Cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate - Generic Drug Details

What are the generic sources for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate and what is the scope of patent protection?

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

Cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate has four hundred and five patent family members in forty-eight countries.

One supplier is listed for this compound.

Summary for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate

International Patents:	405
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	26
Patent Applications:	286
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
DailyMed Link:	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate

Constraining patent/regulatory exclusivity:

8,981,103*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 disoproxil 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 disoproxil fumarate clinical trials

Pharmacology for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil 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 disoproxil 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 DISOPROXIL FUMARATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
STRIBILD	Tablets	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	150 mg/150 mg/ 200 mg/300 mg	203100	1	2018-10-04

US Patents and Regulatory Information for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil 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	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	8,148,374*PED				Y
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	8,981,103*PED				Y
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	7,635,704*PED				Y
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	8,633,219*PED				Y
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	7,176,220*PED				Y

Expired US Patents for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012	9,457,036
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012	8,592,397
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012	9,744,181
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012	8,716,264

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

Country	Patent Number	Title	Estimated Expiration
Brazil	PI0510114	cristal estável de composto 4-oxoquinolina
Croatia	P20161502
Lithuania	PA2016038
Cyprus	1117067
Japan	2011231132	MODULATOR OF PHARMACOKINETIC PROPERTY OF THERAPEUTIC

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

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2487166	1790001-0	Sweden		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND TENOFOVIR ALAFENAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR ALAFENAMIDE FUMARATE; FIRST MARKETING AITHORIZATION NUMBER SE: EU/1/15/1061, 2015-11-23
2487163	122016000120	Germany		PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCHES AKZEPTABLES SALZ DAVON UND ATAZANAVIR ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1025 20150713
2487162	201640054	Slovenia		PRODUCT NAME: COBICISTAT OR PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVAT THEREOF AND DARUNAVIR OR PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVAT THEREOF, ESPECIALLY DARUNAVIR ETHANOLATE; NATIONAL AUTHORISATION NUMBER: EU/1/14/967/001; DATE OF NATIONAL AUTHORISATION: 20141119; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2487162	2016/063	Ireland		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF AND DARUNAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR DARUNAVIR ETHANOLATE; REGISTRATION NO/DATE: EU/1/14/967 20141119
1564210	PA2013018	Lithuania		PRODUCT NAME: ELVITEGRAVIRUM; REGISTRATION NO/DATE: EU/1/13/830/001, 2013 05 24 EU/1/13/830/002 20130524

Market and Financial Outlook for COBICISTAT, ELVITEGRAVIR, EMTRICITABINE, and TENOFOVIR DISOPROXIL FUMARATE

Last updated: February 20, 2026

This report analyzes the current market trends and financial trajectory of the four antiviral agents: Cobicistat, Elvitegravir, Emtricitabine, and Tenofovir Disoproxil Fumarate (TDF). These drugs are primarily used in combination therapies for HIV and hepatitis B, with increasing application in broader antiviral treatments.

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Market Overview

Cobicistat

• Role: Pharmacokinetic enhancer (booster) used in combination regimens for HIV.
• Market Size (2022): Estimated at USD 2.1 billion.
• Growth Rate: Compound annual growth rate (CAGR) of 8% forecasted from 2023–2027.
• Key Players: Gilead Sciences, Johnson & Johnson.
• Drivers: Rising HIV prevalence, expansion of fixed-dose combination (FDC) therapies, patent exclusivity ending for some formulations, encouraging generics.

Elvitegravir

• Role: Integrase inhibitor used in HIV treatment.
• Market Size (2022): Approximates USD 1.8 billion.
• Growth Rate: CAGR of 6% over the next four years.
• Key Players: Gilead Sciences, ViiV Healthcare (Janssen).
• Drivers: Increasing prescribing rates; ongoing research into resistance profiles.

Emtricitabine

• Role: Nucleoside reverse transcriptase inhibitor (NRTI) used in combination regimens.
• Market Size (2022): Estimated at USD 2.5 billion.
• Growth Rate: Projected CAGR of 4% through 2027.
• Key Players: Gilead, Mylan, Teva.
• Drivers: Long-standing safety profile; widespread use.

Tenofovir Disoproxil Fumarate (TDF)

• Role: NRTI used for HIV and hepatitis B.
• Market Size (2022): Approximately USD 3 billion.
• Growth Rate: Expected CAGR of 3% through 2027.
• Key Players: Gilead, Teva, Cipla.
• Drivers: Late-stage patent expiration in key markets; introduction of newer formulations.

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Market Trends & Dynamics

Increasing Use of Fixed-Dose Combinations (FDCs)

• Combination therapies combining these agents improve adherence and reduce resistance.
• Gilead’s formulations, such as Genvoya and Biktarvy, blend these agents with others, driving sales.

Patent Expirations & Generics

• Gilead's TDF patents expired in the US and Europe starting 2020. Generics command price reductions of 50–70%.
• Cobicistat’s exclusivity ends in 2024 in the US, opening opportunities for biosimilars.

Regional Variations

• North America: Largest market; regulatory approvals and high HIV prevalence sustain demand.
• Europe: Similar patterns, with slower generic uptake due to regulatory hurdles.
• Emerging Markets: Rapid growth driven by expanding healthcare infrastructure, lower prices for generics.

Regulatory and Policy Impact

• WHO’s guidelines favor FDCs, bolstering demand.
• Pricing policies and patent litigations influence market accessibility and dynamics.

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Financial Projections

Drug	2022 Market Size (USD billion)	2023–2027 CAGR	Key Drivers
Cobicistat	2.1	8%	HIV treatment expansion
Elvitegravir	1.8	6%	Resistance management
Emtricitabine	2.5	4%	Long-term regimen use
TDF	3.0	3%	Patent expiry, biosimilars

• Overall Growth: The combined market for these agents is projected to grow from USD 9.4 billion in 2022 to approximately USD 11.3 billion by 2027.

Revenue Generators & Risks

• Top Market Drivers: R&D investments in novel formulations, expanding indications for hepatitis B, and global HIV/AIDS initiatives.
• Risks: Patent litigations, regulatory delays, pricing pressures, and the advent of next-generation agents.

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Competitive Landscape

• Major Firms: Gilead Sciences dominates with integrated basket of these agents, whereas others like Teva and Cipla focus on generics.
• Pipeline Developments: Biosimilars for TDF and new integrase inhibitors could disrupt current revenue streams.
• Strategic Initiatives: Partnerships with governments and non-profits for access programs underpin revenue stability.

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Key Takeaways

• The market for these agents is driven by HIV treatment demand and generic entry.
• Growth rates vary; TDF shows slow but steady expansion, while Cobicistat and Elvitegravir benefit from evolving combination therapies.
• Patent expirations and biosimilar development affect pricing and segment revenues.
• Regional disparities influence market penetration opportunities.
• R&D into new formulations and indications sustains longer-term revenue prospects.

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FAQs

Q1: How will patent expirations impact revenue for these drugs?
A: Patent expirations, notably for TDF in 2020, lead to patent cliffs allowing biosimilars and generics to enter, causing price reductions and revenue declines for brand-name producers.

Q2: Which regional markets present the best growth opportunities?
A: Emerging markets in Latin America, Asia, and Africa show rapid growth due to expanding healthcare access and lower generic prices.

Q3: Are there imminent regulatory changes that could influence the market?
A: WHO guidelines favor combination therapies, supporting demand. New regulations for biosimilar approvals could accelerate generic entry.

Q4: What competitive threats do new agents pose?
A: Next-generation integrase inhibitors and long-acting formulations may displace current agents, impacting revenues.

Q5: How significant is the role of pricing negotiations?
A: Critical; public payers and global health organizations negotiate drug prices, especially in low-income countries, influencing overall market size.

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References

[1] Market Research Future. (2023). Pharmaceutical antiviral market analysis.
[2] Gilead Sciences Annual Report. (2022).
[3] World Health Organization. (2022). HIV/AIDS treatment guidelines.
[4] IQVIA. (2022). Global pharmaceutical market data.
[5] U.S. FDA. (2022). Regulatory approvals and patent status summaries.