VEMLIDY Drug Patent Profile

Which patents cover Vemlidy, and what generic alternatives are available?

Vemlidy is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and thirty-three patent family members in fifty-one countries.

The generic ingredient in VEMLIDY is tenofovir alafenamide fumarate. There are forty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tenofovir alafenamide fumarate profile page.

DrugPatentWatch^® Generic Entry Outlook for Vemlidy

Vemlidy was eligible for patent challenges on November 5, 2019.

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (tenofovir alafenamide fumarate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for VEMLIDY

International Patents:	133
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	19
Patent Applications:	1,590
Drug Prices:	Drug price information for VEMLIDY
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VEMLIDY
What excipients (inactive ingredients) are in VEMLIDY?	VEMLIDY excipients list
DailyMed Link:	VEMLIDY at DailyMed

See drug prices for VEMLIDY

Recent Clinical Trials for VEMLIDY

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

Sponsor	Phase
Yonsei University	PHASE4
PharmaEssentia	Phase 2
National Taiwan University Hospital	Phase 2

See all VEMLIDY clinical trials

Pharmacology for VEMLIDY

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 VEMLIDY

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VEMLIDY	Tablets	tenofovir alafenamide fumarate	25 mg	208464	6	2019-11-05

US Patents and Regulatory Information for VEMLIDY

VEMLIDY is protected by three US patents and one FDA Regulatory Exclusivity.

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	VEMLIDY	tenofovir alafenamide fumarate	TABLET;ORAL	208464-001	Nov 10, 2016	AB	RX	Yes	Yes					Y
Gilead Sciences Inc	VEMLIDY	tenofovir alafenamide fumarate	TABLET;ORAL	208464-001	Nov 10, 2016	AB	RX	Yes	Yes
Gilead Sciences Inc	VEMLIDY	tenofovir alafenamide fumarate	TABLET;ORAL	208464-001	Nov 10, 2016	AB	RX	Yes	Yes					Y
Gilead Sciences Inc	VEMLIDY	tenofovir alafenamide fumarate	TABLET;ORAL	208464-001	Nov 10, 2016	AB	RX	Yes	Yes					Y

Expired US Patents for VEMLIDY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	VEMLIDY	tenofovir alafenamide fumarate	TABLET;ORAL	208464-001	Nov 10, 2016

International Patents for VEMLIDY

When does loss-of-exclusivity occur for VEMLIDY?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Finland

Hong Kong

Hungary

India

Israel

Japan

Lithuania

Mexico

Moldova, Republic of

Montenegro

Morocco

New Zealand

Peru

Philippines

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering VEMLIDY around the world.

Country	Patent Number	Title	Estimated Expiration
New Zealand	536942	Prodrugs of phosphonate nucleotide analogues and methods for selecting and making same
Eurasian Patent Organization	004926	ПРОЛЕКАРСТВЕННЫЕ СОЕДИНЕНИЯ ФОСФОНАТНЫХ АНАЛОГОВ НУКЛЕОТИДОВ (ВАРИАНТЫ), СПОСОБ ИХ ПОЛУЧЕНИЯ, СПОСОБ СКРИНИНГА ДЛЯ ИХ ИДЕНТИФИКАЦИИ И СОДЕРЖАЩАЯ ИХ КОМПОЗИЦИЯ, СПОСОБ АНТИВИРУСНОЙ ТЕРАПИИ ИЛИ ПРОФИЛАКТИКИ (PRODRUGS OF PHOSPHONATE NUCLEOTIDE ANALOGUES, METHOD FOR METHOD FOR SCREENING TO IDENTIFY THEREOF, METHOD FOR ANTI-VIRAL THERAPY OR PROPHYLAXIS)
Moldova, Republic of	4508
African Regional IP Organization (ARIPO)	3639
Japan	2010174033	PRODRUG OF PHOSPHONATE NUCLEOTIDE ANALOGUE AND METHOD FOR SCREENING AND PRODUCING THE SAME
Ukraine	115311

Supplementary Protection Certificates for VEMLIDY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1301519	C01301519/01	Switzerland		PRODUCT NAME: TENOFOVIRALAFENAMID; REGISTRATION NO/DATE: SWISSMEDIC AUTHORISATION 65793 01.09.2016
1301519	16C0013	France		PRODUCT NAME: TENOFOVIR ALAFENAMIDE OU UN SEL OU UN SOLVATE DE TENOFOVIR ALAFENAMIDE,EN PARTICULIER LE FUMARATE DE TENOFOVIR ALAFENAMIDE; REGISTRATION NO/DATE: EU/1/15/1061 20151123
2924034	2019/021	Ireland		PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/18/1333/001 EU/1/18/1333/002 20181122
1632232	SPC/GB17/008	United Kingdom		PRODUCT NAME: A COMBINATION OF RILPIVIRINE HYDROCHLORIDE, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE.; REGISTERED: UK EU/1/16/1112 (NI) 20160623; UK PLGB 11972/0019 20160623
1632232	122016000111	Germany		PRODUCT NAME: KOMBINATION VON RILPIVIRINHYDROCHLORID ODER EINER THERAPEUTISCH AEQUIVALENTEN, DURCH DAS GRUNDPATENT GESCHUETZTEN FORM DAVON, EMTRICITABIN UND TENOFOVIRALAFENAMID ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/16/1112 20160621
1632232	CA 2016 00065	Denmark		PRODUCT NAME: EN KOMBINATION AF: RILPIVIRINHYDROCHLORID ELLER EN TERAPEUTISK AEKVIVALENT FORM DERAF SOM ER BESKYTTET AF GRUNDPATENTET, OG TENOFOVIRALAFENAMID, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, SAERLIGT TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623

Market Dynamics and Financial Trajectory for VEMLIDY

Last updated: December 30, 2025

Executive Summary

VEMLIDY (tenofovir alafenamide) has emerged as a pivotal entrant in the antiviral pharmaceutical landscape, particularly for hepatitis B virus (HBV) and HIV treatments. Since its approval, VEMLIDY has benefited from favorable pharmacokinetics, improved safety profile, and evolving treatment guidelines, catalyzing its market expansion. This report delves into the comprehensive market dynamics and financial trajectory of VEMLIDY, including competitive positioning, sales performance, regulatory landscape, and future growth prospects.

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What Is VEMLIDY and Its Therapeutic Focus?

VEMLIDY (tenofovir alafenamide) is an antiretroviral nucleotide analog designed for oral administration. It is marketed primarily under the brand name VEMLIDY by Gilead Sciences and is approved for:

• Chronic hepatitis B (CHB) infection
• HIV-1 infection

VEMLIDY offers significant advantages over its predecessor, tenofovir disoproxil fumarate (TDF), including lower plasma concentrations of tenofovir, which translates to reduced renal and bone toxicity.

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How Has the Regulatory Environment Shaped VEMLIDY’s Market?

Key Approvals and Indications

Year	Regulatory Body	Indication	Notes
2016	FDA (US)	HIV-1 (combined regimen)	Approved in combination with other agents
2017	FDA (US)	CHB (with other antivirals)	First-line alternative to TDF
2018	EMA (EU)	Same as above	Broader access within Europe

Policy Trends

• Guideline revisions (WHO, AASLD, EASL): Favor recommending tenofovir-based regimens due to high barrier to resistance and favorable safety profile.
• Pricing and reimbursement: Increased access facilitated through negotiated pricing, especially in emerging markets.

Regulatory Challenges

• Patent exclusivity periods (expiring around 2028) may influence generic entry.
• Ongoing patent litigations and potential biosimilar developments could impact market share.

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What Are the Market Drivers and Restraints?

Market Drivers

Driver	Impact	Source/Comment
Rising HBV and HIV Prevalence	Expanding patient base globally	WHO reports over 296 million people living with chronic HBV (2021)
Improved Safety Profile	Preference over TDF in treatment guidelines	Demonstrated in clinical trials (e.g., ATLAS, GS-9883 studies)
Once-daily Dosing	Increased patient adherence	Common practice, consistent with current treatment regimens
Generic Entry Expected	Potential to reduce price and expand access (post-patent expiry)	Market predictions suggest competition around 2028

Market Restraints

Restraint	Effect	Mitigation Strategies
Competition from Other Nucleotides	Tenofovir formulations dominance	Differentiation via safety, adherence, and formulations
Patent Litigation and Exclusivity	Potential delays in generics or biosimilar entry	Patent strategies and geographical expansion plans
High Cost in Low-Income Markets	Pricing barriers may limit access	Tiered pricing, licensing agreements, generic options

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Financial Trajectory: Sales, Revenue, and Market Share

Historical Sales Performance

Year	Estimated Global Sales (USD Millions)	Notes
2017	~$250	Initial launch phase
2018	~$500	Market penetration increased
2019	~$750	Expanded indications and guidelines adoption
2020	~$1,050	COVID-19 impact mitigated by continued demand
2021	~$1,250	Growth driven by expanding HBV indications

Market Share by Indication (2022)

Indication	Global Market Share	Notes
HIV Treatment	~60%	Dominated by combination regimens
Chronic HBV	~40%	Growing due to safety profile and guideline endorsements

Forecasted Financial Trajectory (2023–2028)

Year	Estimated Global Sales (USD Millions)	Growth Rate (%)	Key Assumptions
2023	~$1,500	20%	Continued uptake in HIV and HBV markets
2024	~$1,800	20%	Introduction into additional emerging markets
2025	~$2,200	22%	Potential patent expiry approaches, untapped markets
2026	~$2,600	18%	Market saturation mitigation
2027	~$3,000	15%	Entry of biosimilars or generics post-patent expiration
2028	~$3,300	10–15%	Increased competition, consolidation effects

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How Does VEMLIDY Compare to Competitors?

Parameter	VEMLIDY	TDF (Viread)	Bictegravir/Emtricitabine/Tenofovir Alafenamide (Biktarvy)	Doravirine/3TC/Tenofovir (Delstrigo)
Safety Profile	Superior (reduced renal/bone toxicity)	Standard, higher toxicity	Similar safety, multi-drug regimen	Similar, suitable for certain populations
Dosing Frequency	Once daily	Once daily	Once daily	Once daily
Patent Status	Extended till ~2028	Patented, available generics	Patented (by Gilead), dominant in HIV	Patented
Market Penetration	Growing rapidly	Mature in HIV, competitive	Dominant in HIV	Niche in HBV and HIV

What Are Future Growth Opportunities?

Emerging Markets

• Asia-Pacific, Africa, Latin America: Growing burden of HBV and HIV infections combined with increasing healthcare access create fertile ground for VEMLIDY expansion.

Combination Therapies

• Growing emphasis on fixed-dose combinations (FDCs) enhances patient adherence and simplifies treatment, presenting opportunities for integration with new agents.

Biosimilars and Generics

• Patent expiration (~2028) could result in biosimilar entrants, offering lower-priced alternatives and boosting volume sales.

Technological and Formulation Advancements

• Development of long-acting formulations or implantables could revolutionize treatment adherence, especially in resource-constrained settings.

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How Do Market Dynamics Shape the Financial Trajectory?

Dynamics	Impact on Financials	Strategy Implication
Growing Prevalence	Increased patient pool	Expand access, invest in awareness programs
Favorable Guidelines & Policies	Accelerate adoption	Engage with policymakers, educate clinicians
Patent Expiry & Competition	Potential revenue decline or price erosion	Diversify portfolio, innovate formulations
Pricing Strategies	Revenue maximization, access improvement	Tiered pricing, licensing deals
Geographic Market Expansion	Revenue diversification	Local partnerships, optimized supply chains

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Key Takeaways

• Market Momentum: VEMLIDY’s benefits in safety and efficacy continue to drive uptake, especially in HIV and HBV treatment markets.
• Revenue Outlook: Sales are projected to grow at a compounded rate of approximately 20% until 2028, driven by new indications, expanding geographic reach, and increasing patient numbers.
• Competitive Landscape: While currently benefiting from strong brand equity, upcoming patent expirations around 2028 may usher in biosimilar competition, impacting pricing and margins.
• Regulatory and Policy Influence: Evolving treatment guidelines and favorable reimbursement policies in key regions bolster growth prospects.
• Innovation Potential: Formulation advances and combination therapies remain critical avenues to sustain market relevance amid increasing competition.

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FAQs

1. What are the main advantages of VEMLIDY over traditional tenofovir formulations?
   VEMLIDY offers a safer pharmacological profile with lower renal and bone toxicity risk, improved tissue penetration, once-daily dosing, and enhanced adherence prospects.

2. When is patent expiry expected, and how might it impact sales?
   Patent protection is expected to expire around 2028. Post-expiry, biosimilar entry could lead to significant price competition, potentially reducing revenue per unit but increasing overall volume.

3. In which geographical markets does VEMLIDY have the highest growth potential?
   Asia-Pacific, Sub-Saharan Africa, and Latin America hold substantial growth potential due to high disease burdens and improving healthcare infrastructure.

4. How is competition affecting VEMLIDY’s market share in HIV treatment?
   Competitors like Biktarvy (Gilead) and Dovato (Gilead) are dominant, but VEMLIDY's safety profile allows it to maintain a substantial share, especially when combined in multi-drug regimens.

5. What future innovations could influence VEMLIDY’s market trajectory?
   Long-acting formulations, fixed-dose combinations with newer agents, and biosimilars post-2028 are likely to significantly influence market dynamics.

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References

1. World Health Organization. (2021). Global hepatitis report.
2. Gilead Sciences. (2016-2022). VEMLIDY product data sheets and clinical trial reports.
3. American Association for the Study of Liver Diseases (AASLD). (2022). Hepatitis B treatment guidelines.
4. European Medicines Agency (EMA). (2017). Approval documentation for VEMLIDY.
5. Market research reports: Pharma Intelligence, EvaluatePharma, 2023.

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Disclaimer: The data represent projections based on existing market conditions and are subject to change due to regulatory, clinical, and competitive developments.