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

Stem definition	Drug id	CAS RN
antivirals, hepatitis C Virus (HCV) NS5A inhibitors	5154	1377049-84-7

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: velpatasvir GS-5816 GS5816	pan-genotypic NS5A inhibitor for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection Molecular weight: 883.02 Formula: C49H54N8O8 CLOGP: 6.41 LIPINSKI: 3 HAC: 16 HDO: 4 TPSA: 193.10 ALOGS: -5.21 ROTB: 13 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

velpatasvir
GS-5816
GS5816

pan-genotypic NS5A inhibitor for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection

Molecular weight: 883.02
Formula: C49H54N8O8
CLOGP: 6.41
LIPINSKI: 3
HAC: 16
HDO: 4
TPSA: 193.10
ALOGS: -5.21
ROTB: 13

Status: ONP

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

Drug dosage:

None

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	4	Bocci G, Oprea TI, Benet LZ

Approvals:

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Date	Agency	Company
Jan. 8, 2019	PMDA	Gilead Sciences K.K.
July 6, 2016	EMA	GILEAD SCIENCES IRELAND UC
June 28, 2016	FDA	GILEAD SCIENCES INC

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FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

None

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
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:85185	hepatitis C virus nonstructural protein 5A inhibitors
FDA EPC	N0000191256	Hepatitis C Virus NS5A Inhibitor
FDA MoA	N0000185503	P-Glycoprotein Inhibitors
FDA MoA	N0000190107	Organic Anion Transporting Polypeptide 1B1 Inhibitors
FDA MoA	N0000190108	Organic Anion Transporting Polypeptide 1B3 Inhibitors
FDA MoA	N0000190109	Organic Anion Transporting Polypeptide 2B1 Inhibitors
FDA MoA	N0000190113	Breast Cancer Resistance Protein Inhibitors

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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

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Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	11.48	acidic
pKa2	12.26	acidic
pKa3	12.93	acidic
pKa4	13.17	acidic
pKa5	6.49	Basic
pKa6	5.8	Basic

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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;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
150MG;37.5MG/PACKET	EPCLUSA	GILEAD SCIENCES INC	N214187	June 10, 2021	RX	PELLETS	ORAL	8735372	March 21, 2028	FOR THE TREATMENT OF HEPATITIS C
150MG;37.5MG/PACKET	EPCLUSA	GILEAD SCIENCES INC	N214187	June 10, 2021	RX	PELLETS	ORAL	9085573	March 21, 2028	FOR THE TREATMENT OF HEPATITIS C
150MG;37.5MG/PACKET	EPCLUSA	GILEAD SCIENCES INC	N214187	June 10, 2021	RX	PELLETS	ORAL	7964580	March 26, 2029	FOR THE TREATMENT OF HEPATITIS C
150MG;37.5MG/PACKET	EPCLUSA	GILEAD SCIENCES INC	N214187	June 10, 2021	RX	PELLETS	ORAL	8633309	March 26, 2029	FOR THE TREATMENT OF HEPATITIS C
150MG;37.5MG/PACKET	EPCLUSA	GILEAD SCIENCES INC	N214187	June 10, 2021	RX	PELLETS	ORAL	8889159	March 26, 2029	FOR THE TREATMENT OF HEPATITIS C
150MG;37.5MG/PACKET	EPCLUSA	GILEAD SCIENCES INC	N214187	June 10, 2021	RX	PELLETS	ORAL	9284342	Sept. 13, 2030	FOR THE TREATMENT OF HEPATITIS C
150MG;37.5MG/PACKET	EPCLUSA	GILEAD SCIENCES INC	N214187	June 10, 2021	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	8575135	Nov. 16, 2032	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;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;50MG	EPCLUSA	GILEAD SCIENCES INC	N208341	March 19, 2020	RX	TABLET	ORAL	March 19, 2023	NEW STRENGTH
200MG;50MG	EPCLUSA	GILEAD SCIENCES INC	N208341	March 19, 2020	RX	TABLET	ORAL	July 14, 2023	INFORMATION ADDED TO THE LABELING DESCRIBING A PHASE 2, MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY/EFFICACY OF SOFOSBUVIR/VELPATASVIR IN SUBJECTS WITH CHRONIC HCV INFECTION WHO HAVE RECEIVED A LIVER TRANSPLANT
200MG;50MG	EPCLUSA	GILEAD SCIENCES INC	N208341	March 19, 2020	RX	TABLET	ORAL	Sept. 19, 2023	PEDIATRIC EXCLUSIVITY
200MG;50MG	EPCLUSA	GILEAD SCIENCES INC	N208341	March 19, 2020	RX	TABLET	ORAL	Jan. 14, 2024	PEDIATRIC EXCLUSIVITY
200MG;50MG	EPCLUSA	GILEAD SCIENCES INC	N208341	March 19, 2020	RX	TABLET	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
200MG;50MG	EPCLUSA	GILEAD SCIENCES INC	N208341	March 19, 2020	RX	TABLET	ORAL	March 19, 2027	TX OF PED PTS 6 YRS OF AGE & OLDER OR WEIGHING AT LEAST 17 KG WITH CHRONIC HEPATITIS C VIRUS 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
200MG;50MG	EPCLUSA	GILEAD SCIENCES INC	N208341	March 19, 2020	RX	TABLET	ORAL	Sept. 19, 2027	PEDIATRIC EXCLUSIVITY

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Bioactivity Summary:

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Target	Class	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Genome polyprotein	Polyprotein	POLG_HCV6A	INHIBITOR	EC50	11.10	DRUG LABEL	DRUG LABEL
Genome polyprotein	Polyprotein	POLG_HCVBK	INHIBITOR	EC50	10.80	DRUG LABEL	DRUG LABEL
Genome polyprotein	Polyprotein	POLG_HCVH	INHIBITOR	EC50	10.85	DRUG LABEL	DRUG LABEL
Genome polyprotein	Polyprotein	POLG_HCVJF	INHIBITOR	EC50	10.98	DRUG LABEL	DRUG LABEL
Genome polyprotein	Polyprotein	POLG_HCVED	INHIBITOR	EC50	11.05	DRUG LABEL	DRUG LABEL
Genome polyprotein	Polyprotein	POLG_HCVK3	INHIBITOR	EC50	11.40	DRUG LABEL	DRUG LABEL
Genome polyprotein	Polyprotein	POLG_HCVJP	INHIBITOR	EC50	11.40	DRUG LABEL	DRUG LABEL
Genome polyprotein	Polyprotein	POLG_HCVSA	INHIBITOR	EC50	10.43	DRUG LABEL	DRUG LABEL
Nonstructural protein 5A	Unclassified	Q5L478_9HEPC		EC50	11	CHEMBL

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External reference:

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ID	Source
016909	NDDF
11269	IUPHAR_LIGAND_ID
1799206	RXNORM
31777	MMSL
4035867	VANDF
67683363	PUBCHEM_CID
719641001	SNOMEDCT_US
816105002	SNOMEDCT_US
9960	INN_ID
C000604171	MESH_SUPPLEMENTAL_RECORD_UI

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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	100 mg	ORAL	NDA	36 sections
Epclusa	HUMAN PRESCRIPTION DRUG LABEL	2	61958-2201	TABLET, FILM COATED	100 mg	ORAL	NDA	36 sections
Epclusa	HUMAN PRESCRIPTION DRUG LABEL	2	61958-2203	TABLET, FILM COATED	50 mg	ORAL	NDA	36 sections
Epclusa	HUMAN PRESCRIPTION DRUG LABEL	2	61958-2203	TABLET, FILM COATED	50 mg	ORAL	NDA	36 sections
Epclusa	HUMAN PRESCRIPTION DRUG LABEL	2	61958-2204	PELLET	50 mg	ORAL	NDA	36 sections
Epclusa	HUMAN PRESCRIPTION DRUG LABEL	2	61958-2204	PELLET	50 mg	ORAL	NDA	36 sections
Epclusa	HUMAN PRESCRIPTION DRUG LABEL	2	61958-2205	PELLET	37.50 mg	ORAL	NDA	36 sections
Epclusa	HUMAN PRESCRIPTION DRUG LABEL	2	61958-2205	PELLET	37.50 mg	ORAL	NDA	36 sections
Epclusa Access	HUMAN PRESCRIPTION DRUG LABEL	2	61958-2202	TABLET, FILM COATED	100 mg	ORAL	Export only	31 sections
Sofosbuvir and Velpatasvir	HUMAN PRESCRIPTION DRUG LABEL	2	72626-2701	TABLET, FILM COATED	100 mg	ORAL	NDA AUTHORIZED GENERIC	35 sections

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