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Last Updated: December 22, 2024

EFAVIRENZ Drug Patent Profile


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Which patents cover Efavirenz, and what generic alternatives are available?

Efavirenz is a drug marketed by Aurobindo Pharma, Aurobindo Pharma Ltd, Cipla, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Mylan, Strides Pharma, Hetero Labs Ltd V, Laurus, and Teva Pharms Usa. and is included in twenty-one NDAs.

The generic ingredient in EFAVIRENZ is efavirenz; lamivudine; tenofovir disoproxil fumarate. There are twenty-six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the efavirenz; lamivudine; tenofovir disoproxil fumarate profile page.

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Drug patent expirations by year for EFAVIRENZ
Drug Prices for EFAVIRENZ

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Recent Clinical Trials for EFAVIRENZ

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

SponsorPhase
Merck Sharp & Dohme LLCPhase 3
Africa Health Research InstitutePhase 3
TakedaPhase 1

See all EFAVIRENZ clinical trials

Paragraph IV (Patent) Challenges for EFAVIRENZ
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SUSTIVA Capsules efavirenz 50 mg, 100 mg and 200 mg 020972 1 2016-11-03
SUSTIVA Tablets efavirenz 600 mg 021360 1 2009-04-09

US Patents and Regulatory Information for EFAVIRENZ

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 efavirenz CAPSULE;ORAL 078064-001 Dec 15, 2017 RX No No ⤷  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
Hetero Labs Ltd Iii EFAVIRENZ efavirenz TABLET;ORAL 078886-001 Apr 27, 2018 AB RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurobindo Pharma EFAVIRENZ efavirenz TABLET;ORAL 205322-001 Aug 30, 2018 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
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, 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

EU/EMA Drug Approvals for EFAVIRENZ

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Teva B.V. Efavirenz Teva efavirenz EMEA/H/C/002352
Efavirenz is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and children 3 years of age and older.Efavirenz has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease inhibitor (PI)-containing regimens. Although cross-resistance of efavirenz with protease inhibitors (PIs) has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI-based combination therapy after failure of regimens containing efavirenz.
Authorised yes no no 2012-01-09
Merck Sharp & Dohme B.V. Stocrin efavirenz EMEA/H/C/000250
Stocrin is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and children three years of age and older.Stocrin has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease-inhibitor (PI)-containing regimens. Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI-based combination therapy after failure of regimens containing Stocrin.
Authorised no no no 1999-05-28
Bristol-Myers Squibb Pharma EEIG Sustiva efavirenz EMEA/H/C/000249
Sustiva is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and children three years of age and older.Sustiva has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease-inhibitor (PI)-containing regimens. Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI-based combination therapy after failure of regimens containing Sustiva.
Authorised no no no 1999-05-28
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

EFAVIRENZ Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Efavirenz

Introduction

Efavirenz, a crucial antiretroviral drug used in the treatment of HIV/AIDS, is part of a dynamic and evolving market. The drug's market is influenced by various factors, including technological advancements, changing treatment guidelines, and competitive strategies.

Market Drivers

Increasing Prevalence of HIV

The global Efavirenz market is driven significantly by the increasing prevalence of HIV infection, particularly in developing countries. This rising demand for effective antiretroviral therapy (ART) fuels the growth of the Efavirenz market[1][4].

Advancements in Treatment Options

The development of combination therapies, which often include Efavirenz, is gaining popularity. These regimens offer better efficacy and patient compliance, contributing to the market's growth. Additionally, advancements in drug delivery systems, such as long-acting formulations, are expected to drive future market growth[1][4].

Regulatory and Healthcare Infrastructure

Well-established healthcare infrastructure in regions like North America and Europe, along with high awareness levels about HIV/AIDS, contribute to the dominant market position of these regions. However, the Asia Pacific region is expected to witness significant growth due to improving access to healthcare facilities and increasing HIV prevalence[1].

Market Challenges

High Cost of Treatment

The high cost of antiretroviral therapy, including Efavirenz, poses a significant challenge, especially in resource-limited settings. This high cost can limit access to the drug, affecting market growth[1][4].

Drug Resistance

The emergence of drug-resistant strains of the HIV virus limits the efficacy of Efavirenz and other antiretroviral drugs, hindering market growth. This necessitates continuous research and development to combat resistance[1][5].

Side Effects

Efavirenz is associated with side effects such as rash, dizziness, and neuropsychiatric symptoms, which can impact patient compliance and overall market performance[1].

Patent Expiry and Generic Competition

The expiration of patents for Efavirenz has led to the entry of generic versions, resulting in price competition and reduced profit margins for manufacturers. This shift towards generics can alter the financial trajectory of the market[1][4].

Market Opportunities

Development of Long-Acting Formulations

The development of long-acting formulations of Efavirenz offers extended drug release and reduces the frequency of dosing, which can enhance patient compliance and drive market growth[1].

Expansion in Emerging Markets

There is significant potential for market expansion in emerging markets, particularly in the Asia Pacific region, where access to healthcare is improving and the prevalence of HIV is increasing[1].

Collaborations and Innovations

Collaborations with research institutions and healthcare organizations can facilitate knowledge exchange and lead to innovative solutions in HIV treatment, including the development of new formulations and treatment regimens[1].

Competitive Landscape

Revenue Generation and Market Expansion

The growing demand for Efavirenz presents significant revenue generation opportunities for pharmaceutical companies. Expanding product portfolios to include Efavirenz can help companies penetrate new markets and increase their market share[1][4].

Research and Development

Investing in research and development activities related to Efavirenz can lead to the development of improved formulations and contribute to scientific advancements. Companies like Bristol-Myers Squibb and Mylan are focusing on strengthening their product portfolios through such strategies[1][4].

Market Share and Key Players

The market is highly competitive, with several pharmaceutical companies competing for market share. The entry of generic versions has intensified competition, and companies are now focusing on product differentiation, pricing strategies, and geographical expansion to maintain their market position[1][4].

Regional Analysis

North America and Europe

These regions currently dominate the Efavirenz market due to their well-established healthcare infrastructure and high awareness levels about HIV/AIDS. However, the market in these regions is mature and may experience slower growth compared to emerging markets[1].

Asia Pacific

The Asia Pacific region is expected to witness significant growth due to the increasing prevalence of HIV and improving access to healthcare facilities. This region offers substantial opportunities for market expansion and revenue growth[1].

Financial Trajectory

Revenue Growth

The global Efavirenz market is expected to witness steady revenue growth during the forecast period, driven by the increasing demand for antiretroviral therapy and advancements in treatment options. The market size is projected to expand significantly from 2025 to 2031[1][4].

Impact of Generic Competition

The entry of generic versions of Efavirenz has led to price competition, reducing profit margins for manufacturers. However, this also makes the drug more accessible to a wider population, potentially increasing overall market size[1][4].

Investment in R&D

Investments in research and development are crucial for the financial trajectory of the Efavirenz market. Companies that invest in developing new formulations and improving existing ones are likely to maintain or increase their market share and revenue[1][4].

SWOT Analysis

Strengths

  • Established efficacy and safety profile of Efavirenz
  • Wide acceptance and inclusion in treatment guidelines
  • Availability of generic versions, leading to cost advantages[1]

Weaknesses

  • Side effects associated with Efavirenz treatment
  • Emergence of drug-resistant strains impacting efficacy
  • High cost of treatment for patients in resource-limited settings[1]

Opportunities

  • Development of long-acting formulations
  • Expansion in emerging markets
  • Collaborations for innovation and research[1]

Threats

  • Patent expiration and entry of generic versions
  • Competition from other antiretroviral drugs
  • Stringent regulatory requirements for drug approval[1]

Future Outlook

The future outlook for the Efavirenz market remains positive, driven by the increasing prevalence of HIV infection and advancements in treatment options. The development of long-acting formulations, personalized medicine approaches, and the integration of digital health technologies will shape the future of HIV treatment, including the use of Efavirenz[1].

Personalized Medicine and Telemedicine

Advancements in genetic testing and personalized medicine may lead to tailored treatment regimens for HIV patients. The integration of telemedicine and digital health platforms will improve patient adherence and outcomes, further driving market growth[1].

Key Takeaways

  • The Efavirenz market is driven by the increasing prevalence of HIV infection and advancements in treatment options.
  • The market faces challenges such as high treatment costs, drug resistance, and side effects.
  • Opportunities for growth include the development of long-acting formulations and expansion in emerging markets.
  • The competitive landscape is characterized by intense competition, with a focus on product differentiation and geographical expansion.
  • The future outlook is positive, with a focus on personalized medicine and digital health technologies.

FAQs

What are the primary drivers of the Efavirenz market?

The primary drivers include the increasing prevalence of HIV infection, advancements in treatment options, and the availability of advanced healthcare infrastructure[1].

What are the main challenges facing the Efavirenz market?

The main challenges include the high cost of treatment, the emergence of drug-resistant strains, and side effects associated with Efavirenz[1].

How is the competitive landscape of the Efavirenz market?

The market is highly competitive, with several pharmaceutical companies focusing on product differentiation, pricing strategies, and geographical expansion. The entry of generic versions has intensified competition[1][4].

What are the opportunities for growth in the Efavirenz market?

Opportunities include the development of long-acting formulations, expansion in emerging markets, and collaborations for innovation and research[1].

What is the future outlook for the Efavirenz market?

The future outlook is positive, driven by advancements in treatment options, personalized medicine approaches, and the integration of digital health technologies[1].

Cited Sources:

  1. MarkWide Research: Efavirenz Market 2024-2032 | Size, Share, Growth.
  2. Oxford Academic: Final 192-Week Efficacy and Safety Results of the ADVANCE Trial.
  3. SciELO: Public supply of AIDS drugs.
  4. Cognitive Market Research: Global Efavirenz Market Report 2024 Edition.
  5. Oxford Academic: Clinical Outcomes After Viremia Among People Receiving Dolutegravir vs Efavirenz-Based First-Line Antiretroviral Therapy.

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