CliffBio
small molecule

DUVYZAT

GIVINOSTAT HYDROCHLORIDE

Loss of exclusivityMay 2040latest FDA-listed patent expiry
CompanyITALFARMACO SPA

Drug detail

Brand nameDUVYZAT
Active ingredientGIVINOSTAT HYDROCHLORIDE
StrengthEQ 8.86MG BASE/ML
Dosage formSUSPENSION
RouteORAL
ModalitySmall molecule
FDA approvalMarch 2024
Marketing statusRX

Listed patents

PatentExpiresType
12606519May 2040substance, product
10688047October 2036product
9421184February 2032use U-3885
9867799February 2032use U-3885
7329689January 2027substance, product

Regulatory exclusivity

CodeExpires
ODE-473March 2031
NCEMarch 2029

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.

DUVYZAT patent cliff — loss of exclusivity May 2040 | CliffBio