CliffBio
small molecule

MEKINIST

TRAMETINIB DIMETHYL SULFOXIDE

Loss of exclusivityApril 2031latest FDA-listed patent expiry
CompanyNovartis →View the full company profile on CliffBio

Drug detail

Brand nameMEKINIST
Active ingredientTRAMETINIB DIMETHYL SULFOXIDE
StrengthEQ 0.05MG BASE/ML
Dosage formSOLUTION
RouteORAL
ModalitySmall molecule
FDA approvalMarch 2023
Marketing statusRX

Listed patents

PatentExpiresType
8703781*PEDApril 2031—
8703781October 2030substance, product
7378423*PEDNovember 2027—
7378423May 2027substance, product

Regulatory exclusivity

CodeExpires
PEDSeptember 2030
ODE-428March 2030
PEDSeptember 2026
NPMarch 2026

More from Novartis

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 April 2031 | CliffBio