Harvoni(ledipasvir)
Harvoni (ledipasvir) is a small molecule pharmaceutical. Ledipasvir was first approved as Harvoni on 2014-10-10. It is used to treat chronic hepatitis c and hepatitis c in the USA. It has been approved in Europe to treat chronic hepatitis c.
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Commercial
Therapeutic Areas
Trade Name
FDA
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Combinations
Harvoni
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ledipasvir
+
Sofosbuvir
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| HARVONI | Gilead Sciences | N-205834 RX | 2014-10-10 | 2 products, RLD, RS |
| HARVONI | Gilead Sciences | N-212477 RX | 2019-08-28 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| harvoni | New Drug Application | 2024-12-26 |
| harvoni access | Export only | 2021-06-25 |
| ledipasvir and sofosbuvir | NDA authorized generic | 2025-01-10 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hepatitis c | — | D006526 | B19.2 |
| chronic hepatitis c | EFO_0004220 | D019698 | B18.2 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
LEDIPASVIR / SOFOSBUVIR, HARVONI, GILEAD SCIENCES INC | |||
| 2026-08-28 | ODE*, ODE-262, ODE-263, ODE-264 | ||
| 2024-10-07 | PED | ||
| 2024-04-07 | ODE*, ODE-136 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Ledipasvir / Sofosbuvir, Harvoni, Gilead Sciences Inc | |||
| 10039779 | 2034-01-30 | DS, DP | U-1470, U-2369, U-2370 |
| 9393256 | 2032-09-14 | U-1470 | |
| 10456414 | 2032-09-14 | DP | |
| 8618076 | 2030-12-11 | DS, DP | U-1470 |
| 9284342 | 2030-09-13 | DS, DP | U-1470 |
| 8088368 | 2030-05-12 | DS, DP | |
| 8273341 | 2030-05-12 | U-1470 | |
| 8822430 | 2030-05-12 | DS, DP | U-1470 |
| 8841278 | 2030-05-12 | DP | U-1470 |
| 9511056 | 2030-05-12 | DP | U-1470 |
| 7964580 | 2029-03-26 | DS, DP | U-1470 |
| 8633309 | 2029-03-26 | DS, DP | U-1470 |
| 8889159 | 2029-03-26 | DP | U-1470 |
| 8334270 | 2028-03-21 | DS, DP | U-1470 |
| 8580765 | 2028-03-21 | DS, DP | U-1470 |
| 8735372 | 2028-03-21 | U-1470 | |
| 9085573 | 2028-03-21 | DS, DP | U-1470 |
HCPCS
No data
Clinical
Clinical Trials
137 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatitis c | D006526 | — | B19.2 | 2 | 31 | 15 | 5 | 8 | 60 |
| Hepatitis | D006505 | — | K75.9 | 2 | 17 | 11 | 4 | 8 | 41 |
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | — | 14 | 7 | 4 | 6 | 31 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | 1 | 12 | 3 | 3 | 7 | 25 |
| Thalassemia | D013789 | EFO_1001996 | D56 | — | — | — | 1 | — | 1 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | — | 1 | — | 1 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | — | — | 1 | — | 1 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | — | — | 1 | — | 1 |
| Interstitial lung diseases | D017563 | EFO_0004244 | J84.9 | — | — | — | 1 | — | 1 |
| Autoimmune diseases | D001327 | EFO_0000540 | M30-M36 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | 1 | 15 | 7 | — | 2 | 25 |
| Communicable diseases | D003141 | — | — | — | 11 | 6 | — | 2 | 19 |
| Hepatitis b | D006509 | — | — | — | 10 | 5 | — | 2 | 17 |
| Virus diseases | D014777 | — | B34 | — | 6 | 1 | — | — | 6 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | 2 | — | 1 | 4 |
| Coinfection | D060085 | — | — | — | 1 | 3 | — | — | 4 |
| Hiv | D006678 | — | O98.7 | — | — | 2 | — | 1 | 3 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | — | 1 | 1 | — | 1 | 3 |
| Hepacivirus | D016174 | — | — | — | — | 1 | — | 1 | 2 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | 1 | — | 1 | 2 |
Show 2 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic hepatitis | D006521 | — | K73.9 | — | 2 | — | — | 1 | 3 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | 2 | — | — | — | 2 |
| Chronic hepatitis b | D019694 | EFO_0004239 | B18.1 | — | 1 | — | — | — | 1 |
| Blood coagulation disorders | D001778 | EFO_0009314 | D68.9 | — | 1 | — | — | — | 1 |
| Hemostatic disorders | D020141 | — | — | — | 1 | — | — | — | 1 |
| Renal insufficiency | D051437 | — | N19 | — | 1 | — | — | — | 1 |
| Herpesviridae infections | D006566 | EFO_0007309 | B00.4 | — | 1 | — | — | — | 1 |
| Porphyria cutanea tarda | D017119 | — | E80.1 | — | 1 | — | — | — | 1 |
| Erythropoietic porphyria | D017092 | — | — | — | 1 | — | — | — | 1 |
| Porphyrias | D011164 | EFO_0000665 | — | — | 1 | — | — | — | 1 |
Show 3 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Ledipasvir |
| INN | ledipasvir |
| Description | Ledipasvir is a benzimidazole derivative that is used in combination with sofosbuvir (under the trade name Harvoni) for the treatment of chronic hepatitis C genotype 1 infection. It has a role as an antiviral drug and a hepatitis C protease inhibitor. It is a carbamate ester, a L-valine derivative, a bridged compound, a carboxamide, a benzimidazole, a member of fluorenes, an organofluorine compound, a member of imidazoles, a N-acylpyrrolidine and an azaspiro compound. |
| Classification | Small molecule |
| Drug class | antivirals: nonstructural protein 5A (NS5A) inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | COC(=O)N[C@H](C(=O)N1CC2(CC2)C[C@H]1c1nc(-c2ccc3c(c2)C(F)(F)c2cc(-c4ccc5[nH]c([C@@H]6[C@H]7CC[C@H](C7)N6C(=O)[C@@H](NC(=O)OC)C(C)C)nc5c4)ccc2-3)c[nH]1)C(C)C |
Identifiers
| PDB | — |
| CAS-ID | 1256388-51-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2374220 |
| ChEBI ID | 85089 |
| PubChem CID | 67505836 |
| DrugBank | DB09027 |
| UNII ID | 013TE6E4WV (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Harvoni – Gilead Sciences
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Estimated US medical usage
Ledipasvir
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Sofosbuvir
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Harvoni, Harvoni access, Ledipasvir and sofosbuvir
Adverse Events
Top Adverse Reactions
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24,376 adverse events reported
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