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Last Updated: January 17, 2020

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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 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 TRIUMEQ profile page.

The generic ingredient in TRIUMEQ is abacavir sulfate; dolutegravir sodium; lamivudine. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the abacavir sulfate; dolutegravir sodium; lamivudine profile page.
Summary for 205551
Generic Entry Opportunity 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)
TRIUMEQ abacavir sulfate; dolutegravir sodium; lamivudine TABLET;ORAL 205551 NDA A-S Medication Solutions 50090-1606 50090-1606-0 30 TABLET, FILM COATED in 1 BOTTLE (50090-1606-0)
Paragraph IV (Patent) Challenges for 205551
Tradename Dosage Ingredient NDA Submissiondate
TRIUMEQ TABLET;ORAL abacavir sulfate; dolutegravir sodium; lamivudine 205551 2017-08-14

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
Patent:  Start TrialPatent Expiration:Oct 5, 2027Product Flag?YSubstance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Dec 8, 2029Product Flag?YSubstance Flag?YDelist Request?

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

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