Lamivudine

Treats human immunodeficiency virus type 1 (HIV‑1) infection. Sold as Epivir, Epivir-Hbv. Every FDA application for this active ingredient: 4 branded and 25 generic.

As of Nov 15, 2026, FDA lists 29 applications for Lamivudine (sold as Epivir, Epivir-Hbv), first approved Nov 17, 1995, with 15 new uses approved and 0 published complete response letters.

First approved: Nov 17, 1995
Applications: 29
New uses approved: 15
Complete response letters: 0
Medicare spending, 2025: $5.9M
First approved in the EU: Aug 8, 1996

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Lamivudine Hbv	Part D	$3.6M	+28%	2,109
Lamivudine	Part D	$2.3M	-13%	3,470
Epivir	Part D	$51K	-21%	26

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

LAMIVUDINE 10 MG/ML ORAL SOLN: $0.218 per MLGeneric · -6% in a year
LAMIVUDINE 150 MG TABLET: $0.480 per unitGeneric · +16% in a year
LAMIVUDINE 300 MG TABLET: $1.42 per unitGeneric · +12% in a year

Approvals in the EU (EMA)

First approved in the EU 9 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Lamivudine Teva Pharma B.V., genericTeva B.V. · Dec 10, 2009
Lamivudine Teva, genericTeva B.V. · Oct 23, 2009
ZeffixGlaxoSmithKline Trading Services Limited · Jul 29, 1999
Epivir, new substanceViiV Healthcare BV · Aug 8, 1996

Shortages

FDA's drug shortage list, as of Nov 13, 2026

Shortage	Status	First posted	Updated
Lamivudine Tablet	To Be Discontinued	Oct 19, 2026	Oct 19, 2026

Clinical Trials

64 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Effects of Switch to Doravirine/Islatravir vs. Continued Antiretroviral Therapy on Biomarkers of Aging Among Virologically Suppressed People With HIVEpigenetic Aging · The University of Texas Health Science Center, Houston	Phase 2	Not yet recruiting	Oct 13, 2026
A Phase 2b Study Evaluating VH4011499 Capsid Inhibitor Long-Acting Injectable Plus Cabotegravir in Treatment Naïve Adults (CINERGY)HIV Infections · ViiV Healthcare	Phase 2	Not yet recruiting	Sep 11, 2026
An Adaptive Platform Trial for Evaluation of Novel Treatment Regimens in Children and Adolescents With HIV in AfricaHIV Infection · University College, London	Phase 3	Not yet recruiting	Aug 28, 2026
Effectiveness and Safety of Darunavir/Cobicistat Plus Lamivudine Compared With Darunavir/Cobicistat Plus Tenofovir Alafenamide/Emtricitabine in Virologically Suppressed People Living With HIV at 24 and 48 Weeks of Follow-upHIV Infection, Antiretroviral Therapy · Instituto Mexicano del Seguro Social	Phase 4	Recruiting	Jul 1, 2026
Sleep Outcomes and Multidimensional Sleep Assessment - a Randomized Trial of Dolutegravir- vs Doravirine-based Antiretroviral Therapy in People Living With HIVHIV (Human Immunodeficiency Virus), Sleep · University of Witwatersrand, South Africa	Phase 4	Not yet recruiting	Jun 29, 2026
Lamivudine as a Novel Clinical Effort for Rett SyndromeRett Syndrome · Maria Denise Fernandes Carvalho de Andrade	Phase 2	Enrolling by invitation	Jun 10, 2026
Comparative Trial Between Ainuovirine(ANV)/Lamivudine(3TC)/Tenofovir(TDF) and Efavirenz(EFV)/Lamivudine/Tenofovir RegimensHIV, Art Therapy · Shanghai Public Health Clinical Center	Phase 4	Not yet recruiting	Jun 8, 2026
Dolutegravir/Lamivudine in Treatment-Naïve Pregnant WomenHIV-1-infection · Fundación Huésped	Phase 4	Recruiting	Jun 1, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Nov 17, 1995	EpivirNDA 20596 · New dosage form	Viiv Hlthcare	32	Marketed
Dec 8, 1998	Epivir-HbvNDA 21003 · New dosage form	Glaxosmithkline	13	Discontinued
Dec 8, 1998	Epivir-HbvNDA 21004 · New dosage form	Glaxosmithkline	14	Discontinued
Nov 22, 2004	EpivirNDA 20564 · New molecular entity	Viiv Hlthcare	32	Marketed
Nov 17, 2011	LamivudineANDA 202032	Aurobindo Pharma Ltd	7	Discontinued
Dec 2, 2011	LamivudineANDA 91606	Apotex	9	Marketed
Jan 2, 2014	LamivudineANDA 202941	Apotex	4	Marketed
Jan 2, 2014	LamivudineANDA 203260	Hetero Labs Ltd V	3	Marketed
Jan 6, 2014	LamivudineANDA 203277	Hetero Labs Ltd V	5	Marketed
Oct 31, 2014	LamivudineANDA 203564	Chartwell Molecular	5	Marketed
Dec 18, 2014	LamivudineANDA 205217	Lupin	7	Discontinued
Dec 31, 2014	LamivudineANDA 204002	Aurobindo Pharma USA	4	Discontinued
Mar 4, 2016	LamivudineANDA 204528	Natco	5	Discontinued
Nov 21, 2016	LamivudineANDA 77464	Aurobindo Pharma	3	Marketed
Nov 21, 2016	LamivudineANDA 77695	Aurobindo Pharma	3	Marketed
Nov 21, 2016	LamivudineANDA 203586	Breckenridge	0	Discontinued
Nov 21, 2016	LamivudineANDA 206974	Somerset Theraps LLC	2	Marketed
Mar 3, 2017	LamivudineANDA 77221	Cipla	3	Marketed
Apr 19, 2018	LamivudineANDA 90457	Strides Pharma	2	Marketed
Mar 5, 2019	LamivudineANDA 78545	Pharmobedient	0	Discontinued
Mar 21, 2019	LamivudineANDA 211306	Annora	0	Marketed
May 1, 2019	LamivudineANDA 90198	Macleods Pharms	1	Marketed
Oct 6, 2023	LamivudineANDA 91475	Hetero Labs Ltd Iii	0	Marketed
—	LamivudineANDA 77357	Ranbaxy	0	Discontinued
—	LamivudineANDA 77980	Cipla Limited	0	Discontinued
—	LamivudineANDA 78636	Teva Pharms	0	Discontinued
—	LamivudineANDA 78850	Invagen Pharms	0	Discontinued
—	LamivudineANDA 90433	Alkem Labs Ltd	0	Discontinued
—	LamivudineANDA 200406	Micro Labs Ltd	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA