NDAINTRAUTERINESYSTEM
Approved
Nov 1984
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
PARAGARD T 380A (copper) by CooperSurgical. Approved for copper-containing intrauterine device [epc]. First approved in 1984.
Drug data last refreshed 10h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ParaGard T 380A is a copper-containing intrauterine device (IUD) approved for long-acting reversible contraception. It works through a non-hormonal mechanism where copper ions create a hostile environment for sperm, preventing fertilization. The device is placed directly into the uterus and provides contraceptive efficacy for up to 10 years.
LOE Approaching1.0 years to LOE
Product approaching loss of exclusivity in 2027 with moderate competitive pressure (30%); commercial teams should prepare transition strategies and market defense initiatives.
Mechanism of Action
Pharmacologic Class:
Copper-containing Intrauterine Device
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Effects of Copper Versus Levonorgestrel Intrauterine Devices on Mucosal Microbiota and Barrier Function Among Young African Women
Started Jul 2026
120 enrolled
Vaginal Microbial Diversity
Comparative Performance of 64Copper [64Cu]-SAR-bis-PSMA vs 68Ga PSMA-11 PET CT for the Detection of Prostate Cancer Recurrence in the Setting of Biochemical Failure Following Radical Prostatectomy
Started Nov 2024
50 enrolled
Prostate Cancer (Post Prostatectomy)
Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer
Started Apr 2024
439 enrolled
Prostate CancerProstate Adenocarcinoma
Copper Cu 64 PSMA I&T PET Imaging in Men With Suspected Recurrence of Prostate Cancer
Started Apr 2024
235 enrolled
Prostate CancerProstate AdenocarcinomaBiochemical Recurrence of Malignant Neoplasm of Prostate
Performance and Safety of MEX-CD1 Low-volume Continuous Veno-venous Haemodialysis Medical Device for Copper-extraction in Patients With Wilson's Disease
Started Jan 2024
1 enrolled
Hepatolenticular Degeneration; Wilson
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.