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

Dosage:

TABLET;ORAL

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					Y
Viiv Hlthcare	TRIUMEQ PD	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET, FOR SUSPENSION;ORAL	215413-001	Mar 30, 2022		RX	Yes	Yes					Y
Viiv Hlthcare	TRIUMEQ PD	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET, FOR SUSPENSION;ORAL	215413-001	Mar 30, 2022		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
Viiv Hlthcare	TRIUMEQ	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET;ORAL	205551-001	Aug 22, 2014
Viiv Hlthcare	TRIUMEQ	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET;ORAL	205551-001	Aug 22, 2014

International Patents for ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE

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 ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE

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 Abacavir Sulfate, Dolutegravir Sodium, and Lamivudine

Last updated: July 30, 2025

Introduction

The global pharmaceutical landscape for antiretroviral therapy (ART) remains robust, driven by persistent HIV/AIDS prevalence, evolving treatment guidelines, and advancements in drug formulations. Among the key players in this domain are Abacavir Sulfate, Dolutegravir Sodium, and Lamivudine — components forming core regimens for HIV management. This analysis explores the market dynamics influencing these drugs and assesses their financial trajectories amid competitive, regulatory, and technological trends.

Current Market Landscape

The antiretroviral drugs industry has experienced substantial growth, expected to sustain due to increasing global HIV/AIDS burdens. According to UNAIDS, approximately 38 million people globally live with HIV, underpinning a sustained demand for effective ART regimens [1].

Abacavir Sulfate serves as a nucleoside reverse transcriptase inhibitor (NRTI), often combined with other agents like Lamivudine and Dolutegravir in fixed-dose combinations (FDCs). It remains a pivotal alternative for patients intolerant to other agents due to hypersensitivity reactions linked to HLA-B*5701 allele sensitivity, which has narrowed its scope but maintained its clinical relevance.

Dolutegravir Sodium, an integrase strand transfer inhibitor (INSTI), commands a significant share due to its high efficacy, tolerability, and simplified dosing regimen. Its introduction disrupted older therapies, leading to an accelerated adoption and rapid market penetration.

Lamivudine, another NRTI, remains foundational in ART, valued for its safety profile, affordability, and applicability in first-line treatments, especially in resource-constrained settings.

Collectively, these agents comprise key components of first-line and second-line regimens, with a notable shift toward integrase inhibitors like Dolutegravir, fueling their market growth.

Market Drivers

1. Global HIV/AIDS Burden and Treatment Expansion

An expanding HIV-positive population, particularly in Africa and parts of Asia, sustains demand. The UNAIDS 2021 estimates suggest that approximately 75% of people living with HIV are on ART, with coverage steadily increasing [1]. Governments and international organizations (e.g., WHO, PEPFAR) promote the adoption of potent, well-tolerated therapies, favoring Dolutegravir-based regimens.

2. Favorable Clinical Profiles and Regulatory Approvals

Dolutegravir's robust efficacy, minimal side effects, and low resistance development contribute to its dominance. Regulatory approvals for fixed-dose combinations incorporating Dolutegravir and Lamivudine, such as Epzicom and Triumeq, have accelerated market penetration.

3. Patent Expirations and Generic Competition

Patent expirations of key formulations have lowered prices, expanding access—particularly in low- and middle-income countries. Indian manufacturers and other generic producers have gained significant market share, increasing affordability and volume sales.

4. Strategic Partnering and Licensing Agreements

Pharmaceutical companies leverage licensing (e.g., Gilead's licensing of its HIV drugs to generics) to penetrate markets rapidly and expand distribution channels, influencing market trajectories significantly.

5. Evolving Treatment Guidelines

The 2019 WHO consolidated guidelines recommend Dolutegravir-based regimens as the preferred first-line treatment, reinforcing its market position. This shift encourages healthcare systems to adopt these newer formulations, further promoting sales.

Market Challenges

1. Safety and Tolerability Concerns

Initial concerns for Dolutegravir regarding neuropsychiatric side effects and potential conception risks have prompted caution, particularly in specific patient populations. Ongoing research and post-marketing surveillance influence prescribing patterns.

2. Pricing and Reimbursement Policies

Cost pressures, especially in resource-limited settings, influence procurement decisions. While generics reduce prices, negotiations with governments and payers continue to impact profit margins.

3. Regulatory and Patent Barriers

Despite patent expirations, some regions still face regulatory delays, and patent litigations can restrict market entry of generic versions, affecting volume growth.

4. Resistance Development

Though currently low, long-term resistance patterns influence clinical enthusiasm and future usage trends, impacting the financial outlook.

Financial Trajectory and Market Forecast

Historical Growth Trends

The antiretroviral market has demonstrated Compound Annual Growth Rates (CAGRs) averaging 5–7% over the past decade, driven mainly by Dolutegravir's rising adoption. The global market valuation for HIV therapeutics was estimated at USD 22 billion in 2022 and is projected to reach USD 30 billion by 2030, with a CAGR of approximately 4.5% [2].

Forecast for Specific Drugs

• Abacavir Sulfate: Its market is stabilizing due to aging formulations and competition from newer agents with better safety profiles. However, demand persists for specific patient subsets, with a forecasted modest CAGR of 1–2%.

• Dolutegravir Sodium: Expected to dominate growth, with projections indicating a CAGR of 8–10%, supported by expanding global approvals, patent extensions in certain jurisdictions, and increasingly favorable guidelines.

• Lamivudine: As a legacy product, the market growth will remain slow, primarily serving fixed-dose combinations in emerging markets. Forecasted growth aligns with ABC, at around 2–3%.

Emerging Trends Influencing Financial Outlook

• Fixed-Dose Combinations (FDCs): The trend toward simplified, once-daily FDCs enhances adherence, increasing sales volume. Dolutegravir-based FDCs are particularly favored.

• Novel Delivery Systems: Long-acting injectables and formulations under clinical development could reshape the market landscape, impacting traditional oral agents' revenues.

• Market Penetration in Low-Income Countries: Initiatives by international agencies to subsidize costs will sustain volume growth for generics, especially for Lamivudine and Abacavir.

• Patent Landscapes: Patent cliff events for certain formulations in key markets will further accelerate availability of low-cost generics, boosting revenues.

Competitive Landscape

Major players include Gilead Sciences, ViiV Healthcare (a GSK and Pfizer joint venture), and generic manufacturers from India and China. ViiV's Dolutegravir-based products like Tivicay and Triumeq secure substantial market share. Gilead's portfolio, including Biktarvy (combination of Bictegravir, Emtricitabine, and Tenofovir Alafenamide), also influences market dynamics.

Regulatory and Patent Outlook

Regulatory approvals continue to expand for Dolutegravir-containing regimens across emerging markets, with patent expirations in various jurisdictions occurring from 2023 onward. These events are anticipated to significantly increase generic competition, reducing prices and encouraging broader access, thereby expanding revenue streams.

Conclusion

The market for Abacavir Sulfate, Dolutegravir Sodium, and Lamivudine remains a dynamic segment within the global HIV therapeutics landscape. While Dolutegravir's superior efficacy and safety profile propel its market growth, legacy drugs like Abacavir and Lamivudine will sustain steady, albeit slower, revenues, primarily in resource-limited settings. Strategic licensing, patent expiries, and favorable regulatory environments are pivotal in shaping the future financial trajectory, with a clear trend toward more affordable, simplified regimens.

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Key Takeaways

• Dominance of Dolutegravir: The drug's high efficacy, tolerability, and regulatory endorsement position it as the cornerstone of future HIV therapy markets, expected to grow at an 8–10% CAGR.

• Market Expansion in Developing Countries: Generic manufacturing and subsidy programs will continue to drive volume growth for all three drugs, especially in Africa and Asia.

• Pricing Dynamics: Patent expiries and licensing agreements will lead to significant price reductions, expanding access but compressing profit margins for originators.

• Regulatory Developments: Accelerated approvals and shifting guidelines favor Dolutegravir-based regimens, influencing the financial prospects of associated drugs.

• Emerging Technologies: Long-acting formulations and novel delivery systems hold transformative potential, though near-term financial impacts remain uncertain.

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FAQs

1. How will patent expirations influence the market share of Abacavir Sulfate and Lamivudine?
Patent expirations will enable generic manufacturers to produce lower-cost versions, increasing accessibility and volume sales in emerging markets. This will reduce revenues for originator companies but expand overall market size.

2. What is the expected impact of new formulations like long-acting injectables on the market?
Long-acting injectables could shift market preferences by improving adherence, especially among populations with adherence challenges. They may also command premium pricing, potentially boosting revenue streams for innovative formulations.

3. Are safety concerns limiting Dolutegravir's market growth?
While initial safety concerns, such as neuropsychiatric events, prompted cautious use, ongoing research and post-marketing data have mitigated these issues. Regulatory agencies maintain support for Dolutegravir, and its usage is expanding globally.

4. How do treatment guidelines influence market dynamics?
Guidelines endorsing Dolutegravir-based regimens have accelerated their adoption across healthcare systems, directly impacting sales volumes and revenue growth.

5. Will the demand for Abacavir Sulfate decline significantly?
Yes, as newer agents with better safety profiles become standard, Abacavir's market is expected to decline gradually. However, it will retain niche relevance for certain patient groups and in specific markets.

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References

[1] UNAIDS. "Global HIV & AIDS Statistics — 2022 Fact Sheet." UNAIDS, 2022.
[2] Research and Markets. "HIV Therapeutics Market Report," 2023.