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CUVRIOR Drug Patent Profile

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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 and one Paragraph IV challenge.

This drug has eighteen 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.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for CUVRIOR

International Patents:	18
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Patent Applications:	32
Drug Prices:	Drug price information for CUVRIOR
What excipients (inactive ingredients) are in CUVRIOR?	CUVRIOR excipients list
DailyMed Link:	CUVRIOR at DailyMed

Drug patent expirations by year for CUVRIOR

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

Generic Entry Date for CUVRIOR^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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	Copper Chelator
Mechanism of Action	Copper Chelating Activity 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

Paragraph IV (Patent) Challenges for CUVRIOR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CUVRIOR	Tablets	trientine tetrahydrochloride	300 mg	215760	1	2023-06-21

US Patents and Regulatory Information for CUVRIOR

CUVRIOR is protected by two US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of CUVRIOR is ⤷ Try a Trial.

This potential generic entry date is based on patent ⤷ Try a Trial.
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

Crystalline form of triethylenetetramine tetrahydrochloride and its pharmaceutical use
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Crystalline form of triethylenetetramine tetrahydrochloride and its pharmaceutical use
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD FOR THE TREATMENT OF ADULT PATIENTS WITH STABLE WILSON’S DISEASE WHO ARE DE-COPPERED AND TOLERANT TO PENICILLAMINE

FDA Regulatory Exclusivity protecting CUVRIOR

NEW PRODUCT
Exclusivity Expiration: ⤷ Try a Trial

TREATMENT OF ADULT PATIENTS WITH STABLE WILSON’S DISEASE WHO ARE DE-COPPERED AND TOLERANT TO PENICILLAMINE
Exclusivity Expiration: ⤷ Try a Trial

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Glossary

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

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

Patent: 5080
Estimated Expiration: ⤷ Try a Trial

Australia

Patent: 19263969
Estimated Expiration: ⤷ Try a Trial

Brazil

Patent: 2020018451
Estimated Expiration: ⤷ Try a Trial

Canada

Patent: 96423
Estimated Expiration: ⤷ Try a Trial

China

Patent: 1479798
Estimated Expiration: ⤷ Try a Trial

Patent: 4394904
Estimated Expiration: ⤷ Try a Trial

Colombia

Patent: 20013806
Estimated Expiration: ⤷ Try a Trial

Eurasian Patent Organization

Patent: 2092241
Estimated Expiration: ⤷ Try a Trial

European Patent Office

Patent: 52145
Estimated Expiration: ⤷ Try a Trial

Germany

Patent: 724752
Estimated Expiration: ⤷ Try a Trial

Japan

Patent: 21531322
Estimated Expiration: ⤷ Try a Trial

Morocco

Patent: 919
Estimated Expiration: ⤷ Try a Trial

Patent: 726
Estimated Expiration: ⤷ Try a Trial

Singapore

Patent: 202010785U
Estimated Expiration: ⤷ Try a Trial

South Korea

Patent: 210005270
Estimated Expiration: ⤷ Try a Trial

Spain

Patent: 69049
Estimated Expiration: ⤷ Try a Trial

Taiwan

Patent: 2002956
Estimated Expiration: ⤷ Try a Trial

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.

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Country	Patent Number	Title	Estimated Expiration
South Korea	20210005270	트리에틸렌테트라민 테트라클로라이드의 결정형 및 이의 약제학적 용도	⤷ Try a Trial
Colombia	2020013806	Forma cristalina de tetracloruro de trietilentetramina y usos farmacéuticos de la misma	⤷ Try a Trial
Morocco	51919	Forme cristalline du tetrachlorhydrate de triethylenetetramine et utilisation pharmaceutique correspondante	⤷ Try a Trial
Australia	2019263969	Crystalline form of triethylenetetramine tetrahydrochloride and its pharmaceutical use	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration