CliffBio
small molecule

TARPEYO

BUDESONIDE

Loss of exclusivityJanuary 2043latest FDA-listed patent expiry
CompanyCALLIDITAS THERAPEUTICS AB

Drug detail

Brand nameTARPEYO
Active ingredientBUDESONIDE
Strength4MG
Dosage formCAPSULE, DELAYED RELEASE
RouteORAL
ModalitySmall molecule
FDA approvalDecember 2021
Marketing statusRX

Listed patents

PatentExpiresType
11896719January 2043use U-3810
12171882January 2043use U-4086
12311057January 2043product
12171883January 2043product
8491932May 2029product

Regulatory exclusivity

CodeExpires
ODE-464December 2030
ODE-389December 2028

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.

TARPEYO patent cliff — loss of exclusivity January 2043 | CliffBio