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 (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition Approval Response FDA-2015-P-4959 Cardinal Health Regulatory Sciences filed a suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting permission to submit an ANDA for Trientine Hydrochloride Capsules, 500 mg, a higher strength of the listed drug Syprine (trientine hydrochloride) Capsule	Suitability	2020-12-01	Open	—

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Syprine (2023)

Total Spending

$702K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$218.12

Spending Trend

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

YoY Change:+18.6%

5yr CAGR:+0.2%

Source: CMS Medicare Part D Spending by Drug (2023). 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.