TECOVIRIMAT - Generic Drug Details

What are the generic drug sources for tecovirimat and what is the scope of patent protection?

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

Dosage:

CAPSULE;ORAL

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			Y
Siga Technologies	TPOXX	tecovirimat	SOLUTION;INTRAVENOUS	214518-001	May 18, 2022		RX	Yes	Yes
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			Y	Y
Siga Technologies	TPOXX	tecovirimat	CAPSULE;ORAL	208627-001	Jul 13, 2018		RX	Yes	Yes			Y

Expired US Patents for TECOVIRIMAT

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

International Patents for TECOVIRIMAT

Country	Patent Number	Title	Estimated Expiration
South Korea	20160028489
South Korea	20160062208	다형체 형태 ＳＴ―２４６ 및 제조방법 (POLYMORPHIC FORMS ST-246 AND METHODS OF PREPARATION)
Japan	5898196
China	106074370
Mexico	368106

Supplementary Protection Certificates for TECOVIRIMAT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1638938	2290024-5	Sweden		PRODUCT NAME: TECOVIRIMAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/21/1600/001 20220107
2549871	22C1023	France		PRODUCT NAME: TECOVIRIMAT, SOUS TOUTES LES FORMES RELEVANT DE LA PROTECTION DU BREVET DE BASE; REGISTRATION NO/DATE: EU/1/21/1600/001 20220106
1638938	301177	Netherlands		PRODUCT NAME: TECOVIRIMAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1600/001 20220107
2549871	122022000033	Germany		PRODUCT NAME: TECOVIRIMAT; REGISTRATION NO/DATE: EU/1/21/1600 20220106
1638938	122022000032	Germany		PRODUCT NAME: TECOVIRIMAT ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1600 20220106

Market Dynamics and Financial Trajectory for Tecovirimat

Last updated: February 16, 2026

Tecovirimat, marketed as TPOXX, is an antiviral drug developed by SIGA Technologies for the treatment of orthopoxvirus infections, primarily smallpox. Its development and potential utilization influence its market and financial prospects.

Market Landscape

Regulatory Status and Approvals:

• Approved by the FDA in 2018 for smallpox (HHS Emergency Use Authorization prior to approval).
• Approved in Europe by the EMA in 2022.
• U.S. CDC stockpile holds significant quantities for biodefense preparedness.

Target Diseases and Market Drivers:

• Smallpox remains eradicated, but Tecovirimat's primary market stems from biodefense and research uses.
• Emerging concerns related to bioterrorism and potential use of orthopoxvirus as bioweapons sustain demand.
• The U.S. government has invested heavily in stockpiling supplies and supporting R&D.

Competitive Landscape:

• No approved direct competitors for smallpox.
• Other antivirals like brincidofovir are under investigation but lack approval.
• The primary competition is from vaccine-based prevention, not antivirals.

Market Drivers and Barriers

Drivers:

• Biodefense preparedness policies.
• Growing global investments in biological threat countermeasures.
• Potential use of Tecovirimat for research or off-label purposes in related orthopoxvirus infections.

Barriers:

• Limited clinical indications restrict commercial flexibility outside biodefense.
• Dependence on government stockpiling budgets.
• No widespread outpatient usage or commercial distribution for natural infections.

Financial Trajectory

Revenue Outlook:

• SIGA reported $59.3 million in product sales in 2022, up from $45.2 million in 2021 [1].
• Revenue mainly from government contracts and stockpile sales.
• Limited commercial sales outside government channels.

Cost Structure and Investment:

• Steady R&D expenditure primarily funded by government grants and existing revenue streams.
• Continued lobbying and regulatory expenses to maintain stockpile status and expand indications.

Growth Potential:

• Short-term growth tied to procurement cycles and biodefense priorities.
• Longer-term prospects uncertain; could increase with expanded indications for orthopoxvirus infections.
• Potential license extensions for other viruses like monkeypox could open new markets, especially if smallpox is reconsidered in post-pandemic biosecurity strategies.

Valuation and Market Cap:

• SIGA's market capitalization was approximately $700 million as of early 2023.
• Stock fluctuation reflects advances in regulatory approvals, government procurement deals, and pipeline developments.

Future Risks and Opportunities

Risks:

• Changes in biodefense funding and policies.
• The emergence of alternative treatments or vaccines.
• Geopolitical factors affecting government budgets and priorities.

Opportunities:

• Expanded government contracts or international licensing agreements.
• Conversion of stockpiled supplies into commercial therapy options for orthopoxvirus infections.
• Potential for approval in treating monkeypox, which has increased global attention.

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Key Takeaways

• Tecovirimat's market depends on biodefense needs, with limited commercial uses outside government stockpiling.
• Revenue growth is linked to government procurement cycles, with current sales driven by U.S. and international biodefense initiatives.
• Long-term growth prospects hinge on regulatory developments, new indications, and biodefense policy shifts.
• Competitive landscape remains limited, with no direct antiviral rivals for smallpox.
• Market valuation remains sensitive to government funding and emerging infectious disease concerns.

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Frequently Asked Questions

1. What is the primary application of Tecovirimat?
It is used to treat orthopoxvirus infections, mainly smallpox, under biodefense initiatives.

2. How does Tecovirimat generate revenue?
Revenue primarily comes from government procurement, including stockpiling and distribution agreements.

3. Are there plans to expand Tecovirimat’s indications?
Potential exists for expanded use in treating other orthopoxviruses like monkeypox, which could increase its market.

4. What competitors exist for Tecovirimat?
No direct antiviral competitors for smallpox; vaccines are the primary preventive measure.

5. How does government policy influence Tecovirimat’s market?
Biodefense funding, stockpile policies, and biodefense preparedness strategies heavily influence demand.

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Sources
[1] SIGA Technologies Annual Reports and SEC Filings (2022)