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Drug ReportsSofosbuvir
Sovaldi(sofosbuvir)
Epclusa, Harvoni, Sovaldi, Vosevi (sofosbuvir) is a small molecule pharmaceutical. Sofosbuvir was first approved as Sovaldi on 2013-12-06. 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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Clinical
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5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
digestive system diseasesD004066
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Sovaldi (discontinued: Sofosbuvir)
Combinations
Epclusa, Harvoni, Vosevi
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Sofosbuvir
+
Velpatasvir
Tradename
Company
Number
Date
Products
EPCLUSAGilead SciencesN-208341 RX2016-06-28
2 products, RLD, RS
EPCLUSAGilead SciencesN-214187 RX2021-06-10
2 products, RLD, RS
Ledipasvir
+
Sofosbuvir
Tradename
Company
Number
Date
Products
HARVONIGilead SciencesN-205834 RX2014-10-10
2 products, RLD, RS
HARVONIGilead SciencesN-212477 RX2019-08-28
2 products, RLD, RS
Sofosbuvir
Tradename
Company
Number
Date
Products
SOVALDIGilead SciencesN-204671 RX2013-12-06
2 products, RLD, RS
SOVALDIGilead SciencesN-212480 RX2019-08-28
2 products, RLD, RS
Sofosbuvir
+
Velpatasvir
+
Voxilaprevir
Tradename
Company
Number
Date
Products
VOSEVIGilead SciencesN-209195 RX2017-07-18
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
epclusaNew Drug Application2024-06-05
epclusa accessExport only2020-12-18
harvoniNew Drug Application2021-06-28
harvoni accessExport only2021-06-25
ledipasvir and sofosbuvirNDA authorized generic2021-06-25
sofosbuvir and velpatasvirNDA authorized generic2022-05-04
sovaldiNew Drug Application2023-02-06
sovaldi accessExport only2020-12-20
voseviNew Drug Application2024-03-14
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hepatitis c—D006526B19.2
chronic hepatitis cEFO_0004220D019698B18.2
Agency Specific
FDA
EMA
Expiration
Code
SOFOSBUVIR / VELPATASVIR, EPCLUSA, GILEAD SCIENCES INC
2028-12-10PED
2028-06-10ODE-376
2027-09-19PED
2027-03-19ODE-293
2025-04-27M-277
2024-01-14PED
2023-09-19PED
2023-07-14M-264
2023-05-15PED
2023-03-19NPP, NS
LEDIPASVIR / SOFOSBUVIR, HARVONI, GILEAD SCIENCES INC
2026-08-28ODE*, ODE-262, ODE-263, ODE-264
2024-10-07PED
2024-04-07ODE*, ODE-136
SOFOSBUVIR, SOVALDI, GILEAD SCIENCES INC
2026-08-28ODE*, ODE-258
2024-10-07PED
2024-04-07ODE*, ODE-135
Patent Expiration
Patent
Expires
Flag
FDA Information
Sofosbuvir / Velpatasvir / Voxilaprevir, Vosevi, Gilead Sciences Inc
109128142037-06-01DP
113380072037-06-01DPU-2039, U-2040
92967822034-07-17DS, DP
98687452032-11-16DS, DP
89570462028-03-21U-2039, U-2040
Sofosbuvir / Velpatasvir, Epclusa, Gilead Sciences Inc
97574062034-01-30DP
100860112034-01-30U-1470
111167832034-01-30DPU-1470, U-2039, U-2040
117074792034-01-30DPU-1470
85751352032-11-16DS, DPU-1470, U-2039, U-2040
89213412032-11-16DS, DPU-1470, U-2039, U-2040
89407182032-11-16DS, DPU-1470, U-2039, U-2040
Ledipasvir / Sofosbuvir, Harvoni, Gilead Sciences Inc
100397792034-01-30DS, DPU-1470, U-2369, U-2370
93932562032-09-14U-1470
104564142032-09-14DP
86180762030-12-11DS, DPU-1470, U-2039, U-2040
92843422030-09-13DS, DPU-1470, U-2039, U-2040
80883682030-05-12DS, DP
82733412030-05-12U-1470
88224302030-05-12DS, DPU-1470
88412782030-05-12DPU-1470
95110562030-05-12DPU-1470
79645802029-03-26DS, DPU-1470, U-2039, U-2040
86333092029-03-26DS, DPU-1470, U-2039, U-2040
88891592029-03-26DPU-1470, U-2039, U-2040
83342702028-03-21DS, DPU-1470, U-2039, U-2040
85807652028-03-21DS, DPU-1470, U-2039, U-2040
87353722028-03-21U-1470, U-2039, U-2040
90855732028-03-21DS, DPU-1470, U-2039, U-2040
Sofosbuvir, Sovaldi, Gilead Sciences Inc
95499412029-03-26U-1958
ATC Codes
J: Antiinfectives for systemic use
— J05: Antivirals for systemic use
— J05A: Direct acting antivirals
— J05AP: Antivirals for treatment of hcv infections
— J05AP08: Sofosbuvir
— J05AP51: Sofosbuvir and ledipasvir
— J05AP55: Sofosbuvir and velpatasvir
— J05AP56: Sofosbuvir, velpatasvir and voxilaprevir
HCPCS
No data
Clinical
Clinical Trials
420 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 cD006526—B19.2231201007489381
HepatitisD006505HP_0012115K75.92082705072276
Hepatitis aD006506EFO_0007305B151561453759204
Chronic hepatitis cD019698EFO_0004220B18.2853403343163
InfectionsD007239EFO_0000544—2353641185
Hepatitis bD006509——225293864
Communicable diseasesD003141——125263760
Chronic hepatitisD006521—K73.91161441242
Virus diseasesD014777—B34110142732
Hiv infectionsD015658EFO_0000764B202796830
Show 42 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HepacivirusD016174———34—512
Kidney transplantationD016030——121——3
Metabolic syndromeD024821EFO_0000195E88.810—11—12
CryoglobulinemiaD003449EFO_0005846D89.1—11—12
Intravenous substance abuseD015819————1—12
Hematologic diseasesD006402EFO_0005803D75.9——1——1
Male infertilityD007248EFO_0004248N46—11——1
InfertilityD007246HP_0000789——11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Kidney diseasesD007674EFO_0003086N0811——23
Severe acute respiratory syndromeD045169EFO_0000694J12.81—1———1
Blood coagulation disordersD001778EFO_0009314D68.9—1———1
Hemostatic disordersD020141———1———1
HypertensionD006973EFO_0000537I10—1———1
Liver failureD017093HP_0001399K72.9—1———1
Portal hypertensionD006975EFO_0000666K76.6—1———1
Hematologic neoplasmsD019337——11———1
NeoplasmsD009369—C8011———1
Herpesviridae infectionsD006566EFO_0007309B00.4—1———1
Show 8 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———7———18
Deglutition disordersD003680HP_0002015R13.11————1
Hepatic insufficiencyD048550——1————1
PregnancyD011247EFO_0002950Z33.11————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InflammationD007249MP_0001845—————22
Chronic renal insufficiencyD051436—N18————22
HemoglobinopathiesD006453—D58.2————11
Retinal diseasesD012164HP_0000479H35.9————11
Joint diseasesD007592HP_0003040M12.9————11
Gastrointestinal diseasesD005767——————11
Rna virus infectionsD012327——————11
Digestive system diseasesD004066HP_0011024K92.9————11
Viral hepatitis humanD006525EFO_0004196—————11
Pregnancy complicationsD011248——————11
Show 6 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSofosbuvir
INNsofosbuvir
Description
Sofosbuvir is a nucleotide conjugate that is used in combination with ledipasvir (under the trade name Harvoni) for the treatment of chronic hepatitis C genotype 1 infection. It has a role as a prodrug, an antiviral drug and a hepatitis C protease inhibitor. It is a L-alanyl ester, a phosphoramidate ester, a nucleotide conjugate, an organofluorine compound and an isopropyl ester. It is functionally related to a uridine 5'-monophosphate.
Classification
Small molecule
Drug classphosphoro-derivatives; antivirals: RNA polymerase (NS5B) inhibitors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CC(C)OC(=O)[C@H](C)N[P@](=O)(OC[C@H]1O[C@@H](n2ccc(=O)[nH]c2=O)[C@](C)(F)[C@@H]1O)Oc1ccccc1
Identifiers
PDB—
CAS-ID1190307-88-0
RxCUI—
ChEMBL IDCHEMBL1259059
ChEBI ID85083
PubChem CID45375808
DrugBankDB08934
UNII IDWJ6CA3ZU8B (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Harvoni – Gilead Sciences
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Sovaldi – Gilead Sciences
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Vosevi – Gilead Sciences
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Epclusa – Gilead Sciences
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Estimated US medical usage
Sofosbuvir
+
Ledipasvir
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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Refill frequency
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 9,631 documents
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Safety
Black-box Warning
Black-box warning for: Epclusa, Epclusa access, Harvoni, Harvoni access, Ledipasvir and sofosbuvir, Sofosbuvir and velpatasvir, Sovaldi, Sovaldi access, Vosevi
Adverse Events
Top Adverse Reactions
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60,014 adverse events reported
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