small molecule

ORLYNVAH

PROBENECID; SULOPENEM ETZADROXIL

Loss of exclusivityDecember 2039latest FDA-listed patent expiry
CompanyIterum TherapeuticsView the full company profile on CliffBio

Drug detail

Brand nameORLYNVAH
Active ingredientPROBENECID; SULOPENEM ETZADROXIL
Strength500MG;500MG
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalOctober 2024
Marketing statusRX

Listed patents

PatentExpiresType
12544337December 2039product
11478428December 2039product
12109197April 2039use U-4026
11554112April 2039use U-4026
7795243June 2029substance, product

Regulatory exclusivity

CodeExpires
GAINOctober 2034
NCEOctober 2029

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.

ORLYNVAH patent cliff — loss of exclusivity December 2039 | CliffBio