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, Aurobindo Pharma Ltd, Cipla, Dr Reddys, Hetero Labs Ltd Iii, Lupin Ltd, MSN, Teva Pharms Usa, and Zydus Lifesciences, and is included in eleven NDAs. There are two patents 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. Thirteen suppliers are listed for this compound. There are eight tentative approvals for this compound.

Summary for darunavir

International Patents:	48
US Patents:	2
Tradenames:	2
Applicants:	10
NDAs:	11
Drug Master File Entries:	25
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	96
Clinical Trials:	220
Patent Applications:	6,298
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
Centre Mère et Enfant de la Fondation Chantal Biya	Phase 1/Phase 2
AMS-PHPT Research Collaboration	Phase 1/Phase 2
University of Zimbabwe Clinical Research Centre (UZCRC)	Phase 1/Phase 2

See all darunavir clinical trials

Generic filers with tentative approvals for DARUNAVIR

Applicant	Application No.	Strength	Dosage Form
		150MG	TABLET;ORAL
		600MG	TABLET;ORAL
		400MG	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
Msn	DARUNAVIR	darunavir	TABLET;ORAL	215389-001	Nov 28, 2023	AB	RX	No	No
Lupin Ltd	DARUNAVIR	darunavir	TABLET;ORAL	202073-002	Sep 29, 2022	AB	RX	No	No
Amneal	DARUNAVIR	darunavir	TABLET;ORAL	212493-002	Dec 8, 2023	AB	RX	No	No
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-004	Dec 18, 2008		RX	Yes	No					Y
Lupin Ltd	DARUNAVIR	darunavir	TABLET;ORAL	202073-001	Sep 29, 2022	AB	RX	No	No

Expired US Patents for darunavir

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-001	Jun 23, 2006
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-003	Oct 21, 2008
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-005	Dec 18, 2008
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-004	Dec 18, 2008
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-003	Oct 21, 2008

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/004068 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 (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/000707 PREZISTA, 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/004891 400mg 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/004273 400 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
Denmark	1567529
Cyprus	1119311
Australia	2012205289	Pseudopolymorphic forms of a HIV protease inhibitor
Cyprus	1117928
Hungary	E034389

Supplementary Protection Certificates for darunavir

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0810209	33/2007	Austria		PRODUCT NAME: DARUNAVIR UND DESSEN PHARMAZEUTISCH VERTRAEGLICHE SALZE; REGISTRATION NO/DATE: EU/1/06/380/001 - EU/1/06/380/008 20070212
0810209	122007000045	Germany		PRODUCT NAME: DARUNAVIR ODER PHARMAZEUTISCH VERTRAEGLICHE SALZE, ESTER ODER PRODRUGS DAVON; REGISTRATION NO/DATE: EU/1/06/380/001 20070212
0810209	C300283	Netherlands		PRODUCT NAME: DARUNAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER, IN HET BIJZONDER DARUNAVIR ETHANOLAAT; REGISTRATION NO/DATE: EU/1/06/380/001 20070212
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
0810209	SZ 33/2007	Austria		PRODUCT NAME: DARUNAVIR UND DESSEN PHARMAZEUTISCH VERTRAEGLICHE SALZE

Darunavir Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Darunavir

Introduction to Darunavir

Darunavir, a protease inhibitor, is a crucial antiretroviral medication used in the treatment of HIV infection. It is often boosted with low-dose ritonavir to enhance its efficacy. The drug has gained significant traction due to its superior safety profile and effectiveness in managing HIV, particularly in treatment-experienced patients.

Market Size and Projections

The darunavir market has been experiencing steady growth, driven by increasing global demand for effective HIV treatments. As of 2023, the darunavir market was valued at USD 1.12 billion and is projected to reach USD 1.52 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 4.8% from 2024 to 2031[1].

Segmentation and Market Analysis

The darunavir market is segmented based on application, product, and geographical regions.

Application Segments

• Darunavir Tablets: These are a common form of the drug and are widely used.
• Darunavir Oral Suspension: This form is particularly useful for patients who have difficulty swallowing tablets.
• Darunavir Combination Therapies: These include fixed-dose combinations and other antiretroviral therapies.
• Generic Darunavir: The availability of generic versions has expanded access to the drug.
• Darunavir-Based Fixed-Dose Combinations: These combinations enhance treatment adherence and efficacy[1].

Product Segments

• HIV Treatment: Darunavir is primarily used in the treatment of HIV.
• Antiretroviral Therapy: It is often used as part of a broader antiretroviral regimen.
• Combination Therapy: Darunavir is frequently combined with other antiretrovirals.
• Treatment for Resistant Strains: Its effectiveness against resistant HIV strains is a significant market driver.
• HIV Prevention: While not its primary use, darunavir can be part of pre-exposure prophylaxis (PrEP) regimens in certain cases[1].

Geographical Segments

The market is analyzed across regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. The Asia-Pacific region is expected to show significant growth due to increasing healthcare infrastructure and access to HIV treatment[1].

Market Drivers

Several factors are driving the growth of the darunavir market:

Increasing Global Prevalence of HIV/AIDS

The rising number of HIV/AIDS cases globally necessitates effective treatment options, making darunavir a critical component of antiretroviral therapy[1].

Advances in Healthcare Infrastructure

Improvements in healthcare infrastructure, especially in emerging countries, have increased access to HIV treatment, thereby boosting the demand for darunavir[1].

Continuous Clinical Research

Ongoing research into optimal treatment regimens and the development of combination therapies containing darunavir contribute to its growing market presence[1].

Cost-Effectiveness

Studies have shown that darunavir/ritonavir regimens are cost-effective, especially in treatment-experienced patients, which further supports its market growth. For instance, a study indicated that darunavir/ritonavir remained cost-effective over various parameter ranges, with an incremental cost-effectiveness ratio (ICER) of US$23,057 per quality-adjusted life-year (QALY) gained[2].

Competitive Landscape

The darunavir market is competitive, with several key players:

• Janssen Pharmaceuticals: The original developer of darunavir.
• Mylan: Known for its generic versions of the drug.
• Teva: Another major player in the generic market.
• Aurobindo Pharma, Cipla, Sun Pharma, Hetero Drugs, Emcure Pharmaceuticals, Glenmark, and Zydus Cadila: These companies are also significant contributors to the market, offering various formulations and combinations of darunavir[1].

Financial Performance and Projections

The financial trajectory of the darunavir market is robust, with steady growth anticipated:

• Market Value: The market was valued at USD 1.12 billion in 2023 and is expected to reach USD 1.52 billion by 2031[1].
• CAGR: A CAGR of 4.8% from 2024 to 2031 indicates a stable and growing market[1].
• Segmental Growth: The fastest-growing segments are expected to be combination therapies and generic darunavir, driven by their cost-effectiveness and broader accessibility[1].

Regional Market Dynamics

• North America and Europe: These regions have a well-established market for darunavir due to high awareness and advanced healthcare systems.
• Asia-Pacific: This region is expected to show the highest growth rate due to increasing healthcare infrastructure and access to HIV treatment.
• Middle East and Africa: These regions are also seeing growth, though at a slower pace, due to improving healthcare access and awareness[1].

Challenges and Opportunities

Challenges

• Drug Resistance: The emergence of drug-resistant HIV strains can impact the efficacy of darunavir.
• Regulatory Hurdles: Strict regulatory environments can slow down the approval and launch of new formulations.
• Competition: The presence of other antiretroviral drugs and generics can pose competition[4].

Opportunities

• Emerging Markets: Expanding healthcare access in emerging countries presents significant growth opportunities.
• Research and Development: Continuous R&D into combination therapies and fixed-dose combinations can enhance market share.
• Public Health Initiatives: Global initiatives to combat HIV/AIDS can increase demand for effective treatments like darunavir[1].

Key Takeaways

• The darunavir market is valued at USD 1.12 billion in 2023 and is projected to reach USD 1.52 billion by 2031.
• The market is driven by its effectiveness, advances in healthcare infrastructure, and continuous clinical research.
• Key players include Janssen Pharmaceuticals, Mylan, Teva, and several other generic manufacturers.
• The Asia-Pacific region is expected to show the highest growth rate.
• The market faces challenges such as drug resistance and regulatory hurdles but offers opportunities in emerging markets and R&D.

FAQs

1. What is the current market size of the darunavir market? The darunavir market was valued at USD 1.12 billion in 2023[1].

2. What is the projected growth rate of the darunavir market from 2024 to 2031? The market is expected to grow at a CAGR of 4.8% from 2024 to 2031[1].

3. Which region is expected to dominate the global darunavir market? The Asia-Pacific region is expected to show the highest growth rate due to increasing healthcare infrastructure and access to HIV treatment[1].

4. What are the key drivers of the darunavir market? Key drivers include the increasing global prevalence of HIV/AIDS, advances in healthcare infrastructure, and continuous clinical research into optimal treatment regimens[1].

5. Is darunavir cost-effective compared to other antiretroviral therapies? Yes, studies have shown that darunavir/ritonavir regimens are cost-effective, with an ICER of US$23,057 per QALY gained[2].

Cited Sources

1. Market Research Intellect, "Darunavir Market Size and Projections - Market Research Intellect"
2. PubMed, "US cost effectiveness of darunavir/ritonavir 600/100 mg..."
3. Market Research Intellect, "Darunavir Ethanolate Market Size and Projections"
4. Cognitive Market Research, "Global Darunavir Market Report 2024 Edition"
5. JAMA Network, "Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults and Adolescents"