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EPIVIR-HBV

NDA

LAMIVUDINE | N021004 | GLAXOSMITHKLINE

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

403 trials from ClinicalTrials.gov, 2 active, 322 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Early Infant HIV Treatment in Botswana NCT02369406	Phase 2/3	Active	Harvard School of Public Health (HSPH)	67	2015-05-04 → 2029-06-30
DTG/3TC Fixed Dose Formulations for the Maintenance of Virological Suppression in Children With HIV Infection Aged 2 to <15 Years Old NCT04337450	Phase 2/3	Active	PENTA Foundation	386	2022-04-22 → 2026-09-30
Telbivudine Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B NCT00131742	Phase 3	Completed	Novartis	—	2004-07 → 2007-01
A Study of Disease Progression and Anti-HIV Treatments NCT00001068	Phase 2	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	210	— → 1998-10
A Phase IV, Open Label, 4-period Cross-over Study to Investigate a Drug Interaction Between Lamivudine and Sorbitol Oral Solutions in Healthy Volunteers NCT02634073	Phase 4	Completed	ViiV Healthcare	16	2016-01-01 → 2016-03-11
Efficacy and Safety of a Dolutegravir-based Regimen for the Initial Management of HIV Infected Adults in Resource-limited Settings NCT02777229	Phase 3	Completed	ANRS, Emerging Infectious Diseases	616	2016-07 → 2021-07
Clinical Trial to Evaluate the Efficacy, Pharmacokinetics (PK) Interactions and Safety of Dolutegravir Plus 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in HIV-1-Infected Solid Organ Transplant Patients NCT03360682	Phase 4	Completed	Fundacion Clinic per a la Recerca Biomédica	19	2018-04-13 → 2020-05-21
A Phase II Study of Intermittent Recombinant Human Interleukin-2 (rhIL-2) by Intravenous or Subcutaneous Administration in Subjects With HIV Infection on Highly Active Antiretroviral Therapy (HAART) Compared to HAART Alone NCT00000870	Phase 2	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	200	— → 2007-03
A Study of Three Anti-HIV Drug Combinations in Patients Who Have Taken Amprenavir NCT00001095	Phase 2	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	94	— → 1999-10
A Comparison of Three Anti-HIV Drug Combinations Containing Saquinavir Soft Gelatin Capsules Used in HIV-1 Infected Patients NCT00002378	Phase 3	Completed	Hoffmann-La Roche	825	—

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain24 active DMFs14 inactive

19 active API suppliers hold Drug Master Files for this ingredient.

CIPLA LTDLAMIVUDINE USP

DMF 175352004

MATRIX PHARMACORP PRIVATE LTDLAMIVUDINE USP

DMF 177502004

HETERO LABS LTDLAMIVUDINE USP (PROCESS I)

DMF 182522005

APITORIA PHARMA PRIVATE LTDLAMIVUDINE USP

DMF 187132005

LUPIN LTDLAMIVUDINE USP

DMF 212302008

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDLAMIVUDINE USP

DMF 212782008

SIGNA SA DE CVLAMIVUDINE METHANOL SOLVATE USP

DMF 229312009

SHIJIAZHUANG LONZEAL PHARMACEUTICALS CO LTDLAMIVUDINE

DMF 229822009

APITORIA PHARMA PRIVATE LTDLAMIVUDINE USP (CRYSTALLINE POLYMORPH FORM I)

DMF 236012010

HETERO LABS LTDLAMIVUDINE USP (PROCESS II)

DMF 246092011

HETERO LABS LTDLAMIVUDINE, USP (FORM I)

DMF 249472011

WISDOM PHARMACEUTICAL CO LTDLAMIVUDINE

DMF 267392013

MATRIX PHARMACORP PRIVATE LTDLAMIVUDINE USP (PROCESS-II)

DMF 296132015

LANTECH PHARMACEUTICALS LTDLAMIVUDINE COUPLED ESTER

DMF 317792017

LAURUS LABS LTDLAMIVUDINE USP

DMF 318542017

LAURUS LABS LTDLAMIVUDINE USP (PROCESS 1)

DMF 326332018

VIVIN DRUGS AND PHARMACEUTICALS LTDLAMIVUDINE USP

DMF 338912019

SMS PHARMACEUTICALS LTDLAMIVUDINE USP

DMF 343102019

SV LABS PRIVATE LTDLAMIVUDINE COUPLED ESTER (NON-STERILE DRUG INTERMEDIATE)

DMF 345002021

VANDANA LIFE SCIENCES PRIVATE LTDLAMIVUDINE COUPLED ESTER (NON-STERILE DRUG INTERMEDIATE)

DMF 349502020

STYRAX LIFE SCIENCES PRIVATE LTDLAMIVUDINE USP

DMF 359202021

VIYASH LIFE SCIENCES PRIVATE LTDLAMIVUDINE

DMF 373032023

ARENE LIFE SCIENCES PRIVATE LTDLAMIVUDINE

DMF 391242023

EMNAR PHARMA PRIVATE LTDLAMIVUDINE

DMF 421142025

AUROBINDO PHARMA LTDInactiveLAMIVUDINE USP

DMF 179002004

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveLAMIVUDINE USP

DMF 200672006

ANHUI BIOCHEM PHARM CO LTDInactiveLAMIVUDINE

DMF 204682007

RANBAXY LABORATORIES LTDInactiveLAMIVUDINE (FORM I)

DMF 206382007

VITALIFE LABORATORIES (A DIV ARCH PHARMALABS LTD)InactiveLAMIVUDINE USP

DMF 215482008

SIBRA PHARMACEUTICALS LTD AN ARCH ENTERPRISEInactiveLAMIVUDINE USP

DMF 215492008

CIPLA LTDInactiveLAMIVUDINE USP (PROCESS 3)

DMF 217632008

CIPLA LTDInactiveLAMIVUDINE USP (PROCESS 2)

DMF 217642008

RANBAXY LABORATORIES LTDInactiveLAMIVUDINE (DRUG SUBSTANCE INTERMEDIATE)

DMF 233212009

TIANISH LABORATORIES PRIVATE LTDInactiveLAMIVUDINE USP (LVD)

DMF 234312010

SHIJIAZHUANG LONZEAL PHARMACEUTICALS CO LTDInactiveLAMIVUDINE FORM I

DMF 270022013

LUPIN LTDInactiveLAMIVUDINE (PROCESS-B)

DMF 270072013

TIANJIN SEGA PHARMA CO LTDInactiveLAMIVUDINE USP

DMF 272472013

LUPIN LTDInactiveLAMIVUDINE USP

DMF 364012021

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Dec 27, 2021	SUPPL -23	View Letter (PDF)
Dec 7, 2018	SUPPL -20	View Letter (PDF)
Sep 29, 2017	SUPPL -17	View Letter (PDF)
May 10, 2017	SUPPL -16	View Letter (PDF)
Dec 24, 2013	SUPPL -15	View Letter (PDF)
Jan 27, 2011	SUPPL -13	View Letter (PDF)
Oct 4, 2007	SUPPL -10	View Letter (PDF)
Dec 2, 2004	SUPPL -6	View Letter (PDF)
Sep 29, 2004	SUPPL -7	View Letter (PDF)
Nov 25, 2003	SUPPL -5	View Letter (PDF)
Aug 16, 2001	SUPPL -2	View Letter (PDF)
Dec 8, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5MG/ML

RLD

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Dec 8, 1998

No patent or exclusivity listings for this strength.