small molecule

CRESEMBA

ISAVUCONAZONIUM SULFATE

Loss of exclusivityJune 2031FDA regulatory exclusivity expiry
CompanyAstellas Pharma UsSee this company's full patent-cliff portfolio

Drug detail

Brand nameCRESEMBA
Active ingredientISAVUCONAZONIUM SULFATE
Strength372MG
Dosage formPOWDER
RouteINTRAVENOUS
ModalitySmall molecule
FDA approvalMarch 2015
Marketing statusRX

Listed patents

PatentExpiresType
6812238*PEDApril 2026
6812238October 2025substance

Regulatory exclusivity

CodeExpires
PEDJune 2031
ODE-453December 2030
ODE-459December 2030
GAINSeptember 2027
PEDJune 2027
NPPDecember 2026
PEDSeptember 2022
ODE-90March 2022
ODE-305March 2022

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the FDA regulatory exclusivity expiry; estimates are projections, not legal advice.

CRESEMBA patent cliff — loss of exclusivity June 2031 | CliffBio