VIREAD Drug Patent Profile

When do Viread patents expire, and when can generic versions of Viread launch?

Viread is a drug marketed by Gilead Sciences Inc and is included in two NDAs.

The generic ingredient in VIREAD is tenofovir disoproxil fumarate. There are forty-two drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the tenofovir disoproxil fumarate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Viread

A generic version of VIREAD was approved as tenofovir disoproxil fumarate by TEVA PHARMS USA on March 18^th, 2015.

Summary for VIREAD

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	91
Patent Applications:	3,543
Drug Prices:	Drug price information for VIREAD
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VIREAD
What excipients (inactive ingredients) are in VIREAD?	VIREAD excipients list
DailyMed Link:	VIREAD at DailyMed

See drug prices for VIREAD

Recent Clinical Trials for VIREAD

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

Sponsor	Phase
Doris Duke Charitable Foundation	Phase 4
Albert Einstein College of Medicine	Phase 4
Université Protestant au Congo	Phase 4

See all VIREAD clinical trials

Pharmacology for VIREAD

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 VIREAD

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VIREAD	Tablets	tenofovir disoproxil fumarate	150 mg, 200 mg, and 250 mg	021356	1	2012-05-17
VIREAD	Tablets	tenofovir disoproxil fumarate	300 mg	021356	1	2010-01-26

US Patents and Regulatory Information for VIREAD

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	POWDER;ORAL	022577-001	Jan 18, 2012		RX	Yes	Yes
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-004	Jan 18, 2012	AB	RX	Yes	No
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-002	Jan 18, 2012	AB	RX	Yes	No
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-003	Jan 18, 2012	AB	RX	Yes	No
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-001	Oct 26, 2001	AB	RX	Yes	Yes

Expired US Patents for VIREAD

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-001	Oct 26, 2001
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-001	Oct 26, 2001
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-002	Jan 18, 2012
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-001	Oct 26, 2001
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-004	Jan 18, 2012
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-003	Jan 18, 2012

International Patents for VIREAD

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

Country	Patent Number	Title	Estimated Expiration
China	1251679
Singapore	106656	NUCLEOTIDE ANALOG COMPOSITION AND SYNTHESIS METHOD
Japan	4083691
China	100384859
Japan	2014159450	NUCLEOTIDE ANALOGS
Spain	2131116

Supplementary Protection Certificates for VIREAD

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663240	122015000087	Germany		PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN FORM DAVON, DIE DURCH DAS GRUNDPATENT GESCHUETZT IST, WIE Z.B EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, UND TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1301519	132016000035069	Italy		PRODUCT NAME: TENOFOVIR ALAFENAMIDE O UN SUO SALE O UN SOLVATO DELLO STESSO, IN PARTICOLARE TENOFOVIR ALAFENAMIDE FUMARATO(GENVOYA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1061, 20151123
0582455	08C0021	France		PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
1663240	379 5033-2016	Slovakia		PRODUCT NAME: RILPIVIRIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/TENOFOVIR-ALAFENAMID VO VSETKYCH FORMACH CHRA- NENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1112 20160623
1663240	PA2015037	Lithuania		PRODUCT NAME: RILPIVIRINUM + TENOFOVIRUM DISOPROXILUM + EMTRICITABINUM; REGISTRATION NO/DATE: EU/1/11/737/001 2011 11 28, EU/1/11/737/002 20111128
1663240	CA 2016 00063	Denmark		PRODUCT NAME: RILPIVIRIN ELLER TERAPEUTISK AEKVIVALENT FORM DERAF BESKYTTET AF GRUNDPATENTET SASOM ET FARMACEUTISK ACCEPTABELT SALT FX HYDROCHLORIDSALTET AF RILPIVIRIN OG TENOFOVIRALAFENAMID ELLER FARMACEUTISK ACCEPTABELT SALT DERAF FX TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623

Market Dynamics and Financial Trajectory for VIREAD (Tenofovir Disoproxil Fumarate)

Last updated: November 20, 2025

Introduction

VIREAD (tenofovir disoproxil fumarate) is a cornerstone antiviral medication primarily used in the management of HIV-1 and chronic hepatitis B virus (HBV) infections. Approved by the U.S. Food and Drug Administration in 2001, VIREAD has since maintained a significant position within the global pharmaceutical landscape. This analysis explores the evolving market dynamics and financial trajectory shaping VIREAD’s current and future prospects, driven by therapeutic demand, patent considerations, competitive landscape, regulatory policies, and technological innovations.

Market Overview

Therapeutic Demand and Epidemiology

VIREAD’s primary indications—HIV-1 and chronic HBV infections—align with ongoing global health challenges. According to the World Health Organization (WHO), approximately 38 million people worldwide live with HIV/AIDS, with more than 25 million on antiretroviral therapy (ART) as of 2021 [1]. Meanwhile, chronic HBV affects over 296 million individuals globally, with significant prevalence in Asia and sub-Saharan Africa [2].

The rising prevalence of these conditions sustains consistent demand for antiviral therapies. Particularly, the global HIV market is projected to expand at a compound annual growth rate (CAGR) of approximately 2-3% over the next five years, driven by increased diagnosis, treatment access, and aging populations [3].

Pharmacological Profile and Positioning

VIREAD’s efficacy, tolerability, and once-daily dosing established its initial dominance. Its well-characterized safety profile enabled widespread adoption. However, the emergence of newer drugs with improved safety, efficacy, and dosing convenience—such as tenofovir alafenamide (TAF)—has begun influencing market share.

Competitive Landscape and Patent Dynamics

Introduction of Tenofovir Alafenamide

In 2015, Gilead Sciences launched VEKLURY (remdesivir) and TAF-based formulations, including Gilead’s DESCOVY and Biktarvy, which incorporate TAF. Compared to VIREAD (TDF), TAF exhibits superior renal and bone safety profiles, prompting shifts in prescribing practices.

Patent Expirations and Generic Entry

VIREAD’s primary patents, filed in the early 2000s, began expiring around 2018–2020 in key markets like the U.S. and Europe. This has facilitated the entry of generic manufacturers, substantially reducing pricing and impacting Gilead’s revenues from VIREAD.

In the United States, the generic version of tenofovir disoproxil fumarate was approved in late 2020. The increased generic competition is expected to sustain a downward price trajectory, potentially reducing VIREAD’s contribution to Gilead’s top-line revenue by approximately 50% over the next three years [4].

Regulatory and Policy Influences

Global and regional health policies heavily influence market dynamics.

• Pricing and Reimbursement: Governments and insurers are increasingly favoring cost-effective options. The availability of generics and pricing negotiations have capped revenue potential for branded formulations.

• Treatment Guidelines: While VIREAD remains recommended in certain regimens, newer formulations like TAF are preferred where available, owing to safety benefits.

• Patent Challenges: Legal battles over patent extensions and patent cliffs in different jurisdictions have accelerated generic entry, pressuring the market share of VIREAD.

Technological and Pharmacological Innovations

Shift Toward TAF

The transition from TDF (VIREAD) to TAF-based therapies, such as Gilead’s DESCOVY, is notable. TAF delivers similar antiviral efficacy with less systemic exposure, translating into improved safety profiles. As clinicians prefer TAF-based regimens, VIREAD’s market share diminishes.

Development of Long-Acting Formulations

Research into long-acting injectable formulations aims to improve adherence and therapeutic outcomes. Although these innovations are primarily in advanced clinical trials, their potential to disrupt oral therapy markets could influence VIREAD’s future relevance.

Financial Trajectory and Revenue Outlook

Historical Revenue Performance

Gilead’s HIV franchise, including VIREAD, represented a substantial share of revenues historically, with peak sales surpassing $3 billion annually. As of 2022, VIREAD accounted for a declining segment owing to patent expiration and competition, with current annual sales estimated below $1 billion [5].

Projected Revenue Trends

• Short-term (1–2 years): Revenue from VIREAD will likely decline by 20-30%, attributable to generic competition and shrinking prescribing due to safety concerns associated with TDF in certain populations.
• Medium to Long-term (3–5 years): Continued erosion expected, with revenues possibly falling below $500 million, replaced by newer, patent-protected formulations like TAF-based therapies.
• Potential for Market Stabilization: A niche market may persist for VIREAD in specific regions or patient groups where TAF-based options are less accessible or contraindicated.

Impact on Company Portfolio

Gilead is shifting focus toward next-generation therapies and long-acting injectables, with revenues increasingly driven by these products. While VIREAD’s contribution wanes, its legacy maintains relevance in understanding the evolution of antiviral treatment and pricing pressures.

Strategic Considerations

• Diversification: Companies must diversify beyond older assets like VIREAD, investing in innovative treatments to offset revenue declines.
• Pricing Strategies: Price reductions on generics have compressed margins but increased access, critical for global health initiatives.
• Regulatory Engagement: Continuous engagement with health authorities can facilitate approval of new formulations and combination therapies, maintaining market relevance.

Conclusion

VIREAD’s market dynamic trajectory exemplifies the classic lifecycle of a pharmaceutical blockbuster—initial rapid growth, followed by patent expiry, increased competition, and decline in revenues. While its foundational role in HIV and HBV treatment remains recognized, the advent of newer formulations and generics poised to reduce its market share significantly. The company's strategic pivot toward innovation and long-acting therapies will determine its ability to sustain revenue streams amid an evolving therapeutic landscape.

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Key Takeaways

• The global burden of HIV and HBV sustains demand for antiviral drugs, but VIREAD’s dominance is waning due to patent expiry and competition.
• Introduction of tenofovir alafenamide (TAF) offers improved safety profiles, shifting prescription preferences away from VIREAD.
• Generic entry since 2020 has led to significant price erosion, projected to slash revenues substantially over the next few years.
• Strategic innovation in long-acting formulations and combination therapies remains essential to offset revenue declines.
• Companies must adapt to regulatory, technological, and market shifts to sustain profitability in the evolving antiviral landscape.

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FAQs

1. What is the primary use of VIREAD?
VIREAD is used to treat HIV-1 infections and chronic hepatitis B virus (HBV) infection, functioning as part of combination antiretroviral therapy.

2. How has patent expiration affected VIREAD’s market share?
Patent expiration and subsequent generic approvals have led to increased price competition and a significant reduction in VIREAD’s revenues, with generics capturing a growing share.

3. How does VIREAD compare to newer drugs like TAF-based therapies?
While VIREAD has proven efficacy, TAF-based therapies offer improved renal and bone safety profiles, making them preferable in many clinical settings.

4. What are the future prospects for VIREAD?
VIREAD’s role is diminishing due to competition, but it may retain niche markets where TAF options are limited. Its legacy influences ongoing drug development and pricing strategies.

5. What strategic moves can companies adopt to maintain profitability?
Focusing on innovative formulations, expanding into long-acting therapies, engaging with regulatory agencies, and diversifying the portfolio can help offset declining revenues from older drugs.

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References

[1] World Health Organization. HIV/AIDS fact sheet. 2021.

[2] World Health Organization. Hepatitis B fact sheet. 2022.

[3] MarketResearch.com. Global HIV Therapeutics Market Report. 2022.

[4] Gilead Sciences. Annual Financial Reports. 2020–2022.

[5] IQVIA. Pharmaceutical Market Reports. 2022.