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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. Two suppliers are 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^th, 2017.

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

There have been fifteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Historic data indicate that 48% of cases that proceed to trial are decided in favor of the generic patent challenger.

Summary for TRIUMEQ

International Patents:	128
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	1
Clinical Trials:	15
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TRIUMEQ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRIUMEQ
DailyMed Link:	TRIUMEQ at DailyMed

See drug prices for TRIUMEQ

Generic Entry Opportunity Date for TRIUMEQ

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
Catholic University of the Sacred Heart	Phase 3
Azienda Ospedaliera Universitaria Senese	Phase 3
Ospedale Amedeo di Savoia	Phase 3

See all TRIUMEQ clinical trials

Recent Litigation for TRIUMEQ

Identify potential future generic entrants

District Court Litigation

Case Name	Date
ViiV Healthcare Company v. Gilead Sciences, Inc.	2018-02-07
ViiV Healthcare Company v. Sandoz Inc.	2017-12-11
ViiV Healthcare Company v. Cipla Limited	2017-12-04

See all TRIUMEQ litigation

PTAB Litigation

Petitioner	Date
Teva Pharmaceuticals USA, Inc.	2015-01-08
Apotex Corp.	2014-06-02

See all TRIUMEQ litigation

Pharmacology for TRIUMEQ

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

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			Y	Y
Viiv Hlthcare	TRIUMEQ	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET;ORAL	205551-001	Aug 22, 2014		RX	Yes	Yes			Y	Y

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
Viiv Hlthcare	TRIUMEQ	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET;ORAL	205551-001	Aug 22, 2014
Viiv Hlthcare	TRIUMEQ	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET;ORAL	205551-001	Aug 22, 2014

International Patents for TRIUMEQ

Country	Patent Number	Estimated Expiration
Japan	5086478
Mexico	302718
Mexico	312216
Japan	5317257
Denmark	1874117

Supplementary Protection Certificates for TRIUMEQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0817637	23/2005	Austria		PRODUCT NAME: KOMBINATION, UMFASSEND ABACAVIR BZW. EIN PHYSIOLOGISCH AKZEPTABLES SALZ, ESTER, SALZ DES ESTERS ODER SOLVAT DAVON UND LAMIVUDIN BZW. EIN PHYSIOLOGISCH AKZEPTABLES SALZ, ESTER, SALZ DES; REGISTRATION NO/DATE: EU/1/04/298/001, EU/1/04/298/002 20041217
1874117	CR 2014 00032	Denmark		PRODUCT NAME: DOLUTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, HERUNDER DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892/001-002 20140121
1874117	30/2014	Austria		PRODUCT NAME: DOLUTEGRAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH DELUTEGRAVIR-NATRIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 (MITTEILUNG) 20140121
1874117	C20140020 00130	Estonia		PRODUCT NAME: DOLUTEGRAVIIR;REG NO/DATE: K(2014)305 (LOPLIK) 21.01.2014
1874117	PA2014021,C1874117	Lithuania		PRODUCT NAME: DOLUTEGRAVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS, ISKAITANT DOLUTEGRAVIRO NATRIO DRUSKA; REGISTRATION NO/DATE: EU/1/13/892/001, 2014-01-16 EU/1/13/892/002 20140116