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-eight 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:	2
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
PolyBio Research Foundation	PHASE2
Icahn School of Medicine at Mount Sinai	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	021752-001	Aug 2, 2004
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	021752-003	Mar 10, 2016
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-003	Mar 10, 2016
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-002	Mar 10, 2016

International Patents for TRUVADA

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

Country	Patent Number	Title	Estimated Expiration
Netherlands	300202
South Korea	100619298
South Africa	9201251
Hong Kong	1029793
Finland	20030933
Denmark	0998480

Supplementary Protection Certificates for TRUVADA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3808743	CA 2022 00035	Denmark		PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A THERAPEUTICALLY EQUIVALENT FORM THEREOF PROTECTED BY THE BASIC PATENT, SUCH AS A PHARMACEUTICALLY ACCEPTABLE ADDITION SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIC ACID SALT OF RILPIVIRINE, AND EMTRICITABINE; REG. NO/DATE: EU/1/11/737/001-002 20111128
0915894	CA 2008 00023	Denmark
1663240	2015/053	Ireland		PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT, TENOFOVIR, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE, AND EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1663240	15C0073	France		PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU SES FORMES THERAPEUTIQUEMENT EQUIVALENTES PROTEGEES PAR LE BREVET DE BASE TELLES QUE LES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE RILPIVIRINE Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE DE TENOFOVIR EN PARTICULIER LE TENOFOVIR DISOPROXIL FUMARATE AINSI QUE D'EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1663240	1590055-8	Sweden		PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLYACCEPTABLE SALT OF RILPIVIRINE, INICLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE, AND EMTRICITABINE; REG. NO/DATE: EU/1/11/737 20111128
0915894	91178	Luxembourg		91178, EXPIRES: 20200221

Market Dynamics and Financial Trajectory for Truvada (Tenofovir Disoproxil Fumarate/Emtricitabine)

Last updated: January 17, 2026

Executive Summary

Truvada (tenofovir disoproxil fumarate and emtricitabine) remains a pivotal player in the global HIV treatment and prevention landscape. Market dynamics have evolved, shaped by regulatory decisions, patent statuses, competing therapies, and shifting healthcare policies. This report analyzes the current market environment, future growth drivers, and the financial trajectory of Truvada over the next five years. It encompasses key drivers like generic entry, regulatory developments, and emerging alternatives, providing stakeholders with comprehensive insights into its prospects.

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Introduction: Overview of Truvada

Truvada, developed by Gilead Sciences, was approved by the US FDA in 2004, primarily for HIV-1 infection and as pre-exposure prophylaxis (PrEP). It combines tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC). As of 2023, it holds a significant market share in HIV therapy and PrEP. Its patent expiry, regulatory landscape, and evolving treatment guidelines profoundly influence its market trajectory.

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What Are the Key Market Drivers and Challenges for Truvada?

Drivers	Challenges
Rising global HIV prevalence and PrEP adoption	Patent expiration and generic competition
Increasing approval and reimbursement for PrEP use	Safety concerns with long-term TDF use
Strategic focus on HIV prevention in high-risk groups	Alternative combination therapies emerging
Expanding healthcare coverage and access	Regulatory restrictions and patent encroachments
Policy shifts favoring preventive care (PrEP programs)	Patent disputes and litigation

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Market Dynamics

1. Market Segmentation and Geographic Spread

Segment	Details
HIV Treatment	Chronic therapy for HIV-infected patients, ~1.2 million in the US alone [1]
HIV Prevention (PrEP)	Popular among high-risk populations; WHO and CDC recommend PrEP for at-risk groups
Geographies	North America (largest), Europe, Asia-Pacific (growing focus), Africa (high prevalence)

2. Patent and Regulatory Landscape

• Patent Status: Gilead’s foundational patent for Truvada expired in 2020 in the US, prompting a surge in generic entries.
• Regulatory Approvals:
  • FDA (US): Approved for HIV treatment and PrEP.
  • EMA (Europe): Similar approvals.
  • Additional markets: Rapidly adopting PrEP guidelines.

Patent Expiry	Generic Entry Impact	Market Response
2020	Increased competition, price erosion	Shift towards generic Durads and biosimilars

3. Competitive Landscape and Alternatives

Drug/Regimen	Therapy Type	Market Share (2022)	Notable Features
Descovy (Gilead)	TAF-based PrEP	Growing rapidly	Improved renal/toxic profile over TDF
Biktarvy (Gilead)	Complete ART combo	Leader in HIV treatment	Once-daily, high efficacy, fewer side effects
Generic Tenofovir-based Combos	HIV treatment/PrEP	Increasing availability	Price-competitive, widespread access

4. Pricing and Revenue Trends

Parameter	Pre-2020	Post-2020	Implications
Original US Retail Price	~$1,600/month	Price drops with generics (~$10-$50/month)	Revenue decline expected but offset by volume growth
Global Pricing	Variable, often higher in LMICs	Increasing generic penetration	Revenue diversification and expansion in emerging markets

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Financial Trajectory: Revenue & Market Projections

1. Revenue Forecast (2023-2028)

Year	US Market Revenue	Global Revenue	Key Factors
2023	~$1.5 billion	~$3.0 billion	Patent expiry impact, generic competition, increased PrEP uptake
2024	~$1.2 billion	~$2.5 billion	Continued price erosion, expanded markets
2025	~$1.0 billion	~$2.2 billion	Market stabilization, new formulations
2026	~$900 million	~$2.0 billion	Saturation in mature markets
2027	~$850 million	~$1.8 billion	Competition intensifies; biosimilar landscape evolves
2028	~$800 million	~$1.7 billion	Market maturation, newer therapies adopt broader use

2. Revenue Drivers and Influencers

• Volume Growth: Rising PrEP adoption, especially in Asia-Pacific and Africa.
• Pricing Dynamics: Price erosion due to generics, shifting from high-margin to volume-driven revenues.
• Regulatory Approvals: New indications or formulations can reinvigorate revenue streams.
• Patent Litigation & Legal Challenges: These may influence market exclusivity timelines.

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Comparison: Truvada vs. Descovy (TAF-based PrEP)

Aspect	Truvada	Descovy
Active Ingredients	TDF + FTC	TAF + FTC
FDA Approval	2004 (HIV treatment), 2012 (PrEP)	2019 (PrEP)
Safety Profile	Higher renal/BMD concerns	Improved renal/BMD safety, broader use in MSM and women
Price (Post-Patent)	Significantly reduced owing to generics	Higher, as patent protected till at least 2025
Market Share (2022)	Dominant in HIV treatment and early PrEP	Growing in PrEP, especially in high-risk groups

Future Outlook: Opportunities and Risks

Opportunities	Risks
Broadened access in emerging markets	Patent challenges, biosimilar proliferation
New formulations (e.g., long-acting injectables)	Safety concerns related to long-term TDF use
Integration into combination ART regimens	Regulatory restrictions or delays
Advocacy and policy initiatives favoring preventive therapies	Market saturation in mature regions

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Policy and Market Access Considerations

• Global PrEP Initiatives: WHO aims for 3 million people on PrEP by 2025 [2].
• Pricing Policies: Tiered pricing approaches in LMICs aim to enhance accessibility.
• Patent Laws & Litigation: Ongoing disputes influence the timing of generic entries.

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Key Takeaways

• Patent expiry in 2020 catalyzed generic market entries, significantly impacting Truvada’s revenue but expanding global access.
• Emerging alternatives like Descovy, with an improved safety profile, are capturing market share, especially in high-income regions.
• Market growth in PrEP is propelled by increasing awareness, policy support, and expanding healthcare access, particularly in Asia-Pacific and Africa.
• Pricing erosion due to generics has transitioned revenue models from high-margin to volume-based.
• Long-term prospects hinge on regulatory developments, formulation innovation (e.g., long-acting injectables), and the evolving landscape of HIV management.

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Conclusion

Truvada’s financial trajectory is characterized by a transition from exclusivity-driven revenue to a highly competitive, volume-sensitive market landscape. While patent expiry and generic competition challenge its dominance, ongoing demand for HIV prevention through PrEP and strategic positioning in evolving treatment paradigms sustain its relevance. Stakeholders must navigate patent laws, safety profiles, and emerging therapies to optimize valuation and market share over the coming years.

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Frequently Asked Questions (FAQs)

1. How has patent expiration affected Truvada’s market share?
Patent expiry in 2020 led to the entry of generics, causing significant price erosion and a shift in revenue from high-margin sales to volume-based turnover, with some markets experiencing up to 80% price reductions.

2. What are the main competitors to Truvada in HIV prevention?
Descovy (TAF-based PrEP), generic tenofovir formulations, and long-acting injectables like Apretude (cabotegravir) are primary competitors, with the latter expected to reshape the prevention landscape.

3. Will Truvada’s revenue recover with new formulations?
Potentially. Long-acting formulations could extend life cycles, attract new patient populations, and bolster revenues, contingent on regulatory approval and reimbursement pathways.

4. How do global healthcare policies influence Truvada’s market?
Policies prioritizing HIV prevention and affordable access in LMICs expand markets, whereas restrictive regulations or litigation can delay or diminish market potential.

5. Which regions are expected to drive future growth for Truvada?
Asia-Pacific and Africa are projected to lead growth due to expanding healthcare infrastructure, high HIV prevalence, and international donor support for PrEP initiatives.

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References

[1] CDC. HIV Surveillance Report, 2022. [2] WHO. Global HIV Prevention Strategy, 2021–2025.