TRIENTINE TETRAHYDROCHLORIDE - Generic Drug Details

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What are the generic sources for trientine tetrahydrochloride and what is the scope of freedom to operate?

Trientine tetrahydrochloride is the generic ingredient in one branded drug marketed by Orphalan and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Trientine tetrahydrochloride has eighteen patent family members in sixteen countries.

One supplier is listed for this compound.

Summary for TRIENTINE TETRAHYDROCHLORIDE

International Patents:	18
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	13
Patent Applications:	47
What excipients (inactive ingredients) are in TRIENTINE TETRAHYDROCHLORIDE?	TRIENTINE TETRAHYDROCHLORIDE excipients list
DailyMed Link:	TRIENTINE TETRAHYDROCHLORIDE at DailyMed

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

Generic Entry Date for TRIENTINE TETRAHYDROCHLORIDE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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.

Recent Clinical Trials for TRIENTINE TETRAHYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Orphalan	Phase 1
Alexion Pharmaceuticals	Phase 2
Manchester University NHS Foundation Trust	Phase 2

See all TRIENTINE TETRAHYDROCHLORIDE clinical trials

Pharmacology for TRIENTINE TETRAHYDROCHLORIDE

Drug Class	Copper Chelator
Mechanism of Action	Copper Chelating Activity Metal Chelating Activity

Anatomical Therapeutic Chemical (ATC) Classes for TRIENTINE TETRAHYDROCHLORIDE

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 TRIENTINE TETRAHYDROCHLORIDE

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 TRIENTINE TETRAHYDROCHLORIDE

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Orphalan	CUVRIOR	trientine tetrahydrochloride	TABLET;ORAL	215760-001	Apr 28, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Orphalan	CUVRIOR	trientine tetrahydrochloride	TABLET;ORAL	215760-001	Apr 28, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Orphalan	CUVRIOR	trientine tetrahydrochloride	TABLET;ORAL	215760-001	Apr 28, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 TRIENTINE TETRAHYDROCHLORIDE

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Country	Patent Number	Title	Estimated Expiration
Colombia	2020013806	Forma cristalina de tetracloruro de trietilentetramina y usos farmacéuticos de la misma	⤷ Sign Up
European Patent Office	3652145	FORME CRISTALLINE DU TÉTRACHLORHYDRATE DE TRIÉTHYLÈNETÉTRAMINE ET UTILISATION PHARMACEUTIQUE CORRESPONDANTE (CRYSTALLINE FORM OF TRIETHYLENETETRAMINE TETRAHYDROCHLORIDE AND ITS PHARMACEUTICAL USE)	⤷ Sign Up
Spain	2769049		⤷ Sign Up
South Korea	20210005270	트리에틸렌테트라민 테트라클로라이드의 결정형 및 이의 약제학적 용도	⤷ Sign Up
Brazil	112020018451	forma cristalina de tetracloreto de trietilenotetra-amina, composição farmacêutica, método de produção de formas cristalinas de tetracloreto de trietilenotetra-amina e forma cristalina ou composição farmacêutica	⤷ Sign Up
Singapore	11202010785U	CRYSTALLINE FORM OF TRIETHYLENETETRAMINE TETRAHYDROCHLORIDE AND ITS PHARMACEUTICAL USE	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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