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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 five patents protecting this drug. Additional details are available on the TRIUMEQ profile page.

The generic ingredient in TRIUMEQ is abacavir sulfate; dolutegravir sodium; lamivudine. There are eleven 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.

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)

Summary 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:5,905,082*PEDPatent Expiration:Nov 18, 2016Product Flag?Substance Flag?Delist Request?Y
Patent:6,294,540*PEDPatent Expiration:Nov 14, 2018Product Flag?Substance Flag?Delist Request?Y
Patent:6,417,191*PEDPatent Expiration:Sep 28, 2016Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book 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;ORAL205551-001Aug 22, 20145,905,082*PED► subscribe
Viiv Hlthcare
TRIUMEQ
abacavir sulfate; dolutegravir sodium; lamivudine
TABLET;ORAL205551-001Aug 22, 20146,417,191*PED► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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