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

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

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

Cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate has four hundred and four patent family members in forty-eight countries.

One supplier is listed for this compound.

Summary for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

International Patents:	404
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	26
Patent Applications:	286
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
DailyMed Link:	COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE at DailyMed

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

Constraining patent/regulatory exclusivity:

10,039,718*PED

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 DISOPROXIL 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
Weill Medical College of Cornell University	N/A

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

Pharmacology for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL 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 DISOPROXIL 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 DISOPROXIL FUMARATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
STRIBILD	Tablets	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	150 mg/150 mg/ 200 mg/300 mg	203100	1	2018-10-04

US Patents and Regulatory Information for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL 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	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	7,176,220*PED				Y
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	8,981,103*PED				Y
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	8,148,374*PED				Y
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	10,039,718*PED				Y
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	9,891,239*PED				Y
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	7,635,704*PED				Y

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012	8,716,264
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012	5,977,089*PED
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012	8,592,397
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012	5,814,639*PED
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012	6,642,245*PED
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012	9,457,036

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

Country	Patent Number	Title	Estimated Expiration
Taiwan	200811167
Japan	2016172773	治療薬の薬物動態特性の調節 (ADJUSTMENT OF PHARMACOKINETICS OF CURATIVE MEDICINE)
Japan	2014221845	併用治療のための錠剤 (TABLETS FOR COMBINATION THERAPY)
European Patent Office	3689353	MODULATEURS DE PROPRIÉTÉS PHARMACOCINÉTIQUES D'AGENTS THÉRAPEUTIQUES (MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS)
Japan	2011522790
Croatia	P20090077

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

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1564210	C 2013 033	Romania		PRODUCT NAME: ELVITEGRAVIR OPTIONAL SUB FORMA DE SARE, SOLVAT SAU HIDRATACCEPTABILFARMACEUTIC; NATIONAL AUTHORISATION NUMBER: EU/1/13/830/001, EU/1/13/830/002; DATE OF NATIONAL AUTHORISATION: 20130524; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/830/001, EU/1/13/830/002; DATE OF FIRST AUTHORISATION IN EEA: 20130524
2487162	17C1002	France		PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN SOLVATE ET LE DARUNAVIR OU SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN SOLVATE, EN PARTICULIER L'ETHANOLATE DE DARUNAVIR; REGISTRATION NO/DATE: EU/1/14/967 20141121
2049506	15C0078	France		PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE COBICISTAT; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527
2487162	284 1-2017	Slovakia		PRODUCT NAME: KOBICISTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/DARUNAVIR VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/14/967 20141121
2049506	300780	Netherlands		PRODUCT NAME: COBICISTAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527
2487166	132017000002828	Italy		PRODUCT NAME: COBICISTAT O UN SALE FARMACEUTICAMENTE ACCETTABILE DELLO STESSO E TENOFOVIR ALAFENAMIDE O UN SALE FARMACEUTICAMENTE ACCETTABILE DELLO STESSO, IN PARTICOLARE TENOFOVIR ALAFENAMIDE FUMARATO(GENVOYA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1061, 20151123

Market Dynamics and Financial Trajectory for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Last updated: July 29, 2025

Introduction

The landscape of antiretroviral therapy (ART) has evolved significantly over the past decade, driven by innovation in drug formulations and increasing global demand. The combination therapy comprising Cobicistat, Elvitegravir, Emtricitabine, and Tenofovir Disoproxil Fumarate (collectively referred to as the "Quadruple Regimen") exemplifies this trajectory. This analysis dissects the current market dynamics and projects the financial trajectory of these key pharmaceuticals, considering factors such as patent statuses, competitive landscape, regulatory shifts, and global health initiatives.

Market Overview

The global antiretroviral market is projected to grow at a compounded annual growth rate (CAGR) of approximately 6-8% over the next five years, reaching an estimated valuation of USD 40 billion by 2027 [1]. The quadruple combination therapy, widely endorsed by the World Health Organization (WHO) and various national health agencies, remains central to treatment protocols for HIV-1 infection, especially in high-burden regions such as sub-Saharan Africa, Asia-Pacific, and Latin America.

Key Components and Role in Therapy

• Cobicistat: A pharmacokinetic enhancer (booster) that inhibits cytochrome P450 3A enzymes, thereby increasing the plasma concentration of co-administered drugs without direct antiviral activity.
• Elvitegravir: An integrase strand transfer inhibitor (INSTI) that prevents viral DNA integration into the host genome.
• Emtricitabine: A nucleoside reverse transcriptase inhibitor (NRTI) with a long-standing efficacy and safety profile.
• Tenofovir Disoproxil Fumarate (TDF): An NRTI highly effective in suppressing viral replication but associated with renal and bone toxicity concerns (prompting newer formulations such as Tenofovir Alafenamide).

These agents are often combined into single-tablet regimens, improving patient adherence—a critical determinant of treatment success.

Market Dynamics

Patent and Regulatory Landscape

Patent expirations of key molecules, notably TDF, have introduced generic alternatives, intensifying price competition. Gilead Sciences' patent on TDF expired in several jurisdictions in recent years, enabling biosimilar entrants [2]. Meanwhile, newer formulations like Tenofovir Alafenamide (TAF) offer comparable efficacy with improved safety profiles, placing competitive pressure on existing TDF formulations.

Regulatory agencies such as the FDA and EMA have increasingly approved fixed-dose combinations (FDCs), including the quadruple regimen, streamlining access and adherence. The approval of combination products, such as Gilead’s Biktarvy and Vitekta, has further polarized the market, compelling incumbent brand holders to innovate or optimize pricing strategies.

Competitive Landscape

Major players encompass Gilead Sciences, ViiV Healthcare (a GSK/Johnson & Johnson joint venture), and MSD. The emergence of generics has notably reduced prices, especially in high-volume markets, impacting revenue trajectories for originator firms.

• Gilead: Traditional leader with TDF-based formulations; now pivoting towards TAF-based combinations and broadening access through licensing agreements.
• ViiV Healthcare: Focuses on integrase inhibitor-based regimens like Dolutegravir, challenging the dominance of older TDF/FTC-based combos.
• Generics and Biosimilars: Countries with patent expirations witness a flood of biosimilars, forcing price reductions and shifting market share.

Global Health Initiatives

International agencies, including the WHO and USAID, promote generic procurement and scaling-up of ART in low-income countries, exerting downward pressure on prices. The Global Fund and PEPFAR significantly influence treatment access and thus influence the revenue potential of branded drugs within these markets.

Pricing Trends and Revenue Projections

Prices for branded regimens have declined by up to 60% in low- and middle-income countries over the past decade [3]. Despite this, the high volume of patients and the recurring nature of treatment sustain robust revenues for leading pharmaceutical firms.

In high-income regions, premium pricing persists, with annual per-patient costs reaching USD 20,000–30,000 [4]. As patents expire and generics dominate, revenue from branded formulations is anticipated to decrease at a CAGR of approximately 3-5%, while emerging TAF-containing formulations may see accelerated growth in developed markets owing to their superior safety profiles.

Financial Trajectory

Revenue Forecasts

• Short-term (1-3 years): Revenue stability for incumbent firms, driven by existing formulations and steady demand in mature markets. Launch of improved regimens with TAF integration expected to boost sales.
• Mid-term (3-5 years): Revenue shifts favor TAF-based formulations and fixed-dose combinations with enhanced safety amenities; patent cliffs for old TDF-based drugs accelerate generic penetration.
• Long-term (5+ years): Market consolidation with generics and biosimilars capturing significant market share; potential for breakthrough therapies or long-acting injectables to displace oral regimens.

Profitability and Investment Outlook

The transition toward TAF-based products, combined with cost efficiencies gained through manufacturing scale and patent protections, suggests sustained profitability for leading innovators. Conversely, generics manufacturers will benefit from manufacturing cost reductions and expanding access programs, although profit margins will be tighter.

Emerging Trends and Opportunities

• Long-Acting Injectables: Injectable formulations (e.g., Gilead’s Cabotegravir) show promise in reducing dosing frequency, potentially transforming revenue streams and requiring significant R&D infrastructural investment [5].
• Digital Adherence Tools: Integration with digital health platforms can improve treatment outcomes, indirectly supporting revenue through better patient retention.
• Global Access Initiatives: Partnerships with governments and non-profits present opportunities for volume-driven growth, particularly in underserved demographics.

Conclusion

The pharmaceutical market for the combination of Cobicistat, Elvitegravir, Emtricitabine, and Tenofovir Disoproxil Fumarate exhibits resilient growth driven by global HIV/AIDS management strategies. Patent expirations and the advent of safer, more efficacious formulations are reshaping competitive dynamics. The forecast predicts sustained revenues for established players while opening avenues for innovation, especially in long-acting modalities. Manufacturers must actively navigate patent landscapes, regulatory shifts, and cost pressures to optimize their financial trajectories in this evolving market.

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Key Takeaways

• Market resilience: Despite declining prices due to generics, fundamental demand remains high owing to the global burden of HIV/AIDS.
• Patent expirations: Accelerate generic entry, pressuring prices but also creating opportunities for licensing and biosimilar growth.
• Innovation focus: Transition to TAF and long-acting injectables positions industry participants for future revenue growth.
• Regulatory environment: Favorable approvals for combination drugs and fixed-dose formulations streamline access and adherence.
• Global health initiatives: Extensive funding and procurement programs sustain demand in developing countries, offsetting pricing pressures elsewhere.

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FAQs

1. How will patent expirations impact the revenue of major pharmaceutical companies for these drugs?
Patent expirations facilitate generic entry, leading to substantial price reductions. While this diminishes revenue from branded formulations, companies can mitigate impacts through developing next-generation formulations, expanding indications, or licensing arrangements.

2. What role will biosimilars play in the future of this drug market?
Biosimilars will significantly increase competition, especially in low- and middle-income countries. They will likely drive down prices, improve access, and reshape profit margins for originators.

3. Are long-acting injectable therapies expected to replace oral regimens?
Long-acting injectables demonstrate promise in enhancing adherence and reducing dosing frequency. While unlikely to fully replace oral regimens soon, they are poised to become a significant component of future HIV treatment protocols.

4. How are global health initiatives influencing market dynamics?
Programs like PEPFAR and the Global Fund increase demand for affordable generics, fostering price compression but also expanding access and treatment coverage, which can stabilize or grow overall market size.

5. What are the key risks facing the financial growth of these drugs?
Regulatory changes, patent disputes, emergence of superior therapies, and market saturation pose risks. Additionally, political and economic factors influencing drug pricing and procurement can impact revenues.

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References

[1] MarketWatch. (2022). Global Antiretroviral Market Analysis.
[2] Gilead Sciences. (2021). Patent and Biosimilar Landscape.
[3] WHO. (2020). Global Price Report for HIV Medicines.
[4] IMS Health. (2021). HIV Drug Pricing Trends.
[5] Gilead Sciences. (2022). Advancements in Long-Acting HIV Therapies.