small molecule

COTELLIC

COBIMETINIB FUMARATE

Loss of exclusivityDecember 2036latest FDA-listed patent expiry
CompanyGenentechView the full company profile on CliffBio

Drug detail

Brand nameCOTELLIC
Active ingredientCOBIMETINIB FUMARATE
StrengthEQ 20MG BASE
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalNovember 2015
Marketing statusRX

Listed patents

PatentExpiresType
11254649*PEDDecember 2036
10590102*PEDDecember 2036
10478400*PEDDecember 2036
10590102June 2036substance, product
11254649June 2036substance, product
10478400June 2036substance, product
11087354*PEDDecember 2034
11087354June 2034use U-1776
7803839*PEDMay 2030
7803839November 2029substance, product
8362002*PEDApril 2027
8362002October 2026use U-1776
11597699October 2026use U-3554

Regulatory exclusivity

CodeExpires
ODE-416October 2029
PEDJanuary 2026
M-278July 2025

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.

COTELLIC patent cliff — loss of exclusivity December 2036 | CliffBio