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 two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-eight patent family members in forty-two 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:	58
US Patents:	2
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 two US patents.

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	8,754,065*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
Hungary	230960	Prodrugs of phosphonate nucleotide analogues and compositions thereof
Chile	2014000370
Cyprus	1119411

Supplementary Protection Certificates for VEMLIDY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663240	122016000108	Germany		PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN, DURCH DAS GRUNDPATENT GESCHUETZTEN FORM DAVON, Z.B. EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, UND TENOFOVIRALAFENAMID ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/16/1112 20160621
1419152	12C0036	France		PRODUCT NAME: COMBINAISON DE RILPIVIRINE ET TOUTES SES FORMES THERAPEUTIQUEMENT EQUIVALENTES PROTEGEES PAR LE BREVET DE BASE, TELLES QUE LES SELS D'ADDITION PHARMACEUTIQUEMENT ACCEPTABLES DE RILPIVIRINE, Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE ET DE TENOFOVIR, EN PARTICULIER LE TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/11/737/001 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

Market Dynamics and Financial Trajectory for VEMLIDY

Last updated: February 19, 2026

VEMLIDY (tenofovir alafenamide) is an antiviral drug used primarily for the treatment of chronic hepatitis B virus (HBV) infection. It competes with older formulations such as tenofovir disoproxil fumarate (TDF). Its market positioning, adoption rates, and financial outlook are shaped by competitive factors, regulatory approvals, and evolving treatment guidelines.

Market Positioning and Regulatory Status

VEMLIDY is marketed by Gilead Sciences. Approved by the U.S. Food and Drug Administration (FDA) in November 2016, it is indicated for the treatment of chronic HBV infection. It gained approval in other regions, including the European Union and Japan, with respective regulatory agencies following similar timelines.

VEMLIDY positions itself as a safer alternative to TDF, due to its improved safety profile, particularly regarding renal toxicity and bone mineral density.

Clinical Adoption and Market Penetration

VEMLIDY benefits from Gilead’s established HBV treatment franchise, which includes existing products like Viread (TDF). The drug's adoption is influenced by the following factors:

• Clinical Guidelines: American Association for the Study of Liver Diseases (AASLD) and European Association for the Study of the Liver (EASL) recommend tenofovir-based regimens as first-line treatments, favoring VEMLIDY for patients at risk of renal or bone issues.

• Physician Preference: Preference for VEMLIDY is driven by its safety profile; however, TDF remains prevalent due to cost considerations.

• Pricing and Reimbursement: The premium price of VEMLIDY, compared to generics or older tenofovir formulations, limits its adoption in price-sensitive markets.

• Market Challenges: Competition from other nucleotide/nucleoside analogs, such as entecavir and tenofovir alafenamide (generic), impacts growth.

Financial Performance and Revenue Projections

Gilead reports VEMLIDY revenues as part of their total HBV franchise. Precise sales figures are not broken out separately but can be inferred through company filings and analyst estimates.

In 2022, Gilead’s HBV franchise generated approximately $1 billion globally, with VEMLIDY comprising a significant share. Growth is projected to be modest, driven by:

• New Patient Initiation: Controlled by updates to clinical guidelines favoring tenofovir-based treatments.
• Market Saturation: Established patient pools limit rapid expansion.
• Pricing Strategies: Maintaining premium pricing sustains revenues but constrains volume growth.

Analysts forecast annual revenue increases of approximately 3-5% over the next five years based on current market dynamics and unmet needs in specific patient populations.

Competitive Landscape

• Generics and Biosimilars: The entry of generic tenofovir formulations (TDF) reduces VEMLIDY’s price advantage.

• Other Innovations: Newer drugs targeting hepatitis B mechanisms or combination therapies could change treatment paradigms.

• Pipeline Developments: Gilead is exploring agents with improved efficacy and safety profiles, but none are yet on the market.

Risk Factors and Opportunities

Risks:

• Price erosion due to generic competition.
• Slower-than-expected adoption in primary care settings.
• Regulatory changes impacting reimbursement and prescribing.

Opportunities:

• Growth in Asia-Pacific markets as hepatitis B prevalence rises.
• Expansion into pediatric populations with new formulations.
• Clinical studies demonstrating benefits over existing therapies solidify market position.

Key Financial Metrics

Metric	2022 (Estimate)	2023 (Forecast)	Source
Revenue from HBV franchise	~$1 billion	$1.05-$1.10 billion	Gilead reports, analyst estimates [1]
CAGR (2023-2028)	—	3-5%	Market analysis
Market share in HBV drugs	~20%	Slight increase	IMS Health, Evaluate Pharma estimates

Conclusion

VEMLIDY’s market trajectory shows slow but steady growth driven by its safety advantages, regulatory support, and Gilead's pricing and marketing strategies. Competition from generics and shifting treatment guidelines remain significant factors influencing its financial performance.

Key Takeaways

• VEMLIDY has a stable market share within Gilead’s HBV treatment portfolio.
• Revenue growth prospects depend on market expansion in emerging regions and maintaining pricing strategies.
• Competitive pressures from generics limit aggressive market penetration.
• Clinical guidelines favoring tenofovir-based regimens support sustained demand.
• Future pipeline innovations could further influence VEMLIDY’s market share.

FAQs

1. How does VEMLIDY compare to TDF in terms of safety?
VEMLIDY has demonstrated reduced renal toxicity and less impact on bone mineral density compared to TDF, making it preferable for patients at risk of these side effects.

2. Is VEMLIDY available as a generic?
No. Gilead holds patents and exclusivity rights that prevent generic production until patent expiry or patent challenges.

3. What is the pricing strategy for VEMLIDY?
VEMLIDY is priced at a premium relative to TDF generics, reflecting its safety profile and brand positioning.

4. Which markets are the primary revenue contributors?
The U.S. remains the largest market, followed by Europe and Japan. Emerging markets like China and India see limited uptake due to affordability issues.

5. What developments could impact VEMLIDY’s growth?
Introduction of new therapies, biosimilars, or changes in international treatment guidelines could alter its market share.

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References

[1] Gilead Sciences. (2023). Annual Report 2022. Retrieved from https://www.gilead.com/investors/financial-information