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Details for Generic Name: lamivudine

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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 eight patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has forty patent family members in twenty-eight countries.

There are twenty-four 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

Drug Master File Entries: see list24
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: Active, not recruiting 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

Estimate The Effect Of Lersivirine On The Pharmacokinetics Of Abacavir/Lamivudine In Healthy Subjects
Status: Completed Condition: Healthy Volunteers

Courtesy of
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
Aurobindo Pharma Ltd
TABLET;ORAL202032-001Nov 17, 2011RXNo<disabled><disabled>
Merck Sharp Dohme
lamivudine; raltegravir potassium
TABLET;ORAL206510-001Feb 6, 2015DISCNNo7,169,780<disabled>YY <disabled>
Hetero Labs Ltd V
TABLET;ORAL203260-001Jan 2, 2014RXNo<disabled><disabled>
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International Patent Family for Ingredient: lamivudine

Country Document Number Publication Date
Iceland3873Dec 04, 1992
United Kingdom9111902Jul 24, 1991
African Intellectual Property Organization (OAPI)9913Sep 15, 1994
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ISSN: 2162-2639

Preferred citation:

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

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