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CU-7

NDA

COPPER | N017408 | GD SEARLE LLC

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

4 trials from ClinicalTrials.gov — 3 recruiting, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Safety of a Contraceptive Copper Vaginal Ring NCT07666997	N/A	Not Yet Recruiting	Elle, MD Biotechnologies Inc.	8	2026-10-01 → 2027-04-30
Natural History of Wilson Disease NCT03334292	—	Recruiting	Yale University	300	2017-12-18 → 2029-11-15
An Investigational Scan (64Cu-DOTA-Trastuzumab PET/MRI) in Imaging Patients With HER2+ Breast Cancer With Brain Metastasis NCT05376878	Phase 4	Recruiting	City of Hope Medical Center	10	2022-12-21 → 2027-04-27
Patient Factors Associated With Fragmentation of Copper Intrauterine Device (IUD) Requiring Hysteroscopic Removal NCT07351084	—	Completed	University of Kansas Medical Center	44	2025-02-28 → 2025-06-26

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

API Supply Chain4 active DMFs3 inactive

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

COOPERSURGICAL INCCOPPER T MODEL TCU 380A INTRAUTERINE CONTRACEPTIVE

DMF 82981989

NUVIEW LIFE SCIENCES INCCOPPER CHLORIDE (CU-64) RADIOCHEMICAL

DMF 194852006

CURIUM US LLCCOPPER CHLORIDE

DMF 334722019

CHEMCON GMBHCOPPER (II) CHLORIDE DIHYDRATE

DMF 343432021

ALDRICH CHEMICAL CO INCInactiveCOPPER (II) CHLORIDE DIHYDRATE

DMF 94171991

ARENOL CHEMICAL CORPInactiveCOPPER GLYCINATE MONOHYDRATE

DMF 111771994

NUVIEW LIFE SCIENCES INCInactiveCOPPER CHLORIDE CU-67 RADIOCHEMICAL

DMF 197912006

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

Products (1)

#001 — 89MG

0 patents0 exclusivities▴

INTRAUTERINE DEVICE;INTRAUTERINE | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.