COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE - Generic Drug Details

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

Cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate is the generic ingredient in one branded drug marketed by Janssen Prods and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate has four hundred and ninety-six patent family members in fifty-two countries.

One supplier is listed for this compound.

Summary for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

International Patents:	496
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	3
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
DailyMed Link:	COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

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

Sponsor	Phase
Janssen Sciences Ireland UC	Phase 3
Janssen R&D Ireland	Phase 3
Gilead Sciences	Phase 2

See all COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE clinical trials

Pharmacology for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Drug Class	Cytochrome P450 3A Inhibitor Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor Protease Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors HIV Protease Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Nucleoside Reverse Transcriptase Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

J05AE	Protease 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

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

V03AX	Other therapeutic products
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

Paragraph IV (Patent) Challenges for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SYMTUZA	Tablets	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	800 mg/150 mg/ 200 mg/10 mg	210455	1	2021-08-16

US Patents and Regulatory Information for COBICISTAT; DARUNAVIR; 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
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes			Y	Y
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes			Y	Y
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes			Y

Expired US Patents for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018

International Patents for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Country	Patent Number	Title	Estimated Expiration
Portugal	2744810
Japan	2019059790
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)

Supplementary Protection Certificates for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2487166	2016C/065	Belgium		PRODUCT NAME: COBICISTAT AND TENOFOVIR ALAFENAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/15/1061 20151123
1301519	1690012-8	Sweden		PRODUCT NAME: TENOFOVIR ALAFENAMIDE OR A SALT OR SOLVATE THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REG. NO/DATE: EU/1/15/1061/001-002 20151123
3150586	PA2020508,C3150586	Lithuania		PRODUCT NAME: KOBICISTATAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ARBA SOLVATAS, DARUNAVIRAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ARBA SOLVATAS, YPAC DARUNAVIRO ETANOLATAS, IR EMTRICITABINAS, ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/17/1225 20170921

Market Dynamics and Financial Trajectory for Cobicistat, Darunavir, Emtricitabine, and Tenofovir Alafenamide Fumarate

Last updated: July 30, 2025

Introduction

The global pharmaceutical landscape continues to evolve rapidly, driven by innovations in antiviral therapies targeting HIV/AIDS. A core component of these developments involves combination regimens utilizing agents such as cobicistat, darunavir, emtricitabine, and tenofovir alafenamide fumarate (TAF). These drugs form the backbone of several high-impact antiretroviral therapies (ART), with significant implications for market dynamics and revenue forecasts. This report examines the current landscape, key drivers, competitive influences, and the financial trajectories of these pivotal compounds.

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Market Overview of Key Agents

Cobicistat is a pharmacokinetic enhancer (booster) used to increase the systemic exposure of other antiretrovirals, notably protease inhibitors such as darunavir. Darunavir is a protease inhibitor with robust efficacy, widely prescribed in ART regimens. Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI), often co-formulated with other agents, contributing to once-daily dosing and improved adherence. Tenofovir alafenamide fumarate (TAF), a novel prodrug of tenofovir, offers similar efficacy to tenofovir disoproxil fumarate (TDF) but with reduced renal and bone toxicity.

Combined, these agents derive commercial strength from their inclusion in products such as Darunavir/cobicistat/emtricitabine/TAF (brand names like Symtuza) and similar formulations, dominating major HIV therapy markets.

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Market Dynamics

Epidemiological Drivers

HIV/AIDS remains a substantial global health challenge, affecting approximately 38 million individuals worldwide per UNAIDS [1]. While the prevalence of HIV has plateaued in some regions, increasing access to potent ART has driven a decline in AIDS-related mortality, fueling sustained demand for advanced antiretroviral therapies.

The expansion of ART coverage, especially in emerging markets, provides consistent growth opportunities. Government policies, international funding (e.g., PEPFAR, Global Fund), and advancements in treatment guidelines converge to sustain a global demand for these agents [2].

Regulatory and Patent Trends

Patent protections for initial formulations of these drugs have progressively expired or are nearing expiry, leading to the entry of generic equivalents. For instance, patents on certain formulations of TDF expired in multiple jurisdictions, prompting competition. Conversely, patents for TAF formulations, particularly co-formulated products, remain robust, supporting branded drug sales momentarily [3].

Regulatory agencies' approvals for new combinations or improved formulations—such as long-acting injectables—also influence market dynamics. The FDA's approval of Gilead's Biktarvy (containing bictegravir, emtricitabine, and TAF) has shifted market share towards integrase inhibitor-based regimens, influencing the positioning of cobicistat and darunavir-containing products [4].

Competitive Landscape

The market is intensely competitive, featuring major pharmaceutical players like Gilead Sciences, Janssen (Johnson & Johnson), ViiV Healthcare, and Teva. Gilead's early dominance in TDF and TAF-based regimens positions it favorably, but recent launches and biosimilar entrants challenge this supremacy.

Certain formulations, such as darunavir/cobicistat/emtricitabine/TAF, benefit from favorable clinical profiles, tolerability, and simplified dosing, reinforcing their market share. However, the advent of integrase inhibitors with once-daily dosing and fewer side effects has begun to encroach upon protease inhibitor space [5].

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Financial Trajectory

Revenue Trends and Forecasts

Preliminary analyses suggest that the global antiviral market, valued at approximately $29 billion in 2022 [6], will grow at a compound annual growth rate (CAGR) of 4-6% through 2030, driven mainly by expanding indications and improved formulations.

Cobicistat: A niche but critical agent, cobicistat's revenue is closely tied to the performance of co-formulations like Darunavir/cobicistat/emtricitabine/TAF. Although generic versions threaten branded sales, intellectual property protections and formulary preferences sustain revenue.

Darunavir: With a mature patent landscape, darunavir's sales peaked post-launch but are projected to decline gradually owing to patent expiries and competition from integrase inhibitors. Nonetheless, it remains a preferred option for many patients resistant to newer agents, underpinning steady revenue streams estimated at $300–400 million annually [7].

Emtricitabine: Its broad use across multiple formulations guarantees consistent demand. However, the shift towards combination regimens incorporating TAF diminishes standalone emtricitabine sales, though combination product sales offset this decline.

Tenofovir Alafenamide Fumarate: The TAF market is burgeoning, with projections indicating a CAGR of approximately 15% from 2022 to 2030 [8]. Revenue from TAF-based products could exceed $10 billion globally by 2030, owing to superior safety profiles and regulatory endorsements.

Impact of Patent and Biosimilar Competition

Patents on initial formulations have begun to lapse, prompting genericization and price erosion, notably in developed markets. For instance, Gilead's TDF formulations faced biosimilar entry, leading to significant revenue reductions.

In contrast, TAF's patent protections and proprietary formulations offer a short-term growth runway, although patent cliffs loom for some TAF-containing products by mid-2020s, potentially initiating price competition.

Pipeline and Innovation

Advancements such as long-acting injectables (e.g., cabotegravir/rilpivirine) promise to alter the treatment paradigm, potentially reducing reliance on daily oral agents including cobicistat and darunavir. Such innovations could reshape revenue models, with initial high-value injections competing against traditional pills [9].

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Market Challenges and Opportunities

Challenges:

• Patent expiry and generics dilute revenues for marketed drugs.
• Increasing competition from integrase inhibitors (e.g., Biktarvy, Dolutegravir-based regimens).
• Regulatory approval delays or rejections of new formulations.
• Adherence challenges in certain populations, affecting market penetration.

Opportunities:

• Expansion into pediatric and underserved populations.
• Development of long-acting formulations reducing pill burden.
• Strategic alliances and licensing to extend patent life or access emerging markets.
• Innovations targeting resistance profiles.

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Regulatory and Pricing Outlook

Pricing strategies will vary by region, with high-income markets favoring premium pricing for innovative formulations and controlled price erosion in emerging markets through biosimilar competition. Governments' procurement policies and international funding significantly influence revenue streams.

Regulatory agencies' evolving standards emphasize safety and efficacy, particularly for new combinations involving cobicistat and TAF, impacting approval timelines and market access.

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Key Takeaways

• The market for cobicistat, darunavir, emtricitabine, and TAF remains robust but is undergoing significant transformation driven by patent expiries, emerging competition, and innovation.

• TAF-based regimens are poised for substantial growth, propelled by superior safety profiles and approval of new indications, with revenues potentially surpassing $10 billion by 2030.

• The sustainability of revenue for cobicistat and darunavir hinges on patent protection, clinical positioning, and market acceptance amidst growing adoption of integrase inhibitor-based therapies.

• Strategic positioning through pipeline innovations, long-acting formulations, and geographic expansion will be critical for maintaining market relevance.

• Market entrants must navigate complex regulatory landscapes and price sensitivities to capitalize on opportunities within evolving HIV treatment paradigms.

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FAQs

1. How will patent expiries affect the revenue of drugs containing cobicistat and darunavir?
Patent expiries in key markets will enable biosimilar and generic entries, leading to price competition and revenue decline for branded versions. However, proprietary formulations and combination patents can extend market exclusivity temporarily.

2. What role does TAF play in the future of HIV therapy?
TAF offers enhanced safety, potency, and tolerability over TDF, driving its adoption in high-value combination regimens. Its market growth is expected to continue strongly through 2030, reshaping treatment standards.

3. Are there pending developments that could replace or diminish the use of protease inhibitors like darunavir?
Yes, long-acting injectables and integrase inhibitors are gaining favor due to their convenient dosing and favorable side-effect profiles, potentially leading to reduced use of protease inhibitors over time.

4. How does global HIV prevalence influence the pharmaceutical market for these drugs?
Higher prevalence and expanded access in emerging markets sustain demand, while evolving treatment guidelines in high-income countries shape the specific market share and revenue potential.

5. What strategic moves could pharmaceutical companies leverage to remain competitive?
Investing in pipeline innovations, developing long-acting formulations, securing patent protections, and entering emerging markets are key strategies to maintain competitiveness amidst patent cliffs and new entrants.

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References

1. UNAIDS. Global HIV & AIDS statistics — 2022 fact sheet. [Online] Available at: https://www.unaids.org

2. WHO. HIV/AIDS treatment and prevention guidelines. 2022.

3. U.S. Patent and Trademark Office. Patent expiration timelines for HIV drugs. 2022.

4. FDA. Approval of Biktarvy for HIV treatment. 2020.

5. MarketWatch. HIV drugs market analysis. 2022.

6. Fortune Business Insights. Global Antiviral Drugs Market Size, Share & Industry Analysis. 2022.

7. Evaluate Pharma. Darunavir revenue forecast. 2022.

8. Grand View Research. Tenofovir Alafenamide Market Size & Trends. 2022.

9. Gilead Sciences. Long-acting injectable antiretrovirals development pipeline. 2022.