Viewing data from:

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Teva Pharmaceutical Industries Ltd. (Teva) - Citizen Petition FDA-2013-P-0163 · 4 docket documents Teva Pharmaceutical Industries Ltd. filed this citizen petition pursuant to 21 C.F.R. section 10.30 and section 505(j) of the Federal Food, Drug, and Cosmetic Act, requesting that the FDA refrain from approving any ANDA referencing ParaGard T 380A intrauterine copper contraceptive unless applicants	505(q) Stay Request	2013-03-01	Withdrawn	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

73 trials from ClinicalTrials.gov — 1 recruiting, 3 active, 49 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Cu64-DOTA-trastuzumab PET and Markers Predicting Response to Neoadjuvant Trastuzumab + Pertuzum in HER2+ Breast Cancer NCT02827877	Phase 2	Active	City of Hope Medical Center	18	2016-07-15 → 2026-09-25
Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer NCT02226276	N/A	Active	City of Hope Medical Center	10	2015-01-07 → 2026-09-29
Positron Emission Tomography in Women With Advanced HER2-Positive Breast Cancer NCT01093612	N/A	Active	City of Hope Medical Center	18	2011-03-16 → 2026-09-08
Disulfiram/Copper Combination In The Treatment of Newly Diagnosed Glioblastoma Multiform NCT01777919	Phase 2	Not Yet Recruiting	Olympion Medical Center	32	2027-01 → 2030-01
Copper Histidinate Treatment for Menkes Disease NCT04074512	—	APPROVED_FOR_MARKETING	Sentynl Therapeutics, Inc.	—	—
Copper Cu 64 Dotatate for the Detection, Localization and Monitoring of SSTR Expressing (NETs)NCT04334837	—	APPROVED_FOR_MARKETING	Curium US LLC	—	—
Copper Cu 64 TP3805 PET in Detecting Cancer in Patients With Prostate Cancer Undergoing Surgery NCT02603965	Phase 1	Completed	Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University	25	2013-08 → 2014-09
64 Cu-DOTA-alendronate PET Imaging in Localizing and Characterizing Breast Calcifications in Participants Before Undergoing Mastectomy NCT03542695	Early Phase 1	Completed	City of Hope Medical Center	1	2021-11-03 → 2024-05-31
Orthodontic Archwire Effectiveness Trial NCT02659813	N/A	Completed	University of Dundee	64	2016-10 → 2021-08-17
Tracking IUD Bleeding Experiences: An Evaluation of Bleeding Profiles in New Intrauterine Device Users NCT02311478	N/A	Completed	University of Utah	79	2014-12 → 2017-02

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

API Supply Chain6 active DMFs3 inactive

6 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

EMNAR PHARMA PRIVATE LTDCOPPER SULFATE PENTAHYDRATE

DMF 434242026

C RAY THERAPEUTICS (CHENGDU) CO LTDCOPPER [64CU] CHLORIDE FOR RADIOLABELLING

DMF 435682026

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.