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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 ten patents protecting this drug.

This drug has ninety-five patent family members in twenty-three 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:	95
US Patents:	10
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	29
Patent Applications:	33
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 eleven 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	8,802,714
Siga Technologies	TPOXX	tecovirimat	CAPSULE;ORAL	208627-001	Jul 13, 2018		RX	Yes	Yes	8,124,643		Y	Y
Siga Technologies	TPOXX	tecovirimat	SOLUTION;INTRAVENOUS	214518-001	May 18, 2022		RX	Yes	Yes	8,039,504		Y

Expired US Patents for TPOXX

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

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
Australia	2011285871	ST-246 liquid formulations and methods
Israel	258239	ושיטות st-תוצרות פולימורפיות של 246 להכנתן (Polymorphic forms st-246 and methods of preparation)
Canada	2529761	COMPOSES, COMPOSITIONS ET PROCEDES PERMETTANT DE TRAITER ET DE PREVENIR DES INFECTIONS A ORTHOPOXVIRUS ET DES MALADIES ASSOCIEES (COMPOUNDS, COMPOSITIONS AND METHODS FOR TREATMENT AND PREVENTION OF ORTHOPOXVIRUS INFECTIONS AND ASSOCIATED DISEASES)
Peru	20170944	FORMAS POLIMORFICAS DE ST-246 Y METODOS DE PREPARACION

Supplementary Protection Certificates for TPOXX

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

TPOXX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TPOXX

Introduction

TPOXX, also known as tecovirimat, is a groundbreaking antiviral drug developed by SIGA Technologies, Inc., a commercial-stage pharmaceutical company focused on the health security market. This article delves into the market dynamics and financial trajectory of TPOXX, highlighting its significance, regulatory approvals, sales performance, and future prospects.

Regulatory Approvals and Development

TPOXX was approved by the FDA in 2018 for the treatment of smallpox, using the FDA's "Animal Rule" due to the ethical and practical impossibility of conducting human efficacy trials for a disease eradicated in 1980. The drug also received Fast Track and Orphan Drug Designation, facilitating its development and approval process[5].

Market Significance

TPOXX is crucial in addressing the long-term impact and risks of orthopox viruses, including smallpox and monkeypox. The creation of a joint procurement mechanism by the European Commission allows EU countries to efficiently order oral TPOXX, underscoring its global importance in public health preparedness[1].

Sales Performance

Recent Financial Results

In the second quarter of 2024, SIGA reported product sales of $21 million, with a total of $45 million for the first six months. A significant portion of these sales came from IV TPOXX deliveries to the U.S. Government, amounting to $18 million. Additionally, SIGA received a substantial procurement order of approximately $113 million for oral TPOXX from the U.S. Government under the 19C BARDA contract[2][3].

International Sales

TPOXX has seen diverse sales across various regions. In the second quarter of 2024, SIGA delivered oral TPOXX to a new customer in the ASEAN region and secured an $11 million order from another customer in the Asia Pacific region. These international sales highlight the expanding global market for TPOXX[3].

European Market

The European Commission's joint procurement mechanism is expected to generate initial orders of approximately $18 million for oral TPOXX within 60 days. This mechanism allows EU countries to acquire and reorder TPOXX efficiently, contributing to the drug's growing market presence in Europe[1].

Financial Trajectory

Revenue Growth

SIGA's financial performance has shown significant improvement. For the first six months of 2024, product sales reached $44.6 million, up from $7.0 million in the previous year. Total revenues for the same period increased to $47.2 million, compared to $14.2 million in 2023. The operating income for the first half of 2024 was $12.4 million, a marked turnaround from a loss of $6.7 million in the first half of 2023[2][3].

Procurement Orders

The $113 million procurement order from the U.S. Government for oral TPOXX is a major financial boost. This order, along with other international contracts, positions SIGA for continued revenue growth and financial stability[2][3].

Clinical Trials and Efficacy

STOMP Study

Recent interim results from the STOMP clinical trial indicated that TPOXX did not show significant improvement over placebo in treating mild to moderate mpox. However, the drug maintained its strong safety profile, and its efficacy in severe cases was not assessed in this study. This outcome aligns with previous findings that antivirals are most effective when administered early in infection and in severe cases[4].

Future Prospects

Diversification and Expansion

SIGA is committed to diversifying and expanding its revenue base. The company aims to progress its clinical programs, negotiate future contracts with the U.S. Government, and promote public health. The amendment to its international promotion agreement with Meridian Medical Technologies allows SIGA greater control over international promotions, enhancing its ability to meet global customer needs[2][3].

Regulatory and Market Risks

Despite the positive trajectory, SIGA faces several risks, including the potential modification or cancellation of government contracts, delays in supply chain operations, and the need for additional regulatory approvals. However, the company's strong performance and strategic initiatives mitigate these risks to some extent[2][3].

Capital Management

SIGA has demonstrated prudent capital management. In April 2024, the company paid a special cash dividend of $0.60 per share, up from $0.45 per share the previous year. This move reflects the company's commitment to enhancing shareholder value[2].

Conclusion

TPOXX has established itself as a critical component in the global response to orthopox viruses, with a robust market presence and significant financial growth. Despite some challenges in clinical trials, the drug's safety profile and the company's strategic initiatives position it for continued success.

Key Takeaways

• Regulatory Approvals: TPOXX was approved by the FDA in 2018 using the "Animal Rule" and received Fast Track and Orphan Drug Designation.
• Sales Performance: Significant sales growth in 2024, including a $113 million procurement order from the U.S. Government.
• International Sales: Diverse sales across the U.S., Europe, ASEAN, and Asia Pacific regions.
• Financial Trajectory: Revenue growth and operating income turnaround in 2024.
• Clinical Trials: Mixed results from the STOMP study, but strong safety profile maintained.
• Future Prospects: Commitment to diversifying revenue base, progressing clinical programs, and promoting public health.

FAQs

What is TPOXX used for?

TPOXX (tecovirimat) is used for the treatment of smallpox and other orthopox viruses, including monkeypox.

Who developed TPOXX?

TPOXX was developed by SIGA Technologies, Inc. in partnership with the U.S. Government and funded by the Biomedical Advanced Research and Development Authority (BARDA).

What is the significance of the joint procurement mechanism in Europe?

The joint procurement mechanism allows EU countries to efficiently order and reorder oral TPOXX, enhancing their preparedness against orthopox viruses.

How has SIGA's financial performance been in 2024?

SIGA reported significant revenue growth in 2024, with product sales of $45 million for the first six months and a total revenue of $47.2 million.

What were the findings of the STOMP clinical trial for TPOXX in treating mpox?

The STOMP trial found that TPOXX did not improve time to lesion resolution compared to placebo in adults with mild to moderate mpox, but it maintained a strong safety profile.