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Cefuroxime axetil - Generic Drug Details
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What are the generic sources for cefuroxime axetil and what is the scope of freedom to operate?
Cefuroxime axetil
is the generic ingredient in two branded drugs marketed by Glaxosmithkline, Sun Pharm Inds Ltd, Alkem Labs Ltd, Ani Pharms Inc, Apotex, Aurobindo Pharma Ltd, Fosun Pharma, Lupin, Orchid Hlthcare, Ranbaxy Labs Ltd, and Wockhardt, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.There are sixty-two drug master file entries for cefuroxime axetil. Seventeen suppliers are listed for this compound.
Summary for cefuroxime axetil
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 11 |
| NDAs: | 13 |
| Drug Master File Entries: | 62 |
| Suppliers / Packagers: | 17 |
| Bulk Api Vendors: | 47 |
| Clinical Trials: | 8 |
| Patent Applications: | 4,410 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for cefuroxime axetil |
| DailyMed Link: | cefuroxime axetil at DailyMed |
Recent Clinical Trials for cefuroxime axetil
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Louisville | Phase 0 |
| Julio Ramirez | Phase 0 |
| James Graham Brown Cancer Center | Phase 0 |
Pharmacology for cefuroxime axetil
| Drug Class | Cephalosporin Antibacterial |
US Patents and Regulatory Information for cefuroxime axetil
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lupin | CEFUROXIME AXETIL | cefuroxime axetil | TABLET;ORAL | 065135-001 | Jul 25, 2003 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Glaxosmithkline | CEFTIN | cefuroxime axetil | TABLET;ORAL | 050605-001 | Dec 28, 1987 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Sun Pharm Inds Ltd | CEFUROXIME AXETIL | cefuroxime axetil | TABLET;ORAL | 065118-003 | Apr 25, 2003 | 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 |
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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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