TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

TRALEMENT

CUPRIC SULFATE
Approved 2020-07-02
1
Indication
--
Phase 3 Trials
5
Years on Market

Details

Status
Prescription
First Approved
2020-07-02
Routes
INTRAVENOUS
Dosage Forms
SOLUTION

TRALEMENT Approval History

Loading approval history...

What TRALEMENT Treats

1 FDA approvals

Originally approved for its first indication in 2020 .

  • Other (1)
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

Full development history with FDA approval milestones

Loading...
Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

TRALEMENT FDA Label Details

Pro

Indications & Usage

FDA Label (PDF)

Tralement ® is indicated in adult and pediatric patients weighing at least 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Tralement is a combination of trace elements (zinc sulfate, cupric sulfate, manganese sulfate and selenious acid) indicated in adult and pediatric patients weighing at least 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.

TRALEMENT Patents & Exclusivity

Latest Patent: Jun 2041

Patents (30 active)

US12150957 Expires Jul 1, 2041
US12150956 Expires Jul 1, 2041
US11975022 Expires Jul 1, 2041
US11786548 Expires Jul 1, 2041
US11998565 Expires Jul 1, 2041
+ 20 more patents
Source: FDA Orange Book

Want competitive intelligence?

See who's developing similar drugs and track their progress

View Pipeline Dashboard

Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.