PREZCOBIX Drug Patent Profile

When do Prezcobix patents expire, and what generic alternatives are available?

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

The generic ingredient in PREZCOBIX is cobicistat; darunavir ethanolate. 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 June 26, 2027. This may change due to patent challenges or generic licensing.

There have been fifteen 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

US Patents:	3
Applicants:	1
NDAs:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PREZCOBIX

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	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	205395-001	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	Yes			Y

International Patents for PREZCOBIX

See the table below for patents covering PREZCOBIX around the world.

Country	Patent Number	Title	Estimated Expiration
African Regional IP Organization (ARIPO)	3089
African Regional IP Organization (ARIPO)	3250
Argentina	075369
Australia	2009242451
Australia	2010210598

Supplementary Protection Certificates for PREZCOBIX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2487162	201640054	Slovenia		PRODUCT NAME: COBICISTAT OR PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVAT THEREOF AND DARUNAVIR OR PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVAT THEREOF, ESPECIALLY DARUNAVIR ETHANOLATE; NATIONAL AUTHORISATION NUMBER: EU/1/14/967/001; DATE OF NATIONAL AUTHORISATION: 20141119; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2487166	122016000104	Germany		PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON UND TENOFOVIRALAFENAMID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; AUTHORISATION NO/DATE: EU/1/15/1061 20151119
2487166	CA 2017 00004	Denmark		PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG TENOFOVIRALAFENAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061/001-002 20151123
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
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

Investment Scenario, Market Dynamics, and Financial Trajectory for PREZCOBIX

Last updated: February 3, 2026

Summary

PREZCOBIX (darunavir/cobicistat) is an antiretroviral therapy (ART) approved for the treatment of HIV-1 infection, marketed by Merck & Co. Since COVID-19, the HIV therapeutic segment remains critical, with an increasing global need for effective treatment options. This report analyzes the current investment environment, market dynamics, and expected financial trajectory for PREZCOBIX, offering insights to stakeholders and investors.

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1. What is PREZCOBIX and How Does It Fit in the HIV Treatment Landscape?

Description and Composition

• Active Ingredients: Darunavir (protease inhibitor) and cobicistat (pharmacokinetic enhancer).
• Indication: Treatment of HIV-1 infection in adult patients.
• Formulation: Film-coated tablets, once daily dosing.

Mechanism of Action

• Darunavir inhibits HIV-1 protease, preventing viral replication.
• Cobicistat boosts darunavir levels by inhibiting CYP3A enzymes, enhancing efficacy.

Approval Timeline

• FDA Approval: 2014
• EMA Approval: 2015
• Key Labeling: Once-daily regimen, favorable tolerability, resistance profile support.

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2. What Are the Market Dynamics Affecting PREZCOBIX?

a. Global HIV Market Size and Growth Trends

Year	Global HIV Population (Million)	HIV Treatment Market (USD Billion)	CAGR (2018-2022)	Source
2018	36.9	22.8	4.2%	UNAIDS[1], Fortune Business Insights[2]
2022	38.4	29.1

Key Drivers:

• Increasing global HIV prevalence, especially in Africa and Southeast Asia.
• Rising access to antiretroviral therapy (ART).
• WHO's initiative to end AIDS as a public health threat by 2030.

b. Competitive Landscape

Key Competitors	Market Share (%)	Strengths	Limitations
Kaletra (lopinavir/ritonavir)	20%	Established, broad spectrum, early entry	Side effects, dosing complexity
Triumeq (dolutegravir/abacavir/lamivudine)	25%	Once-daily, high efficacy, resistance profile	Cost, access in some regions
Pisauv (darunavir + cobicistat, generic)	Growing	Cost advantage, comparable efficacy	Brand recognition, patent status
PREZCOBIX (merck)	~15%	High barrier to resistance, favorable tolerability	Competition from generics, patent expiry

c. Patent and Regulatory Environment

• Patent expiration for PREZCOBIX expected around 2025 in key markets.
• Patent extensions and secondary patents (e.g., formulations) can sustain exclusivity.
• Regulatory pathways favor expanding indications, e.g., for pediatric or resistant HIV types.

d. Pricing & Reimbursement Landscape

• High-priced original formulations in North America (€50-€80/day).
• Generics leading to price erosion in emerging markets.
• Reimbursement policies driven by national health scheme negotiations.

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3. What Is the Financial Trajectory for PREZCOBIX?

a. Revenue Forecasts (2023-2030)

Year	Estimated Global Revenue (USD Million)	Assumptions	Notes
2023	350	Stable market share, no significant patent losses	Focus on developed markets
2024	370	Slight CAGR growth (2.9%)	Inclusion in treatment guidelines, improved access
2025	380	Patent expiry impacts, generics enter	Slight decline in branded revenues, offset by new formulations or indications
2026-2030	330-350 (avg)	Market genericization, biosimilars, price pressures	Strategic marketing and potential label expansions to sustain revenue

b. Cost Structure and profitability

Cost Element	Approximate % of Revenue	Notes
Manufacturing	10-15%	Efficiency improvements can reduce costs
R&D	8-12%	Focus on new indications, formulations
Marketing & Sales	20-25%	Key for maintaining market share
Regulatory & Legal	3-5%	Patents, compliance
Operating Margin	20-30%	Branded HIV drugs typically high margin

c. Strategic Factors Impacting Future Revenue

• Expansion into resistant HIV populations.
• Line extension: fixed-dose combinations, pediatric formulations.
• Price competition and generic penetration post patent expiry.
• Regional growth in Africa & Asia, supported by GAVI and national programs.

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4. How Do Regulatory Policies and Patent Protections Shape Investment?

Policy Aspect	Impact on PREZCOBIX	References
Patent Expiry (2025)	Entry of generics, pricing erosion	USPTO, EMA patent timelines
Data Exclusivity (EU/US)	5-8 years, delaying generic entry	USFDA, EMA regulations
Compulsory Licensing	Potential in low-income regions, impacts revenues	TRIPS Agreement
Price Controls in Europe/Asia	Limits on pricing, constrains market expansion	National policies

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5. What Are the Investment Opportunities and Risks?

Opportunities

• Market Penetration: Growing HIV prevalence offers sustained demand.
• Line Extension & New Indications: Developing formulations for resistant HIV or pediatric use.
• Strategic Alliances: Collaborations for access in underserved markets.
• Patent Strategies: Securing secondary patents to extend exclusivity.

Risks

• Patent Cliff: Approaching expiration may lead to revenue decline.
• Generic Competition: Cost advantages could erode market share.
• Pricing Pressures: Especially in public health sectors and emerging markets.
• Regulatory Delays: Possible hurdles in approval or indication expansion.

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Comparison with Competitors

Attribute	PREZCOBIX	Triumeq	Kaletra	Generic Darunavir+Cobicistat
Dosing	Once daily	Once daily	Twice daily	Once or twice daily
Resistance Profile	High barrier	High	Moderate	Similar, dependent on formulation
Cost (USD/day)	$5-8 (brand)	$4-7	$3-6	<$1 in generics
Patent Expiry	2025 (approximate)	2023-2024	N/A	Varies by region

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Key Takeaways

• Market Outlook: The global HIV treatment market remains robust, with a projected CAGR of 4-5% through 2030.
• Revenue Drivers: Increasing prevalence, treatment access expansion, and pipeline innovations.
• Competitive Dynamics: Patent expiration (~2025) may accelerate generic penetration, pressing revenue but opening new opportunities via reformulations.
• Investment Strategy: Focus on patent protections, indication expansion, and geographic growth in emerging markets.
• Risks: Patent cliffs, price competition, and regulatory changes necessitate strategic planning.

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FAQs

1. When is PREZCOBIX's patent protection set to expire?

Patent protection is expected to expire around 2025 in key markets such as the US and EU, after which generics are anticipated to enter the market.

2. What are the primary competitors to PREZCOBIX?

Main competitors include Triumeq, Kaletra, and generic darunavir/cobicistat formulations, which challenge market share through cost and efficacy.

3. How does the patent landscape influence future revenues?

Patent expiry exposes PREZCOBIX to generic competition, risking revenue erosion but also paving the way for line extensions and new formulations to mitigate losses.

4. What regional markets present growth opportunities?

Emerging markets in Africa, Southeast Asia, and Latin America are expanding HIV treatment access, offering significant growth potential post-patent expiry.

5. What are the key regulatory considerations affecting PREZCOBIX?

Regulatory policies favoring generic entry, data exclusivity periods, and potential compulsory licensing are critical factors influencing strategic planning and investment.

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References

[1] UNAIDS. Global HIV & AIDS Statistics — 2022 Fact Sheet. https://unaids.org
[2] Fortune Business Insights. HIV Therapeutics Market Size & Trends. 2022.
[3] USFDA. Patent and exclusivity policies.
[4] EMA. Patent and market exclusivity regulations.
[5] GlobalData. HIV market analysis reports, 2022-2023.