Is there a generic for Chlorhexidine gluconate?

Yes. The FDA Orange Book lists 16 approved generic (ANDA) applications for Chlorhexidine gluconate, referencing the brand READYPREP CHG. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Chlorhexidine gluconate?

READYPREP CHG (NDA 207964, MEDLINE INDUSTRIES) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Chlorhexidine gluconate?

The Orange Book lists 2 patents against Chlorhexidine gluconate products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Chlorhexidine gluconate are approved?

Chlorhexidine gluconate is approved in the following dosage forms: aerosol, metered, cloth, solution, sponge, tablet.

FDA Orange Book · active-ingredient family

Chlorhexidine gluconate

Chlorhexidine gluconate is approved as 16 brand and 16 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:READYPREP CHG · NDA 207964

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · aerosol, metered, cloth, solution, sponge, tablet

Product	Applicant	Application	TE	Approved
READYPREP CHGRLD	MEDLINE INDUSTRIES	NDA 207964	—	Nov 20, 2018
CHLORHEXIDINE GLUCONATERLD	SAGE PRODS	NDA 021669	—	Apr 25, 2005
PERIOCHIPRLD	DEXCEL PHARMA	NDA 020774	—	May 15, 1998
PERIDEXRLD	SOLVENTUM	NDA 019028	AT	Aug 13, 1986
DYNA-HEX 2RLD	XTTRIUM	NDA 019422	—	Dec 17, 1985
EXIDINERLD	XTTRIUM	NDA 019127	—	Dec 24, 1984
HIBICLENSRLD	MOLNLYCKE HLTH	NDA 017768	—	Approved Prior to Jan 1, 1982
HIBISTATRLD	MOLNLYCKE HLTH	NDA 018300	—	Approved Prior to Jan 1, 1982
HIBICLENSRLD	MOLNLYCKE HLTH	NDA 018423	—	Approved Prior to Jan 1, 1982
CHLORHEXIDINE GLUCONATE	BAJAJ	NDA 020111	—	Sep 11, 1997
BIOSCRUB	GRIFFEN	NDA 019822	—	Mar 31, 1989
PHARMASEAL SCRUB CARE	CAREFUSION 2200	NDA 019793	—	Dec 02, 1988
CHLORHEXIDINE GLUCONATE	KENDALL IL	NDA 019490	—	Mar 27, 1987
CHG SCRUB×2	ECOLAB	NDA 019258	—	Jul 22, 1986
EXIDINE	XTTRIUM	NDA 019421	—	Dec 17, 1985
DYNA-HEX 4	XTTRIUM	NDA 019125	—	Dec 24, 1984

Generic (ANDA) products (16)

Product	Applicant	Application	TE	Approved
PERIOGARD	COLGATE-PALMOLIVE CO	ANDA 203212	AT	Jan 28, 2016
CHLORHEXIDINE GLUCONATE	PHARMOBEDIENT	ANDA 077789	AT	Jun 18, 2009
PAROEX	SUNSTAR AMERICAS	ANDA 076434	—	Nov 29, 2005
CHLORHEXIDINE GLUCONATE	CHARTWELL RX	ANDA 075006	AT	Mar 03, 2004
CHLORHEXIDINE GLUCONATE	BAJAJ	ANDA 075561	AT	Nov 14, 2000
E-Z SCRUB	BECTON DICKINSON	ANDA 073416	—	Mar 14, 2000
CHLORHEXIDINE GLUCONATE	SCIEGEN PHARMS	ANDA 074356	—	May 07, 1996
CHLORHEXIDINE GLUCONATE	LYNE	ANDA 074291	AT	Dec 28, 1995
CHLORHEXIDINE GLUCONATE	PHARM ASSOC	ANDA 074522	AT	Dec 15, 1995
PERIOGARD	COLGATE PALMOLIVE CO	ANDA 073695	—	Jan 14, 1994
PREVACARE R	J AND J	ANDA 072292	—	Jan 28, 1992
MICRODERM	J AND J	ANDA 072255	—	Apr 15, 1991
MICRODERM	J AND J	ANDA 072295	—	Feb 28, 1991
CHLORHEXIDINE GLUCONATE	BECTON DICKINSON	ANDA 072525	—	Oct 24, 1989
BRIAN CARE	SOAPCO	ANDA 071419	—	Dec 17, 1987
STERI-STAT	MATRIX MEDCL	ANDA 070104	—	Jul 24, 1986

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7427574	Apr 25, 2026	2 mo ago	Product
7935093	Oct 02, 2027	in 1 yr 4 mo	ProductU-1022

Chlorhexidine gluconate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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