← Patent-cliff monitor small molecule HARVONI LEDIPASVIR; SOFOSBUVIR
Loss of exclusivity July 2034 latest FDA-listed patent expiry
Drug detail Brand name HARVONI Active ingredient LEDIPASVIR; SOFOSBUVIR Strength 45MG;200MG Dosage form TABLET Route ORAL Modality Small molecule FDA approval August 2019 Marketing status RX
Listed patents Patent Expires Type 10039779*PED July 2034 — 10039779 January 2034 substance, product 9393256*PED March 2033 — 10456414 September 2032 product 9393256 September 2032 use U-1470 8618076*PED June 2031 — 9284342*PED March 2031 — 8618076 December 2030 substance, product 8273341*PED November 2030 — 8088368*PED November 2030 — 8841278*PED November 2030 — 8822430*PED November 2030 — 9511056*PED November 2030 — 9284342 September 2030 substance, product 8841278 May 2030 product 8088368 May 2030 substance, product 8273341 May 2030 use U-1470 9511056 May 2030 use U-1470 8822430 May 2030 substance, product 8633309*PED September 2029 — 7964580*PED September 2029 — 8889159*PED September 2029 — 8889159 March 2029 product 8633309 March 2029 substance, product 7964580 March 2029 substance, product 8735372*PED September 2028 — 8580765*PED September 2028 — 9085573*PED September 2028 — 8334270*PED September 2028 — 9085573 March 2028 substance, product 8735372 March 2028 use U-1470 8580765 March 2028 substance, product 8334270 March 2028 substance, product
Regulatory exclusivity Code Expires ODE* August 2026
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.