small molecule

CRESEMBA

ISAVUCONAZONIUM SULFATE

Loss of exclusivityJune 2031FDA regulatory exclusivity expiry

CompanyAstellas Pharma Us →View the full company profile on CliffBio

Drug detail

Brand name	CRESEMBA
Active ingredient	ISAVUCONAZONIUM SULFATE
Strength	74.5MG
Dosage form	CAPSULE
Route	ORAL
Modality	Small molecule
FDA approval	November 2022
Marketing status	RX

Listed patents

Patent	Expires	Type
10603280*PED	March 2028	—
10206879*PED	March 2028	—
10603280	September 2027	product
10206879	September 2027	product
6812238*PED	April 2026	—
6812238	October 2025	substance

Regulatory exclusivity

Code	Expires
PED	June 2031
ODE-458	December 2030
ODE-454	December 2030
GAIN	September 2027
PED	June 2027
NPP	December 2026
PED	September 2022
ODE*	March 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.

Drug detail

Listed patents

Regulatory exclusivity

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