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Generated: August 19, 2017

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Chlorhexidine gluconate - Generic Drug Details

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

Chlorhexidine gluconate
is the generic ingredient in twenty-seven branded drugs marketed by Molnlycke Hlth, Matrix Medcl, Wockhardt, Bajaj Medical Llc, Colgate-palmolive Co, Becton Dickinson, Soapco, Xttrium, Teva, Griffen, 3M, Sunstar Americas, J And J, Hi Tech Pharma, Ecolab, Apotex Inc, Sage Prods, Dexcel Pharma, Kendall Il, Lyne, Carefusion 2200, Colgate Palmolive Co, Prof Dspls, and Becton Dickinson Co, and is included in thirty-four NDAs. There are fourteen 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-seven drug master file entries for chlorhexidine gluconate. Sixty suppliers are listed for this compound.

Summary for Generic Name: chlorhexidine gluconate

Tradenames:27
Patents:14
Applicants:24
NDAs:34
Drug Master File Entries: see list57
Suppliers / Packagers: see list60
Bulk Api Vendors: see list62
Clinical Trials: see list274
Patent Applications: see list9,589
Therapeutic Class:Dental and Oral Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:chlorhexidine gluconate at DailyMed

Pharmacology for Ingredient: chlorhexidine gluconate

Physiological EffectDecreased Cell Wall Integrity
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 WITH TINT
chlorhexidine gluconate; isopropyl alcohol
SPONGE;TOPICAL020832-002May 3, 2005OTCYesYes► Subscribe► SubscribeY ► Subscribe
Becton Dickinson Co
CHLORAPREP WITH TINT
chlorhexidine gluconate; isopropyl alcohol
SPONGE;TOPICAL020832-005Apr 3, 2006OTCYesYes► Subscribe► SubscribeY ► Subscribe
Becton Dickinson Co
CHLORAPREP ONE-STEP
chlorhexidine gluconate; isopropyl alcohol
SPONGE;TOPICAL020832-004Aug 20, 2003OTCYesYes► Subscribe► SubscribeY ► Subscribe
Becton Dickinson Co
CHLORAPREP WITH TINT
chlorhexidine gluconate; isopropyl alcohol
SPONGE;TOPICAL020832-005Apr 3, 2006OTCYesYes► Subscribe► SubscribeY ► Subscribe
Becton Dickinson Co
CHLORAPREP WITH TINT
chlorhexidine gluconate; isopropyl alcohol
SPONGE;TOPICAL020832-002May 3, 2005OTCYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: chlorhexidine gluconate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Dexcel Pharma
PERIOCHIP
chlorhexidine gluconate
TABLET;DENTAL020774-001May 15, 1998► Subscribe► Subscribe
Molnlycke Hlth
HIBICLENS
chlorhexidine gluconate
SPONGE;TOPICAL018423-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Dexcel Pharma
PERIOCHIP
chlorhexidine gluconate
TABLET;DENTAL020774-001May 15, 1998► Subscribe► Subscribe
Molnlycke Hlth
HIBICLENS
chlorhexidine gluconate
SPONGE;TOPICAL018423-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Molnlycke Hlth
HIBICLENS
chlorhexidine gluconate
SPONGE;TOPICAL018423-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: chlorhexidine gluconate

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
8,221,365Disinfectant delivery system, and method of providing alcohol-free disinfection► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: chlorhexidine gluconate

Country Document Number Estimated Expiration
Canada2467155► Subscribe
Canada2467150► Subscribe
Canada2551688► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
Argus Health
AstraZeneca
Dow
US Army
Healthtrust
Novartis
Accenture
Farmers Insurance
Federal Trade Commission

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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