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Last Updated: December 22, 2024

EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE - Generic Drug Details


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What are the generic drug sources for efavirenz; lamivudine; tenofovir disoproxil fumarate and what is the scope of patent protection?

Efavirenz; lamivudine; tenofovir disoproxil fumarate is the generic ingredient in three branded drugs marketed by Aurobindo Pharma Ltd, Laurus, Macleods Pharms Ltd, Mylan Labs Ltd, and Mylan, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound.

Summary for EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Recent Clinical Trials for EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

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

SponsorPhase
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le SidaN/A
Professor Francois VenterPhase 3
Yu-Jay Corp.Phase 3

See all EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE clinical trials

US Patents and Regulatory Information for EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Macleods Pharms Ltd EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE efavirenz; lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 210649-001 Mar 15, 2019 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mylan Labs Ltd SYMFI efavirenz; lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 022142-001 Mar 22, 2018 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurobindo Pharma Ltd EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE efavirenz; lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 022343-001 Aug 15, 2018 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Laurus EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE efavirenz; lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 212786-001 May 14, 2020 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate

Introduction

The combination of efavirenz, lamivudine, and tenofovir disoproxil fumarate is a crucial antiretroviral therapy (ART) regimen used to treat HIV-1 infection. This combination, often referred to as a single-tablet regimen (STR), has significant implications for both patient health and market dynamics.

Market Size and Growth

The global market for efavirenz, lamivudine, and tenofovir disoproxil fumarate is expected to experience substantial growth over the forecast period. According to market reports, the prevalence of HIV infection worldwide drives the demand for effective ART regimens. By 2019, approximately 38 million people globally were living with HIV/AIDS, with 25.4 million accessing antiretroviral therapy[4].

Revenue and Forecast

The revenue growth for this combination drug is projected to be robust, driven by increasing demand and advancements in treatment protocols. The market is forecasted to grow from 2025 to 2031, with the base year for calculations being 2023. This growth is supported by the expanding access to ART globally and the introduction of new products with improved capabilities[1][4].

Regional Analysis

The market for efavirenz, lamivudine, and tenofovir disoproxil fumarate is diverse and regionally varied. Regions with high HIV prevalence, such as sub-Saharan Africa, are expected to dominate the market. However, other regions, including North America and Europe, also contribute significantly due to their advanced healthcare systems and higher adoption rates of ART regimens[1].

Competitive Landscape

The market is highly competitive, with several key players such as Gilead Sciences, Cipla, Macleods Pharmaceuticals, Bristol-Myers Squibb, Teva, Strides Pharma, Hetero, Aurobindo Pharma, and Mylan. These companies are continuously innovating and launching new products to capture market share. For instance, Mylan launched a new HIV treatment, Symfi Lo, which is a single-tablet regimen containing efavirenz, lamivudine, and tenofovir disoproxil fumarate[4].

Cost-Effectiveness and Budget Impact

The cost-effectiveness of the efavirenz, lamivudine, and tenofovir disoproxil fumarate combination is a critical factor in its adoption. Studies have shown that this regimen is more cost-effective compared to other ART combinations. For example, the combination of tenofovir disoproxil fumarate (TDF), emtricitabine (FTC), and efavirenz (EFV) was found to be superior and more cost-effective than the fixed-dose zidovudine (ZDV)/lamivudine (3TC) and EFV regimen[3][5].

Budget Impact Analysis

A budget impact analysis in Spain indicated that the use of a set combination of efavirenz, emtricitabine, and tenofovir could lead to slight budgetary savings or surpluses by reducing the number of daily doses. This reduction in daily doses can improve patient compliance and quality of life, thereby reducing overall healthcare costs[2].

Drivers and Opportunities

Increasing Prevalence of HIV

The ongoing prevalence of HIV infection globally is a significant driver for the market. Despite a 23% decline in new HIV infections since 2010, the total number of new infections remains high, driving the demand for effective ART regimens[4].

Advancements in Treatment Protocols

Continuous advancements in treatment protocols and the introduction of new products with improved capabilities are key drivers. Single-tablet regimens like Symfi Lo offer convenience and improved patient compliance, contributing to market growth[4].

Government Initiatives and Funding

Government initiatives and funding for HIV treatment programs also play a crucial role. The United Nations Programme on HIV and AIDS (UNAIDS) and other global health organizations are working to increase access to ART, which is expected to boost the market[4].

Restraints and Challenges

COVID-19 Impact

The COVID-19 pandemic has had a negative impact on the production and distribution of antiretroviral medicines, including efavirenz, lamivudine, and tenofovir disoproxil fumarate. Lockdowns and border closures have led to supply chain disruptions and potential cost increases[4].

Patent Expirations

Patent expirations for key drugs can lead to increased competition from generic manufacturers, which may affect the market dynamics and pricing strategies of branded products[1].

Regulatory Hurdles

Regulatory requirements and approval processes can be stringent and time-consuming, posing challenges for new product launches and market entry[1].

Technological Trends

Single-Tablet Regimens

The trend towards single-tablet regimens (STRs) is significant. These regimens simplify treatment by combining multiple drugs into one tablet, improving patient compliance and reducing the complexity of treatment regimens[3][4].

Generic and Biosimilar Options

The availability of generic and biosimilar versions of these drugs is increasing, offering more affordable treatment options and expanding access to ART globally[4].

Market Attractiveness

The market attractiveness for efavirenz, lamivudine, and tenofovir disoproxil fumarate is high due to the growing demand for effective HIV treatments and the ongoing innovations in the field. The combination of these factors makes this market segment highly attractive for pharmaceutical companies and investors[1].

Consumer Behavior Analysis

Patient compliance and quality of life are critical factors influencing consumer behavior. The convenience of single-tablet regimens and the reduced number of daily doses contribute to higher patient compliance, which in turn drives market demand[2].

SWOT Analysis

Strengths

  • High demand due to global HIV prevalence
  • Cost-effectiveness and superior clinical outcomes
  • Continuous innovations and new product launches

Weaknesses

  • Supply chain disruptions due to COVID-19
  • Patent expirations leading to generic competition
  • Regulatory hurdles for new product approvals

Opportunities

  • Increasing access to ART globally
  • Government initiatives and funding
  • Advancements in treatment protocols

Threats

  • Competition from generic and biosimilar products
  • Regulatory changes and pricing pressures
  • Potential side effects and resistance development

Key Takeaways

  • The market for efavirenz, lamivudine, and tenofovir disoproxil fumarate is expected to grow significantly due to increasing demand and advancements in treatment protocols.
  • The combination is cost-effective and offers superior clinical outcomes, making it a preferred choice for HIV treatment.
  • Single-tablet regimens are a key trend, improving patient compliance and quality of life.
  • Despite challenges such as COVID-19 disruptions and patent expirations, the market remains attractive due to ongoing innovations and government initiatives.

FAQs

What are the key drivers of the efavirenz, lamivudine, and tenofovir disoproxil fumarate market?

The key drivers include the increasing prevalence of HIV, advancements in treatment protocols, and government initiatives to increase access to ART.

How does the COVID-19 pandemic impact the market for this combination drug?

The COVID-19 pandemic has disrupted the production and distribution of antiretroviral medicines, leading to supply chain issues and potential cost increases.

What are the benefits of single-tablet regimens like efavirenz, lamivudine, and tenofovir disoproxil fumarate?

Single-tablet regimens simplify treatment, improve patient compliance, and reduce the complexity of treatment regimens, leading to better clinical outcomes and quality of life.

Which regions are expected to dominate the market for this combination drug?

Regions with high HIV prevalence, such as sub-Saharan Africa, are expected to dominate the market, along with regions like North America and Europe due to their advanced healthcare systems.

How does the cost-effectiveness of this combination compare to other ART regimens?

The combination of efavirenz, lamivudine, and tenofovir disoproxil fumarate is more cost-effective compared to other ART combinations, offering superior clinical outcomes and lower healthcare resource utilization[3][5].

Sources

  1. Cognitivemarketresearch.com: Efavirenz/Lamivudine/Tenofovir Compound Drugs Market Report.
  2. Redalyc.org: Budget impact of a set-dose combination of efavirenz, emtricitabine, and tenofovir.
  3. Pubmed.ncbi.nlm.nih.gov: Tenofovir disoproxil fumarate, emtricitabine, and efavirenz versus zidovudine/lamivudine and efavirenz.
  4. Alliedmarketresearch.com: Efavirenz Market Insights Analysis | Forecast Growth - 2030.
  5. Pubmed.ncbi.nlm.nih.gov: Cost-effectiveness analysis of emtricitabine/tenofovir versus lamivudine/zidovudine.

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