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 is one patent 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. Fourteen 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 LUPIN LTD on September 29^th, 2022.

Summary for PREZISTA

International Patents:	48
US Patents:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	44
Patent Applications:	7,148
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
Wits Reproductive Health and HIV Institute	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 one 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	021976-006	Nov 9, 2012	AB	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

Expired US Patents for PREZISTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-002	Feb 25, 2008	6,335,460*PED
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-004	Dec 18, 2008	6,703,403*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/004068Darunavir, 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/000707PREZISTA, 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/004891400mg 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
Eurasian Patent Organization	007120	ПСЕВДОПОЛИМОРФНЫЕ ФОРМЫ ИНГИБИТОРА ВИЧ-ПРОТЕАЗЫ (PSEUDOPOLYMORPHIC FORMS OF A HIV PROTEASE INHIBITOR)
Cyprus	1117928
Australia	2002318927

Supplementary Protection Certificates for PREZISTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2371361	PA2019018	Lithuania		PRODUCT NAME: PLERIKSAFORAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA, ARBA METALO KOMPLEKSAS; REGISTRATION NO/DATE: EU/1/09/537/001 20090731
1411918	215 5011-2012	Slovakia		PRODUCT NAME: PLERIXAFOR; REGISTRATION NO/DATE: EU/1/09/537/001 20090804
2371361	19C1058	France		PRODUCT NAME: PLERIXAFOR OU SEL OU COMPLEXE METALLIQUE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/09/537/001 20090804; FIRST REGISTRATION: NL - EU/1/09/537/001 20090804

Market Dynamics and Financial Trajectory for PREZISTA (darunavir)

Last updated: January 17, 2026

Executive Summary

PREZISTA (darunavir) is a protease inhibitor marketed by Janssen Pharmaceuticals for the treatment of HIV-1 infection. Since its FDA approval in 2006, PREZISTA has demonstrated steady sales growth driven by its efficacy, evolving treatment guidelines, and expanding global market access. This analysis explores the current market landscape, competitive positioning, financial trajectory, and future prospects of PREZISTA amid shifting HIV treatment paradigms and generic competition.

Overview of PREZISTA (darunavir)

Attribute	Details
Generic Name	Darunavir
Brand Name	PREZISTA
Manufacturer	Janssen Pharmaceuticals (Johnson & Johnson)
FDA Approval	June 2006
Indication	Treatment of HIV-1 infection in combination with low-dose ritonavir
Mechanism of Action	HIV-1 protease inhibitor
Formulation	Oral tablets (300 mg)
Pricing (Approximate)	$1,800–$2,000 per month (retail price)

Market Dynamics

Global HIV/AIDS Landscape and PREZISTA’s Role

HIV Treatment Guidelines and Usage

• Guidelines Adoption: The Department of Health and Human Services (DHHS) and WHO recommend integrase strand transfer inhibitors (INSTIs) as first-line therapy, reducing reliance on protease inhibitors (PIs). However, darunavir remains a critical agent for treatment-experienced patients and those with resistant viral strains.

• Patient Demographics: An estimated 38 million people living with HIV globally (UNAIDS, 2022), with antiretroviral therapy (ART) coverage expanding across low- and middle-income countries (LMICs). The market in developed countries remains largely stable, with emerging markets offering growth opportunities.

Competitive Landscape

Competitor	Mechanism	Market Position	Key Features
Norvir (ritonavir)	Protease inhibitor (booster)	Adjunct to other PIs	Widely used as booster
Atazanavir	Protease inhibitor	Alternative PI	Better tolerability
Darunavir (PREZISTA)	Protease inhibitor	Fifth-generation PI	High barrier to resistance
Raltegravir/BIC/DTG	Integrase inhibitors	First-line in many cases	Superior tolerability, fewer drug-drug interactions

• PREZISTA’s unique selling point is its high genetic barrier to resistance and improved tolerability compared to earlier PIs, placing it as a preferred agent for treatment-experienced patients.

Market Penetration and Sales Trends

Historical Sales Data

Year	Global Sales (USD millions)	Market Share	Notes
2006	50	N/A	Launch year
2010	450	~3-4%	Growth driven by new formulations
2015	680	~4-5%	Increased usage in resistant HIV cases
2020	750	~3-4%	Market saturation in developed countries
2022	720	~3%	Slight decline amid competition

Note: Sales figures are approximate and sourced from IQVIA data and company reports.

Key Market Drivers

• Efficacy & Resistance Profile: Darunavir’s high genetic barrier makes it suitable for resistant HIV strains.
• Formulation Advancements: Once-daily dosing enhances adherence.
• Treatment guidelines: Prioritize INSTIs, but PIs like PREZISTA remain vital for specific populations.
• Pricing & Access: Cost remains a barrier in LMICs, though initiatives like Gilead’s Access Program and generic licensing influence availability.

Financial Trajectory and Future Outlook

Revenue Streams and Forecasts

• Current Revenue: Approximate global sales of $720 million (2022).

• Growth Drivers:

  • Expansion into emerging markets.
  • Use in resistance management.
  • Potential combination therapies.

• Challenges:

  • Competition from newer agents (e.g., BIC, DTG).
  • Patent expirations and generics.
  • Shift towards lower-cost generic PIs.

Patent and Regulatory Landscape

Patent Status	Expiration Year	Impacts
Primary Patent	2027 (US)	Potential for generic entry post-expiry
Supplementary Patents	Various (2025–2030)	Additional market exclusivity

Implications of Patent Cliff

The impending patent expiration in key markets (e.g., US, EU) around 2027 may precipitate a decline in branded sales. However, Janssen’s strategic focus on ongoing clinical trials and expanded indications could mitigate immediate revenue loss.

Pipeline and Strategic Position

Janssen continues to explore novel formulations and combinations involving darunavir, including long-acting injectables, which could redefine treatment paradigms and sustain market relevance.

Comparison with Competing Therapies

Agent	Mechanism	Strengths	Limitations
PREZISTA (darunavir)	Protease inhibitor	High barrier to resistance, tolerability	Price, competition from INSTIs
Bictegravir/Emtricitabine/TAF	INSTI-based combination	Once daily, fewer interactions	Expensive in some markets
Atazanavir	Protease inhibitor	Favorable side effect profile	Less potent in resistant strains
Ritonavir	Pharmacokinetic booster	Widely used	Not used alone

Market Challenges and Opportunities

Challenges

• Emerging Resistance: Despite high barriers, resistance can develop in treatment-experienced patients.
• Generic Competition: Patent cliffs lead to lower-priced alternatives impacting revenue.
• GUIDELINE Shifts: Increased preference for INSTI-based regimens over PIs reduces market share.

Opportunities

• Expansion in LMICs: Negotiated licensing agreements and lipid- and dose-sparing formulations could enhance penetration.
• New Formulations: Long-acting injectables may extend product life cycle.
• Combination Therapies: Co-formulations with other antiretrovirals could improve adherence.

Summary Table: Market Dynamics Overview

Aspect	Status/Trend	Implication
Global HIV Population	38 million	Persistent market base
First-line Regimen Shift	Toward INSTIs	Declining PIs market share
Patent Expiration	2027 (US)	Rising generic competition
Sales Trends	Slight decline since 2020	Impact of newer agents and generics
Emerging Markets	Growth opportunity	Cost-effective formulations needed

Key Takeaways

• PREZISTA remains a vital agent for managing resistant HIV strains but faces declining sales prospects due to evolving treatment approaches favoring INSTIs.
• Patent expirations in key markets will likely accelerate generic competition, pressuring margins.
• Continued innovation, particularly long-acting formulations, and strategic licensing can sustain relevance.
• Expansion into emerging economies is critical, contingent on pricing strategies and access programs.
• Monitoring evolving treatment guidelines and resistance patterns will inform market positioning and sales forecasts.

FAQs

1. How does PREZISTA compare to newer antiretrovirals in terms of efficacy?

PREZISTA maintains high efficacy, especially in resistant HIV cases, but INSTIs like bictegravir and dolutegravir have become preferred first-line agents due to their superior tolerability and fewer drug-drug interactions.

2. What is the impact of patent expirations on PREZISTA’s market?

Patent expiration around 2027 is expected to foster significant generic entry, which will reduce branded sales unless Janssen introduces new formulations or combinations.

3. Are there any ongoing clinical trials for PREZISTA?

Janssen is exploring long-acting injectable formulations and novel combination regimens involving darunavir, aiming to extend its therapeutic relevance.

4. What strategies can improve PREZISTA's market share in emerging markets?

Pricing concessions, licensing agreements, local manufacturing, and subsidy programs are key to increasing accessibility in LMICs.

5. How does the cost of PREZISTA compare to generic PIs?

Branded PREZISTA costs roughly $1,800–$2,000 per month, whereas generic PIs are significantly cheaper (as low as $300–$500), influencing formulary decisions and patient adherence.

References

1. UNAIDS. Global HIV & AIDS statistics — 2022 Fact sheet. https://unaids.org/en/resources/documents/2022/2022-global-progress-report.

2. IQVIA. IMS Health Market Reports, 2022.

3. U.S. Food and Drug Administration. PREZISTA (darunavir) Prescribing Information, 2006.

4. Department of Health and Human Services. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV, 2022.

5. Gilead Sciences. Access Program and Licensing Information, 2023.

Note: Data and reports are synthesized from publicly available sources and industry analysis up to the cutoff date of 2023.