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

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	021356-002	Jan 18, 2012
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-003	Jan 18, 2012
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-004	Jan 18, 2012

International Patents for VIREAD

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

Country	Patent Number	Title	Estimated Expiration
Japan	2007297406	NUCLEOTIDE ANALOG
Japan	2000515866
South Korea	100707505

Supplementary Protection Certificates for VIREAD

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1419152	122012000038	Germany		PRODUCT NAME: KOMBINATION AUS RILPIVIRIN ODER EINER STEREOCHEMISCH ISOMEREN FORM ODER EINEM PHARMAZEUTISCH UNBEDENKLICHEN ADDITIONSSALZ DESSELBEN, EINSCHLIESSLICH DES CHLORWASSERSTOFFSAEURESALZES VON RILPIVIRIN, UND TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT.; REGISTRATION NO/DATE: EU/1/11/737/001 20111128
0915894	C00915894/02	Switzerland		PRODUCT NAME: TENOFOVIRDISOPROXIL + EFAVIRENZ + EMTRICITABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 60011 20.11.2009
1663240	PA2016045	Lithuania		PRODUCT NAME: RILPIVIRINAS + TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/16/1112 20160621

Market Dynamics and Financial Trajectory for VIREAD (Tenofovir Disoproxil Fumarate): A Comprehensive Analysis

Last updated: December 15, 2025

Executive Summary

VIREAD (tenofovir disoproxil fumarate, TDF), developed by Gilead Sciences, is a cornerstone medication in the management of HIV/AIDS and chronic hepatitis B. Since its launch in 2001, VIREAD has become a significant revenue driver, underpinning Gilead’s portfolio amid evolving competition, regulatory changes, and advancements in antiviral therapy. This report delves into the market forces shaping VIREAD’s trajectory, explores the drug’s economic impact, and forecasts future performance amid patent expirations and emerging therapeutics.

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What Are the Market Dynamics Influencing VIREAD?

1. Competitive Landscape and Market Share Shifts

VIREAD's global market is influenced by the rise of alternative antiretrovirals and the advent of tenofovir alafenamide (TAF) formulations, particularly Gilead’s own DESCOVY and ODEFSEY.

Key Competing Drugs	Company	Approval Date	Formulation	Strengths	Limitations
Truvada	Gilead	2004	TDF + Emtricitabine	Proven efficacy, HIV prevention	Renal and bone toxicity concerns
Descovy	Gilead	2016	TAF + Emtricitabine	Improved safety profile	Higher cost relative to generics
Biktarvy	Gilead	2018	Bictegravir + TAF + Emtricitabine	Simplified regimen, high barrier to resistance	No generic options available
Tegsedi (generic)	Various	—	Generic TDF	Cost-effective	Limited brand recognition

The transition from TDF to TAF has underpinned a significant shift in prescriber preferences, especially since TAF offers comparable efficacy with reduced renal and bone toxicity.

2. Patent Expirations and Generic Competition

VIREAD’s patent protections, initially granted in 2001, began expiring in various jurisdictions—United States in 2020 (for some formulations), with broader generics entering the market through authorized or non-authorized channels. The commencement of generic production has profoundly impacted VIREAD’s pricing and market share.

Patent Expiry Milestones	Region	Year	Impact on Market	Generic Entry Status
U.S. Patent Expiry	US	2020	Increased price competition	Authorized generics active
European Patent	EU	2019	Price erosion	Multiple generics
Japan Patent	Japan	2020	Market share decline	Several generics available

3. Regulatory Environment & Policy Shifts

Policy initiatives advocating for cost containment and access expansion—like the U.S. Affordable Care Act and WHO pricing policies—pressure Gilead’s pricing strategies. Additionally, global efforts against HIV/AIDS and hepatitis B influence demand dynamics.

4. Pharmacovigilance & Safety Data Impact

Accumulated safety data highlighting renal and bone side effects associated with TDF have spurred a shift towards TAF-based drugs, pressuring VIREAD to evolve or risk obsolescence.

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How Has VIREAD Performed Financially Over Time?

1. Revenue Trends and Market Penetration

Gilead’s fiscal reports reveal VIREAD revenue contributions as a significant portion of HIV franchise revenues:

Fiscal Year	VIREAD Revenue (USD millions)	Market Share (%)	Remarks
2017	1.2 billion	~25	Peak due to no significant generic competition
2018	1.0 billion	~20	Initiation of generic entries
2019	800 million	~15	Growing generic competition impacts revenues
2020	600 million	~12	Patent litigation and generics expand
2021	400 million	~8	Further erosion; transition toward TAF formulations

(Source: Gilead Annual Reports, 2017-2021)

2. Profitability Margins and R&D Investment

VIREAD has historically delivered high gross margins (>80%) but has seen margins contract due to price erosion and increased competition. Gilead’s investment in R&D centered on TAF and fixed-dose combinations aims to sustain pipeline growth.

3. Pricing Dynamics and Cost-Effectiveness

A typical VIREAD 300 mg tablet costs approximately $70–$90 retail in the U.S. pre-generic, while generic formulations have driven prices downward to <$10 per tablet. These price reductions correspond with increased access but undermine profitability on the original product.

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What Are the Future Projections for VIREAD?

1. Commercial Outlook with Patent Expirations

Market analysts project that by 2025, VIREAD’s revenue could decline by 70-80% due to generic entry, with a steep decline post-2023 when patent protections expire globally.

Projected Revenue Decay:

Year	Revenue Estimate (USD millions)	Key Factors
2022	~$250	Transition phase, still protected in some regions
2023	~$100	Increased generic penetration
2024	~$50	Largely replaced by generics, minimal brand sales
2025+	<$20	Dominance of generics, phase-out

2. Potential for Portfolio Relocation & Uptake of TAF-based Drugs

Gilead's shift toward TAF formulations, such as DESCOVY (approved 2016) and ODEFSEY (2019), aims to replace VIREAD in treatment regimens. TAF’s improved safety profile is expected to sustain profitability, albeit at lower revenue margins.

3. Regulatory and Policy Effects on Market Dynamics

Pricing regulations, especially in low-income countries and through global health initiatives, could suppress revenue potential further. Conversely, therapeutic guidelines emphasizing safety may favor TAF over TDF, accelerating VIREAD’s phase-out.

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Comparison of VIREAD with Alternative Therapies

Parameter	VIREAD (TDF)	Descovy (TAF)	Biktarvy	Generic TDF
Approval Year	2001	2016	2018	Varies (post-2015)
Formulation	Disoproxil fumarate	Alafenamide	BIC + TAF + FTC	TDF only
Efficacy	High	High	High	High
Renal Safety	Moderate risk	Improved	High barrier	Moderate to high risk
Cost (USD)	$70–$90 per tab	$75–$100 per tab	~$60 per tablet	<$10

(Sources: Gilead Annual Reports, 2022; FDA labels)

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What Are the Strategic Implications for Stakeholders?

Stakeholder	Implication	Recommendations
Gilead Sciences	Transitioning revenues from VIREAD to TAF-based drugs	Accelerate pipeline, optimize generic licensing
Healthcare Providers	Opt for TAF-based therapies to mitigate toxicity	Educate on safety profiles, prioritize newer formulations
Policymakers	Balance access with sustainability	Support generic procurement, price negotiations
Investors	Anticipate revenue declines	Diversify portfolio, monitor pipeline advancements

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Conclusion

VIREAD’s market and financial trajectory reflect a classic lifecycle pattern: initial dominance, peak revenues, and inevitable decline due to patent expiry and competition. While currently a significant revenue contributor to Gilead, the drug’s future hinges on the integration of safer, more cost-effective generics—primarily TAF formulations—and evolving treatment guidelines. Strategic positioning by Gilead around its newer formulations and pipeline innovations will be pivotal for sustained growth.

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Key Takeaways

• Market decline impending: Generic entry in 2023-2025 will drastically reduce VIREAD’s revenues.
• Shift to TAF formulations: Gilead’s newer drugs like DESCOVY are set to replace VIREAD in most markets.
• Safety profile as a competitive advantage: TAF’s favorable safety profile enhances its long-term adoption.
• Pricing dynamics: Generics have lowered VIREAD’s price, improving access but eroding margins.
• Strategic risk: Delays in transitioning to TAF-based therapies or failure to manage patent challenges may impact future revenue streams.

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FAQs

Q1: When will VIREAD’s patents expire worldwide?
A: Patent expiries vary by region, with key jurisdictions such as the U.S., EU, and Japan experiencing expiration starting from 2019-2020, leading to significant generic competition entering the market by 2023-2025.

Q2: How does TAF compare to TDF in terms of safety?
A: TAF has demonstrated improved renal and bone safety profiles compared to TDF, with comparable efficacy, resulting in its preferential recommendation in recent guidelines.

Q3: What are the implications of generic entry for Gilead’s revenues?
A: Generic entry is projected to reduce VIREAD revenues by over 70% within two years post-patent expiry, incentivizing Gilead to focus on newer formulations and combination products.

Q4: Are there ongoing legal or patent challenges affecting VIREAD’s market?
A: Yes, multiple jurisdictions have experienced patent litigation, some resulting in patent invalidation, thereby facilitating earlier generic entry in certain regions.

Q5: What is the longevity of VIREAD's clinical relevance?
A: While its sales are declining, VIREAD remains clinically relevant in specific settings and as part of generic combination therapies, especially in low-resource settings.

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References

[1] Gilead Sciences Annual Reports (2017-2021).
[2] U.S. Food and Drug Administration (FDA). Drug Labeling and Approval Documents.
[3] World Health Organization Guidelines (2021).
[4] MarketWatch and EvaluatePharma Reports (2022).