cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate - Profile

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

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.

Summary for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate

International Patents:	407
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate

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.

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	7,176,220*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	8,148,374*PED				Y
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	8,633,219*PED				Y
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	10,039,718*PED				Y
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	9,891,239*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

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	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	9,457,036
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
African Regional IP Organization (ARIPO)	3089
African Regional IP Organization (ARIPO)	3250
Argentina	075369
Australia	2009242451
Australia	2010210598
Australia	2014221210
Australia	2015200637

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

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2487163	PA2016039,C2487163	Lithuania		PRODUCT NAME: KOBICISTATAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA IR ATAZANAVIRAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA, YPAC ATAZANAVIRO SULFATAS; REGISTRATION NO/DATE: EU/1/15/1025 20150713
2487162	122016000103	Germany		PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ ODER SOLVAT DAVON UND DARUNAVIR ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ ODER SOLVAT DAVON, INSBESONDERE DARUNAVIRETHANOLAT; AUTHORISATION NO/DATE: EU/1/14/967 20141119
2487166	122016000104	Germany		PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON UND TENOFOVIRALAFENAMID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; AUTHORISATION NO/DATE: EU/1/15/1061 20151119
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
1564210	2013C/063	Belgium		PRODUCT NAME: ELVITEGRAVIR SOUS TOUTES LES FORMES COMME PROTEGE PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/13/830/001 20130527
2487162	PA2016040,C2487162	Lithuania		PRODUCT NAME: KOBICISTATAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ARBA SOLVATAS IR DARUNAVIRAS,ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ARBA SOLVATAS, YPAC DARUNAVIRO ETANOLATAS; REGISTRATION NO/DATE: EU/1/14/967 20141119
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

Cobicistat, Elvitegravir, Emtricitabine, and Tenofovir Disoproxil Fumarate: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Summary

This analysis evaluates the investment potential, market landscape, and future financial trajectory of a fixed-dose combination (FDC) comprising cobicistat, elvitegravir, emtricitabine, and tenofovir disoproxil fumarate (TDF). This drug combination is used primarily in HIV treatment, with a competitive focus on once-daily regimens. Its market positioning is influenced by patent status, competitive dynamics, regulatory approvals, and evolving HIV treatment guidelines. Projected revenues, R&D investments, and competitive threats suggest a steady but constrained growth trajectory over the next five years, with opportunities driven by emerging formulations, patent expirations, and global health initiatives.

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Introduction

The combination of cobicistat, elvitegravir, emtricitabine, and TDF forms the basis of several marketed antiretroviral therapies, notably Genvoya and Stribild, developed by Gilead Sciences. The drug class has maintained a dominant position in HIV treatment, but evolving market dynamics and patent landscapes are key to assessing its long-term investment potential.

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Market Overview

Category	Data	Source / Notes
Global HIV prevalence (2022)	~38 million	UNAIDS[1]
Estimated HIV treatment market (2023)	~$30 billion	IQVIA[2]
Key therapeutic segments	NRTIs, integrase inhibitors (INSTIs), fixed-dose combinations	Focus on simplicity and adherence
Market share of TAF vs. TDF	TAF gaining, but TDF still dominant (~70%) in certain segments	Gilead’s shifting portfolio[3]

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Drug Composition and Mechanism

Component	Role	Brand Approximations	Notes
Cobicistat	Pharmacokinetic enhancer	Genvoya, Stribild	Boosts elvitegravir levels via CYP3A4 inhibition
Elvitegravir	Integrase inhibitor	-	Blocks viral DNA integration
Emtricitabine	Nucleoside reverse transcriptase inhibitor (NRTI)	-	Viral reverse transcriptase chain terminator
Tenofovir Disoproxil Fumarate (TDF)	NRTI	-	Viral DNA chain termination; patent expiry impacts dynamics

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Market Dynamics

1. Patent Status and Generic Competition

Aspect	Details	Timeline	Implications
Patent expiration	TDF patent expired in key markets (e.g., US, EU)	Around 2020–2022	Rising generics; price erosion
Elvitegravir and Cobicistat patents	Still under patent protection (US patent till 2027)	-	Market exclusivity, delaying generic entry
Impact	Generics targeting TDF component and fixed-dose combinations	Post-2022	Price competition increases, potential market share erosion

2. Competitive Landscape

Competitors	Products	Differentiators	Market Share (est. 2023)
Gilead	Genvoya, Stribild, bictegravir-based regimens	Brand recognition, efficacy, tolerability	>70% of FDC HIV market
ViiV Healthcare	Dolutegravir-based regimens	Higher barrier to resistance	Rapidly gaining market share
Generic Manufacturers	TDF, emtricitabine, combinations	Cost-effectiveness	Growing, especially in LMICs
Emerging therapies	New INSTIs, long-acting injectables	Competitive pressures	Potential disruptors

3. Regulatory and Policy Trends

• Global Initiatives: WHO’s 2021 recommendations favor tenofovir alafenamide (TAF)-based regimens over TDF for improved safety, impacting TDF sales.
• Patent filings: Extensions and secondary patents may prolong exclusivity, but some jurisdictions challenge patents, potentially expanding generic access.

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Financial Trajectory and Revenue Projections

1. Historical Revenue (Gilead’s HIV Portfolio)

Year	Revenue (USD millions)	Notes
2018	~$8,204	Dominance of TDF-based regimens
2019	~$8,678	Slight growth, patent expiry on certain TDF formulations noted
2020	~$8,169	Transition to TAF formulations impact revenues
2021	~$8,842	Diversification continued
2022	~$9,260	Market stabilization

2. Revenue Drivers (2023–2028)

Driver	Impact	Assumptions/Forecasts
Patent expiry of TDF	Price erosion, generic competition	Begins ~2022–2024; some decline through 2026
Shift to TAF-based products	Revenue transfer	Expected to reduce TDF component revenue by 20–30%
Market penetration of generics	Price reduction, volume increase	Entry in LMICs, impact in high-income countries limited initially
Development of new formulations	Extended lifecycle	Long-acting injectables, combo pills in late-stage R&D
Regulatory approval of competitors	Market share redistribution	Impact varying by geography

Revenue Projection (USD millions)	2023	2024	2025	2026	2027	2028
Base case (conservative)	9,000	8,700	8,200	7,700	7,200	6,800
Optimistic case	9,500	9,200	8,900	8,600	8,300	8,000

Note: These projections incorporate generic competition, patent expiries, and shifts to newer formulations.

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Investment Considerations

1. Revenue Stability

While the current market is sizable, revenue stability hinges on patent protection, the pace of generic entry, and penetration into emerging markets. The innovation pipeline, including long-acting injectables and TAF-based combinations, supports phased growth but presents risks associated with R&D costs and regulatory hurdles.

2. R&D and Lifecycle Management

Gilead’s pipeline includes injectable formulations (e.g., Cabotegravir + Rilpivirine), which could encroach upon existing TDF-based regimens. Investment in lifecycle management, including patent extensions and new combinations, remains critical.

3. Regulatory & Legal Risks

Potential patent litigations and patent cliff exposures could impact exclusivity periods. Additionally, regulatory shifts favoring TAF over TDF may accelerate generic uptake of TDF-based combinations.

4. Market Expansion in LMICs

Price concessions and generic proliferation could expand access but compress margins. However, volume growth remains a significant opportunity with global health initiatives.

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Comparison with Alternative Therapies

Attribute	Cobicistat/Elvitegravir/Emtricitabine/TDF	Dolutegravir-based Regimens	Long-acting Injectables
Efficacy	High	High	Comparable or superior
Resistance Barrier	Moderate	High	High
Cost	Moderate to High (brand)	Lower (generic)	Higher (injectables)
Convenience	Once daily	Once daily	Monthly to bi-monthly
Patent Status	Some patents expiring	Longer patents, newer formulations	Still under development

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FAQs

Q1: How does the patent expiry of TDF impact the future revenue of the cobicistat/elvitegravir/emtricitabine/TDF combination?
A1: Patent expiry generally leads to increased generic competition for TDF, reducing the cost and market share of brand-name combinations. Consequently, revenues decline unless offset by newer formulations such as TAF-based products.

Q2: What are the key growth prospects for this drug combination?
A2: Growth opportunities include penetration into emerging markets through generics, lifecycle management via new formulations like long-acting injectables, and expansion into advanced treatment guidelines favoring combo regimens.

Q3: How is the shift from TDF to TAF influencing the market?
A3: The move to TAF improves safety and tolerability but results in patent protections that delay generic availability. This shift may reduce TDF-based regimen revenues and increase competition among TAF-based therapies.

Q4: What risks threaten the long-term commercial viability of cobicistat-containing regimens?
A4: Patent challenges, emerging generics, stiff competition from newer INSTIs, and regulatory preferences for TAF undermine long-term exclusivity and pricing power.

Q5: Are injectable formulations a significant threat or opportunity for existing combination therapies?
A5: They represent both a threat to conventional oral regimens by offering longer dosing intervals and an opportunity for lifecycle extension. Early R&D success could alter competitive dynamics.

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Key Takeaways

• The cobicistat/elvitegravir/emtricitabine/TDF combination remains relevant but faces patent expiries and generics, compressing revenues over the next 3–5 years.
• Transition toward TAF-based formulations and innovative delivery methods (e.g., long-acting injectables) are critical to sustaining growth.
• The overall market is consolidating around high-barrier drugs like dolutegravir, reducing the relative attractiveness of TDF-based regimens.
• Licensing and patent strategies, combined with R&D investments in novel formulations, are essential variables influencing future financial trajectory.
• The sector’s growth is driven by global health initiatives, particularly in LMICs, but profits are increasingly challenged by cost pressures.

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References

1. UNAIDS. Global HIV & AIDS statistics — 2022.
2. IQVIA. HIV Treatment Market Analysis, 2023.
3. Gilead Sciences. Annual Reports and Product Pipeline, 2022.