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CUVRIOR

NDA

TRIENTINE TETRAHYDROCHLORIDE | N215760 | ORPHALAN SA

1 strength5 unique patents1 unique exclusivity

Patent Timeline

5 unique patents, 1 exclusivity by expiration date

Active (5)TodayExclusivity

2026

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2029

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2039

Today

May. 3, 2039

May. 3, 2039

May. 3, 2039

May. 3, 2039

May. 3, 2039

ODE-401

Apr. 28, 2029

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Orphalan SA v. Novitium Pharma LLC 1:2023cv01079	D. Del.	2023-09-29	Terminated 2023-12-01	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Trientine Tetrahydrochloride (TETA 4HCL) for the Treatment of Wilson's Disease NCT03539952	Phase 3	Completed	Orphalan	77	2018-09-03 → 2022-01-18

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

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$10408.75

Highest Price

$10408.75

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
81802-0001-72CUVRIOR 300MG TAB	$10408.75	FSS	Orphalan Limited	06/14/2029

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

Medicare Part D Spending

CMS annual spending data for Cuvrior (2024)

Total Spending

$1.6M

Total Claims

Beneficiaries

Avg Cost/Unit

$201.86

Spending Trend

$378K(2023)→$1.6M(2024)

YoY Change:+5.5%

5yr CAGR:+5.5%

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

API Supply Chain3 active DMFs

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

SS PHARMA LLCTRIENTINE TETRAHYDROCHLORIDE

DMF 381202023

MSN ORGANICS PRIVATE LTDTRIENTINE TETRAHYDROCHLORIDE

DMF 381542023

BIOPHORE INDIA PHARMACEUTICALS PVT LTDTRIENTINE TETRAHYDROCHLORIDE

DMF 383712023

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 2, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 300MG

RLD

5 patents1 exclusivity▴

TABLET;ORAL | Approved: Apr 28, 2022

Patents (5) · 4 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10988436	May 3, 2039	—	Yes	—	—	—
11072577	May 3, 2039	—	—	—		—
12358861	May 3, 2039	—	Yes	Yes		—
12358862	May 3, 2039	—	Yes	Yes		—
12662445Newly listed — daily FDA feed, not yet in monthly Orange Book edition	May 3, 2039	—	Yes	Yes		—

Exclusivities (1)

Code	Date	Status
ODE-401	Apr 28, 2029	Active