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Chlorhexidine gluconate - Generic Drug Details

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What are the generic drug sources for chlorhexidine gluconate and what is the scope of patent protection?

Chlorhexidine gluconate is the generic ingredient in twenty-eight branded drugs marketed by Xttrium, Sage Prods, Medline Industries, Akorn, Bajaj, Lyne, Pharm Assoc, Wockhardt Bio Ag, Sunstar Americas, 3M, Colgate Palmolive Co, Colgate-palmolive Co, Soapco, Ecolab, Molnlycke Hlth, J And J, Matrix Medcl, Griffen, Becton Dickinson, Kendall Il, Carefusion 2200, Dexcel Pharma, 3m Health Care, Becton Dickinson Co, and Prof Dspls, and is included in thirty-six 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-eight drug master file entries for chlorhexidine gluconate. Fifty-eight suppliers are listed for this compound.

Summary for chlorhexidine gluconate

International Patents:	3
US Patents:	11
Tradenames:	28
Applicants:	25
NDAs:	36
Drug Master File Entries:	58
Finished Product Suppliers / Packagers:	58
Raw Ingredient (Bulk) Api Vendors:	37
Clinical Trials:	115
Patent Applications:	7,203
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for chlorhexidine gluconate
Drug Sales Revenues:	Drug sales revenues for chlorhexidine gluconate
What excipients (inactive ingredients) are in chlorhexidine gluconate?	chlorhexidine gluconate excipients list
DailyMed Link:	chlorhexidine gluconate at DailyMed

See drug prices for chlorhexidine gluconate

See drug sales revenues for chlorhexidine gluconate

Recent Clinical Trials for chlorhexidine gluconate

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

Sponsor	Phase
BIOSCIENCE LABORATORIES, INC.	Early Phase 1
Zaycor Healthcare Corp	Early Phase 1
Karolinska Institutet	Phase 2

See all chlorhexidine gluconate clinical trials

Pharmacology for chlorhexidine gluconate

Physiological Effect

Decreased Cell Wall Integrity

Medical Subject Heading (MeSH) Categories for chlorhexidine gluconate

Anti-Infective Agents, Local

Disinfectants

Mouthwashes

Paragraph IV (Patent) Challenges for CHLORHEXIDINE GLUCONATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
HIBICLENS	SPONGE;TOPICAL	chlorhexidine gluconate	018423

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
Kendall Il	CHLORHEXIDINE GLUCONATE	chlorhexidine gluconate	SPONGE;TOPICAL	019490-001	Mar 27, 1987		DISCN	No	No
Matrix Medcl	STERI-STAT	chlorhexidine gluconate	SOLUTION;TOPICAL	070104-001	Jul 24, 1986		DISCN	No	No
Pharm Assoc	CHLORHEXIDINE GLUCONATE	chlorhexidine gluconate	SOLUTION;DENTAL	074522-001	Dec 15, 1995	AT	RX	No	No
Becton Dickinson Co	CHLORAPREP WITH TINT	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-002	May 3, 2005		OTC	Yes	Yes			Y
Dexcel Pharma	PERIOCHIP	chlorhexidine gluconate	TABLET;DENTAL	020774-001	May 15, 1998		RX	Yes	Yes

Expired US Patents for chlorhexidine gluconate

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

International Patents for chlorhexidine gluconate

Country	Patent Number	Estimated Expiration
Canada	2467155
Canada	2467150
Canada	2551688