small molecule

TEPMETKO

TEPOTINIB HYDROCHLORIDE

Loss of exclusivityMarch 2030latest FDA-listed patent expiry
CompanyEMD SeronoView the full company profile on CliffBio

Drug detail

Brand nameTEPMETKO
Active ingredientTEPOTINIB HYDROCHLORIDE
StrengthEQ 225MG BASE
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalFebruary 2021
Marketing statusRX

Listed patents

PatentExpiresType
8580781March 2030substance, product
8329692October 2029substance, product
8927540July 2028use U-3078
8658643July 2028use U-3077
9403799July 2028use U-3077
9062029July 2028product
8921357May 2028substance, product
9284300April 2028product

Regulatory exclusivity

CodeExpires
ODE-325February 2028
NCEFebruary 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.

TEPMETKO patent cliff — loss of exclusivity March 2030 | CliffBio