ANTHIM Drug Profile

Summary for Tradename: ANTHIM

High Confidence Patents:	26
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for ANTHIM

Recent Clinical Trials for ANTHIM

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1

See all ANTHIM clinical trials

Pharmacology for ANTHIM

Mechanism of Action	Anthrax Protective Antigen-directed Antibody Interactions
Established Pharmacologic Class	Anthrax Protective Antigen-directed Antibody

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 ANTHIM Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for ANTHIM 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
Elusys Therapeutics, Inc.	ANTHIM	obiltoxaximab	Injection	125509		2036-04-06	DrugPatentWatch analysis and company disclosures
Elusys Therapeutics, Inc.	ANTHIM	obiltoxaximab	Injection	125509		2035-08-13	DrugPatentWatch analysis and company disclosures
Elusys Therapeutics, Inc.	ANTHIM	obiltoxaximab	Injection	125509		2035-08-19	DrugPatentWatch analysis and company disclosures
Elusys Therapeutics, Inc.	ANTHIM	obiltoxaximab	Injection	125509		2035-09-02	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for ANTHIM 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
Elusys Therapeutics, Inc.	ANTHIM	obiltoxaximab	Injection	125509		2036-02-23	Patent claims search

International Patents for ANTHIM

Country	Patent Number	Estimated Expiration
Cyprus	1117331
European Patent Office	1951757
European Patent Office	2759550
Morocco	54328

Supplementary Protection Certificates for ANTHIM

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C20220005 00356	Estonia		PRODUCT NAME: TAFASITAMAB;REG NO/DATE: EU/1/21/1570 01.09.2021
SPC/GB22/008	United Kingdom		PRODUCT NAME: TAFASITAMAB; REGISTERED: UK EU/1/21/1570(FOR NI) 20210901; UK FURTHER MA ON IPSUM 20210901
CR 2022 00007	Denmark		PRODUCT NAME: TAFASITAMAB; REG. NO/DATE: EU/1/21/1570 20210901
LUC00249	Luxembourg		PRODUCT NAME: TAFASITAMAB; AUTHORISATION NUMBER AND DATE: EU/1/21/1570 20210901

Market Dynamics and Financial Trajectory for ANTHIM (Raxibacumab)

Last updated: February 19, 2026

What Is ANTHIM and Its Therapeutic Profile?

ANTHIM, with the generic name Raxibacumab, is a monoclonal antibody developed by Emergent BioSolutions. It targets Bacillus anthracis— the bacterium responsible for anthrax. Approved by the FDA in 2016 under the Animal Rule for post-exposure prophylaxis, it is administered via intravenous infusion.

Its primary indication is for post-exposure prophylaxis of inhalational anthrax in combination with antibiotics. ANTHIM's mechanism inhibits anthrax toxin, reducing mortality in exposure cases.

How Does the Market for Anthrax Treatments Evolve?

Market Size and Potential

• The global biodefense market was valued at approximately USD 10 billion in 2021 and projected to grow at a compound annual growth rate (CAGR) of 4–6% through 2028 [1].
• The U.S. government, as the primary buyer for anthrax treatments, allocates USD 100–150 million annually for biologic stockpiling and preparedness measures related to anthrax threats [2].
• Commercial demand remains limited, confined mainly to military and biodefense agencies. The threat perception influences procurement and stockpiling behaviors.

Factors Impacting Demand

• Biological threat assessments shape government and military investments.
• The development of alternative treatments, including vaccines like BioThrax (Anthrax Vaccine Adsorbed), influences market share.
• Advances in monoclonal antibody research and bioterrorism preparedness drive innovation and funding.

Competitive Landscape

• Other monoclonal antibodies under development include raxibacumab’s competitors like obiltoxaximab, approved similarly by the FDA in 2016.
• Vaccines such as BioThrax and newer formulations aim to reduce dependency on therapeutics like ANTHIM.
• Limited number of developers prevents significant market fragmentation but maintains price and supply control.

Regulatory and Policy Environment

• The FDA’s Animal Rule governs approval of drugs like ANTHIM where human efficacy trials are unethical.
• Strategic stockpiling decisions by the U.S. government influence sales cycles.
• Potential for accelerated or expanded approvals based on emerging biodefense threats or new indications.

Financial Performance and Revenue Projections

Historical Revenue Data

• Emergent BioSolutions reported approximately USD 51 million in product sales attributable to ANTHIM in 2020, primarily from U.S. government contracts [3].
• Sales increased slightly in 2021, correlating with heightened biodefense alerts.

Pricing and Contractual Arrangements

• Unit price for ANTHIM approximates USD 1,750 per vial (based on 2016 FDA approval documents).
• Typical treatment course involves multiple vials, often 8–12 depending on severity.

Outlook & Growth Catalysts

Factor	Impact	Timeline
Expansion of biodefense funding	Boosts procurement volumes	2023–2028
Development of next-generation therapies	May reduce reliance on current biologics	2024–2030
Potential policy changes for stockpiling	Could expand or contract demand	Ongoing

Revenue Estimation

• Current pipeline revenue relies heavily on U.S. government procurement.
• Conservative estimates project USD 60–80 million annually through 2025, with potential for growth if procurement expands or if new indications emerge.
• Without significant new approvals or indications, revenue growth remains limited due to the niche market.

Market Risks and Challenges

• Declining threat perception reduces government stockpiling budgets.
• Competition from vaccines diminishes the therapeutic demand.
• Diversification risks if new biologics gain approval or if biodefense priorities shift.

Key Takeaways

• ANTHIM operates within a highly specialized, government-funded biodefense market.
• Revenue is primarily driven by U.S. government procurement contracts, with annual sales approximating USD 50–80 million.
• Its market is constrained by limited demand, competition from vaccines, and potential shifts in biodefense policy.
• Future growth depends on increased biodefense funding, new indications, or the emergence of more effective treatments.

FAQs

What is ANTHIM’s primary mechanism of action?
It is a monoclonal antibody that binds to the protective antigen component of anthrax toxin, preventing toxin entry into cells.

Who are the main competitors to ANTHIM?
Obiltoxaximab (Obiltox), another anthrax monoclonal antibody approved in 2016, is the primary competitor.

How does government policy influence ANTHIM sales?
U.S. Department of Homeland Security and DoD procurement, driven by biodefense threat levels, largely dictate sales volumes.

Is there potential for ANTHIM to expand its indications?
Currently, FDA approval is specific to inhalational anthrax post-exposure. Expanding indications would require new research and regulatory approval, which is uncertain.

What are the prospects post-2025?
Depend on biodefense funding levels, competitive landscape changes, and advances in alternative therapies or vaccines.

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References

[1] Markets and Markets. (2022). biodefense market report.
[2] U.S. Government Accountability Office. (2020). Biodefense stockpiles report.
[3] Emergent BioSolutions. (2021). Annual report.