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TRIUMEQ PD Drug Patent Profile

When do Triumeq Pd patents expire, and when can generic versions of Triumeq Pd launch?

Triumeq Pd 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 fifty-five patent family members in thirty-five countries.

The generic ingredient in TRIUMEQ PD 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 Pd

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 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

Summary for TRIUMEQ PD

International Patents:	155
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	19
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TRIUMEQ PD
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRIUMEQ PD
DailyMed Link:	TRIUMEQ PD at DailyMed

See drug prices for TRIUMEQ PD

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

NDA:

215413

Dosage:

TABLET, FOR SUSPENSION;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 PD

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

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

See all TRIUMEQ PD clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for TRIUMEQ PD

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J05AJ	Integrase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for TRIUMEQ PD

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TRIUMEQ PD	Tablets for Oral Suspension	abacavir sulfate; dolutegravir sodium; lamivudine	60 mg/5 mg/30 mg	215413	1	2023-03-31

US Patents and Regulatory Information for TRIUMEQ PD

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

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 PD

FDA Regulatory Exclusivity protecting TRIUMEQ PD

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 PD	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET, FOR SUSPENSION;ORAL	215413-001	Mar 30, 2022		RX	Yes	Yes					Y
Viiv Hlthcare	TRIUMEQ PD	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET, FOR SUSPENSION;ORAL	215413-001	Mar 30, 2022		RX	Yes	Yes
Viiv Hlthcare	TRIUMEQ PD	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET, FOR SUSPENSION;ORAL	215413-001	Mar 30, 2022		RX	Yes	Yes					Y
Viiv Hlthcare	TRIUMEQ PD	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET, FOR SUSPENSION;ORAL	215413-001	Mar 30, 2022		RX	Yes	Yes

International Patents for TRIUMEQ PD

When does loss-of-exclusivity occur for TRIUMEQ PD?

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

Australia

Brazil

Canada

China

European Patent Office

Hong Kong

Japan

Mexico

Russian Federation

Singapore

South Korea

Spain

Taiwan

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 PD around the world.

Country	Patent Number	Title	Estimated Expiration
Norway	20161315	Polysyklisk karbamoylpyridonderivat som har integrase inhibitorisk aktivitet
Japan	6130891
Portugal	3045206
Spain	2437268
Mexico	2007013351	DERIVADO DE CARBAMOILPIRIDONA POLICICLICO QUE TIENE ACTIVIDAD INHIBIDORA DE LA INTEGRASA DE HIV. (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY.)
Slovenia	3045206

Supplementary Protection Certificates for TRIUMEQ PD

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0817637	C00817637/01	Switzerland		PRODUCT NAME: ABACAVIR + LAMIVUDIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 56977 31.10.2005
2465580	21C1023	France		PRODUCT NAME: CABOTEGRAVIR OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; NAT. REGISTRATION NO/DATE: EU/1/20/1481 20201221; FIRST REGISTRATION: - EU/1/20/1481 20201221
2465580	LUC00210	Luxembourg		PRODUCT NAME: CABOTEGRAVIR; AUTHORISATION NUMBER AND DATE: EU/1/20/1481 20201221
1874117	122014000066	Germany		PRODUCT NAME: DOLUTEGRAVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH DOLUTEGRAVIRNATRIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140116
2465580	PA2021512	Lithuania		PRODUCT NAME: KABOTEGRAVIRAS; REGISTRATION NO/DATE: EU/1/20/1481 20201217
1874117	300676	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