small molecule

LUPRON DEPOT-PED KIT

LEUPROLIDE ACETATE

Loss of exclusivityFebruary 2031latest FDA-listed patent expiry
CompanyABBVIE ENDOCRINE INC

Drug detail

Brand nameLUPRON DEPOT-PED KIT
Active ingredientLEUPROLIDE ACETATE
Strength45MG
Dosage formPOWDER
RouteINTRAMUSCULAR
ModalitySmall molecule
FDA approvalApril 2023
Marketing statusRX

Listed patents

PatentExpiresType
8921326February 2031product
9617303March 2028use U-3611

Regulatory exclusivity

CodeExpires
NSApril 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.

LUPRON DEPOT-PED KIT patent cliff — loss of exclusivity February 2031 | CliffBio