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Generated: September 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020978

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NDA 020978 describes ZIAGEN, which is a drug marketed by Viiv Hlthcare and is included in two NDAs. It is available from two suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the ZIAGEN profile page.

The generic ingredient in ZIAGEN is abacavir sulfate. There are eleven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the abacavir sulfate profile page.

Summary for NDA: 020978

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:2
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 020978

Suppliers and Packaging for NDA: 020978

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZIAGEN
abacavir sulfate
SOLUTION;ORAL 020978 NDA ViiV Healthcare Company 49702-222 49702-222-48 1 BOTTLE in 1 CARTON (49702-222-48) > 240 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrengthEQ 20MG BASE/ML
Approval Date:Dec 17, 1998TE:AARLD: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:► SubscribePatent Expiration:Nov 14, 2018Product Flag?Substance Flag?Delist Request?Y
Patent:► SubscribePatent Expiration:Aug 4, 2019Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 020978

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare
ZIAGEN
abacavir sulfate
SOLUTION;ORAL020978-001Dec 17, 1998► Subscribe► Subscribe
Viiv Hlthcare
ZIAGEN
abacavir sulfate
SOLUTION;ORAL020978-001Dec 17, 1998► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Covington
Moodys
Queensland Health
US Army
Novartis
Daiichi Sankyo
Citi
Accenture
Fish and Richardson
AstraZeneca

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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