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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 215413


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NDA 215413 describes TRIUMEQ 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 TRIUMEQ PD profile page.

The generic ingredient in TRIUMEQ PD is abacavir sulfate; dolutegravir sodium; lamivudine. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the abacavir sulfate; dolutegravir sodium; lamivudine profile page.
Summary for 215413
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215413
Generic Entry Date for 215413*:
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: 215413
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRIUMEQ PD abacavir sulfate; dolutegravir sodium; lamivudine TABLET, FOR SUSPENSION;ORAL 215413 NDA ViiV Healthcare Company 49702-258 49702-258-37 1 KIT in 1 CARTON (49702-258-37) * 90 TABLET, FILM COATED in 1 BOTTLE (49702-272-59)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, FOR SUSPENSION;ORALStrengthEQ 60MG BASE;EQ 5MG BASE;30MG
Approval Date:Mar 30, 2022TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 15, 2026
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Dec 15, 2026
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:⤷  Sign UpPatent Expiration:Apr 5, 2028Product Flag?Substance Flag?Delist Request?Y

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