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Last Updated: May 2, 2024

Trientine tetrahydrochloride - Generic Drug Details

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What are the generic drug 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:	12
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^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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
Alexion Pharmaceuticals	Phase 2
University of Manchester	Phase 2
National Institute for Health Research, United Kingdom	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	⤷ 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
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 trientine tetrahydrochloride

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Country	Patent Number	Title	Estimated Expiration
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	⤷ Try a Trial
Eurasian Patent Organization	202092241	КРИСТАЛЛИЧЕСКАЯ ФОРМА ТЕТРАГИДРОХЛОРИДА ТРИЭТИЛЕНТЕТРАМИНА И ЕЕ ФАРМАЦЕВТИЧЕСКОЕ ПРИМЕНЕНИЕ	⤷ Try a Trial
Japan	2021531322	トリエチレンテトラミン四塩酸塩の結晶形およびその医薬用途	⤷ Try a Trial
Spain	2769049		⤷ Try a Trial
Australia	2019263969	Crystalline form of triethylenetetramine tetrahydrochloride and its pharmaceutical use	⤷ Try a Trial
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)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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