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. 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 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

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	800 mg/150 mg	205395	1	2020-07-24

US Patents and Regulatory Information for PREZCOBIX

PREZCOBIX is protected by four 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	TABLET;ORAL	205395-001	Jan 29, 2015		RX	Yes	Yes			Y	Y
Janssen Prods	PREZCOBIX	cobicistat; darunavir	TABLET;ORAL	205395-001	Jan 29, 2015		RX	Yes	Yes					Y
Janssen Prods	PREZCOBIX	cobicistat; darunavir	TABLET;ORAL	205395-001	Jan 29, 2015		RX	Yes	Yes			Y

Expired US Patents for PREZCOBIX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Prods	PREZCOBIX	cobicistat; darunavir	TABLET;ORAL	205395-001	Jan 29, 2015
Janssen Prods	PREZCOBIX	cobicistat; darunavir	TABLET;ORAL	205395-001	Jan 29, 2015
Janssen Prods	PREZCOBIX	cobicistat; darunavir	TABLET;ORAL	205395-001	Jan 29, 2015
Janssen Prods	PREZCOBIX	cobicistat; darunavir	TABLET;ORAL	205395-001	Jan 29, 2015
Janssen Prods	PREZCOBIX	cobicistat; darunavir	TABLET;ORAL	205395-001	Jan 29, 2015
Janssen Prods	PREZCOBIX	cobicistat; darunavir	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/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
African Regional IP Organization (ARIPO)	3915	Modulators of pharmacokinetic properties of therapeutics
Montenegro	02582	Modulatori farmakokinetičkih svojstava terapeutika (Modulators of pharmacokinetic properties of therapeutics)
Poland	374321	Pseudopolimorficzne postacie inhibitora proteazy HIV (PSEUDOPOLYMORPHIC FORMS OF A HIV PROTEASE INHIBITOR)
Portugal	3150586
Singapore	173544	TABLETS FOR COMBINATION THERAPY
Spain	2498370

Supplementary Protection Certificates for PREZCOBIX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2049506	15C0078	France		PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE COBICISTAT; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527
2487163	2017002	Norway		PRODUCT NAME: KOBICISTAT ELLER FARMASOEYTISK; REG. NO/DATE: EU/1/15/1025 20150810
2487166	300860	Netherlands		PRODUCT NAME: COBICISTAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN TENOFOVIR-ALAFENAMIDE, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIR-ALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/15/1061 20151123
2049506	C02049506/01	Switzerland		PRODUCT NAME: COBICISTAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 62673 18.10.2013
2487163	PA2016039,C2487163	Lithuania		PRODUCT NAME: KOBICISTATAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA IR ATAZANAVIRAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA, YPAC ATAZANAVIRO SULFATAS; REGISTRATION NO/DATE: EU/1/15/1025 20150713
3150586	SPC/GB20/024	United Kingdom		PRODUCT NAME: COBICISTAT, OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, DARUNAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, AND EMTRICITABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/17/1225(NI) 20170925; UK PLGB00242/0664 20170925

Market Dynamics and Financial Trajectory for PREZCOBIX

Introduction to PREZCOBIX

PREZCOBIX, a combination of darunavir and cobicistat, is a crucial antiretroviral medication used in the treatment of HIV-1 infection. Developed by Janssen, a subsidiary of Johnson & Johnson, this drug has been a significant player in the HIV treatment market.

Market Context: HIV Drugs Market

The global HIV drugs market is experiencing steady growth, driven by several key factors. The market size was valued at $34.13 billion in 2023 and is projected to reach $58.24 billion by 2032, growing at a CAGR of 6.2% from 2024 to 2032[1].

Key Drivers of Market Growth

• Increasing Patient Population: The rise in the number of individuals living with HIV globally is a major driver. According to UNAIDS, approximately 39 million people were living with HIV in 2022[4].
• New Product Launches: Continuous innovation and the launch of new products, such as the potential expansion of PREZCOBIX to pediatric use, contribute significantly to market growth[3].
• Government Initiatives: Government-run awareness programs and initiatives to increase diagnosis and treatment rates also play a crucial role[1][4].
• Market Penetration: Key companies are increasing their market penetration in developing regions, further boosting the market[1].

Distribution Channels and Market Share

The hospital pharmacies segment is expected to dominate the market during the forecast period, largely due to the high number of HIV patients seeking treatment in hospitals. However, online pharmacies are anticipated to witness the highest CAGR due to convenience, improved logistics, and attractive discounts[1][4].

Regional Dynamics

North America, particularly the U.S., holds a significant share of the HIV drugs market. This dominance is attributed to the high prevalence of HIV infection, strong healthcare infrastructure, and the presence of major players like Gilead Sciences, Inc. and Johnson & Johnson[1][4].

PREZCOBIX Specifics

Pediatric Expansion

Johnson & Johnson has submitted a supplemental New Drug Application (sNDA) to the U.S. FDA to expand the indication of PREZCOBIX to include the treatment of HIV-1 infection in pediatric patients aged 6 and older, weighing at least 25 kg. This expansion could significantly increase the market share of PREZCOBIX by catering to a previously underserved demographic[3].

Market Impact

The approval of PREZCOBIX for pediatric use would not only enhance its market position but also align with the broader trend of increasing demand for HIV drugs. This expansion would be particularly beneficial in regions with high HIV prevalence among children, contributing to the overall growth of the HIV drugs market.

Financial Trajectory

Revenue Contribution

As part of Johnson & Johnson's pharmaceutical segment, PREZCOBIX contributes to the company's overall revenue. In Q2 2023, Johnson & Johnson reported a 3.1% operational sales growth in the pharmaceutical segment, which includes revenues from HIV medications like PREZCOBIX[2].

Growth Projections

Given the expected growth of the HIV drugs market and the potential expansion of PREZCOBIX into the pediatric market, the financial trajectory for this drug is likely to be positive. The increasing demand for antiretroviral therapies and the strategic positioning of PREZCOBIX in both adult and pediatric treatment options will likely drive revenue growth.

Competitive Landscape

The HIV drugs market is highly competitive, with major players such as Gilead Sciences, Inc., ViiV Healthcare, and Merck & Co., Inc. However, Johnson & Johnson's strong presence and innovative pipeline, including PREZCOBIX, position the company favorably in this market[1][4].

Challenges and Opportunities

Challenges

• The COVID-19 pandemic had an adverse impact on the HIV drugs market due to supply chain disruptions and reduced new patient prescriptions. However, as the pandemic's effects wane, the market is expected to recover[1].
• Competition from other antiretroviral therapies and generic alternatives could pose challenges to PREZCOBIX's market share.

Opportunities

• Expanding into emerging markets, particularly in regions with high unmet medical demands, offers significant growth opportunities for PREZCOBIX and other HIV drugs[4].
• Continuous research and development in HIV treatment, including the exploration of new patient populations like pediatrics, can drive innovation and market growth.

Key Takeaways

• The global HIV drugs market is growing steadily, driven by increasing patient populations, new product launches, and government initiatives.
• PREZCOBIX, with its potential expansion into pediatric use, is well-positioned to capture a larger market share.
• North America, particularly the U.S., remains a dominant region for HIV drugs due to high prevalence and strong healthcare infrastructure.
• The financial trajectory for PREZCOBIX is positive, driven by market growth and strategic expansions.

FAQs

1. What is PREZCOBIX used for? PREZCOBIX is used for the treatment of HIV-1 infection. It is a combination of darunavir and cobicistat.

2. What is the current market size of the HIV drugs market? The global HIV drugs market size was valued at $34.13 billion in 2023[1].

3. What is the projected growth rate of the HIV drugs market? The market is expected to grow at a CAGR of 6.2% from 2024 to 2032[1].

4. Which region dominates the HIV drugs market? North America, particularly the U.S., dominates the HIV drugs market due to high prevalence and strong healthcare infrastructure[1][4].

5. What is the significance of the pediatric expansion of PREZCOBIX? The pediatric expansion of PREZCOBIX would cater to a previously underserved demographic, increasing the drug's market share and aligning with the broader trend of increasing demand for HIV drugs[3].

Cited Sources

1. Fortune Business Insights - HIV Drugs Market Size & Growth | Global Report [2024-2032][1]
2. Johnson & Johnson - Johnson & Johnson Reports Q2 2023 Results[2]
3. Janssen - Johnson & Johnson Submits Supplemental New Drug Application to U.S. FDA Seeking Expanded Pediatric Indication for PREZCOBIX[3]
4. Allied Market Research - HIV Drugs Market Size, Share and Growth Analysis | Report, 2032[4]