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
10335388April 2036use U-4565
RE49948September 2034substance, product
9908845September 2034substance, product

Regulatory exclusivity

CodeExpires
I-994June 2029
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.