Nevirapine - PharmaKB

Viramune(nevirapine)

Nevirapine, Viramune (nevirapine) is a small molecule pharmaceutical. Nevirapine was first approved as Viramune on 1996-06-21. It is used to treat acquired immunodeficiency syndrome and HIV infections in the USA. It has been approved in Europe to treat HIV infections.

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

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Completion date

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Therapeutic Areas

Therapeutic Area	MeSH
infections	D007239
urogenital diseases	D000091642
immune system diseases	D007154

Trade Name

FDA

EMA

Nevirapine (discontinued: Nevirapine, Viramune)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Nevirapine

Tradename	Company	Number	Date	Products
VIRAMUNE	Boehringer Ingelheim	N-020636 DISCN	1996-06-21	1 products, RLD
VIRAMUNE	Boehringer Ingelheim	N-020933 DISCN	1998-09-11	1 products, RLD
VIRAMUNE XR	Boehringer Ingelheim	N-201152 DISCN	2011-03-25	2 products, RLD

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Lamivudine

Nevirapine

Zidovudine

Tradename	Company	Number	Date	Products
LAMIVUDINE, NEVIRAPINE AND ZIDOVUDINE	Micro Laboratories	N-205626 DISCN	2018-08-13	1 products, RLD

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Labels

FDA

EMA

Brand Name	Status	Last Update
nevirapine	ANDA	2024-09-04
nevirapine oral	ANDA	2012-05-23
viramune	New Drug Application	2024-10-21

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
hiv infections	EFO_0000764	D015658	B20
acquired immunodeficiency syndrome	EFO_0000765	D000163	B20
hepatitis b	—	D006509	—

Agency Specific

FDA

EMA

No data

Patent Expiration

Patent	Expires	Flag	FDA Information
Nevirapine, Viramune Xr, Boehringer Ingelheim
8460704	2029-03-12		U-1409

ATC Codes

J: Antiinfectives for systemic use

— J05: Antivirals for systemic use

— J05A: Direct acting antivirals

— J05AG: Non-nucleoside reverse transcriptase inhibitors

— J05AG01: Nevirapine

— J05AR: Antivirals for treatment of hiv infections, combinations

— J05AR05: Zidovudine, lamivudine and nevirapine

— J05AR07: Stavudine, lamivudine and nevirapine

HCPCS

No data

Clinical

Clinical Trials

235 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hiv infections	D015658	EFO_0000764	B20	28	39	52	39	40	188
Acquired immunodeficiency syndrome	D000163	EFO_0000765	B20	5	6	15	8	10	42
Hiv	D006678	—	—	3	6	4	13	11	33
Infections	D007239	EFO_0000544	—	4	6	9	1	8	28
Tuberculosis	D014376	EFO_0000774	A15-A19	—	3	3	4	1	10
Immunologic deficiency syndromes	D007153	HP_0002721	D84.9	—	1	3	2	1	6
Malaria	D008288	EFO_0001068	B54	1	—	1	3	1	6
Hepatitis c	D006526	—	B19.2	—	—	—	1	3	4
Hepatitis	D006505	HP_0012115	K75.9	—	—	—	2	2	4
Lipodystrophy	D008060	HP_0009125	E88.1	—	1	—	2	1	4

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Communicable diseases	D003141	—	—	2	2	3	—	6	13
Pregnancy	D011247	EFO_0002950	Z33.1	1	2	6	—	1	10
Coinfection	D060085	—	—	—	—	1	—	1	2
Chorioamnionitis	D002821	—	O41.12	—	—	1	—	—	1

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Renal insufficiency	D051437	HP_0000083	N19	1	1	—	—	—	2
Viremia	D014766	—	B34.9	—	1	—	—	—	1
Inflammation	D007249	MP_0001845	—	1	1	—	—	—	1
Parasitemia	D018512	—	—	1	1	—	—	—	1
Hiv seropositivity	D006679	—	—	—	1	—	—	—	1
Neutropenia	D009503	—	D70	—	1	—	—	—	1
Anemia	D000740	HP_0001903	D64.9	—	1	—	—	—	1

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—	—	—	4	—	—	—	—	4

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hepatitis b	D006509	—	—	—	—	—	—	2	2
Chronic hepatitis c	D019698	EFO_0004220	B18.2	—	—	—	—	1	1
Chronic hepatitis b	D019694	EFO_0004239	B18.1	—	—	—	—	1	1
Wasting syndrome	D019282	—	—	—	—	—	—	1	1
Cachexia	D002100	HP_0004326	R64	—	—	—	—	1	1
Mycobacterium avium-intracellulare infection	D015270	EFO_0007386	—	—	—	—	—	1	1
Mycobacterium infections	D009164	—	A31.9	—	—	—	—	1	1
Opportunistic infections	D009894	—	—	—	—	—	—	1	1
Neurobehavioral manifestations	D019954	EFO_0004364	—	—	—	—	—	1	1
Medication adherence	D055118	EFO_0006344	—	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Nevirapine
INN	nevirapine
Description	Nevirapine is a dipyridodiazepine that is 5,11-dihydro-6H-dipyrido[3,2-b:2',3'-e][1,4]diazepine which is substituted by methyl, oxo, and cyclopropyl groups at positions 4, 6, and 11, respectively. A non-nucleoside reverse transcriptase inhibitor with activity against HIV-1, it is used in combination with other antiretrovirals for the treatment of HIV infection. It has a role as an antiviral drug and a HIV-1 reverse transcriptase inhibitor. It is a dipyridodiazepine and a member of cyclopropanes.
Classification	Small molecule
Drug class	tricyclic compounds; antivirals
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	Cc1ccnc2c1NC(=O)c1cccnc1N2C1CC1