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 one NDA. There are six patents protecting this drug.

This drug has seventy patent family members in twenty-one 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 will be eligible for patent challenges on July 13, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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:	70
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	23
Patent Applications:	76
What excipients (inactive ingredients) are in TPOXX?	TPOXX excipients list
DailyMed Link:	TPOXX at DailyMed

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for TPOXX

NDA:

208627

Dosage:

CAPSULE;ORAL

^*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.

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 six US patents and two FDA Regulatory Exclusivities.

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	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
Siga Technologies	TPOXX	tecovirimat	CAPSULE;ORAL	208627-001	Jul 13, 2018		RX	Yes	Yes

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

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
Mexico	2012010859	FORMAS POLIMORFICAS ST-246 Y METODOS DE PREPARACION. (POLYMORPHIC FORMS ST-246 AND METHODS OF PREPARATION.)
Spain	2632313
South Korea	20170102070	다형체 형태 ＳＴ―２４６ 및 제조방법 (POLYMORPHIC FORMS ST-246 AND METHODS OF PREPARATION)
Denmark	1638938
European Patent Office	3006425	COMPOSITION PHARMACEUTIQUE DESTINEES AU TRAITEMENT ET A LA PRÉVENTION D'UNE INFECTION CAUSÉE PAR DES ORTHOPOXVIRUS (PHARMACEUTICAL COMPOSITION FOR USE IN THE TREATMENT AND PREVENTION OF ORTHOPOXVIRUS INFECTIONS AND ASSOCIATED DISEASES)