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Serving leading biopharmaceutical companies globally:

Cipla
Julphar
Fish and Richardson
Accenture
Cerilliant
Chinese Patent Office
Chubb
Medtronic
Queensland Health
Moodys

Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020564

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NDA 020564 describes EPIVIR, which is a drug marketed by Viiv Hlthcare and Glaxosmithkline and is included in four NDAs. It is available from six suppliers. There is one patent protecting this drug and three Paragraph IV challenges. Additional details are available on the EPIVIR profile page.

The generic ingredient in EPIVIR is lamivudine. There are twenty-eight drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the lamivudine profile page.
Summary for 020564
Tradename:EPIVIR
Applicant:Viiv Hlthcare
Ingredient:lamivudine
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 020564
Medical Subject Heading (MeSH) Categories for 020564
Suppliers and Packaging for NDA: 020564
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPIVIR lamivudine TABLET;ORAL 020564 NDA KAISER FOUNDATION HOSPITALS 0179-0087 N 0179-0087-70
EPIVIR lamivudine TABLET;ORAL 020564 NDA Rebel Distributors Corp 21695-367 E 21695-367-06

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Nov 17, 1995TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Jun 24, 2002TE:ABRLD:Yes

Expired US Patents for NDA 020564

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare EPIVIR lamivudine TABLET;ORAL 020564-001 Nov 17, 1995 ➤ Sign Up ➤ Sign Up
Viiv Hlthcare EPIVIR lamivudine TABLET;ORAL 020564-003 Jun 24, 2002 ➤ Sign Up ➤ Sign Up
Viiv Hlthcare EPIVIR lamivudine TABLET;ORAL 020564-003 Jun 24, 2002 ➤ Sign Up ➤ Sign Up
Viiv Hlthcare EPIVIR lamivudine TABLET;ORAL 020564-003 Jun 24, 2002 ➤ Sign Up ➤ Sign Up
Viiv Hlthcare EPIVIR lamivudine TABLET;ORAL 020564-001 Nov 17, 1995 ➤ Sign Up ➤ Sign Up
Viiv Hlthcare EPIVIR lamivudine TABLET;ORAL 020564-001 Nov 17, 1995 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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AstraZeneca
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US Department of Justice
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Fuji
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