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Last Updated: August 9, 2020

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HIBICLENS Drug Profile

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When do Hibiclens patents expire, and when can generic versions of Hibiclens launch?

Hibiclens is a drug marketed by Molnlycke Hlth and is included in two NDAs.

The generic ingredient in HIBICLENS is chlorhexidine gluconate. There are fifty-eight drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the chlorhexidine gluconate profile page.

US ANDA Litigation and Generic Entry Outlook for Hibiclens

A generic version of HIBICLENS was approved as chlorhexidine gluconate by BECTON DICKINSON on October 24th, 1989.

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Drug patent expirations by year for HIBICLENS
Drug Sales Revenue Trends for HIBICLENS

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Recent Clinical Trials for HIBICLENS

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SponsorPhase
Carilion ClinicPhase 4
University of WashingtonPhase 4
Clinical Directors NetworkN/A

See all HIBICLENS clinical trials

Paragraph IV (Patent) Challenges for HIBICLENS
Tradename Dosage Ingredient NDA Submissiondate
HIBICLENS SPONGE;TOPICAL chlorhexidine gluconate 018423

US Patents and Regulatory Information for HIBICLENS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Molnlycke Hlth HIBICLENS chlorhexidine gluconate SOLUTION;TOPICAL 017768-001 Approved Prior to Jan 1, 1982 OTC Yes Yes   Start Trial   Start Trial   Start Trial
Molnlycke Hlth HIBICLENS chlorhexidine gluconate SPONGE;TOPICAL 018423-001 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   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 HIBICLENS

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

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Serving leading biopharmaceutical companies globally:

Colorcon
Express Scripts
Boehringer Ingelheim
Baxter
Dow
Harvard Business School

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