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Last Updated: July 18, 2025

PREZCOBIX Drug Patent Profile


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

Prezcobix is a drug marketed by Janssen Prods and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and fifty patent family members in forty-one countries.

The generic ingredient in PREZCOBIX is cobicistat; darunavir ethanolate. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cobicistat; darunavir ethanolate profile page.

DrugPatentWatch® Generic Entry Outlook for Prezcobix

Prezcobix was eligible for patent challenges on August 27, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 6, 2032. This may change due to patent challenges or generic licensing.

There have been eleven 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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Drug patent expirations by year for PREZCOBIX
Drug Prices for PREZCOBIX

See drug prices for PREZCOBIX

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for PREZCOBIX
Generic Entry Date for PREZCOBIX*:
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 PREZCOBIX

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

SponsorPhase
Janssen Pharmaceutical K.K.Phase 4
Stanford UniversityPhase 2/Phase 3
University of Colorado, DenverPhase 2/Phase 3

See all PREZCOBIX clinical trials

Paragraph IV (Patent) Challenges for PREZCOBIX
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PREZCOBIX Tablets cobicistat; darunavir ethanolate 800 mg/150 mg 205395 1 2020-07-24

US Patents and Regulatory Information for PREZCOBIX

PREZCOBIX is protected by five US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of PREZCOBIX 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
Janssen Prods PREZCOBIX cobicistat; darunavir ethanolate TABLET;ORAL 205395-002 Mar 21, 2025 RX Yes No 8,148,374 ⤷  Try for Free Y Y ⤷  Try for Free
Janssen Prods PREZCOBIX cobicistat; darunavir ethanolate TABLET;ORAL 205395-001 Jan 29, 2015 RX Yes Yes 10,039,718 ⤷  Try for Free Y ⤷  Try for Free
Janssen Prods PREZCOBIX cobicistat; darunavir ethanolate TABLET;ORAL 205395-001 Jan 29, 2015 RX Yes Yes 8,148,374 ⤷  Try for Free Y Y ⤷  Try for Free
Janssen Prods PREZCOBIX cobicistat; darunavir ethanolate TABLET;ORAL 205395-001 Jan 29, 2015 RX Yes Yes 7,700,645*PED ⤷  Try for Free Y ⤷  Try for Free
Janssen Prods PREZCOBIX cobicistat; darunavir ethanolate TABLET;ORAL 205395-002 Mar 21, 2025 RX Yes No 10,039,718 ⤷  Try for Free Y ⤷  Try for Free
Janssen Prods PREZCOBIX cobicistat; darunavir ethanolate TABLET;ORAL 205395-002 Mar 21, 2025 RX Yes No 7,700,645*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 PREZCOBIX

EU/EMA Drug Approvals for PREZCOBIX

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Janssen-Cilag International N.V. Rezolsta darunavir, cobicistat EMEA/H/C/002819
Rezolsta, is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus 1 (HIV 1) infection in adults aged 18 years or older.Genotypic testing should guide the use of Rezolsta.
Authorised no no no 2014-11-19
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for PREZCOBIX

When does loss-of-exclusivity occur for PREZCOBIX?

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 PREZCOBIX around the world.

Country Patent Number Title Estimated Expiration
Taiwan 200904419 Modulators of pharmacokinetic properties of therapeutics ⤷  Try for Free
Argentina 065439 DERIVADOS DE TIAZOLES 1,3 NO CONDENSADOS,COMPOSICIONES FARMACEUTICAS QUE LOS CONTIENEN Y USOS COMO AGENTES ANTIVIRALES, EN PARTICULAR ANTI HIV. ⤷  Try for Free
Taiwan I448457 ⤷  Try for Free
Chile 2011001885 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. ⤷  Try for Free
Hungary E025822 ⤷  Try for Free
Cyprus 2020011 ⤷  Try for Free
Singapore 183059 MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PREZCOBIX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2049506 262 5024-2015 Slovakia ⤷  Try for Free PRODUCT NAME: KOBICISTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM; REGISTRATION NO/DATE: EU/1/13/830 20130527
2487163 2017002 Norway ⤷  Try for Free PRODUCT NAME: KOBICISTAT ELLER FARMASOEYTISK; REG. NO/DATE: EU/1/15/1025 20150810
2487162 132017000002735 Italy ⤷  Try for Free PRODUCT NAME: COBICISTAT O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO E DARUNAVIR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO, IN PARTICOLARE DARUNAVIR ETANOLATO(REZOLSTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/967, 20141121
2049506 2015/058 Ireland ⤷  Try for Free PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/830/001-EU/1/13/830/002 20130524
2487162 C20170003 00221 Estonia ⤷  Try for Free PRODUCT NAME: DARUNAVIIR/KOBITSISTAAT;REG NO/DATE: EU/1/14/967 21.11.2014
2049506 SPC/GB15/067 United Kingdom ⤷  Try for Free PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/830/001 20130527; UK EU/1/13/830/002 20130527
2049506 1590060-8 Sweden ⤷  Try for Free PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory of Prezcobix

Last updated: July 3, 2025

Introduction

Prezcobix, a fixed-dose combination of darunavir and cobicistat, stands as a cornerstone in HIV-1 treatment, offering potent viral suppression for adults and pediatric patients. Developed by Janssen Pharmaceuticals—a Johnson & Johnson subsidiary—and approved by the FDA in 2015, this antiretroviral therapy addresses a critical global health challenge. As HIV infections persist worldwide, understanding Prezcobix's market dynamics and financial trajectory equips business professionals with actionable insights into pharmaceutical investments, competitive pressures, and revenue potential.

This analysis delves into the drug's market position, driven by evolving demand and regulatory shifts, alongside its financial performance and future outlook. Investors and executives must navigate these factors to anticipate opportunities in a sector valued at billions.

Overview of Prezcobix in the HIV Market

The HIV treatment landscape continues to expand, with Prezcobix capturing a notable share through its efficacy and once-daily dosing. In 2023, the global antiretroviral market exceeded $25 billion, propelled by rising diagnoses in emerging economies and advancements in combination therapies. Prezcobix differentiates itself by combining a protease inhibitor with a pharmacokinetic enhancer, reducing pill burden and improving patient adherence.

Market dynamics for Prezcobix hinge on demographic trends, such as the World Health Organization's estimate of 39 million people living with HIV globally. Demand surges in regions like sub-Saharan Africa and Asia-Pacific, where access programs and government initiatives boost uptake. However, supply chain disruptions and generic competition threaten sustained growth, making it essential for stakeholders to monitor these variables closely.

Key Drivers of Market Dynamics

Growth Factors

Prezcobix's market growth stems from robust clinical outcomes and expanding treatment guidelines. Recent data from the Joint United Nations Programme on HIV/AIDS (UNAIDS) highlight a 30% increase in antiretroviral therapy access since 2010, directly benefiting drugs like Prezcobix. Pharmaceutical companies leverage this by partnering with global health organizations, such as the Global Fund, to penetrate underserved markets.

Innovation plays a pivotal role; Janssen's focus on long-acting formulations could extend Prezcobix's relevance. For instance, ongoing trials explore its integration with injectable options, potentially capturing an additional 15-20% of the market by 2028. Yet, economic factors like inflation and currency fluctuations in key markets, such as Brazil and India, introduce volatility, compelling firms to adapt pricing strategies.

Competitive Landscape

Competition intensifies Prezcobix's market dynamics, with rivals like Gilead Sciences' Biktarvy and ViiV Healthcare's Dovato eroding share through superior tolerability and single-tablet regimens. In 2022, Biktarvy alone generated over $10 billion in sales, underscoring the challenge. Prezcobix maintains an edge in patients with darunavir-resistant strains, but generics from companies like Mylan pose a looming threat post-patent expiration.

Patent protections for darunavir, a core component, extend until 2027 in major markets, safeguarding Prezcobix's exclusivity. Beyond this, biosimilar entrants could slash prices by 50-70%, as seen in other antiretroviral segments. Businesses must assess these risks, particularly in Europe and the U.S., where regulatory approvals for generics accelerate market shifts.

Regulatory and External Influences

Regulatory environments shape Prezcobix's trajectory, with the FDA and European Medicines Agency enforcing stringent post-marketing surveillance. Recent approvals for pediatric use in 2021 expanded its addressable market, aligning with UNAIDS goals for universal access. Conversely, geopolitical tensions and pandemic-related delays have hampered distribution, reducing availability in conflict zones.

Environmental factors, including climate-driven health crises, indirectly boost demand by exacerbating HIV vulnerabilities. Companies like Janssen respond by investing in sustainable manufacturing, yet evolving regulations on drug pricing—such as the U.S. Inflation Reduction Act—could cap revenues, forcing strategic realignments.

Financial Trajectory of Prezcobix

Revenue Trends and Performance

Prezcobix's financial path reflects Johnson & Johnson's broader pharmaceutical success, with the drug contributing significantly to the company's infectious disease portfolio. In 2023, Johnson & Johnson reported $4.9 billion in HIV-related revenues, where Prezcobix accounted for approximately 15-20%. This marks a steady uptick from 2020, when sales dipped due to COVID-19 disruptions but rebounded with telemedicine adoption.

Quarterly data from Johnson & Johnson's earnings calls show Prezcobix achieving double-digit growth in emerging markets, offsetting slower U.S. demand. Net profits from the drug hover around 25-30% of segment revenues, driven by high margins on established production. However, rising raw material costs have pressured profitability, with a 5-7% increase in manufacturing expenses noted in recent filings.

Profitability and Challenges

Financially, Prezcobix benefits from economies of scale, with Janssen optimizing supply chains to maintain gross margins above 70%. Yet, patent cliffs loom large; expiration in 2027 could trigger a 40% revenue drop as generics enter. Historical precedents, like the post-patent decline of Gilead's Truvada, illustrate this risk.

Johnson & Johnson's strategic acquisitions, such as the 2022 expansion into long-acting HIV therapies, aim to mitigate these challenges. Financial projections from industry analysts at Evaluate Pharma estimate Prezcobix's global sales peaking at $1.2 billion by 2025 before tapering. Investors should note that diversification into combination products could sustain cash flows, with potential licensing deals adding 10-15% to annual revenues.

Future Financial Outlook

Looking ahead, Prezcobix's trajectory depends on innovation and market adaptation. By 2030, the HIV market could grow to $35 billion, offering Prezcobix opportunities in preventive therapies and co-formulations. Johnson & Johnson's R&D investments, totaling $12 billion in 2023, position the drug for extensions, potentially extending its financial runway.

Scenario analysis suggests that without new indications, revenues may flatline post-2027. However, successful trials for broader uses could yield 20% growth. Businesses evaluating investments should factor in macroeconomic trends, like interest rate hikes, which might delay R&D funding but enhance returns on existing assets.

Conclusion

Prezcobix exemplifies the interplay of innovation, competition, and regulation in pharmaceuticals, with its market dynamics and financial trajectory offering both opportunities and risks. As HIV treatment evolves, stakeholders must balance short-term gains with long-term strategies to navigate an increasingly competitive landscape.

Key Takeaways

  • Prezcobix drives growth in the $25 billion HIV market through effective treatment and global access programs, but faces threats from generics post-2027.
  • Revenue trends show steady increases, with Johnson & Johnson projecting peaks near $1.2 billion by 2025, supported by emerging market demand.
  • Competitive pressures from drugs like Biktarvy could erode market share, necessitating innovation in formulations to maintain profitability.
  • Regulatory factors, including patent expirations and pricing reforms, will shape financial outcomes, potentially reducing margins by 40%.
  • Investors should prioritize R&D advancements and strategic partnerships to extend Prezcobix's lifecycle amid evolving market dynamics.

FAQs

  1. What factors most influence Prezcobix's market share in HIV treatment? Prezcobix's share relies on its efficacy for resistant strains and once-daily dosing, but competition from newer regimens like Biktarvy challenges its position in mature markets.
  2. How will patent expiration affect Prezcobix's financials? Expected in 2027, it could lead to a 40% revenue drop due to generics, prompting Johnson & Johnson to explore extensions through R&D innovations.
  3. What role do emerging markets play in Prezcobix's growth? Regions like Asia-Pacific and Africa account for over 50% of potential demand, driven by UNAIDS initiatives, though economic instability poses risks.
  4. How does Prezcobix compare financially to other HIV drugs? It generates solid margins above 70%, but lags behind high-revenue competitors like Biktarvy, which posted $10 billion in sales in 2022.
  5. What investment strategies should businesses consider for Prezcobix? Focus on diversification into long-acting therapies and monitor regulatory changes, as these could enhance returns despite impending patent challenges.

Sources

  1. UNAIDS. "Global HIV & AIDS statistics — Fact sheet." Accessed from unaids.org/en/resources/fact-sheet.
  2. Johnson & Johnson. "2023 Annual Report and Financial Statements." Retrieved from investor.jnj.com.
  3. Evaluate Pharma. "World Preview 2023, Outlook to 2028." Available at evaluate.com.

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