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Last Updated: July 10, 2025

GENVOYA Drug Patent Profile


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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

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Summary for GENVOYA
Drug patent expirations by year for GENVOYA
Drug Prices for GENVOYA

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for GENVOYA
Generic Entry Date for GENVOYA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
St. Michael's Hospital, TorontoPhase 2
CIHR Canadian HIV Trials NetworkPhase 2
Unity Health TorontoPhase 2

See all GENVOYA clinical trials

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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of GENVOYA is ⤷  Try for Free.

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 ⤷  Try for Free Y ⤷  Try for Free
Gilead Sciences Inc GENVOYA cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 207561-001 Nov 5, 2015 RX Yes Yes 7,635,704*PED ⤷  Try for Free Y ⤷  Try for Free
Gilead Sciences Inc GENVOYA cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 207561-001 Nov 5, 2015 RX Yes Yes 9,891,239*PED ⤷  Try for Free Y ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for GENVOYA

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)

Patent: 89
Patent: The use of solid carrier particles to improve the processability of a pharmaceutical agent
Estimated Expiration: ⤷  Try for Free

Patent: 50
Patent: Tablets for combination therapy
Estimated Expiration: ⤷  Try for Free

Argentina

Patent: 5369
Patent: COMPRIMIDOS PARA TERAPIA DE COMBINACION PARA EL TRATAMIENTO DE INFECCIONES VIRALES.
Estimated Expiration: ⤷  Try for Free

Australia

Patent: 09242451
Patent: The use of solid carrier particles to improve the processability of a pharmaceutical agent
Estimated Expiration: ⤷  Try for Free

Patent: 10210598
Patent: Tablets for combination therapy
Estimated Expiration: ⤷  Try for Free

Patent: 14221210
Estimated Expiration: ⤷  Try for Free

Patent: 15200637
Patent: TABLETS FOR COMBINATION THERAPY
Estimated Expiration: ⤷  Try for Free

Patent: 16250470
Patent: THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT
Estimated Expiration: ⤷  Try for Free

Patent: 17201473
Patent: Tablets for combination therapy
Estimated Expiration: ⤷  Try for Free

Patent: 18267573
Patent: Tablets for combination therapy
Estimated Expiration: ⤷  Try for Free

Brazil

Patent: 0911871
Patent: uso de partículas veículo sólidas para melhorar a processabilidade de um agente farmacêutico
Estimated Expiration: ⤷  Try for Free

Patent: 1008664
Patent: comprimidos para a terapia de combinação
Estimated Expiration: ⤷  Try for Free

Canada

Patent: 20856
Patent: UTILISATION DE PARTICULES SUPPORTS SOLIDES POUR AMELIORER L'APTITUDE AU TRAITEMENT D'UN AGENT PHARMACEUTIQUE (THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT)
Estimated Expiration: ⤷  Try for Free

Patent: 50521
Patent: PASTILLES DESTINEES A UNE THERAPIE COMBINEE (TABLETS FOR COMBINATION THERAPY)
Estimated Expiration: ⤷  Try for Free

Chile

Patent: 11001885
Patent: Tableta bicapa oral en donde la primera capa comprende al compuesto de formula i (elvitegravir) y al compuesto de formula ii, y la segunda capa comprende al compuesto de formula iii (emtricitabina) y a la sal de formula iv (sal de tenofovir); metodo para la preparacion, util en el tratar infecciones por vih.
Estimated Expiration: ⤷  Try for Free

China

Patent: 2123700
Patent: The use of solid carrier particles to improve the processability of a pharmaceutical agent
Estimated Expiration: ⤷  Try for Free

Patent: 2307573
Patent: Tablets for combination therapy
Estimated Expiration: ⤷  Try for Free

Patent: 3479584
Patent: Use of solid carrier particles to improve the processability of pharmaceutical agent
Estimated Expiration: ⤷  Try for Free

Patent: 4940937
Patent: The use of solid carrier particles to improve the processability of a pharmaceutical agent
Estimated Expiration: ⤷  Try for Free

Colombia

Patent: 21225
Patent: PARTICULAS PORTADORAS SÓLIDAS PARA MEJORAR LA PROCESABILIDAD DE UN AGENTE FARMACÉUTICO
Estimated Expiration: ⤷  Try for Free

Patent: 00187
Patent: TABLETAS PARA TERAPIA DE COMBINACIÓN
Estimated Expiration: ⤷  Try for Free

Croatia

Patent: 0151009
Estimated Expiration: ⤷  Try for Free

Patent: 0151357
Estimated Expiration: ⤷  Try for Free

Cyprus

Patent: 16852
Estimated Expiration: ⤷  Try for Free

Patent: 17067
Estimated Expiration: ⤷  Try for Free

Denmark

Patent: 96633
Estimated Expiration: ⤷  Try for Free

Patent: 93485
Estimated Expiration: ⤷  Try for Free

Ecuador

Patent: 10010636
Patent: EL USO DE PARTÍCULAS TRANSPORTADORAS SÓLIDAS PARA MEJORAR LA PROCESABILIDAD DE UN AGENTE FARMACÉUTICO
Estimated Expiration: ⤷  Try for Free

Patent: 11011307
Patent: COMPRIMIDOS PARA TERAPIA DE COMBINACION
Estimated Expiration: ⤷  Try for Free

Eurasian Patent Organization

Patent: 1313
Patent: ТАБЛЕТКИ ДЛЯ КОМБИНИРОВАННОЙ ТЕРАПИИ (TABLETS FOR COMBINATION THERAPY)
Estimated Expiration: ⤷  Try for Free

Patent: 2950
Patent: ПРИМЕНЕНИЕ ЧАСТИЦ НОСИТЕЛЯ ДИОКСИДА КРЕМНИЯ ДЛЯ УЛУЧШЕНИЯ ТЕХНОЛОГИЧЕСКИХ ХАРАКТЕРИСТИК ФАРМАЦЕВТИЧЕСКОГО АГЕНТА (USE OF SILICON DIOXIDE CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT)
Estimated Expiration: ⤷  Try for Free

Patent: 0123
Patent: ТАБЛЕТКА ДЛЯ ЛЕЧЕНИЯ ВИЧ И СПОСОБ ЛЕЧЕНИЯ ВИЧ С ЕЕ ПРИМЕНЕНИЕМ (TABLET FOR TREATING HIV AND METHOD OF TREATING HIV USING SAME)
Estimated Expiration: ⤷  Try for Free

Patent: 1071173
Patent: ПРИМЕНЕНИЕ ЧАСТИЦ ТВЁРДОГО НОСИТЕЛЯ ДЛЯ УЛУЧШЕНИЯ ТЕХНОЛОГИЧЕСКИХ ХАРАКТЕРИСТИК ФАРМАЦЕВТИЧЕСКОГО АГЕНТА
Estimated Expiration: ⤷  Try for Free

Patent: 1190125
Patent: ТАБЛЕТКИ ДЛЯ КОМБИНИРОВАННОЙ ТЕРАПИИ
Estimated Expiration: ⤷  Try for Free

Patent: 1491658
Patent: ТАБЛЕТКИ ДЛЯ КОМБИНИРОВАННОЙ ТЕРАПИИ
Estimated Expiration: ⤷  Try for Free

Patent: 1591353
Patent: ПРИМЕНЕНИЕ ЧАСТИЦ ТВЕРДОГО НОСИТЕЛЯ ДЛЯ УЛУЧШЕНИЯ ТЕХНОЛОГИЧЕСКИХ ХАРАКТЕРИСТИК ФАРМАЦЕВТИЧЕСКОГО АГЕНТА
Estimated Expiration: ⤷  Try for Free

European Patent Office

Patent: 96633
Patent: UTILISATION DE VEHICULES PARTICULAIRES SOLIDES POUR FACILITER LA FORMULATION D'UN AGENT PHARMACEUTIQUE. (THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT)
Estimated Expiration: ⤷  Try for Free

Patent: 93485
Patent: COMPRIMÉ BICOUCHE CONTENANT DE L'ELVITEGRAVIR, DU COBICISTAT, DE L'EMTRICITABINE ET DU TENOFOVIR (BILAYER TABLETS COMPRISING ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR)
Estimated Expiration: ⤷  Try for Free

Patent: 06032
Patent: UTILISATION DE PARTICULES SUPPORTS SOLIDES POUR AMÉLIORER L'APTITUDE AU TRAITEMENT D'UN AGENT PHARMACEUTIQUE (THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT)
Estimated Expiration: ⤷  Try for Free

Hong Kong

Patent: 53670
Patent: 利用固體載體顆粒來改進藥劑加工性 (THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT)
Estimated Expiration: ⤷  Try for Free

Patent: 64737
Patent: 包括埃替拉韋, ,恩曲他濱和替諾福韋的雙層片劑 (BILAYER TABLETS COMPRISING ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR COBICISTAT)
Estimated Expiration: ⤷  Try for Free

Patent: 15679
Patent: 固體載體顆粒在改善藥物製劑加工性中的應用 (THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT)
Estimated Expiration: ⤷  Try for Free

Hungary

Patent: 25822
Estimated Expiration: ⤷  Try for Free

Patent: 26380
Estimated Expiration: ⤷  Try for Free

Israel

Patent: 8614
Patent: שימוש בחלקיקי נשא מוצק לשיפור היכולת לעיבוד חומר רוקחי (Use of solid carrier particles to improve the processability of a pharmaceutical agent)
Estimated Expiration: ⤷  Try for Free

Patent: 4227
Patent: טבליות עבור טיפול משולב (Tablets for combination therapy)
Estimated Expiration: ⤷  Try for Free

Japan

Patent: 11242
Estimated Expiration: ⤷  Try for Free

Patent: 22213
Estimated Expiration: ⤷  Try for Free

Patent: 11927
Estimated Expiration: ⤷  Try for Free

Patent: 25171
Estimated Expiration: ⤷  Try for Free

Patent: 11522790
Estimated Expiration: ⤷  Try for Free

Patent: 12517432
Estimated Expiration: ⤷  Try for Free

Patent: 14012741
Patent: USE OF SOLID CARRIER PARTICLE TO IMPROVE PROCESSABILITY OF PHARMACEUTICAL AGENT
Estimated Expiration: ⤷  Try for Free

Patent: 14221845
Patent: 併用治療のための錠剤 (TABLETS FOR COMBINATION THERAPY)
Estimated Expiration: ⤷  Try for Free

Mexico

Patent: 2377
Patent: USO DE PARTICULAS TRASPORTADORAS SOLIDAS PARA MEJORAR LA CAPACIDAD DE PROCESAMIENTO DE UN AGENTE FARMACEUTICO. (THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT.)
Estimated Expiration: ⤷  Try for Free

Patent: 10011963
Patent: USO DE PARTICULAS TRASPORTADORAS SOLIDAS PARA MEJORAR LA CAPACIDAD DE PROCESAMIENTO DE UN AGENTE FARMACEUTICO. (THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT.)
Estimated Expiration: ⤷  Try for Free

Patent: 11008289
Patent: TABLETAS PARA TERAPIA COMBINADA. (TABLETS FOR COMBINATION THERAPY.)
Estimated Expiration: ⤷  Try for Free

New Zealand

Patent: 8978
Patent: THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT
Estimated Expiration: ⤷  Try for Free

Patent: 4214
Patent: TABLETS COMPRISING COBICISTAT, ELVITEGRAVIR, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE FOR COMBINATION THERAPY
Estimated Expiration: ⤷  Try for Free

Peru

Patent: 110994
Patent: COMPRIMIDOS ANTIVIRALES QUE COMPRENDEN ELVITEGRAVIR, EMTRICITABINA, DISOPROXIL FUMARATO DE TENOFOVIR Y UN DERIVADO DE TIAZOL
Estimated Expiration: ⤷  Try for Free

Poland

Patent: 96633
Estimated Expiration: ⤷  Try for Free

Patent: 93485
Estimated Expiration: ⤷  Try for Free

Portugal

Patent: 96633
Estimated Expiration: ⤷  Try for Free

Patent: 93485
Estimated Expiration: ⤷  Try for Free

San Marino

Patent: 01500266
Patent: COMPRESSE A DOPPIO STRATO COMPRENDENTI ELVITEGRAVIR, COBICISTAT, EMTRICITABINA E TENOFOVIR
Estimated Expiration: ⤷  Try for Free

Singapore

Patent: 3544
Patent: TABLETS FOR COMBINATION THERAPY
Estimated Expiration: ⤷  Try for Free

Patent: 0618
Patent: THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT
Estimated Expiration: ⤷  Try for Free

Patent: 14007744
Patent: TABLETS FOR COMBINATION THERAPY
Estimated Expiration: ⤷  Try for Free

Patent: 201609006W
Patent: THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT
Estimated Expiration: ⤷  Try for Free

Patent: 201706215U
Patent: Tablets for combination therapy
Estimated Expiration: ⤷  Try for Free

Slovenia

Patent: 96633
Estimated Expiration: ⤷  Try for Free

Patent: 93485
Estimated Expiration: ⤷  Try for Free

South Africa

Patent: 1008007
Patent: THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT
Estimated Expiration: ⤷  Try for Free

South Korea

Patent: 1645759
Estimated Expiration: ⤷  Try for Free

Patent: 1659971
Estimated Expiration: ⤷  Try for Free

Patent: 1738325
Estimated Expiration: ⤷  Try for Free

Patent: 1784647
Estimated Expiration: ⤷  Try for Free

Patent: 110015581
Patent: THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT
Estimated Expiration: ⤷  Try for Free

Patent: 110122729
Patent: TABLETS FOR COMBINATION THERAPY
Estimated Expiration: ⤷  Try for Free

Patent: 160093100
Patent: 조합 요법용 정제 (TABLETS FOR COMBINATION THERAPY)
Estimated Expiration: ⤷  Try for Free

Patent: 160114728
Patent: 제약 제제의 가공성 향상을 위한 고체 담체 입자의 용도 (THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT)
Estimated Expiration: ⤷  Try for Free

Spain

Patent: 48886
Estimated Expiration: ⤷  Try for Free

Patent: 53897
Estimated Expiration: ⤷  Try for Free

Taiwan

Patent: 44367
Estimated Expiration: ⤷  Try for Free

Patent: 1040142
Patent: Tablets for combination therapy
Estimated Expiration: ⤷  Try for Free

Ukraine

Patent: 1193
Patent: ПРИМЕНЕНИЕ ЧАСТИЧЕК ТВЕРДОГО НОСИТЕЛЯ ДЛЯ УЛУЧШЕНИЯ ТЕХНОЛОГИЧЕСКИХ ХАРАКТЕРИСТИК ФАРМАЦЕВТИЧЕСКОГО АГЕНТА;ЗАСТОСУВАННЯ ЧАСТИНОК ТВЕРДОГО НОСІЯ ДЛЯ ПОЛІПШЕННЯ ТЕХНОЛОГІЧНИХ ХАРАКТЕРИСТИК ФАРМАЦЕВТИЧНОГО АГЕНТА (THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT)
Estimated Expiration: ⤷  Try for Free

Patent: 3224
Patent: ТАБЛЕТКИ ДЛЯ КОМБИНИРОВАННОЙ ТЕРАПИИ;ТАБЛЕТКИ ДЛЯ КОМБІНОВАНОЇ ТЕРАПІЇ (Normal;heading 1;heading 2;heading 3;TABLETS FOR COMBINATION THERAPY)
Estimated Expiration: ⤷  Try for Free

Uruguay

Patent: 424
Patent: COMPRIMIDOS CONTENIENDO ELIVITEGRAVIR PARA TRATAMIENTO DE INFECCIONES VIRALES
Estimated Expiration: ⤷  Try for Free

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 ⤷  Try for Free
Spain 2329240 ⤷  Try for Free
Germany 513200 ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for GENVOYA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1564210 122013000088 Germany ⤷  Try for Free PRODUCT NAME: ELVITEGRAVIR ODER EIN HYDRAT, SOLVAT, TAUTOMER ODER PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/830 20130524
2487166 300860 Netherlands ⤷  Try for Free 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 ⤷  Try for Free PRODUCT NAME: TENOFOVIRALAFENAMID; REGISTRATION NO/DATE: SWISSMEDIC AUTHORISATION 65793 01.09.2016
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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.

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