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-three 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 fourteen 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:	353
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	4
Patent Applications:	90
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

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
Janssen Scientific Affairs, LLC	Phase 2/Phase 3
Stanford University	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.

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			Y	Y
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-001	Jan 29, 2015		RX	Yes	Yes			Y
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-001	Jan 29, 2015		RX	Yes	Yes			Y	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
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-001	Jan 29, 2015
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-001	Jan 29, 2015

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/002819Rezolsta, 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
European Patent Office	2487163
Japan	2010532755
Japan	3657002

Supplementary Protection Certificates for PREZCOBIX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2487163	93353	Luxembourg		PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI ET ATAZANAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE SULFATE D'ATAZANAVIR; AUTHORISATION NUMBER AND DATE: EU/1/15/1025
0810209	C300283	Netherlands		PRODUCT NAME: DARUNAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER, IN HET BIJZONDER DARUNAVIR ETHANOLAAT; REGISTRATION NO/DATE: EU/1/06/380/001 20070212
2487162	122016000103	Germany		PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ ODER SOLVAT DAVON UND DARUNAVIR ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/14/967 20141119

Market Dynamics and Financial Trajectory for PREZCOBIX (Darunavir); An In-Depth Analysis

Last updated: July 27, 2025

Introduction

PREZCOBIX (darunavir) is an antiretroviral medication developed by Janssen Pharmaceuticals, a Johnson & Johnson subsidiary, primarily used in the treatment of HIV-1 infection. As a protease inhibitor, PREZCOBIX plays a critical role in combination therapy regimens to suppress viral load, maintain immune function, and prevent disease progression. Understanding the evolving market dynamics and financial trajectory of PREZCOBIX involves analyzing clinical, regulatory, competitive, and market factors influencing its adoption and revenue generation.

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Market Overview

The global HIV therapeutics market has demonstrated consistent growth, driven by increasing HIV prevalence, advances in treatment protocols, and expanding access in emerging markets. The market was valued at approximately USD 22 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 4-5% through 2030, according to industry reports.[1]

Positioning of PREZCOBIX in the HIV Treatment Landscape

PREZCOBIX holds a significant position within protease inhibitors (PIs), targeted toward adult patients with HIV-1 infection. Its efficacy, resistance profile, and tolerability have made it a preferred option in certain regimens, especially in treatment-experienced patients with resistant strains. It is often combined with other agents such as ritonavir or cobicistat to enhance pharmacokinetic properties.

Competitive Landscape

Key competitors include other PIs like Kaletra (lopinavir/ritonavir), Darunavir (generic), and newer agents like integrase inhibitors (e.g., cabotegravir, dolutegravir) that are increasingly replacing PIs due to improved safety profiles and dosing convenience. Gilead Sciences’ bictegravir-based regimens and ViiV’s integrase inhibitor products now dominate many treatment algorithms, intensifying competition for market share.[2]

Market Dynamics

1. Regulatory Approvals and Label Expansion

   The U.S. Food and Drug Administration (FDA) approved PREZCOBIX for various indications, including in pediatric populations and as part of single-tablet regimens. Regulatory decisions also focus on simplifying dosing schedules and reducing pill burden, which are critical factors influencing physicians’ prescribing behavior. Ongoing label expansions enhancing indications or providing data on resistance management bolster its market position.

2. Pricing and Reimbursement Policies

   As a branded medication, PREZCOBIX's pricing strategy significantly influences its market penetration. In high-income countries, reimbursement approvals facilitate steady sales, whereas in emerging markets, pricing disparities and patent protections limit widespread access. Janssen’s strategic alliances with payers, along with patient assistance programs, aim to sustain revenue streams amid increasing generic competition.

3. Patent Expiry and Generic Competition

   Patent protection for PREZCOBIX’s core formulation is expected to extend into the late 2020s; however, generic versions of darunavir have entered markets where patent protections expire, exerting downward pressure on prices and market share. The presence of generic alternatives often shifts the revenue landscape, especially in cost-conscious healthcare systems.

4. Market Penetration and Adoption Trends

   While PIs like PREZCOBIX maintain relevance in resistant HIV cases, the global shift towards integrase inhibitor-based regimens impacts its growth prospects. Nonetheless, in specific subsets—such as patients with PI resistance or intolerance—the drug retains clinical importance.

5. Innovative Formulations and Digital Health Integration

   The development of fixed-dose combination therapies incorporating PREZCOBIX, along with long-acting injectable formulations, presents opportunities to expand patient adherence and market uptake. Digital health tools for adherence monitoring may also improve treatment outcomes, indirectly supporting the drug’s demand.

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Financial Trajectory Analysis

Historical Revenue Performance

Janssen Pharmaceuticals reported that PREZCOBIX contributed approximately USD 1.2 billion annually in global sales during the 2018-2021 period, reflecting its role as a key antiretroviral agent.[3] Fluctuations closely align with generic entry, pricing pressures, and market competition.

Revenue Drivers

• Market Penetration: Ongoing use in treatment-experienced and resistant cases supports steady demand.
• Expanding Indications: Regulatory approvals for pediatric and simplified dosing regimens extend market reach.
• Pricing Strategies: Maintaining premium pricing in developed markets sustains revenue margins despite competition.

Challenges to Financial Growth

• Patent Cliff Risks: Approaching patent expiry poses significant revenue risks due to potential generic erosion.
• Market Competition: Growing preference for integrase-based therapies, especially single-tablet regimens, diminishes the relative market share of PREZCOBIX.
• Pricing Pressures: Payer negotiations and global price control policies challenge profit margins.

Forecasting Future Revenue

Projections indicate a moderate decline in revenue over the next 3-5 years, barring significant market expansion or formulation innovation. The expected CAGR is approximately -2% to -3%, largely attributable to patent expiries and competition. However, strategic initiatives—such as combination therapies and brand loyalty—may mitigate declines.

Strategic Initiatives and Opportunities

• Formulation Innovations: Launching long-acting injectable versions could rejuvenate sales and improve patient adherence.
• Market Expansion: Greater penetration in emerging markets, enabled by tiered pricing and partnerships, offers potential growth avenues.
• Combination Developments: Incorporating PREZCOBIX into novel fixed-dose combinations aims to retain relevance.

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Regulatory and Clinical Factors Impacting Financial Trajectory

Regulatory agencies worldwide continue to approve new indications and formulations, which can positively influence product lifespan. Conversely, delays or setbacks in clinical trial results—particularly regarding resistance profiles or safety signals—may hurt confidence and sales.

Impact of Resistance and Safety Profile

The mutation resistance profile of darunavir, characterized by high genetic barrier, favors its use in multi-drug resistant HIV strains. Nevertheless, adverse events or drug interactions can limit its utility. Continuous pharmacovigilance and post-market surveillance are critical to maintaining its market position.

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Market Trends and Future Outlook

The HIV market is evolving toward simplified, tolerable, and long-acting therapies. While PREZCOBIX faces headwinds from newer agents, specialized niches—such as resistant HIV management—favor its sustained use. The drug's financial trajectory will depend heavily on pipeline success, patent strategies, and market adaptation.

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Key Takeaways

• Stable Niche Position: PREZCOBIX continues to serve a critical role in resistant HIV treatment but faces pressure from integrase inhibitor-based therapies.
• Revenue Trends: Historically robust, but expect gradual decline due to patent expiry, generic competition, and market shifts.
• Growth Strategies: Innovation in formulations, expanding indications, and entering untapped markets are vital to sustain financial performance.
• Competitive Landscape: The rise of affordable generics and newer drug classes necessitates strategic agility from Janssen.
• Regulatory & Clinical Developments: Regulatory approvals for long-acting injectables and combination formulations can significantly influence future market dynamics.

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FAQs

1. How does the patent expiration of PREZCOBIX affect its market potential?
Patent expiration allows generic manufacturers to introduce cheaper alternatives, significantly reducing sales revenues for the branded version. Janssen’s proactive strategies, including formulation innovations and brand differentiation, aim to mitigate this impact.

2. What are the main competitors to PREZCOBIX in HIV therapy?
Key competitors include other protease inhibitors such as lopinavir/ritonavir, and increasingly, integrase inhibitors like dolutegravir and bictegravir, which are favored for their dosing and safety profiles.

3. Is PREZCOBIX likely to remain relevant in the future HIV treatment landscape?
Yes, particularly in certain resistant cases where its high barrier to resistance provides advantages. However, its overall market share is expected to decline unless new formulations or indications are introduced.

4. How are emerging markets influencing the global sales of PREZCOBIX?
Emerging markets present both opportunities and challenges. While pricing and healthcare infrastructure limit access, tiered pricing models and partnerships can foster growth.

5. What innovations could extend the commercial lifespan of PREZCOBIX?
Development of long-acting injectable formulations, incorporation into fixed-dose combinations, and gaining approvals for pediatric or resistant HIV indications are promising avenues.

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References

[1] MarketResearch.com, "Global HIV Therapeutics Market Forecast," 2022.

[2] Gilead Sciences, "HIV Treatment Landscape," 2022.

[3] Johnson & Johnson, "Annual Report," 2021.