CEFPROZIL - Generic Drug Details
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What are the generic drug sources for cefprozil and what is the scope of freedom to operate?
Cefprozil
is the generic ingredient in two branded drugs marketed by Apotex Inc, Aurobindo Pharma, Chartwell Rx, Lupin, Orchid Hlthcare, Ranbaxy Labs Ltd, Sandoz, Corden Pharma, Alkem Labs Ltd, Teva, and Wockhardt, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.There are thirteen drug master file entries for cefprozil. Seven suppliers are listed for this compound.
Summary for CEFPROZIL
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 11 |
| NDAs: | 18 |
| Drug Master File Entries: | 13 |
| Finished Product Suppliers / Packagers: | 7 |
| Raw Ingredient (Bulk) Api Vendors: | 55 |
| Clinical Trials: | 14 |
| Patent Applications: | 6,921 |
| Drug Prices: | Drug price trends for CEFPROZIL |
| What excipients (inactive ingredients) are in CEFPROZIL? | CEFPROZIL excipients list |
| DailyMed Link: | CEFPROZIL at DailyMed |
Recent Clinical Trials for CEFPROZIL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| The Affiliated Hospital of Qingdao University | Phase 1 |
| James Graham Brown Cancer Center | Early Phase 1 |
| Julio Ramirez | Early Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for CEFPROZIL
US Patents and Regulatory Information for CEFPROZIL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ranbaxy Labs Ltd | CEFPROZIL | cefprozil | FOR SUSPENSION;ORAL | 065202-001 | Jun 30, 2006 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Ranbaxy Labs Ltd | CEFPROZIL | cefprozil | TABLET;ORAL | 065198-001 | Dec 13, 2006 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Orchid Hlthcare | CEFPROZIL | cefprozil | TABLET;ORAL | 065267-002 | Dec 19, 2005 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Orchid Hlthcare | CEFPROZIL | cefprozil | TABLET;ORAL | 065267-001 | Dec 19, 2005 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Alkem Labs Ltd | CEFPROZIL | cefprozil | TABLET;ORAL | 090857-001 | Apr 9, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Alkem Labs Ltd | CEFPROZIL | cefprozil | TABLET;ORAL | 090857-002 | Apr 9, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Aurobindo Pharma | CEFPROZIL | cefprozil | FOR SUSPENSION;ORAL | 065381-002 | Jan 30, 2007 | AB | RX | No | 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 |
