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 ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tecovirimat has ninety-five patent family members in twenty-three countries.

One supplier is listed for this compound.

Summary for TECOVIRIMAT

International Patents:	95
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	29
Clinical Trials:	11
Patent Applications:	71
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
Universiteit Antwerpen	Phase 4
European Clinical Research Alliance for Infectious Diseases (ECRAID)	Phase 4
Miquel Ekkelenkamp	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	SOLUTION;INTRAVENOUS	214518-001	May 18, 2022		RX	Yes	Yes	7,737,168
Siga Technologies	TPOXX	tecovirimat	SOLUTION;INTRAVENOUS	214518-001	May 18, 2022		RX	Yes	Yes	9,233,097		Y
Siga Technologies	TPOXX	tecovirimat	SOLUTION;INTRAVENOUS	214518-001	May 18, 2022		RX	Yes	Yes	8,530,509		Y
Siga Technologies	TPOXX	tecovirimat	CAPSULE;ORAL	208627-001	Jul 13, 2018		RX	Yes	Yes	9,339,466		Y	Y
Siga Technologies	TPOXX	tecovirimat	SOLUTION;INTRAVENOUS	214518-001	May 18, 2022		RX	Yes	Yes	9,907,859

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	8,124,643
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	8,530,509
Siga Technologies	TPOXX	tecovirimat	CAPSULE;ORAL	208627-001	Jul 13, 2018	8,802,714
Siga Technologies	TPOXX	tecovirimat	CAPSULE;ORAL	208627-001	Jul 13, 2018	8,530,509

International Patents for TECOVIRIMAT

Country	Patent Number	Title	Estimated Expiration
China	101702904	Chemicals, compositions, and methods for treatment and prevention of orthopoxvirus infections and associated diseases
Mexico	347795	FORMULACIONES LIQUIDAS DE ST-246 Y METODOS. (ST-246 LIQUID FORMULATIONS AND METHODS.)
Japan	2013522371
Japan	2018012735	ＳＴ−２４６の多形型および調製方法 (POLYMORPHIC FORMS OF ST-246 AND METHODS OF PREPARATION)
South Korea	20170102070	다형체 형태 ＳＴ―２４６ 및 제조방법 (POLYMORPHIC FORMS ST-246 AND METHODS OF PREPARATION)

Supplementary Protection Certificates for TECOVIRIMAT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2549871	122022000033	Germany		PRODUCT NAME: TECOVIRIMAT ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; 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
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
1638938	2290024-5	Sweden		PRODUCT NAME: TECOVIRIMAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/21/1600/001 20220107

TECOVIRIMAT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tecovirimat

Introduction

Tecovirimat, known by its brand name TPOXX, is an antiviral drug primarily used for the treatment of smallpox and other orthopoxvirus infections, including monkeypox. The market dynamics and financial trajectory of tecovirimat are influenced by several key factors, including government initiatives, technological advancements, and market demand.

Market Drivers

Government Initiatives and Funding

Government initiatives and funding play a crucial role in driving the market for tecovirimat. Heightened governmental and institutional investments in health emergency preparedness, particularly following recent global health crises, have underscored the necessity for robust antiviral strategies. This has led to significant government contracts and funding for companies like SIGA Technologies, which has received substantial orders for TPOXX from various government entities, including the U.S. Department of Defense and international customers[2][5].

Strategic Collaborations

Strategic collaborations with biotech firms and other pharmaceutical companies are another key driver. These collaborations enhance research and development capabilities, leading to more efficient production and broader distribution of tecovirimat. Companies such as Bavarian Nordic, Emergent BioSolutions, and Johnson & Johnson are actively involved in such collaborations to expand their market presence[1][4].

Regulatory Support

Regulatory approvals and support from bodies like the U.S. FDA are critical for the adoption of tecovirimat. The FDA's approval of TPOXX for smallpox treatment and its inclusion in the Strategic National Stockpile have significantly boosted its market prospects[1][3].

Market Restraints

Stringent Regulatory Frameworks

The market for tecovirimat is hindered by stringent regulatory frameworks. The process of obtaining approvals for antiviral drugs is rigorous and time-consuming, which can slow down market penetration. Additionally, the need for continuous clinical trials and updates to the expanded access investigational new drug (EA-IND) protocol adds to the regulatory complexity[1][3].

High Production Costs

High production costs are another significant restraint. The manufacturing process for tecovirimat is complex and expensive, which can limit its accessibility, especially in developing regions. Companies are working to optimize manufacturing processes to reduce costs, but this remains a challenge[1].

Limited Public Awareness

Limited public awareness about the drug and its benefits can also hinder rapid market adoption. Educating healthcare providers and the public about the efficacy and safety of tecovirimat is crucial for increasing its market share[1].

Market Opportunities

Expanding Distribution Networks

There is a significant opportunity in expanding distribution networks, particularly in developing regions. Companies like SIGA Technologies are focusing on diversifying their customer base and securing international sales, which has contributed to their revenue growth[2][5].

Enhancing Public and Private Sector Partnerships

Strengthening public and private sector partnerships is essential for widespread accessibility of tecovirimat. Collaborations between government agencies, biotech firms, and pharmaceutical companies can facilitate the development and distribution of the drug, making it more accessible globally[1].

Research and Development

Continued research and development are vital for the market growth of tecovirimat. Expanding the spectrum of tecovirimat's efficacy against emerging viral threats and improving its safety and efficacy characteristics are areas of ongoing research. Recent clinical trials, such as the PALM007 and STOMP studies, provide valuable insights into its effectiveness against different strains of mpox[3].

Financial Trajectory

Revenue Growth

SIGA Technologies, a key player in the tecovirimat market, has demonstrated impressive revenue growth. In 2022, the company generated approximately $111 million in revenue, with $71 million coming from international sales of TPOXX. The company's Q2 2024 revenue showed a 76.9% increase over the last twelve months, driven by deliveries to the Department of Defense and international clients[2][5].

International Sales

International sales have been a significant contributor to the financial health of companies involved in the tecovirimat market. SIGA Technologies secured a $9 million Department of Defense contract and achieved its first commercial sale of TPOXX in Africa, highlighting the growing international demand for the drug[5].

Cash Flow and Liquidity

SIGA Technologies' strong financial position is underscored by its cash flow and liquidity. The company holds more cash than debt on its balance sheet, enabling it to pursue growth opportunities and expand into new markets without excessive financial strain[5].

Key Company Profiles

SIGA Technologies

SIGA Technologies is a leading company in the tecovirimat market. The company's recent financial results and operational activities, including the sale of TPOXX to new international customers and the U.S. Department of Defense, highlight its strong market position. SIGA's focus on customer diversification and strategic partnerships has been instrumental in its revenue growth[2][5].

Other Key Players

Other companies such as Bavarian Nordic, Emergent BioSolutions, and Johnson & Johnson are also significant players in the market. These companies are involved in various aspects of tecovirimat development, distribution, and research, contributing to the overall market dynamics[1][4].

Porter’s Five Forces Analysis

The Porter’s Five Forces analysis provides insights into the competitive landscape of the tecovirimat market. This analysis helps companies understand the strength of their current competitive position and identify potential areas for improvement. Key factors include the bargaining power of suppliers, the bargaining power of buyers, the threat of new entrants, the threat of substitute products, and the intensity of competitive rivalry[1].

Clinical Trials and Efficacy

Recent clinical trials, such as the PALM007 and STOMP studies, have provided valuable data on the efficacy and safety of tecovirimat. While the drug was found to be safe, it did not significantly reduce the time to resolution of mpox lesions compared to placebo. These findings suggest that most patients with mpox who do not have severe disease or risk factors for severe disease will recover with supportive care and pain management[3].

Market Forecast

The global monkeypox vaccine and treatment market, which includes tecovirimat, is projected to grow significantly. According to Prophecy Market Insights, the market is expected to reach USD 215.7 billion by 2034, with a compound annual growth rate (CAGR) of 10.7% during the forecast period (2024-2034)[4].

Key Takeaways

• Government initiatives and funding are crucial drivers for the tecovirimat market.
• Strategic collaborations and regulatory support are essential for market growth.
• High production costs and stringent regulatory frameworks are significant restraints.
• Expanding distribution networks and enhancing public and private sector partnerships offer substantial market opportunities.
• SIGA Technologies and other key players are driving revenue growth through international sales and strategic partnerships.
• Clinical trials continue to shape the understanding of tecovirimat's efficacy and safety.

FAQs

What is tecovirimat used for?

Tecovirimat, known by its brand name TPOXX, is an antiviral drug used primarily for the treatment of smallpox and other orthopoxvirus infections, including monkeypox[3].

Which companies are key players in the tecovirimat market?

Key players include SIGA Technologies, Bavarian Nordic, Emergent BioSolutions, and Johnson & Johnson, among others[1][4].

What are the main drivers of the tecovirimat market?

The main drivers include government initiatives and funding, strategic collaborations, and regulatory support[1][2].

What are the significant restraints in the tecovirimat market?

Significant restraints include stringent regulatory frameworks, high production costs, and limited public awareness[1].

What is the projected growth of the monkeypox vaccine and treatment market?

The global monkeypox vaccine and treatment market is projected to grow from USD 85.4 billion in 2024 to USD 215.7 billion by 2034, with a CAGR of 10.7% during the forecast period[4].

Cited Sources:

1. 360iResearch: Tecovirimat Drugs Market Size & Share 2025-2030.
2. GlobeNewswire: SIGA Reports Financial Results for Three and Twelve Months Ended December 31, 2022.
3. CDC: Tecovirimat (TPOXX) for Treatment of Mpox.
4. GlobeNewswire: Monkeypox Vaccine and Treatment Market Share Set to Reach USD 215.7 Billion by 2034.
5. Investing.com: SIGA Technologies secures TPOXX sale in Morocco.