Details for New Drug Application (NDA): 216165

NDA 216165 describes EXBLIFEP, which is a drug marketed by Allecra Theraps and is included in one NDA. 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. 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

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.

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	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:	11,124,526	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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