small molecule

GILOTRIF

AFATINIB DIMALEATE

Loss of exclusivityJanuary 2031latest FDA-listed patent expiry
CompanyBoehringer IngelheimSee this company's full patent-cliff portfolio

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