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TEMBEXA Drug Patent Profile

When do Tembexa patents expire, and when can generic versions of Tembexa launch?

Tembexa is a drug marketed by Emergent Biodefense and is included in two NDAs. There are five patents protecting this drug.

This drug has forty-seven patent family members in fifteen countries.

The generic ingredient in TEMBEXA is brincidofovir. Two suppliers are listed for this compound. Additional details are available on the brincidofovir profile page.

DrugPatentWatch^® Generic Entry Outlook for Tembexa

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 31, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for TEMBEXA

International Patents:	47
US Patents:	5
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	32
Patent Applications:	252
What excipients (inactive ingredients) are in TEMBEXA?	TEMBEXA excipients list
DailyMed Link:	TEMBEXA at DailyMed

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

NDA:

214460

Dosage:

SUSPENSION;ORAL

NDA:

214461

Dosage:

TABLET;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 TEMBEXA

J05AB	Nucleosides and nucleotides excl. reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for TEMBEXA

TEMBEXA is protected by five 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 TEMBEXA

FDA Regulatory Exclusivity protecting TEMBEXA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Emergent Biodefense	TEMBEXA	brincidofovir	SUSPENSION;ORAL	214460-001	Jun 4, 2021		RX	Yes	Yes			Y	Y
Emergent Biodefense	TEMBEXA	brincidofovir	TABLET;ORAL	214461-001	Jun 4, 2021		RX	Yes	Yes			Y	Y
Emergent Biodefense	TEMBEXA	brincidofovir	TABLET;ORAL	214461-001	Jun 4, 2021		RX	Yes	Yes
Emergent Biodefense	TEMBEXA	brincidofovir	TABLET;ORAL	214461-001	Jun 4, 2021		RX	Yes	Yes			Y
Emergent Biodefense	TEMBEXA	brincidofovir	SUSPENSION;ORAL	214460-001	Jun 4, 2021		RX	Yes	Yes

International Patents for TEMBEXA

When does loss-of-exclusivity occur for TEMBEXA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Denmark

Eurasian Patent Organization

European Patent Office

Israel

Japan

Mexico

Russian Federation

South Korea

Spain

Ukraine

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 TEMBEXA around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2017214378	ホスホン酸エステル誘導体およびその合成方法 (PHOSPHONATE ESTER DERIVATIVES AND METHODS OF SYNTHESIS THEREOF)
Israel	224955	צורות מורפיות של אסטרים של חומצה פוספונית ושיטות לסינתזה שלהם (Morphic forms of phosphonic acid esters and methods of synthesis thereof)
South Korea	101812433
China	105899215	十六烷氧基丙基膦酸酯的形态 (Morphic forms of hexadecyloxypropyl-phosphonate esters)
Canada	2809679	DERIVES ESTERS PHOSPHONATES ET LEURS PROCEDES DE SYNTHESE (PHOSPHONATE ESTER DERIVATIVES AND METHODS OF SYNTHESIS THEREOF)