PREZISTA Drug Patent Profile

Which patents cover Prezista, and what generic alternatives are available?

Prezista is a drug marketed by Janssen Prods and is included in two NDAs. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has forty-eight patent family members in twenty-five countries.

The generic ingredient in PREZISTA is darunavir. There are twenty-five drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the darunavir profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Prezista

A generic version of PREZISTA was approved as darunavir by TEVA PHARMS USA on November 21^st, 2017.

Summary for PREZISTA

International Patents:	48
US Patents:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	96
Clinical Trials:	44
Patent Applications:	5,380
Drug Prices:	Drug price information for PREZISTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PREZISTA
What excipients (inactive ingredients) are in PREZISTA?	PREZISTA excipients list
DailyMed Link:	PREZISTA at DailyMed

See drug prices for PREZISTA

Recent Clinical Trials for PREZISTA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Frederick National Laboratory for Cancer Research	Phase 4
Geropharm	N/A
Desmond Tutu HIV Centre	Phase 1

See all PREZISTA clinical trials

Pharmacology for PREZISTA

Drug Class	Protease Inhibitor
Mechanism of Action	Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors HIV Protease Inhibitors

Paragraph IV (Patent) Challenges for PREZISTA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PREZISTA	Tablets	darunavir	800 mg	021976	1	2013-05-14
PREZISTA	Tablets	darunavir	600 mg	021976	4	2010-06-23

US Patents and Regulatory Information for PREZISTA

PREZISTA is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Prods	PREZISTA	darunavir	SUSPENSION;ORAL	202895-001	Dec 16, 2011		RX	Yes	Yes	7,700,645*PED				Y
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-001	Jun 23, 2006		DISCN	Yes	No	7,700,645*PED				Y
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-004	Dec 18, 2008		RX	Yes	No	8,518,987*PED				Y

Expired US Patents for PREZISTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-001	Jun 23, 2006	RE43596*PED
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-003	Oct 21, 2008	8,518,987*PED
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-005	Dec 18, 2008	5,843,946*PED

EU/EMA Drug Approvals for PREZISTA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Mylan Pharmaceuticals Limited	Darunavir Mylan	darunavir	EMEA/H/C/004068 Darunavir, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection (see section 4.2).Darunavir Mylan 75 mg, 150 mg, 300 mg and 600 mg tablets may be used to provide suitable dose regimens (see section 4.2):For the treatment of HIV-1 infection in antiretroviral treatment (ART)-experienced adult patients, including those that have been highly pre-treated.For the treatment of HIV-1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight.In deciding to initiate treatment with darunavir co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir (see sections 4.2, 4.4 and 5.1).Darunavir co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection. Darunavir co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg) (see section 4.2). Darunavir Mylan 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are: antiretroviral therapy (ART)-naïve (see section 4.2). ART-experienced with no darunavir resistance associated mutations (DRV-RAMs) and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 10⁶/L. In deciding to initiate treatment with darunavir in such ART-experienced patients, genotypic testing should guide the use of darunavir (see sections 4.2, 4.3, 4.4 and 5.1).	Authorised	yes	no	no	2017-01-03
Janssen-Cilag International NV	Prezista	darunavir	EMEA/H/C/000707 PREZISTA, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight.PREZISTA, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg).In deciding to initiate treatment with PREZISTA co administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of PREZISTA.PREZISTA, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV 1) infection.PREZISTA 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens:For the treatment of HIV 1 infection in antiretroviral treatment (ART) experienced adult patients, including those that have been highly pre treated.For the treatment of HIV 1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight.In deciding to initiate treatment with PREZISTA co administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of PREZISTA.PREZISTA, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV 1) infection.PREZISTA, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg).PREZISTA 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV 1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (ART) naïve.ART experienced with no darunavir resistance associated mutations (DRV RAMs) and who have plasma HIV 1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 106/L. In deciding to initiate treatment with PREZISTA in such ART experienced patients, genotypic testing should guide the use of PREZISTA.	Authorised	no	no	no	2007-02-11
KRKA, d.d., Novo mesto	Darunavir Krka d.d.	darunavir	EMEA/H/C/004891 400mg and 800 mg Film-coated TabletsDarunavir Krka d.d., co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection.Darunavir Krka d.d., co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection in adult patients (see section 4.2).Darunavir Krka d.d. 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (ART)-naïve (see section 4.2).ART-experienced with no darunavir resistance associated mutations (DRV-RAMs) and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 106/l. In deciding to initiate treatment with darunavir in such ART-experienced patients, genotypic testing should guide the use of darunavir (see sections 4.2, 4.3, 4.4 and 5.1).600mg Film-coated TabletsDarunavir Krka d.d., co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection.Darunavir Krka d.d. 600 mg tablets may be used to provide suitable dose regimens (see section 4.2):For the treatment of HIV-1 infection in antiretroviral treatment (ART)-experienced adult patients, including those that have been highly pre-treated.For the treatment of HIV-1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight.In deciding to initiate treatment with darunavir co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir.	Withdrawn	yes	no	no	2018-01-18

International Patents for PREZISTA

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

Country	Patent Number	Title	Estimated Expiration
Australia	2002318927
Austria	538785
South Korea	20050008715

Supplementary Protection Certificates for PREZISTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0810209	SPC/GB07/038	United Kingdom		PRODUCT NAME: DARUNAVIR OR THE PHARMACEUTICALLY ACCEPTABLE SALT, ESTER OR PRODRUG THEREOF; REGISTERED: UK EU/1/06/380/001 20070212; SPC EXTENSION AUTHORISATION: EU/1/06/380/001 - 008, 20070212
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
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

PREZISTA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Darunavir (Prezista)

Market Overview

Darunavir, marketed under the brand name Prezista, is a protease inhibitor used in the treatment of HIV infection. The market for Darunavir is complex and influenced by several key factors.

Increasing Prevalence of HIV

The global prevalence of HIV infection continues to drive the demand for effective antiretroviral therapies like Darunavir. The increasing number of HIV cases, particularly in emerging economies, presents a significant market opportunity[1][4].

Technological Advancements

The Darunavir market is characterized by continuous technological advancements and innovations in drug formulations. These advancements include the development of combination therapies and novel formulations, which enhance treatment outcomes and patient compliance[1].

Competitive Landscape

The market for Darunavir is highly competitive, with several major pharmaceutical companies involved, including Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson), Mylan N.V., Teva Pharmaceutical Industries Ltd., Hetero Drugs Limited, and Cipla Ltd. These companies compete through various strategies such as pricing, product innovation, and market expansion[1].

Regional Analysis

Developed Markets

In regions like North America and Europe, the market for Darunavir is driven by well-established healthcare systems and higher per capita healthcare expenditures. These regions have a high adoption rate of branded antiviral drugs, including Prezista[1][4].

Emerging Markets

Emerging economies in Asia-Pacific, Latin America, and Africa offer significant growth opportunities due to expanding access to healthcare and increasing awareness about HIV prevention and treatment. Market players need to tailor their strategies to these regional characteristics to maximize their market presence[1].

Financial Trajectory

Revenue Generation

The Darunavir market offers substantial revenue potential for pharmaceutical companies. Despite challenges such as generic competition, the market is expected to witness steady growth driven by the increasing prevalence of HIV and the continuous development of innovative formulations[1].

Financial Performance of Key Players

Johnson & Johnson, the parent company of Janssen Pharmaceuticals, has reported significant sales growth in its pharmaceutical segment. For instance, in 2023, Johnson & Johnson reported a 7.3% increase in fourth-quarter sales, with operational growth of 7.2% and adjusted operational growth of 5.7%. While these figures are not specific to Darunavir, they indicate the overall health of the pharmaceutical division[2].

Market Size and Growth

The global antiviral drugs market, which includes protease inhibitors like Darunavir, was valued at $63.8 billion in 2020 and is expected to be worth around $60 billion by 2030, with a CAGR of -0.5% from 2021 to 2030. However, the HIV segment within this market is expected to witness the fastest growth rate due to high prevalence and treatment rates[4].

SWOT Analysis

Strengths

• Proven Efficacy: Darunavir is a potent protease inhibitor with a proven track record in managing HIV infection.
• Established Brand: The drug has established brand recognition and market presence.
• Innovative Formulations: Various dosage forms allow for personalized treatment approaches[1].

Weaknesses

• Patent Expirations: The expiration of patents and the availability of generic alternatives pose significant challenges to the profitability of branded Darunavir products.
• High Cost: The high cost of treatment can limit accessibility, particularly in low-income regions.
• Adverse Effects: Potential adverse effects and drug resistance can impact patient compliance and treatment success[1].

Opportunities

• Emerging Markets: Growing healthcare infrastructure and increasing awareness about HIV in emerging economies present untapped growth opportunities.
• Technological Advancements: Innovations in drug formulation and combination therapies can drive market expansion.
• Collaborations: Collaborations and partnerships can foster innovation and expand market reach[1].

Threats

• Generic Competition: Generic competition and pricing pressures can erode market share and profit margins.
• Regulatory Challenges: Regulatory hurdles and intellectual property issues may impact market entry and expansion[1].

Key Market Insights

Government Policies and Initiatives

Government policies and initiatives, such as the U.S. government's Ending the HIV Epidemic (EHE) plan, significantly impact the market by increasing the treatment rate and diagnosis of HIV. These initiatives drive the demand for antiretroviral therapies like Darunavir[4].

Pricing Strategies

Pricing strategies play a crucial role in the market dynamics. The high cost of branded antiviral drugs, including Prezista, can be a barrier to access, especially in low-income regions. However, innovative pricing models and collaborations can help mitigate these challenges[1].

Future Outlook

The future of the Darunavir market looks promising, with steady growth expected in the coming years. The increasing prevalence of HIV, coupled with continuous innovations in drug formulations and combination therapies, will drive market expansion. Market players should focus on emerging economies and adopt patient-centric approaches to capitalize on growth opportunities[1].

Key Takeaways

• The Darunavir market is driven by the increasing prevalence of HIV and technological advancements.
• The market is highly competitive, with key players including Janssen Pharmaceuticals, Mylan N.V., and Teva Pharmaceutical Industries Ltd.
• Emerging economies offer significant growth opportunities.
• Patent expirations and generic competition are major challenges.
• Collaborations and innovative formulations are key to market expansion.

FAQs

Q: What is the primary driver of the Darunavir market?

The primary driver of the Darunavir market is the increasing prevalence of HIV infection worldwide, coupled with the need for effective antiretroviral therapy options[1].

Q: Which regions offer the most significant growth opportunities for Darunavir?

Emerging economies in Asia-Pacific, Latin America, and Africa offer the most significant growth opportunities due to expanding access to healthcare and increasing awareness about HIV prevention and treatment[1].

Q: What are the major challenges faced by the Darunavir market?

The major challenges include patent expirations, generic competition, high treatment costs, and potential adverse effects and drug resistance[1].

Q: How does government policy impact the Darunavir market?

Government policies and initiatives, such as the U.S. government's Ending the HIV Epidemic (EHE) plan, increase the treatment rate and diagnosis of HIV, driving the demand for antiretroviral therapies like Darunavir[4].

Q: What role do collaborations play in the Darunavir market?

Collaborations between pharmaceutical companies and research institutions foster innovation, drive the development of novel formulations, and expand market reach[1].

Sources

1. MarkWide Research: Darunavir (Prezista) market 2024-2032 | Size, Share, Growth.
2. Johnson & Johnson: Johnson & Johnson Reports Q4 and Full-Year 2023 Results.
3. PR Newswire: Johnson & Johnson Reports 2021 First-Quarter Results.
4. BioSpace: Antiviral Drugs Market Size, Share, Growth, Trends, Forecast 2022 to 2030.
5. Regeneron: Regeneron Reports Fourth Quarter and Full Year 2022 Financial.