COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE - Generic Drug Details

What are the generic drug sources for cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate and what is the scope of freedom to operate?

Cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate is the generic ingredient in one branded drug marketed by Janssen Prods and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate has four hundred and eighty-five patent family members in fifty-one countries.

One supplier is listed for this compound.

Summary for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

International Patents:	485
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	3
DailyMed Link:	COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

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

Sponsor	Phase
Janssen Sciences Ireland UC	Phase 3
Janssen R&D Ireland	Phase 3
Gilead Sciences	Phase 2

See all COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE clinical trials

Pharmacology for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Drug Class	Cytochrome P450 3A Inhibitor Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor Protease Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors HIV Protease Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Nucleoside Reverse Transcriptase Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

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

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

V03AX	Other therapeutic products
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

Paragraph IV (Patent) Challenges for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SYMTUZA	Tablets	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	800 mg/150 mg/ 200 mg/10 mg	210455	1	2021-08-16

US Patents and Regulatory Information for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes			Y	Y
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes			Y
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes			Y	Y
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes			Y	Y
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes			Y	Y
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes			Y	Y

Expired US Patents for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018

International Patents for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Country	Patent Number	Title	Estimated Expiration
Japan	4881446
European Patent Office	2118082	MODULATEURS DE PROPRIÉTÉS PHARMACOCINÉTIQUES DE PRODUITS THÉRAPEUTIQUES (MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS)
Ukraine	115311	ГЕМІФУМАРАТ ТЕНОФОВІРУ АЛАФЕНАМІДУ (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Cyprus	1117928
New Zealand	579802	Compounds for improving the efficacy of other drugs
Canada	2725819	PROMEDICAMENTS A BASE D'ANALOGUES NUCLEOTIDIQUES DE PHOSPHONATE ET LEURS METHODES DE SELECTION ET D'ELABORATION (PRODRUGS OF PHOSPHONATE NUCLEOTIDE ANALOGUES AND METHODS FOR SELECTING AND MAKING SAME)
Japan	2010519314

Supplementary Protection Certificates for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2487163	300859	Netherlands		PRODUCT NAME: COBICISTAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN ATAZANAVIR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER ATAZANAVIRSULFAAT; REGISTRATION NO/DATE: EU/1/15/1025 20150715
2049506	C02049506/01	Switzerland		PRODUCT NAME: COBICISTAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 62673 18.10.2013
3150586	LUC00156	Luxembourg		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 ACCEPTABLE SALT OR SOLVATE THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/17/1225 20170925
2487166	132017000002828	Italy		PRODUCT NAME: COBICISTAT O UN SALE FARMACEUTICAMENTE ACCETTABILE DELLO STESSO E TENOFOVIR ALAFENAMIDE O UN SALE FARMACEUTICAMENTE ACCETTABILE DELLO STESSO, IN PARTICOLARE TENOFOVIR ALAFENAMIDE FUMARATO(GENVOYA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1061, 20151123
3150586	PA2020508	Lithuania		PRODUCT NAME: KOBICISTANAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS, DARUNAVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS, YPAC DARUNAVIRO ETANOLATAS, IR EMTRICITABINAS, ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/17/1225 20170921
2487163	PA2016039	Lithuania		PRODUCT NAME: ATAZANAVIRAS + KOBICISTATAS; REGISTRATION NO/DATE: EU/1/15/1025 20150713
2049506	92864	Luxembourg		PRODUCT NAME: COBICISTAT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/13/830/001-002 20130527

COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Cobicistat; Darunavir; Emtricitabine; Tenofovir Alafenamide Fumarate

Introduction to the Drug Combination

The drug combination of cobicistat, darunavir, emtricitabine, and tenofovir alafenamide fumarate, marketed as SYMTUZA™, is a significant advancement in the treatment of HIV-1 infection. This single-tablet regimen (STR) combines the protease inhibitor darunavir, the pharmacokinetic booster cobicistat, and the nucleos(t)ide reverse transcriptase inhibitors emtricitabine and tenofovir alafenamide (TAF)[2][4].

Market Size and Growth Projections

The global HIV drugs market, which includes this combination therapy, is projected to experience substantial growth over the next decade. The market size is expected to increase from approximately $36.22 billion in 2024 to around $66.16 billion by 2034, growing at a CAGR of 6.21%[1].

Regional Market Performance

North America

North America dominates the HIV drugs market, driven by the high prevalence of HIV infections in the U.S. and a robust healthcare infrastructure. The U.S. HIV drugs market alone was valued at $11.76 billion in 2023 and is projected to reach $23.23 billion by 2034, growing at a CAGR of 6.38%[1].

Asia Pacific

The Asia Pacific region is anticipated to be the fastest-growing market, driven by the increasing incidence of HIV infections in highly populated countries like China and India. Public awareness campaigns and increasing funding from private and healthcare sectors are also contributing to this growth[1][3].

Segmentation and Dominance

Combination HIV Medicines

The combination HIV medicines segment, which includes SYMTUZA™, is expected to dominate the market. This dominance is due to the better results in managing HIV and co-related infections, as well as the advanced technology incorporated in these treatments[3].

Distribution Channels

Hospital pharmacies currently dominate the sales of HIV drugs, including SYMTUZA™, due to the high number of patients receiving antiretroviral therapy in hospitals. However, the online pharmacies segment is expected to grow at the fastest rate, driven by the digitization of healthcare and improvements in logistics and payment platforms[1].

Clinical Efficacy and Safety

SYMTUZA™ has demonstrated high efficacy in clinical trials, with up to 95% of patients achieving or maintaining virologic suppression. The regimen is well-tolerated, with improvements in renal and bone profiles compared to other treatments. However, it has less favorable effects on some lipids[2][4].

Regulatory Approvals and Global Reach

SYMTUZA™ has received approvals from the U.S. FDA, the European Commission, and Health Canada for the treatment of HIV-1 infection in adults and adolescents aged 12 years and older. Janssen plans additional regulatory filings in other markets worldwide[4].

Competitive Landscape

The global HIV drugs market is highly competitive, with key players such as ViiV Healthcare, Gilead Sciences, Janssen Pharmaceuticals, and Merck dominating the market. These companies are engaged in strategic collaborations and new product launches to expand their market share. For instance, Gilead Sciences and Merck have entered into an agreement for the co-development and co-commercialization of long-acting treatments for HIV patients[3].

Key Drivers of Market Growth

• Increasing Prevalence of HIV: The rising incidence of HIV cases globally is a significant driver of the market.
• Government Support and Initiatives: Increased government support and initiatives in healthcare expenditure and HIV research are contributing to market growth.
• New Product Innovations: The development of advanced treatments like SYMTUZA™ is driving demand.
• Awareness and Economic Growth: Rising awareness about HIV/AIDS and economic growth in emerging markets are also key factors[1][3][5].

Challenges and Opportunities

Challenges

• Drug Resistance: The increasing resistance to existing therapies is a challenge that necessitates continuous innovation in HIV treatments.
• Cost and Accessibility: The high cost of advanced HIV treatments and accessibility issues in some regions remain significant challenges.

Opportunities

• Emerging Markets: The Asia Pacific region offers significant growth opportunities due to its large patient population and increasing healthcare expenditure.
• Technological Advancements: Investments in technologies like 3D bioprinting and the development of multi-class combination products present opportunities for market expansion[1][3][5].

Financial Trajectory

The financial trajectory for SYMTUZA™ and similar combination therapies is promising, given the growing demand for effective HIV treatments. Here are some key financial projections:

• Market Size: The global HIV drugs market is expected to grow from $36.22 billion in 2024 to $66.16 billion by 2034[1].
• CAGR: The market is projected to grow at a CAGR of 6.21% from 2024 to 2034[1].
• Regional Growth: North America will continue to dominate, with the U.S. market growing at a CAGR of 6.38% from 2024 to 2034[1].

Key Takeaways

• The global HIV drugs market, including SYMTUZA™, is expected to grow significantly over the next decade.
• Combination HIV medicines, such as SYMTUZA™, will dominate the market due to their efficacy and advanced technology.
• North America and the Asia Pacific region are key markets, with the latter expected to grow at the fastest rate.
• Regulatory approvals and strategic collaborations are crucial for market expansion.
• Increasing prevalence of HIV, government support, and new product innovations are driving market growth.

FAQs

1. What is SYMTUZA™, and how does it treat HIV-1 infection?

SYMTUZA™ is a single-tablet regimen that combines darunavir, cobicistat, emtricitabine, and tenofovir alafenamide fumarate to treat HIV-1 infection. It is effective in achieving virologic suppression and is well-tolerated, with improvements in renal and bone profiles[2][4].

2. Which regions are expected to drive the growth of the HIV drugs market?

North America currently dominates the market, but the Asia Pacific region is expected to be the fastest-growing market due to the increasing incidence of HIV infections and public awareness campaigns[1][3].

3. What are the key drivers of the HIV drugs market growth?

Key drivers include the increasing prevalence of HIV, government support and initiatives, new product innovations, and rising awareness and economic growth in emerging markets[1][3][5].

4. How does SYMTUZA™ compare to other HIV treatments in terms of efficacy and safety?

SYMTUZA™ has demonstrated high efficacy in clinical trials, with up to 95% of patients achieving or maintaining virologic suppression. It is generally well-tolerated, with improvements in renal and bone profiles, although it has less favorable effects on some lipids[2][4].

5. What are the challenges and opportunities in the HIV drugs market?

Challenges include drug resistance and cost and accessibility issues. Opportunities include growth in emerging markets, technological advancements, and the development of multi-class combination products[1][3][5].

Cited Sources:

1. Precedence Research: "HIV Drugs Market Size to Achieve USD 66.16 Billion by 2034"[1]
2. PubMed: "Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide"[2]
3. Fortune Business Insights: "HIV Drugs Market Size & Growth | Global Report [2024-2032]"[3]
4. Janssen: "Janssen Announces U.S. FDA Approval of SYMTUZA™ (D/C/F/TAF)"[4]
5. The Business Research Company: "HIV Drugs Global Market Report 2024"[5]