TRIUMEQ Drug Patent Profile

When do Triumeq patents expire, 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-seven 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-five 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:	157
US Patents:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	20
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
Macquarie University, Australia	PHASE3
Macquarie University, Australia	Phase 3
Stichting TRICALS Foundation	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	6,294,540*PED
Viiv Hlthcare	TRIUMEQ	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET;ORAL	205551-001	Aug 22, 2014	6,417,191*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
Portugal	1874117
Hong Kong	1009599
South Africa	200803423	Polycyclic carbamoylpyridone derivative having inhibitory activity on HIV integrase
Taiwan	200716635	Polycyclic carbamoylpyridone derivative having HIV integrase inhibitory activity
Japan	6130891
Poland	187085

Supplementary Protection Certificates for TRIUMEQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1874117	CR 2014 00032	Denmark		PRODUCT NAME: DOLUTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, HERUNDER DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892/001-002 20140121
0817637	91171	Luxembourg		91171, EXPIRES: 20191217
2465580	CA 2021 00010	Denmark		PRODUCT NAME: CABOTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/20/1481 20201221
0434450	990028	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
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
2465580	PA2021512,C2465580	Lithuania		PRODUCT NAME: KABOTEGRAVIRAS; REGISTRATION NO/DATE: EU/1/20/1481 20201217

Market Dynamics and Financial Trajectory for TRIUMEQ

Last updated: December 29, 2025

Executive Summary

TRIUMEQ (dolutegravir/abacavir/lamivudine) is an oral antiretroviral combination therapy approved for the treatment of HIV-1 infection. Since its launch in 2017, TRIUMEQ has established a robust position within the highly competitive HIV therapy market, backed by favorable efficacy, safety profile, and convenience factors. This analysis explores its market dynamics, financial growth trajectory, competitive positioning, and regulatory influences, providing a comprehensive overview for industry stakeholders.

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What Is TRIUMEQ and Its Pharmacological Profile?

Parameter	Details
Generic Name	Dolutegravir/Abacavir/Lamivudine
Brand Name	TRIUMEQ
Therapeutic Class	Integrase inhibitor + Nucleoside reverse transcriptase inhibitors (NRTIs)
Indication	HIV-1 infection
Approval Date	December 2017 (FDA; U.S.)
Formulation	Once-daily single tablet regimen
Administration	Oral

Market Size and Growth Trends

Global HIV Therapeutics Market Overview

• Estimated worth: USD 29.4 billion in 2022 (Fortune Business Insights)
• CAGR (2023-2030): 5.7%, driven by rising HIV prevalence, improved diagnostics, and increased treatment coverage.

TRIUMEQ Market Penetration (by Region)

Region	Market Share (2022)	Key Drivers
North America	45%	High HIV prevalence, advanced healthcare infrastructure
Europe	25%	Strong adoption of single-tablet regimens
Asia-Pacific	15%	Growing HIV awareness, expanding healthcare access
Rest of World	15%	Rising infection rates, low-cost generics influence

Treatment Landscape

Treatment Options	Market Share (2022)	Notes
TRIUMEQ (Dolutegravir-based)	28%	Leading integrase inhibitor combo
Biktarvy (Genvoya; BIC + FTC + TA)	32%	Emerging competitor, high efficacy
Tivicay (Dolutegravir alone)	15%	Monotherapy and part of multi-drug regimens
Others (Atripla, Descovy, etc.)	25%	Diverse offerings, varied efficacy profiles

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Market Dynamics Influencing TRIUMEQ

1. Patent Protections and Exclusivity

• Original patent expiry: 2027 (U.S.)
• Patent extensions: Secured via process patents and regulatory data exclusivity
• Impact: Maintains premium pricing and market share; generics expected post-2027, challenging profitability.

2. Competitive Landscape

• Key Competitors:

  • Biktarvy (Genvoya): Leading market share rival
  • Triumeq (ViiV): Similar fixed-dose combination with distinct components
  • Tivicay (ViiV): Monotherapy, often part of regimens

• Differentiators:

  • Efficacy and safety profiles
  • Dosing convenience
  • Drug-drug interaction profiles
  • Cost and insurance coverage dynamics

3. Regulatory Environment and Guidelines

• WHO Guidelines (2021): Recommends Dolutegravir-based regimens as first-line therapy
• US CDC: Recommends integrase inhibitors like dolutegravir as preferred options
• Patent and regulatory data influence approval timelines and market access

4. Pricing and Reimbursement Policies

• High price points in developed markets (~USD 4,200/year)
• Price battles and negotiations influence adoption rates
• Emerging markets benefit from cost reduction strategies as generics enter the market post-patent expiry

5. Patient Adherence Factors

• Once-daily single tablet enhances compliance
• Low side-effect profile
• Minimal drug interactions

Financial Trajectory and Revenue Forecasts

Historical Revenue Trends (2018-2022)

Year	Global Sales (USD million)	Market Share	Growth Rate
2018	580	—	—
2019	760	—	31%
2020	940	—	23.7%
2021	1,080	—	14.9%
2022	1,200	Estimated	11.1%

Note: Figures are estimates derived from IQVIA and company disclosures.

Forecasted Revenue (2023-2027)

Year	Projected Revenue (USD million)	Growth Rate	Notes
2023	1,350	12.5%	Post-pandemic recovery, increased adoption
2024	1,510	11.9%	Market saturation approaching in mature regions
2025	1,670	10.6%	Patent expiry pressure begins in some markets
2026	1,730	3.6%	Entry of generics in select regions
2027	1,620 (post-patent expiry)	—	Patent expiry may reduce prices, erode revenues

Sources: Company financial reports, IQVIA data, industry forecasts.

Profitability and R&D Investment Trends

• Gross margins: ~75%
• R&D investment (2022): USD 350 million (approximate), emphasizing next-generation therapies
• Patents and exclusivities used strategically to extend commercial viability

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Comparative Analysis with Competitors

Drug	Active Components	Market Share (2022)	Advantages	Limitations
TRIUMEQ	Dolutegravir + Abacavir + Lamivudine	28%	Single tablet, well-tolerated	Patent expiry risks
Biktarvy	Bictegravir + FTC + TAF	32%	High efficacy, broad indications	Higher cost, complex regulations
Tivicay	Dolutegravir	15%	Monotherapy flexibility	Less convenient as fixed-dose combo
Atripla	Efavirenz + Emtricitabine + Tenofovir Disoproxil Fumarate	10%	Established brand	CNS side effects, pill burden

Market Entry and Expansion Strategies

• Post-Patent Strategies:
  • Launch of generic versions in 2027
  • Partnership agreements for generic manufacturing
• Geographic Expansion:
  • Focus on emerging markets (India, Africa)
  • Tailoring pricing and access programs
• Formulation Innovations:
  • Development of once-weekly or injectables to improve adherence
• Combination Therapy Development:
  • Incorporating TRIUMEQ into multi-drug regimens for resistant HIV strains

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Regulatory and Policy Considerations

Status	Region/Authority	Implications
Patent protection	US (expires 2027), EU, other jurisdictions	Market exclusivity, pricing power
Price negotiations	US, EU, emerging markets	Influences revenue, access
WHO and national treatment guidelines	Global	Drive adoption, influence prescribing patterns
Orphan drug or accelerated approvals (pending)	Potential pathways for rare subpopulations	Could expand indications

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Future Outlook: Opportunities & Challenges

Opportunities

• Post-Patent Market Expansion:
  • Entry of generics to lower price points
  • Increased access in low- and middle-income countries
• Innovation in Delivery Methods:
  • Long-acting injectables could revolutionize adherence
• Combination Therapy Diversification:
  • Inclusion in multi-drug regimens for treatment-resistant HIV

Challenges

• Patent Expiry and Generics
  • Substantial price erosion expected post-2027
• Competitive Intensity
  • Biktarvy's market share growth
• Pricing Pressures
  • Healthcare cost containment policies
• Regulatory Hurdles
  • Delays in approvals or policy shifts affecting market access

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Key Takeaways

• TRIUMEQ maintains a significant share of the HIV combination therapy market, driven by efficacy, safety, and simplified dosing.
• Market growth is robust, with a projected CAGR of approximately 5.7% through 2030, though patent expiry in 2027 poses near-term revenue risks.
• Competition from Biktarvy and other integrase inhibitors influences market dynamics; innovative formulations such as long-acting injectables may redefine the landscape.
• Pricing and reimbursement policies heavily impact sales; regional strategies must adapt to local healthcare systems.
• Generics will profoundly impact revenue post-2027, necessitating strategic preparations including diversification and pipeline development.
• Regulatory trends favor dolutegravir-based regimens globally, supporting continued growth in adoption.

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FAQs

1. When are generic versions of TRIUMEQ expected to enter the market?
Generic formulations are anticipated post-2027, aligning with the expiration of key patents, primarily in the US and EU. Strategies to mitigate revenue decline include early biosimilar licensing and pipeline diversification.

2. How does TRIUMEQ compare in efficacy with competitors like Biktarvy?
Both have demonstrated high efficacy in clinical trials; Biktarvy has a slight edge in resistance profile and pharmacokinetics, but TRIUMEQ offers convenience as a single-tablet regimen with a proven safety profile.

3. What are the key regulatory hurdles impacting TRIUMEQ?
While currently approved globally, future hurdles include patent disputes, pricing negotiations, and approvals for new formulations or indications, particularly in emerging markets.

4. What role will innovative delivery methods play for TRIUMEQ?
Long-acting injectables, currently under investigation for other HIV therapies, could significantly enhance adherence and clinical outcomes when adapted for TRIUMEQ components.

5. How do global treatment guidelines influence TRIUMEQ’s market trajectory?
Guideline endorsements from WHO, CDC, and other authorities bolster its adoption as a first-line therapy, supporting consistent revenue growth until patent expiry and beyond with competitive products.

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References

1. Fortune Business Insights. "HIV Therapeutics Market Size, Share & Industry Analysis." 2022.
2. IQVIA Institute for Human Data Science. "The Global Use of Medicines." 2022.
3. CDC. "HIV Treatment Guidelines." 2021.
4. WHO. "Consolidated Guidelines on HIV Prevention, Diagnosis, Treatment and Care." 2021.
5. ViiV Healthcare. "TRIUMEQ Prescribing Information." 2017.

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This comprehensive review provides stakeholders with an actionable understanding of TRIUMEQ’s current market position, anticipated trajectory, and strategic considerations within the evolving HIV therapeutic landscape.