Deep knowledge on
small-molecule drugs and
the 100,000 global patents
covering them

Flexible Flat-Rate Plans

Flat-rate pricing for predictable budgeting

Short-term plans for project- or client-based billing

► Plans and Pricing

How are People Using DrugPatentWatch?

DrugPatentWatch Ultimate Plan Preview

Details for Generic Name: lamivudine

« Back to Dashboard
Lamivudine is the generic ingredient in six branded drugs marketed by Viiv Hlthcare, Glaxosmithkline, Silarx Pharms Inc, Apotex, Apotex Inc, Aurobindo Pharma Ltd, Hetero Labs Ltd V, Lupin Ltd, Mylan Pharms Inc, Merck Sharp Dohme, Hetero Labs Ltd Iii, Strides Pharma, and Teva Pharms, and is included in twenty-one NDAs. There are seven patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are twenty-five drug master file entries for lamivudine. Eight suppliers are listed for this compound. There are fifty-eight tentative approvals for this compound.

Summary for Generic Name: lamivudine

Tradenames:6
Patents:7
Applicants:13
NDAs:21
Drug Master File Entries: see list25
Suppliers / Packaging: see list19
Therapeutic Class:Antivirals

Tentative approvals for LAMIVUDINE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL150MG; 300MG; 200MG
<disabled><disabled>TABLET; ORAL150MG; 300MG; 200MG
<disabled><disabled>TABLET; ORAL150MG; 300MG; 600MG

Clinical Trials for: lamivudine

Lamivudine Therapy in Patients With Prior Entecavir Treatment and Undetectable Viral Load
Status: Completed Condition: Hepatitis B, Chronic

Efficacy Study of Different Laboratory Management Strategies and Drug Regimens in HIV-infected Children in Africa
Status: Completed Condition: Human Immunodeficiency Virus

Pharmacokinetics of Lamivudine at Two Different Doses
Status: Completed Condition: HIV Infections

Comparison Between Lamivudine and Entecavir Treatment in Patients
Status: Recruiting Condition: Chronic Hepatitis B

Bioequivalence Study Between Lamivudine Formulations in the Form of Coated Tablet of 150 mg in Healthy Volunteers
Status: Completed Condition: HIV INFECTIONS

A Phase IV, Open Label, 4-period Cross-over Study to Investigate a Drug Interaction Between Lamivudine and Sorbitol Oral Solutions in Healthy Volunteers
Status: Recruiting Condition: Infection, Human Immunodeficiency Virus

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex Inc
LAMIVUDINE
lamivudine
TABLET;ORAL202941-001Jan 2, 2014RXNo<disabled><disabled>
Lupin Ltd
LAMIVUDINE
lamivudine
TABLET;ORAL205217-001Dec 18, 2014RXNo<disabled><disabled>
Apotex
LAMIVUDINE
lamivudine
TABLET;ORAL091606-002Dec 2, 2011RXNo<disabled><disabled>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Orange Book Patents for Generic Ingredient: lamivudine

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline
EPIVIR-HBV
lamivudine
TABLET;ORAL021003-001Dec 8, 1998RE39155*PED<disabled>
Viiv Hlthcare
EPIVIR
lamivudine
SOLUTION;ORAL020596-001Nov 17, 19955,047,407*PED<disabled>
Glaxosmithkline
EPIVIR-HBV
lamivudine
SOLUTION;ORAL021004-001Dec 8, 19985,532,246*PED<disabled>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plan comparison

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

Connect with Social Media:

Follow DrugPatentWatch on Twitter
Connect with DrugPatentWatch on Linkedin
Drug Patents on LinkedIn
`abc