Viewing data from:

BIOSCRUB

NDA

CHLORHEXIDINE GLUCONATE | N019822 | KW GRIFFEN CO

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

357 trials from ClinicalTrials.gov — 33 recruiting, 4 active, 251 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib NCT06120140	Phase 2	Active	Janssen Research & Development, LLC	305	2024-02-16 → 2030-06-30
Chlorhexidine Versus Normal Saline Socket Irrigation for Prevention of Dry Socket After Lower Wisdom Tooth Extraction NCT07814430	N/A	Active	CMH Lahore Medical College and Institute of Dentistry	174	2026-02-14 → 2026-10-28
Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement NCT06489431	Phase 3	Active	Rush University Medical Center	200	2023-12-04 → 2027-12-31
Clinical & Biochemical Evaluation of Antioxidant Vs. Chlorhexidine as an Adjunctive to Non-Surgical Treatment of Stage II-grade B Periodontitis NCT07801417	N/A	Active	Al-Azhar University	36	2025-12-01 → 2027-07-01
Effects of Three Oral Hygiene Protocols on Oral Bacteria in Intensive Care Patients NCT07868549	N/A	By Invitation	University of Zagreb	86	2026-06-01 → 2026-12-31
Effect of Certain Denture Disinfectants on Surface Topography, Microhardness and Dimensional Stability of CAD/CAM Milled Polymethyl Methacrylate and Polyether Ether Ketone Denture Base Materials NCT07672847	N/A	By Invitation	Menoufia University	88	2026-01-31 → 2026-10-30
Anticariogenic Effect of Moringa Oleifera Mouthwash Compared to Chlorhexidine Mouthwash NCT04575948	Phase 2/3	Not Yet Recruiting	Misr International University	90	2027-12 → 2028-12
Virgin Coconut Oil Versus Chlorhexidine Mouthwash in Non-Surgical Periodontal Therapy of Periodontitis Patients. A Randomized Controlled Clinical Trial With Biochemical Assessment.NCT07706387	N/A	Not Yet Recruiting	Ain Shams University	42	2026-07 → 2026-08
ORAL-PROTECT I: Oral Asepsis Preventing Transmission During Intubation NCT07669064	N/A	Not Yet Recruiting	University Hospital Ulm	60	2026-06-20 → 2027-05-01
Effectiveness of Pre-Procedural CPC and Zinc Mouthwash in Reducing Dental Aerosols NCT07880509	Phase 4	Not Yet Recruiting	Colgate Palmolive	60	2026-10-08 → 2026-12-23

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

3 letters from Drugs@FDA

Date	Submission	Document
May 15, 2018	SUPPL -8	View Letter (PDF)
Jan 10, 2013	SUPPL -7	View Letter (PDF)
Jan 9, 2003	SUPPL -6	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 4%

0 patents0 exclusivities▴

SPONGE;TOPICAL | Approved: Mar 31, 1989

No patent or exclusivity listings for this strength.