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. Twelve suppliers are listed for this compound.

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

Sponsor

Phase

Orphalan

Phase 1

Alexion Pharmaceuticals

Phase 2

Manchester University NHS Foundation Trust

Phase 2

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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
Msn	TRIENTINE HYDROCHLORIDE	trientine hydrochloride	CAPSULE;ORAL	211134-001	May 22, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal	TRIENTINE HYDROCHLORIDE	trientine hydrochloride	CAPSULE;ORAL	210619-001	Feb 8, 2019		DISCN	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
Rising	TRIENTINE HYDROCHLORIDE	trientine hydrochloride	CAPSULE;ORAL	212238-001	Feb 20, 2020	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
Watson Labs Teva	TRIENTINE HYDROCHLORIDE	trientine hydrochloride	CAPSULE;ORAL	207567-001	Feb 7, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys	TRIENTINE HYDROCHLORIDE	trientine hydrochloride	CAPSULE;ORAL	211076-001	Jul 3, 2019	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

US Patents:	0
Tradenames:	3
Applicants:	14
NDAs:	15
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	12
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

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