small molecule

TAFINLAR

DABRAFENIB MESYLATE

Loss of exclusivityFebruary 2034latest FDA-listed patent expiry
CompanyNovartisView the full company profile on CliffBio

Drug detail

Brand nameTAFINLAR
Active ingredientDABRAFENIB MESYLATE
StrengthEQ 75MG BASE
Dosage formCAPSULE
RouteORAL
ModalitySmall molecule
FDA approvalMay 2013
Marketing statusRX

Listed patents

PatentExpiresType
10869869*PEDFebruary 2034
10869869August 2033use U-3185
8952018*PEDApril 2031
8703781*PEDApril 2031
8703781October 2030substance, product
8952018October 2030use U-2027
7994185*PEDJuly 2030
8415345*PEDJuly 2030
8415345January 2030substance, product
7994185January 2030substance, product
9233956*PEDNovember 2029
9233956May 2029use U-2032

Regulatory exclusivity

CodeExpires
PEDSeptember 2030
ODE-428March 2030
PEDSeptember 2026
I-908March 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.

TAFINLAR patent cliff — loss of exclusivity February 2034 | CliffBio