Efavirenz; emtricitabine; tenofovir disoproxil fumarate - Generic Drug Details

What are the generic sources for efavirenz; emtricitabine; tenofovir disoproxil fumarate and what is the scope of freedom to operate?

Efavirenz; emtricitabine; tenofovir disoproxil fumarate is the generic ingredient in four branded drugs marketed by Gilead Sciences, Aurobindo Pharma, Cipla, Hetero Labs Ltd V, Laurus, Macleods Pharms Ltd, Teva Pharms Usa, Strides Pharma, and Mylan, and is included in nine NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Efavirenz; emtricitabine; tenofovir disoproxil fumarate has one hundred and twenty-three patent family members in thirty-one countries.

Seven suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for efavirenz; emtricitabine; tenofovir disoproxil fumarate

International Patents:	123
US Patents:	7
Tradenames:	4
Applicants:	9
NDAs:	9
Finished Product Suppliers / Packagers:	7
Clinical Trials:	39
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for efavirenz; emtricitabine; tenofovir disoproxil fumarate
DailyMed Link:	efavirenz; emtricitabine; tenofovir disoproxil fumarate at DailyMed

Recent Clinical Trials for efavirenz; emtricitabine; tenofovir disoproxil fumarate

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

Sponsor	Phase
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida	N/A
Yu-Jay Corp.	Phase 3
University of British Columbia	Phase 4

See all efavirenz; emtricitabine; tenofovir disoproxil fumarate clinical trials

Generic filers with tentative approvals for EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Applicant	Application No.	Strength	Dosage Form
		600MG; 200MG; 300MG	TABLET; ORAL
		300MG	TABLET; ORAL
		200MG	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; emtricitabine; tenofovir disoproxil fumarate

Drug Class	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus 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 Nucleoside Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for efavirenz; emtricitabine; tenofovir disoproxil fumarate

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ATRIPLA	Tablets	efavirenz; emtricitabine; tenofovir disoproxil fumarate	600 mg/200 mg/300 mg	021937	1	2008-12-29

US Patents and Regulatory Information for efavirenz; emtricitabine; 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
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006		DISCN	Yes	No			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
Laurus	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	213541-001	Dec 22, 2021	AB	RX	No	No
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006		DISCN	Yes	No			Y
Aurobindo Pharma	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203041-001	Sep 4, 2018	AB	RX	No	Yes

Expired US Patents for efavirenz; emtricitabine; tenofovir disoproxil fumarate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006

International Patents for efavirenz; emtricitabine; tenofovir disoproxil fumarate

Country	Patent Number	Title	Estimated Expiration
Australia	2004206821	Compositions and methods for combination antiviral therapy
Denmark	2386294
Spain	2308136
Norway	20150656	Preparater og fremgangsmåter for antiviral kombinasjonsterapi
Eurasian Patent Organization	200800033	КОМПОЗИЦИЯ (ВАРИАНТЫ), СПОСОБ ЕЕ ПОЛУЧЕНИЯ, РЕЗЕРВУАР, СОДЕРЖАЩИЙ УКАЗАННУЮ КОМПОЗИЦИЮ, И СПОСОБ ЛЕЧЕНИЯ ВИРУСНЫХ ЗАБОЛЕВАНИЙ С ЕЕ ИСПОЛЬЗОВАНИЕМ

Supplementary Protection Certificates for efavirenz; emtricitabine; tenofovir disoproxil fumarate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0582455	2001C/001	Belgium		PRODUCT NAME: EFAVIRENZ; NATL. REGISTRATION NO/DATE: EU/1/99/110/001 19990604; FIRST REGISTRATION: CH 54908 01 19981120
0582455	C300032	Netherlands		PRODUCT NAME: EFAVIRENZ; REGISTRATION NO/DATE: EU/1/99/110/001-004, EU/1/99/111/001-004 19990528
0582455	08C0021	France		PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
0915894	SPC/GB08/033	United Kingdom		PRODUCT NAME: TENOFOVIR DISOPROXIL AND THE SALTS (IN PARTICULAR THE FUMARATE), HYDRATES, TAUTOMERS AND SOLVATES THEREOF, TOGETHER WITH EMTRICITABINE AND EFAVIRENZ; REGISTERED: UK EU/1/07/430/001 20071213; REASON FOR LAPSE: SURRENDERED
0915894	08C0020	France		PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213

Efavirenz; emtricitabine; tenofovir disoproxil fumarate Market Analysis and Financial Projection Experimental

Global HIV Treatment Market: Focus on Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate

Market Overview

The global HIV treatment market is experiencing significant growth, driven by advancements in antiretroviral therapy (ART) and increasing awareness and prevention efforts. Here, we will delve into the market dynamics and financial trajectory of the combination therapy involving efavirenz, emtricitabine, and tenofovir disoproxil fumarate.

Current Market Size and Growth

The global HIV treatment market stood at $22.38 billion in 2022 and is projected to reach $25.49 billion by 2030, growing at a CAGR of 1.42% during the forecast period of 2023-2030[1].

Combination Therapy: Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate

Efficacy and Tolerability

The combination of efavirenz, emtricitabine, and tenofovir disoproxil fumarate (TDF) is a widely recommended initial antiretroviral therapy. This once-daily, one-tablet regimen has demonstrated bioequivalence to the concomitant administration of individual agents and is generally well tolerated. It has shown superior virological suppression, immunological recovery, and fewer adverse events compared to other regimens[4].

Market Performance

Historically, this combination therapy, often marketed as Atripla, has been a significant player in the HIV treatment market. However, its sales have been impacted by the loss of exclusivity and the introduction of generic alternatives. For instance, in the second quarter of 2021, Atripla sales decreased by 42% year-over-year to $60 million due to generic entrants in the United States[2].

Growth Drivers

Advancements in Antiretroviral Therapy

The development of more effective and tolerable antiretroviral treatments, including combination therapies like efavirenz/emtricitabine/TDF, has been a key growth driver. These advancements have improved treatment accessibility, affordability, and quality of life for HIV patients[1].

Increased Availability and Affordability

The expansion of generic drugs has made antiretroviral therapies more accessible and affordable, contributing to market growth. Generic equivalents of branded medications, such as those for efavirenz/emtricitabine/TDF, have reduced costs and increased treatment penetration[1][3].

Growing Awareness and Prevention Efforts

Enhanced HIV screening and testing initiatives have increased the number of diagnosed cases, driving demand for treatment drugs. Public-private partnerships and government initiatives have also played a crucial role in promoting awareness and improving treatment outcomes[1].

Challenges

Generic Competition

The loss of exclusivity for branded drugs like Atripla has led to significant competition from generic alternatives. This has resulted in decreased sales for these specific combination therapies, despite their efficacy and tolerability[2].

Regulatory Approval and Awareness

Slow regulatory approval processes and lack of awareness in certain regions can hinder the adoption of new and innovative treatments, including long-acting injectables and other advanced therapies that could replace or complement efavirenz/emtricitabine/TDF[5].

Financial Trajectory

Revenue Impact

The financial performance of efavirenz/emtricitabine/TDF has been affected by the introduction of generic competitors. For example, Gilead Sciences reported a 42% year-over-year decline in Atripla sales in the second quarter of 2021. However, the overall HIV product sales for Gilead Sciences were offset by increased demand for other products like Biktarvy and Descovy[2].

Market Share

Despite the decline in sales of specific combination therapies, major pharmaceutical companies like Gilead Sciences, ViiV Healthcare, and Merck continue to dominate the market. These companies are investing heavily in research and development to introduce new and innovative treatments, which helps maintain their market share[1][3].

Future Outlook

Innovations in Treatment

The development of long-acting injectables, implants, and other innovative medications is expected to transform the HIV treatment landscape. For instance, Gilead Sciences' recent FDA application for lenacapavir, a long-acting HIV-1 capsid inhibitor, indicates a shift towards more convenient and effective treatment options[1].

Regional Growth

The Asia Pacific region is anticipated to be the fastest-growing market due to highly populated countries like China and India, along with increasing funding from the private sector and healthcare companies. Initiatives such as Gilead Sciences' Asia Pacific Rainbow Grant Program are expected to drive market growth in this region[3].

Competitive Landscape

The global HIV treatment market is consolidated, with major players like Gilead Sciences, ViiV Healthcare, and Merck leading the market. These companies continue to innovate and expand their product portfolios through strategic collaborations and investments in research and development. For example, the co-development and co-commercialization agreement between Gilead Sciences and Merck Sharp & Dohme for long-acting treatments highlights the collaborative efforts in the industry[1][3].

Impact of COVID-19

The COVID-19 pandemic had a mixed impact on the HIV treatment market. While it disrupted medication supply chains and patient care, it also accelerated pharmaceutical innovation and the adoption of telemedicine. Post-pandemic, the market is expected to see improved access to care, increased innovation, and greater collaboration among stakeholders[1].

Key Takeaways

• The global HIV treatment market is growing, driven by advancements in ART and increasing awareness.
• Combination therapies like efavirenz/emtricitabine/TDF remain crucial despite challenges from generic competition.
• Innovations in long-acting treatments and public-private partnerships are expected to drive future growth.
• Major pharmaceutical companies continue to dominate the market through innovation and strategic collaborations.
• The Asia Pacific region is expected to be a key growth area due to increasing funding and treatment programs.

FAQs

What is the current market size of the global HIV treatment market?

The global HIV treatment market stood at $22.38 billion in 2022 and is projected to reach $25.49 billion by 2030[1].

How has the COVID-19 pandemic impacted the HIV treatment market?

The COVID-19 pandemic disrupted medication supply chains and patient care but also drove increased public health awareness, telemedicine adoption, and accelerated pharmaceutical innovation[1].

What are the key growth drivers for the HIV treatment market?

Key growth drivers include advancements in antiretroviral therapy, increased availability and affordability of treatments, growing awareness and prevention efforts, and rising HIV prevalence[1].

Which regions are expected to drive future growth in the HIV treatment market?

The Asia Pacific region is anticipated to be the fastest-growing market due to highly populated countries and increasing funding from the private sector and healthcare companies[3].

What are the major challenges facing the HIV treatment market?

Challenges include generic competition, slow regulatory approval processes, and lack of awareness in certain regions[2][5].