracts.
  • Classified as a biodefense product, often procured under long-term, fixed-price agreements.
  • In fiscal year 2022, Emergent reported approximately $125 million in revenues from biodefense products, including AVA, representing roughly 15% of total revenue [2].

• Pricing and Costs:

  • Price per dose estimated between $400 and $700 in government stockpiling programs.
  • Manufacturing costs vary based on capacity utilization and raw material prices, with margins approximating 20-30% for contracts.

• Profitability and Trends:

  • With steady government demand, AVA maintains stable revenue flow.
  • Future growth hinges on increased funding, new procurement contracts, and potential extensions or enhancements of current formulations.
  • Cost pressures include raw material supply chain issues and regulatory compliance.

• Outlook and Growth Potential:

  • The biodefense vaccine market is relatively stable but limited in size.
  • Prospects for expansion lie in international markets and new formulations or delivery mechanisms.
  • The U.S. Biodefense Strategic Plan 2018-2028 remains a key policy driver aimed at updating stockpiles, potentially increasing demand.

Competitive Landscape

• Competitors:

  • No licensed competitors exist currently within the U.S. market.
  • Several vaccine candidates under development globally target improved efficacy, oral delivery, or single-dose regimens. These include vaccine candidates from companies like Vaxart and Bavarian Nordic.

• Potential Entry:

  • The limited market size deters many biotechs.
  • Regulatory hurdles and the need for large-scale manufacturing capacity pose barriers for new entrants.

Regulatory and Policy Impact

• U.S. Public Health Policies:

  • Mandates for military personnel and first responders support steady demand.

• International Standards:

  • No widespread approval outside the U.S.; exports depend on bilateral agreements and regulatory classifications.

Conclusion

The anthrax vaccine adsorbed's market remains primarily driven by U.S. government demand, with stable but modest growth prospects. Revenue generation is stable due to long-term procurement contracts, but the limited commercial demand constrains expansion. Future financial performance depends on continued biodefense funding, policy support, and the development of new formulations or delivery systems.

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Key Takeaways

• AVA is the sole FDA-approved human anthrax vaccine, with revenue primarily from U.S. government contracts.
• The biodefense market for AVA is stable but niche, with annual revenues in the hundreds of millions USD.
• Procurement relies heavily on federal government budgets and strategic initiatives.
• Limited competition exists currently, but emerging vaccine candidates could threaten AVA’s market share.
• Growth prospects depend heavily on biodefense spending, policy changes, and innovations in vaccine technology.

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FAQs

1. What is the primary market for anthrax vaccine adsorbed?
   The U.S. government, through federal agencies like HHS, maintains the primary demand via strategic stockpiles and procurement contracts.

2. Are there any approved international markets for AVA?
   Limited; AVA’s approval is restricted mainly to the U.S. No widespread international approval exists currently.

3. What factors could impact AVA’s future revenue?
   Changes in biodefense funding, policy shifts, emergence of alternative vaccines, and regulatory updates.

4. How does AVA compare cost-wise to other biodefense vaccines?
   Cost per dose ranges from $400 to $700. No direct competitors currently, but other biodefense vaccines have similar pricing structures depending on procurement arrangements.

5. What are the main challenges facing AVA’s market?
   Limited commercial demand, competition from emerging candidates, reliance on government contracts, and logistical issues related to dosing regimens.

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References

[1] U.S. Department of Health and Human Services. Budget Overview 2022.
[2] Emergent BioSolutions. Annual Report 2022.