CliffBio
small molecule

CRESEMBA

ISAVUCONAZONIUM SULFATE

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

Drug detail

Brand nameCRESEMBA
Active ingredientISAVUCONAZONIUM SULFATE
Strength186MG
Dosage formCAPSULE
RouteORAL
ModalitySmall molecule
FDA approvalMarch 2015
Marketing statusRX

Listed patents

PatentExpiresType
10603280*PEDMarch 2028—
10206879*PEDMarch 2028—
10206879September 2027product
10603280September 2027product
6812238*PEDApril 2026—
6812238October 2025substance

Regulatory exclusivity

CodeExpires
PEDJune 2031
ODE-454December 2030
ODE-458December 2030
GAINSeptember 2027
PEDJune 2027
NPPDecember 2026
PEDSeptember 2022
ODE-90March 2022
ODE-305March 2022

More from Astellas Pharma Us

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