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Last Updated: September 19, 2020

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Details for New Drug Application (NDA): 213983

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NDA 213983 describes TIVICAY PD, which is a drug marketed by Viiv Hlthcare and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the TIVICAY PD profile page.

The generic ingredient in TIVICAY PD is dolutegravir sodium. There are seventeen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the dolutegravir sodium profile page.
Summary for 213983
Tradename:TIVICAY PD
Applicant:Viiv Hlthcare
Ingredient:dolutegravir sodium
Patents:2
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 213983
Generic Entry Date for 213983*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, FOR SUSPENSION;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: 213983
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIVICAY PD dolutegravir sodium TABLET, FOR SUSPENSION;ORAL 213983 NDA ViiV Healthcare Company 49702-255 49702-255-37 1 BOTTLE in 1 CARTON (49702-255-37) > 60 TABLET, FOR SUSPENSION in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, FOR SUSPENSION;ORALStrengthEQ 5MG BASE
Approval Date:Jun 12, 2020TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Oct 5, 2027Product Flag?YSubstance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Dec 8, 2029Product Flag?YSubstance Flag?YDelist Request?

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