small molecule

GILOTRIF

AFATINIB DIMALEATE

Loss of exclusivityJanuary 2031latest FDA-listed patent expiry
CompanyBoehringer IngelheimView the full company profile on CliffBio

Drug detail

Brand nameGILOTRIF
Active ingredientAFATINIB DIMALEATE
StrengthEQ 20MG BASE
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalJuly 2013
Marketing statusRX

Listed patents

PatentExpiresType
10004743*PEDJanuary 2031
10004743July 2030product
8545884*PEDJune 2030
8426586*PEDApril 2030
8545884December 2029product
8426586October 2029substance
9539258*PEDMay 2027
9539258November 2026use U-1950
RE43431*PEDJuly 2026
RE43431January 2026substance

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.

GILOTRIF patent cliff — loss of exclusivity January 2031 | CliffBio