PREZCOBIX Drug Patent Profile

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

Summary for PREZCOBIX

International Patents:	350
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	4
Patent Applications:	1
Drug Prices:	Drug price information for PREZCOBIX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PREZCOBIX
What excipients (inactive ingredients) are in PREZCOBIX?	PREZCOBIX excipients list
DailyMed Link:	PREZCOBIX at DailyMed

See drug prices for PREZCOBIX

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

Constraining patent/regulatory exclusivity:

10,039,718

NDA:

205395

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

Sponsor	Phase
Janssen Pharmaceutical K.K.	Phase 4
Stanford University	Phase 2/Phase 3
University of Colorado, Denver	Phase 2/Phase 3

See all PREZCOBIX clinical trials

Pharmacology for PREZCOBIX

Drug Class	Cytochrome P450 3A Inhibitor Protease Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors HIV Protease Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors P-Glycoprotein Inhibitors

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.

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		Y	Y
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-001	Jan 29, 2015		RX	Yes	Yes	10,039,718		Y
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-001	Jan 29, 2015		RX	Yes	Yes	8,148,374		Y	Y
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-001	Jan 29, 2015		RX	Yes	Yes	7,700,645*PED				Y
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-002	Mar 21, 2025		RX	Yes	No	10,039,718		Y
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-002	Mar 21, 2025		RX	Yes	No	7,700,645*PED				Y

Expired US Patents for PREZCOBIX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-001	Jan 29, 2015	9,889,115
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-001	Jan 29, 2015	RE42889*PED
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-001	Jan 29, 2015	5,843,946*PED
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-001	Jan 29, 2015	RE43596*PED
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-001	Jan 29, 2015	8,518,987*PED
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-001	Jan 29, 2015	8,597,876*PED
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-001	Jan 29, 2015	7,470,506*PED

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

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)

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 PREZCOBIX around the world.

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

Supplementary Protection Certificates for PREZCOBIX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2049506	262 5024-2015	Slovakia		PRODUCT NAME: KOBICISTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM; REGISTRATION NO/DATE: EU/1/13/830 20130527
2487163	2017002	Norway		PRODUCT NAME: KOBICISTAT ELLER FARMASOEYTISK; REG. NO/DATE: EU/1/15/1025 20150810
2487162	132017000002735	Italy		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		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		PRODUCT NAME: DARUNAVIIR/KOBITSISTAAT;REG NO/DATE: EU/1/14/967 21.11.2014
2049506	SPC/GB15/067	United Kingdom		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		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF

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.