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AboutPricing
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
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6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
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Last update 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
OTC monograph not final2012-09-10
2 in 1laxative stool softener and stiulant laxativeOTC monograph not final2022-01-03
3 concept eyes glossing waterful foundation soft beigeOTC monograph not final2013-10-03
3 concept eyes slim fit pact soft beigeOTC monograph not final2013-10-03
30 soft wipesOTC monograph not final2022-12-08
60 soft wipesOTC monograph not final2022-12-10
acacia pollen american beech american elm american sycamore arizona ash arizona cypress ash mixture aspen pollen australian pine austrian pine bald...Biologic Licensing Application, Bulk ingredient2009-11-19
accentrate pnvunapproved drug other2025-03-10
alabaster beige expert finish makeup broad spectrum spf 25 bare expert finish makeup broad spectrum spf 25 creamy beige expert finish makeup broa...OTC monograph final2021-05-20
alabaster beige expert finish makeup broad spectrum spf 25 bare expert finish makeup broad spectrum spf 25 creamy beige expert finish makeup broad ...C2002632024-10-07
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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
451 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—B19.2753471317135
HepatitisD006505—K75.963128101588
InfectionsD007239EFO_0000544—124251556
Hepatitis aD006506EFO_0007305B155201261455
Chronic hepatitis cD019698EFO_0004220B18.22151791053
Hepatitis bD006509——121211347
Communicable diseasesD003141——119201445
Hiv infectionsD015658EFO_0000764B20—15118
CoinfectionD060085———141—6
Opioid-related disordersD009293EFO_0005611F11———3—3
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Virus diseasesD014777—B34154—413
HepacivirusD016174———22—37
HivD006678—O98.7114—16
Acquired immunodeficiency syndromeD000163EFO_0000765B20—14—16
FibrosisD005355———13—15
Liver cirrhosisD008103EFO_0001422K74.0—11—13
Immunologic deficiency syndromesD007153—D84.9——2——2
CryoglobulinemiaD003449EFO_0005846D89.1—11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic hepatitisD006521—K73.9—3——14
Chronic kidney failureD007676EFO_0003884N18.6—3———3
Liver diseasesD008107EFO_0001421K70-K77—2———2
RecurrenceD012008———2———2
Chronic hepatitis bD019694EFO_0004239B18.1—1———1
Blood coagulation disordersD001778EFO_0009314D68.9—1———1
Hemostatic disordersD020141———1———1
Renal insufficiencyD051437—N19—1———1
HypertensionD006973EFO_0000537I10—1———1
Liver failureD017093—K72.9—1———1
Show 10 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Lung transplantationD016040——1————1
PregnancyD011247EFO_0002950Z33.11————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Recreational drug useD000084783——————11
Pregnancy complicationsD011248——————11
Drug misuseD000076064——————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)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
$
€
£
₣
Vosevi – Gilead Sciences
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Epclusa – Gilead Sciences
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Harvoni – Gilead Sciences
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Sovaldi – 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 17,987 documents
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Safety
Black-box Warning
Black-box warning for: Acacia pollen american beech american elm american sycamore arizona ash arizona cypress ash mixture aspen pollen australian pine austrian pine bald..., Accentrate pnv, Annual blue grass bahia grass brome grass canadian blue grass canary grass corn grass couch quack grass cultivated oat cultivated rye cultivated wh..., 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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65,438 adverse events reported
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