← Patent-cliff monitor small molecule DAYBUE TROFINETIDE
Loss of exclusivity January 2043 latest FDA-listed patent expiry
Drug detail Brand name DAYBUE Active ingredient TROFINETIDE Strength 200MG/ML Dosage form SOLUTION Route ORAL Modality Small molecule FDA approval March 2023 Marketing status RX
Listed patents Patent Expires Type 12492167*PED January 2043 — 11827600*PED January 2043 — 12492167 July 2042 substance, product 11827600 July 2042 substance, product 11370755*PED February 2041 — 11370755 August 2040 substance, product 9212204*PED July 2032 — 9212204 January 2032 use U-3556
Regulatory exclusivity Code Expires PED September 2030 ODE-425 March 2030 PED September 2028 NCE March 2028
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.