small molecule

UTEBZI

TEBIPENEM PIVOXIL HYDROBROMIDE

Loss of exclusivityFebruary 2038latest FDA-listed patent expiry
CompanyGLAXOSMITHKLINE LLC

Drug detail

Brand nameUTEBZI
Active ingredientTEBIPENEM PIVOXIL HYDROBROMIDE
StrengthEQ 300MG BASE
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalJune 2026
Marketing statusRX

Listed patents

PatentExpiresType
10889587February 2038substance, product
12226403December 2037product

Regulatory exclusivity

CodeExpires
GAINJune 2036
NCEJune 2031

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the latest FDA-listed patent expiry; estimates are projections, not legal advice.

UTEBZI patent cliff — loss of exclusivity February 2038 | CliffBio