EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE - Generic Drug Details

What are the generic drug 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, Chartwell Rx, and Mylan, and is included in nine NDAs. There are three 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 sixty-one patent family members in twenty-seven 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:	61
US Patents:	3
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
Aurobindo Pharma	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203041-001	Sep 4, 2018	AB	RX	No	Yes
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006		DISCN	Yes	No			Y
Laurus	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	213541-001	Dec 22, 2021	AB	RX	No	No
Mylan	EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	209061-001	Sep 5, 2024		DISCN	No	No

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

International Patents for EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Country	Patent Number	Title	Estimated Expiration
Japan	5557999
Australia	2006257795	Stable fixed-dose unitary formulations containing tenofovir, a surfactant, efavirenz and emtricitabine
Eurasian Patent Organization	017764	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СПОСОБ ЕЕ ПОЛУЧЕНИЯ И СПОСОБ ЛЕЧЕНИЯ ВИРУСНЫХ ЗАБОЛЕВАНИЙ С ЕЕ ИСПОЛЬЗОВАНИЕМ (PHARMACEUTICAL COMPOSITION, METHOD FOR PREPARATION THEREOF AND METHOD FOR TREATING ANTIVIRAL DISEASES USING SAME)
Japan	2015091883	一体型医薬投薬形態 (UNITARY PHARMACEUTICAL DOSAGE FORM)

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	08C0020	France		PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213

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

Last updated: July 29, 2025

Introduction

The pharmaceutical landscape surrounding antiretroviral therapy (ART), particularly formulations combining efavirenz (EFV), emtricitabine (FTC), and tenofovir disoproxil fumarate (TDF), has become increasingly complex amid evolving clinical, regulatory, and market forces. This triad forms a cornerstone of HIV management, underpinning a substantial segment of global treatment programs. Understanding the current market dynamics and the financial trajectory of these constituents is essential for stakeholders in healthcare, investment, and policy formulation.

Market Overview

The combination of EFV, FTC, and TDF has historically served as a first-line therapy for HIV treatment, owing to its efficacy, tolerability, and cost-effectiveness. For example, regimens such as Atripla — which combine all three agents — have dominated treatment landscapes since approval, with millions of patients globally. However, recent shifts in therapeutic guidelines, patent protections, and competitive innovations reshape their market trajectory.

Market Drivers

1. Global HIV Burden and Treatment Expansion

   The World Health Organization (WHO) estimates over 38 million people living with HIV worldwide, with ongoing efforts to achieve universal access to ART. According to UNAIDS, approximately 28 million people were on treatment globally as of 2021. As treatment coverage expands, demand for fixed-dose combinations involving EFV, FTC, and TDF remains significant, especially in low- and middle-income countries (LMICs).

2. Cost and Patent Landscapes

   The affordability of EFV, FTC, and TDF has historically driven their widespread use. Patent expirations of key formulations, particularly TDF, have facilitated increased generic manufacturing, significantly reducing prices. For instance, Gilead Sciences’ patent expiry for Combivir in regions like India catalyzed generic entry, intensifying competitive pricing.

3. Regulatory Environment and WHO Guidelines

   WHO’s shifting recommendations favor integrase strand transfer inhibitors (INSTIs) over NNRTIs like EFV due to superior tolerability and resistance profiles. Nevertheless, EFV-containing regimens still feature prominently in many national protocols owing to cost advantages and established safety records.

4. Emergence of Novel Therapeutics

   The advent of drugs like dolutegravir and bictegravir has lessened reliance on EFV-based first-line therapies. This transition impacts the sales trajectory of EFV, FTC, and TDF, especially in regions rapidly adopting INSTI-based regimens, which offer improved efficacy and fewer neuropsychiatric side effects.

Market Challenges

1. Regulatory and Patent Expiries

   Patent expirations globally have facilitated the proliferation of generics, which has compressed profit margins for branded formulations. Gilead’s patent estate for TDF, in particular, faced substantial erosion, compelling brand companies to adopt alternative formulations or new combinations.

2. Safety and Side Effect Profile

   TDF's known nephrotoxicity and bone mineral density reduction have prompted shifts toward tenofovir alafenamide (TAF), a safer prodrug. This transition diminishes demand for TDF-based regimens, including those involving EFV and FTC.

3. Market Saturation and Competition

   As generic versions dominate pricing landscapes, profit margins for branded drugs decline. The intense competition among generic manufacturers exerts downward pressure on revenues for EFV, FTC, and TDF formulations.

Financial Trajectory

1. Historical Revenue Trends

   Historically, Gilead Sciences and other innovators generated billions annually from EFV-based products. For example, Gilead's HIV franchise peaked around the mid-2010s, but revenues from EFV-based regimens started declining post-2017 as generics entered markets and new regimens gained favor.

2. Impact of Patent Expiry and Generics

   The patent expiry of TDF in various jurisdictions led to a sharp decline in branded sales. As generic formulations gained market share, company revenues from EFV, FTC, and TDF decreased correspondingly.

3. Transition to TAF and Newer Regimens

   The sector’s financial trajectory now increasingly hinges on newer formulations, such as Gilead's DESCOVY (FTC and TAF) and other INSTI-based therapies, which command higher prices and are less susceptible to patent erosion.

4. Potential Future Revenue Streams

   Despite declining sales of traditional EFV, FTC, and TDF formulations, the ongoing demand in LMICs, driven by global health initiatives, sustains a base revenue stream. Additionally, licensing agreements, direct generics sales, and potential reformulations (e.g., fixed-dose combinations with TAF) offer future growth avenues.

Regulatory and Market Outlook

1. Emerging Trends

   Market data forecast continued decline in EFV, FTC, and TDF-based regimens in favor of newer drugs with better safety profiles and higher barriers to resistance. However, these formulations remain vital in regions where cost and access restrict adoption of newer therapies.

2. Innovations and Pipeline Developments

   Companies are exploring long-acting injectable antiretrovirals and fixed-dose combinations featuring TAF and integrase inhibitors, potentially replacing EFV/FTC/TDF regimens.

3. Market Resilience in Low-Income Settings

   The persistence of demand driven by global health programs, GAVI initiatives, and negotiated discounts sustains revenues for generic manufacturers.

Conclusion

The market dynamics of efavirenz, emtricitabine, and tenofovir disoproxil fumarate are characterized by a migration toward newer, more effective, and safer therapies. Patent expiries, competitive generics, and evolving clinical guidelines have reshaped profitability and adoption patterns. While revenues from traditional EFV/FTC/TDF-based regimens decline, these drugs continue to serve a critical role in global HIV management, particularly in resource-limited settings. Strategic positioning by pharmaceutical companies involves balancing legacy market presence, investing in emerging regimens like TAF-based formulations, and navigating regulatory landscapes to optimize financial outcomes.

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Key Takeaways

• Global HIV Treatment Expansion sustains demand for EFV, FTC, and TDF, especially in LMICs, despite shifting preferences toward newer regimens.
• Patent expiries and generic manufacturing have significantly reduced revenues from branded formulations, prompting strategic shifts toward alternative products.
• Evolving clinical guidelines favor INSTI-based therapies, decreasing dependence on EFV-based regimens and impacting market growth.
• Transition to TAF formulations offers new revenue pathways, positioning companies to maintain competitiveness amidst patent and market shifts.
• Continued demand in resource-limited settings ensures a baseline revenue stream, as global health initiatives prioritize access to affordable HIV treatment.

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FAQs

1. How has patent expiration affected the market for efavirenz, emtricitabine, and tenofovir disoproxil fumarate?
Patent expirations have facilitated the entry of generic manufacturers, leading to significant price reductions and volume increases. This has decreased revenues for branded formulations but expanded access in resource-limited settings.

2. Are efavirenz-based regimens still recommended in HIV treatment guidelines?
While some national guidelines continue to include EFV-based first-line therapies, WHO and many countries are transitioning toward integrase inhibitor-based regimens like dolutegravir due to superior safety and efficacy.

3. What is the impact of safety concerns associated with TDF on the market?
Concerns about nephrotoxicity and bone density loss have prompted a switch to TAF, which offers similar efficacy with improved safety, thereby reducing demand for TDF-based formulations.

4. How does market competition influence the profitability of efavirenz, emtricitabine, and tenofovir disoproxil fumarate?
The proliferation of low-cost generics and intense price competition have compressed profit margins, prompting companies to innovate and diversify their HIV product portfolios.

5. What is the future outlook for these drugs in global HIV management?
While traditional regimens may decline in high-income and some middle-income countries, they will likely remain critical in LMICs due to cost and access considerations. The market will pivot towards newer formulations, but legacy drugs will maintain relevance where affordability is paramount.

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Sources:
[1] UNAIDS. Global HIV & AIDS statistics — 2022 fact sheet.
[2] World Health Organization. Consolidated guidelines on HIV prevention, testing, treatment, service delivery and monitoring — 2021.
[3] Gilead Sciences. Annual reports and investor presentations.
[4] International AIDS Society. Guidelines on the use of antiretroviral drugs — 2023.
[5] MarketResearch.com. Global HIV antivirals market analysis — 2022.