Abacavir sulfate; lamivudine - Generic Drug Details

What are the generic sources for abacavir sulfate; lamivudine and what is the scope of patent protection?

Abacavir sulfate; lamivudine is the generic ingredient in four branded drugs marketed by Pharmobedient, Aurobindo Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Hetero Labs Ltd V, Laurus, Macleods Pharms Ltd, Teva Pharms Usa, Zydus Pharms, Viiv Hlthcare, and Lupin Ltd, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

Six suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for abacavir sulfate; lamivudine

US Patents:	0
Tradenames:	4
Applicants:	12
NDAs:	13
Finished Product Suppliers / Packagers:	6
Clinical Trials:	8
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for abacavir sulfate; lamivudine
DailyMed Link:	abacavir sulfate; lamivudine at DailyMed

Recent Clinical Trials for abacavir sulfate; lamivudine

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
ViiV Healthcare	Phase 4
Gilead Sciences	Phase 3
GlaxoSmithKline	Phase 4

See all abacavir sulfate; lamivudine clinical trials

Generic filers with tentative approvals for ABACAVIR SULFATE; LAMIVUDINE

Applicant	Application No.	Strength	Dosage Form
		60MG; 30MG	TABLET; ORAL
		EQ 300MG BASE; 150MG; 300MG	TABLET; ORAL
		600MG; 300MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for abacavir sulfate; lamivudine

Drug Class	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Cytochrome P450 1A1 Inhibitors Nucleoside Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for abacavir sulfate; 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

Paragraph IV (Patent) Challenges for ABACAVIR SULFATE; LAMIVUDINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EPZICOM	Tablets	abacavir sulfate; lamivudine	600 mg/300 mg	021652	1	2007-09-27

US Patents and Regulatory Information for abacavir sulfate; 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	TRIZIVIR	abacavir sulfate; lamivudine; zidovudine	TABLET;ORAL	021205-001	Nov 14, 2000		DISCN	Yes	No
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004		DISCN	Yes	No
Macleods Pharms Ltd	ABACAVIR SULFATE AND LAMIVUDINE	abacavir sulfate; lamivudine	TABLET;ORAL	212663-001	Dec 19, 2024		DISCN	No	No
Pharmobedient	ABACAVIR SULFATE AND LAMIVUDINE	abacavir sulfate; lamivudine	TABLET, FOR SUSPENSION;ORAL	204311-001	Dec 22, 2023		DISCN	Yes	No
Zydus Pharms	ABACAVIR SULFATE AND LAMIVUDINE	abacavir sulfate; lamivudine	TABLET;ORAL	208990-001	Nov 15, 2018		DISCN	No	No

Expired US Patents for abacavir sulfate; lamivudine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004

Market Dynamics and Financial Trajectory for Abacavir Sulfate and Lamivudine

Last updated: July 29, 2025

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Introduction

Abacavir sulfate and lamivudine are core antiretroviral agents used in the management of human immunodeficiency virus (HIV) infection. Their combined use forms a critical component in fixed-dose combination therapies, aligning with global efforts to enhance adherence, reduce pill burden, and improve treatment outcomes. Given the evolving landscape of HIV therapeutics, understanding the market dynamics and financial trajectories of these drugs is essential for stakeholders, including pharmaceutical companies, healthcare policymakers, and investors.

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Market Overview

Global HIV Treatment Market

The global HIV treatment market is projected to reach USD 30 billion by 2025, driven by increasing prevalence, advances in drug formulation, and expanding access in low- and middle-income countries [1]. As antiretroviral therapy (ART) becomes more accessible, demand for first-line regimens, including abacavir and lamivudine, continues to grow.

Role of Abacavir Sulfate and Lamivudine

Abacavir sulfate and lamivudine are nucleoside reverse transcriptase inhibitors (NRTIs) that inhibit HIV replication. They feature prominently in fixed-dose combinations (FDCs), such as abacavir/lamivudine, which are recommended as first-line therapies in various clinical guidelines (WHO, CDC) [2].

Their significance stems from their efficacy, tolerability, and relatively favorable safety profiles, especially when used as part of potent combinations. Notably, abacavir requires HLA-B*57:01 testing due to hypersensitivity risk, influencing market penetration and adoption strategies.

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Market Drivers

Increasing HIV Prevalence and Treatment Initiatives

According to UNAIDS, approximately 38 million individuals worldwide are living with HIV, with an annual increase in diagnosed cases. The expansion of treatment programs, especially in Africa, Asia, and Latin America, supports sustained demand for affordable, effective ART regimens containing these drugs [3].

Shift Toward Fixed-Dose Combinations

FDCs that include abacavir and lamivudine simplify treatment protocols, enhance adherence, and reduce costs. The market has witnessed a robust shift toward these formulations, particularly in resource-constrained settings, bolstering sales [4].

Patent Expirations and Generic Competition

Patent expirations for major formulations, notably in developed markets like the US and EU, have led to the emergence of generics. This has driven prices downward, expanding access but exerting pressure on brand-name revenue streams [5].

Regulatory and Policy Changes

Global health agencies, including WHO and the Global Fund, prioritize cost-effective, long-acting ARTs. Their policies favor generic options, influencing market dynamics and financial trajectories.

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Market Challenges

Safety and Resistance Concerns

The association of abacavir with hypersensitivity reactions necessitates genetic screening, which may not be universally available. The risk of resistance development also complicates long-term efficacy projections [6].

Pricing and Affordability

While generics reduce prices, high manufacturing costs, supply chain issues, and regulatory hurdles can impact profit margins. Adjustments in price points influence revenue forecasts.

Emerging Therapies

Novel agents, including integrase inhibitors and long-acting injectables (e.g., cabotegravir, rilpivirine), threaten to displace traditional NRTIs, impacting market share and revenues for abacavir and lamivudine [7].

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Financial Trajectory Analysis

Revenue Trends

In the early 2010s, blockbuster sales characterized the market for fixed-dose combinations containing abacavir and lamivudine, with revenues exceeding USD 1 billion annually for some formulations [8]. However, patent expiries and the rise of generics precipitated a decline in branded product sales.

Impact of Patent Expirations

Patents for key FDCs expired between 2015-2020, leading to a surge in generic formulations. This diversification drastically reduced average selling prices (ASPs) and resulted in revenue contraction for originator companies. Nonetheless, volume sales remained resilient in emerging markets.

Market Expansion and Volume Growth

Despite price pressures, global demand remains strong owing to expanding treatment coverage. The overall volume of prescriptions for abacavir/lamivudine formulations is projected to grow at approximately 3-4% annually, driven by increasing access [9].

Profitability Outlook

Generic proliferation emphasizes cost competitiveness, placing pressure on profit margins but also presenting opportunities for volume-based growth. Companies investing in cost-efficient manufacturing and supply chain optimizations are better positioned to sustain profitability.

Pipeline and Lifecycle Management

Innovations like fixed-dose, long-acting injectables for HIV could shift the landscape, potentially diminishing the prominence of traditional oral regimens in the coming decade. Strategic partnerships, licensing, and pipeline diversification are critical for maintaining financial stability.

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Regional Market Dynamics

North America and Europe

Market maturity, patent expirations, and the shift toward novel therapies characterize these regions. While branded sales decline, substantial revenues are maintained through generic sales and treatment adherence programs.

Asia-Pacific and Africa

Rapid treatment scale-up, increasing HIV prevalence, and reliance on low-cost generics contribute to significant market growth. Price sensitivity and access initiatives enhance sales volumes but suppress ASPs.

Emerging Markets

Quality assurance, regulatory hurdles, and logistical challenges impact distribution. Large-scale procurement through agencies like the Global Fund supports sustained demand.

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Competitive Landscape

Major pharmaceutical companies, including Gilead Sciences, Viiv Healthcare, and some generics manufacturers such as Mylan and Cipla, dominate the market. Patent litigation, licensing agreements, and patent pools influence market share and profitability.

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Future Outlook

Long-Term Trends

• Price Competition: Continued generic entry will likely sustain low pricing but may limit revenue growth for originators.

• Regulatory Approvals: Approval of new formulations and fixed-dose combinations will diversify therapeutic options and potentially stimulate growth.

• Global Treatment Goals: UNAIDS’ 95-95-95 targets necessitate policies favoring affordable, accessible ART, reinforcing demand for abacavir and lamivudine-based regimens.

• Innovation and Disruption: Emergence of long-acting injectables and dual therapy regimens could significantly alter the market trajectory.

Financial Modeling

Projection models estimate compound annual growth rates (CAGR) for the global abacavir/lamivudine market to decline modestly (~2-3%) over the next five years due to price competition but with sustained overall revenue driven by volume.

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Key Takeaways

• The abacavir sulfate and lamivudine market is intensely influenced by patent cycles, generic competition, and innovative therapy development.

• While revenues for branded formulations face headwinds, demand driven by global HIV treatment initiatives ensures volume growth, especially in emerging markets.

• Cost pressures and emerging therapies necessitate strategic diversification, cost optimization, and pipeline investment for sustained financial success.

• Policy and regulatory frameworks in different regions significantly impact market access and pricing strategies.

• Long-acting and fixed-dose innovations will shape the future landscape, potentially transforming traditional revenue models.

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FAQs

1. What factors predominantly influence the market share of abacavir and lamivudine?
   Patent status, generic competition, treatment guidelines, safety profiles, and emerging therapies primarily determine market share.

2. How do patent expirations impact the revenue of branded abacavir/lamivudine products?
   Patent expirations lead to increased generic competition, significantly reducing ASPs and overall revenues for originator brands, although total volume sales may persist.

3. What role do emerging markets play in the financial trajectory of these drugs?
   Growing HIV prevalence and treatment programs in Asia and Africa drive volume growth, often relying on cost-effective generics, balancing lower margins with higher sales volumes.

4. How might novel therapies affect the future market for abacavir and lamivudine?
   Long-acting injectables and simplified regimens could replace traditional oral formulations, potentially decreasing demand for these drugs over the long term.

5. What strategies can pharmaceutical companies employ to remain profitable?
   Diversifying pipelines, focusing on cost efficiencies, expanding into new markets, and developing innovative formulations are key strategies to sustain profitability.

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References

[1] MarketsandMarkets, "Global HIV/AIDS Treatment Market," 2022.
[2] WHO Guidelines, "Consolidated Guidelines on HIV Prevention, Testing, Treatment, Service Delivery and Monitoring," 2021.
[3] UNAIDS, "Global HIV & AIDS Statistics — Fact Sheet," 2022.
[4] IMS Health, "Antiretroviral Market Trends," 2020.
[5] Novartis Reports, "Impact of Patent Expirations on HIV Drugs," 2019.
[6] U.S. FDA, "Guidance on Abacavir Hypersensitivity," 2021.
[7] IQVIA, "Emerging Trends in HIV Therapeutics," 2022.
[8] Gilead Sciences Financial Reports, "HIV Treatment Revenue Data," 2015-2020.
[9] CDC, "HIV Treatment Plays and Trends," 2022.