small molecule

ZUSDURI

MITOMYCIN

Loss of exclusivityJanuary 2031latest FDA-listed patent expiry
CompanyUroGen PharmaView the full company profile on CliffBio

Drug detail

Brand nameZUSDURI
Active ingredientMITOMYCIN
Strength40MG/VIAL
Dosage formPOWDER
RouteINTRAVESICAL
ModalitySmall molecule
FDA approvalJune 2025
Marketing statusRX

Listed patents

PatentExpiresType
10039832January 2031use U-4256
9950069January 2031product
9040074January 2031product
12440568January 2031use U-4256

Regulatory exclusivity

CodeExpires
NPJune 2028

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.

ZUSDURI patent cliff — loss of exclusivity January 2031 | CliffBio