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Generated: June 27, 2017
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 fifteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.| Tradenames: | 27 |
| Patents: | 15 |
| Applicants: | 24 |
| NDAs: | 34 |
| Drug Master File Entries: see list | 57 |
| Suppliers / Packagers: see list | 59 |
| Bulk Api Vendors: see list | 62 |
| Clinical Trials: see list | 270 |
| Patent Applications: see list | 9,589 |
| Therapeutic Class: | Dental and Oral Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | chlorhexidine gluconate at DailyMed |
| Physiological Effect | Decreased 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 | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Matrix Medcl | STERI-STAT | chlorhexidine gluconate | SOLUTION;TOPICAL | 070104-001 | Jul 24, 1986 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Carefusion 2200 | PHARMASEAL SCRUB CARE | chlorhexidine gluconate | SPONGE;TOPICAL | 019793-001 | Dec 2, 1988 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Becton Dickinson Co | CHLORAPREP ONE-STEP | chlorhexidine gluconate; isopropyl alcohol | SPONGE;TOPICAL | 020832-001 | Jul 14, 2000 | OTC | Yes | Yes | 5,690,958 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Becton Dickinson Co | CHLORAPREP WITH TINT | chlorhexidine gluconate; isopropyl alcohol | SPONGE;TOPICAL | 020832-005 | Apr 3, 2006 | OTC | Yes | Yes | 7,241,065 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Sage Prods | CHLORHEXIDINE GLUCONATE | chlorhexidine gluconate | CLOTH;TOPICAL | 021669-001 | Apr 25, 2005 | OTC | Yes | Yes | 7,427,574 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Molnlycke Hlth | HIBICLENS | chlorhexidine gluconate | SOLUTION;TOPICAL | 017768-001 | Approved Prior to Jan 1, 1982 | 3,855,140 | ► Subscribe | ||||||||||||||||||||||
Dexcel Pharma | PERIOCHIP | chlorhexidine gluconate | TABLET;DENTAL | 020774-001 | May 15, 1998 | 5,002,769 | ► Subscribe | ||||||||||||||||||||||
Molnlycke Hlth | HIBICLENS | chlorhexidine gluconate | SPONGE;TOPICAL | 018423-001 | Approved Prior to Jan 1, 1982 | 3,855,140 | ► Subscribe | ||||||||||||||||||||||
Molnlycke Hlth | HIBICLENS | chlorhexidine gluconate | SPONGE;TOPICAL | 018423-001 | Approved Prior to Jan 1, 1982 | 3,960,745 | ► Subscribe | ||||||||||||||||||||||
Dexcel Pharma | PERIOCHIP | chlorhexidine gluconate | TABLET;DENTAL | 020774-001 | May 15, 1998 | 5,023,082 | ► Subscribe | ||||||||||||||||||||||
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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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,221,365 | Disinfectant 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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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Canada | 2467150 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2551688 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2467155 | ► 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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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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