small molecule

XTANDI

ENZALUTAMIDE

Loss of exclusivityFebruary 2037latest FDA-listed patent expiry
CompanyAstellas Pharma UsView the full company profile on CliffBio

Drug detail

Brand nameXTANDI
Active ingredientENZALUTAMIDE
Strength40MG
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalAugust 2020
Marketing statusRX

Listed patents

PatentExpiresType
12161628February 2037use U-4104
12502357September 2033use U-4365
11839689September 2033product
7709517August 2027substance, product
8183274August 2026use U-3763
9126941May 2026use U-3763

Regulatory exclusivity

CodeExpires
I-926November 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.

XTANDI patent cliff — loss of exclusivity February 2037 | CliffBio