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Profile for Tradename: EPIVIR-HBV

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Epivir-hbv is a drug marketed by Glaxosmithkline and is included in two NDAs. It is available from three suppliers. There are two patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in EPIVIR-HBV is lamivudine. There are twenty-four drug master file entries for this compound. Eight suppliers are listed for this compound. There are sixty tentative approvals for this compound. Additional details are available on the lamivudine profile page.

Summary for Tradename: EPIVIR-HBV

Patents:2
Applicants:1
NDAs:2
Suppliers / Packagers: see list4

Clinical Trials for: EPIVIR-HBV

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

Lamivudine Therapy in Patients With Prior Entecavir Treatment and Undetectable Viral Load
Status: Active, not recruiting Condition: Hepatitis B, Chronic

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

Relative Bioavailability Study of Two New Dolutegravir/Abacavir/Lamivudine Fixed Dose Combination Tablets
Status: Completed Condition: Healthy Subjects; Infection, Human Immunodeficiency Virus

To Determine if There Are Pharmacokinetic Interactions at Plasma or Intracellular Level Between Nucleosides and Tenofovir
Status: Completed Condition: HIV

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

Safety and Efficacy of Fixed Dose Combination Dolutegravir/Abacavir/Lamivudine FDC Initiated During Acute HIV Infection
Status: Not yet recruiting Condition: HIV; Acute HIV Infection

Lamivudine and Adefovir Dipivoxil Fixed Dose Combination
Status: Completed Condition: Hepatitis B, Chronic

Switch to Tenofovir Versus Continue Lamivudine/Adefovir Treatment in Lamivudine-resistance Chronic Hepatitis B Patients
Status: Recruiting Condition: Chronic Hepatitis B

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
Glaxosmithkline
EPIVIR-HBV
lamivudine
SOLUTION;ORAL021004-001Dec 8, 1998RXYes6,004,968*PED<disabled>Y<disabled>
Glaxosmithkline
EPIVIR-HBV
lamivudine
TABLET;ORAL021003-001Dec 8, 1998RXYes5,905,082*PED<disabled>Y<disabled>
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Paragraph IV activity for: EPIVIR-HBV

Drugname Dosage Strength RLD Submissiondate
lamivudineTablets100 mgEpivir-HBV10/31/2007
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Preferred citation:

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

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