small molecule

WELIREG

BELZUTIFAN

Loss of exclusivityJune 2042latest FDA-listed patent expiry
CompanyMERCK SHARP AND DOHME CORP A SUB OF MERCK AND CO INC

Drug detail

Brand nameWELIREG
Active ingredientBELZUTIFAN
Strength40MG
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalAugust 2021
Marketing statusRX

Listed patents

PatentExpiresType
12358870June 2042product
RE49948September 2034substance, product
9908845September 2034substance, product

Regulatory exclusivity

CodeExpires
ODE-364August 2028
I-968May 2028
I-931December 2026
NCEAugust 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.

WELIREG patent cliff — loss of exclusivity June 2042 | CliffBio