CliffBio
small molecule

ZTALMY

GANAXOLONE

Loss of exclusivitySeptember 2042latest FDA-listed patent expiry
CompanyIMMEDICA PHARMA AB

Drug detail

Brand nameZTALMY
Active ingredientGANAXOLONE
Strength50MG/ML
Dosage formSUSPENSION
RouteORAL
ModalitySmall molecule
FDA approvalJune 2022
Marketing statusRX

Listed patents

PatentExpiresType
12115169September 2042use U-3374
12268696September 2042use U-3374
10603308August 2037use U-3374
12144801August 2037use U-4034
8318714November 2031product
9056116November 2026use U-3374
7858609November 2026product
8022054November 2026product
8367651November 2026product
9029355November 2026product
8618087November 2026use U-3374

Regulatory exclusivity

CodeExpires
ODE-395June 2029
D-197October 2028
NCEJune 2027

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the latest FDA-listed patent expiry; estimates are projections, not legal advice.