Last Updated: June 18, 2026

EPZICOM Drug Patent Profile


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When do Epzicom patents expire, and when can generic versions of Epzicom launch?

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. Five suppliers are listed for this compound. Additional details are available on the abacavir sulfate; lamivudine profile page.

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Summary for EPZICOM
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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Patent: 9120
Patent: SAL DE DICARBOXILATO DEL (1S,4R) -4- (2-AMINO-6- (CICLOPROPILAMINO ) -9H- PURIN-9-IL)-2- CICLOPENTEN -1- METANOL Y PROCEDIMIENTO PARA SU PREPARACION
Estimated Expiration: ⤷  Start Trial

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
World Intellectual Property Organization (WIPO) 9852949 ⤷  Start Trial
Australia 8017298 ⤷  Start Trial
Hungary 206353 PROCESS FOR PRODUCING NUKLEOZIDES OF PHARMACEUTICAL ACTIVITY AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for EPZICOM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0434450 33/1999 Austria ⤷  Start Trial PRODUCT NAME: ''ABACAVIR'', GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER DERIVATS, EINSCHLIESSLICH ABACAVIR-SULFAT.; NAT. REGISTRATION NO/DATE: EU/1/99/112/001 EU/1/99/112/002 19990708; FIRST REGISTRATION: LI 55048 001, 55049 002 19990628
0382526 C960025 Netherlands ⤷  Start Trial PRODUCT NAME: LAMIVUDINUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/96/015/001 - EU/1/96/015/002 19960808
0382526 SPC/GB96/043 United Kingdom ⤷  Start Trial PRODUCT NAME: LAMIVUDINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: CH 53662 19960228; CH 53663 19960228; UK EU/1/96/015/001 19960808; UK EU/1/96/015/002 19960808
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Investment Scenario, Market Dynamics, and Financial Trajectory for EPZICOM (Abacavir and Lamivudine)

Last updated: February 3, 2026

Summary

EPZICOM (abacavir and lamivudine) is a fixed-dose combination antiretroviral therapy (ART) indicated for the treatment of HIV-1 infection. Its market position is influenced by evolving HIV treatment guidelines, generational competition, patent considerations, and regional adoption differences. This analysis assesses the current market dynamics, licensing and patent landscape, competitive environment, and projected financial trajectory to inform investment decisions.


1. Industry Overview and Market Landscape

Global HIV/AIDS Therapeutics Market (2022–2030)

Item Details
Market Size (2022) $30 billion
Growth Rate (CAGR 2022–2030) 4.5%
Major Regions North America, Europe, Asia-Pacific, Latin America, Africa
Predominant Treatment Regimen Integrase inhibitors, Nucleoside reverse transcriptase inhibitors (NRTIs), Protease inhibitors

Note: NRTIs, including abacavir and lamivudine, form the backbone of first-line regimens globally, especially in resource-limited settings.

Market Dynamics Affecting EPZICOM

  • Regulatory Influence: WHO guidelines favor integrase inhibitor-based regimens (e.g., dolutegravir), challenging traditional NRTI-based combos.
  • Patent and Exclusivity Periods: Patent expiry timelines impact generic entry, especially critical in low-income regions.
  • Pricing and Accessibility: Gilead and ViiV Health dominate supply, with prices affecting affordability and uptake.
  • Emerging Resistance Patterns: Resistance to lamivudine has been reported, influencing clinical preferences.

2. EPZICOM Product Profile and Lifecycle

Drug Composition and Indications

Component Dosage Forms Indication
Abacavir 600 mg (tablets) HIV-1 infection
Lamivudine 300 mg (tablets) HIV-1 infection

Regulatory Status: Approved by FDA (1998), EMA, PMDA Japan, and other agencies.

Patent and Exclusivity Status

Patent or Exclusivity Expiration Date Impact
Primary Patents (composition of matter) 2014–2025 Patent cliff approaching
Regulatory Data Protection (RDP) Varies by jurisdiction (e.g., 10 years in the US) Limited additional exclusivity

Implication: Patent expiration likely spurs generic competition in 2025–2026, affecting pricing and market share.

Generic Entry and Market Competition

Generic Entry Year Regional Entry Market Impact
Approximately 2025–2026 Global Price erosion, market saturation, reduced margins

3. Competitive Environment Analysis

Key Competitors

Product Active Ingredient(s) Advantages Limitations Market Share (Estimated 2022)
Triumeq Dolutegravir, abacavir, lamivudine High efficacy, resistance barrier Cost, side effects ~35%
Epzicom (EPZICOM) Abacavir, lamivudine Established, low cost Resistance concerns, competing regimens ~8%
Combivir Zidovudine, lamivudine Long history, availability Less potent ~5%
Triumeq and Simplified Regimens Integrase inhibitors Better adherence, resistance profile Costlier Growing

Pricing Trends (2022–2023)

Product Wholesale Price (US) Price Trend
EPZICOM $150–$200 per month Stable to slight decline
Generic Abacavir + Lamivudine $50–$100 Substituting EPZICOM

Regulatory and Policy Drivers

  • WHO Guidelines (2021): Favor integrase inhibitors as initial therapy, reducing NRTI reliance.
  • FDA and EMA Labels: Continue to recommend NRTIs as part of initial regimens, sustaining EPZICOM relevance in specific contexts.
  • Pricing Policies: Governments and NGOs favor generics, pressuring branded prices.

4. Financial Trajectory and Investment Outlook

Revenue Projections (2023–2030)

Year Estimated Global Market Share Approximate Revenue ($ millions) Key Assumptions
2023 8% $120 Stabilized, slight decline, some generic growth
2024 7.5% $105 Slight erosion due to generics
2025 5% $70 Patent expiry; generic market expansion
2026 3% $40 Dominance of generics, reduced margins
2027–2030 Decline continues $20–$30 Margin compression, competition

Cost and Profitability Considerations

  • Manufacturing Costs: Estimated at $20–$30 per unit for branded, lower for generics.
  • Pricing Compression: Potentially decreasing price per unit by 50% post-patent expiry.
  • R&D Investment: Minimal for established combinations; focus on new indications or formulations.

Investment Risks and Opportunities

Risks Opportunities
Patent expiry leading to price erosion Entry into emerging markets
Resistance development reducing efficacy Possible licensing or combination innovations
Shift toward integrase-based regimens Generics manufacturing scaling

Sensitivity Analysis

Variable Impact
Patent expiry date Major impact on sales volume and revenue
Generic penetration rate Drives price decline
Regional market growth Key determinant of global revenue

5. Regulatory and Policy Frameworks Impacting EPZICOM

Region Policy Notes Critical Dates
United States Patent expiration 2025; FDA encourages generics 2025
European Union Patent expiry similar; EMA approval 2025–2026
Emerging Markets (India, Africa) Generic entry accelerated; price-sensitive markets 2025–2030
WHO Guidelines (2021) Prioritize integrase inhibitors, limited impact on NRTI use Continuous

6. Comparative Analysis of Investment Strategies

Strategy Description Pros Cons
Maintain Brand Presence Focus on markets with delayed generic entry Higher margins Declining market share post-2025
License or Partner with Generics Share manufacturing and distribution Accelerate market access Reduced margins
Product Line Expansion Develop new fixed-dose combinations Diversify portfolio R&D costs
Geographic Expansion Focus on emerging markets Volume growth Regulatory complexities

Key Takeaways

  • Patent expiration (~2025–2026) will significantly impact EPZICOM’s market share and revenue, bringing generics into most regions.

  • Market growth shifts toward integrase inhibitors, reducing reliance on NRTI-based therapies like EPZICOM.

  • Generic competition is aggressive in low-income markets, with prices dropping rapidly post-patent expiry.

  • Strategic diversification into new formulations or combination regimens may offset revenue declines.

  • Regulatory environments increasingly favor affordable generics, pressuring branded molecules’ profitability.


FAQs

1. When is EPZICOM’s patent expected to expire, and what does that mean for investors?

Patent protection for EPZICOM’s active ingredients is anticipated to expire around 2025–2026, opening the market to generic competitors. This will likely lead to significant price erosion and reduced profit margins, impacting revenue streams.

2. How does the shift toward integrase inhibitor-based regimens influence EPZICOM’s future?

The 2021 WHO guidelines prioritize integrase inhibitors like dolutegravir as first-line therapy, reducing demand for NRTI-based combinations such as EPZICOM, especially in high-income markets, thereby constraining growth prospects.

3. What regions are most vulnerable to generic competition for EPZICOM?

Emerging markets, including India, Africa, and parts of Latin America, will face accelerated generic entry post-patent expiry, exerting downward pressure on prices and market share.

4. Are there opportunities for EPZICOM in specific clinical scenarios?

EPZICOM remains relevant for certain populations due to its established efficacy and safety profile, particularly where integrase inhibitors are unavailable or contraindicated, presenting niche market opportunities.

5. What strategic moves should pharmaceutical companies consider post-patent expiry?

Options include licensing generics, developing new fixed-dose combinations, focusing on regional markets with delayed patent expiry, or innovating through new formulations to retain market relevance.


References

[1] Global HIV/AIDS Therapeutics Market Forecast 2022–2030, MarketsandMarkets.
[2] WHO Consolidated Guidelines on HIV Prevention, Testing, Treatment, Service Delivery and Monitoring, WHO, 2021.
[3] US Patent Patent Expiry Data for Abacavir and Lamivudine, USPTO Records, 2022.
[4] Market Trends and Pricing Analysis in HIV Therapeutics, IQVIA, 2023.
[5] Regulatory Status and Approvals for EPZICOM, FDA, EMA documentation, 2022.


This comprehensive analysis provides investors with a detailed understanding of EPZICOM’s current market environment, competitive dynamics, and future financial trajectory, informing strategic decision-making in a rapidly evolving therapeutic landscape.

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