CLINICAL TRIALS PROFILE FOR PREZISTA

All Clinical Trials for PREZISTA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00381303 ↗	GRACE: A Study to Compare the Effectiveness, Safety and Tolerability of PREZISTA (Darunavir)/Ritonavir by Gender and Race When Administered With Other Antiretroviral Medications in Human Immunodeficiency Virus (HIV) Positive Women and Men.	Completed	Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA	Phase 3	2006-11-01	The purpose of this study is to evaluate any differences in the effectiveness, safety, and tolerability of PREZISTA (darunavir; DRV) 600 mg, administered with ritonavir (RTV) 100 mg twice a day on virologic response (defined as a viral load (VL) of < 50 copies/mL) over a 48-week treatment period in HIV-positive women and men. Additional antiretroviral (ARV) agents will also be administered and will be chosen by the Investigator based on resistance testing and prior treatment history (referred to as the Optimized Background Regimen (OBR)).
NCT00381303 ↗	GRACE: A Study to Compare the Effectiveness, Safety and Tolerability of PREZISTA (Darunavir)/Ritonavir by Gender and Race When Administered With Other Antiretroviral Medications in Human Immunodeficiency Virus (HIV) Positive Women and Men.	Completed	Tibotec, Inc	Phase 3	2006-11-01	The purpose of this study is to evaluate any differences in the effectiveness, safety, and tolerability of PREZISTA (darunavir; DRV) 600 mg, administered with ritonavir (RTV) 100 mg twice a day on virologic response (defined as a viral load (VL) of < 50 copies/mL) over a 48-week treatment period in HIV-positive women and men. Additional antiretroviral (ARV) agents will also be administered and will be chosen by the Investigator based on resistance testing and prior treatment history (referred to as the Optimized Background Regimen (OBR)).
NCT00421551 ↗	Study Comparing Efficacy and Safety of Darunavir Boosted With Ritonavir to HART With 2 NRTI and Darunavir Boosted With Ritonavir in HIV-1 Infected Patients ANRS136	Completed	Tibotec Pharmaceutical Limited	Phase 3	2007-03-01	The purpose of this study is to evaluate whether a monotherapy of boosted darunavir is able to maintain the virological success until 48 weeks in comparison to a standard therapy 2 INTI + darunavir/r in HIV infected patients with full viral suppression.
NCT00421551 ↗	Study Comparing Efficacy and Safety of Darunavir Boosted With Ritonavir to HART With 2 NRTI and Darunavir Boosted With Ritonavir in HIV-1 Infected Patients ANRS136	Completed	French National Agency for Research on AIDS and Viral Hepatitis	Phase 3	2007-03-01	The purpose of this study is to evaluate whether a monotherapy of boosted darunavir is able to maintain the virological success until 48 weeks in comparison to a standard therapy 2 INTI + darunavir/r in HIV infected patients with full viral suppression.

Clinical Trial Conditions for PREZISTA

Condition Name

Condition Name for PREZISTA
Intervention	Trials
HIV Infections	17
HIV-1 Infection	6
HIV	5
HIV/AIDS	3

Condition MeSH

Condition MeSH for PREZISTA
Intervention	Trials
HIV Infections	30
Acquired Immunodeficiency Syndrome	12
Infections	10
Infection	8

Clinical Trial Locations for PREZISTA

Trials by Country

Trials by Country for PREZISTA
Location	Trials
United States	78
South Africa	7
Canada	6
Thailand	6
France	6

Trials by US State

Trials by US State for PREZISTA
Location	Trials
New York	7
California	7
Texas	6
North Carolina	6
Florida	5

Clinical Trial Progress for PREZISTA

Clinical Trial Phase

Clinical Trial Phase for PREZISTA
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	8
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for PREZISTA
Clinical Trial Phase	Trials
Completed	31
Terminated	6
Recruiting	3

Clinical Trial Sponsors for PREZISTA

Sponsor Name

Sponsor Name for PREZISTA
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	5
Tibotec, Inc	4
Merck Sharp & Dohme Corp.	4

Sponsor Type

Sponsor Type for PREZISTA
Sponsor	Trials
Other	52
Industry	42
NIH	7

Prezista (Darunavir) Market Dynamics and Patent Landscape

Last updated: February 19, 2026

Prezista (darunavir) is an HIV protease inhibitor with a robust patent portfolio and established market position. Recent clinical trial data reinforce its efficacy, particularly in treatment-experienced patients. The market is characterized by a stable demand driven by ongoing HIV treatment needs, though generic competition is a significant future threat.

What is the Current Clinical Status of Prezista?

Prezista, developed by Janssen Pharmaceuticals, is a second-generation protease inhibitor used in the treatment of human immunodeficiency virus (HIV-1) infection. Its efficacy is well-documented across various patient populations.

• Key Clinical Data:
  • EMERALD-1 Trial: This Phase 3 trial demonstrated non-inferiority of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (DRV/c/FTC/TAF) compared to atazanavir/cobicistat/emtricitabine/tenofovir alafenamide (ATV/c/FTC/TAF) in virologically suppressed, treatment-experienced adults with HIV-1. The primary endpoint of maintaining viral suppression (HIV-1 RNA < 50 copies/mL) at Week 48 was met for both arms [1].
  • EMERALD-2 Trial: The companion Phase 3 trial, EMERALD-2, also confirmed the non-inferiority of DRV/c/FTC/TAF versus ATV/c/FTC/TAF in a similar patient population. These trials support the use of darunavir-containing regimens as a viable option for maintenance therapy [1].
  • GSK-3857428 (Veklury) Co-administration: Studies have evaluated the pharmacokinetic and safety profile of darunavir when co-administered with remdesivir (GSK-3857428) in healthy volunteers. Darunavir's pharmacokinetics were not significantly altered by remdesivir, suggesting potential for co-administration in certain clinical scenarios [2]. However, remdesivir is not a standard HIV treatment.
  • Adolescent Studies: Clinical trials have established the efficacy and safety of darunavir in adolescent populations, allowing for its use in younger individuals living with HIV [3].

What is the Market Landscape for Prezista?

The market for HIV protease inhibitors, including darunavir, is mature but continues to be driven by the chronic nature of HIV infection and the ongoing need for effective antiretroviral therapy (ART).

• Market Size and Growth:

  • The global HIV treatment market was valued at approximately $25 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 4-5% over the next decade. This growth is supported by increased diagnosis rates, improved access to treatment in developing countries, and the development of novel combination therapies [4, 5].
  • Darunavir's market share is significant within the protease inhibitor class, particularly for treatment-experienced patients due to its high genetic barrier to resistance.

• Key Market Drivers:

  • Treatment-Experienced Patients: Prezista's efficacy against multidrug-resistant HIV strains remains a key differentiator.
  • Improved Tolerability and Dosing: Once-daily dosing regimens and improved tolerability profiles compared to older protease inhibitors contribute to patient adherence.
  • Combination Therapies: Prezista is frequently used in combination with other antiretroviral agents, often as a fixed-dose combination (e.g., Symtuza, which includes darunavir, cobicistat, emtricitabine, and tenofovir alafenamide), simplifying treatment regimens.

• Market Challenges:

  • Generic Competition: The primary threat to Prezista's market exclusivity is the impending expiry of key patents and the subsequent introduction of generic darunavir.
  • Development of New Drug Classes: Advances in HIV treatment have led to the development of integrase inhibitors and long-acting injectables, which offer alternative treatment paradigms and may compete with oral protease inhibitor regimens.
  • Pricing Pressures: Healthcare systems globally face increasing pressure to control drug costs, which can impact pricing strategies for established medications.

What is the Patent Status of Prezista (Darunavir)?

The patent landscape for darunavir is complex, with multiple patents covering the compound, its formulations, and methods of use. The expiry of key patents will significantly impact the market dynamics.

• Key Patents and Expiry Dates:

  • Composition of Matter Patents: The primary composition of matter patents for darunavir have largely expired or are nearing expiry in major markets. For instance, U.S. Patent No. 6,977,291, which covers darunavir, expired in 2023 [6].
  • Formulation and Method of Use Patents: Janssen has secured numerous secondary patents related to specific formulations (e.g., once-daily dosing, fixed-dose combinations like Symtuza), manufacturing processes, and methods of treatment. These patents have varying expiry dates.
    • U.S. Patent No. 9,272,959 (Symtuza formulation): This patent is listed in the FDA Orange Book and is set to expire in 2030 [7]. However, patent litigation can alter these timelines.
    • Other formulation and method-of-use patents expire throughout the mid-to-late 2020s and into the early 2030s.

• Patent Litigation:

  • Darunavir has been subject to patent litigation, as is common for high-value pharmaceuticals. Challenges to patent validity and non-infringement claims by generic manufacturers are ongoing.
  • The outcomes of these litigations can significantly influence the timing of generic market entry. For example, court rulings can invalidate secondary patents, allowing for earlier generic launches.

• Generic Entry Projections:

  • With the expiry of core composition of matter patents, generic versions of darunavir are anticipated to enter the market.
  • The exact timing will depend on the resolution of remaining patent disputes and regulatory approvals by agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
  • Generic competition is expected to lead to a significant price reduction for darunavir, impacting Janssen's revenue from the product.

What are the Future Market Projections for Prezista?

The future market for Prezista will be heavily influenced by the interplay between its clinical utility, the introduction of generic competition, and the evolving landscape of HIV treatment.

• Projected Market Share Decline:

  • Post-generic entry, the market share for branded Prezista is expected to decline substantially as lower-cost generic alternatives become available.
  • Sales of generic darunavir are projected to capture a significant portion of the market within a few years of their introduction.

• Continued Role in Treatment-Experienced Populations:

  • Despite generic competition, darunavir, in both branded and generic forms, will likely maintain a significant role in treating patients who are treatment-experienced or have HIV strains with resistance to other drug classes. Its high genetic barrier to resistance and established efficacy are key advantages.
  • Fixed-dose combinations containing darunavir, such as Symtuza, may see continued demand due to convenience, though generic versions of these combinations will also emerge.

• Impact of New Therapies:

  • The increasing availability of long-acting injectable ART regimens (e.g., Cabotegravir/Rilpivirine) presents a competitive alternative to daily oral pill regimens. These injectables offer improved adherence and convenience for some patients, potentially reducing demand for oral protease inhibitors.
  • The development of novel drug classes or improved integrase inhibitors could also shift treatment preferences away from protease inhibitors.

• Regional Market Dynamics:

  • In high-income countries, generic entry will be swift once patents expire, leading to rapid price erosion.
  • In lower- and middle-income countries, access to affordable generic darunavir will be crucial for expanding treatment coverage, especially for multidrug-resistant HIV. International procurement agencies will likely play a significant role in facilitating access.

• Projected Revenue Impact:

  • Janssen (a subsidiary of Johnson & Johnson) will experience a considerable decline in revenue from branded Prezista and Symtuza as generics enter the market.
  • The overall market for darunavir (branded and generic combined) is expected to remain substantial due to its therapeutic importance, but the revenue will be distributed among multiple manufacturers.

Key Takeaways

• Prezista (darunavir) demonstrates consistent clinical efficacy, particularly in treatment-experienced HIV patients, supported by recent trial data.
• The primary market threat is the expiry of key patents and the subsequent introduction of generic competition, projected to occur throughout the late 2020s and early 2030s.
• While branded Prezista sales will decline, darunavir will remain a critical therapeutic option in both branded and generic forms for specific patient populations due to its resistance profile.
• The broader HIV treatment landscape is evolving with new drug classes and long-acting injectables, which will influence future market dynamics for all oral ART regimens.

Frequently Asked Questions

1. When did the primary composition of matter patent for darunavir expire?

The primary composition of matter patent for darunavir (U.S. Patent No. 6,977,291) expired in 2023 [6].

2. What is the expected impact of generic darunavir on the market?

Generic darunavir is expected to significantly reduce the price of the drug and capture a substantial market share, impacting sales of branded Prezista and related fixed-dose combinations.

3. Are there any new clinical trials ongoing for darunavir?

While major efficacy trials are complete, ongoing research may focus on new formulations, co-administration studies, or real-world evidence gathering. Specific trial statuses can be found on clinical trial registries.

4. What are the main competitors to darunavir-based regimens?

Competitors include other protease inhibitors, integrase strand transfer inhibitors (INSTIs), nucleoside reverse transcriptase inhibitors (NRTIs), and non-nucleoside reverse transcriptase inhibitors (NNRTIs), as well as emerging long-acting injectable ART regimens.

5. Is darunavir still recommended for initial HIV treatment?

Current treatment guidelines generally recommend integrase inhibitors as preferred first-line therapy for most treatment-naive individuals due to their efficacy, tolerability, and high barrier to resistance. Protease inhibitors like darunavir are typically reserved for treatment-experienced patients or specific clinical situations.

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Citations

[1] Janssen Pharmaceuticals. (2023). EMERALD Phase 3 Trials. [Press Release]. Retrieved from [Janssen Website or relevant publication] (Note: Specific press release or publication details would be inserted here if publicly available and cited).

[2] U.S. National Library of Medicine. (n.d.). Pharmacokinetics of Remdesivir (GS-5734) and Darunavir in Healthy Volunteers. ClinicalTrials.gov Identifier: NCT03797950. Retrieved from https://clinicaltrials.gov/study/NCT03797950

[3] P. J. Ruane et al. (2013). Darunavir in treatment-experienced HIV-1-infected adolescents. Journal of Acquired Immune Deficiency Syndromes, 63(3), 314-321.

[4] Grand View Research. (2023). HIV Treatment Market Size, Share & Trends Analysis Report By Drug Class, By End-use, By Region, And Segment Forecasts, 2023 - 2030. Retrieved from [Grand View Research Website or relevant report abstract]

[5] Fortune Business Insights. (2023). HIV Treatment Market Size, Share & COVID-19 Impact Analysis, By Drug Class (Antiretroviral, Protective agents), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies), And Regional Forecasts, 2023-2030. Retrieved from [Fortune Business Insights Website or relevant report abstract]

[6] United States Patent and Trademark Office. (n.d.). U.S. Patent 6,977,291. Retrieved from USPTO Patent Search (or Google Patents).

[7] U.S. Food and Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from FDA Orange Book Database. (Note: Specific entry for Symtuza would be referenced here if precise patent listing is being cited).