Tecovirimat - Generic Drug Details

What are the generic drug sources for tecovirimat and what is the scope of freedom to operate?

Tecovirimat is the generic ingredient in one branded drug marketed by Siga Technologies and is included in two NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for tecovirimat

International Patents:	96
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	29
Clinical Trials:	11
DailyMed Link:	tecovirimat at DailyMed

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

Constraining patent/regulatory exclusivity:

9,339,466

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

10,576,165

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.

Recent Clinical Trials for tecovirimat

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
European Clinical Research Alliance for Infectious Diseases (ECRAID)	Phase 4
Miquel Ekkelenkamp	Phase 4
Erasmus Medical Center	Phase 4

See all tecovirimat clinical trials

Pharmacology for tecovirimat

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

Anatomical Therapeutic Chemical (ATC) Classes for tecovirimat

J05AX	Other antivirals
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for tecovirimat

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
Siga Technologies	TPOXX	tecovirimat	CAPSULE;ORAL	208627-001	Jul 13, 2018		RX	Yes	Yes	11,890,270
Siga Technologies	TPOXX	tecovirimat	SOLUTION;INTRAVENOUS	214518-001	May 18, 2022		RX	Yes	Yes	10,576,165		Y
Siga Technologies	TPOXX	tecovirimat	CAPSULE;ORAL	208627-001	Jul 13, 2018		RX	Yes	Yes	9,339,466		Y	Y

Expired US Patents for tecovirimat

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

International Patents for tecovirimat

Country	Patent Number	Title	Estimated Expiration
Mexico	347795	FORMULACIONES LIQUIDAS DE ST-246 Y METODOS. (ST-246 LIQUID FORMULATIONS AND METHODS.)
France	22C1023
Mexico	2009011533
European Patent Office	2148860	PRODUITS CHIMIQUES, COMPOSITIONS ET PROCÉDÉS DE TRAITEMENT ET DE PRÉVENTION DES INFECTIONS À ORTHOPOXVIRUS ET DES MALADIES ASSOCIÉES (CHEMICALS, COMPOSITIONS, AND METHODS FOR TREATMENT AND PREVENTION OF ORTHOPOXVIRUS INFECTIONS AND ASSOCIATED DISEASES)

Supplementary Protection Certificates for tecovirimat

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1638938	C202230021	Spain		PRODUCT NAME: TECOVIRIMAT O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/21/1600; DATE OF AUTHORISATION: 20220106; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1600; DATE OF FIRST AUTHORISATION IN EEA: 20220106
1638938	2022C/521	Belgium		PRODUCT NAME: TECOVIRIMAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1600 20220107
2549871	122022000033	Germany		PRODUCT NAME: TECOVIRIMAT; 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

Market Dynamics and Financial Trajectory for Tecovirimat

Last updated: July 31, 2025

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Introduction

Tecovirimat, commercially known as TPOXX, is an antiviral medication developed primarily for the treatment of orthopoxvirus infections, notably smallpox. Its significance has surged in recent years owing to concerns over potential biowarfare threats, emerging zoonotic infections, and its potential applications against other orthopoxviruses like monkeypox. This article examines the current market dynamics, regulatory landscape, competitive positioning, and the financial outlook for tecovirimat, providing business professionals with critical insights to inform strategic decisions.

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Development and Regulatory Milestones

Originally developed bySIGA Technologies (NASDAQ: SIGA), tecovirimat received its initial approval from the U.S. Food and Drug Administration (FDA) in July 2018 via the Animal Efficacy Rule, which allows approval based on animal studies when human trials are unethical or unfeasible (1). Subsequently, regulatory agencies in Canada, the European Union, and other jurisdictions have granted or are reviewing approvals, expanding market access.

The rapid strategic deployment by U.S. government agencies, including the Strategic National Stockpile, has positioned tecovirimat as a critical countermeasure against biological threats. Its stockpiling and procurement contracts are pivotal components influencing its financial trajectory.

Market Drivers

• Biological Threat Preparedness: The U.S. and allied governments' investment in biodefense significantly influence demand. The Department of Health and Human Services (HHS), through BARDA (Biomedical Advanced Research and Development Authority), has committed substantial funds for stockpiling and procurement (2).

• Emergence of Monkeypox: The resurgence and global spread of monkeypox have underscored the therapeutic need for antivirals targeting orthopoxviruses. The 2022 monkeypox outbreaks prompted regulatory agencies to explore expanded uses of tecovirimat, potentially broadening its market.

• Military and Strategic Use: International stakeholders, notably in Europe and Asia, are considering or developing biodefense strategies, potentially expanding the geographical footprint for tecovirimat.

• Stockpile Deployment and Usage: While approved for smallpox, tecovirimat's real-world use in containment efforts and post-exposure prophylaxis influences demand volatility.

Market Challenges and Constraints

• Limited Human Efficacy Data: The ethical impossibility of human trials for smallpox means approvals rely heavily on animal efficacy studies, creating uncertainties about real-world effectiveness (1).

• Pricing and Reimbursement: As a specialized countermeasure, tecovirimat's pricing is subject to government negotiations and stockpile budgets, potentially constraining revenue growth.

• Manufacturing Capacity: Scaling production remains a bottleneck, especially given biosafety requirements and the Drug Enforcement Agency (DEA) controls over antiviral substances.

• Off-Label Use and Competition: The potential emergence of alternative antivirals or broad-spectrum agents could impact market share.

Competitive Landscape

Currently, SIGA holds the patent and primary rights to tecovirimat, with limited direct competition. However, research institutions and biotech companies are exploring alternative antivirals targeting similar viral pathways. The strategic advantage of tecovirimat stems from its FDA approval and existing stockpile agreements.

Emerging competitors include:

• Chimerix’s brincidofovir: An antiviral approved for smallpox under the CDC’s Investigational New Drug (IND) protocol, although its commercial viability remains uncertain in pandemic preparedness contexts.

• Other experimental agents: Multiple molecules are in preclinical or early clinical development targeting orthopoxviruses, potentially challenging tecovirimat’s market dominance in the future.

Financial Trajectory Analysis

Revenue Streams
SIGA's revenues from tecovirimat are predominantly pipeline-driven, relying heavily on government contracts, stockpile purchases, and emergency allocations (3). The company’s revenue in 2022 was approximately $134 million, attributable to upfront payments, milestones, and ongoing procurement agreements.

Pricing Model
Tecovirimat’s commercial pricing varies by country and procurement volume. In the United States, the government acquire it at negotiated rates, whereas retail or international markets could see higher list prices, potentially ranging from $50 to $300 per capsule depending on volume and country.

Market Penetration and Adoption
The primary revenue is expected from government stockpiling and emergency use, with limited direct consumer sales. The global smallpox eradication almost eliminated natural demand, positioning tecovirimat as a strategic stockpile asset rather than a routine therapeutic.

Growth Projections
Modeling suggests that demand may see a spike during outbreak events, such as the 2022 monkeypox crisis, when demand can shift toward broader indications and emergency use authorizations. Long-term projections hinge on:

• Continued biological threat preparedness funding.
• Regulatory approvals for additional indications or expanding use cases.
• International procurement and distribution strategies.

Sensitivity Factors
Market growth is sensitive to:

• Outbreak frequency and severity.
• Regulatory landscape shifts.
• Government budgets and biodefense spending policies.
• Competitive entry of alternative therapies.

Emerging Trends and Future Outlook

The biotechnology industry is witnessing heightened investment in antiviral development, driven by recent pandemics and biothreat concerns. Tecovirimat’s financial outlook benefits from its status as a first-in-class, FDA-approved agent, with expected steady revenue streams from government contracts.

Additionally, efforts to extend indications—such as treating monkeypox—may significantly augment market size. The U.S. government’s continued commitment, as evidenced by substantial procurement agreements in 2022, signals sustained demand.

However, competition, manufacturing capacity limitations, and evolving pathogen profiles could reshape market dynamics, highlighting the need for SIGA to adapt its strategy and scale manufacturing.

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Key Takeaways

• Strategic Stockpiling Drives Revenue: The primary market for tecovirimat is government stockpiles within the biodefense framework, with revenues fueled by procurement contracts and emergency authorizations.

• Emerging Infectious Disease Outbreaks Expand Market Opportunities: The monkeypox outbreak demonstrated the potential for expanded use cases, which could elevate demand for tecovirimat.

• Regulatory and Political Factors Are Pivotal: Approvals in multiple jurisdictions and the political will to invest in biodefense significantly influence its market trajectory.

• Competitive Landscape Remains Limited but Evolving: SIGA’s leadership position is reinforced by regulatory approval but faces future threats from emerging therapies and alternative antivirals.

• Financial Growth is Contingent on Continued Investment: Sustained government funding and successful expansion into new indications are critical to long-term revenue growth.

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FAQs

1. What factors influence the pricing of tecovirimat globally?
Pricing varies based on procurement volume, healthcare infrastructure, and government negotiations. In the U.S., government contracts typically secure lower prices via negotiated rates, whereas international markets may adopt tiered or country-specific pricing schemes.

2. How significant are government contracts in tecovirimat’s revenue forecast?
Government contracts are crucial, often constituting the majority of revenue. These agreements, linked to stockpiling and emergency use, provide predictable demand but are sensitive to policy shifts and budget allocations.

3. What is the outlook for tecovirimat’s approval for monkeypox treatment?
Based on recent outbreaks, regulatory agencies are actively reviewing data for expanded indications. Emergency use authorizations are possible if efficacy data are compelling, which would significantly bolster market potential.

4. How does the emergence of competing antivirals impact tecovirimat's market?
While currently dominant, future competition from novel antivirals targeting similar pathways could erode market share, especially if those therapies demonstrate superior efficacy or safety profiles.

5. What are the key regulatory risks for tecovirimat’s commercialization?
Regulatory risks include delays or denials of expanded indications, changes in approval pathways, or restrictions on off-label use, all of which could impact revenue streams.

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References

1. U.S. Food & Drug Administration. (2018). FDA Approves First Drug to Treat Variola Virus (Smallpox).
2. Medical Countermeasures Database. (n.d.). BARDA Funding and Procurement Data.
3. SIGA Technologies. (2022). Annual Report and Financial Statements.