small molecule

ONUREG

AZACITIDINE

Loss of exclusivityJune 2030latest FDA-listed patent expiry
CompanyBRISTOL MYERS SQUIBB CO

Drug detail

Brand nameONUREG
Active ingredientAZACITIDINE
Strength300MG
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalSeptember 2020
Marketing statusRX

Listed patents

PatentExpiresType
8846628June 2030product
12053482May 2029use U-2950
11571436May 2029product

Regulatory exclusivity

CodeExpires
ODE-320September 2027

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.

ONUREG patent cliff — loss of exclusivity June 2030 | CliffBio