small molecule

DIFICID

FIDAXOMICIN

Loss of exclusivityJanuary 2028latest FDA-listed patent expiry
CompanyCubist PharmaceuticalsSee this company's full patent-cliff portfolio

Drug detail

Brand nameDIFICID
Active ingredientFIDAXOMICIN
Strength200MG
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalMay 2011
Marketing statusRX

Listed patents

PatentExpiresType
8859510*PEDJanuary 2028
7378508*PEDJanuary 2028
7863249*PEDJanuary 2028
7906489*PEDSeptember 2027
7863249July 2027substance, product
8859510July 2027use U-2741
7378508July 2027substance, product
7906489March 2027use U-2741

Regulatory exclusivity

CodeExpires
ODE-367January 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.

DIFICID patent cliff — loss of exclusivity January 2028 | CliffBio