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:

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 alafenamide fumarate

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

Sponsor	Phase
University of California, Los Angeles	Phase 1/Phase 2
Gilead Sciences	Phase 1/Phase 2
Weill Medical College of Cornell University	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	9,296,769*PED				Y
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	8,981,103*PED				Y
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015		RX	Yes	Yes	7,176,220*PED				Y
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015		RX	Yes	Yes	8,633,219*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	9,891,239*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	7,800,788
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015	7,803,788

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

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1564210	SPC/GB13/065	United Kingdom		PRODUCT NAME: ELVITEGRAVIR; REGISTERED: UK EU/1/13/830/001 20130527; UK EU/1/13/830/002 20130527
2487166	2016/061	Ireland		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND TENOFOVIR ALAFENAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REGISTRATION NO/DATE: EU/1/15/1061 20151119
2049506	61/2015	Austria		PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/830 (MITTEILUNG) 20130527
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
2487162	1790003-6	Sweden		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND DARUNAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR DARUNAVIR ETHANOLATE FIRST REG.NO: EU/1/14/967, 2014-11-21
2487162	300861	Netherlands		PRODUCT NAME: COBICISTAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN EN DARUNAVIR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN. IN HET BIJZONDER DARUNAVIRETHANOLAAT; REGISTRATION NO/DATE: EU/1/14/967 20141121

Last updated: April 25, 2026

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

What product is in scope?

The fixed-dose combination (FDC) is cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate. In commercial markets it is sold as Genvoya® (commonly referenced as the co-packaged FDC of these four actives). The clinical and commercial positioning is for HIV-1 antiretroviral therapy.

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How does the market structure shape pricing and demand?

The HIV market is split between:

• First-line regimens dominated by integrase strand transfer inhibitor (INSTI)-based therapies.
• Backbone nucleos(t)ide reverse transcriptase inhibitors (NRTIs) where TAF-based regimens compete with TDF-based options.

Genvoya’s market logic:

• TAF improves renal and bone safety relative to TDF for many patients, which supports uptake in real-world prescribing.
• Single-tablet regimens drive adherence, which keeps demand resilient when payers support formulary placement.

Competitive pressure:

• INSTI competition is the dominant driver. Key alternatives include:
  • Biktarvy® (bictegravir + emtricitabine + TAF)
  • Triumeq® / dolutegravir-based options (abacavir-based depending on patient profile)
  • Other TAF-based FDCs and long-acting injectable strategies that target adherence and clinic-administered pathways.

Commercial consequence: pricing power is strongest when formulary access is secured, and weakens as “preferred” status shifts toward newer INSTI backbones and payer net-price leverage increases.

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What demand signals matter for cobicistat/elvitegravir/emtricitabine/TAF?

Demand for Genvoya is driven by:

1. Treatment-naïve starts and switches from TDF-based regimens due to tolerability.
2. Maintaining suppression in stable patients who benefit from a well-tolerated, established single-tablet regimen.
3. Formulary tiering and payer utilization controls.

In practical market dynamics, the drug’s growth profile tends to follow a pattern typical for established HIV FDCs:

• Growth early with broad adoption and formulary wins.
• Slower net revenue expansion as penetration reaches maturity and payer discounts intensify.
• Continued revenue resilience even as absolute growth slows due to high switching costs for patients already controlled.

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How do payer and contracting dynamics affect the financial trajectory?

HIV chronic therapy is heavily influenced by:

• National formularies and managed care contracting
• Rebate structures tied to market share
• Switch incentives toward the payer’s preferred INSTI backbone

For older multi-component regimens like Genvoya (versus newer INSTI backbones), the economic pathway is usually:

• Revenue holds through switching from TDF to TAF and via continued use in stable patients.
• Margin compression as payers use aggressive competitive positioning against bictegravir-based single-tablet options and other INSTI FDCs.

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What financial trajectory has been reported for the product category?

Public product-level revenue figures vary by geography and reporting standard (IMS, IQVIA, company disclosures, and payer databases). In the absence of product-specific annual revenue numbers in the provided source corpus, a safe, data-anchored assessment relies on documented regulatory status and market positioning rather than precise sales totals.

What can be stated directly from available reference-grade sources is that the combination is an established marketed HIV regimen with ongoing commercial utilization tied to TAF-based tolerability and fixed-dose convenience.

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What is the competitive replacement risk from newer INSTI backbones?

The replacement risk centers on:

• Payer preference for certain INSTI backbones due to net-price and formulary leverage.
• Efficacy and safety marketing that can translate into switching pressure.

In particular, bictegravir-based regimens (notably Biktarvy) often compete for first-line share. The likely financial impact for Genvoya over time is:

• Lower incremental growth than newer entrants.
• Share erosion at the margin (new initiations and switches), offset partially by continued stable patient demand.

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What role do safety and labeling play in retention vs switching?

TAF-based regimens typically support retention by:

• Improving renal and bone parameters relative to TDF for many patient groups.
• Supporting ongoing use when patients have comorbidities or tolerability concerns.

In addition, the fixed-dose regimen reduces pill burden, which can blunt switching frequency when virologic suppression is stable.

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How do regulatory and exclusivity timelines influence pricing power?

Pricing power generally follows patent and exclusivity life cycles:

• Before patent cliffs, manufacturers sustain premium positioning with fewer legal-to-market threats.
• After exclusivity/patent erosion, generic and biosimilar-equivalent competition (where legally permitted) can rapidly pressure net prices.

For this FDC, the key patent and exclusivity landscape is inherited from:

• Each active component’s IP
• Combination claims and method-of-use claims
• Formulation and crystalline/polymorph IP for TAF

Without a supplied patent event table or source text listing specific expiration dates, a numeric projection of price erosion timing cannot be produced here.

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What’s the most actionable market takeaway for R&D or investment?

For an R&D or investment lens, the combination’s market dynamics point to:

• Chronic demand durability due to fixed-dose convenience and stable patient retention.
• Competitive headwinds driven by newer INSTI FDC backbones with strong formulary capture.
• Net-price compression risk as payer contracting tightens and switching incentives rise.

A portfolio strategy that assumes steady volume but declining net pricing is consistent with how mature HIV regimens typically behave unless a major advantage (new indication, superior tolerability, or payer shift) restores preferential use.

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Market Dynamics Snapshot

Dimension	Expected direction	Commercial mechanism
Demand (volume)	Stable to slowly declining growth	Stable suppression retention offsets slower new starts
Demand (mix)	Shift with payer preferences	Switches to preferred INSTI backbones
Pricing (net)	Downward pressure over time	Rebates and formulary leverage intensify
Competition	High	INSTI-centered portfolio substitution

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Financial Trajectory Framework (What likely happens in financials)

Revenue mechanics

1. Unit volume supported by ongoing patient treatment in mature cohorts.
2. Revenue growth lags because incremental additions slow as penetration saturates.
3. Net sales can remain positive while gross-to-net widens due to rebates and payer contracts.

Cost and margin mechanics

• If pricing pressure increases, operating margin stabilizes only if:
  • procurement and manufacturing efficiency improve, and
  • payer contracts maintain acceptable net price.

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Key Takeaways

1. Cobicistat/elvitegravir/emtricitabine/tenofovir alafenamide fumarate (Genvoya) is a mature HIV single-tablet regimen where demand durability is supported by patient retention and TAF tolerability.
2. INSTI backbone competition is the core headwind, with newer and payer-preferred alternatives driving margin pressure and limiting incremental growth.
3. The financial trajectory is best modeled as stable-to-slow volume change with net-price compression, unless a new payer shift or label expansion restores preference.
4. Patent and exclusivity-driven pricing power is a central determinant of medium-term net price, but specific expiration-driven event timing cannot be quantified from the provided sources.

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FAQs

1. Is cobicistat/elvitegravir/emtricitabine/TAF primarily a first-line or switch regimen?
   It is used for both initiation and switching, with real-world adoption supported by single-tablet convenience and TAF tolerability for appropriate patients.

2. What is the biggest competitive driver for Genvoya’s market share?
   Competition for INSTI-centered formularies, especially newer INSTI FDC options that gain preferred status through payer contracting and perceived clinical differentiation.

3. Does TAF generally support demand versus TDF?
   Yes. TAF-based regimens tend to support continued use where renal/bone tolerability matters relative to TDF, which supports conversion and retention.

4. How do rebates and formulary placement typically impact financial outcomes for mature HIV FDCs?
   Net price often declines as rebates expand and tier placement becomes a competitive battleground, even when unit volume remains steady.

5. What would most likely change the financial trajectory upward?
   A payer preference reset (formulary position improvement), a meaningful label expansion, or other factors that increase mix toward higher utilization relative to competing INSTI backbones.

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References

[1] FDA. “Genvoya (elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide) label.” U.S. Food and Drug Administration.