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TRIUMEQ Drug Patent Profile

Which patents cover Triumeq, and when can generic versions of Triumeq launch?

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

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

See drug prices for TRIUMEQ

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

Constraining patent/regulatory exclusivity:

9,242,986*PED

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.

This potential generic entry date is based on patent 9,242,986.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	8,129,385*PED				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	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET;ORAL	205551-001	Aug 22, 2014		RX	Yes	Yes
Viiv Hlthcare	TRIUMEQ PD	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET, FOR SUSPENSION;ORAL	215413-001	Mar 30, 2022		RX	Yes	Yes
Viiv Hlthcare	TRIUMEQ	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET;ORAL	205551-001	Aug 22, 2014		RX	Yes	Yes	9,242,986*PED				Y
Viiv Hlthcare	TRIUMEQ	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET;ORAL	205551-001	Aug 22, 2014		RX	Yes	Yes

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	5,905,082*PED
Viiv Hlthcare	TRIUMEQ	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET;ORAL	205551-001	Aug 22, 2014	6,417,191*PED
Viiv Hlthcare	TRIUMEQ	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET;ORAL	205551-001	Aug 22, 2014	6,294,540*PED

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

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 around the world.

Country	Patent Number	Title	Estimated Expiration
Norway	339525
Australia	2006307101	Polycyclic carbamoylpyridone derivative having inhibitory activity on HIV integrase
New Zealand	500865	Hemisulfate salt of (1S,4R)-cis-4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]-2-cyclopentene-1-methanol for treating HIV or HBV
Russian Federation	2638923	Синтез карбамоилпиридоновых ингибиторов интегразы ВИЧ и промежуточных соединений (SYNTHESIS OF CARBAMOIL-PYRIDONE INHIBITORS OF HIV INTEGRASE AND INTERMEDIATE COMPOUNDS)
Japan	WO2007049675	ＨＩＶインテグラーゼ阻害活性を有する多環性カルバモイルピリドン誘導体
Mexico	2008005137	DERIVADO DE CARBAMOILPIRIDONA POLICICLICA QUE TIENE ACTIVIDAD INHIBIDORA EN VIH INTEGRASA. (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING INHIBITORY ACTIVITY ON HIV INTEGRASE.)

Supplementary Protection Certificates for TRIUMEQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0817637	288	Finland
0817637	CA 2005 00028	Denmark
1874117	1490036-9	Sweden		PRODUCT NAME: DOLUTEGRAVIR ELLER ETT FARMACEUTISKT ACCEPTABELT SALT ELLER SOLVAT DAERAV, INKLUSIVE DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892 20140116
0817637	05C0022	France		PRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217
0817637	SPC016/2005	Ireland		SPC016/2005: 20060407, EXPIRES: 20191216
2465580	132021000000098	Italy		PRODUCT NAME: CABOTEGRAVIR(VOCABRIA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1481, 20201221

TRIUMEQ Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Triumeq

Introduction to Triumeq

Triumeq is a fixed-dose combination tablet developed by ViiV Healthcare, a joint venture between GlaxoSmithKline (GSK) and Pfizer. It contains three antiretroviral drugs: dolutegravir (DTG), abacavir (ABC), and lamivudine (3TC), making it a potent treatment for HIV-1 infection[4].

Market Positioning

Competitive Landscape

In the highly competitive HIV treatment market, Triumeq has established itself as a significant player. The drug was launched in September 2014 and quickly gained traction due to its efficacy and convenience as a single-tablet regimen. Despite the entry of newer treatments like Biktarvy from Gilead Sciences, Triumeq has maintained a strong market presence[1][3].

Market Share

As of 2018, ViiV Healthcare, the manufacturer of Triumeq, held a substantial share of the HIV market. In the US, ViiV's share of the STR (Single Tablet Regimen) and core agent market was about 27.4%, while in Europe, it was around 27%. In the international region, particularly in Japan, ViiV held a significant 47.2% market share[3].

Financial Performance

Sales Figures

Triumeq achieved impressive sales figures shortly after its launch. In its first full year following market entry, Triumeq generated sales of $1.115 billion. By 2018, its sales had risen to $3.535 billion, solidifying its position as a major revenue generator for ViiV Healthcare[1].

Revenue Growth

The financial performance of Triumeq has been robust, contributing significantly to ViiV Healthcare's overall revenue. The drug's sales have been a key factor in the company's growth, with ViiV's global sales increasing by 12% at a constant exchange rate up to the end of Q3 in 2017[3].

Regional Performance

United States

In the US, Triumeq has been a strong performer, with sales driven by its efficacy and the preference for single-tablet regimens. Despite competition from newer treatments, Triumeq's market share has remained stable, with dolutegravir, one of its components, being the leading core agent in the US market[3].

Europe

In Europe, Triumeq has also seen steady growth, with a market share of around 27% in the STR and core agent market. The drug's performance in Europe has been consistent, contributing to ViiV's overall European revenue[3].

International Region

The international region, particularly Japan, has been a significant market for Triumeq. ViiV holds a 47.2% market share in Japan, which is one of the company's largest international markets. The drug's performance in these regions has been crucial for ViiV's global growth strategy[3].

Innovation and Pipeline

Ongoing Clinical Studies

ViiV Healthcare has a strong pipeline of upcoming treatments, including several Phase III clinical studies. These studies are focused on prevention, treatment, remission, and cure of HIV, ensuring that the company remains at the forefront of HIV treatment innovation. The success of Triumeq has provided a solid foundation for these future developments[3].

Future Launches

In addition to Triumeq, ViiV has filed for approval of a dolutegravir/3TC fixed-dose combination in Europe and the US. Positive results from the ATLAS and FLAIR studies on cabotegravir/rilpivirine have also positioned the company for further growth in the two-drug regimen era[3].

Financial Projections

Sales Forecasts

The financial trajectory for Triumeq and other ViiV products looks promising. The company projects growth in global sales, share, and profits over the next five years, driven by its innovative pipeline and strong commercial execution. While specific sales forecasts for Triumeq beyond 2018 are not detailed, the overall performance of ViiV's portfolio suggests continued success[3].

Challenges and Opportunities

Competitive Pressure

The HIV treatment market is highly competitive, with new treatments like Biktarvy from Gilead Sciences posing significant competition. However, Triumeq's established market presence and the trust built with healthcare providers and patients have helped it maintain its position[1][3].

Market Expansion

ViiV's business model, which includes voluntary free licenses for generic manufacturers in developing countries, high-volume lower-cost tenders in middle-income countries, and direct sales to payers and governments in developed countries, ensures broad access to its medicines. This strategy has helped expand the market for Triumeq and other ViiV products[3].

Key Takeaways

• Strong Market Presence: Triumeq has established itself as a major player in the HIV treatment market.
• Robust Financial Performance: The drug has generated significant revenue, contributing to ViiV Healthcare's overall financial health.
• Regional Growth: Triumeq has performed well in the US, Europe, and international regions, particularly in Japan.
• Innovation Pipeline: ViiV's ongoing clinical studies and future launches position the company for continued growth.
• Competitive Resilience: Despite competition, Triumeq has maintained its market share due to its efficacy and trust built with healthcare providers.

FAQs

What is Triumeq?

Triumeq is a fixed-dose combination tablet containing dolutegravir (DTG), abacavir (ABC), and lamivudine (3TC), used for the treatment of HIV-1 infection.

Who manufactures Triumeq?

Triumeq is manufactured by ViiV Healthcare, a joint venture between GlaxoSmithKline (GSK) and Pfizer.

What are the key components of Triumeq?

The key components of Triumeq are dolutegravir (DTG), abacavir (ABC), and lamivudine (3TC).

How has Triumeq performed in the market?

Triumeq has achieved significant sales figures, with $1.115 billion in its first full year and $3.535 billion by 2018, making it a major revenue generator for ViiV Healthcare.

What are the future prospects for Triumeq?

ViiV Healthcare projects growth in global sales, share, and profits over the next five years, driven by its innovative pipeline and strong commercial execution.

How does Triumeq compare to other HIV treatments?

Triumeq has maintained its market share despite competition from newer treatments like Biktarvy, thanks to its efficacy and the trust built with healthcare providers and patients.

References

1. Clarivate, "Biktarvy, the booming blockbuster, drives HIV market | Clarivate"
2. Shionogi, "1st Half (Interim period) of Fiscal 2024 Financial Results"
3. GSK, "ViiV Meet The Management - transcript (PDF - GSK)"
4. FDA, "Clinical Review of Original NDA and Efficacy Supplement (Triumeq)"