Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 21, 2019

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 one supplier. There is one patent 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 twelve drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the abacavir sulfate profile page.
Summary for 020978
Tradename:ZIAGEN
Applicant:Viiv Hlthcare
Ingredient:abacavir sulfate
Patents:1
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
Paragraph IV (Patent) Challenges for 020978
Tradename Dosage Ingredient NDA Submissiondate
ZIAGEN SOLUTION;ORAL abacavir sulfate 020978 2012-12-27

Profile for product number 001

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

Expired US Patents for NDA 020978

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare ZIAGEN abacavir sulfate SOLUTION;ORAL 020978-001 Dec 17, 1998   Start Trial   Start Trial
Viiv Hlthcare ZIAGEN abacavir sulfate SOLUTION;ORAL 020978-001 Dec 17, 1998   Start Trial   Start Trial
Viiv Hlthcare ZIAGEN abacavir sulfate SOLUTION;ORAL 020978-001 Dec 17, 1998   Start Trial   Start Trial
Viiv Hlthcare ZIAGEN abacavir sulfate SOLUTION;ORAL 020978-001 Dec 17, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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