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

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

Cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate has five hundred and thirty-seven patent family members in fifty-seven countries.

One supplier is listed for this compound.

Summary for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

International Patents:	537
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	11
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
DailyMed Link:	COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE at DailyMed

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

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

Sponsor	Phase
University of California, Los Angeles	Phase 1/Phase 2
Gilead Sciences	Phase 1/Phase 2
Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic	N/A

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

Pharmacology for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Drug Class	Cytochrome P450 3A Inhibitor Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2C9 Inducers Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors HIV Integrase 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; ELVITEGRAVIR; 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

J05AJ	Integrase 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; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GENVOYA	Tablets	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	150 mg/150 mg/ 200 mg/10 mg	207561	1	2023-04-12

US Patents and Regulatory Information for COBICISTAT; ELVITEGRAVIR; 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	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015		RX	Yes	Yes					Y
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015		RX	Yes	Yes					Y
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015		RX	Yes	Yes					Y

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015

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

Country	Patent Number	Title	Estimated Expiration
Canada	2653374
European Patent Office	1301519	PROMEDICAMENTS A BASE D'ANALOGUES NUCLEOTIDIQUES DE PHOSPHONATE ET LEURS METHODES DE SELECTION ET D'ELABORATION (PRODRUGS OF PHOSPHONATE NUCLEOTIDE ANALOGUES AND METHODS FOR SELECTING AND MAKING SAME)
New Zealand	551839	Stable crystal of 4-oxoquinoline compound

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

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1564210	203 5022-2013	Slovakia		PRODUCT NAME: ELVITEGRAVIR ALEBO JEHO HYDRAT, SOLVAT, TAUTOMER ALEBO FARMACEUTICKY PRIJATELNA SOL; NAT. REGISTRATION NO/DATE: EU/1/13/830/001 - EU/1/13/830/002 20130527; FIRST REGISTRATION: EU EU/1/13/830/001 - EU/1/13/830/002 20130527
3150586	301045	Netherlands		PRODUCT NAME: COBICISTAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, DARUNAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, IN HET BIJZONDER DARUNAVIRETHANOLAAT, EN EMTRICITABINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/17/1225 20170925
3150586	CA 2020 00021	Denmark		PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, DARUNAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, ISAER DARUNAVIR ETHANOLAT, OG EMTRICITABIN ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/17/1225 20170925

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

Last updated: July 28, 2025

Introduction

The landscape of antiviral therapies, particularly those targeting HIV and COVID-19, has rapidly evolved with the development of combination drugs containing components like cobicistat, elvitegravir, emtricitabine, and tenofovir alafenamide fumarate. These pharmacologic agents, often integrated into fixed-dose combinations (FDCs), have transformed treatment paradigms and market trajectories. This analysis reviews current market dynamics and forecasts the financial trajectory for drugs comprising these components, focusing on their roles in HIV management, COVID-19 therapeutics, and broader antiviral applications.

Pharmacological Components Overview

• Cobicistat: A pharmacoenhancer used to boost plasma concentrations of other antivirals, particularly integrase inhibitors.
• Elvitegravir: An integrase strand transfer inhibitor (INSTI) critical in HIV therapy.
• Emtricitabine: A nucleoside reverse transcriptase inhibitor (NRTI) with activity against HIV and hepatitis B virus.
• Tenofovir Alafenamide (TAF): A prodrug of tenofovir with improved safety profiles over tenofovir disoproxil fumarate, used in HIV and hepatitis B treatment.

These agents are core components in several leading antiretroviral fixed-dose combinations, such as Genvoya and Biktarvy, which dominate the HIV treatment market.

Current Market Dynamics

HIV Treatment Market

The HIV therapeutic market, valued at approximately USD 24 billion in 2022, continues its growth trajectory driven by increased global diagnosis, persistent unmet needs in low- and middle-income countries, and evolving treatment guidelines emphasizing simplification and safety. Key drugs containing cobicistat, elvitegravir, emtricitabine, and TAF benefit from high clinical adoption due to their efficacy, safety profiles, and convenience of fixed-dose regimens.

Major players like Gilead Sciences and Pfizer dominate this segment. Gilead’s Biktarvy (bictegravir/emtricitabine/TAF) and Genvoya (elvitegravir/cobicistat/emtricitabine/TAF) hold significant market shares, driven by their once-daily dosing and favorable safety profiles.

COVID-19 Therapeutics and Emerging Indications

While these components are not primary COVID-19 treatments, recent research investigates their derivatives and combinations for antiviral activity. The pandemic temporarily heightened interest in antivirals, though market growth here has stabilized. Nevertheless, repurposing and combination therapies evaluated in clinical trials influence long-term prospects.

Regulatory and Patent Landscape

Patents related to fixed-dose combinations (FDCs) containing these components are nearing expiration, opening opportunities for generic competition—particularly from emerging markets—potentially impacting pricing and margins. Nonetheless, proprietary formulations and combination patents continue to sustain premium pricing and market exclusivity for leading brands.

Market Penetration Factors

• Pricing and reimbursement policies: High costs limit access in resource-constrained settings, although tiered pricing and voluntary licensing strategies expand coverage.
• Treatment guidelines shifts: Adoption of integrase inhibitor-based regimens boosts demand for drugs with these components.
• Emerging resistance patterns: Ongoing surveillance affects future drug demand, especially in regions with high HIV prevalence.

Financial Trajectory and Forecasting (2023-2030)

Revenue Forecasts

The global market for antiretroviral fixed-dose combinations featuring these components is projected to grow at a CAGR of approximately 3.5% from 2023 to 2030, reaching USD 35 billion by 2030. Growth drivers include:

• Expanding treatment coverage: An estimated 38 million people living with HIV worldwide (UNAIDS, 2022) sustains steady demand.
• Newer formulations: The launch of next-generation FDCs with improved tolerability catalyzes incremental sales.
• Generics and biosimilars: In markets like India and Africa, patent expirations will introduce cost-effective alternatives, impacting gross margins but enlarging market size.

Profitability Trends

Top-line revenues for market leaders are expected to benefit from patent protections and brand loyalty. However, impending patent cliffs and biosimilar entries may compress margins. Innovator companies are diversifying portfolios into long-acting injectables and novel delivery systems to sustain revenues.

Regulatory and Competitive Risks

Regulatory approvals are increasingly stringent, emphasizing safety and registrational trials. Competitive pressures from emerging biotech firms exploiting novel mechanisms threaten traditional blockbusters, prompting incumbents to invest heavily in R&D.

Global Market Variability

• Developed markets: Stable growth, high reimbursement, and mature competition.
• Emerging markets: Rapid growth potential, driven by government initiatives, but susceptible to pricing pressures and market access challenges.

Impact of Patent Expirations and Generic Competition

Patent expiration for key combinations—like Genvoya and Biktarvy—is anticipated between 2025 and 2028. Generic entrants could erode market share by up to 40%, compelling revenue adjustments and prompting innovation pipelines to offset losses.

Long-Term Outlook: 2030 and Beyond

The trajectory of these components hinges on several factors:

• Continued innovation: Development of long-acting formulations and novel combinations.
• Regulatory evolutions: Simplified approval pathways for bioequivalents.
• Market democratization: Increased access in underserved regions through licensing agreements.
• Emerging health threats: Viral mutations and resistant strains may recalibrate demand.

The growth of these agents within the broader HIV treatment market will be bolstered by their central role in leading combination therapies, ensuring steady revenues despite impending generic competition.

Key Takeaways

• The antiretroviral market, particularly formulations incorporating cobicistat, elvitegravir, emtricitabine, and TAF, is poised for moderate growth driven by expanding access, treatment simplification, and pipeline innovations.
• Leading brands benefit from strong brand loyalty, patent protections, and evolving treatment guidelines favoring integrase inhibitor-based regimens.
• Patent expirations between 2025 and 2028 will catalyze increased generic competition, pressuring prices but also widening market access.
• Companies investing in long-acting formulations and novel delivery platforms will potentially sustain long-term profitability amid patent cliffs.
• The emerging markets will remain critical growth zones, supported by global health initiatives and licensing models, although price competition will intensify.

FAQs

1. How do patent expirations impact the market for drugs containing these components?
   Patent expirations open the door for generic manufacturers, leading to significant price reductions and increased accessibility, but also pose revenue risks for originators.

2. Are there emerging alternatives to these components in HIV therapy?
   Yes, new agents such as long-acting injectables and novel antiviral classes are under development, offering alternative options and potential market shifts.

3. What role do regulatory agencies play in shaping the market trajectory?
   Agencies influence market dynamics through approval processes, encouraging or delaying new formulations, and guiding patent and biosimilar pathways.

4. How significant is the impact of global HIV prevalence on the financial outlook?
   The persistent high prevalence, especially in Africa and Asia, sustains demand, making these components critical to healthcare markets in those regions.

5. What are the prospects of these drugs in COVID-19 or other antiviral applications?
   While primarily HIV therapies, ongoing research into their derivatives and combination therapies could expand their applications, influencing future market growth.

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Sources:
[1] UNAIDS. Global HIV & AIDS statistics — 2022.
[2] IQVIA. The Global Use of Medicines in 2022.
[3] Gilead Sciences Investor Presentations, 2023.
[4] MarketResearch.com, "Antiretroviral Drugs Market Forecast 2023-2030."