# HARVONI — FDA application NDA212477 Informational only - not investment advice. Application NDA212477 · type NDA · FDA status: approved · original approval 2019-08-28 Listed sponsor: GILEAD SCIENCES INC · [GILD company profile](/company/GILD/) · exact_unique Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers. ## FDA application facts | Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 001 | HARVONI | LEDIPASVIR; SOFOSBUVIR | PELLETS | ORAL | 33.75MG;150MG/PACKET | Prescription | not listed | Yes | | 002 | HARVONI | LEDIPASVIR; SOFOSBUVIR | PELLETS | ORAL | 45MG;200MG/PACKET | Prescription | not listed | Yes | ## Orange Book patent and exclusivity listings - Patent 8334270, product 001; listed patent expiry date: 2028-03-21. - Patent 8334270, product 002; listed patent expiry date: 2028-03-21. - Patent 8580765, product 001; listed patent expiry date: 2028-03-21. - Patent 8580765, product 002; listed patent expiry date: 2028-03-21. - Patent 8735372, product 001; listed patent expiry date: 2028-03-21. - Patent 8735372, product 002; listed patent expiry date: 2028-03-21. - Patent 9085573, product 001; listed patent expiry date: 2028-03-21. - Patent 9085573, product 002; listed patent expiry date: 2028-03-21. - Patent 8334270, product 001; listed patent expiry date: 2028-09-21. - Patent 8334270, product 002; listed patent expiry date: 2028-09-21. - Patent 8580765, product 001; listed patent expiry date: 2028-09-21. - Patent 8580765, product 002; listed patent expiry date: 2028-09-21. - Patent 8735372, product 001; listed patent expiry date: 2028-09-21. - Patent 8735372, product 002; listed patent expiry date: 2028-09-21. - Patent 9085573, product 001; listed patent expiry date: 2028-09-21. - Patent 9085573, product 002; listed patent expiry date: 2028-09-21. - Patent 7964580, product 001; listed patent expiry date: 2029-03-26. - Patent 7964580, product 002; listed patent expiry date: 2029-03-26. - Patent 8633309, product 001; listed patent expiry date: 2029-03-26. - Patent 8633309, product 002; listed patent expiry date: 2029-03-26. - Patent 8889159, product 001; listed patent expiry date: 2029-03-26. - Patent 8889159, product 002; listed patent expiry date: 2029-03-26. - Patent 7964580, product 001; listed patent expiry date: 2029-09-26. - Patent 7964580, product 002; listed patent expiry date: 2029-09-26. - Patent 8633309, product 001; listed patent expiry date: 2029-09-26. - Patent 8633309, product 002; listed patent expiry date: 2029-09-26. - Patent 8889159, product 001; listed patent expiry date: 2029-09-26. - Patent 8889159, product 002; listed patent expiry date: 2029-09-26. - Patent 8088368, product 001; listed patent expiry date: 2030-05-12. - Patent 8088368, product 002; listed patent expiry date: 2030-05-12. - Patent 8273341, product 001; listed patent expiry date: 2030-05-12. - Patent 8273341, product 002; listed patent expiry date: 2030-05-12. - Patent 8822430, product 001; listed patent expiry date: 2030-05-12. - Patent 8822430, product 002; listed patent expiry date: 2030-05-12. - Patent 8841278, product 001; listed patent expiry date: 2030-05-12. - Patent 8841278, product 002; listed patent expiry date: 2030-05-12. - Patent 9511056, product 001; listed patent expiry date: 2030-05-12. - Patent 9511056, product 002; listed patent expiry date: 2030-05-12. - Patent 9284342, product 001; listed patent expiry date: 2030-09-13. - Patent 9284342, product 002; listed patent expiry date: 2030-09-13. - Patent 8088368, product 001; listed patent expiry date: 2030-11-12. - Patent 8088368, product 002; listed patent expiry date: 2030-11-12. - Patent 8273341, product 001; listed patent expiry date: 2030-11-12. - Patent 8273341, product 002; listed patent expiry date: 2030-11-12. - Patent 8822430, product 001; listed patent expiry date: 2030-11-12. - Patent 8822430, product 002; listed patent expiry date: 2030-11-12. - Patent 8841278, product 001; listed patent expiry date: 2030-11-12. - Patent 8841278, product 002; listed patent expiry date: 2030-11-12. - Patent 9511056, product 001; listed patent expiry date: 2030-11-12. - Patent 9511056, product 002; listed patent expiry date: 2030-11-12. - Patent 8618076, product 001; listed patent expiry date: 2030-12-11. - Patent 8618076, product 002; listed patent expiry date: 2030-12-11. - Patent 9284342, product 001; listed patent expiry date: 2031-03-13. - Patent 9284342, product 002; listed patent expiry date: 2031-03-13. - Patent 8618076, product 001; listed patent expiry date: 2031-06-11. - Patent 8618076, product 002; listed patent expiry date: 2031-06-11. - Patent 10456414, product 001; listed patent expiry date: 2032-09-14. - Patent 10456414, product 002; listed patent expiry date: 2032-09-14. - Patent 9393256, product 001; listed patent expiry date: 2032-09-14. - Patent 9393256, product 002; listed patent expiry date: 2032-09-14. - Patent 9393256, product 001; listed patent expiry date: 2033-03-14. - Patent 9393256, product 002; listed patent expiry date: 2033-03-14. - Exclusivity ODE-262, product 001; listed exclusivity date: 2026-08-28. - Exclusivity ODE-262, product 002; listed exclusivity date: 2026-08-28. - Exclusivity ODE-263, product 001; listed exclusivity date: 2026-08-28. - Exclusivity ODE-263, product 002; listed exclusivity date: 2026-08-28. - Exclusivity ODE-264, product 001; listed exclusivity date: 2026-08-28. - Exclusivity ODE-264, product 002; listed exclusivity date: 2026-08-28. Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied. ## Compound cross-links - LEDIPASVIR · UNII 013TE6E4WV · no lmmol compound match - SOFOSBUVIR · UNII WJ6CA3ZU8B · no lmmol compound match Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link. ## Related pages - [Sponsor company](/company/GILD/) - [FDA-approved application index](/drug/) - [Large-cap biopharma](/compare/pharma/) Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA212477. FDA data retrieved 2026-08-07. Regulatory listing data as published by FDA; not medical or investment advice.