EFAVIRENZ - Generic Drug Details

What are the generic drug sources for efavirenz and what is the scope of patent protection?

Efavirenz is the generic ingredient in nine branded drugs marketed by Aurobindo Pharma, Bristol Myers Squibb, Aurobindo Pharma Ltd, Cipla, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Mylan, Strides Pharma, Gilead Sciences, Hetero Labs Ltd V, Laurus, Teva Pharms Usa, and Mylan Labs Ltd, and is included in twenty-six NDAs. There are seven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are twenty-six drug master file entries for efavirenz. Eight suppliers are listed for this compound. There are eighteen tentative approvals for this compound.

Summary for EFAVIRENZ

US Patents:	7
Tradenames:	9
Applicants:	13
NDAs:	26
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	107
Clinical Trials:	429
Patent Applications:	6,832
Drug Prices:	Drug price trends for EFAVIRENZ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EFAVIRENZ
What excipients (inactive ingredients) are in EFAVIRENZ?	EFAVIRENZ excipients list
DailyMed Link:	EFAVIRENZ at DailyMed

See drug prices for EFAVIRENZ

Recent Clinical Trials for EFAVIRENZ

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

Sponsor	Phase
Africa Health Research Institute	Phase 3
Merck Sharp & Dohme LLC	Phase 3
Takeda	Phase 1

See all EFAVIRENZ clinical trials

Generic filers with tentative approvals for EFAVIRENZ

Applicant	Application No.	Strength	Dosage Form
		200MG	TABLET; ORAL
		200MG	TABLET; ORAL
		100MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for EFAVIRENZ

Drug Class	Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Cytochrome P450 2B6 Inducers Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C9 Inhibitors Cytochrome P450 3A Inducers Cytochrome P450 3A4 Inhibitors Non-Nucleoside Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for EFAVIRENZ

J05AG	Non-nucleoside reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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
Bristol Myers Squibb	SUSTIVA	efavirenz	TABLET;ORAL	021360-001	Feb 1, 2002		DISCN	Yes	No
Strides Pharma	EFAVIRENZ	efavirenz	TABLET;ORAL	204869-001	Mar 12, 2018	AB	RX	No	No
Bristol Myers Squibb	SUSTIVA	efavirenz	CAPSULE;ORAL	020972-001	Sep 17, 1998		DISCN	Yes	No
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006		DISCN	Yes	No	9,744,181		Y
Strides Pharma	EFAVIRENZ	efavirenz	TABLET;ORAL	078509-001	Jun 16, 2021		DISCN	No	No
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006		DISCN	Yes	No	8,598,185		Y
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

Expired US Patents for EFAVIRENZ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	SUSTIVA	efavirenz	TABLET;ORAL	021360-001	Feb 1, 2002	5,663,169*PED
Bristol Myers Squibb	SUSTIVA	efavirenz	CAPSULE;ORAL	020972-002	Sep 17, 1998	5,811,423
Bristol Myers Squibb	SUSTIVA	efavirenz	CAPSULE;ORAL	020972-003	Sep 17, 1998	5,811,423
Bristol Myers Squibb	SUSTIVA	efavirenz	TABLET;ORAL	021360-001	Feb 1, 2002	5,519,021*PED
Bristol Myers Squibb	SUSTIVA	efavirenz	TABLET;ORAL	021360-001	Feb 1, 2002	5,811,423
Bristol Myers Squibb	SUSTIVA	efavirenz	CAPSULE;ORAL	020972-002	Sep 17, 1998	6,939,964*PED
Bristol Myers Squibb	SUSTIVA	efavirenz	CAPSULE;ORAL	020972-001	Sep 17, 1998	6,555,133*PED

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

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.