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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 205551


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NDA 205551 describes TRIUMEQ, which is a drug marketed by Viiv Hlthcare and is included in two NDAs. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TRIUMEQ profile page.

The generic ingredient in TRIUMEQ 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 205551
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 205551
Generic Entry Date for 205551*:
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: 205551
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRIUMEQ abacavir sulfate; dolutegravir sodium; lamivudine TABLET;ORAL 205551 NDA ViiV Healthcare Company 49702-231 49702-231-13 30 TABLET, FILM COATED in 1 BOTTLE (49702-231-13)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 600MG BASE;EQ 50MG BASE;300MG
Approval Date:Aug 22, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 15, 2026
Regulatory Exclusivity Use:INFORMATION ADDED TO THE LABELING REGARDING THE RESULT OF STUDY 205860
Regulatory Exclusivity Expiration:Dec 15, 2026
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:⤷  Sign UpPatent Expiration:Apr 5, 2028Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 205551

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare TRIUMEQ abacavir sulfate; dolutegravir sodium; lamivudine TABLET;ORAL 205551-001 Aug 22, 2014 ⤷  Sign Up ⤷  Sign Up
Viiv Hlthcare TRIUMEQ abacavir sulfate; dolutegravir sodium; lamivudine TABLET;ORAL 205551-001 Aug 22, 2014 ⤷  Sign Up ⤷  Sign Up
Viiv Hlthcare TRIUMEQ abacavir sulfate; dolutegravir sodium; lamivudine TABLET;ORAL 205551-001 Aug 22, 2014 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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