CEFEPIME HYDROCHLORIDE Drug Patent Profile
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Which patents cover Cefepime Hydrochloride, and what generic alternatives are available?
Cefepime Hydrochloride is a drug marketed by Acs Dobfar, Astral, Fosun Pharma, Hospira Inc, Qilu, Sagent Pharms Inc, and Samson Medcl. and is included in eight NDAs.
The generic ingredient in CEFEPIME HYDROCHLORIDE is cefepime hydrochloride. There are twenty drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the cefepime hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Cefepime Hydrochloride
A generic version of CEFEPIME HYDROCHLORIDE was approved as cefepime hydrochloride by ACS DOBFAR on March 20th, 2008.
Summary for CEFEPIME HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 7 |
| NDAs: | 8 |
| Finished Product Suppliers / Packagers: | 7 |
| Raw Ingredient (Bulk) Api Vendors: | 114 |
| Clinical Trials: | 60 |
| Patent Applications: | 484 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | CEFEPIME HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for CEFEPIME HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Meiji Seika Pharma Co., Ltd. | Phase 3 |
| Linical Co., Ltd. | Phase 2 |
| Allecra | Phase 2 |
Pharmacology for CEFEPIME HYDROCHLORIDE
| Drug Class | Cephalosporin Antibacterial |
Anatomical Therapeutic Chemical (ATC) Classes for CEFEPIME HYDROCHLORIDE
US Patents and Regulatory Information for CEFEPIME HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Acs Dobfar | CEFEPIME HYDROCHLORIDE | cefepime hydrochloride | INJECTABLE;INJECTION | 065441-001 | Mar 20, 2008 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Samson Medcl | CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER | cefepime hydrochloride | POWDER;INTRAVENOUS | 209408-001 | Aug 21, 2018 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Fosun Pharma | CEFEPIME HYDROCHLORIDE | cefepime hydrochloride | INJECTABLE;INJECTION | 090291-001 | Dec 21, 2010 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Astral | CEFEPIME HYDROCHLORIDE | cefepime hydrochloride | INJECTABLE;INJECTION | 212721-002 | Jul 21, 2020 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Hospira Inc | CEFEPIME HYDROCHLORIDE | cefepime hydrochloride | INJECTABLE;INJECTION | 065369-001 | Jun 18, 2007 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
