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Chlorhexidine gluconate - Generic Drug Details
What are the generic sources for chlorhexidine gluconate and what is the scope of freedom to operate?
Chlorhexidine gluconate
is the generic ingredient in twenty-eight branded drugs marketed by Xttrium, Sage Prods, Medline Industries, Bajaj, Hi Tech Pharma, 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 twelve 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. Sixty-three suppliers are listed for this compound.
Summary for chlorhexidine gluconate
| International Patents: | 3 |
| US Patents: | 12 |
| Tradenames: | 28 |
| Applicants: | 25 |
| NDAs: | 36 |
| Drug Master File Entries: | 58 |
| Suppliers / Packagers: | 63 |
| Bulk Api Vendors: | 35 |
| Clinical Trials: | 92 |
| Patent Applications: | 7,126 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for chlorhexidine gluconate |
| Drug Sales Revenues: | Drug sales revenues for chlorhexidine gluconate |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for chlorhexidine gluconate |
| DailyMed Link: | chlorhexidine gluconate at DailyMed |
Recent Clinical Trials for chlorhexidine gluconate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Gustavo Avila-Ortiz DDS, MS, PhD | Phase 4 |
| Osteology Foundation | Phase 4 |
| Montefiore Medical Center | Phase 3 |
Recent Litigation for chlorhexidine gluconate
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Reckitt Benckiser Pharmaceuticals Inc. v. Watson Laboratories Inc. | 2013-10-08 |
Pharmacology for chlorhexidine gluconate
| Physiological Effect | Decreased Cell Wall Integrity |
Medical Subject Heading (MeSH) Categories for chlorhexidine gluconate
Synonyms for chlorhexidine gluconate
| (1E)-2-[6-[[amino-[(E)-[amino-(4-chloroanilino)methylene]amino]methylene]amino]hexyl]-1-[amino-(4-chloroanilino)methylene]guanidine; (2R,3S,4R,5R)-2,3,4,5,6-pentahydroxyhexanoic acid |
| 1-(4-chlorophenyl)-3-[N-[6-[[N-[N-(4-chlorophenyl)carbamimidoyl]carbamimidoyl]amino]hexyl]carbamimidoyl]guanidine; (2R,3S,4R,5R)-2,3,4,5,6-pentahydroxyhexanoic acid |
| 1,1'-Hexamethylene bis(5-(p-chlorophenyl)biguanide), digluconate |
| 1,1'-Hexamethylenebis[5-(4-chlorophenyl)biguanide] Digluconate |
| 1,6-Bis(N5-[p-chlorophenyl]-N1-biguanido)hexane; 1,1 inverted exclamation marka-Hexamethylenebis(5-[p-chlorophenyl]biguanide) |
| 1,6-Bis(N5-[p-chlorophenyl]-N1-biguanido)hexane; 1,1'-Hexamethylenebis(5-[p-chlorophenyl]biguanide) |
| 105791-72-8 |
| 12068-31-4 |
| 124973-71-3 |
| 14007-07-9 |
| 150621-85-5 |
| 151498-43-0 |
| 18472-51-0 |
| 2,4,11,13-Tetraazatetradecanediimidamide, N,N''-bis(4-chlorophenyl)-3,12-diimino-, digluconate |
| 21293-24-3 |
| 227749-99-7 |
| 230296-52-3 |
| 23289-58-9 |
| 40330-16-3 |
| 452971-25-4 |
| 51365-13-0 |
| 52196-45-9 |
| 52387-19-6 |
| 60042-57-1 |
| 60404-86-6 |
| 82432-16-4 |
| 906339-38-6 |
| Abacil |
| AKOS015896303 |
| AKOS025310696 |
| AN-18792 |
| Arlacide G |
| Bioscrub |
| Brian Care |
| C08038 |
| CHEBI:28312 |
| Chlorhexidin glukonatu |
| Chlorhexidine D-digluconate |
| Chlorhexidine di-D-gluconate |
| CHLORHEXIDINE DIGLUCONATE |
| Chlorhexidine digluconate solution |
| Chlorhexidine digluconate solution, 20% in H2O |
| Chlorhexidine digluconate, Pharmaceutical Secondary Standard; Certified Reference Material |
| Chlorhexidine gluconate (JP17/USP) |
| Chlorhexidine gluconate [USAN:USP:JAN] |
| Chx plus concentrate premium chlorhexidine teat dip concentrate |
| Cida-Stat |
| D-Gluconic acid, compd with N,N''-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediimidamide (2:1) |
| D-Gluconic acid, compd. with N1,N14-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediimidamide (2:1) |
| D00858 |
| DTXSID5034519 |
| Dyna-hex |
| EC 242-354-0 |
| Exidine |
| Fight bac |
| Gluconic acid, compd. with 1,1'-hexamethylene bis(5-(p-chlorophenyl)biguanide) (2:1), D- (8CI) |
| Hibiclens |
| Hibiclens (TN) |
| Hibidil |
| Hibiscrub |
| Hibitane |
| Hibitane gluconate |
| I06-2074 |
| J-011837 |
| Kleersight |
| M166 |
| MFCD00083599 |
| Microderm |
| MolPort-006-069-426 |
| MOR84MUD8E |
| N',N'''''-hexane-1,6-diylbis[N-(4-chlorophenyl)(imidodicarbonimidic diamide)]--D-gluconic acid (1/2) |
| Peridex |
| Peridex (TN) |
| Periochip |
| Periogard |
| Periogard (TN) |
| Pharmaseal Scrub Care |
| pHiso-Med |
| Prevacare |
| Prevacare R |
| SCHEMBL34468 |
| Steri-Stat |
| UNII-MOR84MUD8E |
| Unisept |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Soapco | BRIAN CARE | chlorhexidine gluconate | SOLUTION;TOPICAL | 071419-001 | Dec 17, 1987 | OTC | No | No | Start Trial | Start Trial | Start Trial | ||||
| Xttrium | EXIDINE | chlorhexidine gluconate | SOLUTION;TOPICAL | 019422-001 | Dec 17, 1985 | OTC | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Colgate-palmolive Co | PERIOGARD | chlorhexidine gluconate | SOLUTION;DENTAL | 203212-001 | Jan 28, 2016 | AT | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Becton Dickinson Co | CHLORAPREP ONE-STEP | chlorhexidine gluconate; isopropyl alcohol | SPONGE;TOPICAL | 020832-004 | Aug 20, 2003 | OTC | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >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
| 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 | Start Trial | Start Trial |
| Molnlycke Hlth | HIBICLENS | chlorhexidine gluconate | SPONGE;TOPICAL | 018423-001 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
| Molnlycke Hlth | HIBICLENS | chlorhexidine gluconate | SPONGE;TOPICAL | 018423-001 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
| Dexcel Pharma | PERIOCHIP | chlorhexidine gluconate | TABLET;DENTAL | 020774-001 | May 15, 1998 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for chlorhexidine gluconate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2467155 | Start Trial |
| Canada | 2551688 | Start Trial |
| Canada | 2467150 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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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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Site Map
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.