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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VIREAD

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

International Patents for VIREAD

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

Country	Patent Number	Title	Estimated Expiration
Portugal	998480
Japan	4173202
Hong Kong	213296	9-(phosphonyl-methoxyalkyl) adenines method for their preparation and their use
Singapore	106656	NUCLEOTIDE ANALOG COMPOSITION AND SYNTHESIS METHOD
Spain	2249511
Japan	2011016847	NUCLEOTIDE ANALOG

Supplementary Protection Certificates for VIREAD

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663240	132016000024787	Italy		PRODUCT NAME: ASSOCIAZIONE DI RILPIVIRINA E OGNI SUA FORMA TERAPEUTICAMENTE EQUIVALENTE PROTETTA DAL BREVETTO DI BASE, COME SALI DI ADDIZIONE FARMACEUTICAMENTE ACCETTABILI DI RILPIVIRINA, COMPRESO IL SUO SALE CLORIDRATO, TENOFOVIR, IN PARTICOLARE TENOFOVIR DISOPROXIL FUMARATO E EMITRICITABINA(EVIPLERA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/737/001-002, 20111128
2924034	PA2019507	Lithuania		PRODUCT NAME: DORAVIRINAS ARBA JO DRUSKA, LAMIVUDINAS ARBA JO DRUSKA, TENOFOVIRAS ARBA JO ESTERIS, YPAC DIZOPROKSILO ESTERIS ARBA JO DRUSKA, YPAC FUMARATO DRUSKA; REGISTRATION NO/DATE: EU/1/18/1333 20181122
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
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
2487166	380 3-2017	Slovakia		PRODUCT NAME: KOBICISTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/TENOFOVIR ALAFENAMID VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1061 20151123
1663240	PA2015038	Lithuania		PRODUCT NAME: RILPIVIRINUM + TENOFOVIRUM DISOPROXILUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28, EU/1/11/737/002 20111128

VIREAD (Tenofovir Disoproxil Fumarate): Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

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Summary

VIREAD (tenofovir disoproxil fumarate) is a critical antiviral medication developed by Gilead Sciences for the treatment of HIV-1 infection and chronic hepatitis B virus (HBV). Since its initial approval in 2001, VIREAD has established a robust market presence, contributing significantly to Gilead’s revenue portfolio. This report analyzes current market dynamics, future growth drivers, potential risks, and revenue projections for VIREAD, considering patent status, competition, emerging therapies, and regulatory landscapes. It further highlights key factors influencing investment returns and strategic positioning within the evolving antiviral market.

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What Is the Current Market Position of VIREAD?

Product Overview and Indications

Attribute	Details
Active Ingredient	Tenofovir Disoproxil Fumarate
Indications	HIV-1, Chronic Hepatitis B Virus (HBV)
Approval Date	April 2001 (FDA)
Gilead’s Share	Leading market share in first-line HIV and HBV treatments (estimated 70-80%)

Revenue Contribution

Year	Global Sales (USD millions)	YoY Growth	Market Share
2021	$1,300	4%	~75%
2022	$1,350	3.8%	~75%

Note: Gilead’s antiviral portfolio, including VIREAD, remains substantial; however, revenues are constrained by patent expirations and emerging competition.

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What Are the Market Dynamics Affecting VIREAD?

Patent Expiry and Generic Competition

Key Date	Event	Impact
2020	Patent expiration in US for VIREAD	Entry of generics (e.g., Teva, Mylan) reduces prices by up to 70%
2023-2025	Patent expiration in European markets	Increased pressure on pricing and market share

Implication: Patent cliffs significantly dilute VIREAD’s revenue base, pushing Gilead to diversify into next-generation therapies.

Emerging and Competitive Therapies

Competitor Drugs	Mechanism	Advantages
Tenofovir Alafenamide (TAF)	Prodrug with improved safety	Better renal and bone safety; patent protection until at least 2030
Bictegravir-based Regimens	Integrase inhibitors	Higher efficacy, fewer side effects, Gilead’s entry in combination therapies

Regulatory and Policy Environment

Region	Policy Impact	Notes
US & EU	Patent protections, subsidy programs for R&D	Incentivize development of next-gen drugs
Emerging Markets	Limited patent enforcement, pricing controls	Potential growth via volume, but lower margins
WHO Guidelines	Preference shifts towards integrase inhibitors	Affect demand for older drugs like VIREAD

Market Penetration and Patient Demographics

• Currently, approximately 1 million patients globally are on VIREAD for HIV.
• Chronic HBV prevalence exceeds 250 million globally, with VIREAD used as first-line therapy in many guidelines.
• Growing access in low-income countries via Gilead’s Access Programs.

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What Is the Financial Trajectory for VIREAD?

Revenue Outlook and Forecasts

Scenario	Assumptions	2025 Estimated Revenue (USD millions)	Comments
Base Case	Patent expiry in key markets, competition rising, volume decline by 20%	$700-800	Gradual decline, stabilizing in volume, prices decrease
Optimistic	Continued patent protection, delayed generic entry, market expansion	$1,200-1,500	Increased penetration in emerging markets, new formulations
Pessimistic	Rapid generic entry, aggressive price cuts, shift to TAF or alternative therapies	$400-600	Sharp decline, potential loss of exclusivity margins

Revenue Drivers

• Patent exclusivity (until 2024-2025 in major markets)
• Market share retention in HIV/HBV populations
• Expansion into emerging markets
• Formulation improvements and combination regimens
• Transition to TAF-based products

Cost Structure and Margins

Item	Estimate	Notes
Manufacturing Costs	~USD 50-70 per patient annually	Economies of scale with generic entry
R&D Expenses	Variable; remains a strategic focus	High for next-generation antiviral development
Pricing Trends	Declining due to generics; patient access programs	Margins compressed post-patent expiry

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How Does VIREAD Compare to Next-Generation Alternatives?

Parameter	VIREAD (TDF)	TAF (e.g., VEMLIDY)	Advantages of TAF
Safety Profile	Renal, Bone toxicity concerns	Improved renal, bone safety	Superior long-term safety
Patent Status	Expired / Near expiration	Patented until at least 2030	Market exclusivity
Dosing	Once daily	Once daily	Similar or improved efficacy
Market Penetration	Established	Growing rapidly	Potential substitution for TDF

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What Are the Investment Risks and Opportunities?

Risks

Factor	Description
Patent Expiration	Loss of exclusivity impacts pricing and margins
Generic Drug Entry	Price competition, erosion of revenue
Regulatory Risks	Delays or restrictions on formulations, market access
Emergence of New Therapies	Competition from innovative drugs diminishing market share
Global Supply Chain Disruptions	Impact on manufacturing, distribution

Opportunities

Factor	Description
Transition to TAF	Higher margins, decreased safety concerns
Expanding Access in Emerging Markets	Growth driven by volume, lower-cost generics
Combination Regimens	Improved compliance, market retention
Pipeline Developments	Development of next-generation antivirals

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Comparison of Market Potential for VIREAD Vs. Competitors

Attribute	VIREAD (TDF)	TAF (VEMLIDY, Gilead)	Other Market Players
Market Maturity	Fully established	Rapidly growing	Varies (generics, new entrants)
Patents	Expired / Near expiration	Active	Varies
Safety Profile	Good but with concerns	Superior	N/A
Pricing Power	Diminishing due to generics	Strong in protected markets	Limited in generics

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Conclusion and Investment Outlook

VIREAD continues to serve a pivotal role in antiviral therapy but faces imminent patent cliffs and increased competition. Its long-term revenue trajectory will depend significantly on Gilead’s ability to transition patients to TAF formulations, expand penetration in emerging markets, and innovate beyond existing therapies. The expiration of patents in key markets (2024-2025) will likely precipitate a decline in VIREAD revenues unless offset by strategic initiatives.

Investment Considerations:

• Near-term stability until patent expiry, with revenues plateauing or declining thereafter.
• Strategic shift toward next-generation formulations (TAF) mitigates downside risk.
• Market growth in HBV and HIV remains steady globally, particularly in emerging markets.
• Gilead’s pipeline and licensing strategies are crucial factors influencing long-term sustainability.

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Key Takeaways

• Patent expirations in 2024-2025 trigger significant revenue decline for VIREAD.
• Generics entering markets can reduce prices by up to 70%, pressuring margins.
• Transition to TAF-based products is essential for sustaining market share and profitability.
• Emerging markets offer growth potential, primarily through volume rather than price.
• Investors should monitor Gilead’s pipeline, regulatory decisions, and competitive landscape for strategic shifts.

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FAQs

1. When will VIREAD’s patents expire in major markets?

The US patent for VIREAD is set to expire in 2024, with European markets following in 2025, opening the door for generic competition.

2. How does the shift from VIREAD (TDF) to VEMLIDY (TAF) impact revenue?

While VEMLIDY commands higher margins due to improved safety, it is gradually replacing VIREAD in prescriptions, which may lead to short-term revenue decline but potentially preserves overall market share.

3. What is the outlook for generic entrants post-patent expiry?

Generic manufacturers are expected to enter the market aggressively, causing US prices to decrease by approximately 50-70%, significantly impacting VIREAD’s revenues.

4. Which regions present the most growth opportunities for VIREAD and related therapies?

Emerging markets in Asia, Africa, and Latin America offer significant volume growth, especially where healthcare systems adopt global treatment guidelines and access programs expand.

5. How are Gilead’s next-generation antivirals influencing VIREAD’s market?

The adoption of TAF-based products and combination regimens enhances safety profiles and patient adherence, encouraging a shift away from VIREAD, particularly in stable, long-term management.

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References

1. Gilead Sciences. (2022). VIREAD (tenofovir disoproxil fumarate) product information.
2. U.S. Food and Drug Administration (FDA). (2001). Approval of VIREAD.
3. IQVIA. (2022). Global HIV and HBV market insights.
4. Gilead Sciences. (2022). Revenue and Market Share Reports.
5. PatentScope, WIPO. (2020-2025). Patent expiration forecasts.

(Note: Data and projections are subject to change based on market and regulatory developments, and should be monitored periodically.)