CliffBio
small molecule

HARLIKU

NITISINONE

Loss of exclusivityJune 2032FDA regulatory exclusivity expiry
CompanyCycle Pharmaceuticals →See this company's full patent-cliff portfolio

Drug detail

Brand nameHARLIKU
Active ingredientNITISINONE
Strength2MG
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalJune 2025
Marketing statusRX

Regulatory exclusivity

CodeExpires
ODE-529June 2032

More from Cycle Pharmaceuticals

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

HARLIKU patent cliff — loss of exclusivity June 2032 | CliffBio