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CEFOTAXIME Drug Profile
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Which patents cover Cefotaxime, and what generic alternatives are available?
Cefotaxime is a drug marketed by Fresenius Kabi Usa, Hikma, Wockhardt, B Braun, Aurobindo Pharma, Aurobindo Pharma Ltd, Cephazone Pharma, Hospira Inc, and Lupin. and is included in fourteen NDAs.
The generic ingredient in CEFOTAXIME is cefotaxime sodium. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cefotaxime sodium profile page.
Summary for CEFOTAXIME
| US Patents: | 0 |
| Applicants: | 9 |
| NDAs: | 14 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 38 |
| Clinical Trials: | 29 |
| Patent Applications: | 7 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | CEFOTAXIME at DailyMed |
Recent Clinical Trials for CEFOTAXIME
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Fayoum University Hospital | N/A |
| Kasr El Aini Hospital | Phase 2 |
| Centre Hospitalier Universitaire de Besancon | Phase 4 |
Pharmacology for CEFOTAXIME
| Drug Class | Cephalosporin Antibacterial |
US Patents and Regulatory Information for CEFOTAXIME
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lupin | CEFOTAXIME SODIUM | cefotaxime sodium | INJECTABLE;INJECTION | 065124-001 | Sep 24, 2003 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Wockhardt | CEFOTAXIME SODIUM | cefotaxime sodium | INJECTABLE;INJECTION | 065197-003 | Jun 20, 2008 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Fresenius Kabi Usa | CEFOTAXIME | cefotaxime sodium | INJECTABLE;INJECTION | 064200-002 | Mar 24, 2000 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Hospira Inc | CEFOTAXIME SODIUM | cefotaxime sodium | INJECTABLE;INJECTION | 065290-002 | Aug 11, 2006 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Hospira Inc | CEFOTAXIME SODIUM | cefotaxime sodium | INJECTABLE;INJECTION | 065292-001 | Aug 10, 2006 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Hikma | CEFOTAXIME | cefotaxime sodium | INJECTABLE;INJECTION | 065072-003 | Nov 20, 2002 | RX | No | Yes | Start Trial | Start Trial | Start Trial | ||||
| Fresenius Kabi Usa | CEFOTAXIME | cefotaxime sodium | INJECTABLE;INJECTION | 064201-002 | Mar 24, 2000 | DISCN | No | 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 |
