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sofosbuvir 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
antivirals RNA polymerase (NS5B) inhibitors	4811	1190307-88-0

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: sofosbuvir sovaldi PSI-7977	A uridine monophosphate analog inhibitor of HEPATITIS C VIRUS (HCV) polymerase NS5B that is used as an ANTIVIRAL AGENT in the treatment of CHRONIC HEPATITIS C. Molecular weight: 529.46 Formula: C22H29FN3O9P CLOGP: 0.84 LIPINSKI: 2 HAC: 12 HDO: 3 TPSA: 152.73 ALOGS: -2.81 ROTB: 11 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

sofosbuvir
sovaldi
PSI-7977

A uridine monophosphate analog inhibitor of HEPATITIS C VIRUS (HCV) polymerase NS5B that is used as an ANTIVIRAL AGENT in the treatment of CHRONIC HEPATITIS C.

Molecular weight: 529.46
Formula: C22H29FN3O9P
CLOGP: 0.84
LIPINSKI: 2
HAC: 12
HDO: 3
TPSA: 152.73
ALOGS: -2.81
ROTB: 11

Status: ONP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
0.40	g	O

ADMET properties:

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Property	Value	Reference
S (Water solubility)	2 mg/mL	Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Bocci G, Oprea TI, Benet LZ

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Approvals:

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Date	Agency	Company
Dec. 6, 2013	FDA	GILEAD SCIENCES INC
Jan. 16, 2014	EMA	GILEAD SCIENCES IRELAND UC
March 26, 2015	PMDA	Gilead Sciences K.K.

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FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Hepatocellular carcinoma	758.63	21.89	151	10524	2043	63476304
Hepatitis C	688.99	21.89	163	10512	5111	63473236
Anaemia	297.51	21.89	302	10373	293128	63185219
Hepatic encephalopathy	195.60	21.89	73	10602	11209	63467138
Fatigue	156.72	21.89	410	10265	887618	62590729
Hepatitis B reactivation	155.71	21.89	45	10630	3092	63475255
Hepatic cirrhosis	155.07	21.89	78	10597	24656	63453691
Ascites	154.19	21.89	92	10583	40636	63437711
Genotype drug resistance test positive	144.74	21.89	29	10646	404	63477943
Hyperbilirubinaemia	135.45	21.89	56	10619	11258	63467089

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Hepatitis C	2001.81	17.84	540	17230	9290	34929871
Hepatocellular carcinoma	1948.37	17.84	500	17270	7009	34932152
Treatment failure	867.44	17.84	438	17332	46259	34892902
Genotype drug resistance test positive	723.07	17.84	157	17613	988	34938173
Drug ineffective	675.13	17.84	977	16793	455774	34483387
Hepatic encephalopathy	335.44	17.84	159	17611	14526	34924635
Hepatic cirrhosis	316.40	17.84	161	17609	17153	34922008
Liver transplant	272.59	17.84	85	17685	2449	34936712
Ascites	232.25	17.84	191	17579	46380	34892781
Fatigue	231.35	17.84	550	17220	370103	34569058

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Hepatitis C	2455.79	17.62	598	24066	11327	79708397
Hepatocellular carcinoma	2375.64	17.62	552	24112	8469	79711255
Genotype drug resistance test positive	626.95	17.62	131	24533	1177	79718547
Hepatic encephalopathy	482.13	17.62	205	24459	23961	79695763
Hepatic cirrhosis	463.96	17.62	223	24441	34683	79685041
Treatment failure	425.42	17.62	380	24284	170106	79549618
Anaemia	394.47	17.62	579	24085	444436	79275288
Drug ineffective	392.93	17.62	958	23706	1079955	78639769
Ascites	381.26	17.62	256	24408	75306	79644418
Fatigue	363.13	17.62	848	23816	928879	78790845

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	J05AP08	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HCV infections
ATC	J05AP51	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HCV infections
ATC	J05AP55	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HCV infections
ATC	J05AP56	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HCV infections
CHEBI has role	CHEBI:36044	antiviral drugs
CHEBI has role	CHEBI:50266	Prodrugs
CHEBI has role	CHEBI:64924	hepatitis C protease inhibitors
FDA EPC	N0000191493	Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor
FDA MoA	N0000191258	RNA Replicase Inhibitors
MeSH PA	D000890	Anti-Infective Agents

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID
Chronic hepatitis C	indication	128302006
Compensated cirrhosis	indication	371139006
Decompensated cirrhosis of liver	indication	716203000

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.07	acidic
pKa2	11.58	acidic
pKa3	2.07	Basic

Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
150MG/PACKET	SOVALDI	GILEAD SCIENCES INC	N212480	Aug. 28, 2019	RX	PELLETS	ORAL	8334270	March 21, 2028	FOR THE TREATMENT OF HEPATITIS C
150MG/PACKET	SOVALDI	GILEAD SCIENCES INC	N212480	Aug. 28, 2019	RX	PELLETS	ORAL	8580765	March 21, 2028	FOR THE TREATMENT OF HEPATITIS C
150MG/PACKET	SOVALDI	GILEAD SCIENCES INC	N212480	Aug. 28, 2019	RX	PELLETS	ORAL	9085573	March 21, 2028	FOR THE TREATMENT OF HEPATITIS C
150MG/PACKET	SOVALDI	GILEAD SCIENCES INC	N212480	Aug. 28, 2019	RX	PELLETS	ORAL	7964580	March 26, 2029	FOR THE TREATMENT OF HEPATITIS C
150MG/PACKET	SOVALDI	GILEAD SCIENCES INC	N212480	Aug. 28, 2019	RX	PELLETS	ORAL	8633309	March 26, 2029	FOR THE TREATMENT OF HEPATITIS C
150MG/PACKET	SOVALDI	GILEAD SCIENCES INC	N212480	Aug. 28, 2019	RX	PELLETS	ORAL	8889159	March 26, 2029	FOR THE TREATMENT OF HEPATITIS C
150MG/PACKET	SOVALDI	GILEAD SCIENCES INC	N212480	Aug. 28, 2019	RX	PELLETS	ORAL	9284342	Sept. 13, 2030	FOR THE TREATMENT OF HEPATITIS C
150MG/PACKET	SOVALDI	GILEAD SCIENCES INC	N212480	Aug. 28, 2019	RX	PELLETS	ORAL	8618076	Dec. 11, 2030	FOR THE TREATMENT OF HEPATITIS C
150MG;37.5MG/PACKET	EPCLUSA	GILEAD SCIENCES INC	N214187	June 10, 2021	RX	PELLETS	ORAL	8334270	March 21, 2028	FOR THE TREATMENT OF HEPATITIS C
150MG;37.5MG/PACKET	EPCLUSA	GILEAD SCIENCES INC	N214187	June 10, 2021	RX	PELLETS	ORAL	8580765	March 21, 2028	FOR THE TREATMENT OF HEPATITIS C

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
150MG/PACKET	SOVALDI	GILEAD SCIENCES INC	N212480	Aug. 28, 2019	RX	PELLETS	ORAL	April 7, 2024	FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
150MG/PACKET	SOVALDI	GILEAD SCIENCES INC	N212480	Aug. 28, 2019	RX	PELLETS	ORAL	Oct. 7, 2024	PEDIATRIC EXCLUSIVITY
150MG/PACKET	SOVALDI	GILEAD SCIENCES INC	N212480	Aug. 28, 2019	RX	PELLETS	ORAL	Aug. 28, 2026	FOR THE TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 2 OR 3 INFECTION IN PEDIATRIC PATIENTS BETWEEN 3 YEARS OF AGE AND 12 YEARS OF AGE OR WEIGHING 35 KG WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS FOR USE IN COMBINATION WITH RIBAVIRIN
150MG;37.5MG/PACKET	EPCLUSA	GILEAD SCIENCES INC	N214187	June 10, 2021	RX	PELLETS	ORAL	April 27, 2025	UPDATES THE US PRESCRIBING INFORMATION WITH CLINICAL DATA REGARDING THE USE OF SOFOSBUVIR AND VELPATASVIR FOR THE TREATMENT OF CHRONIC HCV GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION IN PEOPLE WHO INJECT DRUGS (PWID), INCLUDING THOSE ON MEDICATION-ASSISTED TREATMENT (MAT) FOR OPIOID USE DISORDER
150MG;37.5MG/PACKET	EPCLUSA	GILEAD SCIENCES INC	N214187	June 10, 2021	RX	PELLETS	ORAL	June 10, 2028	FOR TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE TO LESS THAN 6 YEARS OF AGE WEIGHING LESS THAN 17 KG WITH CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION: WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS; OR WITH DECOMPENSATED CIRRHOSIS FOR USE IN COMBINATION WITH RIBAVIRIN
150MG;37.5MG/PACKET	EPCLUSA	GILEAD SCIENCES INC	N214187	June 10, 2021	RX	PELLETS	ORAL	Dec. 10, 2028	PEDIATRIC EXCLUSIVITY
200MG	SOVALDI	GILEAD SCIENCES INC	N204671	Aug. 28, 2019	RX	TABLET	ORAL	April 7, 2024	FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
200MG	SOVALDI	GILEAD SCIENCES INC	N204671	Aug. 28, 2019	RX	TABLET	ORAL	Oct. 7, 2024	PEDIATRIC EXCLUSIVITY
200MG	SOVALDI	GILEAD SCIENCES INC	N204671	Aug. 28, 2019	RX	TABLET	ORAL	Aug. 28, 2026	FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
200MG/PACKET	SOVALDI	GILEAD SCIENCES INC	N212480	Aug. 28, 2019	RX	PELLETS	ORAL	April 7, 2024	FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)

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Bioactivity Summary:

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Target	Class	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
NS5B protein	Enzyme	Q8JXU8_9HEPC	INHIBITOR	EC50	7.19	CHEMBL	CHEMBL
Genome polyprotein	Polyprotein	POLG_HCVH	INHIBITOR	EC90	6.96	SCIENTIFIC LITERATURE	SCIENTIFIC LITERATURE
Cereblon isoform 4	Unclassified	A4TVL0_9PROT		Ki	4.66	CHEMBL
NS5	Unclassified	A0A143MHK7_ZIKV		EC50	6.92	CHEMBL

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External reference:

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ID	Source
WG6	PDB_CHEM_ID
015326	NDDF
11311503	PUBCHEM_CID
1484911	RXNORM
207812	MMSL
29932	MMSL
4032949	VUID
4032949	VANDF
45375808	PUBCHEM_CID
710806008	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Epclusa	HUMAN PRESCRIPTION DRUG LABEL	2	61958-2201	TABLET, FILM COATED	400 mg	ORAL	NDA	36 sections
Epclusa	HUMAN PRESCRIPTION DRUG LABEL	2	61958-2201	TABLET, FILM COATED	400 mg	ORAL	NDA	36 sections
Epclusa	HUMAN PRESCRIPTION DRUG LABEL	2	61958-2203	TABLET, FILM COATED	200 mg	ORAL	NDA	36 sections
Epclusa	HUMAN PRESCRIPTION DRUG LABEL	2	61958-2203	TABLET, FILM COATED	200 mg	ORAL	NDA	36 sections
Epclusa	HUMAN PRESCRIPTION DRUG LABEL	2	61958-2204	PELLET	200 mg	ORAL	NDA	36 sections
Epclusa	HUMAN PRESCRIPTION DRUG LABEL	2	61958-2204	PELLET	200 mg	ORAL	NDA	36 sections
Epclusa	HUMAN PRESCRIPTION DRUG LABEL	2	61958-2205	PELLET	150 mg	ORAL	NDA	36 sections
Epclusa	HUMAN PRESCRIPTION DRUG LABEL	2	61958-2205	PELLET	150 mg	ORAL	NDA	36 sections
Epclusa Access	HUMAN PRESCRIPTION DRUG LABEL	2	61958-2202	TABLET, FILM COATED	400 mg	ORAL	Export only	31 sections
Harvoni	HUMAN PRESCRIPTION DRUG LABEL	2	61958-1801	TABLET, FILM COATED	400 mg	ORAL	NDA	36 sections

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