← Patent-cliff monitor small molecule HARVONI LEDIPASVIR; SOFOSBUVIR
Loss of exclusivity March 2033 latest FDA-listed patent expiry
Drug detail Brand name HARVONI Active ingredient LEDIPASVIR; SOFOSBUVIR Strength 45MG;200MG/PACKET Dosage form PELLETS Route ORAL Modality Small molecule FDA approval August 2019 Marketing status RX
Listed patents Patent Expires Type 9393256*PED March 2033 — 9393256 September 2032 use U-1470 10456414 September 2032 product 8618076*PED June 2031 — 9284342*PED March 2031 — 8618076 December 2030 substance, product 9511056*PED November 2030 — 8273341*PED November 2030 — 8088368*PED November 2030 — 8841278*PED November 2030 — 8822430*PED November 2030 — 9284342 September 2030 substance, product 8273341 May 2030 use U-1470 9511056 May 2030 use U-1470 8088368 May 2030 substance, product 8841278 May 2030 product 8822430 May 2030 substance, product 8633309*PED September 2029 — 7964580*PED September 2029 — 8889159*PED September 2029 — 7964580 March 2029 substance, product 8889159 March 2029 product 8633309 March 2029 substance, product 9085573*PED September 2028 — 8735372*PED September 2028 — 8580765*PED September 2028 — 8334270*PED September 2028 — 9085573 March 2028 substance, product 8580765 March 2028 substance, product 8735372 March 2028 use U-1470 8334270 March 2028 substance, product
Regulatory exclusivity Code Expires ODE-262 August 2026 ODE-263 August 2026 ODE-264 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.