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Generated: December 18, 2017

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:1
Applicant:1
Ingredient:1
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 49702-226-13 30 TABLET, FILM COATED in 1 BOTTLE (49702-226-13)
TIVICAY dolutegravir sodium TABLET;ORAL 204790 NDA ViiV Healthcare Company 49702-227 49702-227-13 30 TABLET, FILM COATED in 1 BOTTLE (49702-227-13)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Aug 12, 2013TE:RLD:Yes
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
Patent:► SubscribePatent Expiration:Oct 5, 2027Product Flag?YSubstance Flag?YDelist Request?


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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
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McKinsey
Healthtrust
Argus Health
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Fuji

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