CliffBio
small molecule

BYDUREON BCISE

EXENATIDE SYNTHETIC

Loss of exclusivityApril 2031latest FDA-listed patent expiry
CompanyASTRAZENECA AB

Drug detail

Brand nameBYDUREON BCISE
Active ingredientEXENATIDE SYNTHETIC
Strength2MG/0.85ML (2MG/0.85ML)
Dosage formSUSPENSION, EXTENDED RELEASE
RouteSUBCUTANEOUS
ModalitySmall molecule
FDA approvalOctober 2017
Marketing statusDISCN

Listed patents

PatentExpiresType
8895033*PEDApril 2031—
8895033October 2030product
8361972*PEDSeptember 2028—
8361972March 2028use U-2588
8501698*PEDDecember 2027—
8501698June 2027use U-2588
8906851*PEDFebruary 2027—
9884092*PEDFebruary 2027—
8329648*PEDFebruary 2027—
9884092August 2026use U-3189
8906851August 2026use U-3190
8329648August 2026use U-3190
6515117*PEDApril 2026—
6515117October 2025substance, product

More from ASTRAZENECA AB

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 BCISE patent cliff — loss of exclusivity April 2031 | CliffBio