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Drug ReportsLamivudine
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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Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
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
infectionsD007239
digestive system diseasesD004066
urogenital diseasesD000091642
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
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)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Lamivudine
+
Tenofovir disoproxil fumarate
Tradename
Company
Number
Date
Products
CIMDUOMylanN-022141 RX2018-02-28
1 products, RLD, RS
Show 2 discontinued
Efavirenz
+
Lamivudine
+
Tenofovir disoproxil fumarate
Tradename
Company
Number
Date
Products
SYMFI LOMylanN-208255 RX2018-02-05
1 products, RLD, RS
SYMFIMylanN-022142 RX2018-03-22
1 products, RLD, RS
Show 2 discontinued
Lamivudine
Tradename
Company
Number
Date
Products
EPIVIRViiV HealthcareN-020564 RX1995-11-17
2 products, RLD
EPIVIRViiV HealthcareN-020596 RX1995-11-17
1 products, RLD, RS
Show 2 discontinued
Doravirine
+
Lamivudine
+
Tenofovir disoproxil fumarate
Tradename
Company
Number
Date
Products
DELSTRIGOMerck & CoN-210807 RX2018-08-30
1 products, RLD, RS
Lamivudine
+
Raltegravir potassium
Tradename
Company
Number
Date
Products
DUTREBISMerck & CoN-206510 DISCN2015-02-06
1 products
Hide discontinued
Lamivudine
+
Nevirapine
+
Zidovudine
Tradename
Company
Number
Date
Products
LAMIVUDINE, NEVIRAPINE AND ZIDOVUDINEMicro LaboratoriesN-205626 DISCN2018-08-13
1 products, RLD
Hide discontinued
Lamivudine
+
Zidovudine
Tradename
Company
Number
Date
Products
LAMIVUDINE AND ZIDOVUDINEPharmaCareN-022018 DISCN2017-03-17
1 products
COMBIVIRViiV HealthcareN-020857 DISCN1997-09-26
1 products, RLD
Hide discontinued
Dolutegravir sodium
+
Lamivudine
Tradename
Company
Number
Date
Products
DOVATOViiV HealthcareN-211994 RX2019-04-08
1 products, RLD, RS
Abacavir sulfate
+
Lamivudine
Tradename
Company
Number
Date
Products
ABACAVIR SULFATE AND LAMIVUDINEMylanN-204311 DISCN2023-12-22
1 products, RLD
EPZICOMViiV HealthcareN-021652 DISCN2004-08-02
1 products, RLD
Hide discontinued
Abacavir sulfate
+
Dolutegravir sodium
+
Lamivudine
Tradename
Company
Number
Date
Products
TRIUMEQViiV HealthcareN-205551 RX2014-08-22
1 products, RLD, RS
TRIUMEQ PDViiV HealthcareN-215413 RX2022-03-30
1 products, RLD, RS
Abacavir sulfate
+
Lamivudine
+
Zidovudine
Tradename
Company
Number
Date
Products
TRIZIVIRViiV HealthcareN-021205 DISCN2000-11-14
1 products, RLD
Hide discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
abacavir and lamivudineANDA2024-12-11
abacavir sulfate, lamivudine and zidovudineANDA2013-12-17
abacavir, lamivudine and zidovudineANDA2023-10-31
cimduoNew Drug Application2021-02-15
combivirNew Drug Application2023-08-22
delstrigoNew Drug Application2024-11-07
direct rxANDA2015-08-04
dovatoNew Drug Application2024-04-18
efavirenz, lamivudine and tenofovir disoproxil fumarateANDA2024-05-07
epivirNew Drug Application2024-10-29
Show 10 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hiv infectionsEFO_0000764D015658B20
acquired immunodeficiency syndromeEFO_0000765D000163B20
hepatitis b—D006509—
hiv—D006678—
chronic hepatitis bEFO_0004239D019694B18.1
hiv-1—D015497—
Agency Specific
FDA
EMA
Expiration
Code
ABACAVIR SULFATE / DOLUTEGRAVIR SODIUM / LAMIVUDINE, TRIUMEQ, VIIV HLTHCARE
2026-12-15PED
2026-06-15M-294
ABACAVIR SULFATE / DOLUTEGRAVIR SODIUM / LAMIVUDINE, TRIUMEQ PD, VIIV HLTHCARE
2026-12-15PED
2026-06-15NPP
DORAVIRINE / LAMIVUDINE / TENOFOVIR DISOPROXIL FUMARATE, DELSTRIGO, MSD MERCK CO
2025-01-27NPP
Patent Expiration
Patent
Expires
Flag
FDA Information
Doravirine / Lamivudine / Tenofovir Disoproxil Fumarate, Delstrigo, Msd Merck Co
106032822036-11-29DP
108427512036-11-29DP
84869752031-10-07DS, DPU-2395, U-2629, U-3307
Dolutegravir Sodium / Lamivudine, Dovato, Viiv Hlthcare
112349852031-01-24DPU-257
Abacavir Sulfate / Dolutegravir Sodium / Lamivudine, Triumeq, Viiv Hlthcare
92429862029-12-08DS, DP
81293852027-10-05DS, DP
Lamivudine / Raltegravir Potassium, Dutrebis, Merck Sharp Dohme
77547312029-03-11DS, DPU-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
805 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv infectionsD015658EFO_0000764B201—1——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HivD006678——21———3
TuberculosisD014376EFO_0000774A15-A19—1———1
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameLamivudine
INNlamivudine
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 classantineoplastics; antivirals (zidovudine group) (exception: edoxudine)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Nc1ccn([C@@H]2CS[C@H](CO)O2)c(=O)n1
Identifiers
PDB—
CAS-ID134678-17-4
RxCUI—
ChEMBL IDCHEMBL141
ChEBI ID63577
PubChem CID60825
DrugBankDB00709
UNII ID2T8Q726O95 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
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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Number of persons purchased
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Lamivudine
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Abacavir
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Zidovudine
Total medical expenditures per year (USD, in millions)
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Lamivudine
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Lamivudine
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Zidovudine
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 26,597 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, Cimduo, Combivir, Delstrigo, Direct rx, Dovato, Efavirenz, lamivudine and tenofovir disoproxil fumarate, Epivir, Epivir-hbv, Epzicom, Lamivudine, Lamivudine and zidovudine, Lamivudine zidovudine, Symfi, Symfi lo, Triumeq, Triumeq triumeq pd, Trizivir
Adverse Events
Top Adverse Reactions
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51,916 adverse events reported
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