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Chlorhexidine gluconate - Generic Drug Details

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What are the generic sources for chlorhexidine gluconate and what is the scope of chlorhexidine gluconate freedom to operate?

Chlorhexidine gluconate is the generic ingredient in twenty-seven 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, Becton Dickinson Co, and Prof Dspls, and is included in thirty-four NDAs. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Chlorhexidine gluconate has three patent family members in one country.

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

Summary for chlorhexidine gluconate

International Patents:	3
US Patents:	11
Tradenames:	27
Applicants:	24
NDAs:	34
Drug Master File Entries:	57
Suppliers / Packagers:	64
Bulk Api Vendors:	25
Clinical Trials:	285
Patent Applications:	7,131
Formulation / Manufacturing:	see details
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
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
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 TRIPLE SWABSTICK	chlorhexidine gluconate; isopropyl alcohol	SWAB;TOPICAL	021555-003	Jun 10, 2009		OTC	Yes	Yes

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Expired US Patents for chlorhexidine gluconate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Dexcel Pharma	PERIOCHIP	chlorhexidine gluconate	TABLET;DENTAL	020774-001	May 15, 1998
Molnlycke Hlth	HIBICLENS	chlorhexidine gluconate	SPONGE;TOPICAL	018423-001	Approved Prior to Jan 1, 1982
Molnlycke Hlth	HIBICLENS	chlorhexidine gluconate	SOLUTION;TOPICAL	017768-001	Approved Prior to Jan 1, 1982
Dexcel Pharma	PERIOCHIP	chlorhexidine gluconate	TABLET;DENTAL	020774-001	May 15, 1998

Non-Orange Book US Patents for chlorhexidine gluconate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,221,365	Disinfectant delivery system, and method of providing alcohol-free disinfection

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International Patents for chlorhexidine gluconate

Country	Document Number	Estimated Expiration
Canada	2467155
Canada	2467150
Canada	2551688