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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:	39
What excipients (inactive ingredients) are in TPOXX?	TPOXX excipients list
DailyMed Link:	TPOXX at DailyMed

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

NDA:

208627

Dosage:

CAPSULE;ORAL

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

Anatomical Therapeutic Chemical (ATC) Classes for TPOXX

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

US Patents and Regulatory Information for TPOXX

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

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

Patents protecting TPOXX

FDA Regulatory Exclusivity protecting TPOXX

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

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
Japan	2013532729
Canada	2685198	AGENTS CHIMIQUES, COMPOSITIONS ET PROCEDES DE TRAITEMENT ET DE PREVENTION DES INFECTIONS A ORTHOPOXVIRUS ET DES MALADIES ASSOCIEES (CHEMICALS, COMPOSITIONS, AND METHODS FOR TREATMENT AND PREVENTION OF ORTHOPOXVIRUS INFECTIONS AND ASSOCIATED DISEASES)
Canada	2966466	PRODUITS CHIMIQUES, COMPOSITIONS ET PROCEDES DE TRAITEMENT ET DE PREVENTION DES INFECTIONS A ORTHOPOXVIRUS ET DES MALADIES ASSOCIEES (CHEMICALS, COMPOSITIONS, AND METHODS FOR TREATMENT AND PREVENTION OF ORTHOPOXVIRUS INFECTIONS AND ASSOCIATED DISEASES)
China	105111130	Polymorphic forms of ST-246 and methods of preparation
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 TPOXX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1638938	2022C/521	Belgium		PRODUCT NAME: TECOVIRIMAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1600 20220107
1638938	122022000032	Germany		PRODUCT NAME: TECOVIRIMAT ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1600 20220106
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
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