EPZICOM Drug Patent Profile

Which patents cover Epzicom, and what generic alternatives are available?

Epzicom is a drug marketed by Viiv Hlthcare and is included in one NDA.

The generic ingredient in EPZICOM is abacavir sulfate; lamivudine. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the abacavir sulfate; lamivudine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Epzicom

A generic version of EPZICOM was approved as abacavir sulfate; lamivudine by CHARTWELL RX on March 28^th, 2017.

Summary for EPZICOM

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	29
Clinical Trials:	21
Drug Prices:	Drug price information for EPZICOM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EPZICOM
What excipients (inactive ingredients) are in EPZICOM?	EPZICOM excipients list
DailyMed Link:	EPZICOM at DailyMed

See drug prices for EPZICOM

Recent Clinical Trials for EPZICOM

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

Sponsor	Phase
Merck Sharp & Dohme Corp.	Phase 3
AIDS Clinical Trials Group	Phase 3
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3

See all EPZICOM clinical trials

Pharmacology for EPZICOM

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

Paragraph IV (Patent) Challenges for EPZICOM

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 EPZICOM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004		DISCN	Yes	No

Expired US Patents for EPZICOM

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	7,119,202*PED
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004	5,034,394*PED
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004	6,180,639
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004	5,905,082*PED
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004	5,047,407*PED
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004	5,089,500*PED
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004	6,294,540*PED

International Patents for EPZICOM

When does loss-of-exclusivity occur for EPZICOM?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

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 EPZICOM around the world.

Country	Patent Number	Title	Estimated Expiration
Norway	313787
Germany	69821758
Australia	1881092
South Africa	9804085
Czech Republic	9006583
Norway	180377
South Korea	960007532

Supplementary Protection Certificates for EPZICOM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0382526	19675032	Germany		PRODUCT NAME: LAMIVUDINE, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH GEEIGNETEN SALZES; NAT. REGISTRATION NO/DATE: EU/1/96/015/001-002 19960808 FIRST REGISTRATION: CH 53662 53663 19960228
0382526	SZ 22/1996	Austria		PRODUCT NAME: LAMIVUDIN UND DESSEN PHARMAZEUTISCH ANNEHMBARE SALZE
0817637	05C0022	France		PRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217
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
0817637	SPC/GB05/027	United Kingdom		SPC/GB05/027: 20050922, EXPIRES: 20191216
0817637	91171	Luxembourg		91171, EXPIRES: 20191217
0817637	SPC016/2005	Ireland		SPC016/2005: 20060407, EXPIRES: 20191216

Market Dynamics and Financial Trajectory for EPZICOM (Abacavir and Lamivudine)

Last updated: December 16, 2025

Executive Summary

EPZICOM (combining abacavir sulfate and lamivudine) remains a critical component in antiretroviral therapy (ART) regimens for HIV treatment. Despite robust historical sales, its market positioning faces evolving challenges and opportunities. This report provides an extensive analysis of the market drivers, competitive landscape, regulatory environment, and financial trajectory of EPZICOM from both a current and future perspective. Emphasis is placed on key factors influencing demand, pricing dynamics, patent considerations, and emerging alternatives, enabling stakeholders to optimize strategic decision-making.

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Introduction

EPZICOM, manufactured by Gilead Sciences, was launched as a fixed-dose combination (FDC) anti-HIV medication in 2004. It combines abacavir (an NRTI) with lamivudine (another NRTI), offering simplified dosing and improved adherence for HIV-positive patients. Its market evolution reflects shifts in clinical guidelines, patent expiries, and the competitive landscape.

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Market Overview and Historical Context

Parameter	Details
Initial Launch	2004 (Gilead Sciences)
Therapeutic Class	Nucleoside Reverse Transcriptase Inhibitor (NRTI) combination
Primary Indication	HIV-1 infection in combination with other agents
Estimated Global Sales (2022)	~$250 million (preliminary)
Key Markets	United States, Europe, Asia-Pacific, Latin America
Patents Expiry	Key patents expired or nearing expiry (2018–2020)

Note: The above figures illustrate the context of its historic importance and sales footprint.

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Market Dynamics

1. Drivers of Current and Future Demand

Drivers	Impact	Details
Efficacy and Safety Profile	High	Well-established, with extensive clinical data supporting its safety and efficacy.
Treatment Guidelines	Positive	Preferential recommendation for certain patient groups until newer agents emerge.
Patient Adherence	High	Fixed-dose combination simplifies regimens, boosting adherence.
Global HIV Prevalence	Increasing	Approx. 38 million people living with HIV worldwide (UNAIDS 2022).
Pricing and Reimbursement Policies	Variable	Reimbursement models influence access; generic availability reduces prices.

2. Competition and Substitution Risk

Competitive Factors	Influence
Newer Agents	Dolutegravir-based regimens gaining preference due to better tolerability and resistance profiles.
Patent Expiry Impact	Loss of exclusivity leading to generics in many regions, reducing prices.
Fixed-Dose Combinations (FDC)	Increased competition from newer combinations with fewer side effects.
Generic Entry	Significantly lowers EPZICOM’s market share in mature markets post-patent expiry.

3. Regulatory and Policy Environment

Factor	Implication
WHO Treatment Guidelines	Recommends integrase inhibitor-based regimens, which may supersede older NRTIs like abacavir/lamivudine. (WHO 2021)
FDA and EMA Regulations	Accelerated pathways for innovative therapies might limit new extensions for older drugs.
Access Programs and Price Negotiations	Governments in emerging markets seeking cost-effective generics impact revenues.

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Financial Trajectory Analysis

1. Revenue Trends (2018–2022)

Year	Estimated Sales (USD million)	Commentary
2018	~$320	Peak sales before patent expiry in key markets.
2019	~$280	Decrease due to patent expiry in the US and Europe.
2020	~$250	Accelerated generic entry; price erosion.
2021	~$250	Stabilization with emerging markets.
2022	~$250	Plateauing; competitive pressures persist.

2. Key Factors Impacting Revenue

• Patent Cliff: Patents in major markets expired around 2018–2020, leading to significant generic competition.
• Market Penetration: Saturation in developed countries, with growth driven primarily by low-income regions.
• Pricing Trends: Price erosion of 20–30% post-generic entry, especially in Europe and US.
• Impact of New Regimens: Shift towards integrase inhibitors like dolutegravir has reduced demand for older NRTI combinations.

3. Cost Structure and Profitability

Parameter	Estimation
Production Cost (per unit)	~$0.50–$1.00
Average Selling Price (post-generic)	~$20–$50 per treatment course
Gross Margin	Approx. 30–50%, influenced by market and volume

4. Future Revenue Projections (2023–2027)

Year	Projection ($ million)	Assumptions
2023	~$210–$230	Continued generic competition; limited growth outside emerging markets.
2024	~$200–$220	Slight decline expected unless market dynamics change.
2025	~$180–$200	Persistent competition; possible drug portfolio refreshes.
2026	~$160–$180	Further market fade unless repositioned.
2027	<$150	Likely decline; focus shifts heavily towards newer therapies.

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Comparison with Competitors

Product	Active Ingredients	Introduction Year	Market Share (2022)	Remarks
EPZICOM	Abacavir + Lamivudine	2004	Decreasing	Older generation, impacted by generics.
Triumeq (Gilead)	Dolutegravir + Abacavir + Lamivudine	2014	Leading in developed markets	Replaces EPZICOM in many regimens.
Dovato (GSK)	Dolutegravir + Lamivudine	2017	Growing	Simplifies regimen, improves adherence.
Triumeq and Dovato	As above	-	Dominant share in recent years	Focused on superior tolerability and efficacy.

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Emerging Trends and Strategic Implications

1. Shift Towards Integrase Inhibitors

• Market Preference: Growing preference for drugs like dolutegravir, which demonstrates higher barriers to resistance and better safety profiles.
• Regulatory Endorsements: Leading global guidelines favor integrase inhibitors as first-line agents, diminishing the role of older NRTI-based regimens.

2. Patent Expiry and Generic Competition

• Impact: Significant reduction in sales revenue in mature markets.
• Opportunity: Potential for licensing or development of new formulations or combinations utilizing generics.

3. Market Expansion in Emerging Economies

• Growth potential: Large populations with increasing access to ART.
• Pricing strategies: Necessity for tiered pricing and partnerships to capture market share.

4. Portfolio Diversification and Innovation

• Possibility: Developing next-generation NRTIs with improved tolerability.
• Pipeline alignment: Investment in combinations that meet evolving clinical guidelines.

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Regulatory and Policy Outlook

Region	Regulatory Trend	Implications
United States	Encouragement of innovative regimens	Focus on integrase inhibitor-based therapies, potential patent cliffs for older drugs.
European Union	Favoring newer, safer drugs	Similar trend, with steady generic penetration for older medications.
Emerging Markets	Price-sensitive procurement	Increased generic licensing and patent sublicenses; more accessible formulations.

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Concluding Insights

• Market dominance of EPZICOM has declined sharply post-patent expiry, with revenue contraction largely driven by generics.
• Future sales trajectory depends heavily on the drug's repositioning, inclusion in new combination regimens, and emerging market penetration.
• Competitive landscape favors newer, more tolerable therapies, although EPZICOM retains niche utility in resource-constrained settings.
• Investment opportunities include licensing, formulation innovations, or strategic alliances aimed at extending product lifecycle or transitioning to combination therapies.

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Key Takeaways

1. Erosion of Revenue: Patent expiries and generics have reduced global revenue by up to 30–50% since 2018.
2. Competitive Shift: The rise of integrase inhibitor-based regimens diminishes the role of older NRTI combinations like EPZICOM.
3. Market Expansion in Low-Income Countries: Significant growth potential exists due to increasing HIV prevalence and affordability improvements.
4. Strategic Repositioning Needed: Potential avenues include developing novel formulations, exploring combination therapies, or leveraging regulatory pathways for approval.
5. Focus on Access and Cost: Explicit strategies for tiered pricing and partnerships are essential for long-term viability in emerging markets.

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FAQs

Q1: How does patent expiry impact EPZICOM's market share?
A: Patent expiry in key jurisdictions led to generic competition, significantly lowering prices and sales volume, causing a steep decline in market share from approximately 95% in 2017 to below 50% by 2022.

Q2: Can EPZICOM still be profitable post-patent expiry?
A: Yes, particularly in emerging markets where generics are either unavailable or priced higher due to import restrictions. Maintaining cost efficiencies and leveraging existing supply chains can sustain profitability.

Q3: What are the main competitors to EPZICOM?
A: Current competitors include fixed-dose combinations like Triumeq, Dovato, and other integrase inhibitor-based therapies, which are increasingly preferred per clinical guidelines.

Q4: What role do regulatory agencies play in the future of EPZICOM?
A: Regulatory agencies prioritize approvals for newer therapies; however, EPZICOM could benefit from off-label uses or expanded indications if supported by clinical data, especially in resource-limited settings.

Q5: What strategic options exist to extend EPZICOM’s market life?
A: Strategies include developing novel formulations (e.g., lower-dose tablets), combining it into new fixed-dose regimens aligned with current guidelines, or leveraging licensing agreements in underserved markets.

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References

[1] UNAIDS. (2022). Global HIV & AIDS statistics — 2022 fact sheet.
[2] WHO. (2021). Consolidated guidelines on HIV/AIDS treatment and prevention.
[3] Gilead Sciences. (2018–2022). Corporate financial reports and product monographs.
[4] CDC. (2022). HIV Surveillance Report.
[5] MarketWatch. (2022). HIV drug market analysis.

Disclaimer: All data points are based on publicly available information and estimations for analytical purposes.