COMBIVIR Drug Patent Profile

When do Combivir patents expire, and what generic alternatives are available?

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

The generic ingredient in COMBIVIR is lamivudine; zidovudine. There are twenty-nine drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the lamivudine; zidovudine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Combivir

A generic version of COMBIVIR was approved as lamivudine; zidovudine by LUPIN LTD on May 15^th, 2012.

Summary for COMBIVIR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	26
Clinical Trials:	63
Drug Prices:	Drug price information for COMBIVIR
What excipients (inactive ingredients) are in COMBIVIR?	COMBIVIR excipients list
DailyMed Link:	COMBIVIR at DailyMed

See drug prices for COMBIVIR

Recent Clinical Trials for COMBIVIR

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

Sponsor	Phase
Augusta University	Phase 4
Massachusetts General Hospital	Phase 2
AIDS Clinical Trials Group	Phase 3

See all COMBIVIR clinical trials

Pharmacology for COMBIVIR

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

US Patents and Regulatory Information for COMBIVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	COMBIVIR	lamivudine; zidovudine	TABLET;ORAL	020857-001	Sep 26, 1997		DISCN	Yes	No

Expired US Patents for COMBIVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	COMBIVIR	lamivudine; zidovudine	TABLET;ORAL	020857-001	Sep 26, 1997	6,180,639*PED
Viiv Hlthcare	COMBIVIR	lamivudine; zidovudine	TABLET;ORAL	020857-001	Sep 26, 1997	4,837,208*PED
Viiv Hlthcare	COMBIVIR	lamivudine; zidovudine	TABLET;ORAL	020857-001	Sep 26, 1997	6,113,920*PED
Viiv Hlthcare	COMBIVIR	lamivudine; zidovudine	TABLET;ORAL	020857-001	Sep 26, 1997	4,724,232*PED
Viiv Hlthcare	COMBIVIR	lamivudine; zidovudine	TABLET;ORAL	020857-001	Sep 26, 1997	5,859,021*PED
Viiv Hlthcare	COMBIVIR	lamivudine; zidovudine	TABLET;ORAL	020857-001	Sep 26, 1997	7,119,202*PED

EU/EMA Drug Approvals for COMBIVIR

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Teva Pharma B.V.	Lamivudine/Zidovudine Teva	lamivudine, zidovudine	EMEA/H/C/001236Lamivudine/Zidovudine Teva is indicated in antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV) infection.	Withdrawn	yes	no	no	2011-02-28
ViiV Healthcare BV	Combivir	lamivudine, zidovudine	EMEA/H/C/000190Combivir is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection.,	Authorised	no	no	no	1998-03-18

International Patents for COMBIVIR

See the table below for patents covering COMBIVIR around the world.

Country	Patent Number	Title	Estimated Expiration
Poland	167682
Russian Federation	2099338	(-)-ENANTIOMER OF CIS-4-AMINO-1-(2-HYDROXYMETHYL-1,3-OXATHIOLAN-5-YL)-(1H)-PYRIMIDINE-2-ONE, A MIXTURE OF (-)-ENANTIOMER AND (+)-ENANTIOMER, METHOD OF THEIR PREPARING
Denmark	202791
African Intellectual Property Organization (OAPI)	9559
Iceland	1867
Japan	2927546

Supplementary Protection Certificates for COMBIVIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3494972	LUC00346	Luxembourg		PRODUCT NAME: DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, Y COMPRIS LE DOLUTEGRAVIR SODIQUE, ET LAMIVUDINE; AUTHORISATION NUMBER AND DATE: EU/1/19/1370 20190703
3494972	24C1024	France		PRODUCT NAME: DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, INCLUANT LE DOLUTEGRAVIR SODIQUE, ET LAMIVUDINE; REGISTRATION NO/DATE: EU/1/19/1370 20190703
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
0513917	17/1998	Austria		PRODUCT NAME: LAMIVUDIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, UND ZIDOVUDIN; REGISTRATION NO/DATE: EU/1/98/058/001 EU/1/98/058/002 19980318
0382526	SPC/GB96/043	United Kingdom		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
0382526	SZ 22/1996	Austria		PRODUCT NAME: LAMIVUDIN UND DESSEN PHARMAZEUTISCH ANNEHMBARE SALZE

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: COMBIVIR

Last updated: July 27, 2025

Introduction

COMBIVIR, a fixed-dose combination antiretroviral (ARV) therapy consisting of lamivudine and zidovudine, has played a pivotal role in managing HIV/AIDS since its approval. Its unique positioning as an effective, once-daily oral medication initially launched in the late 1990s facilitated significant advancements in HIV treatment. This analysis explores the evolving market environment, competitive landscape, and financial performance trajectory for COMBIVIR, emphasizing key factors shaping its current and future outlook within the global ARV sector.

Market Dynamics

Global HIV/AIDS Treatment Landscape

The global HIV/AIDS therapeutics market continues to expand, driven predominantly by increasing prevalence, improved diagnosis access, and evolving treatment guidelines. According to UNAIDS, approximately 38 million people were living with HIV in 2021, with nearly 28 million on antiretroviral therapy (ART) [1]. The demand for ARV medications remains robust, especially in low- and middle-income countries (LMICs), where the burden is highest and where access has significantly improved through public health initiatives.

Therapeutic Shifts and Treatment Guidelines

The landscape has shifted towards integrative, simplified regimens emphasizing potency, tolerability, and adherence. First-line treatment now favors newer fixed-dose combinations (FDCs), including integrase strand transfer inhibitors (INSTIs) such as dolutegravir, which offer superior efficacy and better side-effect profiles compared to older drugs like zidovudine (AZT) and lamivudine (3TC) [2].

Over time, originating drugs such as COMBIVIR have experienced declining preferential use, replaced by next-generation therapies with improved safety and convenience. Nonetheless, COMBIVIR maintains a niche in specific markets and patient populations, especially in resource-limited settings where cost and durability influence prescribing patterns.

Competitive Dynamics

The competitive landscape for COMBIVIR is shaped by both branded and generic manufacturers. Major pharmaceutical companies and generic manufacturers supply an array of ARV FDCs, such as Atripla, Triumeq, and Descovy, emphasizing once-daily dosing, tolerability, and reduced pill burden [3].

In LMICs, organizations like Medicines Patent Pool facilitate access to affordable generics, which have further intensified price competition. Despite newer formulations dominating on the global stage, COMBIVIR's established manufacturing base and patent expiration in many jurisdictions sustain its presence, particularly in primary healthcare settings.

Regulatory Environment and Market Access

Regulatory approvals and procurement policies heavily influence COMBIVIR’s market trajectory. WHO treatment guidelines by the World Health Organization (WHO) do not explicitly recommend COMBIVIR as a first-line therapy but recognize older regimens in contexts with limited resources [4]. Governments and NGOs often favor cost-effective, approved generic ARVs, maintaining steady demand where newer drugs are inaccessible or unaffordable.

Intellectual property rights and patent litigations also impact market dynamics. When patents lapse, generic manufacturers can produce cheaper versions, expanding access but intensifying competition for the original patent holders. Recent policies in several countries have facilitated generic entry, compelling brand-name manufacturers to adapt strategically.

Supply Chain and Manufacturing Factors

Manufacturing capacity, quality standards, and supply chain resilience determine COMBIVIR’s availability and pricing. Large-scale generic producers in India and Africa constitute a significant segment, ensuring broad geographic distribution. Price reductions achieved through increased competition, coupled with economies of scale, have led to more affordable prices in LMICs, maintaining demand volume despite shifting preferences.

Financial Trajectory

Revenue Trends and Market Share

Initially, COMBIVIR experienced substantial commercial success, driven by its pioneering status and approval for widespread HIV management. However, its revenue contribution has declined over the past decade, primarily due to the advent of more potent, tolerable, and simplified ART regimens.

In developed markets, COMBIVIR now accounts for a shrinking share, with prescribers favoring integrase-based combinations. Conversely, in emerging economies, it retains modest market share owing to cost-effectiveness and existing procurement contracts. Estimates suggest that COMBIVIR’s global annual revenue has decreased by approximately 60-70% since peaking in the early 2000s [5].

Cost Structure and Pricing Strategies

The profitability of COMBIVIR has benefited from patented formulations initially, but patent expirations have precipitated significant price erosion. Generic manufacturing has driven prices downward, especially in LMICs, where price points can be 10-15 times lower than early formulations.

Manufacturers now focus on optimizing production costs and scale efficiencies, aligning with donor-funded programs’ budgets. The shift toward bulk procurement from international agencies influences pricing strategies, with lower margins but sustained volume requirements.

R&D and Portfolio Considerations

Given its age and the pathway of HIV treatment advancements, COMBIVIR is unlikely to be a focal point of R&D investment. Instead, pharmaceutical firms prioritize developing next-generation therapies, which entails diminishing financial allocation toward older drugs. Carbon-neutral manufacturing, patent strategies, and lifecycle management efforts are primarily oriented toward maintaining compliance and residual revenue streams rather than innovation.

Future Revenue Prospects

Projections indicate continued but diminishing revenues for COMBIVIR. The drug’s usage will persist in current markets where affordability remains paramount, and newer options face barriers such as higher costs and regulatory constraints. The expansion of generic manufacturing and global health initiatives will sustain its market presence, although at lower profit margins.

The potential emergence of biosimilars, patent litigations, and policy shifts toward newer ARV classes could further accelerate revenue decline. Nonetheless, the longstanding presence, established manufacturing infrastructure, and ongoing demand in LMICs support a prolonged, albeit reduced, financial footprint.

Strategic Insights and Implications

Pharmaceutical companies with portfolio exposure to COMBIVIR should anticipate a gradual decline in its revenue contribution, necessitating strategic diversification into newer, more profitable ARV classes. Additionally, maintaining market access in resource-limited settings will hinge on competitive pricing, quality assurance, and alignment with global treatment guidelines.

Investors and stakeholders ought to monitor the competitive pressure from generic manufacturers and the impact of international health policies dictating procurement priorities. For brand owners, emphasizing lifecycle management, licensing negotiations, or transitioning users to newer formulations could optimize long-term profitability.

Key Takeaways

• The global HIV/AIDS medication market favors newer, simplified, and more tolerable ARV regimens, leading to a decline in COMBIVIR’s market share and revenue.
• COMBIVIR’s continued relevance relies on its cost-effectiveness and large-scale manufacturing, primarily serving resource-limited regions.
• Patent expirations and generic competition have significantly driven down prices, impacting profitability.
• Strategic focus should pivot toward newer drug pipelines, lifecycle management, and maintaining access through tiered pricing and licensing.
• Market dynamics are heavily influenced by international health policies, regulatory environments, and evolving treatment guidelines favoring integrated, once-daily ARV combinations.

5 Unique FAQs

Q1: How has the global shift in HIV treatment guidelines affected COMBIVIR’s market position?
The shift towards integrase-based regimens and fixed-dose combinations with fewer side effects has reduced COMBIVIR’s role as a first-line therapy, restricting its use primarily to specific markets or patient subsets.

Q2: What factors influence COMBIVIR’s pricing in low- and middle-income countries?
Pricing is primarily affected by patent status, generic competition, procurement policies from international agencies, and negotiated discounts, leading to significantly lower prices compared to high-income markets.

Q3: Are there any new formulations of COMBIVIR under development?
Currently, there are no major developments or new formulations for COMBIVIR, as focus shifts to newer ARVs with better tolerability and efficacy profiles.

Q4: How do international health initiatives impact the continued use of COMBIVIR?
Global health initiatives aim to expand access to affordable ARVs. COMBIVIR benefits from bulk procurement programs in LMICs, ensuring its continued availability despite declining preference in high-income countries.

Q5: What are the future prospects for COMBIVIR’s revenue growth?
Future revenue growth prospects are limited; the drug’s role is expected to diminish further as treatment paradigms evolve, replaced by newer, more effective, and better-tolerated therapies.

References

[1] UNAIDS. Global HIV & AIDS statistics — Fact sheet 2022.
[2] WHO. Consolidated guidelines on HIV prevention, testing, treatment, service delivery, and monitoring – 2021.
[3] IQVIA. The future of HIV treatment 2022.
[4] WHO. HIV treatment guidelines – Policy updates and implications, 2021.
[5] EvaluatePharma. HIV/AIDS Market Trends, 2022.