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CHLORAPREP ONE-STEP Drug 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 three patents protecting this drug.
This drug has twenty-three patent family members in twelve countries.
The generic ingredient in CHLORAPREP ONE-STEP is chlorhexidine gluconate; isopropyl alcohol. There are fifty-eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the chlorhexidine gluconate; isopropyl alcohol profile page.
US ANDA Litigation and Generic Entry Outlook for Chloraprep One-step
Indicators of Generic Entry
Summary for CHLORAPREP ONE-STEP
| International Patents: | 23 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 35 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | CHLORAPREP ONE-STEP at DailyMed |
Recent Clinical Trials for CHLORAPREP ONE-STEP
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of California, San Diego | N/A |
| Gebauer Company | Phase 4 |
| Henry Ford Health System | Phase 4 |
US Patents and Regulatory Information for CHLORAPREP ONE-STEP
| 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 | Start Trial | Start Trial | Y | Start Trial | |||
| Becton Dickinson Co | CHLORAPREP ONE-STEP SEPP | chlorhexidine gluconate; isopropyl alcohol | SWAB;TOPICAL | 021555-001 | Oct 7, 2002 | OTC | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Becton Dickinson Co | CHLORAPREP ONE-STEP | chlorhexidine gluconate; isopropyl alcohol | SPONGE;TOPICAL | 020832-006 | Nov 21, 2006 | 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 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 | 020832-001 | Jul 14, 2000 | Start Trial | Start Trial |
| Becton Dickinson Co | CHLORAPREP ONE-STEP | chlorhexidine gluconate; isopropyl alcohol | SPONGE;TOPICAL | 020832-001 | Jul 14, 2000 | Start Trial | Start Trial |
| Becton Dickinson Co | CHLORAPREP ONE-STEP | chlorhexidine gluconate; isopropyl alcohol | SPONGE;TOPICAL | 020832-001 | Jul 14, 2000 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for CHLORAPREP ONE-STEP
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Russian Federation | 2200532 | Start Trial |
| Australia | 4249296 | Start Trial |
| Canada | 2228942 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
