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Cerilliant
Teva
Fish and Richardson
QuintilesIMS
McKinsey
Citi
Moodys
Express Scripts
Accenture

Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204790

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NDA 204790 describes TIVICAY, which is a drug marketed by Viiv Hlthcare and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TIVICAY profile page.

The generic ingredient in TIVICAY is dolutegravir sodium. There are fifteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dolutegravir sodium profile page.
Summary for 204790
Tradename:TIVICAY
Applicant:Viiv Hlthcare
Ingredient:dolutegravir sodium
Patents:2
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 204790
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIVICAY dolutegravir sodium TABLET;ORAL 204790 NDA ViiV Healthcare Company 49702-226 N 49702-226-13
TIVICAY dolutegravir sodium TABLET;ORAL 204790 NDA ViiV Healthcare Company 49702-227 N 49702-227-13

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Aug 12, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 21, 2020
Regulatory Exclusivity Use:FOR USE WITH RILPIVIRINE AS A COMPLETE REGIMEN TO REPLACE THE CURRENT ARV REGIMEN IN VIROLOGICALLY SUPPRESSED PATIENTS ON A STABLE ARV REGIMEN FOR AT LEAST 6 MONTHS WITH NO HISTORY OF TX FAILURE OR KNOWN SUBSTITUTIONS ASSOC. WITH RESISTANCE TO EITHER ARV
Regulatory Exclusivity Expiration:Aug 12, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Jul 30, 2018
Regulatory Exclusivity Use:UPDATE TO LABELING WITH WEEK 48 RESULTS FROM VIKING-4 IN ANTIRETROVIRAL THERAPY (ART) - EXPERIENCED INTEGRASE STRAND TRANSFER INHIBITOR (INSTI) - RESISTANT SUBJECTS

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Federal Trade Commission
Moodys
Harvard Business School
Healthtrust
Medtronic
QuintilesIMS
Daiichi Sankyo
Chubb

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