Generic COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE INN entry, drug patent expiration information and freedom to operate

Sponsor	Phase
Gilead Sciences	Phase 1/Phase 2
University of California, Los Angeles	Phase 1/Phase 2
Brigham and Women's Hospital	N/A

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

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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	⤷ Start Trial	⤷ Start Trial			Y	⤷ Start Trial
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial			Y	⤷ Start Trial
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial			Y	⤷ Start Trial
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial			Y	⤷ Start Trial
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial			Y	⤷ Start Trial
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial			Y	⤷ Start Trial
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial			Y	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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

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Country	Patent Number	Title	Estimated Expiration
African Regional IP Organization (ARIPO)	3089		⤷ Start Trial
African Regional IP Organization (ARIPO)	3250		⤷ Start Trial
Argentina	075369		⤷ Start Trial
Australia	2009242451		⤷ Start Trial
Australia	2010210598		⤷ Start Trial
Australia	2014221210		⤷ Start Trial
Australia	2015200637		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1564210	13C0061	France	⤷ Start Trial	PRODUCT NAME: ELVITEGRAVIR OU UN HYDRATE, SOLVATE, TAUTOMERE, OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CEUX-CI; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527
2487163	1790002-8	Sweden	⤷ Start Trial	PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND ATAZANAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR ATAZANAVIR SULFATE; FIRST MARKETING AUTHORIZATION NUMBER SE: EG EU/1/15/1025, 2015-07-15
3150586	C202030023	Spain	⤷ Start Trial	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	203 5022-2013	Slovakia	⤷ Start Trial	PRODUCT NAME: ELVITEGRAVIR ALEBO JEHO HYDRAT, SOLVAT, TAUTOMER ALEBO FARMACEUTICKY PRIJATELNA SOL; NAT. REGISTRATION NO/DATE: EU/1/13/830/001 - EU/1/13/830/002 20130527; FIRST REGISTRATION: EU EU/1/13/830/001 - EU/1/13/830/002 20130527
2487162	SPC/GB17/009	United Kingdom	⤷ Start Trial	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
2487163	2016/062	Ireland	⤷ Start Trial	PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND ATAZANAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR ATAZANAVIR SULFATE; REGISTRATION NO/DATE: EU/1/15/1025 20160713
2049506	C20150046	Estonia	⤷ Start Trial	PRODUCT NAME: KOBITSISTAAT; AUTHORISATION NO.: EMA/CHMP/596576/2017, AUTORISATION DATE: 20170914
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Last updated: November 11, 2026

The four-drug combination is marketed primarily as Genvoya, a once-daily HIV-1 treatment developed by Gilead Sciences. Genvoya combines elvitegravir, an integrase strand-transfer inhibitor; cobicistat, a pharmacokinetic enhancer; emtricitabine, an NRTI; and tenofovir alafenamide fumarate, an NRTI prodrug. The product generated substantial revenue after its 2015 launch but has entered a mature phase as Biktarvy displaced Genvoya in treatment-naive and switch patients.

Genvoya’s commercial outlook depends on three factors: continued retention of treatment-experienced patients, the timing and scope of generic entry, and Gilead’s ability to defend the product against newer integrase-based regimens. The product has no biosimilar pathway because it is a small-molecule fixed-dose combination. Generic risk will arise through abbreviated new drug applications, including potential Paragraph IV certifications.

What is Genvoya and how does the four-drug combination work?

Genvoya is a fixed-dose tablet containing:

Component	Dose per tablet	Function
Elvitegravir	150 mg	Integrase strand-transfer inhibitor
Cobicistat	150 mg	CYP3A inhibitor and pharmacokinetic booster
Emtricitabine	200 mg	NRTI
Tenofovir alafenamide fumarate	10 mg	Tenofovir prodrug and NRTI

The regimen is administered once daily with food. The FDA approved Genvoya on November 5, 2015, for treatment of HIV-1 infection in adults and pediatric patients meeting label criteria. Its clinical positioning was based on the lower circulating tenofovir exposure associated with TAF compared with tenofovir disoproxil fumarate, particularly for renal and bone safety considerations. [1]

Genvoya replaced Stribild in much of Gilead’s portfolio. Stribild contains the same antiviral backbone and booster but uses tenofovir disoproxil fumarate rather than TAF.

What FDA regulatory milestones shaped Genvoya’s commercial trajectory?

Milestone	Date	Commercial effect
FDA approval of Genvoya	November 5, 2015	Established the TAF-based successor to Stribild
Initial adult indication	2015	Opened the core treatment market
Pediatric expansion	2016 and later label updates	Extended use into younger patient groups
European authorization	2015	Created a multinational branded market
Biktarvy approval	February 7, 2018	Began internal substitution within Gilead’s HIV portfolio
Biktarvy broadening of use	2018 onward	Accelerated migration from Genvoya among new and switching patients

Biktarvy combines bictegravir, emtricitabine and TAF without cobicistat. Its lower pill burden and absence of a pharmacokinetic booster gave Gilead a more commercially attractive product for many patients. The absence of cobicistat reduces drug-interaction complexity and removes the need for a fourth active pharmaceutical ingredient.

How has Genvoya revenue changed over time?

Gilead does not generally report Genvoya as a standalone segment in the same level of detail as total HIV revenue, but company filings have reported product sales. Genvoya reached multibillion-dollar annual sales before declining as Biktarvy became the company’s leading HIV product.

Period	Market position	Financial trajectory
2016-2018	Rapid adoption of TAF-based treatment	Strong growth as Genvoya displaced Stribild and captured switches
2019-2021	Mature branded product	Revenue remained substantial, but Biktarvy absorbed new starts
2022-2023	Declining share within Gilead HIV	Genvoya sales declined as Biktarvy became the preferred internal growth product
2024 onward	Late-life branded product	Greater exposure to formulary pressure, treatment switching and eventual generic competition

Gilead reported approximately $11.9 billion in Biktarvy sales in 2023, while Genvoya remained a material but much smaller contributor to the HIV franchise. [2] The critical financial point is that Genvoya’s decline does not equal a proportional loss of Gilead HIV revenue. Much of the demand migrated to Biktarvy, preserving revenue within Gilead’s portfolio.

Genvoya’s economic value therefore has two layers:

Direct product revenue from prescriptions.
Franchise value from retaining patients within Gilead’s HIV treatment ecosystem.

The second layer reduces the strategic urgency of defending Genvoya at all costs, particularly where switching to Biktarvy protects the underlying patient relationship.

When does Genvoya lose exclusivity?

Genvoya does not have a single practical loss-of-exclusivity date. Exclusivity is determined by separate protections for the active ingredients, fixed-dose composition, formulation, manufacturing process and approved methods of use.

The principal U.S. protection period is expected to extend beyond the basic five-year new chemical entity period because the combination incorporates previously known ingredients and relies on later-issued formulation and composition patents. Publicly reported patent families associated with Genvoya and its components have included patents with nominal expiration dates in the late 2020s through the early 2030s, subject to patent-term adjustment, patent-term extension, terminal disclaimers, pediatric exclusivity and claim-specific validity.

A commercial generic launch could occur before the latest listed patent expiry if:

A generic applicant prevails in Paragraph IV litigation.
Gilead settles for an authorized generic or licensed launch date.
Relevant patent claims are invalidated or found not infringed.
The applicant launches at risk after a 30-month stay or before final judgment.
The FDA approves a product that does not infringe enforceable claims.

The key financial risk is therefore a staged erosion rather than a single cliff. Earlier generic entry against the fixed-dose composition would be more damaging than a later challenge limited to a manufacturing or method-of-use patent.

What patents protect Genvoya and its formulation?

Genvoya’s patent estate is layered. The relevant protection categories include:

Active-ingredient patents

Elvitegravir, cobicistat, emtricitabine and TAF have different discovery histories and patent families. Some foundational compound patents have expired or are approaching expiration, but those expirations do not necessarily authorize a generic version of the complete Genvoya tablet.

TAF and prodrug patents

TAF is a prodrug designed to deliver tenofovir at lower plasma exposure than TDF. Patent protection around TAF, its salts, compositions and uses has been commercially important across multiple Gilead products, including Genvoya, Odefsey, Descovy and Biktarvy.

Fixed-dose combination patents

The strongest commercial barriers are likely to involve claims covering the specific combination of elvitegravir, cobicistat, emtricitabine and TAF, including dosage ratios and tablet composition.

Formulation patents

Formulation claims can cover excipient systems, tablet architecture, stability, coating and manufacturing parameters. These claims can delay a generic that attempts to copy the commercial tablet even where active-ingredient patents are no longer enforceable.

Method-of-use patents

Method claims may cover treatment of HIV-1 infection, use in particular patient groups and administration in patients with renal or other clinical characteristics. Method-of-use patents are generally less effective against a full-product generic when the label can be carved out, but they can increase litigation complexity.

The FDA Orange Book is the controlling source for listed patents and expiration dates. Gilead’s patent estate should be analyzed claim by claim rather than by relying on one headline expiration date. [3]

What is the Orange Book status of Genvoya?

Genvoya is an FDA-approved prescription drug listed under NDA 208610. The Orange Book identifies the reference product and any patents submitted by the NDA holder for FDA listing. Orange Book listing does not establish patent validity. It does, however, determine the regulatory framework for ANDA applicants that certify against listed patents.

A Paragraph IV certification states that a listed patent is invalid, unenforceable or will not be infringed by the proposed generic. Gilead may sue within 45 days of receiving notice, triggering a statutory stay of final ANDA approval for up to 30 months, subject to court action and regulatory exceptions. [4]

No biosimilar application is relevant to Genvoya. The product is regulated as a small-molecule drug, and generic applicants would use the ANDA pathway rather than the abbreviated pathway under the Public Health Service Act.

Which companies are most likely to challenge Genvoya?

Potential challengers include large generic manufacturers with experience in complex fixed-dose HIV products, including Teva, Viatris, Sandoz, Cipla, Lupin, Sun Pharma and Dr. Reddy’s Laboratories. A challenge would require more than reproducing the active ingredients. The applicant must demonstrate pharmaceutical equivalence, bioequivalence, manufacturing consistency and compliance with the applicable patent certifications.

The main barriers are:

Four active ingredients in one tablet.
The low 10 mg TAF dose.
Cobicistat-related drug-interaction and exposure considerations.
Stability and impurity-control requirements.
Difficulty designing a non-infringing formulation.
Limited commercial value if launch is delayed until the market has shifted to Biktarvy.

A generic company may prefer to challenge Genvoya only if it can obtain an early launch date or if the product retains enough volume to support litigation and manufacturing costs.

What generic entry risks exist?

Genvoya faces three generic-launch scenarios.

Scenario 1: Delayed entry after the last enforceable patent

This produces a conventional price decline, with discounts increasing as multiple suppliers enter. Net sales could fall sharply within two to four years after broad generic availability.

Scenario 2: Licensed or settled entry

Gilead could permit a generic launch on a negotiated date. Such settlements may include authorized-generic rights, supply arrangements or restrictions on the launch market. The economic impact would depend on whether the entrant is a single licensed supplier or part of a broad generic wave.

Scenario 3: At-risk entry

An applicant could launch before final patent resolution. If the generic prevails, Genvoya could experience rapid erosion. If Gilead prevails, damages and injunction risk could materially affect the challenger.

The risk is moderated by Biktarvy. Many clinicians and payers may switch patients rather than use a generic version of an older boosted regimen, particularly when Biktarvy is covered under favorable formulary terms.

What patent litigation and settlement issues affect Genvoya?

The principal litigation exposure concerns ANDA Paragraph IV challenges to patents listed for the fixed-dose product and TAF-related technology. A complete public assessment requires matching each Orange Book patent to docket history, claim scope and settlement terms.

The commercial significance of litigation depends on whether the challenged patent covers:

The complete four-drug combination.
TAF as an active ingredient or prodrug.
The tablet formulation.
A manufacturing process.
A narrow method of use.

A successful challenge to a narrow process patent may not create an immediate launch opportunity if composition and formulation patents remain enforceable. A successful challenge to the core composition patent would have a much larger effect.

How does Genvoya compare with Biktarvy?

Factor	Genvoya	Biktarvy
Active ingredients	Elvitegravir, cobicistat, emtricitabine, TAF	Bictegravir, emtricitabine, TAF
Booster	Required	None
Daily dosing	Once daily with food	Once daily
Pill burden	One tablet	One tablet
Drug-interaction profile	More complex because of cobicistat	Generally simpler
Commercial status	Mature and declining	Gilead’s leading HIV product
Generic exposure	Earlier and more complex late-life risk	Longer branded growth runway
Strategic role	Retention and legacy product	Primary franchise growth product

Biktarvy has taken share from Genvoya through new prescriptions and treatment switches. Genvoya retains value where patients are stable, tolerating therapy and covered under existing formulary arrangements.

What is the competitive landscape for Genvoya?

Genvoya competes with several classes of HIV regimens:

Biktarvy, the main internal substitute.
Triumeq and its successor products.
Dovato, a two-drug regimen.
Juluca, a two-drug maintenance regimen.
Odefsey, another Gilead TAF-based fixed-dose product.
Descovy-based combinations.
Long-acting injectable cabotegravir and rilpivirine.

The market has shifted from single-tablet differentiation toward regimen durability, resistance profile, drug interactions, renal and bone safety, dosing convenience, and long-term cost. Genvoya remains clinically relevant but has less differentiation against newer unboosted products.

How strong is the patent estate for Genvoya?

Genvoya’s patent estate is moderate to strong against immediate generic substitution but weaker as a long-term commercial defense.

Its strengths are:

Multiple patent layers.
TAF-related technology shared across several products.
Complex four-drug formulation.
Potential regulatory delay from Paragraph IV litigation.
Manufacturing and bioequivalence complexity.

Its weaknesses are:

Several ingredients are established generic molecules.
The product competes with Gilead’s own newer regimen.
Method-of-use protection may be narrow.
Generic companies can attack different patents sequentially.
Clinical demand is likely to decline before the latest patent expiry.

The estate is strongest when evaluated as a portfolio defense for Gilead’s TAF platform. It is less powerful as a standalone defense of Genvoya revenue because the company can migrate patients to Biktarvy.

What are the likely financial outcomes?

The most probable trajectory is continued branded erosion before or around broad generic availability, followed by a sharper decline once a substitutable generic enters.

Driver	Effect on Genvoya
Biktarvy switching	Negative
Stable treatment-experienced patients	Supports residual revenue
Favorable formulary placement	Slows decline
Generic fixed-dose approval	Strongly negative
Settlement with delayed entry	Extends branded revenue
TAF platform patents	Supports broader Gilead economics
Long-acting HIV therapies	Negative over time
Price controls and payer pressure	Negative

For valuation purposes, Genvoya should be modeled as a declining mature asset rather than a growth product. The principal value lies in residual cash flow, portfolio retention and the defensive use of Gilead’s TAF and combination-product IP.

Key Takeaways

Genvoya is the principal commercial product associated with cobicistat, elvitegravir, emtricitabine and TAF.
FDA approval occurred on November 5, 2015.
Biktarvy has displaced Genvoya as Gilead’s primary HIV growth product.
Genvoya revenue has declined from its post-launch peak but remains material.
Generic risk is based on the full Orange Book patent estate, not one expiration date.
No biosimilar pathway applies; future challengers would use the ANDA process.
Paragraph IV litigation could delay or accelerate generic entry depending on claim validity and settlement terms.
TAF and fixed-dose formulation patents are more commercially important than the expired or aging compound patents for individual ingredients.
Genvoya’s patent estate is stronger as a platform defense than as a long-term standalone revenue barrier.
A generic launch would likely accelerate decline, but Biktarvy migration limits the impact on Gilead’s overall HIV franchise.

FAQs

Is Genvoya the same drug as Stribild?

No. Both contain elvitegravir, cobicistat and emtricitabine, but Genvoya uses TAF while Stribild uses TDF.

Does Genvoya have a generic equivalent?

A generic equivalent requires approval of a product matching the four-drug formulation and satisfying FDA bioequivalence and patent requirements. Ingredient-level generic availability does not establish a generic equivalent to Genvoya.

Is cobicistat still commercially important?

Yes, but its role is concentrated in boosted regimens such as Genvoya, Stribild, Prezcobix and Evotaz. Unboosted regimens such as Biktarvy reduce the need for cobicistat.

Can a generic manufacturer copy Genvoya before every patent expires?

It may seek approval through Paragraph IV certification or a section viii carve-out, but commercial launch depends on patent litigation, settlement terms, enforceable claims and FDA approval.

Why has Genvoya declined while Gilead HIV revenue remains strong?

Patients have migrated from Genvoya to Biktarvy and other newer regimens. The resulting decline in Genvoya revenue has been partly offset by growth in Gilead’s newer HIV products.

References

U.S. Food and Drug Administration. (2015). Genvoya prescribing information.
Gilead Sciences, Inc. (2024). 2023 annual report.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
U.S. Food and Drug Administration. (2024). Hatch-Waxman amendments and abbreviated new drug applications.

International Patents:	465
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

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

Summary for cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate

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

Recent Clinical Trials for cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate

Pharmacology for cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate

Anatomical Therapeutic Chemical (ATC) Classes for cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate

Paragraph IV (Patent) Challenges for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE