CEFEPIME HYDROCHLORIDE; ENMETAZOBACTAM - Generic Drug Details
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What are the generic sources for cefepime hydrochloride; enmetazobactam and what is the scope of freedom to operate?
Cefepime hydrochloride; enmetazobactam
is the generic ingredient in one branded drug marketed by Allecra Theraps and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Cefepime hydrochloride; enmetazobactam has twenty-five patent family members in eighteen countries.
Summary for CEFEPIME HYDROCHLORIDE; ENMETAZOBACTAM
| International Patents: | 25 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Clinical Trials: | 1 |
| DailyMed Link: | CEFEPIME HYDROCHLORIDE; ENMETAZOBACTAM at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for CEFEPIME HYDROCHLORIDE; ENMETAZOBACTAM
Generic Entry Date for CEFEPIME HYDROCHLORIDE; ENMETAZOBACTAM*:
Constraining patent/regulatory exclusivity:
GENERATING ANTIBIOTIC INCENTIVES NOW Dosage:
POWDER;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for CEFEPIME HYDROCHLORIDE; ENMETAZOBACTAM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Allecra | Phase 2 |
| Linical Co., Ltd. | Phase 2 |
See all CEFEPIME HYDROCHLORIDE; ENMETAZOBACTAM clinical trials
Anatomical Therapeutic Chemical (ATC) Classes for CEFEPIME HYDROCHLORIDE; ENMETAZOBACTAM
US Patents and Regulatory Information for CEFEPIME HYDROCHLORIDE; ENMETAZOBACTAM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Allecra Theraps | EXBLIFEP | cefepime hydrochloride; enmetazobactam | POWDER;INTRAVENOUS | 216165-001 | Feb 22, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Allecra Theraps | EXBLIFEP | cefepime hydrochloride; enmetazobactam | POWDER;INTRAVENOUS | 216165-001 | Feb 22, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Allecra Theraps | EXBLIFEP | cefepime hydrochloride; enmetazobactam | POWDER;INTRAVENOUS | 216165-001 | Feb 22, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Allecra Theraps | EXBLIFEP | cefepime hydrochloride; enmetazobactam | POWDER;INTRAVENOUS | 216165-001 | Feb 22, 2024 | RX | Yes | Yes | ⤷ 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 |
International Patents for CEFEPIME HYDROCHLORIDE; ENMETAZOBACTAM
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| United Kingdom | 201319776 | ⤷ Sign Up | |
| Mexico | 2016005869 | INHIBIDOR DE BETA-LACTAMASA CRISTALINA. (CRYSTALLINE BETA-LACTAMASE INHIBITOR.) | ⤷ Sign Up |
| Chile | 2016001097 | Inhibidor de beta-lactamasa cristalina | ⤷ Sign Up |
| Peru | 20160890 | INHIBIDOR DE BETA-LACTAMASA CRISTALINA | ⤷ Sign Up |
| China | 105873935 | 结晶的β-内酰胺酶抑配制品 (Crystalline beta-lactamase inhibitor) | ⤷ Sign Up |
| Australia | 2014345507 | Crystalline beta-lactamase inhibitor | ⤷ Sign Up |
| Spain | 2427122 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
