small molecule

MEKINIST

TRAMETINIB DIMETHYL SULFOXIDE

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

Drug detail

Brand nameMEKINIST
Active ingredientTRAMETINIB DIMETHYL SULFOXIDE
StrengthEQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalMay 2013
Marketing statusDISCN

Listed patents

PatentExpiresType
10869869*PEDFebruary 2034
10869869August 2033use U-3184
9155706*PEDJuly 2032
9399021*PEDJuly 2032
8580304*PEDJuly 2032
9271941*PEDJuly 2032
9399021January 2032product
8580304January 2032product
9155706January 2032product
9271941January 2032product
8952018*PEDApril 2031
8703781*PEDApril 2031
8952018October 2030use U-2020
8703781October 2030substance, product
7378423*PEDNovember 2027
7378423May 2027substance, product

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.

MEKINIST patent cliff — loss of exclusivity February 2034 | CliffBio