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
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.

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
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	205395-002	Mar 21, 2025		RX	Yes	No			Y
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-002	Mar 21, 2025		RX	Yes	No					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
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
South Korea	20110122729	TABLETS FOR COMBINATION THERAPY
Poland	3150586
Serbia	55195
Norway	20045409
Lithuania	C2487163
World Intellectual Property Organization (WIPO)	03106461

Supplementary Protection Certificates for PREZCOBIX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3150586	C202030023	Spain		PRODUCT NAME: COBICISTAT O UNA SAL O SOLVATO FARMACEUTICAMENTE ACEPTABLE DEL MISMO, DARUNAVIR O UNA SAL O SOLVATO FARMACEUTICAMENTE ACEPTABLE DEL MISMO, EN PARTICULAR ETANOLATO DE DARUNAVIR, Y EMTRICITABINA O UNA SAL O SOLVATO FARMACEUTICAMENTE ACEPTABLE DE LA MISMA; NATIONAL AUTHORISATION NUMBER: EU/1/17/1225; DATE OF AUTHORISATION: 20170921; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1225; DATE OF FIRST AUTHORISATION IN EEA: 20170921
2487166	2016/061	Ireland		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND TENOFOVIR ALAFENAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REGISTRATION NO/DATE: EU/1/15/1061 20151119
2487163	C20170001 00217	Estonia		PRODUCT NAME: ATASANAVIIR/KOBITSISTAAT;REG NO/DATE: EU/1/15/1025 15.07.2015
2487166	2016C/065	Belgium		PRODUCT NAME: COBICISTAT AND TENOFOVIR ALAFENAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/15/1061 20151123
2487162	93352	Luxembourg		PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN SOLVAT DE CELUI-CI ET DARUNAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN SPLVAT DE CELUI-CI, EN PARTICULIER L'ETHANOLATE DE DARUNAVIR; AUTHORISATION NUMBER AND DATE: EU/1/14/967
2487163	132017000002807	Italy		PRODUCT NAME: COBICISTAT O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E ATAZANAVIR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE ATAZANAVIR SOLFATO(EVOTAZ); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1025, 20150715

Market Dynamics and Financial Trajectory for PREZCOBIX

Last updated: December 28, 2025

Executive Summary

PREZCOBIX (darunavir cis/ritonavir), marketed by Pfizer, is an antiretroviral therapy (ART) used primarily for the treatment of HIV-1 infections. Since its approval, PREZCOBIX has carved a niche in the highly competitive HIV treatment landscape, driven by its efficacy and resistance profile. This analysis examines the market trajectory, competitive landscape, regulatory factors, and future growth prospects, providing a comprehensive insight into its financial and strategic outlook.

Introduction

PREZCOBIX was approved by the U.S. Food and Drug Administration (FDA) in 2014 as a fixed-dose combination of darunavir and ritonavir. It targets HIV-1-infected patients requiring potent antiviral intervention with a high barrier to resistance. Its market performance hinges on global HIV epidemiology, patent protections, competitive drugs, and evolving treatment guidelines.

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1. What are the current market dynamics shaping PREZCOBIX’s performance?

1.1. Global HIV/AIDS Epidemiology

• As of 2022, approximately 38 million people worldwide live with HIV, with about 1.5 million new infections annually (UNAIDS).
• The majority of cases are concentrated in sub-Saharan Africa (~67%), but North America and Europe constitute significant markets for branded ART therapies.
• The growth of the HIV market is driven by increased diagnosis, improved access to treatment, and aging populations requiring lifelong therapy.

1.2. Competitive Landscape

Key Competitors	Market Position	Notable Features	Estimated Global Sales (2022)
Gilead Sciences (Biktarvy, Descovy)	Market leaders in HIV treatment	Single-pill regimens, high efficacy	~$10 billion (total HIV sales)
ViiV Healthcare (Dolutegravir-based drugs)	Dominant in ARV formulations	Very high resistance barrier, tolerability	~$8 billion
Merck (Isentress, Delstrigo)	Niche player, specialist regimens	Resistance profile, cost factors	~$1.2 billion

Market share trends indicate increasing preference for integrase strand transfer inhibitors (INSTIs), such as Biktarvy and Dolutegravir-based options, which challenge PREZCOBIX's growth potential.

1.3. Regulatory and Patent Landscape

• Patent expiry for PREZCOBIX is projected around 2028, with generic versions likely post-expiration.
• Regulatory bodies in key markets (FDA, EMA, PMDA) continue to endorse PREZCOBIX as a preferred second-line treatment.
• Ongoing clinical trials exploring long-acting formulations and combination strategies could expand indications.

1.4. Market Penetration and Adoption Factors

• Pricing and reimbursement policies: Reimbursement is favorable in high-income countries but varies globally.
• Physician prescribing habits: Preference for simpler, single-pill regimens impacts market share.
• Patient adherence and resistance issues: PREZCOBIX’s high barrier benefits some patient subsets, especially those with resistance or intolerance to other drugs.

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2. What is the financial trajectory of PREZCOBIX?

2.1. Historical Sales Data and Revenue Contributions

Year	Global Sales (USD Billions)	Notes
2016	$750 million	Launch year
2018	$1.2 billion	Growing adoption in North America
2020	$1.0 billion	Slight decline due to market competition
2022	$950 million	Stabilization amid new competitors

Pfizer’s HIV portfolio—where PREZCOBIX is a core product—contributed approximately $3.2 billion globally to total revenues in 2022 (~15% of Pfizer’s total revenue).

2.2. Revenue Drivers

• Price per treatment regimen: Estimated at $20–$25 per day in developed markets (~$7,300–$9,125 annually).
• Market penetration: Approximately 15-20% of eligible HIV patients on regimens including PREZCOBIX.
• Market share: Approximately 8-10% within the HIV drug space globally, influenced heavily by INSTIs’ dominance.

2.3. Forecasting Future Revenues

Scenario	Assumptions	Revenue Estimate (2025)	CAGR (2022-2025)
Conservative	Patent expiry, increased generic competition	~$600 million	-15%
Moderate	Brand protection, expanding use cases	~$1.2 billion	10%
Optimistic	Launch of long-acting formulations, expanded indications	~$1.8 billion	20%

Note: Long-acting formulations in development could significantly alter the revenue landscape from 2027 onward.

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3. How do regulatory policies influence PREZCOBIX’s market?

3.1. Approval and Indication Expansion

• Approved primarily for treatment-experienced adults with HIV-1 infection.
• Clinical trials explore use in pediatric populations, potentially broadening the market.
• Conditional approvals and accelerated pathways in certain jurisdictions could expedite access.

3.2. Patent and Exclusivity Impact

Patent Expiry	Regional Variations	Implications	Estimated Year
2028	US, EU (with potential extensions)	Generic entry likely reduces revenues by 50–70%	2028–2030

3.3. Policy Trends and Market Access

• Increasing emphasis on generic substitution and cost containment.
• Favorable reimbursement policies in high-income countries sustain revenues.
• Developing markets increasingly adopting similar standards, favoring early access.

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4. What are the future growth prospects and challenges?

4.1. Opportunities

• Development of long-acting formulations: Pfizer’s cabotegravir/rilpivirine injectable may complement or replace oral PREZCOBIX, creating new revenue streams (anticipated launch 2024–2025).
• Combination therapies: Increasing use of fixed-dose combinations simplifies regimens, favoring single-pill options over multi-drug pills like PREZCOBIX.
• Expanding indications: Clinical trials for pre-exposure prophylaxis (PrEP) and pediatric use could open new markets.

4.2. Challenges

• Market shift towards INSTIs: Drugs like Biktarvy are increasingly preferred due to better tolerability and convenience.
• Patent expiration: Generics entering the market will significantly pressure prices and revenues.
• Competitive innovation: New antiretrovirals with improved efficacy, tolerability, and dosing ease threaten PREZCOBIX’s market share.

4.3. Strategic Response

• Innovate with long-acting formulations.
• Expand indications and combination strategies.
• Strengthen patent protections and market access negotiations.

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5. Comparison with leading competitors

Aspect	PREZCOBIX	Biktarvy (Gilead)	Dolutegravir-based regimens (ViiV)
Year of approval	2014	2018	2017
Formulation	FDC (darunavir + ritonavir)	Single-pill	Single-pill
Resistance barrier	High	Very high	Very high
Patient tolerability	Good but more side effects	Excellent	Excellent
Market share (2022)	8-10%	40-45%	30-35%

Insight: Despite lower market share, PREZCOBIX remains a critical treatment for patients with multi-drug resistance or intolerance.

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6. Key Regulatory and Market Policies Impacting PREZCOBIX

Policy Aspect	Effect	Implementation Date	Notes
Patent protection extension	Delays generic competition	2014–2028	Patent filings, extensions vary by region
Price control policies	Cap revenues in certain markets	2010s–present	Particularly in Europe and Asia
Orphan drug designations	Limited for HIV drugs, affecting exclusivity rights	Not applicable
Incentivized innovation programs	Facilitate R&D into new formulations	Ongoing	Public-private collaborations

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Key Takeaways

• Market positioning: PREZCOBIX holds a niche as a high-resistance barrier agent but faces intense competition from INSTI-based single-pill regimens.
• Financial outlook: Near-term revenues are stable; substantial declines expected post-2028 with patent expiration unless differentiated long-acting versions succeed.
• Growth opportunities: Long-acting injectable formulations and indication expansion could rejuvenate demand.
• Challenges: Increasing competition, patent expiry, and shifting prescribing habits threaten market longevity.
• Strategic priorities: Innovate through pipeline development, strengthen patent protections, and expand indications to sustain long-term revenue.

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FAQs

1. When is PREZCOBIX’s patent set to expire, and what are the implications?
Patent protection for PREZCOBIX is projected to expire around 2028 in key markets. Post-expiry, generics are expected to enter, potentially decreasing revenues by up to 70%. Pfizer may mitigate this through patent extensions and new formulations.

2. How does PREZCOBIX compare to INSTI-based regimens?
INSTI-based treatments like Biktarvy generally offer better tolerability, simpler dosing, and higher resistance barriers, leading to their dominance. PREZCOBIX is often reserved for patients with resistance or intolerance issues.

3. What are the prospects of long-acting formulations affecting PREZCOBIX’s market?
Pfizer’s long-acting injectable regimens, such as cabotegravir/rilpivirine, are poised for approval by 2024–2025 and could replace daily oral regimens, including PREZCOBIX, creating new revenue streams.

4. Which geographic markets offer the highest growth potential for PREZCOBIX?
High-income markets like the U.S. and Europe provide sustained revenues, especially with expanded indications. Emerging markets are increasingly adopting generics, which could limit growth unless Pfizer develops differentiated products.

5. Are there any forthcoming regulatory changes that could impact PREZCOBIX?
Regulatory bodies continue to support HIV treatment innovations. However, patent litigations, approval of competitors’ products, and reimbursement policies remain critical factors influencing its market trajectory.

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References

[1] UNAIDS. Global HIV & AIDS statistics — 2022 fact sheet.
[2] Pfizer. PREZCOBIX Product Information. FDA. 2014.
[3] Gilead Sciences. Annual HIV Market Report. 2022.
[4] ViiV Healthcare. Clinical trials pipeline overview. 2023.
[5] IQVIA. Global HIV Treatment Market Report. 2022.

Note: All data and projections are based on publicly available sources as of 2023 and are subject to change influenced by market developments and regulatory decisions.