← Patent-cliff monitor small molecule DIFICID FIDAXOMICIN
Loss of exclusivity November 2034 latest FDA-listed patent expiry
Drug detail Brand name DIFICID Active ingredient FIDAXOMICIN Strength 40MG/ML Dosage form FOR SUSPENSION Route ORAL Modality Small molecule FDA approval January 2020 Marketing status RX
Listed patents Patent Expires Type 9808530*PED November 2034 — 9808530 May 2034 product 8859510*PED January 2028 — 7378508*PED January 2028 — 7863249*PED January 2028 — 7906489*PED September 2027 — 8859510 July 2027 use U-2741 7863249 July 2027 product 7378508 July 2027 substance, product 7906489 March 2027 use U-2741
Regulatory exclusivity Code Expires ODE-367 January 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.