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 nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate has four hundred and sixty-three patent family members in fifty-three countries.

One supplier is listed for this compound.

Summary for cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate

International Patents:	463
US Patents:	9
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

Constraining patent/regulatory exclusivity:

10,039,718*PED

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
Brigham and Women's Hospital	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	8,148,374*PED				Y
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015		RX	Yes	Yes	9,891,239*PED				Y
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015		RX	Yes	Yes	10,039,718*PED				Y
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015		RX	Yes	Yes	8,754,065*PED				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	5,814,639*PED
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015	7,803,788
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015	5,914,331*PED
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015	7,800,788

International Patents for cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate

Country	Patent Number	Title	Estimated Expiration
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)
Japan	2018065870
New Zealand	533641	4-oxoquinoline compounds and utilization thereof as HIV integrase inhibitors
Brazil	PI0510114	cristal estável de composto 4-oxoquinolina

Supplementary Protection Certificates for cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2487163	2016C/066	Belgium		PRODUCT NAME: COBICISTAT ET ATAZANAVIR; AUTHORISATION NUMBER AND DATE: EU/1/15/1025 20150715
2487166	17C1001	France		PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET TENOFOVIR ALAFENAMIDE SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/15/1061 20151123
1564210	PA2013018,C1564210	Lithuania		PRODUCT NAME: ELVITEGRAVIRUM; REGISTRATION NO/DATE: EU/1/13/830/001, 2013-05-24 EU/1/13/830/002 20130524
2487163	132017000002807	Italy		PRODUCT NAME: COBICISTAT O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E ATAZANAVIR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE ATAZANAVIR SOLFATO(EVOTAZ); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1025, 20150715

Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Alafenamide Fumarate: Market Dynamics and Financial Trajectory

Last updated: February 13, 2026

Market Overview

The combination of cobicistat, elvitegravir, emtricitabine, and tenofovir alafenamide fumarate (TAF) primarily targets HIV treatment. These drugs constitute key components of branded antiretroviral therapies, notably Genvoya and Stribild, developed by Gilead Sciences. Their market penetration is driven by shifting preferences towards single-tablet regimens (STRs), increased HIV prevalence, and adoption in both developed and emerging markets.

Key Market Drivers

• Rising HIV Prevalence: Global estimates indicate 38 million people living with HIV as of 2021, with developing countries accounting for over 60% of cases (UNAIDS[1]).
• Preference for STRs: To improve adherence, clinicians favor STRs over multi-pill regimens, fostering demand for these product combinations.
• Patent Expirations: Gilead’s patents for earlier formulations are expiring in select regions, risking generic competition, but TAF-based products benefit from newer patent protections.
• Regulatory Approvals: Governments and health agencies increasingly approve TAF-based therapies due to lower renal and bone toxicity relative to tenofovir disoproxil fumarate (TDF).

Market Dynamics

Aspect	Description
Competitive Landscape	Dominated by Gilead, with generic entrants emerging post-patent expiry. Key competitors include ViiV Healthcare’s Dolutegravir-based regimens and generic options for TDF-based therapies.
Pricing Trends	Gilead’s TAF-based products command premiums (~$38,000–$42,000 annually per patient in the U.S.), driven by patent protections and perceived clinical advantages. Emergence of generics could reduce prices by up to 60% in some markets.
Regulatory Approvals	Approved in over 100 countries, with TAF-containing regimens preferred in North America and Europe. Some emerging markets seen delays due to patent disputes and pricing regulations.
Market Penetration	High in North America and Europe, where brands hold robust patents. Growing use in Asia-Pacific due to increasing healthcare investments.

Financial Trajectory (2019–2028)

• Historical Revenue (2019–2021):
  • Gilead's HIV portfolio, including these drugs, generated approximately $10–12 billion annually.
  • Genvoya and Stribild accounted for ~$3 billion of annual sales, with steady growth driven by volume increases.
• Projected Market Growth (2022–2028):
  • Compound annual growth rate (CAGR) forecasted at 4.5% for HIV regimens including TAF-based therapies.
  • The market is expected to reach approximately $20 billion globally by 2028, driven by expanding treatment coverage in Africa, Asia, and Latin America.
• Impact of Patent Expirations:
  • U.S. patents for Stribild and Genvoya are set to expire between 2024 and 2026, prompting potential revenue declines of 30–50% unless offset by new formulations or indications.
  • Gilead has responded with development of next-generation formulations and combinations, including long-acting injectables.

Year	Estimated Global Revenue (USD)	Notes
2022	$12 billion	Stable growth, early signs of competition.
2024	$13 billion	Patent expiries impact revenue; generics enter markets.
2026	$13.5 billion	Transition phase; new formulations launched.
2028	$20 billion	Market expansion, increased adoption.

Risks and Opportunities

Risks

• Generic competition post-patent expiry.
• Regulatory barriers delaying approvals in emerging markets.
• Pricing controls in low-income countries limiting profit margins.

Opportunities

• Development of long-acting injectable formulations could capture new market segments.
• Expanded indications for HIV prevention and treatment.
• Entry into pediatric or co-morbidity treatment segments.

Key Takeaways

• The HIV treatment landscape favors STRs, supporting sustained demand for these drugs.
• Patent protections sustain higher pricing, but impending patent cliffs pressure revenues.
• Market growth stems from increased global treatment access, especially in developing regions.
• Gilead’s ongoing innovation, including long-acting formulations, aims to sustain leadership.
• Generic competition is inevitable, with potential to reduce prices significantly, especially outside North America and Europe.

FAQs

1. How will patent expiries affect the market for these drugs?
Patent expiries between 2024 and 2026 will likely reduce revenues by up to 50% due to generic entry, prompting shifts toward cost-effective alternatives and formulations.

2. What role do combination therapies play in market growth?
Combination therapies that simplify dosing improve adherence, solidifying their market position. The development of long-acting injectables further enhances this trend.

3. Are there new formulations under development?
Yes. Gilead and competitors are investing in long-acting injectables and fixed-dose combinations to extend market leadership and capture new patient segments.

4. What are the key regional differences in market adoption?
High adoption in North America and Europe due to patent protections. Emerging markets are gradually increasing use, subject to regulatory adaptation and pricing policies.

5. How does the shift toward TAF impact existing TDF-based therapies?
TAF offers a better safety profile and is favored in new regimens, potentially replacing TDF in existing treatments, though TDF remains prevalent in cost-sensitive markets.

References

1. UNAIDS. Global HIV & AIDS statistics — 2022 factsheet.
2. Gilead Sciences annual reports (2019–2021).
3. IQVIA. HIV Market Insights, 2022.
4. Analyst estimates from EvaluatePharma, 2022.
5. World Health Organization. HIV treatment guidelines, 2021.

Note: All projections are based on current patents, regulatory approvals, and market trajectories as of the first quarter of 2023.