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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 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

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
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
TABLET;ORAL202941-001Jan 2, 2014RXNo<disabled><disabled>
Lupin Ltd
TABLET;ORAL205217-001Dec 18, 2014RXNo<disabled><disabled>
TABLET;ORAL091606-002Dec 2, 2011RXNo<disabled><disabled>
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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
TABLET;ORAL021003-001Dec 8, 1998RE39155*PED<disabled>
Viiv Hlthcare
SOLUTION;ORAL020596-001Nov 17, 19955,047,407*PED<disabled>
SOLUTION;ORAL021004-001Dec 8, 19985,532,246*PED<disabled>
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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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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