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Generated: April 18, 2019

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 four 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 seventeen drug master file entries for this compound. Four 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
Generic Entry Opportunity Date for 204790
Generic Entry Date for 204790*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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)

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
Patent:➤ Sign UpPatent Expiration:Oct 5, 2027Product Flag?YSubstance Flag?YDelist Request?
Patent:➤ Sign UpPatent Expiration:Dec 8, 2029Product Flag?YSubstance Flag?YDelist Request?

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