Sofosbuvir - PharmaKB

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

Drug

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Variants

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Events Timeline

YTD

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

Results first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
infections	D007239
digestive system diseases	D004066
signs and symptoms pathological conditions	D013568

Trade Name

FDA

EMA

Sovaldi (discontinued: Sofosbuvir)

Combinations

Epclusa, Harvoni, Vosevi

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Sofosbuvir

Velpatasvir

Tradename	Company	Number	Date	Products
EPCLUSA	Gilead Sciences	N-208341 RX	2016-06-28	2 products, RLD, RS
EPCLUSA	Gilead Sciences	N-214187 RX	2021-06-10	2 products, RLD, RS

Ledipasvir

Sofosbuvir

Tradename	Company	Number	Date	Products
HARVONI	Gilead Sciences	N-205834 RX	2014-10-10	2 products, RLD, RS
HARVONI	Gilead Sciences	N-212477 RX	2019-08-28	2 products, RLD, RS

Sofosbuvir

Tradename	Company	Number	Date	Products
SOVALDI	Gilead Sciences	N-204671 RX	2013-12-06	2 products, RLD, RS
SOVALDI	Gilead Sciences	N-212480 RX	2019-08-28	2 products, RLD, RS

Sofosbuvir

Velpatasvir

Voxilaprevir

Tradename	Company	Number	Date	Products
VOSEVI	Gilead Sciences	N-209195 RX	2017-07-18	1 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
	OTC monograph not final	2012-09-10
2 in 1laxative stool softener and stiulant laxative	OTC monograph not final	2022-01-03
3 concept eyes glossing waterful foundation soft beige	OTC monograph not final	2013-10-03
3 concept eyes slim fit pact soft beige	OTC monograph not final	2013-10-03
30 soft wipes	OTC monograph not final	2022-12-08
60 soft wipes	OTC monograph not final	2022-12-10
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 ingredient	2009-11-19
accentrate pnv	unapproved drug other	2025-03-10
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 final	2021-05-20
alabaster beige expert finish makeup broad spectrum spf 25 bare expert finish makeup broad spectrum spf 25 creamy beige expert finish makeup broad ...	C200263	2024-10-07

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Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
hepatitis c	—	D006526	B19.2
chronic hepatitis c	EFO_0004220	D019698	B18.2

Agency Specific

FDA

EMA

Expiration	Code
SOFOSBUVIR / VELPATASVIR, EPCLUSA, GILEAD SCIENCES INC
2028-12-10	PED
2028-06-10	ODE-376
2027-09-19	PED
2027-03-19	ODE-293
2025-04-27	M-277
2024-01-14	PED
2023-09-19	PED
2023-07-14	M-264
2023-05-15	PED
2023-03-19	NPP, NS
LEDIPASVIR / SOFOSBUVIR, HARVONI, GILEAD SCIENCES INC
2026-08-28	ODE*, ODE-262, ODE-263, ODE-264
2024-10-07	PED
2024-04-07	ODE*, ODE-136
SOFOSBUVIR, SOVALDI, GILEAD SCIENCES INC
2026-08-28	ODE*, ODE-258
2024-10-07	PED
2024-04-07	ODE*, ODE-135

Patent Expiration

Patent	Expires	Flag	FDA Information
Sofosbuvir / Velpatasvir / Voxilaprevir, Vosevi, Gilead Sciences Inc
10912814	2037-06-01	DP
11338007	2037-06-01	DP	U-2039, U-2040
9296782	2034-07-17	DS, DP
9868745	2032-11-16	DS, DP
8957046	2028-03-21		U-2039, U-2040
Sofosbuvir / Velpatasvir, Epclusa, Gilead Sciences Inc
9757406	2034-01-30	DP
10086011	2034-01-30		U-1470
11116783	2034-01-30	DP	U-1470, U-2039, U-2040
11707479	2034-01-30	DP	U-1470
8575135	2032-11-16	DS, DP	U-1470, U-2039, U-2040
8921341	2032-11-16	DS, DP	U-1470, U-2039, U-2040
8940718	2032-11-16	DS, DP	U-1470, U-2039, U-2040
Ledipasvir / Sofosbuvir, Harvoni, Gilead Sciences Inc
10039779	2034-01-30	DS, DP	U-1470, U-2369, U-2370
9393256	2032-09-14		U-1470
10456414	2032-09-14	DP
8618076	2030-12-11	DS, DP	U-1470, U-2039, U-2040
9284342	2030-09-13	DS, DP	U-1470, U-2039, U-2040
8088368	2030-05-12	DS, DP
8273341	2030-05-12		U-1470
8822430	2030-05-12	DS, DP	U-1470
8841278	2030-05-12	DP	U-1470
9511056	2030-05-12	DP	U-1470
7964580	2029-03-26	DS, DP	U-1470, U-2039, U-2040
8633309	2029-03-26	DS, DP	U-1470, U-2039, U-2040
8889159	2029-03-26	DP	U-1470, U-2039, U-2040
8334270	2028-03-21	DS, DP	U-1470, U-2039, U-2040
8580765	2028-03-21	DS, DP	U-1470, U-2039, U-2040
8735372	2028-03-21		U-1470, U-2039, U-2040
9085573	2028-03-21	DS, DP	U-1470, U-2039, U-2040
Sofosbuvir, Sovaldi, Gilead Sciences Inc
9549941	2029-03-26		U-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

450 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 c	D006526	—	B19.2	23	121	102	73	87	381
Hepatitis	D006505	—	K75.9	20	83	72	50	71	278
Hepatitis a	D006506	EFO_0007305	B15	15	62	46	37	59	206
Chronic hepatitis c	D019698	EFO_0004220	B18.2	8	53	41	33	42	163
Infections	D007239	EFO_0000544	—	2	36	37	4	11	87
Hepatitis b	D006509	—	—	2	25	29	3	7	63
Communicable diseases	D003141	—	—	1	26	26	3	7	61
Chronic hepatitis	D006521	—	K73.9	1	16	15	4	12	43
Virus diseases	D014777	—	B34	1	11	14	2	7	33
Hiv infections	D015658	EFO_0000764	B20	2	7	9	6	7	29

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hepacivirus	D016174	—	—	—	3	5	—	5	13
Kidney transplantation	D016030	—	—	1	2	1	—	—	3
Metabolic syndrome	D024821	EFO_0000195	E88.810	—	1	1	—	1	2
Cryoglobulinemia	D003449	EFO_0005846	D89.1	—	1	1	—	1	2
Hematologic diseases	D006402	EFO_0005803	D75.9	—	—	1	—	—	1
Intravenous substance abuse	D015819	—	—	—	—	1	—	—	1
Male infertility	D007248	EFO_0004248	N46	—	1	1	—	—	1
Infertility	D007246	EFO_0000545	—	—	1	1	—	—	1
Persistent infection	D000088562	—	—	—	—	1	—	—	1

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Kidney diseases	D007674	EFO_0003086	N08	1	1	—	—	2	3
Neoplasms	D009369	—	C80	2	1	—	—	1	3
Gastrointestinal diseases	D005767	—	—	—	1	—	—	1	2
Rna virus infections	D012327	—	—	—	1	—	—	1	2
Digestive system diseases	D004066	EFO_0000405	K92.9	—	1	—	—	1	2
Viral hepatitis human	D006525	EFO_0004196	—	—	1	—	—	1	2
Severe acute respiratory syndrome	D045169	EFO_0000694	J12.81	—	1	—	—	—	1
Flaviviridae infections	D018178	EFO_0007274	—	—	1	—	—	—	1
Blood coagulation disorders	D001778	EFO_0009314	D68.9	—	1	—	—	—	1
Hemostatic disorders	D020141	—	—	—	1	—	—	—	1

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—	—	—	7	—	—	—	2	9
Type 1 diabetes mellitus	D003922	EFO_0001359	E10	1	—	—	—	4	5
Deglutition disorders	D003680	—	R13.1	1	—	—	—	—	1
Hepatic insufficiency	D048550	—	—	1	—	—	—	—	1
Pregnancy	D011247	EFO_0002950	Z33.1	1	—	—	—	—	1
Pancreatic ductal carcinoma	D021441	—	—	1	—	—	—	—	1
Non-small-cell lung carcinoma	D002289	—	—	1	—	—	—	—	1
Stomach neoplasms	D013274	EFO_0003897	C16	1	—	—	—	—	1
Adenocarcinoma	D000230	—	—	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Inflammation	D007249	MP_0001845	—	—	—	—	—	2	2
Chronic renal insufficiency	D051436	—	N18	—	—	—	—	2	2
Dental caries	D003731	EFO_0003819	K02	—	—	—	—	2	2
Hemorrhage	D006470	MP_0001914	R58	—	—	—	—	2	2
Hemoglobinopathies	D006453	—	D58.2	—	—	—	—	1	1
Retinal diseases	D012164	—	H35.9	—	—	—	—	1	1
Joint diseases	D007592	—	M12.9	—	—	—	—	1	1
Pregnancy complications	D011248	—	—	—	—	—	—	1	1
Thrombocytopenia	D013921	HP_0001873	D69.6	—	—	—	—	1	1
Patient compliance	D010349	—	—	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Sofosbuvir
INN	sofosbuvir
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 class	phosphoro-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-ID	1190307-88-0
RxCUI	—
ChEMBL ID	CHEMBL1259059
ChEBI ID	85083
PubChem CID	45375808
DrugBank	DB08934
UNII ID	WJ6CA3ZU8B (ChemIDplus, GSRS)

Target

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Variants

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Financial

Revenue by drug

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Vosevi – Gilead Sciences

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Harvoni – Gilead Sciences

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Sovaldi – Gilead Sciences

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Epclusa – Gilead Sciences

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Tabular view

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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Price per prescription (USD)

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Trends

PubMed Central

Top Terms for Disease or Syndrome:

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Additional graphs summarizing 17,917 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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