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Details for New Drug Application (NDA): 020596

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NDA 020596 describes EPIVIR, which is a drug marketed by Viiv Hlthcare and Glaxosmithkline and is included in four NDAs. It is available from seven 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-six drug master file entries for this compound. Twenty suppliers are listed for this compound. There are sixty-nine tentative approvals for this compound. Additional details are available on the lamivudine profile page.

Summary for NDA: 020596

Tradename:
EPIVIR
Applicant:
Viiv Hlthcare
Ingredient:
lamivudine
Patents:2
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 020596

Suppliers and Packaging for NDA: 020596

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPIVIR
lamivudine
SOLUTION;ORAL 020596 NDA ViiV Healthcare Company 49702-205 49702-205-48 240 mL in 1 BOTTLE (49702-205-48)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength10MG/ML
Approval Date:Nov 17, 1995TE:AARLD:Yes
Patent:5,905,082*PEDPatent Expiration:Nov 18, 2016Product Flag?Substance Flag?Delist Request?Y
Patent:6,004,968*PEDPatent Expiration:Sep 20, 2018Product Flag?Substance Flag?Delist Request?Y
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

Expired Orange Book Patents for NDA: 020596

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare
EPIVIR
lamivudine
SOLUTION;ORAL020596-001Nov 17, 19955,047,407*PED► subscribe
Viiv Hlthcare
EPIVIR
lamivudine
SOLUTION;ORAL020596-001Nov 17, 19957,119,202*PED► subscribe
Viiv Hlthcare
EPIVIR
lamivudine
SOLUTION;ORAL020596-001Nov 17, 19955,905,082*PED► subscribe
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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. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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