small molecule

DIFICID

FIDAXOMICIN

Loss of exclusivityNovember 2034latest FDA-listed patent expiry
CompanyCubist PharmaceuticalsView the full company profile on CliffBio

Drug detail

Brand nameDIFICID
Active ingredientFIDAXOMICIN
Strength40MG/ML
Dosage formFOR SUSPENSION
RouteORAL
ModalitySmall molecule
FDA approvalJanuary 2020
Marketing statusRX

Listed patents

PatentExpiresType
9808530*PEDNovember 2034
9808530May 2034product
8859510*PEDJanuary 2028
7378508*PEDJanuary 2028
7863249*PEDJanuary 2028
7906489*PEDSeptember 2027
8859510July 2027use U-2741
7863249July 2027product
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 November 2034 | CliffBio