EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE - Generic Drug Details

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

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

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

One supplier is listed for this compound.

Summary for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

International Patents:	133
US Patents:	3
Tradenames:	2
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	1
Clinical Trials:	45
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
DailyMed Link:	EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE at DailyMed

Recent Clinical Trials for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

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

Sponsor	Phase
Instituto Mexicano del Seguro Social	PHASE3
Jos Antonio Mata Marn	PHASE3
Shanghai Public Health Clinical Center	NA

See all EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE clinical trials

Pharmacology for EMTRICITABINE; 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 EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

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

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 EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DESCOVY	Tablets	emtricitabine; tenofovir alafenamide fumarate	120 mg/15 mg	208215	1	2022-10-31
DESCOVY	Tablets	emtricitabine; tenofovir alafenamide fumarate	200 mg/25 mg	208215	6	2019-11-05

US Patents and Regulatory Information for EMTRICITABINE; 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	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-001	Apr 4, 2016	AB	RX	Yes	Yes	9,296,769*PED				Y
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-002	Jan 7, 2022		RX	Yes	No	8,754,065*PED				Y
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-001	Apr 4, 2016	AB	RX	Yes	Yes
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-002	Jan 7, 2022		RX	Yes	No	9,296,769*PED				Y
Lupin Ltd	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	213926-001	Dec 13, 2024	AB	RX	No	No
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-002	Jan 7, 2022		RX	Yes	No	7,390,791*PED				Y
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-002	Jan 7, 2022		RX	Yes	No

Expired US Patents for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-001	Apr 4, 2016	5,814,639*PED
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-001	Apr 4, 2016	6,703,396*PED
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-001	Apr 4, 2016	7,803,788
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-001	Apr 4, 2016	6,642,245*PED
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-001	Apr 4, 2016	5,914,331*PED

International Patents for EMTRICITABINE; 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
Moldova, Republic of	20140011
Australia	8294101
Eurasian Patent Organization	027768
Israel	230949

Supplementary Protection Certificates for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663240	15C0071	France		PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU SES FORMES THERAPEUTIQUEMENT EQUIVALENTES PROTEGEES PAR LE BREVET DE BASE TELLES QUE LES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE RILPIVIRINE Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE AINSI QUE D'EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1663240	1690062-3	Sweden		PRODUCT NAME: A COMBINATION OF: RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE; EMTRICITABINE; AND TENOFOVIR ALAFENAMIDE, OR A PHARMCEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING TENOFOVIR ALAFENAMIDE FUMARATE.; REG. NO/DATE: EU/1/16/1112 20160623
3808743	2022C/531	Belgium		PRODUCT NAME: EEN COMBINATIE VAN RILPIVIRINE OF EEN FARMACEUTISCH AANVAARDBAAR ADDITIEZOUT VAN RILPIVIRINE, EN EMTRICITABINE; AUTHORISATION NUMBER AND DATE: EU/1/11/737/001-002 20111128
0513200	C00513200/01	Switzerland		PRODUCT NAME: EMTRICITABINE; REGISTRATION NUMBER/DATE: SWISSMEDIC 56880 25.10.2004
1301519	132016000035069	Italy		PRODUCT NAME: TENOFOVIR ALAFENAMIDE O UN SUO SALE O UN SOLVATO DELLO STESSO, IN PARTICOLARE TENOFOVIR ALAFENAMIDE FUMARATO(GENVOYA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1061, 20151123
1301519	300803	Netherlands		PRODUCT NAME: TENOFOVIRALAFENAMIDE OF EEN ZOUT OF SOLVAAT DAARVAN, MET NAME TENOFOVIRALAFENAMIDEFUMARAAT; NATIONAL REGISTRATION NO/DATE: EU/1/15/1061/002 20151123; FIRST REGISTRATION: EU EU/1/15/1061/001 20151123
1301519	SPC/GB16/015	United Kingdom		PRODUCT NAME: TENOFOVIR ALAFENAMIDE OR A SALT OR SOLVATE THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REGISTERED: UK EU/1/15/1061/001 20151123; UK EU/1/15/1061/002 20151123

Market Dynamics and Financial Trajectory for Emtricitabine and Tenofovir Alafenamide Fumarate

Last updated: July 29, 2025

Introduction

Emtricitabine and tenofovir alafenamide fumarate (TAF) are cornerstone antiretroviral agents pivotal in managing HIV/AIDS. Their synergistic use in fixed-dose combinations has reshaped therapeutic strategies, influencing market dynamics and financial trajectories across global healthcare landscapes. Understanding their trajectories involves analyzing R&D investments, regulatory pathways, manufacturing complexities, patent landscapes, market demand, competition, and pricing strategies.

Pharmacological Profiles and Therapeutic Significance

Emtricitabine (FTC), a nucleoside reverse transcriptase inhibitor (NRTI), has demonstrated efficacy in suppressing HIV replication with favorable tolerability profiles. Tenofovir alafenamide fumarate (TAF) is a prodrug of tenofovir, offering improved safety by reducing renal and bone toxicity compared to tenofovir disoproxil fumarate (TDF). Their combination, notably branded as Descovy and Truvada, offers potent viral suppression, adherence advantages, and safety benefits, underpinning their extensive adoption.

Market Dynamics

1. Market Penetration and Adoption Trends

The global HIV drug market has experienced steady growth driven by increasing HIV prevalence, especially in sub-Saharan Africa, Asia-Pacific, and emerging markets. Emtricitabine and TAF-based formulations, such as Gilead Sciences’ Descovy, have captured significant market share due to their superior safety profiles and convenience. The shift from TDF-based to TAF-based formulations reflects a strategic transition, especially in developed markets, further expanding TAF’s footprint.

2. Regulatory Landscape and Patent Trends

Regulatory approvals from agencies like the FDA, EMA, and other national regulators have been pivotal. Gilead's patent protections for TDF and TAF, expiring in different jurisdictions, influence generic entry and pricing strategies. Notably, patent expiry of TDF compounds has catalyzed market entry of biosimilars, fostering price competition, while patent protections for TAF extend its commercial exclusivity into the next decade, safeguarding revenue streams.

3. Competitive Positioning and Pharmaceutical Ecosystem

Key competitors include Gilead, ViiV Healthcare (with products like cabotegravir/rilpivirine), and emerging biosimilars. Gilead’s early commercialization of TAF-containing formulations has secured a dominant position. However, competition from generics post-patent expiry, biosimilars, and new drugs targeting long-acting or injectable modalities influences long-term sales trajectories.

4. Manufacturing and Supply Chain Considerations

Manufacturing complexity, especially in synthesizing high-purity TAF and emtricitabine, impacts production costs and timelines. Gilead’s integrated manufacturing infrastructure has supported scale-up and consistent supply, critical for global access. Supply constraints or regulatory issues can dampen market growth temporarily, emphasizing the importance of resilient supply chains.

5. Pricing Dynamics and Reimbursement Policies

Pricing strategies are driven by patent status, competition, and healthcare policies. Gilead’s premium pricing for branded combinations contrasts with lower-priced generics emerging post-patent expiry. Reimbursement schemes, especially in high HIV burden nations, significantly influence patient access and overall sales volumes. Cost-effectiveness evaluations and global health initiatives also impact market penetration.

6. Emerging Therapies and Future Market Influences

Long-acting injectables and novel combination regimens pose both threats and opportunities. Their potential to enhance adherence may redefine market shares. Clinical pipeline developments may extend or disrupt current dominance, influencing revenue forecasts over the next decade.

Financial Trajectory

1. Historical Revenue Performance

Gilead’s HIV franchise, primarily driven by emtricitabine and TAF-based formulary sales, has historically generated hundreds of millions in annual revenues. For instance, Gilead reported HIV product revenues surpassing $3 billion annually pre-2020, with TAF formulations contributing increasingly due to their safety profile and patent protections.

2. Revenue Forecasts and Growth Drivers

Projected growth hinges on several factors:

• Patent Firmness: Sustained revenues from protected formulations; patent expiries from 2025 onwards introduce revenue risks.
• Market Expansion: Increasing access in low-to-middle-income countries, supported by international funding programs, can boost aggregate sales.
• Product Lifecycle Extensions: Introduction of new formulations, fixed-dose combinations, or long-acting therapies sustains interest and revenue.
• Pipeline Success: Development of next-generation antiretrovirals can replace or complement current assets, influencing financial trajectories.

Analysts forecast a compound annual growth rate (CAGR) of approximately 3–5% for emtricitabine/TAF products over the upcoming five years, with peaks during patent protections.

3. Impact of Patent Expiry and Biosimilar Entry

Post-2025, biosimilar entrants are expected to erode premiums. Price erosion estimates range from 30–50%, compelling market leaders to innovate or diversify portfolios. Revenue models must incorporate these factors to project long-term profitability accurately.

4. Investment and R&D Spending

Continued R&D investments in novel delivery systems (e.g., injectable long-acting formulations), combination regimens, and resistance management influence long-term financial health. Gilead’s commitment to pipeline expansion signals sustained focus, which could translate into future revenue streams.

Conclusion and Strategic Outlook

The market for emtricitabine and TAF is characterized by steady growth, driven by clinical benefits, regulatory support, and evolving treatment paradigms. The transition from TDF to TAF signifies a pivotal shift, with current patent protections enabling robust financial trajectories. However, patent expiries and emerging therapies necessitate adaptive strategies, including pipeline diversification and global market penetration.

Key trends to monitor include patent timelines, biosimilar developments, formulary preferences, and innovations in drug delivery. Firms capable of navigating regulatory challenges, manufacturing complexities, and competitive threats are poised to sustain growth and profitability.

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Key Takeaways

• Market dominance of TAF-based regimens is reinforced by superior safety profiles, fostering higher adoption rates in developed markets.
• Patent expiries beginning in the mid-2020s are set to introduce biosimilars and generics, exerting downward pressure on prices and revenue.
• Emerging long-acting formulations present both competitive threats and growth opportunities, potentially transforming the existing market landscape.
• Manufacturing and regulatory complexities remain critical factors influencing supply stability and market access.
• Strategic innovation and pipeline expansion are essential to sustaining financial growth amid increasing price competition and evolving treatment standards.

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FAQs

1. When are patents for TAF-based formulations expected to expire?
Patent protections for TAF formulations like Descovy are anticipated to extend until at least 2027–2029 in key markets, after which biosimilar competition is likely to increase.

2. How does patent expiration impact the emtricitabine and TAF market?
Patent expiry typically leads to the entry of biosimilars and generics, reducing prices and market share for branded products, thus affecting revenue trajectories.

3. What emerging therapies could disrupt the current market?
Long-acting injectables and novel combination regimens, including cabotegravir-based therapies, are poised to redefine treatment approaches and market shares.

4. What role does manufacturing complexity play in the market outlook?
High manufacturing standards and capacity support supply security, influencing market stability and pricing strategies—delays or disruptions can temporarily hinder sales.

5. How significant is global market expansion for future revenues?
Expanding access in low- and middle-income countries, supported by international health initiatives, will be crucial for sustaining long-term revenue growth.

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Sources
[1] Gilead Sciences Annual Reports and Investor Presentations
[2] U.S. Food and Drug Administration (FDA) Approvals Database
[3] Global Market Insights, “HIV Pharmaceuticals Market Analysis and Forecast” (2022)
[4] World Health Organization (WHO) HIV/AIDS Data
[5] Patent filings and expiry timelines from publicly available patent databases