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TRIUMEQ Drug Patent Profile

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Which patents cover Triumeq, and what generic alternatives are available?

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-five 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-six 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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Summary for TRIUMEQ

International Patents:	155
US Patents:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	19
Patent Applications:	117
Drug Prices:	Drug price information for TRIUMEQ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRIUMEQ
What excipients (inactive ingredients) are in TRIUMEQ?	TRIUMEQ excipients list
DailyMed Link:	TRIUMEQ at DailyMed

Drug patent expirations by year for TRIUMEQ

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TRIUMEQ

Generic Entry Date for TRIUMEQ^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 205551 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

Sponsor	Phase
Stichting TRICALS Foundation	Phase 3
King's College London	Phase 3
Macquarie University, Australia	Phase 3

See all TRIUMEQ clinical trials

Pharmacology for TRIUMEQ

Drug Class	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Cytochrome P450 1A1 Inhibitors HIV Integrase Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Nucleoside Reverse Transcriptase Inhibitors Organic Cation Transporter 2 Inhibitors

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 ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

FDA Regulatory Exclusivity protecting TRIUMEQ

INFORMATION ADDED TO THE LABELING REGARDING THE RESULT OF STUDY 205860
Exclusivity Expiration: ⤷ Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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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	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Viiv Hlthcare	TRIUMEQ PD	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET, FOR SUSPENSION;ORAL	215413-001	Mar 30, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Viiv Hlthcare	TRIUMEQ	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET;ORAL	205551-001	Aug 22, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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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

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
Patent: Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates
Estimated Expiration: ⤷ Sign Up

Patent: 14277831
Patent: SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES
Estimated Expiration: ⤷ Sign Up

Brazil

Patent: 0923217
Patent: processos para a preparação de um composto de piridona, e para a preparação de uma forma cristalina, composto, sal ou um hidrato deste, forma cristalina de um sal de sódio ou um hidrato deste, e, composição farmacêutica.
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 44019
Patent: SYNTHESE D'INHIBITEURS CARBAMOYLPYRIDONE DE L'INTEGRASE DU VIH ET INTERMEDIAIRES (SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES)
Estimated Expiration: ⤷ Sign Up

Patent: 55957
Patent: SYNTHESE D'INHIBITEURS CARBAMOYLPYRIDONE DE L'INTEGRASE DU VIH ET INTERMEDIAIRES (SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES)
Estimated Expiration: ⤷ Sign Up

China

Patent: 2245182
Patent: Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 76080
Patent: SYNTHÈSE D'INHIBITEURS CARBAMOYLPYRIDONE DE L'INTÉGRASE DU VIH ET INTERMÉDIAIRES (SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES)
Estimated Expiration: ⤷ Sign Up

Patent: 10603
Patent: SYNTHÈSE D'INHIBITEURS CARBAMOYLPYRIDONE DE L'INTÉGRASE DU VIH ET INTERMÉDIAIRES (SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES)
Estimated Expiration: ⤷ Sign Up

Hong Kong

Patent: 43626
Patent: 氨基甲酰基吡啶酮HIV整合酶抑制劑和中間體的合成 (SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES)
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 86478
Estimated Expiration: ⤷ Sign Up

Patent: 48595
Estimated Expiration: ⤷ Sign Up

Patent: 30891
Estimated Expiration: ⤷ Sign Up

Patent: 12131791
Patent: SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND THEIR INTERMEDIATES
Estimated Expiration: ⤷ Sign Up

Patent: 12511573
Estimated Expiration: ⤷ Sign Up

Patent: 16041727
Patent: カルバモイルピリドンＨＩＶインテグラーゼ阻害剤及びそれらの中間体の合成 (SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND THEIR INTERMEDIATES)
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 1942
Patent: SINTESIS DE INHIBIDORES DE INTEGRASA DE VIH DE CARBAMOIL-PIRIDONA E INTERMEDIARIOS. (SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES.)
Estimated Expiration: ⤷ Sign Up

Patent: 11006241
Patent: SINTESIS DE INHIBIDORES DE INTEGRASA DE VIH DE CARBAMOIL-PIRIDONA E INTERMEDIARIOS. (SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES.)
Estimated Expiration: ⤷ Sign Up

Russian Federation

Patent: 27451
Patent: СИНТЕЗ КАРБАМОИЛПИРИДОНОВЫХ ИНГИБИТОРОВ ИНТЕГРАЗЫ ВИЧ И ПРОМЕЖУТОЧНЫХ СОЕДИНЕНИЙ (SYNTHESIS OF CARBAMOYL PYRIDONE INHIBITORS OF HIV INTEGRASE AND INTERMEDIATE COMPOUNDS)
Estimated Expiration: ⤷ Sign Up

Patent: 38923
Patent: Синтез карбамоилпиридоновых ингибиторов интегразы ВИЧ и промежуточных соединений (SYNTHESIS OF CARBAMOIL-PYRIDONE INHIBITORS OF HIV INTEGRASE AND INTERMEDIATE COMPOUNDS)
Estimated Expiration: ⤷ Sign Up

Patent: 11121785
Patent: СИНТЕЗ КАРБАМОИЛПИРИДОНОВЫХ ИНГИБИТОРОВ ИНТЕГРАЗЫ ВИЧ И ПРОМЕЖУТОЧНЫХ СОЕДИНЕНИЙ
Estimated Expiration: ⤷ Sign Up

Patent: 13153004
Patent: СИНТЕЗ КАРБАМОИЛПИРИДОНОВЫХ ИНГИБИТОРОВ ИНТЕГРАЗЫ ВИЧ И ПРОМЕЖУТОЧНЫХ СОЕДИНЕНИЙ
Estimated Expiration: ⤷ Sign Up

Singapore

Patent: 1308
Patent: SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES
Estimated Expiration: ⤷ Sign Up

South Korea

Patent: 1733625
Estimated Expiration: ⤷ Sign Up

Patent: 1847887
Estimated Expiration: ⤷ Sign Up

Patent: 110094336
Patent: SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES
Estimated Expiration: ⤷ Sign Up

Patent: 170038116
Patent: 카르바모일피리돈 ＨＩＶ 인테그라제 억제제 및 중간체의 합성 (SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES)
Estimated Expiration: ⤷ Sign Up

Spain

Patent: 41765
Estimated Expiration: ⤷ Sign Up

Taiwan

Patent: 83947
Estimated Expiration: ⤷ Sign Up

Patent: 1030010
Patent: Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates
Estimated Expiration: ⤷ Sign Up

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.

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Country	Patent Number	Title	Estimated Expiration
Israel	186555	(4r,9as)-5-הידרוקסי-4-מתיל-6,10-דיאוקסו-10,9a,9,6,4,3 -הקסאהידרו-2h-1-אוקסא-8a,4a -דיאזא אנטרצן-7-חומצה קרבוקסילית 4,2-דיפלואורו-בנזילאמיד או מלח רוקחי שלו, תכשיר המכיל אותו ושימוש בו בטיפול או מניעת hiv ((4 r,9as)-5-hydroxy-4-methyll-6,1 0-dioxo-3,4,6,9,9a ,10-hexahydro-2h-1-oxa-4a, 8a-diaza-anthracene-7 -carboxylic acid 2,4-difluoro-benzylamide or a pharmaceutically acceptable salt thereof, composition comprising it and uses thereof in the treatment and prophylaxis of hiv)	⤷ Sign Up
Japan	H06211848	CRYSTALLINE OXATHIOLANE DERIVATIVE	⤷ Sign Up
Japan	6130891		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for TRIUMEQ

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1874117	C 2014 024	Romania	⤷ Sign Up	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	1490036-9	Sweden	⤷ Sign Up	PRODUCT NAME: DOLUTEGRAVIR ELLER ETT FARMACEUTISKT ACCEPTABELT SALT ELLER SOLVAT DAERAV, INKLUSIVE DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892 20140116
1874117	14C0041	France	⤷ Sign Up	PRODUCT NAME: DOLUTEGRAVIR ET SES SELS OU SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES,NOTAMMENT LE DOLUTEGRAVIR SODIQUE.; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description