Ledipasvir - PharmaKB

Harvoni(ledipasvir)

Harvoni (ledipasvir) is a small molecule pharmaceutical. Ledipasvir was first approved as Harvoni on 2014-10-10. 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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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

Combinations

Harvoni

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

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

Labels

FDA

EMA

Brand Name	Status	Last Update
harvoni	New Drug Application	2024-12-26
harvoni access	Export only	2025-06-16
ledipasvir and sofosbuvir	NDA authorized generic	2025-01-10

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
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

Patent Expiration

Patent	Expires	Flag	FDA Information
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
9284342	2030-09-13	DS, DP	U-1470
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
8633309	2029-03-26	DS, DP	U-1470
8889159	2029-03-26	DP	U-1470
8334270	2028-03-21	DS, DP	U-1470
8580765	2028-03-21	DS, DP	U-1470
8735372	2028-03-21		U-1470
9085573	2028-03-21	DS, DP	U-1470

ATC Codes

J: Antiinfectives for systemic use

— J05: Antivirals for systemic use

— J05A: Direct acting antivirals

— J05AP: Antivirals for treatment of hcv infections

— J05AP51: Sofosbuvir and ledipasvir

HCPCS

No data

Clinical

Clinical Trials

138 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	5	37	19	24	25	108
Hepatitis	D006505	—	K75.9	6	23	11	8	14	59
Chronic hepatitis c	D019698	EFO_0004220	B18.2	2	17	8	9	18	53
Hepatitis a	D006506	EFO_0007305	B15	4	15	3	7	12	39
Hepatitis b	D006509	—	—	—	10	6	1	2	19
Hiv infections	D015658	EFO_0000764	B20	1	4	2	1	2	9
Hiv	D006678	—	O98.7	—	2	2	2	2	8
Chronic hepatitis b	D019694	EFO_0004239	B18.1	—	4	2	1	1	7
Liver cirrhosis	D008103	EFO_0001422	K74.0	—	—	2	1	2	5
Acquired immunodeficiency syndrome	D000163	EFO_0000765	B20	—	1	1	1	2	5

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Infections	D007239	EFO_0000544	—	1	13	4	—	1	19
Communicable diseases	D003141	—	—	—	11	3	—	—	14
Virus diseases	D014777	—	B34	—	5	1	—	1	6
Fibrosis	D005355	—	—	—	—	2	—	2	4
Hepacivirus	D016174	—	—	—	—	1	—	3	4
Coinfection	D060085	—	—	—	1	2	—	1	4
Hematologic diseases	D006402	EFO_0005803	D75.9	—	—	1	—	—	1
Cryoglobulinemia	D003449	EFO_0005846	D89.1	—	1	1	—	—	1

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Chronic hepatitis	D006521	—	K73.9	1	2	—	—	3	6
Lymphoma	D008223	—	C85.9	—	2	—	—	—	2
Hemophilia a	D006467	EFO_0007267	D66	—	1	—	—	—	1
Hematologic neoplasms	D019337	—	—	1	1	—	—	—	1
Neoplasms	D009369	—	C80	1	1	—	—	—	1
Porphyria cutanea tarda	D017119	—	E80.1	—	1	—	—	—	1
Chronic kidney failure	D007676	EFO_0003884	N18.6	—	1	—	—	—	1
B-cell lymphoma	D016393	—	—	—	1	—	—	—	1
Sickle cell anemia	D000755	EFO_0000697	D57	—	1	—	—	—	1

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—	—	—	2	—	—	—	—	2
Pregnancy	D011247	EFO_0002950	Z33.1	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hemoglobinopathies	D006453	—	D58.2	—	—	—	—	1	1
Kidney diseases	D007674	EFO_0003086	N08	—	—	—	—	1	1
Retinal diseases	D012164	—	H35.9	—	—	—	—	1	1
Substance-related disorders	D019966	EFO_0003890	F13	—	—	—	—	1	1
Only child	D009863	—	—	—	—	—	—	1	1
Thrombocytopenia	D013921	HP_0001873	D69.6	—	—	—	—	1	1
Patient compliance	D010349	—	—	—	—	—	—	1	1
Chronic renal insufficiency	D051436	—	N18	—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Ledipasvir
INN	ledipasvir
Description	Ledipasvir is a benzimidazole derivative that is used in combination with sofosbuvir (under the trade name Harvoni) for the treatment of chronic hepatitis C genotype 1 infection. It has a role as an antiviral drug and a hepatitis C protease inhibitor. It is a carbamate ester, a L-valine derivative, a bridged compound, a carboxamide, a benzimidazole, a member of fluorenes, an organofluorine compound, a member of imidazoles, a N-acylpyrrolidine and an azaspiro compound.
Classification	Small molecule
Drug class	antivirals: nonstructural protein 5A (NS5A) inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	COC(=O)N[C@H](C(=O)N1CC2(CC2)C[C@H]1c1nc(-c2ccc3c(c2)C(F)(F)c2cc(-c4ccc5[nH]c([C@@H]6[C@H]7CC[C@H](C7)N6C(=O)[C@@H](NC(=O)OC)C(C)C)nc5c4)ccc2-3)c[nH]1)C(C)C