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
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	021752-004	Mar 10, 2016	5,922,695*PED
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-004	Mar 10, 2016	5,814,639*PED
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-002	Mar 10, 2016	6,642,245*PED
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-004	Mar 10, 2016	5,977,089*PED
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-001	Aug 2, 2004	8,592,397
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-001	Aug 2, 2004	8,716,264

International Patents for TRUVADA

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

Country	Patent Number	Title	Estimated Expiration
South Korea	100860136
Czech Republic	282747	Použití 1-/2-(hydroxymethyl)-1,3-oxathiazolan-5-yl/5-fluorocytosinu k výrobě léčiva pro ošetřování hepatitidy B (USE OF 1-/2-(HYDROXYMETHYL)-1,3-OXATHIAZOLAN-5-YL/-5-FLUOROCYTOSINE FOR PREPARING A PHARMACEUTICAL PREPARATION)
Iceland	7977	Samsetningar og aðferð til samsettra meðferðar
South Africa	9201658
Japan	2011102308	USE OF 1-(2-(HYDROXYMETHYL)-1,3-OXATHIOLAN-5-YL)-CYTOSINE FOR TREATMENT OF HEPATITIS B
Japan	2010280694	NUCLEOTIDE ANALOG COMPOSITION AND SYNTHESIS METHOD

Supplementary Protection Certificates for TRUVADA

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
1632232	300852	Netherlands		PRODUCT NAME: COMBINATIE VAN: - RILPIVIRINEHYDROCHLORIDE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI; - EMTRICITABINE; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623
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
0513200	300148	Netherlands		300148, 20110131, EXPIRES: 20160130
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	05C0032	France		PRODUCT NAME: TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE; REGISTRATION NO/DATE: EU/1/04/305/001 20050221

Last updated: November 20, 2025

rket Dynamics and Financial Trajectory for the Pharmaceutical Drug: TRUVADA

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Introduction

TRUVADA (emtricitabine and tenofovir disoproxil fumarate) is a combination antiretroviral medication developed by Gilead Sciences. Approved by the FDA in 2004, it initially gained prominence as a treatment for HIV-1 infection. Its role expanded as a key component in both HIV treatment regimens and as a preventative measure for HIV transmission through pre-exposure prophylaxis (PrEP). The evolving landscape of HIV management, patent expirations, regulatory developments, and generics' entry shape TRUVADA's market and financial future.

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Market Overview

HIV Treatment and Prevention Landscape

The global HIV market represents a multibillion-dollar industry, with an estimated value of over USD 30 billion in 2022, driven by increasing prevalence rates and advancements in ART (antiretroviral therapy). TRUVADA's dual functionality in HIV treatment and PrEP positions it uniquely within this space. By 2022, over 1.7 million people globally used PrEP, with the U.S. accounting for a significant share[1].

Key Competitors and Market Penetration

Dominant competitors include Gilead's later-generation medications like DESCOVY (emtricitabine and tenofovir alafenamide) and other ADMER (antiretroviral drugs) such as Bristol-Myers Squibb’s EVG-based formulations, ViiV Healthcare’s CAB-LA (cabotegravir), and generic offerings. Despite fierce competition, TRUVADA's brand recognition sustains its market position, although generic versions pose threats to revenue.

Regulatory and Policy Factors

Regulatory agencies have approved TRUVADA or its generics for both treatment and PrEP. In 2020, the FDA approved DESCOVY, which, with improved safety profiles, gradually substituting TRUVADA, especially given its lower renal and bone toxicity profile[2].

Global Adoption and Access Challenges

Access varies across regions. The highest adoption rates are in North America, with increasing uptake in Europe, Latin America, and parts of Africa. Economic barriers, pricing, and patent laws directly influence market penetration.

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Patent and Legal Landscape

Patent Expiry and Generics

TRUVADA's primary patents expired in the United States in 2020, enabling generics from multiple manufacturers. This transition significantly impacted Gilead's revenue, resulting in a sharp decline of approximately 45% in TRUVADA sales from 2019 to 2021[3].

Legal Battles and Patent Strategies

Gilead has engaged in patent litigations to extend monopolies via method-of-use patents and secondary formulations. However, patent cliffs have prompted the shift toward new formulations and combination therapies to maintain market share.

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Financial Trajectory

Revenue Trends and Impact of Patent Expirations

Gilead's sales of TRUVADA peaked at USD 3.3 billion in 2018, representing a substantial portion of total HIV franchise revenue. Post-2020, sales declined sharply due to generic competition but have shown signs of stabilization with the introduction of new reduced-price formulations and expanded PrEP access programs.

Transition to Descovy and Other Therapies

DESCOVY, Gilead’s successor to TRUVADA with a better safety profile, generated USD 2.7 billion in 2022, offsetting some losses from TRUVADA’s decline[4]. The diversification into these newer therapies has lessened the financial impact of patent cliffs.

PrEP Market Growth and Revenue Opportunities

Despite patent expirations, the PrEP market continues to grow, with annualized global sales exceeding USD 4 billion in 2022. Gilead’s investment in expanding PrEP access and developing long-acting formulations aims to capitalize on this trajectory.

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Market Dynamics Influencing Future Revenue

Generic Competition and Price Erosion

The entrance of multiple generics has driven down prices substantially, with some US generic versions priced as low as USD 20-30 per month. This commoditization constrains Gilead's margins but broadens access.

Innovation and New Formulations

Gilead’s focus on long-acting injectable formulations such as CAB-LA (cabotegravir) offers promising avenues for sustained revenue growth, as these formulations are associated with higher adherence and better clinical outcomes[5].

Policy and Reimbursement Trends

Subsidies, government procurement programs, and insurance coverage influence patient access, impacting sales. Increasing emphasis on preventive healthcare and global health initiatives will likely promote the adoption of PrEP.

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Emerging Opportunities and Challenges

Opportunities

• Expansion into low- and middle-income countries through tiered pricing and partnerships.
• Development of longer-acting PrEP formulations to enhance adherence.
• Strategic collaborations with public health agencies to expand coverage.

Challenges

• Market saturation post-patent expiry leading to significant revenue declines.
• Competitive innovations, especially single-tablet regimens with improved safety profiles.
• Regulatory hurdles in emerging markets.

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Key Takeaways

• Patent expiry in 2020 initiated a sharp decline in TRUVADA’s revenues due to widespread generic competition.
• Shift toward DESCOVY and long-acting injectables reflects Gilead’s strategic pivot to maintain market dominance.
• Global PrEP adoption presents substantial growth opportunities, particularly in regions with rising HIV incidence.
• Pricing strategies and public health initiatives can influence access and sales volumes, especially in developing markets.
• Innovation focus on longer-acting medication formulations and combination therapies remains critical for sustained growth amidst patent challenges.

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FAQs

Q1: How has patent expiration affected TRUVADA's market share?
A: The expiration in 2020 led to the entry of multiple generics, significantly reducing TRUVADA's market share and revenues, prompting Gilead to shift focus toward newer formulations and therapies.

Q2: What is the current status of Gilead’s PrEP market?
A: Gilead remains a leader in PrEP, supported by expanding access programs. The market is expected to grow, especially with longer-acting injections like CAB-LA gaining approval.

Q3: How does DESCOVY compare to TRUVADA?
A: DESCOVY offers a similar efficacy profile but with a better safety profile, mainly due to lower renal and bone toxicity, making it a preferred option in many settings post-TRUVADA patent expiry.

Q4: What role will long-acting HIV prophylactics play in the future?
A: They are expected to revolutionize adherence and effectiveness, creating new revenue streams and expanding market reach further.

Q5: Can TRUVADA be repositioned for other indications?
A: Currently, no; its approved indications are limited to HIV treatment and PrEP. Off-label uses are limited, and regulatory pathways for new indications are challenging.

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References

[1] Gilead Sciences. "Global PrEP Market Report 2022."

[2] FDA. "FDA Approves DESCOVY for Predominantly HIV-Positive Patients."

[3] Gilead Sciences. "Annual Financial Reports 2019-2022."

[4] Gilead Sciences. "Q4 and Full Year 2022 Financial Results."

[5] WHO. "Long-Acting Injectable COVID-19 and HIV Medications: Market and Future Outlook."