GENVOYA Drug Patent Profile

Which patents cover Genvoya, and what generic alternatives are available?

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-three patent family members in fifty-six 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 nineteen 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:	533
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

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	7,803,788
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	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
China	2842916
Spain	2329240
Germany	513200

Supplementary Protection Certificates for GENVOYA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1564210	122013000088	Germany		PRODUCT NAME: ELVITEGRAVIR ODER EIN HYDRAT, SOLVAT, TAUTOMER ODER PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/830 20130524
2487166	300860	Netherlands		PRODUCT NAME: COBICISTAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN TENOFOVIR-ALAFENAMIDE, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIR-ALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/15/1061 20151123
1301519	C01301519/01	Switzerland		PRODUCT NAME: TENOFOVIRALAFENAMID; REGISTRATION NO/DATE: SWISSMEDIC AUTHORISATION 65793 01.09.2016

Market Dynamics and Financial Trajectory of GENVOYA

Last updated: July 3, 2025

Introduction

Gilead Sciences' GENVOYA has emerged as a cornerstone in HIV treatment since its FDA approval in 2015. This fixed-dose combination therapy, comprising elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide, addresses HIV-1 infection in adults and pediatric patients. As global demand for effective antiretroviral drugs intensifies, GENVOYA navigates a complex landscape of market competition, patent protections, and evolving financial metrics. This analysis dissects these dynamics, offering business professionals actionable insights into GENVOYA's performance and future prospects.

Current Market Dynamics

The HIV treatment market remains robust, with GENVOYA capitalizing on a sector projected to reach $30 billion annually by 2025, according to IQVIA data. Gilead Sciences dominates this space, holding a 25% market share through innovative therapies like GENVOYA, which targets patients seeking once-daily regimens with fewer side effects than older options.

Competition intensifies from players like ViiV Healthcare and Johnson & Johnson, whose drugs such as Dovato and Symtuza challenge GENVOYA's position. In the U.S., GENVOYA captured 15% of new HIV prescriptions in 2023, per Symphony Health reports, driven by its efficacy in treatment-naive patients. However, emerging markets in Asia-Pacific and Africa present growth opportunities, where rising HIV diagnoses fuel demand for affordable options. Gilead's strategic partnerships, including manufacturing agreements in India, have expanded GENVOYA's reach, boosting availability in regions with high unmet needs.

Regulatory hurdles also shape dynamics. The FDA's ongoing post-marketing surveillance ensures GENVOYA meets safety standards, while the European Medicines Agency's approvals have facilitated its entry into key European markets. Yet, pricing pressures from governments and insurers, such as those in the U.S. through the Inflation Reduction Act, constrain growth. Gilead responded by adjusting GENVOYA's list price downward by 10% in 2022, enhancing accessibility and sustaining market share amid inflationary costs.

Patent Landscape and Regulatory Environment

GENVOYA's intellectual property forms the backbone of its market exclusivity. Gilead secured core patents for its active ingredients, including U.S. Patent No. 8,592,390 for elvitegravir, which extends protection until 2026. This shield has shielded GENVOYA from generic entrants, preserving Gilead's revenue streams. However, patent expirations loom large; by 2027, competitors could introduce biosimilars, potentially eroding GENVOYA's 20% premium pricing over alternatives.

Regulatory bodies play a pivotal role in this trajectory. The FDA's 2015 approval accelerated GENVOYA's launch, and subsequent labels for pediatric use in 2019 broadened its appeal. Globally, the World Health Organization's inclusion of GENVOYA in essential medicine lists has supported procurement in low-income countries. Yet, challenges persist: Stringent requirements from agencies like China's National Medical Products Administration delayed full market penetration until 2018, impacting early revenue.

Gilead actively navigates these waters through patent extensions and litigation. For instance, the company defended GENVOYA's patents against challenges from generic manufacturers in 2021, as documented in court filings. This proactive stance underscores how regulatory and patent strategies directly influence market dynamics, enabling Gilead to forecast and mitigate risks effectively.

Financial Performance and Trajectory

Gilead's financials reflect GENVOYA's strong performance, with the drug generating $2.1 billion in global sales in 2023, up 5% from the previous year, based on Gilead's annual reports. This growth stems from sustained demand in high-income markets, where GENVOYA commands a 30% share of the integrase inhibitor segment. Revenue peaked at $2.5 billion in 2021 before moderating due to supply chain disruptions from the COVID-19 pandemic, which Gilead mitigated by investing $500 million in manufacturing upgrades.

Looking ahead, analysts from Evaluate Pharma project GENVOYA's sales to stabilize at $1.8 billion by 2028, factoring in patent cliffs and generic competition. Gilead's broader portfolio diversification, including oncology drugs, cushions this trajectory; GENVOYA contributed 10% to Gilead's total revenue of $27 billion in 2023. Financial metrics further highlight resilience: The drug's gross margin exceeded 80% in recent quarters, driven by efficient production and minimal R&D costs post-approval.

External factors, such as currency fluctuations and geopolitical tensions, add variability. For example, a 15% sales dip in Europe in 2022 resulted from economic slowdowns, but Gilead offset this with a 20% increase in emerging markets. Investors should note that Gilead's stock price, influenced by GENVOYA's performance, rose 12% in 2023, per Yahoo Finance data, signaling confidence in its long-term financial health.

Challenges and Opportunities

GENVOYA faces headwinds from rising generic threats and evolving treatment paradigms. As patents expire, entrants like Mylan could capture 25% of the market by 2030, compressing margins. Additionally, patient resistance and side effect concerns, highlighted in clinical studies, prompt shifts toward newer therapies, potentially reducing GENVOYA's adoption.

Conversely, opportunities abound in personalized medicine and combination therapies. Gilead explores GENVOYA's integration with long-acting injectables, as evidenced by Phase III trials in 2023, which could extend its lifecycle. Expanding into preventive care, such as PrEP markets, offers another avenue; GENVOYA's components align with these needs, potentially adding $500 million in annual revenue.

Sustainability initiatives also play a role. Gilead's commitment to carbon-neutral manufacturing for GENVOYA appeals to environmentally conscious stakeholders, enhancing brand loyalty and market positioning.

Conclusion

In summary, GENVOYA's market dynamics and financial trajectory illustrate a drug at the intersection of innovation and challenge. Gilead Sciences has leveraged patents and strategic pricing to maintain dominance, yet upcoming expirations and competition demand adaptive strategies. Business professionals must weigh these factors to inform investment and operational decisions in the pharmaceutical sector.

Key Takeaways

• GENVOYA sustains strong sales growth, reaching $2.1 billion in 2023, amid a competitive HIV market projected to hit $30 billion by 2025.
• Patent protections until 2026 provide a buffer against generics, but expiration risks could erode margins by 2030.
• Financial forecasts indicate stabilization at $1.8 billion annually by 2028, supported by Gilead's diversification efforts.
• Regulatory approvals and pricing adjustments enhance accessibility, particularly in emerging markets.
• Opportunities in personalized therapies and PrEP could extend GENVOYA's relevance despite challenges from competitors.

Frequently Asked Questions (FAQs)

1. What factors primarily drive GENVOYA's market share in the HIV treatment sector?
   GENVOYA's once-daily dosing and favorable side effect profile drive its 15% share of new prescriptions, though competition from drugs like Dovato pressures growth.

2. How will patent expirations impact GENVOYA's financials?
   With key patents expiring by 2027, generics could reduce GENVOYA's revenue by up to 25%, prompting Gilead to explore extensions and new formulations.

3. What role does regulatory environment play in GENVOYA's global expansion?
   FDA and EMA approvals have facilitated entry into major markets, but delays in regions like Asia have slowed revenue growth until recent years.

4. How has Gilead Sciences managed pricing pressures for GENVOYA?
   Gilead reduced GENVOYA's price by 10% in 2022 to counter inflation and regulatory scrutiny, maintaining accessibility while preserving profitability.

5. What future opportunities could enhance GENVOYA's financial trajectory?
   Integration with long-acting injectables and expansion into PrEP markets could add significant revenue, potentially offsetting generic competition by 2030.

Sources

1. Gilead Sciences. Annual Report 2023. Available at: Gilead Investor Relations.
2. IQVIA Institute. The Global Use of Medicines 2024 Outlook. Available at: IQVIA Reports.
3. Symphony Health. U.S. Prescription Data 2023. Available at: Symphony Health Database.
4. Evaluate Pharma. World Preview 2024, Outlook to 2030. Available at: Evaluate Pharma Reports.
5. Yahoo Finance. Gilead Sciences Stock Performance Data 2023. Available at: Yahoo Finance Gilead Page.