Is Trientine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Trientine, including Cuprtin (250 mg, Capsule, hard, SAR 7323.40); Trientine dihydrochloride (250 mg, Capsule, hard, SAR 8450.10); Trientine dihydrochloride Tillomed (250 mg, Capsule, hard, SAR 7662.35).

Is Trientine approved by the US FDA?

Drugs@FDA lists 15 application product lines for Trientine, including SYPRINE (Prescription); TRIENTINE HYDROCHLORIDE (Prescription); TRIENTINE HYDROCHLORIDE (Prescription); TRIENTINE HYDROCHLORIDE (Prescription); TRIENTINE HYDROCHLORIDE (Prescription).

Is Trientine authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Trientine: Cufence.

Active substance

Trientine

SFDA 3
US FDA 15
EMA 1
Health Canada 2
US price lines 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Cuprtin	250 mg	Capsule, hard · Oral use	100 Container	SAR 7323.40	Generic · Prescription	Saudi Amarox	Valid
Trientine dihydrochloride	250 mg	Capsule, hard · Oral use	100 Bottle	SAR 8450.10	NCE · Prescription	Navinta LLC	Valid
Trientine dihydrochloride Tillomed	250 mg	Capsule, hard · Oral use	100 Bottle	SAR 7662.35	Generic · Prescription	Tillomed Laboratories Limited	Valid

Indications — CHI Daman Drug Formulary

WILSON'S DISEASE

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
SYPRINE	250MG	capsule · oral	BAUSCH	Prescription	8 Nov 1985
TRIENTINE HYDROCHLORIDE	250MG	capsule · oral	NAVINTA LLC	Prescription	16 Jan 2019
TRIENTINE HYDROCHLORIDE	250MG	capsule · oral	ZYDUS PHARMS	Prescription	26 Apr 2019
TRIENTINE HYDROCHLORIDE	250MG	capsule · oral	MSN	Prescription	22 May 2019
TRIENTINE HYDROCHLORIDE	250MG	capsule · oral	DR REDDYS	Prescription	3 Jul 2019
TRIENTINE HYDROCHLORIDE	250MG; 500MG	capsule · oral	RISING	Prescription	20 Feb 2020
TRIENTINE HYDROCHLORIDE	250MG	capsule · oral	ECI PHARMS LLC	Prescription	13 Aug 2021
TRIENTINE HYDROCHLORIDE	250MG	capsule · oral	HETERO LABS LTD III	Prescription	23 Jun 2022
TRIENTINE HYDROCHLORIDE	250MG	capsule · oral	WATSON LABS TEVA	Discontinued	7 Feb 2018
TRIENTINE HYDROCHLORIDE	250MG	capsule · oral	AMNEAL	Discontinued	8 Feb 2019
TRIENTINE HYDROCHLORIDE	250MG	capsule · oral	CHARTWELL RX	Discontinued	16 Sep 2019
TRIENTINE HYDROCHLORIDE	250MG	capsule · oral	PH HEALTH	Discontinued	25 Sep 2019
CLOVIQUE	250MG	capsule · oral	CHARTWELL RX	Discontinued	21 Oct 2019
TRIENTINE HYDROCHLORIDE	250MG	capsule · oral	LUPIN	Discontinued	21 May 2020
TRIENTINE HYDROCHLORIDE	250MG	capsule · oral	ACCORD HLTHCARE	Discontinued	30 Aug 2021

EMA European Union — centrally authorised medicines

Cufence Univar Solutions BV · Authorised · authorised 25 Jul 2019 · ATC A16A

Therapeutic indication (EMA)

Cufence is indicated for the treatment of Wilson’s disease in patients intolerant to D-Penicillamine therapy, in adults and children aged 5 years or older.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
MAR-TRIENTINE	02504855	250 MG	CAPSULE · ORAL	MARCAN PHARMACEUTICALS INC
WAYMADE-TRIENTINE	02515067	250 MG	CAPSULE · ORAL	WAYMADE PLC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	TRIENTINE HCL 250 MG CAPSULE	$2.30252	per EA	22 Jul 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.