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

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

Cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate has five hundred and twenty-six patent family members in fifty-six countries.

One supplier is listed for this compound.

Summary for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

International Patents:	526
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	11
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
DailyMed Link:	COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE at DailyMed

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

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

Sponsor	Phase
Gilead Sciences	Phase 1/Phase 2
University of California, Los Angeles	Phase 1/Phase 2
Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic	N/A

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

Pharmacology for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Drug Class	Cytochrome P450 3A Inhibitor Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2C9 Inducers Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors HIV Integrase 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; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

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

J05AJ	Integrase 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; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GENVOYA	Tablets	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	150 mg/150 mg/ 200 mg/10 mg	207561	1	2023-04-12

US Patents and Regulatory Information for COBICISTAT; ELVITEGRAVIR; 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
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015		RX	Yes	Yes					Y
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015		RX	Yes	Yes					Y
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015		RX	Yes	Yes					Y
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015		RX	Yes	Yes					Y
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015		RX	Yes	Yes					Y
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015		RX	Yes	Yes					Y

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015

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

Country	Patent Number	Title	Estimated Expiration
Portugal	2487166
Singapore	10201706215U	Tablets for combination therapy
Ukraine	101193	ПРИМЕНЕНИЕ ЧАСТИЧЕК ТВЕРДОГО НОСИТЕЛЯ ДЛЯ УЛУЧШЕНИЯ ТЕХНОЛОГИЧЕСКИХ ХАРАКТЕРИСТИК ФАРМАЦЕВТИЧЕСКОГО АГЕНТА;ЗАСТОСУВАННЯ ЧАСТИНОК ТВЕРДОГО НОСІЯ ДЛЯ ПОЛІПШЕННЯ ТЕХНОЛОГІЧНИХ ХАРАКТЕРИСТИК ФАРМАЦЕВТИЧНОГО АГЕНТА (THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT)
South Korea	20140004808	MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS
Australia	2010210598	Tablets for combination therapy
Brazil	0112646

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

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3150586	301045	Netherlands		PRODUCT NAME: COBICISTAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, DARUNAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, IN HET BIJZONDER DARUNAVIRETHANOLAAT, EN EMTRICITABINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/17/1225 20170925
3150586	C202030023	Spain		PRODUCT NAME: COBICISTAT O UNA SAL O SOLVATO FARMACEUTICAMENTE ACEPTABLE DEL MISMO, DARUNAVIR O UNA SAL O SOLVATO FARMACEUTICAMENTE ACEPTABLE DEL MISMO, EN PARTICULAR ETANOLATO DE DARUNAVIR, Y EMTRICITABINA O UNA SAL O SOLVATO FARMACEUTICAMENTE ACEPTABLE DE LA MISMA; NATIONAL AUTHORISATION NUMBER: EU/1/17/1225; DATE OF AUTHORISATION: 20170921; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1225; DATE OF FIRST AUTHORISATION IN EEA: 20170921
1564210	CA 2013 00058	Denmark		PRODUCT NAME: ELVITEGRAVIR I ENHVER FORM SOM ER OMFATTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/13/830/001-002 20130524
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
2049506	92864	Luxembourg		PRODUCT NAME: COBICISTAT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/13/830/001-002 20130527
2487162	SPC/GB17/009	United Kingdom		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF AND DARUNAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/14/967 20141121

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

Market Dynamics and Financial Trajectory for the Drug: Cobicistat, Elvitegravir, Emtricitabine, Tenofovir Alafenamide Fumarate

Introduction to the Drug Combination

The drug combination of cobicistat, elvitegravir, emtricitabine, and tenofovir alafenamide fumarate, marketed as Genvoya, is a significant player in the global HIV treatment market. This single-tablet regimen is designed for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older without known mutations associated with resistance to the individual components of the drug[3].

Market Size and Growth

The global HIV treatment market, within which Genvoya operates, is projected to grow at a CAGR of 1.42% from 2023 to 2030, reaching $25.49 billion by 2030 from $22.38 billion in 2022[2].

Key Components and Their Roles

• Elvitegravir: An HIV-1 integrase strand transfer inhibitor that prevents the virus from integrating into the host cell's DNA[3].
• Cobicistat: A pharmacokinetic enhancer that increases the exposure of elvitegravir and tenofovir alafenamide by inhibiting the CYP3A enzyme[3].
• Emtricitabine: A nucleoside reverse transcriptase inhibitor (NRTI) that blocks the replication of the HIV virus[3].
• Tenofovir Alafenamide Fumarate (TAF): An NRTI that provides higher intracellular levels of the active metabolite TFV-DP with lower circulating levels of TFV, reducing the risk of nephrotoxicity and bone mineral density decrease compared to Tenofovir Disoproxil Fumarate (TDF)[3].

Market Drivers

Several factors drive the growth of the market for this drug combination:

• Advancements in Antiretroviral Therapy (ART): The development of more effective and tolerable ARTs, such as Genvoya, has significantly improved treatment outcomes and patient compliance[2].
• Rising HIV Prevalence: Increasing cases of HIV infection globally drive the demand for effective treatment options[2].
• Government Funding and Initiatives: Enhanced government funding and public health initiatives, including increased access to HIV screening and testing, contribute to market growth[2].
• Public-Private Partnerships: Collaborations between pharmaceutical companies and public health organizations facilitate better access to care and innovative treatments[2].

Financial Performance of Gilead Sciences

Gilead Sciences, the manufacturer of Genvoya, has seen significant financial impacts related to its HIV treatment portfolio:

• Revenue Growth: In the second quarter of 2023, Gilead Sciences reported a 5% increase in revenue to $6.6 billion, largely driven by increased sales in HIV and Oncology treatments, despite lower sales of Veklury (remdesivir)[1].
• Full-Year 2023 Performance: Total full-year 2023 revenue decreased by 1% to $27.1 billion, primarily due to a reduction in Veklury sales, but was partially offset by higher HIV and Oncology sales[4].

Impact of COVID-19

The COVID-19 pandemic had a mixed impact on the HIV treatment market:

• Supply Chain Disruptions: The pandemic caused disruptions in medication supply chains and patient care, affecting sales volumes of HIV medications, including those from Gilead Sciences[5].
• Increased Innovation and Telemedicine: However, the pandemic also accelerated pharmaceutical innovation and the adoption of telemedicine, which have contributed to the market's recovery and growth post-pandemic[2].

Competitive Landscape

The global HIV treatment market is dominated by major pharmaceutical companies such as Gilead Sciences, ViiV Healthcare, and Merck. Gilead's comprehensive drug portfolio, including Genvoya and other treatments like Biktarvy, positions the company as a leader in the market[2].

Recent Developments and Innovations

Gilead Sciences continues to innovate, with recent developments such as the FDA application for lenacapavir, a long-acting HIV-1 capsid inhibitor. These efforts are crucial in shaping the future of the global HIV treatment market and maintaining Gilead's competitive edge[2].

Regional Market Dynamics

The US dominates the global HIV treatment market due to broad health insurance coverage, effective HIV awareness programs, and the presence of major pharmaceutical companies engaged in HIV research and drug development. The US market is expected to grow at the fastest CAGR from 2023 to 2030, driven by ongoing advancements in medical technology and pharmaceuticals[2].

Future Outlook

The market for Genvoya and similar antiretroviral therapies is expected to grow substantially, driven by increasing demand for combination therapies, advancements in gene therapy, and the adoption of long-acting injectable treatments. The Asia Pacific region is anticipated to be a significant growth area due to its large population and increasing treatment programs[2][5].

Key Takeaways

• The global HIV treatment market is growing, driven by advancements in ART and increasing HIV prevalence.
• Gilead Sciences' financial performance is influenced by the success of its HIV treatment portfolio, including Genvoya.
• The COVID-19 pandemic had mixed effects on the market but has driven innovation and telemedicine adoption.
• The competitive landscape is dominated by major pharmaceutical companies, with Gilead Sciences being a key player.
• Regional dynamics, especially in the US and Asia Pacific, will play a crucial role in market growth.

FAQs

Q: What is the composition of the drug Genvoya?

A: Genvoya is a fixed-dose combination tablet comprising 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamide fumarate[3].

Q: How has the COVID-19 pandemic affected the HIV treatment market?

A: The pandemic caused supply chain disruptions and lower sales volumes but also accelerated pharmaceutical innovation and telemedicine adoption, contributing to post-pandemic market growth[2][5].

Q: What are the key drivers of the global HIV treatment market?

A: The market is driven by advancements in ART, rising HIV prevalence, government funding, public-private partnerships, and growing awareness and testing initiatives[2].

Q: Which region is expected to grow the fastest in the HIV treatment market?

A: The US is expected to grow at the fastest CAGR from 2023 to 2030, followed by the Asia Pacific region, which is also anticipated to be a significant growth area[2][5].

Q: What are some recent innovations in HIV treatment from Gilead Sciences?

A: Gilead Sciences has recently applied for FDA approval for lenacapavir, a long-acting HIV-1 capsid inhibitor, and continues to invest in research and development for more effective antiretroviral drugs[2].

Cited Sources:

1. Gilead Sciences Announces Second Quarter 2023 Financial Results - Business Wire
2. Global HIV Treatment Market Analysis Report 2023 - Business Wire
3. Australian Public Assessment Report for Elvitegravir / Cobicistat / Emtricitabine / Tenofovir alafenamide (as fumarate) - Therapeutic Goods Administration
4. Gilead Sciences Announces Fourth Quarter and Full Year 2023 Financial Results - Gilead Sciences
5. HIV Drugs Market Size & Growth | Global Report [2024-2032] - Fortune Business Insights