Darunavir - Generic Drug Details

What are the generic drug sources for darunavir and what is the scope of freedom to operate?

Darunavir is the generic ingredient in two branded drugs marketed by Janssen Prods, Amneal, Annora Pharma, Aurobindo Pharma Ltd, Cipla, Dr Reddys, Hetero Labs Ltd Iii, Lupin Ltd, MSN, Mylan, Teva Pharms Usa, and Zydus Lifesciences, and is included in thirteen NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are twenty-five drug master file entries for darunavir. Fourteen suppliers are listed for this compound. There are nine tentative approvals for this compound.

Summary for darunavir

International Patents:	48
US Patents:	1
Tradenames:	2
Applicants:	12
NDAs:	13
Drug Master File Entries:	25
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	96
Clinical Trials:	226
Patent Applications:	7,945
Drug Prices:	Drug price trends for darunavir
What excipients (inactive ingredients) are in darunavir?	darunavir excipients list
DailyMed Link:	darunavir at DailyMed

See drug prices for darunavir

Recent Clinical Trials for darunavir

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

Sponsor	Phase
University of Nairobi	PHASE3
London School of Hygiene and Tropical Medicine	PHASE3
SolidarMed	PHASE3

See all darunavir clinical trials

Generic filers with tentative approvals for DARUNAVIR

Applicant	Application No.	Strength	Dosage Form
		400MG	TABLET;ORAL
		150MG	TABLET;ORAL
		600MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for darunavir

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

Anatomical Therapeutic Chemical (ATC) Classes for darunavir

J05AE	Protease inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for DARUNAVIR

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 darunavir

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma Ltd	DARUNAVIR	darunavir	TABLET;ORAL	210677-001	Nov 28, 2023	AB	RX	No	No
Teva Pharms Usa	DARUNAVIR	darunavir	TABLET;ORAL	202118-001	Nov 21, 2017		DISCN	No	No
Amneal	DARUNAVIR	darunavir	TABLET;ORAL	212493-001	Dec 8, 2023	AB	RX	No	No
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-001	Jun 23, 2006		DISCN	Yes	No					Y

Expired US Patents for darunavir

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-004	Dec 18, 2008
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-004	Dec 18, 2008
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-002	Feb 25, 2008
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-006	Nov 9, 2012

EU/EMA Drug Approvals for darunavir

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 darunavir

Country	Patent Number	Title	Estimated Expiration
Norway	20045409
Brazil	PI0311176	pseudopolimorfo na forma de etanolato, seu uso, processo de preparação do mesmo e composição farmacêutica
European Patent Office	1567529	FORMES PSEUDOPOLYMORPHIQUES DE L'INHIBITEUR DE LA PROTEASE DU VIH (PSEUDOPOLYMORPHIC FORMS OF A HIV PROTEASE INHIBITOR)
South Korea	101128370

Supplementary Protection Certificates for darunavir

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2487162	PA2016040	Lithuania		PRODUCT NAME: DARUNAVIRAS + KOBICISTATAS; REGISTRATION NO/DATE: EU/1/14/967 20141119
3150586	122020000022	Germany		PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON, DARUNAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON UND EMTRICITABIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/17/1225 20170921
2487162	2016C/068	Belgium		PRODUCT NAME: COBICISTAT ET DARUNAVIR; AUTHORISATION NUMBER AND DATE: EU/1/14/967 20141121
0810209	CA 2007 00017	Denmark		PRODUCT NAME: DARUNAVIR OG ET FARMACEUTISK ACCEPTABELT SALT DERAF

Market Dynamics and Financial Trajectory for Darunavir: A Comprehensive Analysis

Last updated: July 28, 2025

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Introduction

Darunavir, marketed primarily under the brand name Prezista among others, is a protease inhibitor (PI) prescribed for treating Human Immunodeficiency Virus (HIV) infections. Since its approval by the U.S. Food and Drug Administration (FDA) in 2011, darunavir has established itself as a cornerstone in antiretroviral therapy (ART) regimens, especially for treatment-experienced patients. This article examines the evolving market dynamics and financial trajectory of darunavir, emphasizing factors influencing its demand, competitive landscape, pricing strategies, and future growth prospects.

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Pharmacological Profile and Clinical Significance

Darunavir inhibits HIV-1 protease, an enzyme essential for viral replication. Its efficacy, high genetic barrier to resistance, and tolerability have made it a preferred option in combination therapies (as part of HAART). Its profile benefits complex treatment regimens, especially in resistance cases, granting it a stable position in the HIV drug market (1).

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Market Dynamics

Global HIV Landscape and Impact on Darunavir Demand

The global HIV epidemic continues to influence the demand for antiretroviral therapies. According to UNAIDS, approximately 38 million people worldwide were living with HIV in 2021, with around 28 million on ART, many of whom are prescribed darunavir as part of their regimen (2). Regions with high HIV prevalence, such as Sub-Saharan Africa, Latin America, and parts of Asia, are crucial markets.

While the majority of HIV patients in developing regions are on first-line therapies involving generic drugs, darunavir's role is increasingly significant in treatment-experienced patients or those with resistance issues. The demand is thus partly driven by the rising need for effective salvage therapies.

Patent Expirations and Generic Competition

Originally marketed by Janssen Pharmaceuticals, darunavir faced patent protections expiring in key markets, including the U.S. and Europe, around 2025-2026. Patent expiry typically results in the entry of generic formulations, exerting downward pressure on prices and profitability (3). These generics often access lower-income markets, expanding the drug’s global reach but compressing revenue streams for originator companies.

Pricing and Reimbursement Dynamics

Pricing strategies for darunavir are influenced by factors including patent protection, regulatory approvals, negotiated discounts, and country-specific reimbursement policies. In high-income markets, originators maintain premium pricing justified by clinical benefits and patents. Conversely, generic entrants stimulate price competition, especially in EMN (Emerging Market Nations).

Reimbursement frameworks, particularly in the U.S., governed by systems like Medicaid and private insurers, impact access and sales volume. The adoption of value-based pricing models also influences pricing strategies in developed markets.

Competitive Landscape

Darunavir competes with other protease inhibitors such as atazanavir, lopinavir, and newer agents like darunavir-based fixed-dose combinations (FDCs). The introduction of alternative drug classes, notably integrase strand transfer inhibitors (INSTIs) such as dolutegravir and bictegravir, has shifted treatment paradigms towards simplified, once-daily regimens with fewer adverse effects (4). This shifting preferences impact darunavir's market share, especially in regimens not requiring multiple drugs.

The development pipeline includes next-generation protease inhibitors and drugs targeting novel mechanisms, promising to challenge darunavir’s market dominance in the future.

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Financial Trajectory

Historical Revenue Trends

Janssen’s annual reports indicate consistent revenue streams from darunavir formulations prior to patent expiry. The peak revenues occurred around 2017–2018, with subsequent stabilization or slight decline as competition intensified (5). The revenues are also influenced by the launch of proprietary FDCs containing darunavir with other agents, which typically command higher margins.

Impact of Patent Expiration

Patent cliffs have significantly influenced the financial performance of darunavir. After patent expiry, revenue erosion is intensively observed as generics flood markets. For instance, in Europe, generic versions of darunavir entered markets in 2025, potentially reducing originator sales by over 50% within the subsequent years. Consequently, Janssen and other producers anticipate a marked decline in revenue from this molecule.

Pricing and Volume Dynamics

To mitigate revenue decline, originators have employed strategies such as:

• Introducing Fixed-Dose Combinations (FDCs): Combining darunavir with ritonavir or cobicistat for simplified regimens enhances patient adherence and preserves margins.
• Expanding Indications: Exploring darunavir's use in pre-exposure prophylaxis (PrEP) remains limited but could provide future revenue streams.
• Pricing Adjustments Post-Patent: Offering lower-cost generic versions in emerging markets to retain volume share.

Emergence of Generics and Market Penetration

Post-patent, generics are projected to capture a significant proportion of the market. According to industry estimates, generic darunavir is priced 30-50% lower than branded versions, significantly impacting profits for originator companies (6). The pace of market penetration in developing nations is high, driven by affordability and access initiatives.

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Future Outlook and Growth Opportunities

Innovations and Pipeline Developments

Though current formulations face stiff generic competition, ongoing research aims to improve upon darunavir's pharmacokinetic profile and resistance management. Next-generation protease inhibitors with higher barriers to resistance or less frequent dosing may extend its relevance.

Regulatory and Policy Factors

International efforts to expand access in low-income countries, such as the WHO’s prequalification initiatives and tiered pricing, may extend darunavir’s reach, stabilizing demand in certain segments.

Market Expansion into Niche Indications

While primarily an HIV therapy, exploratory uses in other viral infections or for chemoprophylaxis are unlikely to significantly alter its financial trajectory without substantial clinical breakthroughs.

Impact of Emerging Therapies

The rapid adoption of INSTIs, especially once-daily regimens with favorable side-effect profiles, is reducing reliance on protease inhibitors like darunavir. Market share is expected to decline unless sustained by resistance or specific patient needs.

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Regulatory and Competitive Challenges

Regulatory agencies are scrutinizing the safety profile of long-term protease inhibitor use due to metabolic adverse effects such as dyslipidemia and insulin resistance. These safety concerns could influence prescribing patterns, impacting revenue potential.

Furthermore, patent disputes and patent extensions remain pivotal. If originator companies can prolong patent protections through secondary patents or patent evergreening strategies, it may temporarily shield revenues.

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Key Takeaways

• Evolving Market Influences: HIV prevalence, treatment guidelines, and resistance patterns significantly shape darunavir’s demand.
• Patent and Generic Competition: Patent expiration around 2025-2026 remains a critical juncture; generics will pressure revenues but expand access.
• Pricing Trends: Premium pricing in developed markets contrasts with aggressive price reductions in emerging markets post-patent expiry.
• Shifting Treatment Paradigms: INSTI-based therapies are eroding protease inhibitor market share, compelling darunavir to innovate or target niche segments.
• Upcoming Opportunities: Next-generation formulations, fixed-dose combinations, and expanded indications may bolster darunavir’s longevity.

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Conclusion

Darunavir’s market dynamics are intricately linked to the global HIV epidemic, regulatory policies, and competitive innovations. While patent expirations present challenges, strategic positioning through FDCs and emerging markets could sustain its relevance. Nevertheless, the prominence of newer drug classes and safety considerations suggest a gradual decline in its market share over the next decade, necessitating adaptive strategies from manufacturers and stakeholders.

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FAQs

1. When is darunavir’s patent expiry, and how will it impact the market?
Patent protections for darunavir are expected to lapse around 2025-2026 in major markets, ushering in generic competition that will reduce average selling prices and sales revenues for branded formulations.

2. How does darunavir compare to newer antiretroviral agents?
Darunavir offers high efficacy in resistant HIV strains but faces competition from INSTIs like dolutegravir, which boast simpler dosing, fewer side effects, and broader adoption, leading to a declining share in first-line therapies.

3. What are the primary regions driving darunavir sales?
The U.S. and Europe lead in developed-market sales, while emerging markets like India, South Africa, and Latin America contribute significantly as access expands. Post-patent, these regions will see increased generic use.

4. Are there new formulations or indications for darunavir?
Current research is focused on improved formulations and fixed-dose combinations. No significant new indications beyond HIV treatment are anticipated in the near future.

5. What strategies can originator companies adopt to preserve profitability?
They may leverage patent litigations, develop novel formulations, expand into niche markets, negotiate favorable reimbursement policies, or focus on high-resistance cases where generics are less preferred.

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References

1. UNAIDS. Global HIV & AIDS statistics — 2022 fact sheet.
2. UNAIDS. Global AIDS update 2022.
3. Market Research Future. Darunavir market analysis, 2022.
4. WHO Guidelines. Consolidated guidelines on HIV treatment, 2021.
5. Janssen Annual Reports. Financial and sales data, 2017–2022.
6. Industry Reports. Generic drug market forecasts, 2023.

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(Note: This analysis is based on publicly available data and industry estimates as of 2023. Future market developments may vary based on regulatory changes, scientific breakthroughs, and market dynamics.)