PARAGARD T 380A (copper) · COOPERSURGICAL
Paragard is a copper-containing intrauterine system used to prevent pregnancy in females of reproductive potential. It provides long-term contraceptive protection for up to 10 years. This system is placed within the uterus to help patients manage their reproductive health over an extended period.
How PARAGARD T 380A Works
Paragard works by continuously releasing copper into the uterine cavity. This copper interferes with sperm transport and the fertilization of an egg; it may also prevent implantation.
Details
- Status
- Prescription
- First Approved
- 1984-11-15
- Patent Cliff
- 2027
- Routes
- INTRAUTERINE
- Dosage Forms
- SYSTEM
PARAGARD T 380A Approval History
What PARAGARD T 380A Treats
1 indicationsPARAGARD T 380A is approved for 1 conditions since its original approval in 1984. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Prevention of pregnancy
Same approved indications as MIUDELLA (same active ingredient).
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01777919 GLIODIS | PK-18081973 | Ph 2 | not yet recruiting | Disulfiram/Copper Combination In The Treatment of Newly Diagnosed Glioblastoma Multiform |
| NCT04265274 | BREAST-SK-001 | Ph 2 | withdrawn | Vinorelbine, Cisplatin, Disulfiram and Copper in CTC_EMT Positive Refractory Metastatic Breast Cancer. |
| NCT02963051 | Pro00071007 | Ph 1 | terminated | A Phase Ib Study of Intravenous Copper Loading With Oral Disulfiram in Metastatic, Castration Resistant Prostate Cancer |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
PARAGARD T 380A FDA Label Details
Indications & Usage
FDA Label (PDF)Paragard is indicated for prevention of pregnancy in females of reproductive potential for up to 10 years. Paragard is a copper-containing intrauterine system (IUS) indicated for prevention of pregnancy in females of reproductive potential for up to 10 years.
PARAGARD T 380A Patents & Exclusivity
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.