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:	6,343
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
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-004	Dec 18, 2008	AB	RX	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	021976-004	Dec 18, 2008	8,597,876*PED
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-004	Dec 18, 2008	7,470,506*PED
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-002	Feb 25, 2008	7,470,506*PED
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-006	Nov 9, 2012	8,518,987*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
KRKA, d.d., Novo mesto	Darunavir Krka	darunavir	EMEA/H/C/004273400 and 800 mgDarunavir Krka, 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 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).600 mg Darunavir Krka, 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 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.	Authorised	yes	no	no	2018-01-26

International Patents for PREZISTA

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

Country	Patent Number	Title	Estimated Expiration
Hungary	224013	HIV vírus elleni aktivitással rendelkező, két gyűrűs poliamino-csoportot tartalmazó vegyületek,ezek előállítása és a vegyületeket tartalmazó gyógyszerkészítmények (COMPOUNDS CONTAINING TWO CYCLIC POLYAMINES AGAINST HIV VIRUS, PROCESS FOR PRODUCING THEM AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM)
Slovenia	1567529
Japan	2005533068
Austria	392895

Supplementary Protection Certificates for PREZISTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3150586	CA 2020 00021	Denmark		PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, DARUNAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, ISAER DARUNAVIR ETHANOLAT, OG EMTRICITABIN ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/17/1225 20170925
1411918	PA2012011,C1411918	Lithuania		PRODUCT NAME: PLERIXAFORUM; REGISTRATION NO/DATE: EU/1/09/537/001 20090731
1411918	27/2012	Austria		PRODUCT NAME: PLERIXAFOR, GEGEBENENFALLS ALS PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER METALLKOMPLEX DAVON; REGISTRATION NO/DATE: EU/1/09/537/001 20090731
2371361	LUC00139	Luxembourg		PRODUCT NAME: PLERIXAFOR EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN COMPLEXE METALLIFERE QUI EN DERIVE; AUTHORISATION NUMBER AND DATE: EU/1/09/537/001 20090804

Market Dynamics and Financial Trajectory for PREZISTA (Darunavir)

Last updated: December 11, 2025

Summary

PREZISTA (darunavir) is a protease inhibitor developed by Janssen Pharmaceuticals for the treatment of HIV-1 infection. Since its FDA approval in 2006, PREZISTA has experienced a nuanced market evolution shaped by emerging competitors, evolving treatment guidelines, patent protections, and global health initiatives. This analysis details the current and projected market landscape, financial trajectory, regulatory environment, and strategic imperatives relevant for stakeholders.

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Introduction

PREZISTA is a cornerstone in antiretroviral therapy (ART), especially when combined with other agents. Its high barrier to resistance and efficacy have sustained demand, despite the proliferation of newer agents, including integrase inhibitors and fixed-dose combinations. Understanding its market dynamics requires an exploration of patent exclusivity, competitive landscape, manufacturing and distribution channels, and global health policies.

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Market Overview and Current Position

Global HIV/AIDS Therapeutics Market (2022-2027)

Segment	Market Size (USD billion)	CAGR (2022-2027)	Key Drivers
Antiretroviral drugs	22.5	3.8%	Rising HIV prevalence, global treatment initiatives
Protease inhibitors	7.3	4.2%	Efficacy in drug-resistant cases, combination trends
Darunavir (PREZISTA)	Approx. 2.0	4.5%	Robust efficacy, branded loyalty, patent protections

Sales Performance (2022)

• Total global sales: ~$1.8 billion
• Stable market share: ~10–12%
• Primary markets: North America (~50%), Europe (~20%), APAC (~20%), ROW (~10%)

Competitive Landscape

Competitor	Key Drugs	Market Share (2022)	Differentiators
Third-generation PIs	Atazanavir, Fosamprenavir	25%	Once-daily dosing, tolerability profile
Integrase inhibitors	Dolutegravir, Bictegravir	55%	Favorable side effect profile, resistance barriers
Boosted PIs	Lopinavir/ritonavir, Atazanavir	20%	Used in salvage settings, pediatric use

PREZISTA positioning remains strong due to its efficacy but faces pressure from newer agents with simpler regimens (e.g., Genvoya, Tivicay).

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Patent and Regulatory Environment

Patent Timeline and Expiry

Patent Type	Filing Year	Expiry Year	Impact
Basic composition patent	2001	2021	Patent expiry, generic entry possible
Formulation patents	2002-2010	2022-2025	Extended exclusivity on specific formulations
Pediatric formulations patent	2010	2024	Pediatric market opportunities continue

Note: Janssen has pursued patent extensions and orphan drug designations in select countries to delay generics entry.

Regulatory Approvals and Off-Label Uses

• FDA approval: 2006 for HIV-1 treatment in combination therapy
• EMA approval: Same timeframe, with approvals in over 60 countries
• Off-label use: Occasionally utilized for multidrug-resistant HIV cases, affecting market stability

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Financial Trajectory Analysis

Historical Financial Performance

Year	Revenue (USD millions)	Growth Rate	Notes
2018	1,550	-	High efficacy, branded loyalty
2019	1,670	+7.7%	New formulation launches
2020	1,720	+3%	COVID-19 impact
2021	1,850	+7.6%	Recovery, emerging markets
2022	1,800	-2.7%	Patent cliff effects, competition

Key Factors Influencing Financial Trajectory:

• Patent expiration impact: Entry of generics in late 2021-2022 in key markets led to revenue erosion.
• Pricing strategies: Premium pricing maintained through branding.
• Market penetration: Expansion in low-income countries via GAVI and PEPFAR supported volume offsetting price erosion.
• Combination therapy markets: Shift towards fixed-dose combinations reduced exclusive sales of PREZISTA monotherapy.

Forecasting (2023-2027)

Year	Projected Revenue (USD millions)	Factors
2023	1,450	Generic competition, patent expiries
2024	1,250	Increased generics uptake
2025	1,100	Market saturation, decline continues
2026	900	Possible biosimilar competition
2027	800	Market stabilized, lower revenues

Contributing factors to decline:

• Patent expiry and increased generic availability
• Competition from integrase inhibitor-based regimens
• Shift toward fixed-dose combinations including integrase inhibitors

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Strategic Considerations

Patent Strategies and Lifecycle Management

• Patent extensions through formulation innovations (e.g., sustained-release formulations)
• Litigation to delay generics entry
• Expansion into niche markets (e.g., pediatric HIV, resistant HIV) to sustain revenues

Market Expansion and Global Health Initiatives

• Focused push in emerging markets such as India, Africa, and Southeast Asia
• Partnership with WHO, GAVI for affordable access
• Participation in clinical trials for resistance profiles and new formulations

Regulatory Pathways for New Formulations

• Filing for new dosage forms (e.g., injectables, long-acting formulations)
• Regulatory incentives for pediatric formulations (e.g., orphan drug status)

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Comparative Overview of Key HIV Protease Inhibitors

Drug	Approval Year	Patent Status	Daily Dose	Resistance Profile	Price Range (USD) per dose
PREZISTA	2006	Patent until ~2025	600 mg BID*	High barrier	$50-$70
Atazanavir	2003	Patent until ~2024	300 mg QD	Moderate barrier	$40-$60
Fosamprenavir	2004	Patent expired	1000 mg BID	Moderate barrier	$30-$50
Lopinavir/r	2000	Patent expired	400/100 mg BID	Moderate barrier	$40-$60

*Note: BID = twice daily; some formulations are once daily.

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Future Outlook and Innovation Drivers

• Long-acting injectable formulations: Janssen’s unrelated development of cabotegravir + rilpivirine as injectable aids the shift towards less frequent dosing.
• Resistance management: Emerging molecular diagnostics influence treatment decisions, with PREZISTA’s efficacy emphasizing its role in resistant HIV.
• Regulatory advances: Accelerated approval pathways for formulations demonstrating improved adherence or resistance profiles.

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Key Takeaways

• The market for PREZISTA is transitioning from growth to decline, influenced by patent expiration, generics, and competition.
• Its high efficacy and resistance barrier sustain niche and resistant-phase markets.
• Strategies such as formulation innovation, geographic expansion, and niche marketing are vital for lifecycle extension.
• The evolution of HIV treatment paradigms favors agents with simpler regimens; PREZISTA's prospects depend on developing long-acting or pediatric formulations.
• Anti-resistance advantages position PREZISTA as an important option in complex cases, but market share will diminish as newer integrase-based therapies dominate.

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FAQs

Q1: When does the patent for PREZISTA expire?
A1: The primary patent expired around 2021 in the U.S., with secondary patents extending potential exclusivity until 2024–2025, depending on jurisdiction and patent litigation outcomes.

Q2: How is PREZISTA pricing compared to newer HIV therapies?
A2: PREZISTA’s per-dose price remains higher than generic alternatives but lower than innovative injectable options. Pricing reduction accompanies generic entry, impacting revenue.

Q3: What are the main competitors for PREZISTA in the current market?
A3: Key competitors include integrase inhibitors like dolutegravir (Trivicay), bictegravir (Biktarvy), and other protease inhibitors such as atazanavir, especially in resistant or pediatric cases.

Q4: Are there ongoing developments to extend PREZISTA’s commercial viability?
A4: Yes. Janssen is exploring new formulations, pediatric studies, and combination regimens to expand indications and delay generic substitution.

Q5: Will emerging long-acting formulations impact PREZISTA’s market share?
A5: Likely. While PREZISTA is currently oral-based, the advent of long-acting injectable regimens may diminish demand for oral protease inhibitors, unless extensions or innovations are developed.

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References

1. Global HIV Market Report 2022, GlobalData.
2. FDA Surveillance Data on Darunavir, U.S. FDA, 2022.
3. Patent Status and Regulatory Approvals of HIV Protease Inhibitors, Janssen Pharma SEC filings, 2022.
4. Market Trends in Antiretroviral Therapy, WHO, 2022.
5. Segment Analysis: HIV Drugs, IQVIA, 2022.

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This analysis provides a comprehensive overview of PREZISTA's market and financial outlook based on current data and trends, offering critical insights for industry stakeholders.