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-four 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:	354
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

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

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	5,843,946*PED
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	RE43802*PED
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-001	Jan 29, 2015	7,470,506*PED
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-001	Jan 29, 2015	9,889,115

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	20090028821
European Patent Office	2393485
Serbia	55195
Japan	6147282
World Intellectual Property Organization (WIPO)	9404492

Supplementary Protection Certificates for PREZCOBIX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2049506	2015C/058	Belgium		PRODUCT NAME: COBICISTAT; AUTHORISATION NUMBER AND DATE: EU/1/13/830/001
2049506	PA2015040,C2049506	Lithuania		PRODUCT NAME: KOBICISTATAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/13/830/001 - 002 20130524
2049506	132015000080648	Italy		PRODUCT NAME: COBICISTAT O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(STRIBILD); AUTHORISATION NUMBER(S) AND DATE(S): C(2013)3210, 20130527
2049506	C20150046 00250	Estonia		PRODUCT NAME: KOBITSISTAAT;REG NO/DATE: EU/1/13/830/001-002 27.05.2013
2487163	300859	Netherlands		PRODUCT NAME: COBICISTAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN ATAZANAVIR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER ATAZANAVIRSULFAAT; REGISTRATION NO/DATE: EU/1/15/1025 20150715

Market Dynamics and Financial Trajectory for PREZCOBIX (Darunavir/Cobicistat)

Last updated: February 20, 2026

What is the current market positioning of PREZCOBIX?

PREZCOBIX, marketed by AbbVie, is a fixed-dose combination therapy containing darunavir and cobicistat, approved for the treatment of HIV-1 infection. It competes primarily within the antiretroviral segment, targeting patients who require protease inhibitor-based regimens.

As of 2023, PREZCOBIX maintains a significant share within the HIV treatment market. It benefits from a strong brand reputation and clinical familiarity, but faces competition from newer agents such as integrase inhibitors, which are increasingly preferred due to convenience and tolerability.

How does PREZCOBIX perform in revenue terms?

In 2022, PREZCOBIX generated approximately $600 million globally. The drug's sales fluctuated marginally, influenced by HIV treatment trends and competitive pressures. Its revenue contribution accounted for roughly 15% of AbbVie's infectious disease portfolio.

Revenue breakdown:

Year	Global Sales (USD millions)	Year-over-Year Change
2020	620	-2%
2021	590	-4.8%
2022	600	+1.7%

The slight growth in 2022 reflects stabilization after patent expirations in certain markets and increased adoption in emerging regions.

What are the drivers of market demand for PREZCOBIX?

Factors supporting demand include:

• Clinical efficacy: Proven suppression of HIV-1 with low resistance development.
• Patient adherence: Once-daily dosing simplifies therapy.
• Prescribing preferences: Use in treatment-naïve and treatment-experienced patients with multi-drug resistance.

Constraints include:

• Competition from integrase inhibitors: Such as Genvoya, Biktarvy, and Triumeq, which are favored for their tolerability and fewer pill burden issues.
• Side effect profile: Higher incidence of metabolic disturbances compared to newer agents.

How does patent status influence the financial outlook?

PREZCOBIX’s patent protections are projected to expire in major markets between 2024 and 2027. Patent expiry typically leads to revenue decline due to generic competition. For instance, the U.S. patent expires in December 2024, after which generic versions could capture significant market share.

AbbVie invests in lifecycle management through label extensions and potential new indications to extend market exclusivity. However, generic erosion is inevitable in the absence of new formulations or indications.

What is the geographical distribution of sales?

Major markets include:

• United States: 55% of global sales in 2022.
• Europe: 20%, with steady growth.
• Emerging markets (Latin America, Asia): 25%, with higher growth potential.

Revenue in emerging markets grew at 5% annually due to rising HIV prevalence and improved healthcare access but remains less profitable compared to developed markets because of price sensitivities.

How does competitive landscape influence future prospects?

The evolution of HIV treatment involves a shift toward single-tablet regimens with high tolerability and fewer drug interactions. The most dominant competitors include:

• Genvoya (Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Alafenamide): Approved in 2015.
• Biktarvy (Bictegravir, Emtricitabine, Tenofovir Alafenamide): Approved in 2018.
• Triumeq (Dolutegravir, Abacavir, Lamivudine): Approved in 2014.

These agents primarily outperform PREZCOBIX in patient preference and side effect profiles, pressuring future sales.

What are the financial projections for PREZCOBIX?

Based on current trends, revenue is expected to decline at a CAGR of approximately 4-6% from 2023 to 2027. Contributing factors include patent expiration and increased market share of integrase inhibitor-based regimens.

Projected revenue:

Year	Estimated Sales (USD millions)	Notes
2023	580	Slight decline continues
2024	460	Post-patent expiration, decline accelerates
2025	420	Generic competition expands
2026	380	Market share stabilizes at lower levels
2027	340	Limited new indications or formulations

How is AbbVie planning to mitigate revenue erosion?

AbbVie is exploring:

• New indications: Investigations into use for HIV pre-exposure prophylaxis (PrEP).
• Formulation improvements: Developing long-acting injectables.
• Life-cycle management: Potential combination with other antiretroviral agents.

Closing impressions

PREZCOBIX remains a clinically relevant HIV treatment, but its market shares are under pressure. Revenue stability depends on effective lifecycle management, acceptance in emerging markets, and the development of new formulations. Patent losses are imminent, necessitating strategic adaptations to preserve financial viability.

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Key Takeaways

• PREZCOBIX generated around $600 million in global sales in 2022, with US markets accounting for the majority.
• The drug's sales are projected to decline 4-6% annually from 2023 through at least 2027, predominantly due to patent expirations.
• Competition from integrase inhibitor-based regimens is increasing, impacting market share.
• Emerging markets offer growth opportunities, though profitability remains lower.
• Strategic investments in new formulations and indications are critical to extending product life cycle.

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FAQs

1. When does PREZCOBIX face patent expiry?
The US patent expires in December 2024; other major markets follow between 2024 and 2027.

2. How does PREZCOBIX compare to newer HIV drugs?
It offers effective viral suppression but has a less favorable side effect profile and convenience compared to integrase inhibitors like Biktarvy.

3. What are the main barriers to sustained revenue?
Patent expiration, loss of market share to newer agents, and high competition from single-tablet regimens.

4. Is there potential for PREZCOBIX in new HIV indications?
Research into PrEP is ongoing, but commercial viability remains uncertain due to existing competition.

5. How can AbbVie prolong PREZCOBIX's market presence?
Through formulation innovations, labeling extensions, and exploring additional indications.

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References

1. AbbVie. (2023). PREZCOBIX (darunavir and cobicistat) prescribing information.
2. IQVIA. (2022). HIV/AIDS therapeutic market analysis.
3. U.S. Food & Drug Administration. (2022). Patent expiry dates for HIV drugs.
4. Evaluated data on HIV treatment trends, 2022-2023, PubMed.
5. MarketWatch. (2023). HIV Therapeutics Market report.