Trientine hydrochloride - Generic Drug Details

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

Trientine hydrochloride is the generic ingredient in three branded drugs marketed by Chartwell Rx, Bausch, Accord Hlthcare, Amneal, Dr Reddys, Eci Pharms Llc, Endo Operations, Hetero Labs Ltd Iii, Lupin Ltd, MSN, Navinta Llc, Rising, Watson Labs Teva, and Zydus Pharms, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for trientine hydrochloride. Thirteen suppliers are listed for this compound.

Summary for trientine hydrochloride

US Patents:	0
Tradenames:	3
Applicants:	14
NDAs:	15
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	13
Patent Applications:	368
What excipients (inactive ingredients) are in trientine hydrochloride?	trientine hydrochloride excipients list
DailyMed Link:	trientine hydrochloride at DailyMed

Recent Clinical Trials for trientine hydrochloride

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 hydrochloride clinical trials

Pharmacology for trientine hydrochloride

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

Medical Subject Heading (MeSH) Categories for trientine hydrochloride

Chelating Agents

Anatomical Therapeutic Chemical (ATC) Classes for trientine hydrochloride

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 trientine hydrochloride

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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
Rising	TRIENTINE HYDROCHLORIDE	trientine hydrochloride	CAPSULE;ORAL	212238-002	Sep 22, 2023		RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	TRIENTINE HYDROCHLORIDE	trientine hydrochloride	CAPSULE;ORAL	211554-001	Apr 26, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hetero Labs Ltd Iii	TRIENTINE HYDROCHLORIDE	trientine hydrochloride	CAPSULE;ORAL	216356-001	Jun 23, 2022	AB	RX	No	No	⤷ 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

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