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 freedom to operate?

Chlorhexidine gluconate; isopropyl alcohol is the generic ingredient in ten branded drugs marketed by 3m Health Care, Becton Dickinson Co, and Prof Dspls, and is included in four NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Chlorhexidine gluconate; isopropyl alcohol has twenty-two patent family members in twelve countries.

Four suppliers are listed for this compound.

Summary for CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

International Patents:	22
US Patents:	2
Tradenames:	10
Applicants:	3
NDAs:	4
Finished Product Suppliers / Packagers:	4
Clinical Trials:	24
DailyMed Link:	CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

Generic Entry Date for CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: REVISIONS TO THE LABELING TO DESCRIBE MODIFIED FORMULATION BASED ON RESULTS OF STUDIES EM-05-014624 AND EM-05-014815 Dosage: SOLUTION;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

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

Sponsor	Phase
Yaneve Fonge	Phase 4
University of Wisconsin, Madison	Phase 4
University of California, San Diego	N/A

See all CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL clinical trials

Pharmacology for CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

Physiological Effect	Decreased Cell Wall Integrity

Anatomical Therapeutic Chemical (ATC) Classes for CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

A01AB	Antiinfectives and antiseptics for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

B05CA	Antiinfectives
B05C	IRRIGATING SOLUTIONS
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

D08AC	Biguanides and amidines
D08A	ANTISEPTICS AND DISINFECTANTS
D08	ANTISEPTICS AND DISINFECTANTS
D	Dermatologicals

D09AA	Medicated dressings with antiinfectives
D09A	MEDICATED DRESSINGS
D09	MEDICATED DRESSINGS
D	Dermatologicals

R02AA	Antiseptics
R02A	THROAT PREPARATIONS
R02	THROAT PREPARATIONS
R	Respiratory system

S01AX	Other antiinfectives
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

S03AA	Antiinfectives
S03A	ANTIINFECTIVES
S03	OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S	Sensory organs

US Patents and Regulatory Information for CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

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Glossary

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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 ONE-STEP SEPP	chlorhexidine gluconate; isopropyl alcohol	SWAB;TOPICAL	021555-001	Oct 7, 2002		OTC	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Becton Dickinson Co	CHLORAPREP ONE-STEP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-006	Nov 21, 2006		OTC	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Prof Dspls	PREVANTICS SWABSTICK	chlorhexidine gluconate; isopropyl alcohol	SWAB;TOPICAL	021524-002	Jun 3, 2005		OTC	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Becton Dickinson Co	CHLORAPREP TRIPLE SWABSTICK	chlorhexidine gluconate; isopropyl alcohol	SWAB;TOPICAL	021555-003	Jun 10, 2009		OTC	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

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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	⤷ Sign Up	⤷ Sign Up
Becton Dickinson Co	CHLORAPREP ONE-STEP FREPP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-003	Apr 26, 2002	⤷ Sign Up	⤷ Sign Up
Becton Dickinson Co	CHLORAPREP ONE-STEP FREPP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-003	Apr 26, 2002	⤷ Sign Up	⤷ Sign Up
Becton Dickinson Co	CHLORAPREP WITH TINT	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-005	Apr 3, 2006	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

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Country	Patent Number	Title	Estimated Expiration
Spain	2318196		⤷ Sign Up
Japan	4688791		⤷ Sign Up
Japan	2006520271		⤷ Sign Up
Spain	2601493		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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