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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 three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and ninety-eight patent family members in fifty-eight countries.

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

Summary for TRIUMEQ

International Patents:	198
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	1
Clinical Trials:	11
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRIUMEQ
DailyMed Link:	TRIUMEQ at DailyMed

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.

Pharmacology for TRIUMEQ

Ingredient-type	Nucleoside Analog
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

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
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

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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

Paragraph IV (Patent) Challenges for TRIUMEQ

Drugname	Dosage	Strength	RLD	Date
	Tablets	600 mg/50 mg/300 mg

Non-Orange Book US Patents for TRIUMEQ

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
9,051,337	Substituted 10-hydroxy-9,11-dioxo-2,3,4a,5,9,11,13,13a-octahydro-1h-pyrido[1,2-a]pyrr- olo[1',2':3,4]imidazo[1,2-d]pyrazine-8-carboxamides
9,273,065	Substituted pyrido[1',2':4,5]pyrazino[1,2-a]pyrimidines as HIV integrase inhibitors
7,858,788	Bicyclic carbamoylpyridone derivative having HIV integrase inhibitory activity
8,624,023	Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates

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International Patents for TRIUMEQ

Country	Document Number	Estimated Expiration
Australia	2006307101
Japan	5317257
Taiwan	201030010
Australia	7912398

Supplementary Protection Certificates for TRIUMEQ

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
99C0033	Belgium		PRODUCT NAME: ABACAVIR SULFATE; NATL. REGISTRATION NO/DATE: EU/1/99/112/001 19990708; FIRST REGISTRATION: CH 55048 19990628
0676	Netherlands		PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, MET INBEGRIP VAN DOLUTEGRAVIR NATRIUM; REGISTRATION NO/DATE: EU/1/13/892 20140121
0140020 00130	Estonia		PRODUCT NAME: DOLUTEGRAVIIR;REG NO/DATE: K(2014)305 (LOPLIK) 21.01.2014
2014021,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