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Last Updated: May 20, 2022

CHLORAPREP ONE-STEP Drug Patent Profile


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When do Chloraprep One-step patents expire, and when can generic versions of Chloraprep One-step launch?

Chloraprep One-step is a drug marketed by Becton Dickinson Co and is included in two NDAs. There are two patents protecting this drug.

This drug has twelve patent family members in eleven countries.

The generic ingredient in CHLORAPREP ONE-STEP is chlorhexidine gluconate; isopropyl alcohol. There are fifty-eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the chlorhexidine gluconate; isopropyl alcohol profile page.

DrugPatentWatch® Generic Entry Outlook for Chloraprep One-step

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 14, 2023. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for CHLORAPREP ONE-STEP
International Patents:12
US Patents:2
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 42
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in CHLORAPREP ONE-STEP?CHLORAPREP ONE-STEP excipients list
DailyMed Link:CHLORAPREP ONE-STEP at DailyMed
Drug patent expirations by year for CHLORAPREP ONE-STEP
DrugPatentWatch® Estimated Generic Entry Opportunity Date for CHLORAPREP ONE-STEP
Generic Entry Date for CHLORAPREP ONE-STEP*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SPONGE;TOPICAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for CHLORAPREP ONE-STEP

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Henry Ford Health SystemPhase 4
Gebauer CompanyPhase 4
Fondazione Policlinico Universitario Agostino Gemelli IRCCSN/A

See all CHLORAPREP ONE-STEP clinical trials

Pharmacology for CHLORAPREP ONE-STEP
Physiological EffectDecreased Cell Wall Integrity

US Patents and Regulatory Information for CHLORAPREP ONE-STEP

CHLORAPREP ONE-STEP is protected by two US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of CHLORAPREP ONE-STEP is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting CHLORAPREP ONE-STEP

Liquid applicator with a mechanism for fracturing multiple ampoules
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Antiseptic applicator with mechanism for fracturing multiple ampoules
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 ONE-STEP chlorhexidine gluconate; isopropyl alcohol SPONGE;TOPICAL 020832-001 Jul 14, 2000 OTC Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Becton Dickinson Co CHLORAPREP ONE-STEP SEPP chlorhexidine gluconate; isopropyl alcohol SWAB;TOPICAL 021555-001 Oct 7, 2002 OTC Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Becton Dickinson Co CHLORAPREP ONE-STEP chlorhexidine gluconate; isopropyl alcohol SPONGE;TOPICAL 020832-006 Nov 21, 2006 OTC Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Becton Dickinson Co CHLORAPREP ONE-STEP chlorhexidine gluconate; isopropyl alcohol SPONGE;TOPICAL 020832-004 Aug 20, 2003 OTC Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 CHLORAPREP ONE-STEP

International Patents for CHLORAPREP ONE-STEP

When does loss-of-exclusivity occur for CHLORAPREP ONE-STEP?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 04220817
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0408318
Estimated Expiration: See Plans and Pricing

Canada

Patent: 19176
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 10961
Estimated Expiration: See Plans and Pricing

Patent: 17866
Estimated Expiration: See Plans and Pricing

Japan

Patent: 88791
Estimated Expiration: See Plans and Pricing

Patent: 06520271
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 05009881
Estimated Expiration: See Plans and Pricing

Spain

Patent: 01493
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering CHLORAPREP ONE-STEP around the world.

Country Patent Number Title Estimated Expiration
Australia 2002243289 See Plans and Pricing
Japan 4435478 See Plans and Pricing
Canada 2428099 APPLICATEUR DE LIQUIDE DOTE D'AILERONS DIAMETRALEMENT OPPOSES (LIQUID APPLICATOR WITH DIAMETRICALLY OPPOSED WINGS) See Plans and Pricing
World Intellectual Property Organization (WIPO) 9707729 See Plans and Pricing
>Country >Patent Number >Title >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 verification 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.