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Chlorhexidine gluconate - Generic Drug Details

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What are the generic drug sources for chlorhexidine gluconate and what is the scope of chlorhexidine gluconate patent protection?

Chlorhexidine gluconate is the generic ingredient in twenty-eight branded drugs marketed by Xttrium, Sage Prods, Apotex Inc, Hi Tech Pharma, Lyne, Teva, Wockhardt Bio Ag, Sunstar Americas, 3M, Colgate Palmolive Co, Colgate-palmolive Co, Soapco, Ecolab, Bajaj Medical Llc, Molnlycke Hlth, J And J, Matrix Medcl, Griffen, Becton Dickinson, Kendall Il, Carefusion 2200, Dexcel Pharma, 3m Health Care, Becton Dickinson Co, and Prof Dspls, and is included in thirty-five NDAs. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are fifty-seven drug master file entries for chlorhexidine gluconate. Sixty-six suppliers are listed for this compound.

Summary for chlorhexidine gluconate

US Patents:	11
Tradenames:	28
Applicants:	25
NDAs:	35
Drug Master File Entries:	57
Suppliers / Packagers:	66
Bulk Api Vendors:	29
Clinical Trials:	72
Patent Applications:	7,122
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for chlorhexidine gluconate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for chlorhexidine gluconate
DailyMed Link:	chlorhexidine gluconate at DailyMed

Pharmacology for chlorhexidine gluconate

Physiological Effect

Decreased Cell Wall Integrity

Medical Subject Heading (MeSH) Categories for chlorhexidine gluconate

Anti-Infective Agents, Local

Disinfectants

Mouthwashes

Synonyms for chlorhexidine gluconate

(1E)-2-[6-[[amino-[(E)-[amino-(4-chloroanilino)methylene]amino]methylene]amino]hexyl]-1-[amino-(4-chloroanilino)methylene]guanidine; (2R,3S,4R,5R)-2,3,4,5,6-pentahydroxyhexanoic acid

1-(4-chlorophenyl)-3-[N-[6-[[N-[N-(4-chlorophenyl)carbamimidoyl]carbamimidoyl]amino]hexyl]carbamimidoyl]guanidine; (2R,3S,4R,5R)-2,3,4,5,6-pentahydroxyhexanoic acid

1,1'-Hexamethylene bis(5-(p-chlorophenyl)biguanide), digluconate

1,1'-Hexamethylenebis[5-(4-chlorophenyl)biguanide] Digluconate

1,6-Bis(N5-[p-chlorophenyl]-N1-biguanido)hexane; 1,1 inverted exclamation marka-Hexamethylenebis(5-[p-chlorophenyl]biguanide)

1,6-Bis(N5-[p-chlorophenyl]-N1-biguanido)hexane; 1,1'-Hexamethylenebis(5-[p-chlorophenyl]biguanide)

105791-72-8

12068-31-4

124973-71-3

14007-07-9

150621-85-5

151498-43-0

18472-51-0

2,4,11,13-Tetraazatetradecanediimidamide, N,N''-bis(4-chlorophenyl)-3,12-diimino-, digluconate

21293-24-3

227749-99-7

230296-52-3

23289-58-9

40330-16-3

452971-25-4

51365-13-0

52196-45-9

52387-19-6

60042-57-1

60404-86-6

82432-16-4

906339-38-6

Abacil

AKOS015896303

AKOS025310696

AN-18792

Arlacide G

Bioscrub

Brian Care

C08038

CHEBI:28312

Chlorhexidin glukonatu

Chlorhexidine D-digluconate

Chlorhexidine di-D-gluconate

CHLORHEXIDINE DIGLUCONATE

Chlorhexidine digluconate solution

Chlorhexidine digluconate solution, 20% in H2O

Chlorhexidine digluconate, 20% w/v aqueous solution

Chlorhexidine digluconate, pharmaceutical secondary standard; traceable to USP and PhEur

Chlorhexidine gluconate (JP17/USP)

Chlorhexidine gluconate [USAN:USP:JAN]

Chx plus concentrate premium chlorhexidine teat dip concentrate

Cida-Stat

D-Gluconic acid, compd with N,N''-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediimidamide (2:1)

D-Gluconic acid, compd. with N,N''-bis(4-chlorophenyl) -3,12-diimino-2,4,11,13-tetraazatetradecanediimidamide (2:1)

D-Gluconic acid, compd. with N1,N14-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediimidamide (2:1)

D00858

DTXSID5034519

Dyna-hex

EC 242-354-0

Exidine

Fight bac

Gluconic acid, compd. with 1,1'-hexamethylene bis(5-(p-chlorophenyl)biguanide) (2:1), D- (8CI)

Hibiclens

Hibiclens (TN)

Hibidil

Hibiscrub

Hibitane

Hibitane gluconate

I06-2074

J-011837

Kleersight

M166

MFCD00083599

Microderm

MolPort-006-069-426

MOR84MUD8E

N',N'''''-hexane-1,6-diylbis[N-(4-chlorophenyl)(imidodicarbonimidic diamide)]--D-gluconic acid (1/2)

Peridex

Peridex (TN)

Periochip

Periogard

Periogard (TN)

Pharmaseal Scrub Care

pHiso-Med

Prevacare

Prevacare R

SCHEMBL34468

Steri-Stat

UNII-MOR84MUD8E

Unisept

US Patents and Regulatory Information for chlorhexidine gluconate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Colgate-palmolive Co	PERIOGARD	chlorhexidine gluconate	SOLUTION;DENTAL	203212-001	Jan 28, 2016	AT	RX	No	No
Becton Dickinson Co	CHLORAPREP ONE-STEP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-004	Aug 20, 2003		OTC	Yes	Yes			Y
Becton Dickinson Co	CHLORAPREP WITH TINT	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-005	Apr 3, 2006		OTC	Yes	Yes			Y
Becton Dickinson Co	CHLORAPREP WITH TINT	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-002	May 3, 2005		OTC	Yes	Yes			Y

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Expired US Patents for chlorhexidine gluconate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Molnlycke Hlth	HIBICLENS	chlorhexidine gluconate	SOLUTION;TOPICAL	017768-001	Approved Prior to Jan 1, 1982
Molnlycke Hlth	HIBICLENS	chlorhexidine gluconate	SPONGE;TOPICAL	018423-001	Approved Prior to Jan 1, 1982
Molnlycke Hlth	HIBICLENS	chlorhexidine gluconate	SPONGE;TOPICAL	018423-001	Approved Prior to Jan 1, 1982
Molnlycke Hlth	HIBICLENS	chlorhexidine gluconate	SPONGE;TOPICAL	018423-001	Approved Prior to Jan 1, 1982

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International Patents for chlorhexidine gluconate

Country	Document Number	Estimated Expiration
Canada	2551688
Canada	2467150
Canada	2467155