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
EMA
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 | 2025-06-16 |
| 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
138 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 | 28 | 14 | 4 | 7 | 54 |
| Hepatitis | D006505 | — | K75.9 | 2 | 15 | 10 | 2 | 5 | 33 |
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | — | 13 | 7 | 4 | 4 | 28 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | 1 | 10 | 3 | 1 | 4 | 18 |
| 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 |
| Interstitial lung diseases | D017563 | EFO_0004244 | J84.9 | — | — | — | 1 | — | 1 |
| Autoimmune diseases | D001327 | EFO_0000540 | M30-M36 | — | — | — | 1 | — | 1 |
| Intravenous substance abuse | D015819 | — | — | — | — | — | 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 | 13 | 4 | — | — | 18 |
| Hepatitis b | D006509 | — | — | — | 10 | 5 | — | 2 | 17 |
| Communicable diseases | D003141 | — | — | — | 11 | 3 | — | — | 14 |
| Virus diseases | D014777 | — | B34 | — | 5 | 1 | — | — | 5 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | 1 | — | 1 | 3 |
| Hiv | D006678 | — | O98.7 | — | — | 2 | — | 1 | 3 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | — | 1 | 1 | — | 1 | 3 |
| Coinfection | D060085 | — | — | — | 1 | 2 | — | — | 3 |
| Hepacivirus | D016174 | — | — | — | — | 1 | — | 1 | 2 |
| Fibrosis | D005355 | — | — | — | — | 1 | — | 1 | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | 2 | — | — | — | 2 |
| Chronic hepatitis | D006521 | — | K73.9 | — | 1 | — | — | — | 1 |
| Hemophilia a | D006467 | EFO_0007267 | D66 | — | 1 | — | — | — | 1 |
| Chronic hepatitis b | D019694 | EFO_0004239 | B18.1 | — | 1 | — | — | — | 1 |
| Porphyria cutanea tarda | D017119 | — | E80.1 | — | 1 | — | — | — | 1 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | 1 | — | — | — | 1 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | — | 1 | — | — | — | 1 |
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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Number of persons purchased
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Number of purchases
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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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24,464 adverse events reported
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