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-seven 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-four 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:	157
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	20
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

Constraining patent/regulatory exclusivity:

9,242,986*PED

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	PHASE3
King's College London	Phase 3
Macquarie University, Australia	Phase 3

See all TRIUMEQ PD clinical trials

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.

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 PD	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET, FOR SUSPENSION;ORAL	215413-001	Mar 30, 2022		RX	Yes	Yes	9,242,986*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 PD	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET, FOR SUSPENSION;ORAL	215413-001	Mar 30, 2022		RX	Yes	Yes	8,129,385*PED				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
Slovenia	1874117
European Patent Office	3187225	DÉRIVÉ DE CARBAMOYLPYRIDONE POLYCYCLIQUE DOTÉ D'UNE ACTIVITÉ INHIBITRICE DE L'INTÉGRASE DU VIH (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY)
South Korea	20080009733	POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY

Supplementary Protection Certificates for TRIUMEQ PD

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0434450	C990028	Netherlands		PRODUCT NAME: ABACAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN/OF VAN EEN FARMACEUTISCH AANVAARDBAAR ESTER, IN HET BIJZONDER ABACAVIR SULFAAT; REGISTRATION NO/DATE: EU/1/99/112/001-002 19990708
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
1874117	2023C/545	Belgium		PRODUCT NAME: DOULUTEGRAVIR SODIQUE; AUTHORISATION NUMBER AND DATE: EU/1/13/892 20140121

Market Dynamics and Financial Trajectory for TRIUMEQ PD

Last updated: July 28, 2025

Introduction

TRIUMEQ PD (abacavir, dolutegravir, and lamivudine) is a fixed-dose combination antiretroviral (ARV) therapy used in the treatment of HIV-1 infection. As a pivotal drug within the HIV therapeutic landscape, TRIUMEQ PD’s market prospects are shaped by an intricate web of clinical efficacy, regulatory environments, competitive forces, and evolving healthcare policies. This article explores the current market dynamics and projects the financial trajectory of TRIUMEQ PD, considering recent developments and future trends.

Market Overview

HIV Treatment Landscape

The global HIV therapeutics market has demonstrated steady growth, driven by expanding patient populations and evolving treatment guidelines favoring combination therapies with improved tolerability and adherence features. According to IQVIA, the HIV drug market surpassed $26 billion in 2022, with a CAGR of approximately 4% from 2018 to 2022. The shift toward single-tablet regimens (STRs), such as TRIUMEQ PD, underpins market expansion, as these formulations enhance patient compliance and simplify treatment protocols.

Positioning of TRIUMEQ PD

TRIUMEQ PD is positioned as a once-daily STR comprising abacavir, dolutegravir, and lamivudine—agents with well-established efficacy and safety profiles. Its combination offers potent viral suppression and a favorable side-effect profile, making it suitable for initiating therapy and maintaining long-term treatment. Its inclusion in core treatment guidelines, such as those from WHO and US CDC, bolsters its market presence.

Market Drivers

Advancements in Treatment Guidelines

Current HIV treatment guidelines prioritize regimens with high efficacy, low resistance potential, and minimal side effects. The favorable pharmacokinetics of TRIUMEQ PD support these criteria, encouraging its adoption as a first-line therapy across diverse populations.

Patient Preference for Simplified Regimens

Conditioned by improved adherence and quality of life, patients increasingly favor STRs. TRIUMEQ PD’s once-daily dosing and tolerability satisfy these demands, positively impacting market penetration.

Regulatory Approvals and Inclusion in Treatment Guidelines

Regulatory approval from agencies such as the FDA (U.S.), EMA (Europe), and other regions facilitates market access. Additionally, inclusion in WHO prequalification and treatment guidelines cements its position globally, especially in resource-limited settings.

Demographic Expansion

The rising prevalence of HIV, notably in sub-Saharan Africa and Southeast Asia, amplifies demand. Efforts to expand access and implementation of universal treatment programs serve as growth catalysts for TRIUMEQ PD.

Market Challenges

Generic Competition

The entry of generic formulations, particularly for similar ARV combinations, exerts downward pressure on pricing and market share. As patent cliffs approach—TRIUMEQ PD’s primary patents expire in key territories—generic competition is poised to intensify.

Pricing and Reimbursement Policies

Government agencies and insurers prioritize cost containment, which may limit market prices for branded therapies. Negotiated discounts, especially in low- and middle-income countries, influence revenue streams.

Emerging Therapies

Next-generation ARVs with improved resistance profiles, tolerability, or long-acting formulations (e.g., injectable cabotegravir and rilpivirine) may erode market share for traditional oral regimens over time.

Financial Trajectory Projections

Revenue Outlook

Analysts project the global revenue for TRIUMEQ PD to reach approximately $1.2 billion by 2025, driven by increasing global HIV treatment rates and enhanced access initiatives. Factors supporting revenue growth include:

• Expansion in emerging markets due to international aid and procurement programs.
• Intensified efforts to replace older regimens with more efficacious and tolerable options.
• Broader adoption in pediatric and treatment-naïve populations.

Impact of Patent Expirations

Patent expirations slated for 2024–2026 in major markets are expected to precipitate a significant decline in revenue from branded TRIUMEQ PD formulations, with generic versions anticipated to capture substantial market share. The revenue drop could approach 30–40% in these regions within two years post-patent expiry unless the company diversifies offerings or innovates.

Portfolio Diversification Strategies

To mitigate patent cliff impacts, companies are investing in:

• Developing long-acting injectable formulations to cater to adherence challenges.
• Expanding indications for pediatric and adolescent populations.
• Engaging in strategic licensing and partnerships to maintain market relevancy.

Profitability Forecast

Profit margins for TRIUMEQ PD are projected to stabilize at approximately 45–50% pre-patent expiry, with profitability potentially decreasing post-generic entry due to price competition. Nonetheless, the existing market presence and pipeline investments may buffer margin erosion.

Geography-Specific Dynamics

• United States and Europe: High per-unit prices and established treatment protocols support robust revenues until patent expiry.
• Emerging Markets: Lower prices reflect pricing strategies compatible with local reimbursement policies but offer volume-driven growth, balancing profitability pressures.

Market Trends and Future Outlook

Shift Toward Long-acting ARVs

The development and regulatory approval of injectable ARVs herald a paradigm shift. Long-acting formulations promise superior adherence and convenience, posing a competitive threat to oral STRs like TRIUMEQ PD. Companies are actively investing in such innovations to sustain market relevance.

Personalized Medicine and Resistance Management

Advances in resistance testing and personalized treatment initiate a new frontier, influencing drug utilization patterns. Drugs effective against resistant strains or with broader genetic coverage may see increased demand.

Policy and Global Initiatives

International health agencies' goal to end AIDS by 2030 drives massive procurement and distribution efforts. Pooled procurement strategies and subsidies in low-income countries benefit TRIUMEQ PD’s market access, fostering volume growth.

Conclusion: Summarizing the Financial Trajectory

TRIUMEQ PD is positioned at a pivotal point in its lifecycle. Short to medium-term, revenues are expected to grow moderately, buoyed by global HIV treatment expansion and increased access in underserved regions. However, patent expiries and the rise of long-acting ARVs threaten sustained revenue growth beyond 2024. Diversification, innovation, and strategic collaborations will be critical for maintaining profitability.

Manufacturers that proactively adapt—by advancing long-acting formulations, expanding indications, and optimizing pricing strategies—can expect to navigate the evolving market landscape successfully. The intersection of clinical innovation, policy shifts, and competitive dynamics will ultimately define TRIUMEQ PD’s financial trajectory in the coming years.

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Key Takeaways

• Robust Near-term Growth: Market expansion driven by increasing global HIV treatment coverage favors TRIUMEQ PD’s revenue growth until patent expiration.
• Patent Cliff Risks: Significant revenue decline probable post-2024 due to generic competition; strategic diversification is essential.
• Innovation as a Cornerstone: Investment in long-acting ARVs and resistance management will determine future market positioning.
• Emerging Market Opportunities: Growth potential remains high in resource-limited settings with evolving international procurement programs.
• Strategic Adaptation Needed: Sustained profitability depends on proactive responses to market disruptions, including pipeline development, pricing strategies, and partnerships.

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FAQs

Q1: When will TRIUMEQ PD’s patents typically expire, and how will this impact the market?
Patent expirations are expected between 2024 and 2026 in key jurisdictions, leading to increased generic competition, price reductions, and potential revenue declines by 30-40%.

Q2: What are the main competitors to TRIUMEQ PD in the HIV therapy market?
Major competitors include other STRs such as Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide), Dovato (dolutegravir, lamivudine), and emerging long-acting formulations.

Q3: How do regulatory agencies influence TRIUMEQ PD’s market dynamics?
Regulatory approvals facilitate access and reimbursement, while inclusion in treatment guidelines boosts prescription rates. Conversely, delays or restrictions can limit market penetration.

Q4: What is the outlook for long-acting ARV formulations in relation to TRIUMEQ PD?
Long-acting injectables are poised to revolutionize HIV treatment, offering improved adherence and convenience, potentially reducing demand for oral STRs like TRIUMEQ PD in the long term.

Q5: How does the global goal of ending AIDS by 2030 impact the market for drugs like TRIUMEQ PD?
International initiatives increase funding, procurement, and access programs, creating a favorable environment for volume growth but intensifying price competition and regulatory scrutiny.

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References

1. IQVIA. (2022). Global HIV Therapeutics Market Analysis.
2. WHO. (2021). Consolidated Guidelines on HIV Prevention, Testing, Treatment, Service Delivery and Monitoring.
3. U.S. Food and Drug Administration. (2020). Approval and Regulatory Status of TRIUMEQ.
4. GSK. (2022). pipeline and strategic initiatives for HIV therapies.
5. MarketsandMarkets. (2022). HIV & AIDS Therapeutics Market Forecast.