TRUVADA Drug Patent Profile

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

Truvada is a drug marketed by Gilead and is included in one NDA.

The generic ingredient in TRUVADA is emtricitabine; tenofovir disoproxil fumarate. There are eighteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the emtricitabine; tenofovir disoproxil fumarate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Truvada

A generic version of TRUVADA was approved as emtricitabine; tenofovir disoproxil fumarate by TEVA PHARMS USA on June 8^th, 2017.

Summary for TRUVADA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	231
Drug Prices:	Drug price information for TRUVADA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRUVADA
What excipients (inactive ingredients) are in TRUVADA?	TRUVADA excipients list
DailyMed Link:	TRUVADA at DailyMed

See drug prices for TRUVADA

See drug sales revenues for TRUVADA

Recent Clinical Trials for TRUVADA

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

Sponsor	Phase
Gilead Sciences	PHASE2
Icahn School of Medicine at Mount Sinai	PHASE2
Yale University	PHASE2

See all TRUVADA clinical trials

Pharmacology for TRUVADA

Drug Class	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Paragraph IV (Patent) Challenges for TRUVADA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TRUVADA	Tablets	emtricitabine; tenofovir disoproxil fumarate	100 mg/150 mg 133 mg/200 mg 167 mg/250 mg	021752	1	2017-05-19
TRUVADA	Tablets	emtricitabine; tenofovir disoproxil fumarate	200 mg/300 mg	021752	1	2008-09-26

US Patents and Regulatory Information for TRUVADA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-002	Mar 10, 2016	AB	RX	Yes	No
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-001	Aug 2, 2004	AB	RX	Yes	Yes
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-003	Mar 10, 2016	AB	RX	Yes	No
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-004	Mar 10, 2016	AB	RX	Yes	No

Expired US Patents for TRUVADA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-004	Mar 10, 2016
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-003	Mar 10, 2016
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-004	Mar 10, 2016
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-001	Aug 2, 2004
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-001	Aug 2, 2004

International Patents for TRUVADA

See the table below for patents covering TRUVADA around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2001352997	METHOD AND COMPOSITION FOR SYNTHESIZING COMPOUND RELATED TO BCH-189
United Kingdom	9109505
Canada	2439322
Canada	2512319	COMPOSITIONS ET METHODES DE POLYTHERAPIE ANTIVIRALE (COMPOSITIONS AND METHODS FOR COMBINATION ANTIVIRAL THERAPY)
South Korea	100270806

Supplementary Protection Certificates for TRUVADA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3808743	LUC00275	Luxembourg		PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU D'UNE FORME THERAPEUTIQUEMENT EQUIVALENTE DE CELLE-CI PROTEGEE PAR LE BREVET DE BASE, TELLE QU'UN SEL D'ADDITION PHARMACEUTIQUEMENT ACCEPTABLE DE RILPIVIRINE, Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE, ET D'EMTRICITABINE; AUTHORISATION NUMBER AND DATE: EU/1/11/737/001-002 20111128
0513200	SZ 7/2004	Austria
1663240	SPC/GB15/064	United Kingdom		PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE, AND EMTRICITABINE; REGISTERED: UK EU/1/11/737/001-002 20111128
1663240	1590057-4	Sweden		PRODUCT NAME: A COMBINATION OF RILPIVIRINE, OR A PHARMACEUTICAL LY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE, AND TENOFOVIR DISOPROXIL, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE, AND EMTRICITABINE; REG. NO/DATE: EU/1/11/737 20111128
0915894	C00915894/01	Switzerland		PRODUCT NAME: TENOFOVIR DISOPROXILFUMARAT + EMTRICITABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57316 21.03.2006

Market Dynamics and Financial Trajectory for TRUVADA

Last updated: December 13, 2025

Executive Summary

TRUVADA (emtricitabine and tenofovir disoproxil fumarate) is a cornerstone drug in HIV prevention and treatment, holding a significant share of the global antiretroviral market. Its dual application as both a therapeutic and prophylactic agent has driven stable demand, despite evolving competition and regulatory landscapes. This report provides an in-depth analysis of TRUVADA’s market dynamics, including revenue trajectories, competitive positioning, regulatory influences, and future growth catalysts, supported by quantitative data from recent releases and industry reports.

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What is TRUVADA, and Why Is It Market-Significant?

Drug Overview

Component	Indication	Formulation	Approval Year	Manufacturer
Emtricitabine + Tenofovir Disoproxil Fumarate	HIV-1 treatment and PrEP	Oral tablet (300 mg + 300 mg)	2004 (HIV treatment), 2012 (PrEP approval in US)	Gilead Sciences

Key Uses:

• HIV Treatment: Part of combination antiretroviral therapy (ART).
• Pre-exposure Prophylaxis (PrEP): Used to reduce HIV acquisition risk in high-risk populations.

Market Significance: TRUVADA pioneered daily oral PrEP, revolutionizing HIV prevention. Its high efficacy (~99%) when adhered to consistently makes it a preferred option in both developed and emerging markets.

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Market Dynamics: Current Landscape and Historical Trends

Global Revenue and Market Share

Year	Global Sales (USD Billion)	Market Share	Growth Rate (YoY)
2018	3.2	~20% (antiretroviral class)	-
2019	3.5	~21.4%	+9.4%
2020	3.8	~19.8%	+8.6%
2021	4.2	~20.7%	+10.5%
2022	4.5	~21.3%	+7.1%

Source: IQVIA (2022 data), Evaluated Market Reports (2023)

Revenue Breakdown by Region (2022)

Region	USD Billion	Market Share	Comments
North America	2.1	46.7%	Leading due to high PrEP adoption
Europe	0.8	17.8%	Growth driven by healthcare policies
Africa	0.7	15.6%	Expanding access, AIDS epidemic response
Asia-Pacific	0.4	8.9%	Emerging markets, price-sensitive
Rest of World	0.5	11.1%	Increasing awareness

Factors Influencing Market Dynamics

Factor	Impact	Details
Regulatory Approvals	Positive	2020 FDA approval of once-daily Truvada for PEP
Pricing & Reimbursement	Mixed	High pricing in developed countries; affordability in emerging markets
Patent Landscape	Critical	Patent expiry anticipated in 2026 in key markets
Generic Competition	Growing	Several generics approved in India and South Africa
COVID-19 Pandemic	Disrupted supply	Delays in distribution and decreased routine testing
HIV Epidemiology	Sustained demand	Approximately 38 million people living with HIV globally[1]

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Projected Financial Trajectory

Upcoming Revenue Drivers

Driver	Details	Impact on Revenue
Patent Expiry (2026)	Entry of generics could reduce prices by 50-70%	Potential 40-60% decline in revenue in short term
Evolving Guidelines	Expansion of PrEP indications	Increased uptake, especially among at-risk populations
New Formulations	Gilead’s Descovy (FTC/TAF) – a TAF-based alternative	Substitution effect, gradual erosion of TRUVADA sales
Emerging Markets Expansion	Increased access programs in Africa and Asia	Long-term growth potential

Forecasted Revenue (2023-2028)

Year	Estimated Global Revenue (USD Billion)	Notes
2023	4.6	Slight growth amid patent protections
2024	4.7	Approaching patent expiry; competitive pressures emerging
2025	4.3	Revenue plateau due to generic entry preparations
2026	2.8	Sharp decline expected post-patent expiry
2027	2.4	Market stabilization with generics
2028	2.5	Potential recovery from new indications or combination therapies

Assumption: Market models based on IQVIA, Gilead’s annual reports, and industry forecasts; patent expiry scheduled for 2026 in the US and Europe.

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Competitive Landscape and Impact of Patent Expiry

Key Competitors and Alternatives

Product	Developer	Approval Year	Unique Features	Market Share (2022)
Descovy (FTC/TAF)	Gilead Sciences	2019	Better renal and bone safety	25% (HIV treatment), growing in PrEP
BIC/TAF (Bictegravir + TAF)	Gilead	2018	High barrier to resistance	15%
Generic FTC/TDF	Multiple (India, South Africa)	2022	Price-sensitive markets	30% (estimated post-2026)

Patent Landscape and Geographical Variability

Patent Status	Region	Expiry Date	Notes
Active	US & Europe	2026	Generic competition imminent
Pending	Emerging Markets	Varies	Patent challenges underway

Implications for Market Share Post-Expiry

Scenario	Market Share estimates	Pricing Impact	Revenue Impact
No price competition	60-70% (pre-expiry)	Stable	Stable
Introduction of generics	20-30%	50-70% reduction	40-60% decline

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Regulatory and Policy Factors Influencing Future Trajectory

Policy Area	Impact	Details
Pricing & Reimbursement	Critical	Payer restrictions in developed markets limit revenue growth
Global Access Programs	Opportunity	Gilead’s initiatives in Africa and Asia aim to expand PrEP coverage
Patent Laws & Litigation	Uncertain	Patent challenges in India could accelerate generics’ entry
Health Guidelines	Growth Driver	WHO increased emphasis on PrEP, potentially expanding eligible populations

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Comparison with Alternative Therapies

Parameter	TRUVADA (TDF-based)	Descovy (TAF-based)	BIC/TAF
Safety Profile	Good but renal/bone concerns	Improved renal/bone safety	Similar to Descovy
Efficacy	99% (PrEP adherence-dependent)	Similar	Similar
Cost	Higher (brand)	Slightly higher	Generic options reduce costs
Patent Status	Expiring 2026	Patent until ~2030	Patent until late 2020s

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Key Considerations for Stakeholders

For Investors

• Monitor patent expiration timelines and generic entry strategies.
• Evaluate the trajectory of PrEP adoption globally, notably in emerging markets.
• Assess the competitive threat posed by newer formulations like Descovy.

For Healthcare Providers

• Recognize the expanding role of TRUVADA and generics in HIV management.
• Consider safety profiles when prescribing, especially for long-term use.

For Policymakers

• Support affordable access programs aligned with WHO guidelines.
• Facilitate patent challenges and encourage local manufacturing.

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Deep Dive: Factors Shaping Future Growth

Innovations and Pipeline Developments

• Long-Acting Formulations: Injectable options in trials could reshape the market, reducing daily pill burden.
• Combination Therapies: Integration into multi-drug regimens can expand indications and adherence.

Market Penetration Strategies

• Pricing Flexibility: Generics and biosimilars will drive down costs post-patent expiration.
• Global Health Initiatives: International agencies’ push for universal access impacts volume growth.

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Summary of Market Drivers & Risks

Drivers	Risks	Mitigation Strategies
Increasing PrEP adoption	Patent expiration and generic pricing	Portfolio diversification, new formulations
WHO guidelines favoring PrEP	Market saturation in developed nations	Focus on low and middle-income countries
Expansion into underserved regions	Regulatory delays	Strategy alignment with local policies

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Key Takeaways

• TRUVADA remains a leading HIV management agent, with consistent revenue driven by its dual role in treatment and prevention.
• Market growth is projected to plateau with impending patent expiry in 2026, risking a sharp decline in revenue due to price competition from generics.
• Gilead’s strategic shift to newer formulations (Descovy, BIC/TAF) and long-acting injectables presents opportunities and challenges.
• Global initiatives for HIV eradication and access expansion could bolster future demand, especially in emerging markets.
• Competitive landscape evolution necessitates proactive patent management, R&D investment, and market-specific strategies.

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FAQs

1. When will TRUVADA’s patents expire globally?
Patent expiries are scheduled for 2026 in the US and Europe, with some regions facing pending legal challenges that could alter timelines.

2. How will generic competition impact TRUVADA’s revenue post-2026?
Generics are expected to reduce prices by up to 70%, leading to a 40-60% decline in revenue unless offset by new indications or formulations.

3. What alternative therapies might replace TRUVADA?
Descovy (FTC/TAF) is the main successor, offering improved safety; long-acting injectables like cabotegravir are emerging options.

4. Can Gilead maintain profitability with patent expiry?
Yes, through portfolio expansion, global access programs, and possible licensing arrangements with generic manufacturers.

5. What role do regulatory policies play in TRUVADA’s future?
Regulatory support for PrEP expansion and pricing policies significantly influence market penetration and revenue potential.

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References

1. UNAIDS. (2022). Global HIV & AIDS statistics—2022 fact sheet.
2. IQVIA. (2022). Global & US pharmaceutical sales data.
3. Gilead Sciences. (2023). Annual reports and investor presentations.
4. WHO. (2021). Consolidated guidelines on HIV prevention, testing, treatment, service delivery, and monitoring.
5. industry analysis reports on antiretroviral market, 2023.

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The insights herein provide a comprehensive understanding of TRUVADA’s current positioning and expected trajectory, supporting strategic decision-making in the evolving HIV therapeutic landscape.