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

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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, Lamivudine (discontinued: Epivir-hbv, Lamivudine)

Combinations

Abacavir lamivudine, Abacavir sulfate, lamivudine zidovudine, Cimduo, Delstrigo, Dovato, Efavirenz, lamivudine tenofovir disoproxil, Lamivudine zidovudine, Symfi, Symfi lo, Triumeq (discontinued: Abacavir lamivudine, Combivir, Dutrebis, Efavirenz, lamivudine tenofovir disoproxil, Epzicom, Lamivudine tenofovir disoproxil, Lamivudine zidovudine, Lamivudine, nevirapine zidovudine, Temixys, Trizivir)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Lamivudine

Tenofovir disoproxil fumarate

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

Show 2 discontinued

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	ViiV Healthcare	N-020564 RX	1995-11-17	2 products, RLD
EPIVIR	ViiV Healthcare	N-020596 RX	1995-11-17	1 products, RLD, RS

Show 2 discontinued

Doravirine

Lamivudine

Tenofovir disoproxil fumarate

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

Lamivudine

Raltegravir potassium

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

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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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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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Dolutegravir sodium

Lamivudine

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

Abacavir sulfate

Lamivudine

Tradename	Company	Number	Date	Products
ABACAVIR SULFATE AND LAMIVUDINE	Mylan	N-204311 DISCN	2023-12-22	1 products, RLD
EPZICOM	ViiV Healthcare	N-021652 DISCN	2004-08-02	1 products, RLD

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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

Zidovudine

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

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Labels

FDA

EMA

Brand Name	Status	Last Update
abacavir and lamivudine	ANDA	2025-05-31
abacavir sulfate, lamivudine and zidovudine	ANDA	2013-12-17
abacavir, lamivudine and zidovudine	ANDA	2023-10-31
cimduo	New Drug Application	2021-02-15
combivir	New Drug Application	2023-08-22
delstrigo	New Drug Application	2025-06-12
direct rx	ANDA	2015-08-04
dovato	New Drug Application	2024-04-18
efavirenz, lamivudine and tenofovir disoproxil fumarate	ANDA	2024-05-07
epivir	New Drug Application	2024-08-15

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Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
hiv infections	EFO_0000764	D015658	B20
acquired immunodeficiency syndrome	EFO_0000765	D000163	B20
hepatitis b	—	D006509	—
hiv	—	D006678	O98.7
chronic hepatitis b	EFO_0004239	D019694	B18.1
hiv-1	—	D015497	—

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

814 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	48	125	164	120	101	539
Acquired immunodeficiency syndrome	D000163	EFO_0000765	B20	16	31	57	29	26	155
Infections	D007239	EFO_0000544	—	17	27	41	18	23	123
Hepatitis b	D006509	—	—	3	23	26	42	29	120
Hepatitis	D006505	—	K75.9	2	22	23	41	21	106
Hiv	D006678	—	O98.7	12	18	21	40	15	96
Hepatitis a	D006506	EFO_0007305	B15	2	19	20	36	18	93
Chronic hepatitis b	D019694	EFO_0004239	B18.1	2	16	21	37	16	91
Communicable diseases	D003141	—	—	5	10	18	6	9	46
Chronic hepatitis	D006521	—	K73.9	1	11	12	19	4	46

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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
Lymphoma	D008223	—	C85.9	1	5	1	—	—	5
Hiv-2	D015498	—	—	—	—	3	—	1	4
Malaria	D008288	EFO_0001068	B54	1	—	2	—	—	3
Liver transplantation	D016031	EFO_0010682	—	—	—	1	—	2	3
Neoplasms	D009369	—	C80	1	1	1	—	1	3
Aids-related complex	D000386	EFO_0007137	B20	—	2	1	—	—	3
Amyotrophic lateral sclerosis	D000690	EFO_0000253	G12.21	—	1	2	—	—	3
Motor neuron disease	D016472	EFO_0003782	G12.2	—	1	2	—	—	3
Sclerosis	D012598	—	—	—	1	2	—	—	3

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Liver failure	D017093	—	K72.9	1	1	—	—	2	3
Metabolic bone diseases	D001851	—	—	—	1	—	—	1	2
Highly active antiretroviral therapy	D023241	—	—	—	1	—	—	1	2
Non-hodgkin lymphoma	D008228	—	C85.9	—	2	—	—	—	2
Hepatic insufficiency	D048550	—	—	1	1	—	—	1	2
Syndrome	D013577	—	—	—	1	—	—	1	2
Ebola hemorrhagic fever	D019142	EFO_0007243	A98.4	—	1	—	—	—	1
Small cell carcinoma	D018288	—	—	—	1	—	—	—	1
Small cell lung carcinoma	D055752	—	—	—	1	—	—	—	1
Respiratory tract infections	D012141	—	J06.9	1	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	—	—	—	5	—	—	—	—	5
Gender dysphoria	D000068116	—	F64	1	—	—	—	—	1
Medication adherence	D055118	EFO_0006344	—	1	—	—	—	—	1
Aids dementia complex	D015526	EFO_0002608	—	1	—	—	—	—	1
Crush injuries	D000071576	—	T14.8	1	—	—	—	—	1
Retinal detachment	D012163	EFO_0005773	H33.2	1	—	—	—	—	1
Dissociative disorders	D004213	—	F44.1	1	—	—	—	—	1
Glioma	D005910	EFO_0000520	—	1	—	—	—	—	1
Smoking cessation	D016540	EFO_0004319	—	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hypertension	D006973	EFO_0000537	I10	—	—	—	—	2	2
Portal hypertension	D006975	EFO_0000666	K76.6	—	—	—	—	2	2
Bone density	D015519	EFO_0003923	M85	—	—	—	—	1	1
Chemical and drug induced liver injury	D056486	EFO_0004228	—	—	—	—	—	1	1
Meningeal tuberculosis	D014390	—	A17.0	—	—	—	—	1	1
Sustained virologic response	D000072230	—	—	—	—	—	—	1	1
Esophageal and gastric varices	D004932	EFO_0009545	I85	—	—	—	—	1	1
Hypotension	D007022	EFO_0005251	I95	—	—	—	—	1	1
Acute liver failure	D017114	—	—	—	—	—	—	1	1
Bone fractures	D050723	EFO_0003931	T14.8	—	—	—	—	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

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Delstrigo – Merck & Co

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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

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Safety

Black-box Warning

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

Adverse Events

Top Adverse Reactions

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45,892 adverse events reported

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