Lamivudine - PharmaKB

Epivir(lamivudine)

/ Lamivudine /, Abacavir / Lamivudine, Abacavir / Lamivudine / Zidovudine, Cimduo, Combivir, Delstrigo, Dovato, Dutrebis, Epivir, Kivexa, Lamivudine, Lamivudine / Zidovudine, 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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Clinical

Drug

Target

Variants

Financial

Trends

Safety

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

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
ABACAVIR SULFATE AND LAMIVUDINE	Mylan	N-204311 PEND	2023-12-22	1 products, RLD

Show 1 discontinued

Abacavir sulfate

Lamivudine

Zidovudine

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

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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
LAMIVUDINE AND ZIDOVUDINE	PharmaCare	N-022018 DISCN	2017-03-17	1 products
COMBIVIR	ViiV Healthcare	N-020857 DISCN	1997-09-26	1 products, RLD

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Labels

FDA

EMA

Brand Name	Status	Last Update
abacavir and lamivudine	ANDA	2023-10-30
abacavir sulfate, lamivudine and zidovudine	ANDA	2016-05-04
abacavir, lamivudine and zidovudine	ANDA	2023-10-31
delstrigo	New Drug Application	2023-11-14
dovato	New Drug Application	2023-11-03
efavirenz, lamivudine and tenofovir disoproxil fumarate	ANDA	2023-11-15
epzicom	New Drug Application	2022-12-14
symfi	New Drug Application	2019-09-09
symfi lo	New Drug Application	2019-10-15
triumeq	New Drug Application	2021-03-23

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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
ABACAVIR SULFATE / DOLUTEGRAVIR SODIUM / LAMIVUDINE, TRIUMEQ, VIIV HLTHCARE
2026-12-15	PED
2026-06-15	M-294
ABACAVIR SULFATE / DOLUTEGRAVIR SODIUM / LAMIVUDINE, TRIUMEQ PD, VIIV HLTHCARE
2026-12-15	PED
2026-06-15	NPP
DORAVIRINE / LAMIVUDINE / TENOFOVIR DISOPROXIL FUMARATE, DELSTRIGO, MSD MERCK CO
2025-01-27	NPP

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

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

787 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	38	111	143	101	83	458
Hiv	D006678	—	O98.7	12	17	20	38	13	90
Chronic hepatitis b	D019694	EFO_0004239	B18.1	2	11	16	34	14	76
Infections	D007239	EFO_0000544	—	7	5	15	5	5	37
Acquired immunodeficiency syndrome	D000163	EFO_0000765	B20	2	5	12	10	2	29
Hepatitis b	D006509	—	—	—	6	9	5	8	27
Tuberculosis	D014376	EFO_0000774	A15-A19	4	6	6	4	3	21
Hiv-1	D015497	—	—	—	4	3	4	—	11
Hepatocellular carcinoma	D006528	—	C22.0	—	—	1	3	3	7
Cardiovascular diseases	D002318	HP_0001626	—	—	1	—	3	2	6

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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	4	—	—	9
Liver cirrhosis	D008103	EFO_0001422	K74.0	1	1	2	—	4	7
Hiv seropositivity	D006679	—	—	—	1	2	—	—	3
Malaria	D008288	EFO_0001068	B54	1	—	2	—	—	3
Liver transplantation	D016031	EFO_0010682	—	—	—	1	—	2	3
Lymphoma	D008223	—	C85.9	1	3	1	—	—	3
Chronic hepatitis c	D019698	EFO_0004220	B18.2	—	—	1	—	1	2
Hiv-2	D015498	—	—	—	—	2	—	—	2
Neoplasms	D009369	—	C80	—	—	1	—	1	2
Liver diseases	D008107	HP_0002910	K70-K77	1	1	1	—	—	2

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pulmonary tuberculosis	D014397	EFO_1000049	A15	1	1	—	—	—	2
Non-hodgkin lymphoma	D008228	—	C85.9	—	2	—	—	—	2
Liver failure	D017093	HP_0001399	K72.9	1	1	—	—	1	2
Respiratory tract infections	D012141	—	J06.9	1	1	—	—	—	1
Htlv-ii infections	D015491	EFO_1001349	—	—	1	—	—	—	1
Metabolic bone diseases	D001851	HP_0000938	—	—	1	—	—	—	1
Alzheimer disease	D000544	EFO_0000249	F03	1	1	—	—	—	1
Colorectal neoplasms	D015179	—	—	—	1	—	—	—	1
Glomerulonephritis	D005921	HP_0000099	N05	—	1	—	—	—	1
Chronic hepatitis d	D019701	—	—	—	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	—	—	—	4	—	—	—	—	4
Gender dysphoria	D000068116	—	F64	1	—	—	—	—	1
Medication adherence	D055118	EFO_0006344	—	1	—	—	—	—	1
Aids dementia complex	D015526	EFO_0002608	—	1	—	—	—	—	1
Lung diseases	D008171	HP_0002088	J98.4	1	—	—	—	—	1
Multidrug-resistant tuberculosis	D018088	EFO_0007381	—	1	—	—	—	—	1
Retinal detachment	D012163	EFO_0005773	H33.2	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Portal hypertension	D006975	EFO_0000666	K76.6	—	—	—	—	2	2
Bone density	D015519	EFO_0003923	M85	—	—	—	—	1	1
Meningeal tuberculosis	D014390	—	A17.0	—	—	—	—	1	1
Sustained virologic response	D000072230	—	—	—	—	—	—	1	1
Acute liver failure	D017114	HP_0004448	—	—	—	—	—	1	1
Patient preference	D057240	—	—	—	—	—	—	1	1
Inferior wall myocardial infarction	D056989	EFO_1000983	—	—	—	—	—	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

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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	—
ChEMBL ID	CHEMBL141
ChEBI ID	63577
PubChem CID	60825
DrugBank	DB00709
UNII ID	2T8Q726O95 (ChemIDplus, GSRS)

Target

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Variants

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Financial

Revenue by drug

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Delstrigo – Merck Sharp & Dohme

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Estimated US medical usage

Lamivudine

Abacavir

Total medical expenditures per year (USD, in millions)

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Lamivudine

Abacavir

Zidovudine

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Lamivudine

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Lamivudine

Zidovudine

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Trends

PubMed Central

Top Terms for Disease or Syndrome:

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Additional graphs summarizing 25,409 documents

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Safety

Black-box Warning

Black-box warning for: Abacavir and lamivudine, Abacavir sulfate, lamivudine and zidovudine, Abacavir, lamivudine and zidovudine, Delstrigo, Dovato, Efavirenz, lamivudine and tenofovir disoproxil fumarate, Epzicom, Symfi, Symfi lo, Triumeq, Triumeq triumeq pd, Trizivir

Adverse Events

Top Adverse Reactions

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42,662 adverse events reported

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