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Last Updated: December 13, 2019

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HIBICLENS Drug Profile

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When do Hibiclens patents expire, and what generic alternatives are available?

Hibiclens is a drug marketed by Molnlycke Hlth and is included in two NDAs.

The generic ingredient in HIBICLENS is chlorhexidine gluconate. There are fifty-eight drug master file entries for this compound. Sixty-three suppliers are listed for this compound. Additional details are available on the chlorhexidine gluconate profile page.

US ANDA Litigation and Generic Entry Outlook for Hibiclens

A generic version of HIBICLENS was launched as chlorhexidine gluconate by BECTON DICKINSON on December 13th, 2019.

Drug patent expirations by year for HIBICLENS
Drug Sales Revenue Trends for HIBICLENS

See drug sales revenues for HIBICLENS

Recent Clinical Trials for HIBICLENS

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Carilion ClinicPhase 4
University of WashingtonPhase 4
Clinical Directors NetworkN/A

See all HIBICLENS clinical trials

Synonyms for HIBICLENS
(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, Pharmaceutical Secondary Standard; Certified Reference Material
Chlorhexidine gluconate
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 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 (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
Paragraph IV (Patent) Challenges for HIBICLENS
Tradename Dosage Ingredient NDA Submissiondate
HIBICLENS SPONGE;TOPICAL chlorhexidine gluconate 018423

US Patents and Regulatory Information for HIBICLENS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Molnlycke Hlth HIBICLENS chlorhexidine gluconate SOLUTION;TOPICAL 017768-001 Approved Prior to Jan 1, 1982 OTC Yes Yes   Start Trial   Start Trial   Start Trial
Molnlycke Hlth HIBICLENS chlorhexidine gluconate SPONGE;TOPICAL 018423-001 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for HIBICLENS

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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
Mallinckrodt
Dow
Boehringer Ingelheim
AstraZeneca
McKinsey

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