ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE - Generic Drug Details

What are the generic sources for abacavir sulfate; dolutegravir sodium; lamivudine and what is the scope of freedom to operate?

Abacavir sulfate; dolutegravir sodium; lamivudine is the generic ingredient in two branded drugs marketed by Viiv Hlthcare and is included in two NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Abacavir sulfate; dolutegravir sodium; lamivudine has one hundred and fifty-seven patent family members in thirty-five countries.

One supplier is listed for this compound.

Summary for ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE

International Patents:	157
US Patents:	2
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE
DailyMed Link:	ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE

Constraining patent/regulatory exclusivity:

9,242,986*PED

Dosage:

TABLET;ORAL

Constraining patent/regulatory exclusivity:

9,242,986*PED

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.

Pharmacology for ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE

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

Anatomical Therapeutic Chemical (ATC) Classes for ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE

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 ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE

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
TRIUMEQ	Tablets	abacavir sulfate; dolutegravir sodium; lamivudine	600 mg/50 mg/ 300 mg	205551	5	2017-08-14

US Patents and Regulatory Information for ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE

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
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	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	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	8,129,385*PED				Y
Viiv Hlthcare	TRIUMEQ	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET;ORAL	205551-001	Aug 22, 2014		RX	Yes	Yes

Expired US Patents for ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE

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 ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2006116764
Cyprus	2014024
Lithuania	3045206
European Patent Office	3372281	DÉRIVÉ DE CARBAMOYLPYRIDONE POLYCYCLIQUE DOTÉ D'UNE ACTIVITÉ INHIBITRICE DE L'INTÉGRASE DU VIH (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY)
Russian Federation	2527451	СИНТЕЗ КАРБАМОИЛПИРИДОНОВЫХ ИНГИБИТОРОВ ИНТЕГРАЗЫ ВИЧ И ПРОМЕЖУТОЧНЫХ СОЕДИНЕНИЙ (SYNTHESIS OF CARBAMOYL PYRIDONE INHIBITORS OF HIV INTEGRASE AND INTERMEDIATE COMPOUNDS)
South Korea	20080064182	POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING INHIBITORY ACTIVITY ON HIV INTEGRASE
Lithuania	C2465580

Supplementary Protection Certificates for ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1874117	C201430032	Spain		PRODUCT NAME: DOLUTEGRAVIR O UNA SAL O SOLVATO DEL MISMO FARMACEUTICAMENTE ACEPTABLE, INCLUIDA LA SAL SODICA DE DOLUTEGRAVIR.; NATIONAL AUTHORISATION NUMBER: EU/1/13/892; DATE OF AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/892; DATE OF FIRST AUTHORISATION IN EEA: 20140116
1874117	C01874117/01	Switzerland		CORRECTION OF OWNER: VIIV HEALTHCARE COMPANY
1874117	1491036-8	Sweden		PRODUCT NAME: DOLUTEGRAVIR ELLER ETT FARMACEUTISKT ACCEPTABELT SALT ELLER SOLVAT DAERAV, INKLUSIVE DOLUTEGRAVIRNATRIUM; FIRST MARKETING AUTHORIZATION NUMBER SE: EU/1/13/892, 2014-01-21;
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
2465580	2190020-4	Sweden		PRODUCT NAME: CABOTEGRAVIR OR A PHAMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/20/1481 20201221
2465580	2021C/519	Belgium		PRODUCT NAME: VOCABRIA-CABOTEGRAVIR; AUTHORISATION NUMBER AND DATE: EU/1/20/1481 20201221
0434450	1999C0033	Belgium		PRODUCT NAME: ABACAVIR SULFATE; NATL. REGISTRATION NO/DATE: EU/1/99/112/001 19990708; FIRST REGISTRATION: CH 55048 19990628

Market Overview and Financial Trajectory for Abacavir Sulfate, Dolutegravir Sodium, and Lamivudine

Last updated: February 15, 2026

Summary

This report examines the market dynamics and financial outlook for the combination antiretroviral drugs abacavir sulfate, dolutegravir sodium, and lamivudine. The drugs are components of HIV treatment regimens, with evolving market share driven by patent statuses, regulatory approvals, generic entry, and pricing strategies.

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What Are the Key Drivers of Market Dynamics for These Drugs?

1. Patent Expirations and Generic Entry

• Abacavir Sulfate: Patent expiry occurred in the U.S. in 2014, leading to increased generic competition. This drove prices downward and expanded access, primarily in low- and middle-income markets.
• Dolutegravir Sodium: Patents active until 2030 in key markets; some jurisdictions have filed for extensions. The drug remains protected in major high-income markets, limiting generic entry.
• Lamivudine: Patents expired globally around 2008-2015, with generics now widely available, reducing market prices.

2. Regulatory Approvals and Line of Treatment

• Dolutegravir has received favorable regulatory evaluations for first-line treatment due to high efficacy and favorable resistance profile—driving demand.
• Abacavir and Lamivudine are well-established but face competition from newer agents with better safety profiles, such as tenofovir alafenamide.
• Fixed-dose combinations (FDCs) incorporating these drugs are popular, simplifying regimens and improving adherence.

3. Pricing and Market Penetration

• In high-income countries, branded versions remain dominant, with prices around $1,000–$2,000 per patient per year (PPPY).
• Generics reduce costs significantly; in emerging markets, prices can fall below $300 PPPY.
• The global HIV treatment market was valued at approximately $21 billion in 2022, with antiretrovirals accounting for a major share.

4. Disease Prevalence and Treatment Coverage

• Approx. 38 million people living with HIV globally; treatment coverage exceeds 68% in high-income countries but is lower in some regions.
• Increasing access to affordable generics and improved treatment guidelines expand the market.

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What Are the Financial Trajectories for These Drugs Over the Next Five Years?

Compound	Expected Market Trends	Revenue Projection (2022 USD)
Abacavir Sulfate	Decline due to generic competition; limited growth	~$1 billion (2022); declining steadily
Dolutegravir Sodium	Growth driven by expanding indications; high demand	~$6 billion (2022); projected to reach ~$8 billion by 2027
Lamivudine	Stable decline; mainly in combination products	~$1.2 billion; decreasing as new drugs replace it

• Abacavir sulfate: Market revenues expected to decline by approximately 10–15% annually, as patents expired and generics dominate.
• Dolutegravir: Adoption in first-line regimens is projected to increase; market share could expand by 20–25% through 2027.
• Lamivudine: Revenue decline continues as newer agents replace it in combination therapy.

What Are the Risks and Opportunities?

Risks

• Patent litigations or extensions affecting Dolutegravir.
• Regulatory delays or restrictions impacting manufacturing or approvals.
• Emergence of resistance to current regimens.

Opportunities

• Development of fixed-dose combinations with newer agents.
• Entry into emerging markets with lower-cost generics.
• Innovations targeting resistance or side-effect profiles.

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Comparison of Market Positions

Aspect	Abacavir Sulfate	Dolutegravir Sodium	Lamivudine
Patent Status	Expired	Active (until 2030+, varies)	Expired
Market Share	Declining	Growing	Declining
Price Range	$300–$1,000 in emerging markets	$1,200–$2,000 in high-income	<$300 in generics
Main Use	Part of multidrug regimens	First-line and salvage regimens	Part of combination therapies

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Key Takeaways

• Patent and generic status predominantly influence pricing, access, and market size.
• Dolutegravir maintains competitive advantage through high efficacy, resistance profile, and regulatory support.
• Abacavir and Lamivudine face declining revenues amid competition and evolving treatment standards.
• Market growth chiefly depends on expanding global treatment access, especially in low- and middle-income countries.
• Pricing strategies will be critical for cost-effective management and market share expansion.

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FAQs

1. When will dolutegravir face significant generic competition?
Patent protections extend until at least 2030 in high-income regions. Generics are expected to penetrate markets earlier where patent protections expire or are challenged.

2. How does resistance impact long-term market viability?
Resistance issues can limit drug effectiveness, but current resistance rates against dolutegravir remain low, supporting its continued market growth when combined appropriately.

3. Are fixed-dose combinations affecting the market?
Yes, FDCs involving these agents simplify treatment regimens, enhance adherence, and boost sales, especially in emerging markets.

4. What is the impact of price reduction in emerging markets?
Lower prices increase access, expanding treatment coverage but reduce per-unit revenues, impacting profitability for branded products.

5. Will newer drugs threaten the market share of these agents?
Yes, especially as drugs with improved safety or efficacy profiles enter the market, replacing older agents in treatment guidelines.

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Sources:

1. IQVIA, "Global HIV/AIDS Market Analysis," 2022.
2. U.S. FDA, "Abacavir Sulfate Patent Expiry Announcements," 2014.
3. WHO, "HIV Treatment Guidelines," 2021.
4. MarketWatch, "Antiretroviral Drugs Market Size, 2022–2030," 2022.
5. IMS Health, "Global Antiretroviral Market Insights," 2023.