EXBLIFEP
Growthcefepime hydrochloride; enmetazobactam
NDAINTRAVENOUSPOWDERPriority Review
Approved
Feb 2024
Lifecycle
Growth
Competitive Pressure
0/100
Mechanism of Action
[ See Microbiology ( ].
Indications (18)
the treatment of pneumonia (moderate to severe) caused by susceptible strains of Streptococcus pneumoniaeincluding cases associated with concurrent bacteremiaPseudomonas aeruginosaKlebsiella pneumoniaeEnterobacter speciesthe treatment of uncomplicatedcomplicated urinary tract infections (including pyelonephritis) caused by susceptible isolates of Escherichia colithe infection is severecaused by Escherichia coliProteus mirabilisthe infection is mild to moderateincluding cases associated with concurrent bacteremia with these bacteriathe treatment of uncomplicated skinskin structure infections caused by Staphylococcus aureus (methicillin-susceptible isolates only)Streptococcus pyogenesthe treatment of complicated intra-abdominal infections (used in combination with metronidazole) in adults caused by susceptible isolates of Escherichia coliviridans group streptococciBacteroides fragilis [ see Clinical Studies () ]
Loss of Exclusivity
LOE Date
Nov 7, 2034
105 months away
Patent Expiry
Nov 7, 2034
Exclusivity Expiry
Feb 22, 2034