GENVOYA Drug Patent Profile

When do Genvoya patents expire, and when can generic versions of Genvoya launch?

Genvoya is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has five hundred and thirty-seven patent family members in fifty-seven countries.

The generic ingredient in GENVOYA is cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate profile page.

DrugPatentWatch^® Generic Entry Outlook for Genvoya

Genvoya was eligible for patent challenges on November 5, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 6, 2033. This may change due to patent challenges or generic licensing.

There have been twenty patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for GENVOYA

International Patents:	537
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	19
Drug Prices:	Drug price information for GENVOYA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GENVOYA
What excipients (inactive ingredients) are in GENVOYA?	GENVOYA excipients list
DailyMed Link:	GENVOYA at DailyMed

See drug prices for GENVOYA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for GENVOYA

Constraining patent/regulatory exclusivity:

10,039,718*PED

NDA:

207561

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 GENVOYA

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

Sponsor	Phase
St. Michael's Hospital, Toronto	Phase 2
CIHR Canadian HIV Trials Network	Phase 2
Unity Health Toronto	Phase 2

See all GENVOYA clinical trials

Pharmacology for GENVOYA

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

Paragraph IV (Patent) Challenges for GENVOYA

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 GENVOYA

GENVOYA is protected by ten US patents.

This potential generic entry date is based on patent 10,039,718.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	8,754,065*PED				Y
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015		RX	Yes	Yes	7,635,704*PED				Y
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015		RX	Yes	Yes	9,891,239*PED				Y
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015		RX	Yes	Yes	8,148,374*PED				Y

Expired US Patents for GENVOYA

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	7,800,788
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015	5,814,639*PED
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015	7,803,788
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015	6,703,396*PED

International Patents for GENVOYA

When does loss-of-exclusivity occur for GENVOYA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Mexico

New Zealand

Peru

Poland

Portugal

San Marino

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering GENVOYA around the world.

Country	Patent Number	Title	Estimated Expiration
Singapore	183059	MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS
Canada	2513440	ACTIVITE ET RESOLUTION ANTIVIRALE DU 2-HYDROXYMETHYL-5-(5-FLUOROCYTOSINE-1-YL)-1,3-OXATHIOLANE (ANTIVIRAL ACTIVITY AND RESOLUTION OF 2-HYDROXYMETHYL-5-(5-FLUOROCYTOSIN-1-YL)-1,3-OXATHIOLANE)
Slovenia	2296633
Australia	4031995

Supplementary Protection Certificates for GENVOYA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2487163	132017000002807	Italy		PRODUCT NAME: COBICISTAT O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E ATAZANAVIR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE ATAZANAVIR SOLFATO(EVOTAZ); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1025, 20150715
2487163	2016C/066	Belgium		PRODUCT NAME: COBICISTAT ET ATAZANAVIR; AUTHORISATION NUMBER AND DATE: EU/1/15/1025 20150715
1564210	C01564210/01	Switzerland		CHANGE OF ADDRESS OF THE OWNER: JAPAN TOBACCO INC., 1-1, TORANOMON 4-CHOME, MINATO-KU, TOKYO 105-6927, JP
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

Market Dynamics and Financial Trajectory for GENVOYA

Last updated: July 27, 2025

Introduction

GENVOYA (elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide) represents a pivotal antiretroviral therapy (ART) for treating HIV-1 infections. Launched by Gilead Sciences, Inc., it capitalizes on the evolving landscape of HIV management, increasingly emphasizing simplified regimens, improved safety profiles, and once-daily dosing. This report examines the market dynamics shaping GENVOYA's trajectory and analyzes the financial considerations for stakeholders invested in its commercial performance.

Market Landscape and Competitive Environment

HIV Treatment Market Profile

The global HIV treatment market is mature yet expanding, driven by increasing diagnosis rates and advancements in antiviral agents. The UNAIDS 2021 report estimates approximately 37.7 million people globally living with HIV, with an annual initiation of millions on ART annually (UNAIDS, 2021). The market predominantly relies on combination therapies designed to optimize adherence, efficacy, and tolerability—all features embedded within GENVOYA.

Competitive Positioning

GENVOYA competes primarily with other integrase strand transfer inhibitor (INSTI)-based regimens such as Gilead’s Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide), and non-INSTI options like Dolutegravir-based treatments and fixed-dose combinations from various generic manufacturers.

Strengths:

• Once-daily administration enhances adherence.
• Favorable safety profile, particularly with reduced renal and bone toxicity due to tenofovir alafenamide formulation.
• Simplified regimen combining four agents into a single pill.

Weaknesses:

• Patent protections delaying generic competition.
• Market shifts favoring integrase inhibitors with better tolerability or lower costs.

Patent and Regulatory Dynamics

Gilead secured patents till late 2020s and early 2030s, effectively delaying generic entry (U.S. Patent No. 8,820,899). However, patent litigations, challenges, and biosimilar developments may influence future pricing and market share. Regulatory approvals across different geographies continue to expand, facilitating access in emerging markets, although pricing and reimbursement policies vary.

Market Dynamics Influencing GENVOYA

Increasing Prevalence and Treatment Adoption

Rising HIV prevalence, especially in regions like Sub-Saharan Africa, Latin America, and parts of Asia, fuels demand. Policy shifts toward earlier diagnosis and immediate treatment initiation drive increased prescription of fixed-dose combinations like GENVOYA. The US CDC reports that over 1.2 million Americans are living with HIV, with approximately 80% on ART (CDC, 2022).

Treatment Guidelines and Clinical Evidence

Major guidelines—such as those from the US Department of Health and Human Services and the WHO—recommend INSTI-based regimens, including GENVOYA, as first-line treatments due to superior efficacy and tolerability. Clinical trials demonstrate robust viral suppression rates (>95%) over prolonged periods, bolstering market confidence.

Pricing Strategies and Reimbursement Policies

Gilead’s premium pricing, justified by clinical benefits and brand recognition, sustains healthy revenue streams. Insurance reimbursements and national health schemes influence uptake, with high-income countries embracing newer regimens faster than resource-limited settings. Differential pricing strategies and voluntary licensing facilitate access in select emerging markets.

Competitive Pressures and Market Share Erosion

Introduction of next-generation drugs, such as bictegravir-based regimens and generic options post-patent expiry, pose threats. The market is also impacted by patent cliffs, drug shortages, and manufacturing bottlenecks, which could affect availability and pricing.

Financial Trajectory Analysis

Revenue Performance and Growth Drivers

Gilead’s HIV franchise, including GENVOYA, consistently contributes substantially to its total revenue. For Q2 2022, Gilead reported HIV revenue of approximately $2.07 billion—a 9% increase year-over-year, driven by increased demand for existing therapies and expansion into new markets. The contribution from GENVOYA remains significant, possibly accounting for around 40-50% of Gilead’s HIV sales.

Factors influencing revenue trajectory include:

• Market penetration: Increased adoption in new geographical regions.
• Pricing dynamics: Steady or increasing prices in developed markets.
• Patent protection: Ensuring premium pricing until patent expiration.
• Pipeline developments: Introducing emergent therapies or formulations.

Impact of Patent Expiry and Biosimilar Competition

Patent expiration, anticipated in the early 2030s (predominantly in the U.S.), could precipitate generics’ entry. Historically, generic versions reduce prices by 70-90%, sharply impacting revenue. Gilead’s strategic investments in pipeline drugs and formulation improvements aim to mitigate this impact by extending exclusivity and maintaining market share.

Cost Dynamics and Margins

Manufacturing efficiencies, procurement negotiations, and economies of scale have enabled Gilead to optimize margins. The fixed-dose nature reduces distribution complexity, enhancing supply chain efficiency. However, increased R&D expenditures and costs associated with patent litigations exert upward pressure on operational expenses.

Future Growth Projections

Analysts project steady growth in the HIV therapeutics segment, including GENVOYA, driven by:

• Expanding markets in low- and middle-income countries.
• Ongoing clinical trials supporting label expansions or improved formulations.
• Patient-centric approaches emphasizing ease of use and safety.

Foresight suggests revenues could plateau as patent expiry approaches unless Gilead innovates or diversifies within the HIV space.

Market Challenges and Opportunities

Challenges:

• Patent Challenges and Biosimilar Competition: Inevitable patent expirations invite generic competition, risking revenue erosion.
• Pricing and Reimbursement Pressures: Healthcare payers demand value-based pricing, squeezing profit margins.
• Regulatory and Political Factors: Drug pricing policies and import restrictions may influence market access.

Opportunities:

• Emerging Markets Penetration: Growing HIV burdens and supportive policies in developing nations open new avenues.
• Product Line Expansion: Development of long-acting injectables targeting adherence challenges.
• Combination Therapies: Innovation in multi-class regimens for tailored treatments.

Conclusion

GENVOYA operates within a dynamic, highly competitive HIV treatment landscape characterized by technological advancements, patent landscapes, and shifting market access paradigms. Its current financial trajectory is robust, bolstered by clinical efficacy, brand strength, and strategic market positioning. However, impending patent cliffs and emergent biosimilar options necessitate proactive innovation and diversified offerings to sustain long-term profitability.

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Key Takeaways

• Gilead’s GENVOYA remains a cornerstone in HIV treatment, driving substantial revenue through high efficacy and patient adherence benefits.
• Patent protections secure near-term market exclusivity, but biosimilars and generics threaten future revenue streams post-expiry.
• Market dynamics favor continued growth in developing regions, aided by policy shifts and increased diagnosis.
• Financial performance relies heavily on strategic pricing, market expansion, and pipeline innovation.
• Stakeholders must proactively address competitive threats and regulatory developments to optimize returns.

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FAQs

1. When is GENVOYA’s patent set to expire, and what does this imply for its market exclusivity?
Patent protection is expected to last until the early 2030s, after which generic versions may enter the market, significantly impacting Gilead’s revenue from GENVOYA.

2. How does GENVOYA compare to its main competitors like Biktarvy?
GENVOYA offers a once-daily, four-in-one fixed-dose combination with a strong safety profile, similar to Biktarvy. Competitive advantages hinge on formulation, price, and regional availability. Biktarvy, however, has gained market share due to later market entry and perceived tolerability.

3. What role do emerging markets play in GENVOYA’s growth strategy?
Emerging markets represent significant growth opportunities due to rising HIV prevalence and expanding healthcare infrastructure. Gilead’s licensing agreements and pricing strategies facilitate access, potentially offsetting mature market revenue declines.

4. How are recent regulatory and political trends affecting Gilead’s HIV portfolio?
Policy shifts toward value-based pricing and universal access initiatives could pressure margins. Conversely, increased global focus on HIV elimination goals supports demand and market presence.

5. What innovative developments could influence GENVOYA’s future market position?
Long-acting injectables, fixed-dose combination advances, and personalized medicine approaches are promising avenues. Gilead’s pipeline forward-looking drugs could extend product life cycles and reinforce market leadership.

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Sources
[1] UNAIDS. (2021). Global HIV/AIDS statistics.
[2] CDC. (2022). HIV Surveillance Report.
[3] Gilead Sciences Inc. Annual Reports and Patent Publications.
[4] World Health Organization. Guidelines for HIV Treatment.