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Last Updated: December 22, 2024

EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE Drug Patent Profile


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Which patents cover Efavirenz, Emtricitabine, And Tenofovir Disoproxil Fumarate, and when can generic versions of Efavirenz, Emtricitabine, And Tenofovir Disoproxil Fumarate launch?

Efavirenz, Emtricitabine, And Tenofovir Disoproxil Fumarate is a drug marketed by Aurobindo Pharma, Cipla, Hetero Labs Ltd V, Laurus, Macleods Pharms Ltd, and Teva Pharms Usa. and is included in six NDAs.

The generic ingredient in EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE is efavirenz; emtricitabine; tenofovir disoproxil fumarate. There are twenty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the efavirenz; emtricitabine; tenofovir disoproxil fumarate profile page.

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Summary for EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE
Drug patent expirations by year for EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE
Recent Clinical Trials for EFAVIRENZ, EMTRICITABINE, AND 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
Yu-Jay Corp.Phase 3
University of AlbertaPhase 4

See all EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE clinical trials

US Patents and Regulatory Information for EFAVIRENZ, EMTRICITABINE, AND 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
Aurobindo Pharma EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203041-001 Sep 4, 2018 AB RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Laurus EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 213541-001 Dec 22, 2021 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Cipla EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 206894-001 Jun 3, 2019 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hetero Labs Ltd V EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203053-001 Jan 24, 2022 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Pharms Usa EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 091215-001 Nov 9, 2018 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Macleods Pharms Ltd EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 204287-001 Sep 13, 2021 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, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE Market Analysis and Financial Projection Experimental

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

Introduction

The combination of efavirenz, emtricitabine, and tenofovir disoproxil fumarate is a cornerstone in the treatment of HIV-1 infection. This antiretroviral therapy (ART) has been widely used due to its efficacy and convenience. Here, we delve into the market dynamics and financial trajectory of this drug combination.

Market Size and Growth

The global market for tenofovir disoproxil fumarate and its combination drugs, including the efavirenz-emtricitabine-tenofovir combination, has seen significant growth. As of 2023, the market size was substantial, although exact figures are not disclosed in publicly available reports[1].

The compound annual growth rate (CAGR) for this market is expected to be robust from 2024 to 2031, driven by increasing demand for effective HIV treatments and the expansion of healthcare access in various regions.

Regional Analysis

The market for efavirenz, emtricitabine, and tenofovir disoproxil fumarate is segmented into major regions such as North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. Each region has its own set of contributing countries, and the revenue share varies significantly across these regions.

North America, particularly the United States, has been a significant market due to high healthcare spending and the presence of major pharmaceutical companies like Gilead Sciences. However, the loss of exclusivity for key drugs like Truvada and Atripla has led to a decline in sales in this region[3].

Application and End-Use

This combination drug is primarily used in the treatment of HIV-1 infection. It is often prescribed as a first-line treatment for antiretroviral-naive patients due to its superior outcomes in achieving and maintaining viral suppression and increasing CD4 cell counts[4].

Hospital Segment

The hospital segment accounts for a noticeable share of the global market for this drug combination. Hospitals are key end-users, and the demand from this segment is expected to grow significantly in the near future[1].

Financial Performance

Revenue Trends

The financial performance of the efavirenz-emtricitabine-tenofovir combination has been influenced by several factors, including patent expirations and the rise of generic competitors. For instance, the sales of Truvada and Atripla, which are key products containing tenofovir disoproxil fumarate, decreased significantly in 2021 due to generic entrants in the United States following the loss of exclusivity[3].

However, other products like Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) have seen increased demand, offsetting some of the losses. Biktarvy sales increased by 24% year-over-year in the second quarter of 2021, driven by higher demand in all geographies[3].

Cost-Effectiveness

Studies have shown that the combination of emtricitabine/tenofovir disoproxil fumarate and efavirenz is cost-effective compared to other antiretroviral regimens. For example, a cost-effectiveness analysis revealed that the regimen including TVD + EFV resulted in significant savings and a higher percentage of patients with undetectable viral loads compared to the COMB + EFV regimen[5].

Budget Impact

Budget impact analyses have indicated that the use of this combination can lead to slight surpluses or even budgetary savings by reducing the number of daily doses, which can improve patient quality of life. In a study focusing on the Spanish healthcare system, the substitution of various drug regimens with the efavirenz-emtricitabine-tenofovir combination showed varying budget impacts, but generally suggested cost-effectiveness[2].

Competitive Landscape

The market for efavirenz, emtricitabine, and tenofovir disoproxil fumarate is competitive, with several key players. Gilead Sciences is a major player, with products like Truvada, Atripla, and Biktarvy. Other companies, such as Alkem Laboratories, are also expanding their product portfolios and business in the global market[1].

Drivers and Opportunities

Increasing Demand for HIV Treatments

The global demand for effective HIV treatments continues to rise, driven by the growing number of HIV-infected individuals and the need for antiretroviral therapies.

Expanding Healthcare Access

Improving healthcare access in developing regions presents significant opportunities for market growth.

Technological Advancements

Advancements in pharmaceutical technology, such as the development of more convenient and effective drug formulations, drive market growth.

Restraints and Challenges

Patent Expirations

The loss of exclusivity for key drugs has led to the entry of generic competitors, reducing sales for branded products.

Regulatory Changes

Changes in regulatory environments can impact the market dynamics, particularly in regions with stringent approval processes.

Economic Factors

Economic fluctuations and budget constraints in healthcare systems can affect the adoption and sales of these drugs.

Market Trends

Shift to New Formulations

There is a trend towards newer formulations like tenofovir alafenamide (TAF), which is seen in products like Biktarvy. TAF offers improved renal and bone safety profiles compared to tenofovir disoproxil fumarate (TDF)[3].

Increased Focus on Pre-Exposure Prophylaxis (PrEP)

The demand for PrEP is increasing, driven by public health initiatives to prevent HIV infection. This has positively impacted the sales of drugs like Descovy (emtricitabine/tenofovir alafenamide)[3].

Key Takeaways

  • The global market for efavirenz, emtricitabine, and tenofovir disoproxil fumarate is expected to grow, driven by increasing demand for HIV treatments and expanding healthcare access.
  • The financial performance of this drug combination has been impacted by patent expirations and the rise of generic competitors.
  • The combination is cost-effective and offers superior outcomes in HIV treatment.
  • Market trends include a shift towards newer formulations and an increased focus on PrEP.

FAQs

What is the primary use of the efavirenz, emtricitabine, and tenofovir disoproxil fumarate combination?

The primary use is in the treatment of HIV-1 infection, particularly as a first-line treatment for antiretroviral-naive patients.

How has the loss of exclusivity affected the sales of Truvada and Atripla?

The loss of exclusivity led to a significant decline in sales for Truvada and Atripla due to the entry of generic competitors in the United States.

What are the cost-effectiveness implications of using this drug combination?

Studies have shown that the combination of emtricitabine/tenofovir disoproxil fumarate and efavirenz is cost-effective, resulting in significant savings and better treatment outcomes.

Which regions are key markets for this drug combination?

North America, Europe, Asia Pacific, Middle East & Africa, and Latin America are the major regions, with North America being particularly significant due to high healthcare spending.

What are the trends in the market for this drug combination?

There is a trend towards newer formulations like tenofovir alafenamide and an increased focus on pre-exposure prophylaxis (PrEP).

Sources

  1. Cognitive Market Research, "Tenofovir Disoproxil Fumarate and Its Combination Drugs Market Report 2024".
  2. Redalyc, "Budget impact of a set-dose combination of efavirenz-emtricitabine-tenofovir in patients infected with HIV-1".
  3. Business Wire, "Gilead Sciences Announces Second Quarter 2021 Financial Results".
  4. PubMed, "Tenofovir disoproxil fumarate, emtricitabine, and efavirenz versus zidovudine/lamivudine and efavirenz in antiretroviral-naive patients".
  5. PubMed, "Cost-effectiveness analysis of emtricitabine/tenofovir versus lamivudine/zidovudine in antiretroviral-naive, HIV-1-infected patients".

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