Details for New Drug Application (NDA): 216165
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NDA 216165 describes EXBLIFEP, which is a drug marketed by Allecra Theraps and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the EXBLIFEP profile page.
The generic ingredient in EXBLIFEP is cefepime hydrochloride; enmetazobactam. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cefepime hydrochloride; enmetazobactam profile page.
The generic ingredient in EXBLIFEP is cefepime hydrochloride; enmetazobactam. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cefepime hydrochloride; enmetazobactam profile page.
Summary for 216165
| Tradename: | EXBLIFEP |
| Applicant: | Allecra Theraps |
| Ingredient: | cefepime hydrochloride; enmetazobactam |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 216165
Generic Entry Date for 216165*:
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.
Pharmacology for NDA: 216165
Suppliers and Packaging for NDA: 216165
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EXBLIFEP | cefepime hydrochloride; enmetazobactam | POWDER;INTRAVENOUS | 216165 | NDA | Allecra Therapeutics SAS | 83289-101 | 83289-101-02 | 10 VIAL, SINGLE-DOSE in 1 CARTON (83289-101-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 2GM BASE/VIAL;0.5GM/VIAL | ||||
| Approval Date: | Feb 22, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 22, 2034 | ||||||||
| Regulatory Exclusivity Use: | GENERATING ANTIBIOTIC INCENTIVES NOW | ||||||||
| Regulatory Exclusivity Expiration: | Feb 22, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Nov 7, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | USE OF SPECIFIED POLYMORPHS OF EXBLIFEP (CEFEPIME AND ENMETAZOBACTAM) FOR TREATING COMPLICATED URINARY TRACT INFECTIONS (CUTI) INCLUDING PYELONEPHRITIS CAUSED BY DESIGNATED SUSCEPTIBLE MICROORGANISMS | ||||||||
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