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CHLORAPREP ONE-STEP Drug Patent Profile
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Which patents cover Chloraprep One-step, 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
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 |
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
| Sponsor | Phase |
|---|---|
| Henry Ford Health System | Phase 4 |
| Gebauer Company | Phase 4 |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | N/A |
Pharmacology for CHLORAPREP ONE-STEP
| Physiological Effect | Decreased Cell Wall Integrity |
Anatomical Therapeutic Chemical (ATC) Classes for CHLORAPREP ONE-STEP
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 ⤷ Try it Free.
This potential generic entry date is based on patent ⤷ Try it Free.
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: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Antiseptic applicator with mechanism for fracturing multiple ampoules
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
| 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 | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Becton Dickinson Co | CHLORAPREP ONE-STEP SEPP | chlorhexidine gluconate; isopropyl alcohol | SWAB;TOPICAL | 021555-001 | Oct 7, 2002 | OTC | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Becton Dickinson Co | CHLORAPREP ONE-STEP | chlorhexidine gluconate; isopropyl alcohol | SPONGE;TOPICAL | 020832-006 | Nov 21, 2006 | OTC | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | Y | ⤷ Try it Free | |||
| Becton Dickinson Co | CHLORAPREP ONE-STEP | chlorhexidine gluconate; isopropyl alcohol | SPONGE;TOPICAL | 020832-004 | Aug 20, 2003 | OTC | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Becton Dickinson Co | CHLORAPREP ONE-STEP | chlorhexidine gluconate; isopropyl alcohol | SPONGE;TOPICAL | 020832-006 | Nov 21, 2006 | OTC | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | Y | ⤷ Try it Free | |||
| Becton Dickinson Co | CHLORAPREP ONE-STEP FREPP | chlorhexidine gluconate; isopropyl alcohol | SPONGE;TOPICAL | 020832-003 | Apr 26, 2002 | OTC | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Becton Dickinson Co | CHLORAPREP ONE-STEP | chlorhexidine gluconate; isopropyl alcohol | SPONGE;TOPICAL | 020832-008 | Oct 23, 2008 | OTC | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| >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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Becton Dickinson Co | CHLORAPREP ONE-STEP | chlorhexidine gluconate; isopropyl alcohol | SPONGE;TOPICAL | 020832-006 | Nov 21, 2006 | ⤷ Try it Free | ⤷ Try it Free |
| Becton Dickinson Co | CHLORAPREP ONE-STEP | chlorhexidine gluconate; isopropyl alcohol | SPONGE;TOPICAL | 020832-001 | Jul 14, 2000 | ⤷ Try it Free | ⤷ Try it Free |
| Becton Dickinson Co | CHLORAPREP ONE-STEP | chlorhexidine gluconate; isopropyl alcohol | SPONGE;TOPICAL | 020832-001 | Jul 14, 2000 | ⤷ Try it Free | ⤷ Try it Free |
| Becton Dickinson Co | CHLORAPREP ONE-STEP | chlorhexidine gluconate; isopropyl alcohol | SPONGE;TOPICAL | 020832-001 | Jul 14, 2000 | ⤷ Try it Free | ⤷ Try it Free |
| Becton Dickinson Co | CHLORAPREP ONE-STEP | chlorhexidine gluconate; isopropyl alcohol | SPONGE;TOPICAL | 020832-004 | Aug 20, 2003 | ⤷ Try it Free | ⤷ Try it Free |
| Becton Dickinson Co | CHLORAPREP ONE-STEP | chlorhexidine gluconate; isopropyl alcohol | SPONGE;TOPICAL | 020832-001 | Jul 14, 2000 | ⤷ Try it Free | ⤷ Try it Free |
| Becton Dickinson Co | CHLORAPREP ONE-STEP | chlorhexidine gluconate; isopropyl alcohol | SPONGE;TOPICAL | 020832-001 | Jul 14, 2000 | ⤷ Try it Free | ⤷ Try it Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for CHLORAPREP ONE-STEP
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Germany | 60325094 | ⤷ Try it Free |
| Canada | 2428099 | ⤷ Try it Free |
| Spain | 2159651 | ⤷ Try it Free |
| Canada | 2263158 | ⤷ Try it Free |
| Austria | 202686 | ⤷ Try it Free |
| China | 1231602 | ⤷ Try it Free |
| European Patent Office | 1581300 | ⤷ Try it Free |
| >Country | >Patent Number | >Estimated Expiration |
