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Last Updated: February 22, 2024

TRIUMEQ Drug Patent 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 two NDAs. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and fifty-three patent family members in thirty-five 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.

DrugPatentWatch® 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 June 8, 2030. This may change due to patent challenges or generic licensing.

There have been twenty-two 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

See drug prices for TRIUMEQ

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
King's College LondonPhase 3
Macquarie University, AustraliaPhase 3
Stichting TRICALS FoundationPhase 3

See all TRIUMEQ clinical trials

Paragraph IV (Patent) Challenges for TRIUMEQ
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TRIUMEQ Tablets abacavir sulfate; dolutegravir sodium; lamivudine 600 mg/50 mg/ 300 mg 205551 5 2017-08-14

US Patents and Regulatory Information for TRIUMEQ

TRIUMEQ is protected by two US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TRIUMEQ is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting TRIUMEQ

Substituted 5-hydroxy-3,4,6,9,9a, 10-hexanhydro-2h-1-oxa04a,8a-diaza-anthracene-6,10-dioness
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting TRIUMEQ

INFORMATION ADDED TO THE LABELING REGARDING THE RESULT OF STUDY 205860
Exclusivity Expiration: ⤷  Try a Trial

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Viiv Hlthcare TRIUMEQ PD abacavir sulfate; dolutegravir sodium; lamivudine TABLET, FOR SUSPENSION;ORAL 215413-001 Mar 30, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Viiv Hlthcare TRIUMEQ abacavir sulfate; dolutegravir sodium; lamivudine TABLET;ORAL 205551-001 Aug 22, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Viiv Hlthcare TRIUMEQ PD abacavir sulfate; dolutegravir sodium; lamivudine TABLET, FOR SUSPENSION;ORAL 215413-001 Mar 30, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Viiv Hlthcare TRIUMEQ abacavir sulfate; dolutegravir sodium; lamivudine TABLET;ORAL 205551-001 Aug 22, 2014 ⤷  Try a Trial ⤷  Try a Trial
Viiv Hlthcare TRIUMEQ abacavir sulfate; dolutegravir sodium; lamivudine TABLET;ORAL 205551-001 Aug 22, 2014 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for TRIUMEQ

When does loss-of-exclusivity occur for TRIUMEQ?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 09325128
Estimated Expiration: ⤷  Try a Trial

Patent: 14277831
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0923217
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 44019
Estimated Expiration: ⤷  Try a Trial

Patent: 55957
Estimated Expiration: ⤷  Try a Trial

China

Patent: 2245182
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 76080
Estimated Expiration: ⤷  Try a Trial

Patent: 10603
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 43626
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 86478
Estimated Expiration: ⤷  Try a Trial

Patent: 48595
Estimated Expiration: ⤷  Try a Trial

Patent: 30891
Estimated Expiration: ⤷  Try a Trial

Patent: 12131791
Estimated Expiration: ⤷  Try a Trial

Patent: 12511573
Estimated Expiration: ⤷  Try a Trial

Patent: 16041727
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 1942
Estimated Expiration: ⤷  Try a Trial

Patent: 11006241
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 27451
Estimated Expiration: ⤷  Try a Trial

Patent: 38923
Estimated Expiration: ⤷  Try a Trial

Patent: 11121785
Estimated Expiration: ⤷  Try a Trial

Patent: 13153004
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 1308
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1733625
Estimated Expiration: ⤷  Try a Trial

Patent: 1847887
Estimated Expiration: ⤷  Try a Trial

Patent: 110094336
Estimated Expiration: ⤷  Try a Trial

Patent: 170038116
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 41765
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 83947
Estimated Expiration: ⤷  Try a Trial

Patent: 1030010
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TRIUMEQ around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 1950212 DÉRIVÉ DE CARBAMOYLPYRIDONE POLYCYCLIQUE AYANT UNE ACTIVITÉ D'INHIBITION SUR L'INTÉGRASE DU VIH (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING INHIBITORY ACTIVITY ON HIV INTEGRASE) ⤷  Try a Trial
Japan H06211848 CRYSTALLINE OXATHIOLANE DERIVATIVE ⤷  Try a Trial
Japan 2012511573 ⤷  Try a Trial
Norway 2021018 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TRIUMEQ

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1874117 C 2014 024 Romania ⤷  Try a 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
2465580 132021000000098 Italy ⤷  Try a Trial PRODUCT NAME: CABOTEGRAVIR(VOCABRIA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1481, 20201221
1874117 1490036-9 Sweden ⤷  Try a Trial PRODUCT NAME: DOLUTEGRAVIR ELLER ETT FARMACEUTISKT ACCEPTABELT SALT ELLER SOLVAT DAERAV, INKLUSIVE DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892 20140116
2465580 301109 Netherlands ⤷  Try a Trial PRODUCT NAME: CABOTEGRAVIR; REGISTRATION NO/DATE: EU/1/20/1481 20201217
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Harvard Business School
Moodys
Merck
Express Scripts
Johnson and Johnson

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 verification 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.