small molecule

BYDUREON

EXENATIDE SYNTHETIC

Loss of exclusivitySeptember 2028latest FDA-listed patent expiry
CompanyASTRAZENECA AB

Drug detail

Brand nameBYDUREON
Active ingredientEXENATIDE SYNTHETIC
Strength2MG/VIAL
Dosage formFOR SUSPENSION, EXTENDED RELEASE
RouteSUBCUTANEOUS
ModalitySmall molecule
FDA approvalJanuary 2012
Marketing statusDISCN

Listed patents

PatentExpiresType
8361972*PEDSeptember 2028
8361972March 2028use U-2588
8501698*PEDDecember 2027
8501698June 2027product
9884092*PEDFebruary 2027
8329648*PEDFebruary 2027
8906851*PEDFebruary 2027
8906851August 2026use U-3188
8329648August 2026use U-3190
9884092August 2026use U-3188
6515117*PEDApril 2026
6515117October 2025substance, product

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.

BYDUREON patent cliff — loss of exclusivity September 2028 | CliffBio