CEFUROXIME AXETIL - Generic Drug Details
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What are the generic drug 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, Anda Repository, Ani Pharms, Apotex, Aurobindo Pharma, Chartwell Rx, Fosun Pharma, Lupin, and Ranbaxy Labs Ltd, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.There are thirty drug master file entries for cefuroxime axetil. Sixteen suppliers are listed for this compound.
Summary for CEFUROXIME AXETIL
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 11 |
NDAs: | 13 |
Drug Master File Entries: | 30 |
Finished Product Suppliers / Packagers: | 16 |
Raw Ingredient (Bulk) Api Vendors: | 105 |
Clinical Trials: | 8 |
Patent Applications: | 5,701 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for CEFUROXIME AXETIL |
What excipients (inactive ingredients) are in CEFUROXIME AXETIL? | CEFUROXIME AXETIL excipients list |
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 | Early Phase 1 |
James Graham Brown Cancer Center | Early Phase 1 |
Julio Ramirez | Early Phase 1 |
Pharmacology for CEFUROXIME AXETIL
Drug Class | Cephalosporin Antibacterial |
Anatomical Therapeutic Chemical (ATC) Classes for CEFUROXIME AXETIL
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Chartwell Rx | CEFUROXIME AXETIL | cefuroxime axetil | TABLET;ORAL | 065166-003 | Jul 29, 2005 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Ranbaxy Labs Ltd | CEFUROXIME AXETIL | cefuroxime axetil | TABLET;ORAL | 065043-003 | Feb 15, 2002 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Apotex | CEFUROXIME AXETIL | cefuroxime axetil | TABLET;ORAL | 065069-001 | Oct 2, 2002 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Glaxosmithkline | CEFTIN | cefuroxime axetil | TABLET;ORAL | 050605-001 | Dec 28, 1987 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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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