CUVRIOR Drug Patent Profile

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

Cuvrior is a drug marketed by Orphalan and is included in one NDA. There are two patents protecting this drug.

This drug has seventeen patent family members in sixteen countries.

The generic ingredient in CUVRIOR is trientine tetrahydrochloride. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the trientine tetrahydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Cuvrior

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 3, 2039. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for CUVRIOR

International Patents:	17
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Patent Applications:	32
What excipients (inactive ingredients) are in CUVRIOR?	CUVRIOR excipients list
DailyMed Link:	CUVRIOR at DailyMed

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

NDA:

215760

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.

Pharmacology for CUVRIOR

Drug Class	Metal Chelator
Mechanism of Action	Metal Chelating Activity

Anatomical Therapeutic Chemical (ATC) Classes for CUVRIOR

A16AX	Various alimentary tract and metabolism products
A16A	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for CUVRIOR

CUVRIOR is protected by two 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 CUVRIOR

FDA Regulatory Exclusivity protecting CUVRIOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Orphalan	CUVRIOR	trientine tetrahydrochloride	TABLET;ORAL	215760-001	Apr 28, 2022		RX	Yes	Yes
Orphalan	CUVRIOR	trientine tetrahydrochloride	TABLET;ORAL	215760-001	Apr 28, 2022		RX	Yes	Yes
Orphalan	CUVRIOR	trientine tetrahydrochloride	TABLET;ORAL	215760-001	Apr 28, 2022		RX	Yes	Yes				Y
Orphalan	CUVRIOR	trientine tetrahydrochloride	TABLET;ORAL	215760-001	Apr 28, 2022		RX	Yes	Yes

International Patents for CUVRIOR

When does loss-of-exclusivity occur for CUVRIOR?

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

Argentina

Australia

Brazil

Canada

China

Colombia

Eurasian Patent Organization

European Patent Office

Germany

Japan

Morocco

Singapore

South Korea

Spain

Taiwan

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 CUVRIOR around the world.

Country	Patent Number	Title	Estimated Expiration
Morocco	51919	Forme cristalline du tetrachlorhydrate de triethylenetetramine et utilisation pharmaceutique correspondante
Taiwan	202002956	Crystalline form of triethylenetetramine tetrachloride and its pharmaceutical uses
China	114394904	三亚乙基四胺四盐酸盐的晶形及其医药用途 (Crystalline forms of triethylenetetramine tetrahydrochloride and medical uses thereof)
Australia	2019263969	Crystalline form of triethylenetetramine tetrahydrochloride and its pharmaceutical use
China	111479798	三亚乙基四胺四盐酸盐的晶形及其医药用途 (Crystalline form of triethylenetetramine tetrahydrochloride and pharmaceutical use thereof)