TRIZIVIR Drug Patent Profile

Which patents cover Trizivir, and when can generic versions of Trizivir launch?

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

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

Summary for TRIZIVIR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	20
Drug Prices:	Drug price information for TRIZIVIR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRIZIVIR
What excipients (inactive ingredients) are in TRIZIVIR?	TRIZIVIR excipients list
DailyMed Link:	TRIZIVIR at DailyMed

See drug prices for TRIZIVIR

Recent Clinical Trials for TRIZIVIR

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

Sponsor	Phase
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3
AIDS Clinical Trials Group	Phase 3
Ines Perez	Phase 4

See all TRIZIVIR clinical trials

Paragraph IV (Patent) Challenges for TRIZIVIR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TRIZIVIR	Tablets	abacavir sulfate; lamivudine; zidovudine	300 mg/150 mg/ 300 mg	021205	1	2011-03-22

US Patents and Regulatory Information for TRIZIVIR

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

Expired US Patents for TRIZIVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	TRIZIVIR	abacavir sulfate; lamivudine; zidovudine	TABLET;ORAL	021205-001	Nov 14, 2000	5,089,500*PED
Viiv Hlthcare	TRIZIVIR	abacavir sulfate; lamivudine; zidovudine	TABLET;ORAL	021205-001	Nov 14, 2000	6,417,191*PED
Viiv Hlthcare	TRIZIVIR	abacavir sulfate; lamivudine; zidovudine	TABLET;ORAL	021205-001	Nov 14, 2000	6,180,639*PED
Viiv Hlthcare	TRIZIVIR	abacavir sulfate; lamivudine; zidovudine	TABLET;ORAL	021205-001	Nov 14, 2000	4,724,232

International Patents for TRIZIVIR

When does loss-of-exclusivity occur for TRIZIVIR?

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 TRIZIVIR around the world.

Country	Patent Number	Title	Estimated Expiration
Greece	3019919
China	1326743
Poland	153459
Germany	19975058

Supplementary Protection Certificates for TRIZIVIR

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

Market Dynamics and Financial Trajectory for TRIZIVIR

Last updated: July 31, 2025

Introduction

TRIZIVIR, a combination antiviral medication comprising zidovudine (AZT), lamivudine (3TC), and abacavir (ABC), has historically occupied a niche in the HIV therapeutic landscape. Originally launched by GlaxoSmithKline (GSK), this fixed-dose combination facilitated simplified regimens for HIV management. Its market trajectory has been influenced by evolving treatment guidelines, patent expirations, emergence of novel therapies, and regulatory shifts. This analysis delineates the current market dynamics, competitive landscape, and future financial outlook for TRIZIVIR.

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Historical Context and Product Profile

Introduced in the early 2000s, TRIZIVIR was part of the first wave of fixed-dose combinations aimed at improving adherence among HIV patients. By combining three agents into a single pill, it aimed to reduce pill burden and enhance compliance. The formulation proved effective, with long-standing use in the treatment of HIV-1. Its standard dosing included once-daily administration, aligning with best practices for antiretroviral therapy (ART).

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Patent Expiration and Generic Competition

A significant inflection point for TRIZIVIR occurred with the expiry of patent protections. The primary patent protections for GSK’s formulations began to expire around 2013-2014, leading to the advent of generic equivalents in different markets, particularly in emerging economies such as India and sub-Saharan Africa. The availability of low-cost generics quickly eroded TRIZIVIR’s market share in regions where affordability and access are primary concerns[^1].

In the United States, patent cliff effects were felt earlier, with generic versions entering the market post-2014. The proliferation of generics reduced brand-specific revenues and increased price competition, which is typical in the pharmaceutical industry for established compounds.

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Regulatory Environment and Market Access

Stringent regulatory pathways, especially in the U.S. and Europe, have played a role in shaping TRIZIVIR’s market position. The FDA’s approval frameworks for bioequivalent generics facilitated widespread availability[^2]. In contrast, in low- and middle-income countries, registration and procurement policies often favor generic versions, further diminishing TRIZIVIR’s exclusivity.

Additionally, the shift towards integrase strand transfer inhibitor (INSTI)-based regimens, such as those including dolutegravir and bictegravir, has led to a decline in the use of nucleoside reverse transcriptase inhibitors (NRTIs) — the core components of TRIZIVIR[^3].

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Evolving Treatment Guidelines and Medical Trends

Global HIV treatment guidelines have progressively favored newer, more potent, and better-tolerated agents. Notably, the World Health Organization (WHO) updated its guidelines in recent years, recommending drugs like dolutegravir due to superior efficacy and safety profiles[^4].

This move away from older NRTIs impacts TRIZIVIR’s market. Healthcare providers prefer newer combinations such as TAF (tenofovir alafenamide)-based therapies which present fewer renal and bone toxicity concerns.

Consequently, the demand for TRIZIVIR has declined steadily in regions aligning with these guidelines, diminishing its revenue-generating potential.

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Current Market Landscape

The global HIV antiretroviral market is valued at approximately USD 21 billion in 2023, with the fixed-dose combination segment representing a significant share[^5]. While TRIZIVIR remains available in select markets, its prominence is limited primarily to treatment regimens in development countries, offering affordable options post-patent expiry.

Large pharmaceutical firms such as GSK have shifted focus toward newer, patented regimens and novel drug classes. The company’s portfolio updates reflect decreased emphasis on TRIZIVIR, aligning with broader industry trends toward integrase-based therapies.

In contrast, generic manufacturers within India and Africa continue to produce and distribute TRIZIVIR-compatible formulations. These generics account for a considerable segment of the HIV treatment market in emerging economies, though often at lower margins.

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Financial Trajectory and Forecast

The revenue trajectory for TRIZIVIR has been markedly downward over the past decade. In 2014, peak revenues from TRIZIVIR in developed markets were estimated at USD 300 million annually for GSK. Post-2014, revenues declined steeply owing to patent expiry and emerging competition, falling below USD 50 million by 2020[^6].

Forecasts suggest continued decline, with residual demand confined to regions with limited access to newer therapies. The shift in global treatment protocols towards integrase inhibitors is expected to accelerate the obsolescence of TRIZIVIR as a commercially significant entity.

Key factors influencing future financial outlook include:

• Patent status: In markets where patents remain robust, branded formulations may sustain marginal revenues.
• Generic proliferation: In low-income markets, generics will continue to underpin sales, albeit at lower price points.
• Regulatory policies: Governments' adoption of new treatment guidelines and procurement dynamics will further diminish TRIZIVIR’s market share.
• Pipeline innovations: The advent of long-acting injectables and combination therapies could further marginalize oral NRTI-based regimens.

Projections— by 2025, revenues from TRIZIVIR are expected to decrease to below USD 10 million globally, primarily derived from limited niche markets and legacy treatment programs.

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Competitive and Strategic Considerations

The declining financial trajectory necessitates strategic repositioning for stakeholders holding TRIZIVIR assets. Some considerations include:

• Portfolio diversification: Leveraging existing manufacturing capabilities for newer ARV formulations.
• Partnerships and licensing: Engaging with generic firms for co-promotion or licensing to mitigate decline.
• Market adaptation: Focusing on low-cost formulations, especially in emerging markets, to maintain residual revenues.
• Innovation pipeline: Investing in long-acting injectables or novel mechanisms that could replace NRTI-based regimens in clinical practice.

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Conclusion

TRIZIVIR’s market dynamics reflect a broader industry shift away from first-generation fixed-dose NRTI combinations toward newer, more effective, and better-tolerated therapies. Patent expiry and subsequent generics proliferation, coupled with evolving treatment guidelines favoring integrase inhibitors, have precipitated a sharp decline in its financial trajectory. While residual markets persist primarily in low-income regions, the overall outlook indicates a continued phased obsolescence.

Stakeholders must adapt by aligning strategic portfolios with current clinical and regulatory trends, emphasizing innovation, and targeting niches resistant to generic competition.

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Key Takeaways

• Patent expiration and generic entry have drastically reduced TRIZIVIR’s revenues, with substantial declines post-2014.
• Evolving guidelines favor newer regimens, notably INSTI-based therapies, further reducing demand for NRTI combinations like TRIZIVIR.
• Financial outlook forecasts continued decline, with revenues primarily from low-income markets and legacy programs.
• Market strategy for stakeholders involves diversification, licensing, and innovation to mitigate obsolescence risks.
• Future innovations such as long-acting injectables may further displace oral NRTI-based combinations, accelerating TRIZIVIR’s market disappearance.

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FAQs

1. What factors led to the decline of TRIZIVIR’s market share?
The primary reasons include patent expiration leading to generics, shifting clinical guidelines favoring newer regimens (especially INSTIs), and the development of long-acting injectable therapies that render older oral combinations less relevant.

2. Are there ongoing patents protecting TRIZIVIR formulations?
While primary patents have expired in many jurisdictions, some secondary formulations or specific combination patents may still provide protections in certain markets, although their commercial impact is limited.

3. Is TRIZIVIR still recommended in any current HIV treatment guidelines?
No. Major global guidelines now prioritize integrase inhibitor-based regimens due to superior efficacy and safety profiles, making TRIZIVIR obsolete in frontline treatment.

4. How does the availability of generics affect TRIZIVIR’s pricing?
Generics significantly decrease prices, particularly in emerging markets, reducing profitability for brand manufacturers and constraining revenue streams.

5. What are the future prospects for TRIZIVIR in low-income countries?
While it remains accessible due to affordability, its use is likely to decline further as global treatment policies adopt newer agents, overshadowing older NRTI-based combinations.

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Sources

[^1]: WHO Global HIV/AIDS Response. Progress Report 2022.
[^2]: U.S. Food and Drug Administration. Bioequivalence Requirements for Generic Drugs.
[^3]: Department of Health and Human Services. Guidelines for the Use of Antiretroviral Agents.
[^4]: WHO Consolidated Guidelines on HIV Prevention, Testing, Treatment, Service Delivery and Monitoring – 2021.
[^5]: MarketsandMarkets. HIV Therapeutics Market Analysis, 2023.
[^6]: GSK Annual Reports, 2014–2020.