small molecule

TUKYSA

TUCATINIB

Loss of exclusivityApril 2038latest FDA-listed patent expiry
CompanySeagenView the full company profile on CliffBio

Drug detail

Brand nameTUKYSA
Active ingredientTUCATINIB
Strength50MG
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalApril 2020
Marketing statusRX

Listed patents

PatentExpiresType
11207324April 2038use U-3783
11666572April 2038use U-3783
12048698April 2038use U-3783
8648087April 2034substance, product
11504370March 2033use U-2788
9457093October 2032product
9693989May 2027product

Regulatory exclusivity

CodeExpires
ODE-422January 2030
ODE-309April 2027
I-906January 2026

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.

TUKYSA patent cliff — loss of exclusivity April 2038 | CliffBio