Viewing data from:

SYPRINE

NDA

TRIENTINE HYDROCHLORIDE | N019194 | BAUSCH HEALTH AMERICAS INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Cardinal Health Regulatory Sciences FDA-2015-P-4959 · 4 docket documents Cardinal Health Regulatory Sciences filed this suitability petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to submit an Abbreviated New Drug Application for trientine hydrochloride capsules in 500-mg strength, which differs from the 250-m	Other	2015-12-22	Granted	Cardinal Health Regulatory Sciences

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

10 trials from ClinicalTrials.gov, 6 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study of Tetrathiomolybdate in Patients With Wilson Disease NCT00004339	Phase 3	Completed	National Center for Research Resources (NCRR)	90	1994-01
Trial of Trientine Plus Pegylated Liposomal Doxorubicin and Carboplatin in Epithelial Ovarian Cancer NCT03480750	Phase 1/2	Completed	National Cheng-Kung University Hospital	18	2012-09 → 2019-12
A Phase 1 Study to Assess the Effects in the Body of a Single Dose of Trientine Dihydrochloride in Wilson's Disease Patients NCT01874028	Phase 1	Completed	Univar BV	20	2013-05 → 2014-03
Single Daily Dosage of Trientine for Maintenance Treatment for Wilson Disease NCT01472874	N/A	Completed	Yale University	8	2010-01 → 2011-07
Trientine Tetrahydrochloride (TETA 4HCL) for the Treatment of Wilson's Disease NCT03539952	Phase 3	Completed	Orphalan	77	2018-09-03 → 2022-01-18
Trientine and Carboplatin in Advanced Malignancies NCT01178112	Phase 1	Completed	M.D. Anderson Cancer Center	56	2010-07 → 2014-08
Trientine Hydrochloride for the Prevention of Macular Edema Associated With Pan-retinal Photocoagulation for Severe Non-proliferative and Proliferative Diabetic Retinopathy NCT01213888	N/A	Terminated	University of British Columbia	3	2010-11 → 2013-04
Study to Assess Long-Term Outcomes of Trientine in Wilson Disease Patients Withdrawn From Therapy With d-Penicillamine NCT02426905	Phase 4	UNKNOWN	Univar BV	90	2016-01 → 2018-07
A Pilot Study of Trientine With Vemurafenib for the Treatment BRAF Mutated Metastatic Melanoma NCT02068079	Phase 1	Withdrawn	Duke University	—	2014-04 → 2015-11
Trientine Hydrochloride for the Prevention of Macular Edema After Cataract Surgery in Patients With Type 2 Diabetes Mellitus NCT01295073	Phase 2	Withdrawn	University of British Columbia	—	—

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$15919.11

Highest Price

$20946.19

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00187-2120-10SYPRINE 250MG	$20946.19	FSS	Bausch Health US, LLC	04/30/2026
00187-2120-10SYPRINE 250MG	$15919.11	Big4	Bausch Health US, LLC	04/30/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Syprine (2024)

Total Spending

$1.4M

Total Claims

Beneficiaries

—

Avg Cost/Unit

$198.83

Spending Trend

$3.0M(2019)→$2.7M(2020)→$767K(2021)→$617K(2022)→$702K(2023)→$1.4M(2024)

YoY Change:-8.8%

5yr CAGR:-0.3%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain9 active DMFs2 inactive

9 active API suppliers hold Drug Master Files for this ingredient.

CHEMWERTH INCTRIENTINE HYDROCHLORIDE USP

DMF 290192015

TAPI NL BVTRIENTINE HYDROCHLORIDE USP

DMF 290852015

BIOPHORE INDIA PHARMACEUTICALS PVT LTDTRIENTINE HYDROCHLORIDE

DMF 295272015

SS PHARMA LLCTRIENTINE HYDROCHLORIDE USP

DMF 308782016

NAVINTA LLCTRIENTINE HYDROCHLORIDE USP

DMF 309052016

MSN ORGANICS PRIVATE LTDTRIENTINE HYDROCHLORIDE USP

DMF 310852016

EMCURE PHARMACEUTICALS LTDTRIENTINE HYDROCHLORIDE USP

DMF 313952017

COHANCE LIFESCIENCES LTDTRIENTINE HYDROCHLORIDE

DMF 329562018

DASAMI LAB PRIVATE LTDTRIENTINE HYDROCHLORIDE

DMF 349102020

TIANISH LABORATORIES PRIVATE LTDInactiveTRIENTINE HYDROCHLORIDE USP

DMF 321132017

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDInactiveTRIENTINE HYDROCHLORIDE USP

DMF 377772022

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 250MG

RLDAB

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Nov 8, 1985

No patent or exclusivity listings for this strength.