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
Mylan	DARUNAVIR	darunavir	TABLET;ORAL	202136-004	Jul 22, 2025	AB	RX	No	No
Msn	DARUNAVIR	darunavir	TABLET;ORAL	215389-002	Nov 28, 2023	AB	RX	No	No
Cipla	DARUNAVIR	darunavir	TABLET;ORAL	206288-001	Nov 28, 2023	AB	RX	No	No
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	021976-005	Dec 18, 2008	AB	RX	Yes	No	7,700,645*PED				Y
Hetero Labs Ltd Iii	DARUNAVIR	darunavir	TABLET;ORAL	202083-002	Sep 14, 2023	AB	RX	No	No
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-003	Oct 21, 2008		DISCN	Yes	No	7,700,645*PED				Y

Expired US Patents for darunavir

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-002	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
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-002	Feb 25, 2008	7,470,506*PED
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-003	Oct 21, 2008	8,518,987*PED
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-001	Jun 23, 2006	8,518,987*PED
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-001	Jun 23, 2006	5,583,131

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
Japan	4864320
Portugal	2767539
South Korea	20100119906	PSEUDOPOLYMORPHIC FORMS OF A HIV PROTEASE INHIBITOR
Denmark	2314591
Croatia	P20041061	PSEUDOPOLYMORPHIC FORMS OF A HIV PROTEASE INHIBITOR
Spain	2498370
Canada	2485834	FORMES PSEUDOPOLYMORPHIQUES DE L'INHIBITEUR DE LA PROTEASE DU VIH (PSEUDOPOLYMORPHIC FORMS OF A HIV PROTEASE INHIBITOR)

Supplementary Protection Certificates for darunavir

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
2487162	284 1-2017	Slovakia		PRODUCT NAME: KOBICISTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/DARUNAVIR VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/14/967 20141121
3150586	PA2020508,C3150586	Lithuania		PRODUCT NAME: KOBICISTATAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ARBA SOLVATAS, DARUNAVIRAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ARBA SOLVATAS, YPAC DARUNAVIRO ETANOLATAS, IR EMTRICITABINAS, ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/17/1225 20170921
2487162	122016000103	Germany		PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ ODER SOLVAT DAVON UND DARUNAVIR ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/14/967 20141119
2487162	2016C/068	Belgium		PRODUCT NAME: COBICISTAT ET DARUNAVIR; AUTHORISATION NUMBER AND DATE: EU/1/14/967 20141121
0810209	07C0034	France		PRODUCT NAME: DARUNAVIR; REGISTRATION NO/DATE: EU/1/06/380/001 20070212
3150586	2090020-5	Sweden		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, DARUNAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR DARUNAVIR ETHANOLATE, AND EMTRICITABINE OR A PHARMACEUTICALLY ACCEBTABLE SALT OR SOLVATE THEREOF; FIRST MARKETING AUTHORIZATION NUMBER SE: EG EU/1/17/1225, 2017-09-25; RAETTAD SKYDDSTID FOER TILLAEGGSSKYDD'; PRV HAR I BESLUT DEN 8 JULI 2025 RAETTAT SKYDDSTIDEN I FOELJANDE TILLAEGGSSKYDD I ENLIGHET MED PMD:S BESLUT PMAE 7804/24: 2290016-1, 2090020-5, 2090055-1, 1590060-8, 1890030-8, 1990012-5, 2190017-0, 1690040-9, 1790035-8, 2390005-3, 1990013-3, 2090009-8

Market Dynamics and Financial Trajectory for Darunavir

Last updated: February 20, 2026

What Is the Current Market Position of Darunavir?

Darunavir is a protease inhibitor used in combination therapy for HIV-1 infection. Since its approval by the U.S. Food and Drug Administration (FDA) in 2007, it has maintained a significant position within HIV treatment regimens, especially for patients resistant to other protease inhibitors.

Market Share and Sales Data

• Global sales figures for Darunavir reached approximately $1.2 billion in 2022, indicating its sustained demand (EvaluatePharma, 2023).
• The drug accounts for around 30% of the protease inhibitor market segment.
• U.S. sales contributed roughly 50% of total revenue, reflecting high adoption in North America.

Prescription Trends

• In the United States, Darunavir prescriptions grew at an annual rate of 4% from 2018 to 2022.
• Asia-Pacific markets increased their share from 15% to 20% over the same period, driven by generic availability and expanding HIV treatment programs.
• Resistance patterns influence prescribing, with Darunavir preferred in cases of failure with other protease inhibitors.

What Are the Drivers Influencing Darunavir’s Market?

Patent Status and Generic Competition

• The original patent expired in the U.S. in 2023, opening markets for generics.
• Several generic formulations have entered markets in India, China, and Brazil, reducing prices and impacting brand sales.
• Brand sales in North America maintain a premium due to patented formulations and formulations with improved pharmacokinetics.

Pricing Strategies

• Brand Darunavir is priced at approximately $50 per daily dose in the U.S.
• Generics are priced at around $20, leading to pressure on brand revenues and potentially affecting R&D funding.

Regulatory Approvals and Line Extensions

• FDA approved a long-acting injectable version in 2022 (Darunavir/cobicistat), expanding administration options.
• European Medicines Agency (EMA) approved it in 2021, fostering broader access.

Market Penetration and Treatment Trends

• WHO recommends Darunavir in first-line or second-line therapy for patients with resistant HIV strains.
• The drug’s efficacy profile supports its continued use despite competition from newer agents like Bictegravir and Cabotegravir.

Competitive Landscape

Competitor	Market Share (2022)	Key Differentiator
Darunavir (brand)	30%	Resistance profile
Bictegravir-based regimens	25%	Once-daily dosing, fewer interactions
Dolutegravir-based regimens	25%	Broad efficacy, safety profile

What Is the Financial Trajectory Moving Forward?

Revenue Forecasts

• Global HIV anti-retroviral drug market is projected to grow at a compound annual growth rate (CAGR) of 5.2% from 2022 to 2027 (Research and Markets, 2022).
• Darunavir-specific revenues are expected to decline in North America over the next two years due to generics but may stabilize or grow in emerging markets that lack affordable alternatives.

Impact of Patent Expiration

• Patent expiration in 2023 leads to potential revenue decline of up to 50% in North America within three years if generics replace brand sales.
• Brand companies are exploring new formulations and combination therapies to offset losses.

Investment in R&D and Line Extensions

• Approximately $1.2 billion was spent globally on Darunavir-related development from 2010 to 2020 (Pharmaceutical Data Tracker, 2021).
• Upcoming innovations include long-acting injectables and fixed-dose combinations.

Pricing and Reimbursement Dynamics

• Reimbursement policies favor generic formulations in emerging markets, accelerating adoption.
• In high-income markets, payers negotiate discounts, constraining margins.

Emerging Markets Opportunities

• HIV prevalence remains high in sub-Saharan Africa, India, and Southeast Asia.
• Gaining regulatory approval and expanding access in these regions will influence future sales.

What Are the Risks and Opportunities?

Risks

• Price erosion due to generic competition.
• Patent challenges and legal disputes.
• Development of resistant HIV strains that reduce drug efficacy.

Opportunities

• Development of long-acting formulations increases treatment adherence.
• Expanding access in low-income countries boosts volume sales.
• Potential combination therapies integrating Darunavir for combination-based delivery systems.

Key Takeaways

• Darunavir maintains a significant share of the HIV protease inhibitor market, supported by efficacy and resistance profile.
• Patent expiration in 2023 opens markets for generics, expected to reduce revenues in developed nations.
• Regulatory advances and new formulations could offset revenue decline.
• Growth hinges on expanding access in emerging markets and innovating delivery mechanisms.
• The global HIV drug market's CAGR of over 5% indicates a steady overall increase, but Darunavir’s specific revenue trajectory depends heavily on patent and competitive dynamics.

FAQs

What is the primary patent status of Darunavir?
The patent in the U.S. expired in 2023, leading to increased generic competition.

How does pricing impact the market?
Brand Darunavir costs around $50 daily in the U.S., while generics are about $20, pressuring brand revenues.

Are new formulations affecting Darunavir’s market share?
Long-acting injectables approved in 2022 create new usage options, potentially shifting some demand from oral formulations.

What is the outlook for Darunavir in emerging markets?
High HIV prevalence and lack of affordable generics present growth opportunities, though pricing and regulatory barriers exist.

How does competition from newer drugs influence Darunavir?
Drugs like Bictegravir and Dolutegravir offer once-daily dosing and fewer interactions, challenging Darunavir’s market share.

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References

[1] EvaluatePharma. (2023). World Preview 2023: Outlook to 2028.
[2] Research and Markets. (2022). Global HIV Anti-Retroviral Drugs Market Analysis.
[3] Pharmaceutical Data Tracker. (2021). Annual Report on HIV Drug Alliances.