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 Alberta	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
Cipla	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	206894-001	Jun 3, 2019	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
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006		DISCN	Yes	No
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006		DISCN	Yes	No			Y

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
South Korea	101151011
Slovenia	1890681
New Zealand	564045	Stable fixed-dose formulations containing a combination of antivirals (emtricitabine and tenofovir DF), method for producing thereof using dry granulation
Germany	602006004731

Supplementary Protection Certificates for EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0582455	2001C/001	Belgium		PRODUCT NAME: EFAVIRENZ; NATL. REGISTRATION NO/DATE: EU/1/99/110/001 19990604; FIRST REGISTRATION: CH 54908 01 19981120
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; TENOFOVIR DISOPROXIL FUMARATE

Last updated: January 19, 2026

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Executive Summary

This report provides a comprehensive analysis of the market dynamics and financial trajectory of a fixed-dose combination (FDC) comprising efavirenz, emtricitabine, and tenofovir disoproxil fumarate— a pivotal antiretroviral therapy (ART) in HIV treatment. The analysis covers current market size, growth drivers, competitive landscape, regulatory environment, and future revenue projections through 2030. It emphasizes the drug’s role in global HIV management, delineates key market players, and assesses factors influencing profitability.

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1. Overview of the Drug Composition and Therapeutic Indication

Component	Mechanism	Indication	Brand/Generic Names	Approval Year
Efavirenz	Non-nucleoside reverse transcriptase inhibitor (NNRTI)	HIV-1 infection	Sustiva (brand), generic versions	1997 (Sustiva)
Emtricitabine	Nucleoside reverse transcriptase inhibitor (NRTI)	HIV-1, HBV	Emtriva, generic	2003
Tenofovir disoproxil fumarate (TDF)	NRTI, nucleotide analog	HIV-1, HBV	Viread, generic	2001

Note: The combination is primarily marketed under various brand names such as Atripla (AbbVie, now discontinued), Descovy (Gilead), and generics.

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2. Current Market Size and Penetration

Region	Estimated 2022 Market Value	Annual Growth Rate (2022-2027)	Notes
Global	~$2.5 billion	4.6%	DRUGS with similar profile dominate initial HIV regimens
North America	~$1.2 billion	3.8%	Maturation of market with high penetration of savings programs
Europe	~$700 million	4.2%	NICE guidelines favor generic affordability
Asia-Pacific	~$400 million	6.0%	Growing access in India, Southeast Asia

Source: IQVIA Pharmaceutical Market Reports 2022[1].

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3. Market Drivers

• Increasing HIV Prevalence: An estimated 38 million globally living with HIV (UNAIDS, 2022)[2].

• Treatment Guidelines Expansion: WHO (2021) endorses ART initiation for all HIV-positive individuals, raising demand.

• Cost Competitiveness of Generics: Countries shifting to generic formulations reduce prices, expanding access.

• Patient Preference for Fixed-Dose Combinations: Simplifies adherence, improving treatment outcomes.

• Patent Expirations & Portfolio Diversification: Expiry of patents (e.g., Gilead’s Tenofovir Disoproxil Fumarate in 2020) leads to biosimilar entry.

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4. Competitive Landscape

Major Players	Market Share (2022)	Key Offerings	Strategic Initiatives
Gilead Sciences	55%	Truvada, Descovy	Biosimilars, combination therapies
AbbVie	20%	Atripla (discontinued), generic options	Brand upgrades, combination patents
Teva, Mylan, other generics	15%	Multiple generics	Price competition
Others	10%	Innovative formulations	R&D investments

Market Entry Barriers: Patent protections, regulatory approvals, manufacturing capacity.

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5. Regulatory Environment

• Key Agencies: FDA (U.S.), EMA (Europe), PMDA (Japan), etc.

• Regulatory Trends:

  • Accelerated approvals for generics and biosimilars.
  • Incentives for access in low-income countries.
  • Post-approval safety monitoring impacting market dynamics.

• Patent Status: Many formulations off-patent, enabling generic proliferation.

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6. Financial Trajectory Analysis (2023–2030)

Parameter	Assumption	2022 Baseline ($ Billion)	Projected 2030 ($ Billion)	Notes
Market Value	CAGR of 4.6%	$2.5	~$3.9	Driven by increased access and population growth
Revenue of leading brands	Market share stabilization	$1.4	~$2.3	Biosimilars potentially capturing 20-30%
R&D & pipeline investments	Steady	$500 million	$700 million	Focus on long-acting formulations

Projection Methodology: Based on compound annual growth rates (CAGR), considering patent expiries, access expansion, and health policy changes.

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7. Opportunities & Risks

Opportunities	Risks
Growing treatment coverage in low-income countries	Competitive price erosion
Development of long-acting injectables	Patent litigations & regulatory delays
Incorporation into pediatric formulations	Market saturation in mature regions

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8. Comparative Analysis with Alternative Regimens

Regimen	Advantages	Disadvantages	Future Outlook
Efavirenz-based FDC	Well-established, generic options	CNS side effects, resistance issues	Phasing out in favor of newer drugs
Integrase inhibitors (e.g., Dolutegravir)	Better tolerability	Cost in some regions	Growing dominance, potential substitution

Note: The shift towards integrase inhibitors is influencing market share adjustments for efavirenz-containing therapies.

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9. Challenges Impacting Market and Financial Deviation

• Regulatory hurdles: Delays in approval of biosimilars.
• Pricing pressures: Global push for lower prices affecting margins.
• Patent litigations: Patent disputes delaying generic entry.
• Supply Chain Constraints: Raw material shortages impacting production.

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10. Future Market Drivers and Innovation Opportunities

• Long-Acting Injectable Formulations: Projects like Gilead's Cabotegravir extend dosing intervals.
• Combination with New Agents: Incorporating agents targeting latent reservoirs.
• Digital Adherence Monitoring: Apps and wearables improving compliance.

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Conclusion: Market Outlook and Strategic Insights

The combined efavirenz, emtricitabine, and tenofovir disoproxil fumarate segment is poised for steady growth over the next decade, driven primarily by increased global HIV treatment access, patent expiries, and declining prices of generics. While established in North America and Europe, emerging markets promise substantial expansion opportunities, provided regulatory and pricing barriers are managed.

Larger market players are investing in long-acting formulations, which may disrupt existing formulations' market share. The impact of patent expiration and biosimilar entry will further influence pricing strategies and profitability. Companies should focus on diversifying portfolios, optimizing margins through cost efficiencies, and navigating regulatory landscapes to capitalize on forthcoming growth.

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Key Takeaways

• The HIV antiretroviral market, especially fixed-dose combinations like efavirenz/emtricitabine/tenofovir disoproxil fumarate, is expected to grow robustly, reaching approximately $3.9 billion globally by 2030.
• Patent expiries and generic proliferation are pivotal, resulting in significant price reductions and broader access, especially in low-income regions.
• Market leaders are investing heavily in long-acting formulations, which hold potential to redefine therapy adherence and market dynamics.
• Pricing pressures and regulatory challenges persist but can be mitigated through strategic portfolio management and innovation.
• The evolving treatment landscape favors integrase inhibitors and long-acting injectables, potentially impacting demand for efavirenz-based therapies over time.

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FAQs

Q1: How will patent expiries influence the market for efavirenz, emtricitabine, and tenofovir disoproxil fumarate?
A1: Patent expiries enable generic manufacturers to enter the market, significantly reducing prices. This fosters broader access, especially in emerging markets, but also pressures brand-name sales and profit margins.

Q2: What emerging therapies could disrupt the current market?
A2: Long-acting injectable formulations like Gilead's Cabotegravir and rilpivirine, and combination therapies with improved tolerability, are poised to replace many oral regimens, including efavirenz-based FDCs.

Q3: Which regions hold the highest growth potential?
A3: The Asia-Pacific and African markets are set to see the highest compound annual growth, driven by increased HIV prevalence and expanding access to affordable ART.

Q4: How do regulatory policies impact market growth?
A4: Approvals for biosimilars and generics, alongside policies encouraging treatment access, accelerate market expansion but also pose registration and compliance challenges.

Q5: What strategies can pharmaceutical companies adopt to maximize profitability?
A5: Diversifying portfolios, investing in innovative formulations (long-acting injectables), forming strategic partnerships, and navigating patent laws effectively are key strategies.

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References

[1] IQVIA. (2022). Global Pharmaceutical Market Reports.

[2] UNAIDS. (2022). Global HIV & AIDS Statistics.

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Note: This report is intended for strategic decision-making and does not constitute investment advice.