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US Department of Justice
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Generated: November 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021003

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NDA 021003 describes EPIVIR-HBV, which 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. Additional details are available on the EPIVIR-HBV profile page.

The generic ingredient in EPIVIR-HBV 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 021003

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 021003

Medical Subject Heading (MeSH) Categories for 021003

Suppliers and Packaging for NDA: 021003

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPIVIR-HBV
lamivudine
TABLET;ORAL 021003 NDA GlaxoSmithKline LLC 0173-0662 0173-0662-00 60 TABLET, FILM COATED in 1 BOTTLE (0173-0662-00)
EPIVIR-HBV
lamivudine
TABLET;ORAL 021003 NDA State of Florida DOH Central Pharmacy 53808-0893 53808-0893-1 30 TABLET, FILM COATED in 1 BLISTER PACK (53808-0893-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Dec 8, 1998TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Nov 18, 2016Product Flag?Substance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021003

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline
EPIVIR-HBV
lamivudine
TABLET;ORAL021003-001Dec 8, 1998► Subscribe► Subscribe
Glaxosmithkline
EPIVIR-HBV
lamivudine
TABLET;ORAL021003-001Dec 8, 1998► Subscribe► Subscribe
Glaxosmithkline
EPIVIR-HBV
lamivudine
TABLET;ORAL021003-001Dec 8, 1998► Subscribe► Subscribe
Glaxosmithkline
EPIVIR-HBV
lamivudine
TABLET;ORAL021003-001Dec 8, 1998► Subscribe► Subscribe
Glaxosmithkline
EPIVIR-HBV
lamivudine
TABLET;ORAL021003-001Dec 8, 1998► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

UBS
McKesson
AstraZeneca
Cantor Fitzgerald
Boehringer Ingelheim
Merck
QuintilesIMS
Fish and Richardson
Moodys
Covington

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