TENOFOVIR ALAFENAMIDE FUMARATE - Generic Drug Details

What are the generic drug sources for tenofovir alafenamide fumarate and what is the scope of freedom to operate?

Tenofovir alafenamide fumarate is the generic ingredient in three branded drugs marketed by Lupin Ltd, Apotex, and Gilead Sciences Inc, and is included in three NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tenofovir alafenamide fumarate has one hundred and thirty-three patent family members in fifty-one countries.

There are six drug master file entries for tenofovir alafenamide fumarate. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for TENOFOVIR ALAFENAMIDE FUMARATE

International Patents:	133
US Patents:	3
Tradenames:	3
Applicants:	3
NDAs:	3
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	35
Clinical Trials:	92
Patent Applications:	1,342
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TENOFOVIR ALAFENAMIDE FUMARATE
DailyMed Link:	TENOFOVIR ALAFENAMIDE FUMARATE at DailyMed

Recent Clinical Trials for TENOFOVIR ALAFENAMIDE FUMARATE

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

Sponsor	Phase
Instituto Mexicano del Seguro Social	PHASE3
Jos Antonio Mata Marn	PHASE3
Guangzhou 8th People's Hospital	NA

See all TENOFOVIR ALAFENAMIDE FUMARATE clinical trials

Generic filers with tentative approvals for TENOFOVIR ALAFENAMIDE FUMARATE

Applicant	Application No.	Strength	Dosage Form
		EQ 25MG BASE	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for TENOFOVIR ALAFENAMIDE FUMARATE

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

Anatomical Therapeutic Chemical (ATC) Classes for TENOFOVIR ALAFENAMIDE FUMARATE

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for TENOFOVIR ALAFENAMIDE FUMARATE

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 TENOFOVIR ALAFENAMIDE FUMARATE

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
Apotex	TENOFOVIR ALAFENAMIDE FUMARATE	tenofovir alafenamide fumarate	TABLET;ORAL	213867-001	Mar 21, 2024		DISCN	No	No
Gilead Sciences Inc	VEMLIDY	tenofovir alafenamide fumarate	TABLET;ORAL	208464-001	Nov 10, 2016	AB	RX	Yes	Yes	9,296,769*PED				Y

Expired US Patents for TENOFOVIR ALAFENAMIDE FUMARATE

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 TENOFOVIR ALAFENAMIDE FUMARATE

Country	Patent Number	Title	Estimated Expiration
Japan	2010174033	PRODRUG OF PHOSPHONATE NUCLEOTIDE ANALOGUE AND METHOD FOR SCREENING AND PRODUCING THE SAME
Philippines	12014500349
Portugal	2744810

Supplementary Protection Certificates for TENOFOVIR ALAFENAMIDE FUMARATE

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 TENOFOVIR ALAFENAMIDE FUMARATE

Last updated: September 8, 2025

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Introduction

Tenofovir Alafenamide Fumarate (TAF) constitutes a pivotal advancement in antiretroviral therapy (ART), primarily in the management of HIV and hepatitis B infections. Developed as a safer, more efficient prodrug of tenofovir, TAF has gained considerable attention following its approval for multiple indications, including as part of fixed-dose combinations. This article examines the current market dynamics and forecasts the financial trajectory of TAF, analyzing factors influencing adoption, competitive landscape, regulatory pathways, and future growth prospects.

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Market Overview

TAF is marketed under several brand names, notably Genvoya (Gilead Sciences), Descovy (Gilead), and others by licensing partnerships. By 2022, Gilead Sciences held dominant market share owing to its early successful launch and extensive patent portfolio. The global HIV/AIDS therapeutics market was valued at approximately USD 25 billion in 2021, with antiretrovirals like TAF representing a significant fraction of this revenue (Source: IQVIA).

Expanding indications, including potential use in hepatitis B virus (HBV) treatment, further augment its market size. The drug's favorable safety profile—reduced renal toxicity and bone mineral density concerns compared to tenofovir disoproxil fumarate (TDF)—drives sustained demand, especially amid increasing awareness of long-term health complications associated with ART.

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Market Dynamics

Drivers

• Enhanced Safety Profile: TAF exhibits superior renal and bone safety, facilitating longer-term adherence and expanding use among vulnerable populations, such as older adults and those with comorbidities.

• Regulatory Approvals and Label Expansions: The U.S. FDA approved Descovy for PrEP (pre-exposure prophylaxis) in 2019, accelerating market penetration. Similar approvals in Europe and Asia bolster TAF's footprint.

• Rising Global HIV Prevalence: An estimate of 38 million people living with HIV worldwide bolsters the demand for effective, tolerable ART options (UNAIDS 2022).

• Patent Exclusivity and Strategic Collaborations: Gilead's patent portfolio and licensing agreements with generic manufacturers protect market share in multiple regions, while encouraging authorized generics.

Challenges

• Pricing and Reimbursement: High costs and variable insurance coverage across regions limit access, especially in low- and middle-income countries (LMICs). While Gilead has engaged in tiered pricing models, affordability remains a challenge.

• Emerging Competitors and Generics: Patent expirations and biosimilar entries threaten Gilead's dominance. Competitors like ViiV Healthcare and Merck are advancing their own ARV portfolios with alternative prodrugs like tenofovir alafenamide-based compounds.

• Regulatory Hurdles for New Indications: Although approvals broaden TAF's scope, regulatory delays or rejections could impede rapid market expansion.

Competitive Landscape

Major players include:

• Gilead Sciences: Commercially dominant with Genvoya and Descovy. Its global distribution network and robust R&D pipeline sustain its market share (Source: Gilead Annual Report 2022).

• ViiV Healthcare: Focuses on HIV treatments; developing TAF-based formulations and alternatives.

• Generic Manufacturers: Once patents expiry, they aim to offer lower-cost versions, especially critical in LMICs.

• Innovative Therapies: Entry of long-acting injectable ART options (e.g., Cabotegravir) pose competition in treatment paradigms.

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Financial Trajectory

Revenue Trends

Gilead's HIV franchise, with TAF-containing products, generated over USD 12 billion in 2022, with TAF products contributing significantly due to widespread adoption (Source: Company Annual Report). Descovy's sales increased by approximately 20% YoY, driven by PrEP adoption and expanding indications.

Forecasted Growth

According to industry analysts (e.g., Evaluate Pharma), the TAF segment is projected to achieve a CAGR of approximately 10–12% over the next five years, driven primarily by:

• Expanded use in PrEP protocols in North America and Europe.
• Access expansion in LMICs through tiered pricing and licensing.
• Growing treatment rates for hepatitis B where TAF formulations are approved.

Potential revenue from emerging markets could reach USD 8-10 billion globally by 2028, with the lion’s share attributed to North America and Europe, followed by Asia-Pacific.

Influencing Factors

• Patent Landscape: Patent protections for key formulations granted into the early 2030s stabilize revenue streams. Patent cliffs could impact market share if generic alternatives gain approval earlier.

• Regulatory Approvals in New Territories: Approvals in populous regions—India, Africa—will significantly influence revenue growth.

• Pipeline Advancements: Investigations into combination therapies and long-acting formulations could redefine the market, either expanding or cannibalizing current sales.

• Pricing Strategies: Tiered and differential pricing will be pivotal to penetrate resource-limited settings, impacting overall revenue growth.

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Regulatory Environment

Global regulatory agencies have shown a proactive stance in approving TAF-based products:

• FDA (USA): Approved in multiple indications, including for PrEP (Descovy) and HIV treatment.
• EMA (Europe): Approved several TAF-containing formulations.
• WHO: Recommends TAF-containing regimens as preferred options, influencing procurement by governments and NGOs.

Regulatory approvals in emerging markets often depend on licensing agreements and local partnerships, influencing regional access and sales.

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Future Outlook

The future of TAF hinges on several factors:

• Continued patent protections delay widespread generic competition.
• Expansion into hepatitis B treatment markets, with approvals in countries like China and South Africa.
• Development of long-acting formulations, potentially facilitating monthly or bimonthly dosing, could revolutionize adherence and treatment paradigms.
• Strategic collaborations and licensing will determine reach into resource-limited markets.
• Evolving regulatory policies could streamline access but also challenge existing patent protections.

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Key Takeaways

• Dominance with Caveats: Gilead remains the market leader with TAF-based products, but patent expiries and generic competition pose imminent threats.
• Growth Opportunities: Expanding indications, geographic markets, and formulation innovations present substantial upside.
• Access Challenges: High prices and regulatory delays hinder penetration in LMICs; tiered pricing and licensing are critical strategies.
• Competitive Landscape: Innovations in long-acting therapies and alternative formulations are set to redefine market dynamics.
• Regulatory Influence: Approvals by key agencies continually shape market trajectory, with emerging markets offering lucrative growth avenues.

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FAQs

1. What factors contribute to the market growth of Tenofovir Alafenamide Fumarate?
Market growth is driven by its improved safety profile, expanding indications in HIV and hepatitis B, favorable regulatory approvals, increasing global prevalence of target diseases, and strategic licensing agreements. These factors collectively enhance adoption and sales volume.

2. How does TAF compare to its predecessor TDF in terms of market potential?
While TDF pioneered the nucleoside reverse transcriptase inhibitors (NRTIs) market, TAF offers comparable efficacy with significantly reduced renal and bone toxicity. This safety advantage boosts its market potential, especially for long-term treatment, and positions it as the preferred agent in new formulations and regimens.

3. What are the main risks faced by companies marketing TAF?
Patent cliffs and the advent of generics threaten revenue streams. Regulatory hurdles in emerging markets, pricing pressures, and competition from novel long-acting injectables also pose risks. Additionally, healthcare policy shifts affecting drug pricing and access could impact profitability.

4. What is the significance of the patent landscape for TAF?
Patents protect proprietary formulations until the early 2030s, enabling companies like Gilead to maintain exclusivity. Once patents expire, low-cost generics could dominate, reducing revenue potential and forcing market share shifts.

5. How will emerging markets influence the future of TAF?
Emerging markets represent significant growth potential for TAF due to rising HIV and HBV burdens. Access strategies, including tiered pricing and licensing, are essential. Successful penetration could substantially increase total sales, aligning with global health goals.

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References

1. IQVIA, "Healthcare Data and Insights," 2022.
2. UNAIDS, "Global HIV & AIDS Statistics," 2022.
3. Gilead Sciences, "Annual Report," 2022.
4. Evaluate Pharma, "Market Forecasts," 2022.
5. World Health Organization, "Guidelines Approved Treatments," 2022.