Generic competition · all medicines · read 12 November 2026
Is there a generic of Ledipasvir; Sofosbuvir, and who makes it?
Ledipasvir; Sofosbuvir appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed. 2 groups have a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming. This is the Orange Book's listing, not a forecast.
Compiled and checked by Vincent Wesley Couey (ORCID 0009-0005-6869-308X) from the Orange Book data files, downloaded 12 November 2026.
- Ledipasvir; Sofosbuvir appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed.
- 2 groups have a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming.
- Patents and exclusivities are shown as listed by the application holder; the Orange Book does not rule on them, and a listed patent is not a statement that a generic is blocked. This says nothing about price, supply or quality.
Pellets, Oral
Brand listed, no generic listed as marketed
Brand listed as marketed: Harvoni. No generic is listed as marketed.
Patents and exclusivities still listed
- 21 March 2028Patent 8580765 drug substance
- 21 March 2028Patent 8334270 drug substance
- 21 March 2028Patent 8735372
- 21 March 2028Patent 9085573 drug substance
- 21 September 2028Patent 8580765*PED
- 21 September 2028Patent 8334270*PED
- 21 September 2028Patent 8735372*PED
- 21 September 2028Patent 9085573*PED
23 more patents are listed.
Tablet, Oral
Brand listed, no generic listed as marketed
Brand listed as marketed: Harvoni. No generic is listed as marketed.
Patents and exclusivities still listed
- 21 March 2028Patent 8334270 drug substance
- 21 March 2028Patent 8580765 drug substance
- 21 March 2028Patent 8735372
- 21 March 2028Patent 9085573 drug substance
- 21 September 2028Patent 8334270*PED
- 21 September 2028Patent 8580765*PED
- 21 September 2028Patent 8735372*PED
- 21 September 2028Patent 9085573*PED
25 more patents are listed.
US Food and Drug Administration, Orange Book data files, downloaded 12 November 2026. A listed patent is not a ruling that a generic is blocked, and no figure here says anything about price, supply or quality. Check the Orange Book.
Where can you go from this result?
Open it in the check to search another medicine, or see every brand with no generic listed. The FDA explains generic approval in how generic drugs are approved and the FDA generic drug facts, and the Orange Book itself is the FDA Orange Book. To check what is available now, ask your pharmacist, and see the FDA drug shortages page.