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NDA

POVIDONE-IODINE | N019382 | CLINIPAD CORP

3 strengths0 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
Citizen Petition from 3M Health Care FDA-1975-N-0012 · 250 docket documents 3M Health Care filed this citizen petition under 21 CFR §10.30 and section 701(e) of the Federal Food, Drug, and Cosmetic Act on June 15, 1995, requesting that the FDA amend the Tentative Final Monograph for topical antimicrobial drug products to include povidone-iodine acrylate copolymer (0.5-1.0%	Other	2012-09-25	Granted	3M Health Care

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

Clinical Trials

91 trials from ClinicalTrials.gov, 1 active, 55 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Nasal Decolonization of Dialysis Patients Noses NCT04210505	Phase 4	Active	Marin L. Schweizer, PhD	302	2020-09-29 → 2024-01-31
Preoperative Bath in Patients Submitted to Hip Arthroplasty NCT03001102	N/A	Completed	Federal University of Minas Gerais	162	2015-08 → 2018-03
Parasitic Ulcer Treatment Trial Pilot NCT03484507	Phase 2	Completed	University of California, San Francisco	49	2018-01-01 → 2022-11-15
The Amputation Surgical Site Infection Trial (ASSIT)NCT02018094	Phase 4	Completed	Hull University Teaching Hospitals NHS Trust	160	2013-10-08 → 2017-01-02
PVP-I Nasal Sprays and SARS-CoV-2 Nasopharyngeal Titers (for COVID-19)NCT04347954	Phase 1/2	Completed	Stanford University	47	2020-08-15 → 2020-12-13
Does Preoperative Vaginal Preparation With Povidone-iodine Before Cesarean Delivery Reduce the Risk of Endometritis?NCT01437228	Phase 4	Completed	Erzincan Military Hospital	668	2010-10 → 2011-04
Chlorhexidine Gluconate Versus Povidone Iodine at Cesarean Delivery: a Randomized Controlled Trial NCT01975805	N/A	Completed	University of Southern California	60	2010-01 → 2012-05
Vancomycin Powder and Dilute Povidone Iodine Lavage for Infection Prophylaxis in High Risk Total Joint Arthroplasty NCT04075526	Phase 1	Completed	NYU Langone Health	2,129	2019-10-01 → 2025-12-13
Nasal Decolonization for Orthopedic Trauma Patients NCT04146116	Phase 4	Completed	University of Iowa	65	2020-02-19 → 2021-06-08
Pilot Evaluation of the Application Procedure on the Antimicrobial Effects of 2 Antiseptics NCT00692484	Phase 3	Completed	C. R. Bard	122	2007-10 → 2008-02

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

API Supply Chain5 active DMFs

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

BASF SEPOVIDONE-IODINE

DMF 30171977

SHANGHAI YUKING WATER SOLUBLE MATERIAL TECH CO LTDPOVIDONE-IODINE

DMF 298882015

HUZHOU SUNFLOWER PHARMACEUTICAL CO LTDPOVIDONE-IODINE

DMF 334622018

PRACHI PHARMACEUTICALS PVT LTDPOVIDONE-IODINE USP

DMF 336192019

RN LABORATORIES EUROPE BVPOVIDONE-IODINE USP (1-VINYL-2-PYRROLIDINONE POLYMER, COMPOUND WITH IODINE)

DMF 344872020

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

Products (3)

Sort:

#001 — 10%

0 patents0 exclusivities▴

SOLUTION;TOPICAL | Approved: Jul 25, 1989

No patent or exclusivity listings for this strength.

#002 — 5%

0 patents0 exclusivities▾

SPONGE;TOPICAL | Approved: Jul 25, 1989

#003 — 5%

0 patents0 exclusivities▾

SPONGE;TOPICAL | Approved: Jul 25, 1989