Viewing data from:

PARAGARD T 380A

NDA

COPPER | N018680 | COOPERSURGICAL INC

1 strength0 unique patents1 unique exclusivity

Patent Timeline

0 unique patents, 1 exclusivity by expiration date

TodayExclusivity

2027

Today

D-193

Jun. 28, 2027

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

No clinical trials found on ClinicalTrials.gov for this drug

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.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Jul 1, 2024	SUPPL -74	View Letter (PDF)
Sep 6, 2019	SUPPL -69	View Letter (PDF)
Sep 6, 2019	SUPPL -70	View Letter (PDF)
Jun 13, 2013	SUPPL -66	View Letter (PDF)
Sep 8, 2005	SUPPL -60	View Letter (PDF)
May 29, 2003	SUPPL -57	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 309MG/COPPER

RLD

0 patents1 exclusivity▴

SYSTEM;INTRAUTERINE | Approved: Nov 15, 1984

Exclusivities (1)

Code	Date	Status
D-193	Jun 28, 2027	< 1 year