VEMLIDY Drug Patent Profile

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

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
National Taiwan University Hospital	Phase 2
PharmaEssentia	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	9,296,769*PED				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	7,390,791*PED				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	7,803,788

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
Japan	2010174033	PRODRUG OF PHOSPHONATE NUCLEOTIDE ANALOGUE AND METHOD FOR SCREENING AND PRODUCING THE SAME
Serbia	55353	TENOFOVIR ALAFENAMID HEMIFUMARAT (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Japan	5956537

Supplementary Protection Certificates for VEMLIDY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2924034	PA2019507,C2924034	Lithuania		PRODUCT NAME: DORAVIRINAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, DERINYJE SU LAMIVUDINU IR TENOFOVIRO DIZOPROKSILIO FUMARATU; REGISTRATION NO/DATE: EU/1/18/1333 20181122
0582455	08C0021	France		PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213

Market Dynamics and Financial Trajectory for VEMLIDY

Last updated: July 27, 2025

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Introduction

VEMLIDY (tenofovir alafenamide or TAF) has emerged as a pivotal antiviral agent within the global pharmaceutical landscape, primarily indicated for the treatment of chronic hepatitis B virus (HBV) infection. Developed by Gilead Sciences, VEMLIDY represents a significant evolution in tenofovir-based therapies, positioning itself amidst an increasingly competitive and rapidly evolving market. This analysis explores the dynamic market forces and projected financial trajectories that influence VEMLIDY’s standing in the pharmaceutical industry.

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Product Profile and Therapeutic Significance

VEMLIDY is a prodrug of tenofovir designed for enhanced hepatic delivery, offering improved safety profiles, particularly concerning renal and bone toxicity, compared to earlier formulations like tenofovir disoproxil fumarate (TDF). Its efficacy in suppressing HBV replication, combined with a favorable tolerability profile, underpins its clinical utility. The drug’s approval by U.S. FDA in 2019 for HBV treatment has catalyzed its adoption, particularly among patients requiring long-term management of HBV.

Market Landscape and Key Drivers

1. Rising Prevalence of Hepatitis B

Globally, HBV affects approximately 296 million people, with high prevalence rates in Asia and sub-Saharan Africa. Despite advances in vaccination, chronic HBV remains a major cause of liver cirrhosis and hepatocellular carcinoma. The persistent high burden sustains demand for effective antiviral therapies like VEMLIDY.

2. Competitive Positioning

VEMLIDY competes with other tenofovir formulations, notably TDF and tenofovir alafenamide fumarate (TAF) from other manufacturers. Gilead’s strategic emphasis on safety advantages has positioned VEMLIDY as the preferred option for patients intolerant of or requiring a safer long-term regimen.

3. Clinical and Regulatory Progress

Regulatory approvals in multiple countries bolster market access. Gilead’s ongoing trials and post-marketing data reinforce VEMLIDY’s safety and efficacy credentials, facilitating wider adoption in clinical practice.

4. Market Penetration Strategies

Gilead employs direct sales to healthcare providers, partnerships with healthcare systems, and patient assistance programs. These initiatives aim to expand VEMLIDY’s reach, especially in emerging markets where HBV prevalence is high yet access barriers exist.

Market Challenges and Constraints

1. Competition from Generics

The expiration of patents related to earlier tenofovir formulations raises the threat of generics, potentially pressuring VEMLIDY’s pricing and market share. To counter this, Gilead emphasizes patient safety benefits and clinical differentiation.

2. Pricing and Reimbursement Dynamics

Pricing strategies for VEMLIDY must navigate complex reimbursement landscapes. Payer resistance to high-cost therapies and negotiations influence revenue streams, especially in cost-sensitive markets.

3. Market Awareness and Adoption Rates

Awareness among healthcare providers regarding VEMLIDY’s safety profile influences prescribing patterns. Educational initiatives and clinical guidelines impact its uptake.

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Financial Trajectory and Revenue Outlook

1. Revenue Growth Potential

Since its launch in 2019, VEMLIDY’s sales have demonstrated robust growth, driven by increasing global demand for HBV therapies. Gilead reported globally significant sales figures, with estimates indicating a compound annual growth rate (CAGR) of approximately 15-20% over the next five years, assuming continued adoption and market expansion.

2. Market Expansion Strategies

Gilead’s initiatives include expanding indications, such as utilizing VEMLIDY in combination regimens, and entering new markets, notably Asia, Africa, and Latin America. These regions collectively account for over 80% of the global HBV burden, representing substantial growth opportunities.

3. Impact of Patent and Regulatory Developments

Patent protections in key markets extend until at least 2030, providing exclusivity and revenue security. While patent cliffs elsewhere may threaten future revenues, ongoing patent filings and formulation improvements aim to sustain market dominance.

4. Cost-Effectiveness and Reimbursement Trends

Cost-effectiveness analyses favor VEMLIDY due to its safety profile, supporting reimbursement negotiations. Over time, improved payer acceptance and wider insurance coverage are expected to positively influence sales volumes.

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Market Risks and Opportunities

Risks

• Patent Expiry and Generics: Potential erosion of market share post-patent expiration on earlier tenofovir formulations.
• Emerging Competitors: Development of next-generation antivirals or novel agents targeting HBV could threaten VEMLIDY’s market position.
• Healthcare Policy Shifts: Changes in reimbursement policies or shifts toward generic drugs impact pricing power.

Opportunities

• Expanding Indications: Clinical trials exploring VEMLIDY’s utility in HIV co-infection and other viral diseases could diversify revenue streams.
• Partnership and Licensing Deals: Collaborations in emerging markets could accelerate adoption.
• Formulation Advancements: Fixed-dose combinations and new delivery methods may enhance adherence and market appeal.

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Future Outlook and Strategic Recommendations

The future financial trajectory for VEMLIDY hinges on sustained market penetration, competitive positioning, and regulatory dynamics. Gilead’s focus on clinical differentiation, strategic market expansion, and safeguarding patents will be pivotal. Anticipated growth is supported by increasing global HBV awareness, strategic partnerships, and expanding health infrastructure in emerging economies.

To optimize financial outcomes, Gilead should prioritize:

• Deepening clinical evidence for VEMLIDY’s advantages.
• Accelerating access programs in high-burden regions.
• Innovating formulations and combination therapies.
• Navigating patent landscapes proactively to mitigate generic entry threats.

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Key Takeaways

• Strong Market Fundamentals: High global HBV prevalence sustains demand for VEMLIDY, with safety profile advantages fostering long-term patient retention.
• Strategic Positioning: Differentiation through safety benefits and regional expansion are critical growth drivers.
• Revenue Trajectory: Projected CAGR of 15-20% over five years, contingent on market penetration and patent protections.
• Competitive Risks: Patent expirations and emerging competitors necessitate continuous innovation and strategic market management.
• Growth Opportunities: Exploring additional indications, combination therapies, and expanding access in emerging markets offers upside potential.

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FAQs

1. How does VEMLIDY compare to other tenofovir formulations?
VEMLIDY offers superior safety concerning renal and bone toxicity compared to TDF, making it preferable for long-term management of HBV in patients with comorbidities.

2. What is the current market outlook for VEMLIDY?
The outlook is positive, with expected strong growth driven by increasing global HBV burden, regional market expansion, and clinical positioning, supported by patent protections and strategic initiatives.

3. Are there upcoming regulatory or patent expirations that could impact VEMLIDY?
Patent protections extend until at least 2030 in key markets. Patent expirations for older tenofovir formulations may lead to generic competition, but Gilead’s focus on innovation and clinical differentiation mitigates this risk.

4. What are the main challenges facing VEMLIDY’s market growth?
Challenges include generic erosion post-patent expiration, payer resistance to high prices, intense competition from new antivirals, and regulatory variations across regions.

5. How might VEMLIDY’s indication expansion influence its financial trajectory?
Broader indications, such as combination HIV therapies, could significantly diversify revenue streams, elevate sales volumes, and reinforce market dominance.

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References

1. Gilead Sciences. (2019). VEMLIDY (tenofovir alafenamide) [Product label].
2. World Health Organization. (2022). Global hepatitis report.
3. IMS Health. (2023). Pharmaceutical market analysis reports.
4. ClinicalTrials.gov. (2023). List of ongoing VEMLIDY clinical trials.
5. Bloomberg Industry Reports. (2023). Hepatitis B therapeutic market dynamics.