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HIBISTAT

NDA

CHLORHEXIDINE GLUCONATE | N018300 | MOLNLYCKE HEALTH CARE

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

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Parke, Davis & Company FDA-1984-P-0331 · 7 docket documents Parke, Davis and Company filed this citizen petition on November 29, 1984, requesting that the FDA find an abbreviated new drug application suitable for a surgical hand scrub product containing 1.5 percent chlorhexidine gluconate and include it in the Approved Prescription Drug Product List to indic	Other	2017-07-03	Granted	Parke, Davis & Company
Citizen Petition from Stuart Pharmaceuticals FDA-1985-P-0383 · 4 docket documents Stuart Pharmaceuticals, a division of ICI Americas Inc., filed this citizen petition under Section 701(a) of the Federal Food, Drug, and Cosmetic Act on March 21, 1985, requesting that the FDA Commissioner refuse to approve Abbreviated New Drug Applications for topical chlorhexidine gluconate antimi	505(q)	2010-04-28	Denied	Stuart Pharmaceuticals

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

Clinical Trials

299 trials from ClinicalTrials.gov — 2 recruiting, 227 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Antimicrobial Effect of Tropolone Containing Versus Tropolone Free Mouthwash NCT03384537	Early Phase 1	Recruiting	Cairo University	30	2024-02-08 → 2026-12
Perioperative Respiratory Care and Outcomes for Patients Undergoing High Risk Abdominal Surgery NCT04256798	Phase 3	Recruiting	University of Birmingham	12,942	2020-11-13 → 2026-06-01
Chlorhexidine-Alcohol Versus Povidone Iodine-Alcohol, Combined or Not With Use of a Bundle of New Devices, for Prevention of Intravascular-catheter Colonization and Catheter Failure NCT03757143	Phase 4	Completed	Poitiers University Hospital	1,000	2019-01-07 → 2019-09-27
Single Dose CHG Pharmacokinetic Study NCT03331263	Phase 1	Completed	Medline Industries	12	2017-07-21 → 2017-08-06
Device for Bacteremia Prevention in Post Cardiac Surgical Intensive Care Unit Patients NCT03309137	N/A	Completed	Alison Fox-Robichaud	100	2017-11-19 → 2020-11-30
Efficacy of 0.12% Chlorhexidine Gluconate for Peri-implant Mucositis and Gingivitis NCT02639377	Phase 2	Completed	Universidade Federal do Rio Grande do Norte	29	2012-10 → 2013-12
Neonatal Package Study in Rural District of Pakistan NCT02279381	Phase 4	Completed	Aga Khan University	1,450	2014-11 → 2015-11
The Efficacy of Chlorhexidine Gluconate Pre - Disinfection Scrubbing in Preventing Surgical Site Infections for Hepatectomy Patients NCT01782573	Phase 4	Completed	Changhua Christian Hospital	100	2011-10 → 2012-09
In-vivo Efficacy of Patient Preoperative Prep, ZuraPrep (ZP)NCT03782103	Phase 3	Completed	Zurex Pharma, Inc.	156	2019-01-25 → 2019-09-26
In Vivo Preoperative Skin Preparation Efficacy Study Within a Defined Product Coverage Area NCT03681990	Phase 2	Completed	Solventum US LLC	28	2017-06-06 → 2017-07-04

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

API Supply Chain9 active DMFs18 inactive

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

XTTRIUM LABORATORIES INCCHLORHEXIDINE GLUCONATE 20% SOLUTION USP

DMF 57821985

FAR SPECIALTY PRODUCTS INC DBA FAR CHEMICALCHLORHEXIDINE GLUCONATE 20% SOLUTION, USP

DMF 191282006

CADILA PHARMACEUTICALS LTDCHLORHEXIDINE GLUCONATE SOLUTION USP

DMF 195832006

RN LABORATORIES PVT LTDCHLORHEXIDINE GLUCONATE 20% SOLUTION

DMF 219462008

MEDICHEM SACHLORHEXIDINE GLUCONATE SOLUTION (DGLP)

DMF 251492011

GARONIT PHARMACEUTICALS INCCHLORHEXIDINE GLUCONATE SOLUTION USP 20%

DMF 254172011

AVA INCCHLORHEXIDINE GLUCONATE 20% SOLUTION, USP

DMF 262132012

SMAART PHARMACEUTTICALSCHLORHEXIDINE GLUCONATE SOLUTION BP

DMF 353332021

HUNAN LIJIE BIOCHEMICAL CO LTDCHLORHEXIDINE GLUCONATE

DMF 373942022

SSL INTERNATIONALInactiveCHLORHEXIDINE GLUCONATE 20% SOLUTION

DMF 17101971

ZENECA PHARMACEUTICALSInactiveCHLORHEXIDINE GLUCONATE 20% SOLUTION B.P.

DMF 30031977

ORION CORP LTDInactiveCHLORHEXIDINE GLUCONATE SOLUTION BP 20%

DMF 32901978

LONZA INCInactiveCHLORHEXIDINE GLUCONATE, 20% SOLUTION, BP 73 & CHLORHEXIDINE DIACETATE

DMF 40121980

WHITMOYER LABS INCInactiveCHLORHEXIDINE (BASE, DIHYDROCHLORIDE, GLUCONATE AND DIACETATE)

DMF 54531984

DELTA SYNTHETIC CO LTDInactiveCHLORHEXIDINE GLUCONATE (BULK)

DMF 59301985

ALCOLAC INCInactiveCHLORHEXIDINE GLUCONATE

DMF 69871987

PLIVA PHARMACEUTICAL CHEMICAL FOOD & COSMETIC INDUSTRYInactiveCHLORHEXIDINE GLUCONATE SOLUTION

DMF 83631989

DEGUSSA AG WERK RADEBEULInactiveCHLORHEXIDINE

DMF 84511990

MEDICHEM SAInactiveCHLORHEXIDINE GLUCONATE

DMF 97011992

ARZNEIMITTELWERK DRESDEN GMBHInactiveCHLORHEXIDINE (BASE)

DMF 114651995

THATCHER COInactiveCHLORHEXIDINE GLUCONATE, 20% (W/V)

DMF 124921997

ROHIT PLASTICS AND CHEMICALSInactiveCHLORHEXIDINE GLUCONATE 20%

DMF 162062002

BASIC PHARMA CHEMInactiveCHLORHEXIDINE GLUCONATE (BP)

DMF 173012004

GLIDE CHEM PVT LTDInactiveCHLORHEXIDINE GLUCONATE SOLUTION 20%

DMF 175592004

BASIC PHARMA LIFE SCIENCE PVT LTDInactiveCHLORHEXIDINE GLUCONATE

DMF 218782008

VIPOR CHEMICALS PRIVATE LTDInactiveCHLORHEXIDINE GLUCONATE SOLUTION BP

DMF 230192009

DISHMAN CARBOGEN AMCIS LTDInactiveCHLORHEXIDINE GLUCONATE SOLUTION

DMF 332382018

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Apr 23, 2018	SUPPL -19	View Letter (PDF)
May 29, 2012	SUPPL -18	View Letter (PDF)
Jan 15, 2004	SUPPL -14	View Letter (PDF)
Jan 15, 2004	SUPPL -15	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.5%

RLD

0 patents0 exclusivities▴

SOLUTION;TOPICAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.