Epivir(lamivudine)

Cimduo, Combivir, Delstrigo, Dovato, Dutrebis, Epivir, Epivir-hbv, Epzicom, Kivexa, Symfi, Triumeq, Trizivir, Zeffix (lamivudine) is a small molecule pharmaceutical. Lamivudine was first approved as Epivir on 1995-11-17. It is used to treat acquired immunodeficiency syndrome, hepatitis b, and HIV infections in the USA. It has been approved in Europe to treat chronic hepatitis b and HIV infections.

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Therapeutic Areas

Therapeutic Area	MeSH
infections	D007239
digestive system diseases	D004066
urogenital diseases	D000091642
immune system diseases	D007154
signs and symptoms pathological conditions	D013568

Trade Name

FDA

EMA

Epivir, Epivir-hbv (generic drugs available since 2011-12-02)

Combinations

Cimduo, Combivir, Delstrigo, Dovato, Epzicom, Symfi, Symfi lo, Triumeq, Trizivir (generic drugs available since 2011-12-02, discontinued: Dutrebis, Temixys)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Abacavir sulfate

Dolutegravir sodium

Lamivudine

Tradename	Company	Number	Date	Products
TRIUMEQ	ViiV Healthcare	N-205551 RX	2014-08-22	1 products, RLD, RS
TRIUMEQ PD	ViiV Healthcare	N-215413 RX	2022-03-30	1 products, RLD, RS

Abacavir sulfate

Lamivudine

Tradename	Company	Number	Date	Products
EPZICOM	ViiV Healthcare	N-021652 RX	2004-08-02	1 products, RLD, RS

Abacavir sulfate

Lamivudine

Zidovudine

Tradename	Company	Number	Date	Products
TRIZIVIR	ViiV Healthcare	N-021205 RX	2000-11-14	1 products, RLD, RS

Dolutegravir sodium

Lamivudine

Tradename	Company	Number	Date	Products
DOVATO	ViiV Healthcare	N-211994 RX	2019-04-08	1 products, RLD, RS

Doravirine

Lamivudine

Tenofovir disoproxil fumarate

Tradename	Company	Number	Date	Products
DELSTRIGO	Merck Sharp & Dohme	N-210807 RX	2018-08-30	1 products, RLD, RS

Efavirenz

Lamivudine

Tenofovir disoproxil fumarate

Tradename	Company	Number	Date	Products
SYMFI LO	Mylan	N-208255 RX	2018-02-05	1 products, RLD, RS
SYMFI	Mylan	N-022142 RX	2018-03-22	1 products, RLD, RS

Show 2 discontinued

Lamivudine

Tradename	Company	Number	Date	Products
EPIVIR-HBV	GSK	N-021003 RX	1998-12-08	1 products, RLD, RS
EPIVIR-HBV	GSK	N-021004 RX	1998-12-08	1 products, RLD, RS
EPIVIR	ViiV Healthcare	N-020564 RX	1995-11-17	2 products, RLD
EPIVIR	ViiV Healthcare	N-020596 RX	1995-11-17	1 products, RLD, RS

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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Lamivudine

Raltegravir potassium

Tradename	Company	Number	Date	Products
DUTREBIS	Merck Sharp & Dohme	N-206510 DISCN	2015-02-06	1 products

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Lamivudine

Tenofovir disoproxil fumarate

Tradename	Company	Number	Date	Products
CIMDUO	Mylan	N-022141 RX	2018-02-28	1 products, RLD, RS

Show 2 discontinued

Lamivudine

Zidovudine

Tradename	Company	Number	Date	Products
COMBIVIR	ViiV Healthcare	N-020857 RX	1997-09-26	1 products, RLD, RS

Show 1 discontinued

Labels

FDA

EMA

Brand Name	Status	Last Update
cimduo	New Drug Application	2021-02-15
combivir	New Drug Application	2019-05-10
delstrigo	New Drug Application	2021-10-31
dovato	New Drug Application	2021-03-23
epivir	New Drug Application	2020-09-01
epzicom	New Drug Application	2021-02-17
symfi	New Drug Application	2019-10-15
temixys	New Drug Application	2021-01-25
triumeq	New Drug Application	2021-03-23
trizivir	New Drug Application	2021-02-17

Indications

FDA

EMA

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

Agency Specific

FDA

EMA

Expiration	Code
DORAVIRINE / LAMIVUDINE / TENOFOVIR DISOPROXIL FUMARATE, DELSTRIGO, MSD MERCK CO
2025-01-27	NPP
2023-08-30	NCE
DOLUTEGRAVIR SODIUM / LAMIVUDINE, DOVATO, VIIV HLTHCARE
2023-08-06	I-839

Patent Expiration

Patent	Expires	Flag	FDA Information
Doravirine / Lamivudine / Tenofovir Disoproxil Fumarate, Delstrigo, Msd Merck Co
10603282	2036-11-29	DP
10842751	2036-11-29	DP
8486975	2031-10-07	DS, DP	U-2395, U-2629, U-3307
Dolutegravir Sodium / Lamivudine, Dovato, Viiv Hlthcare
11234985	2031-01-24	DP	U-257
Abacavir Sulfate / Dolutegravir Sodium / Lamivudine, Triumeq, Viiv Hlthcare
9242986	2029-12-08	DS, DP
8129385	2027-10-05	DS, DP
Lamivudine / Raltegravir Potassium, Dutrebis, Merck Sharp Dohme
7754731	2029-03-11	DS, DP	U-1663
7169780	2023-10-03	DS, DP
7820660	2023-04-25	DP

ATC Codes

J: Antiinfectives for systemic use

— J05: Antivirals for systemic use

— J05A: Direct acting antivirals

— J05AF: Nucleoside and nucleotide reverse transcriptase inhibitors

— J05AF05: Lamivudine

— J05AR: Antivirals for treatment of hiv infections, combinations

— J05AR01: Zidovudine and lamivudine

— J05AR02: Lamivudine and abacavir

— J05AR04: Zidovudine, lamivudine and abacavir

— J05AR05: Zidovudine, lamivudine and nevirapine

— J05AR07: Stavudine, lamivudine and nevirapine

— J05AR11: Lamivudine, tenofovir disoproxil and efavirenz

— J05AR12: Lamivudine and tenofovir disoproxil

— J05AR13: Lamivudine, abacavir and dolutegravir

— J05AR16: Lamivudine and raltegravir

— J05AR24: Lamivudine, tenofovir disoproxil and doravirine

— J05AR25: Lamivudine and dolutegravir

— J05AR27: Lamivudine, tenofovir disoproxil and dolutegravir

HCPCS

No data

Clinical

Clinical Trials

540 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	33	86	110	77	56	349
Hiv	D006678		O98.7	8	6	7	26	5	48
Chronic hepatitis b	D019694	EFO_0004197	B18.1	1	3	10	26	2	42
Infections	D007239	EFO_0000544		7	3	11	5	1	27
Acquired immunodeficiency syndrome	D000163	EFO_0000765	B20	2	3	6	7	2	20
Hepatitis b	D006509			—	3	4	4	6	17
Tuberculosis	D014376	EFO_0000774	A15-A19	2	—	3	3	2	10
Hiv-1	D015497			—	3	3	2	—	8
Liver neoplasms	D008113	EFO_1001513	C22.0	—	—	1	3	2	6
Lipodystrophy	D008060		E88.1	—	1	—	4	—	5

Show 26 more

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pregnancy	D011247	EFO_0002950	Z33.1	5	—	2	—	—	7
Liver cirrhosis	D008103	EFO_0001422	K74.0	1	1	2	—	2	5
Malaria	D008288	EFO_0001068	B54	1	—	1	—	—	2
Neoplasms	D009369		C80	—	—	1	—	1	2
Hiv seropositivity	D006679			—	—	2	—	—	2
Amyotrophic lateral sclerosis	D000690	EFO_0000253	G12.21	—	1	1	—	—	2
Glycogen storage disease type ii	D006009	Orphanet_365	E74.02	—	—	1	—	—	1
Hiv-2	D015498			—	—	1	—	—	1
Breast feeding	D001942			—	—	1	—	—	1
Disease progression	D018450			—	—	1	—	—	1

Show 6 more

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Non-hodgkin lymphoma	D008228		C85.9	—	2	—	—	—	2
Lymphoma	D008223		C85.9	1	2	—	—	—	2
Metabolic bone diseases	D001851	HP_0000938		—	1	—	—	—	1
Alzheimer disease	D000544	EFO_0000249	F03	1	1	—	—	—	1
Colorectal neoplasms	D015179			—	1	—	—	—	1
Glomerulonephritis	D005921		N05	—	1	—	—	—	1
Chronic hepatitis d	D019701			—	1	—	—	—	1
Polyarteritis nodosa	D010488	EFO_0009012	M30.0	—	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
Gender dysphoria	D000068116		F64	1	—	—	—	—	1
Medication adherence	D055118	EFO_0006344		1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Bone density	D015519	EFO_0003923	M85	—	—	—	—	1	1
Meningeal tuberculosis	D014390		A17.0	—	—	—	—	1	1
Liver transplantation	D016031	EFO_0010682		—	—	—	—	1	1
Acute liver failure	D017114			—	—	—	—	1	1
B-cell chronic lymphocytic leukemia	D015451		C91.1	—	—	—	—	1	1
Malnutrition	D044342	EFO_0008572	E40-E46	—	—	—	—	1	1
Protein-energy malnutrition	D011502	EFO_0009563	E41	—	—	—	—	1	1
Kwashiorkor	D007732	EFO_1001009	E40	—	—	—	—	1	1
Cryptococcal meningitis	D016919	EFO_0007228	B45.1	—	—	—	—	1	1
Sexually transmitted diseases	D012749		A50-A64	—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	LAMIVUDINE
INN	lamivudine
Description	Lamivudine is a monothioacetal that consists of cytosine having a (2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl moiety attached at position 1. An inhibitor of HIV-1 reverse transcriptase, it is used as an antiviral in the treatment of AIDS and hepatitis B. It has a role as a HIV-1 reverse transcriptase inhibitor, an antiviral drug, an anti-HBV agent, an allergen, a prodrug and an EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor. It is a monothioacetal, a primary alcohol, an oxacycle and a nucleoside analogue. It is functionally related to a cytosine.
Classification	Small molecule
Drug class	antineoplastics; antivirals (zidovudine group) (exception: edoxudine)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	Nc1ccn([C@@H]2CS[C@H](CO)O2)c(=O)n1

Identifiers

PDB	—
CAS-ID	134678-17-4
RxCUI	68244
ChEMBL ID	CHEMBL141
ChEBI ID	63577
PubChem CID	60825
DrugBank	DB00709
UNII ID	2T8Q726O95 (ChemIDplus, GSRS)

Target

Agency Approved

No data

Alternate

No data

Variants

Clinical Variant

No data

Financial

No data

Trends

PubMed Central

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Safety

Black-box Warning

Black-box warning for: Cimduo, Combivir, Delstrigo, Dovato, Epivir, Epzicom, Symfi, Temixys, Triumeq, Trizivir

Adverse Events

Top Adverse Reactions

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6,425 adverse events reported

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