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Chlorhexidine gluconate; isopropyl alcohol - Generic Drug Details

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

Chlorhexidine gluconate; isopropyl alcohol is the generic ingredient in nine branded drugs marketed by Becton Dickinson Co and Prof Dspls, and is included in three NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Chlorhexidine gluconate; isopropyl alcohol has thirty-three patent family members in thirteen countries.

There are fifty-seven drug master file entries for chlorhexidine gluconate; isopropyl alcohol. Two suppliers are listed for this compound.

Summary for chlorhexidine gluconate; isopropyl alcohol

International Patents:	33
US Patents:	6
Tradenames:	9
Applicants:	2
NDAs:	3
Drug Master File Entries:	57
Suppliers / Packagers:	2
Clinical Trials:	11
DailyMed Link:	chlorhexidine gluconate; isopropyl alcohol at DailyMed

US Patents and Regulatory Information for chlorhexidine gluconate; isopropyl alcohol

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 TRIPLE SWABSTICK	chlorhexidine gluconate; isopropyl alcohol	SWAB;TOPICAL	021555-003	Jun 10, 2009		OTC	Yes	Yes
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 ONE-STEP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-008	Oct 23, 2008		OTC	Yes	Yes
Becton Dickinson Co	CHLORAPREP SINGLE SWABSTICK	chlorhexidine gluconate; isopropyl alcohol	SWAB;TOPICAL	021555-002	May 10, 2005		OTC	Yes	Yes
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	020832-007	Oct 10, 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; isopropyl alcohol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Becton Dickinson Co	CHLORAPREP WITH TINT	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-005	Apr 3, 2006
Becton Dickinson Co	CHLORAPREP ONE-STEP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-001	Jul 14, 2000
Becton Dickinson Co	CHLORAPREP ONE-STEP SEPP	chlorhexidine gluconate; isopropyl alcohol	SWAB;TOPICAL	021555-001	Oct 7, 2002
Becton Dickinson Co	CHLORAPREP ONE-STEP FREPP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-003	Apr 26, 2002
Becton Dickinson Co	CHLORAPREP ONE-STEP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-001	Jul 14, 2000
Becton Dickinson Co	CHLORAPREP ONE-STEP FREPP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-003	Apr 26, 2002
Becton Dickinson Co	CHLORAPREP ONE-STEP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-004	Aug 20, 2003

Non-Orange Book US Patents for chlorhexidine gluconate; isopropyl alcohol

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
6,991,393	Liquid applicator for coloring a liquid

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International Patents for chlorhexidine gluconate; isopropyl alcohol

Country	Document Number	Estimated Expiration
Australia	2003300115
European Patent Office	1610961
Japan	2006520271
Spain	2318196
Canada	2512593
World Intellectual Property Organization (WIPO)	0246089
Portugal	1581300