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Cefotaxime sodium - Generic Drug Details
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What are the generic sources for cefotaxime sodium and what is the scope of freedom to operate?
Cefotaxime sodium
is the generic ingredient in seven branded drugs marketed by Fresenius Kabi Usa, Hikma, Wockhardt, B Braun, Aurobindo Pharma, Aurobindo Pharma Ltd, Cephazone Pharma, Hospira Inc, Lupin, Sanofi Aventis Us, and Us Pharm Holdings, and is included in seventeen NDAs. Additional information is available in the individual branded drug profile pages.There are fourteen drug master file entries for cefotaxime sodium. One supplier is listed for this compound.
Summary for cefotaxime sodium
| US Patents: | 0 |
| Tradenames: | 7 |
| Applicants: | 11 |
| NDAs: | 17 |
| Drug Master File Entries: | 14 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 103 |
| Clinical Trials: | 7 |
| Patent Applications: | 1,396 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | cefotaxime sodium at DailyMed |
Recent Clinical Trials for cefotaxime sodium
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Fayoum University Hospital | Phase 4 |
| Fundação de Amparo à Pesquisa do Estado de São Paulo | Phase 4 |
| Federal University of São Paulo | Phase 4 |
Pharmacology for cefotaxime sodium
| Drug Class | Cephalosporin Antibacterial |
Medical Subject Heading (MeSH) Categories for cefotaxime sodium
US Patents and Regulatory Information for cefotaxime sodium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Us Pharm Holdings | CLAFORAN | cefotaxime sodium | INJECTABLE;INJECTION | 050547-003 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Wockhardt | CEFOTAXIME | cefotaxime sodium | INJECTABLE;INJECTION | 065197-001 | Aug 29, 2006 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Hospira Inc | CEFOTAXIME SODIUM | cefotaxime sodium | INJECTABLE;INJECTION | 065290-001 | Aug 11, 2006 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Hospira Inc | CEFOTAXIME SODIUM | cefotaxime sodium | INJECTABLE;INJECTION | 065290-003 | Aug 11, 2006 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Lupin | CEFOTAXIME SODIUM | cefotaxime sodium | INJECTABLE;INJECTION | 065124-001 | Sep 24, 2003 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Hikma | CEFOTAXIME | cefotaxime sodium | INJECTABLE;INJECTION | 065071-001 | Nov 20, 2002 | RX | No | Yes | 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 |
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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.
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