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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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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
digestive system diseasesD004066
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Sovaldi (generic drugs available since 2022-01-27)
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)
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
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
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 Application2021-06-18
harvoniNew Drug Application2021-06-28
sovaldiNew Drug Application2020-12-21
voseviNew Drug Application2019-11-21
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
chronic hepatitis cEFO_0004220D019698B18.2
hepatitis c—D006526B19.2
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
95859062028-03-21DS, DPU-2039, U-2040
Sofosbuvir / Velpatasvir, Epclusa, Gilead Sciences Inc
97574062034-01-30DP
100860112034-01-30U-1470
111167832034-01-30DPU-1470, U-2039, U-2040
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
244 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 cD006526B19.2631243522111
Chronic hepatitis cD019698EFO_0004220B18.25211719763
Hepatitis bD006509—262515
Hiv infectionsD015658EFO_0000764B202314312
Covid-19D000086382U07.1—552—9
Liver cirrhosisD008103EFO_0001422K74.0——2428
Chronic hepatitis bD019694EFO_0004197B18.1—53118
HivD006678O98.7—233—8
Liver neoplasmsD008113EFO_1001513C22.0—113—5
Chronic kidney failureD007676EFO_0003884N18.6—113—5
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HepacivirusD016174—22—26
HepatitisD006505HP_0012115K75.9121—14
FibrosisD005355——1—23
Metabolic syndromeD024821EFO_0000195E88.81—11——1
CryoglobulinemiaD003449EFO_0005846D89.1—11——1
Intravenous substance abuseD015819——1——1
Male infertilityD007248EFO_0004248N46—11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic hepatitisD006521K73.9—1——12
Lung diseasesD008171EFO_0003818J98.411———1
Hematologic neoplasmsD01933711———1
Liver transplantationD016031EFO_0010682—1———1
Kidney transplantationD016030—1———1
Hepatitis eD016751EFO_0007303—1———1
Porphyria cutanea tardaD017119E80.1—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—7———18
Hepatic insufficiencyD0485501————1
PregnancyD011247EFO_0002950Z33.11————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Retinal diseasesD012164HP_0000479H35.9————11
Rna virus infectionsD012327————11
Digestive system diseasesD004066EFO_0000405K92.9————11
Viral hepatitis humanD006525EFO_0004196————11
Pregnancy complicationsD011248————11
Chronic renal insufficiencyD051436N18————11
Treatment adherence and complianceD000074822————11
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)
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
RxCUI1484911
ChEMBL IDCHEMBL1259059
ChEBI ID85083
PubChem CID45375808
DrugBankDB08934
UNII IDWJ6CA3ZU8B (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Vosevi - Gilead Sciences
$
€
£
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Sovaldi - Gilead Sciences
$
€
£
₣
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Epclusa - Gilead Sciences
$
€
£
₣
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Harvoni - Gilead Sciences
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 8,519 documents
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Safety
Black-box Warning
Black-box warning for: Epclusa, Harvoni, Sovaldi, Vosevi
Adverse Events
Top Adverse Reactions
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432 adverse events reported
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