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.

This drug has one hundred and forty-nine patent family members in thirty-three 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 December 8, 2029. 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:	149
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
Stichting TRICALS Foundation	Phase 3
King's College London	Phase 3
Macquarie University, Australia	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

US Patents and Regulatory Information for TRIUMEQ PD

TRIUMEQ PD is protected by two US patents.

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

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

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
Japan	5086478
Mexico	2011006241	SINTESIS DE INHIBIDORES DE INTEGRASA DE VIH DE CARBAMOIL-PIRIDONA E INTERMEDIARIOS. (SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES.)
Hungary	E044978

Supplementary Protection Certificates for TRIUMEQ PD

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2465580	PA2021512,C2465580	Lithuania		PRODUCT NAME: KABOTEGRAVIRAS; REGISTRATION NO/DATE: EU/1/20/1481 20201217
1874117	2014C/038	Belgium		PRODUCT NAME: DOULUTEGRAVIR SODIQUE; AUTHORISATION NUMBER AND DATE: EU/1/13/892 20140121
1874117	SPC/GB14/041	United Kingdom		PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTERED: UK EU/1/13/892/001-006 20140121