ORLYNVAH

Growth

sulopenem etzadroxil and probenecid

Iterum Therapeutics
NDAORALTABLETPriority Review
Approved
Oct 2024
Lifecycle
Growth
Competitive Pressure
0/100

Mechanism of Action

etzadroxil, a penem antibacterial drug [see Microbiology ] and probenecid, a renal tubular transport inhibitor. Probenecid inhibits OAT3-mediated renal clearance of sulopenem, resulting in increased plasma concentrations of sulopenem .

Indications (4)

uncomplicated urinary tract infections (uUTI) caused by the designated microorganisms Escherichia coliKlebsiella pneumoniaeProteus mirabilis in adult womenno alternative oral antibacterial treatment options

Loss of Exclusivity

LOE Date
Dec 23, 2039
168 months away
Patent Expiry
Dec 23, 2039
Exclusivity Expiry
Oct 25, 2034

Patent Records (5)

Patent #ExpiryTypeUse Code
7795243
Jun 3, 2029
SubstanceProduct
U-4026
11554112
Apr 1, 2039
U-4026
12109197
Apr 1, 2039
U-4026
11478428
Dec 23, 2039
Product
U-4026
12544337
Dec 23, 2039
Product
U-4026
Company
Iterum Therapeutics
Iterum Therapeutics
DUBLIN 1, Ireland
External Resources
DailyMed
Full prescribing information
FDA Drugs@FDA
FDA approval history
RxNorm
Drug nomenclature & identifiers