Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 12, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018423

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NDA 018423 describes HIBICLENS, which is a drug marketed by Molnlycke Hlth and is included in two NDAs. It is available from two suppliers. Additional details are available on the HIBICLENS profile page.

The generic ingredient in HIBICLENS is chlorhexidine gluconate. There are fifty-eight drug master file entries for this compound. Sixty-three suppliers are listed for this compound. Additional details are available on the chlorhexidine gluconate profile page.
Summary for 018423
Tradename:HIBICLENS
Applicant:Molnlycke Hlth
Ingredient:chlorhexidine gluconate
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 018423
Paragraph IV (Patent) Challenges for 018423
Tradename Dosage Ingredient NDA Submissiondate
HIBICLENS SPONGE;TOPICAL chlorhexidine gluconate 018423

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SPONGE;TOPICALStrength4% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Expired US Patents for NDA 018423

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   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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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