Generated: December 18, 2017
DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 020596
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, which is a drug marketed by Viiv Hlthcare and Glaxosmithkline and is included in four NDAs. It is available from six suppliers. There are two patents 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 020596
|Formulation / Manufacturing:||see details|
Pharmacology for NDA: 020596
Medical Subject Heading (MeSH) Categories for 020596
Suppliers and Packaging for NDA: 020596
||National Drug Code
||ViiV Healthcare Company
||240 mL in 1 BOTTLE (49702-205-48)
|Complete Access Available with Subscription
Summary for product number 001
|Approval Date:||Nov 17, 1995||TE:||AA||RLD:||Yes|
|Regulatory Exclusivity Expiration:||Mar 23, 2018
|Regulatory Exclusivity Use:||ONCE DAILY DOSING IN PEDIATRIC PATIENTS 3 MONTHS OF AGE AND OLDER IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS FOR THE TREATMENT OF HIV-1 INFECTION|
|Patent:||► Subscribe||Patent Expiration:||Nov 18, 2016||Product Flag?||Substance Flag?||Delist Request?|
|Patent:||► Subscribe||Patent Expiration:||Sep 20, 2018||Product Flag?||Substance Flag?||Delist Request?||Y|
Expired Orange Book Patents for NDA: 020596
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