small molecule

PIXCLARA

FLORETYROSINE F-18

Loss of exclusivitySeptember 2031FDA regulatory exclusivity expiry
CompanyTELIX PHARMACEUTICALS US INC

Drug detail

Brand namePIXCLARA
Active ingredientFLORETYROSINE F-18
Strength5-300mCi/ML
Dosage formSOLUTION
RouteINTRAVENOUS
ModalitySmall molecule
FDA approvalSeptember 2026
Marketing statusRX

Regulatory exclusivity

CodeExpires
NCESeptember 2031

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