TPOXX Drug Patent Profile

Which patents cover Tpoxx, and when can generic versions of Tpoxx launch?

Tpoxx is a drug marketed by Siga Technologies and is included in two NDAs. There are eight patents protecting this drug.

This drug has ninety-six patent family members in twenty-four countries.

The generic ingredient in TPOXX is tecovirimat. One supplier is listed for this compound. Additional details are available on the tecovirimat profile page.

DrugPatentWatch^® Generic Entry Outlook for Tpoxx

Tpoxx was eligible for patent challenges on July 13, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 23, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for TPOXX

International Patents:	96
US Patents:	8
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	111
What excipients (inactive ingredients) are in TPOXX?	TPOXX excipients list
DailyMed Link:	TPOXX at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TPOXX

Constraining patent/regulatory exclusivity:

9,339,466

NDA:

208627

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

10,576,165

NDA:

214518

Dosage:

SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for TPOXX

Drug Class	Orthopoxvirus VP37 Envelope Wrapping Protein Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 3A Inducers

US Patents and Regulatory Information for TPOXX

TPOXX is protected by nine US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 9,339,466.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Siga Technologies	TPOXX	tecovirimat	CAPSULE;ORAL	208627-001	Jul 13, 2018		RX	Yes	Yes	7,737,168
Siga Technologies	TPOXX	tecovirimat	SOLUTION;INTRAVENOUS	214518-001	May 18, 2022		RX	Yes	Yes	7,737,168
Siga Technologies	TPOXX	tecovirimat	CAPSULE;ORAL	208627-001	Jul 13, 2018		RX	Yes	Yes	12,433,868		Y

Expired US Patents for TPOXX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Siga Technologies	TPOXX	tecovirimat	SOLUTION;INTRAVENOUS	214518-001	May 18, 2022	8,530,509
Siga Technologies	TPOXX	tecovirimat	CAPSULE;ORAL	208627-001	Jul 13, 2018	8,124,643
Siga Technologies	TPOXX	tecovirimat	SOLUTION;INTRAVENOUS	214518-001	May 18, 2022	8,802,714

International Patents for TPOXX

When does loss-of-exclusivity occur for TPOXX?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Argentina

Australia

Brazil

Canada

Chile

China

Denmark

European Patent Office

France

Israel

Japan

Mexico

New Zealand

Peru

Russian Federation

Singapore

South Africa

South Korea

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TPOXX around the world.

Country	Patent Number	Title	Estimated Expiration
South Africa	201300930	ST-246 LIQUID FORMULATIONS AND METHODS
Canada	2793533	FORMES POLYMORPHES ST-246 ET PROCEDES DE PREPARATION (POLYMORPHIC FORMS OF ST-246 AND METHODS OF PREPARATION)
European Patent Office	2192901

Supplementary Protection Certificates for TPOXX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1638938	122022000032	Germany		PRODUCT NAME: TECOVIRIMAT ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1600 20220106
1638938	301177	Netherlands		PRODUCT NAME: TECOVIRIMAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1600/001 20220107
1638938	2290024-5	Sweden		PRODUCT NAME: TECOVIRIMAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/21/1600/001 20220107

Market Dynamics and Financial Trajectory for TPOXX (Tecovirimat)

Last updated: December 29, 2025

Summary

TPOXX (tecovirimat) is an antiviral medication developed primarily for the treatment of orthopoxvirus infections, notably smallpox. With the resurgence of interest in biodefense and infectious disease preparedness, TPOXX's market landscape is evolving rapidly. This article delineates the current market environment, regulatory pathways, competitive landscape, and financial prospects of TPOXX. Key drivers include biothreat preparedness, FDA approvals, government contracts, and emerging indications, while challenges stem from the rarity of target diseases, market size limitations, and competition from alternative therapies.

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What Are the Market Drivers for TPOXX?

Driver	Details	Impact
Biodefense Preparedness	U.S. government designates smallpox as a biological threat. TPOXX qualifies as a stockpiled drug under CDC and BARDA programs.	Sustains demand through stockpiling and government procurement contracts.
Regulatory Approvals	FDA approval (2018) under the Animal Rule accelerates market entry and confidence.	Facilitates wider distribution and emergency use authorization.
Emerging Infectious Diseases	Potential for adaptation to other orthopoxviruses or emergent viral strains	Expands therapeutic indications and market size.
Strategic Partnerships	Agreements with BARDA, CDC, and defense agencies foster manufacturing scale-up and funding.	Ensures supply chain stability and financial backing.
Potential for Off-label Use	Use in related poxvirus infections and bioterror event response	Presents additional revenue streams.

Current Market Landscape

Regulatory and Approvals Timeline

Year	Milestone	Agency/Authority	Significance
2013	FDA grants Orphan Drug Designation	FDA	Incentivizes development despite rarity.
2018	FDA approval on basis of animal studies	FDA	Breakthrough for biodefense; sets precedent for pandemic preparedness.
2020	Emergency Use Authorization (EUA) for smallpox exposure	FDA	Enhances deployment in biothreat scenarios.

Major Stakeholders

Entity	Role	Contribution	Notes
SIGA Technologies	Developer, manufacturer	Led development, holds patents	Market leader for TPOXX.
BARDA (Biomedical Advanced Research and Development Authority)	Funding agency	Provides grants and procurement contracts	Ensures supply and readiness.
CDC	Regulatory and strategic partner	Guides policies and targeted deployment	Manages stockpile inventory.
Defense Agencies	Strategic user	Assesses biodefense utility	Potential markets in military applications.

Market Size and Forecasts

Dimension	Figures	Data Source	Notes
Global Smallpox Preparedness Market	~$200 million (2023)	MarketResearch.com	Driven by government budgets for biodefense.
Estimated Annual Demand (U.S.)	10,000 – 15,000 courses	CDC, BARDA	For stockpiling and emergency use.
Broader Orthopoxvirus Treatment Market	Potential expansion to cowpox, monkeypox	Emerging data	Opportunities with recent monkeypox outbreaks.

Financial Trajectory: Revenue Streams & Projections

Source	Current Revenue (2023)	Projected (2025)	Key Factors
Government Contracts	~$100 million	~$200 million	Stockpiling, surge capacity.
Clinical Sales (Emergency Use)	~$50 million	~$120 million	Rapid response during outbreaks.
International Licensing & Distribution	~$20 million	~$50 million	Expanding beyond U.S.

How Does the Competitive Landscape Shape Up?

Competitor	Product	Approval Status	Market Share	Strengths/Weaknesses
SIGA Technologies	TPOXX (Tecovirimat)	Approved (2018)	~85%	First-to-market, stockpiling advantage.
Ancillary Options	CMX001 (Brincidofovir)	Approved for other indications	Niche	Alternative for poxvirus, but less proven.
Emerging Biologics	mAbs targeting orthopoxviruses	Early-stage	Unknown	Potential future threat or complement.

What Are the Key Policies Affecting TPOXX Market?

• FDA Animal Rule (2004): Allows approval based on animal efficacy data for severe or life-threatening conditions where human trials are unethical or infeasible.
• US Biodefense Strategies (2010–2023): Inclusion of prioritized pathogens in national frameworks increases funding and strategic stockpiling.
• WHO Guidelines: Potential framework for international deployment in outbreak scenarios.
• International Stockpile Policies: Countries such as Canada, Australia, and UK explore procurement aligned with CDC policies.

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Comparative Analysis: TPOXX vs. Potential Alternatives

Criteria	TPOXX	Brincidofovir (CMX001)	Emerging Immunotherapies
Approvals	FDA approved	Approved for CMV and adenovirus	Clinical-stage
Indications	Smallpox, orthopoxviruses	Broader antiviral spectrum	Poxvirus-specific
Market Penetration	~85% global share	Limited	Not yet commercialized
Safety Profile	Well-characterized	Symptoms include gastrointestinal effects	Unknown
Price Point	~$75,000 per course	~$90,000 per course	TBD

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What Are the Future Financial Opportunities?

Expansion to Emerging Indications

• Monkeypox: Recent outbreaks have revived interest; TPOXX has potential for EUA or approval.
• Other Orthopoxviruses: Research on cowpox or vaccinia could open new markets.
• Biothreat Preparedness: Continuous investment in stockpiles supports resilient demand.

Geographic Expansion

Region	Market Potential	Barriers	Strategy
North America	High	Regulatory Approval	Leverage existing approvals, expand contracts
Europe	Moderate	EMA approval process	Partner with local agencies or acquire approvals
Asia-Pacific	Growing	Market awareness, regulatory hurdles	Collaborate with governments, adapt pricing

Market Growth Assumptions

• CAGR of ~12% from 2023–2028 driven by:
  • Increasing biodefense budgets.
  • Rising incidence of orthopoxvirus-related outbreaks (e.g., monkeypox).
  • Government procurement cycles.

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Key Takeaways

• Market Revenue Is Predominantly Driven by Government Demand: Strategic stockpiling and biodefense policies underpin sales, with revenues concentrated in North America.
• Regulatory Approvals Enable Broader Deployment: FDA’s animal rule approval and EUA facilitate response capabilities, creating additional revenue channels.
• Emerging Indications and Pathogens Offer Growth Potential: Recent monkeypox outbreaks have spotlighted TPOXX's utility beyond smallpox, presenting a shift toward broader antiviral markets.
• International Expansion Remains Limited but Promising: Global policies and collaborations are critical for capturing wider markets.
• Competitive Dynamics Favor SIGA’s TPOXX in the Short to Medium Term: While alternatives exist, TPOXX’s first-mover advantage, established supply chains, and strategic partnerships create barriers for competitors.

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FAQs

1. What is the primary use case for TPOXX?
TPOXX is primarily indicated for treating smallpox, particularly in scenarios involving biothreats, and has investigational or emergency use authorization for other orthopoxvirus infections like monkeypox.

2. How does government policy influence TPOXX sales?
Government policies—such as stockpiling mandates, biodefense funding, and regulatory approvals—are pivotal, often dictating procurement volumes and usage protocols, thus significantly impacting revenues.

3. What is the potential for TPOXX in treating monkeypox?
Recent outbreaks have lit a renewed focus on TPOXX’s efficacy; preliminary data suggest potential utility, prompting authorities to consider EUA or expanded indications as outbreaks grow.

4. How competitive is the market for antiviral treatments targeting orthopoxviruses?
Currently, TPOXX holds the dominant position, with few direct competitors. The landscape may evolve as biologics or adjunct therapies are developed.

5. What are the main risks to sustainable growth of TPOXX?
Market size limitations due to the rarity of smallpox and orthopoxvirus infections, regulatory hurdles in international markets, and potential emergence of effective competitors are key risks.

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References

1. FDA. “Tecovirimat (TPOXX) for the Treatment of Smallpox: Approval Summary,” 2018.
2. CDC. “Smallpox Vaccination and Therapeutics,” Centers for Disease Control and Prevention, 2022.
3. BARDA. “Biodefense Stockpile and Contracting Data,” U.S. Department of Health & Human Services, 2023.
4. MarketResearch.com. “Global Biodefense Market Analysis,” 2023.
5. WHO. “Guidelines for Poxvirus Management,” World Health Organization, 2021.

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Conclusion

TPOXX’s market landscape is shaped by government prioritization, biodefense policies, and recent zoonotic concerns. While its current revenue streams are heavily reliant on strategic stockpiling and biodefense budgets, expanding indications, international collaborations, and emerging outbreaks could propel future growth. The competitive environment remains favorable for SIGA, but diversification into new indications will be critical to sustain momentum amid evolving biothreats and infectious disease landscapes.

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