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Last Updated: February 22, 2020

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TRIUMEQ Drug Profile


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Which patents cover Triumeq, and when can generic versions of Triumeq launch?

Triumeq is a drug marketed by Viiv Hlthcare and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty-eight patent family members in thirty-three countries.

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.

US ANDA Litigation and Generic Entry Outlook for Triumeq

Triumeq was eligible for patent challenges on August 12, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 8, 2029. This may change due to patent challenges or generic licensing.

There have been nineteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for TRIUMEQ
Drug Prices for TRIUMEQ

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Generic Entry Opportunity Date for TRIUMEQ
Generic Entry Date for TRIUMEQ*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Clinical Trials for TRIUMEQ

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of NairobiPhase 4
Ospedale Amedeo di SavoiaPhase 3
Azienda Ospedaliera San PaoloPhase 3

See all TRIUMEQ clinical trials

Recent Litigation for TRIUMEQ

Identify potential future generic entrants

District Court Litigation
Case NameDate
ViiV Healthcare Company v. Gilead Sciences, Inc.2018-02-07
ViiV Healthcare Company v. Sandoz Inc.2017-12-11
ViiV Healthcare Company v. Cipla Limited2017-12-04

See all TRIUMEQ litigation

PTAB Litigation
PetitionerDate
Teva Pharmaceuticals USA, Inc.2015-01-08
Apotex Corp.2014-06-02

See all TRIUMEQ litigation

Synonyms for TRIUMEQ
1319715-09-7
Abacavir / dolutegravir / lamivudine
Abacavir and dolutegravir and lamivudine
Abacavir mixture with dolutegravir and lamivudine
Abacavir sulfate mixture with dolutegravir and lamivudine
Abacavir, dolutegravir and lamivudine
Paragraph IV (Patent) Challenges for TRIUMEQ
Tradename Dosage Ingredient NDA Submissiondate
TRIUMEQ TABLET;ORAL abacavir sulfate; dolutegravir sodium; lamivudine 205551 2017-08-14

US Patents and Regulatory Information for TRIUMEQ

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Viiv Hlthcare TRIUMEQ abacavir sulfate; dolutegravir sodium; lamivudine TABLET;ORAL 205551-001 Aug 22, 2014 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Viiv Hlthcare TRIUMEQ abacavir sulfate; dolutegravir sodium; lamivudine TABLET;ORAL 205551-001 Aug 22, 2014 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for TRIUMEQ

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

Supplementary Protection Certificates for TRIUMEQ

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1874117 1490036-9 Sweden   Start Trial PRODUCT NAME: DOLUTEGRAVIR ELLER ETT FARMACEUTISKT ACCEPTABELT SALT ELLER SOLVAT DAERAV, INKLUSIVE DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892 20140116
1874117 C 2014 024 Romania   Start Trial PRODUCT NAME: DOLUTEGRAVIR SAU O SARE SAU SOLVAT AL ACESTUIAACCEPTABILE FARMACEUTIC, INCLUSIV DOLUTEGRAVIR DESODIU; NATIONAL AUTHORISATION NUMBER: EU/1/13/892; DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/892; DATE OF FIRST AUTHORISATION IN EEA: 20140116
1874117 C300676 Netherlands   Start Trial PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, MET INBEGRIP VAN DOLUTEGRAVIR NATRIUM; REGISTRATION NO/DATE: EU/1/13/892 20140121
0817637 05C0022 France   Start Trial PRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
AstraZeneca
McKesson
Moodys
Harvard Business School
Merck

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