Trientine Hydrochloride

Treats Wilson’s disease. Sold as Syprine. Every FDA application for this active ingredient: 1 branded and 14 generic.

As of Nov 15, 2026, FDA lists 15 applications for Trientine Hydrochloride (sold as Syprine), first approved Nov 8, 1985, with 0 new uses approved and 0 published complete response letters.

First approved: Nov 8, 1985
Applications: 15
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $6.0M
First approved in the EU: Sep 5, 2017

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Trientine HCl	Part D	$4.3M	+3%	121
Syprine	Part D	$1.7M	+15%	11

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

TRIENTINE HCL 250 MG CAPSULE: $2.30 per unitGeneric · -47% in a year

Orphan Designations (FDA)

One designation, 0 approved for the designated use; see all orphan designations

Treatment of manganismCerberus Princeton, LLC · designated Nov 2, 2010

Approvals in the EU (EMA)

First approved in the EU 382 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

CufenceUnivar Solutions BV · Jul 25, 2019
Cuprior, new substanceOrphalan · Sep 5, 2017

Clinical Trials

4 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Trientine Tetrahydrochloride Administered Once a Day for the First Line Treatment of Wilson's Disease Patients.Wilson's Disease · Orphalan	Phase 3	Recruiting	Mar 12, 2026
Off Treatment Urinary Copper Excretion in Wilson Disease, Pilot StudyWilson Disease · Yale University	—	Recruiting	Dec 24, 2025
Circadian Variation of Urinary Copper Excretion in Wilson Disease PatientsWilson Disease · Hospices Civils de Lyon	—	Recruiting	May 28, 2024
International Wilson's Disease Patient Registry (iWilson Registry)Wilson's Disease · Orphalan	—	Recruiting	Feb 15, 2022

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Nov 8, 1985	SyprineNDA 19194 · New molecular entity	Bausch	8	Marketed
Feb 7, 2018	Trientine HydrochlorideANDA 207567	Watson Labs Teva	0	Discontinued
Jan 16, 2019	Trientine HydrochlorideANDA 211251	Navinta LLC	0	Marketed
Feb 8, 2019	Trientine HydrochlorideANDA 210619	Amneal	0	Discontinued
Apr 26, 2019	Trientine HydrochlorideANDA 211554	Zydus Pharms	0	Marketed
May 22, 2019	Trientine HydrochlorideANDA 211134	Msn	0	Marketed
Jul 3, 2019	Trientine HydrochlorideANDA 211076	Dr Reddys	1	Marketed
Sep 16, 2019	Trientine HydrochlorideANDA 209415	Chartwell Rx	0	Discontinued
Sep 25, 2019	Trientine HydrochlorideANDA 210096	Ph Health	0	Discontinued
Oct 21, 2019	CloviqueANDA 209731	Chartwell Rx	0	Discontinued
Feb 20, 2020	Trientine HydrochlorideANDA 212238	Rising	2	Marketed
May 21, 2020	Trientine HydrochlorideANDA 211637	Lupin	0	Discontinued
Aug 13, 2021	Trientine HydrochlorideANDA 209945	Eci Pharms LLC	0	Marketed
Aug 30, 2021	Trientine HydrochlorideANDA 212929	Accord Hlthcare	0	Discontinued
Jun 23, 2022	Trientine HydrochlorideANDA 216356	Hetero Labs Ltd Iii	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA