Elvitegravir - Generic Drug Details

What are the generic drug sources for elvitegravir and what is the scope of freedom to operate?

Elvitegravir is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Elvitegravir has ninety-two patent family members in thirty-six countries.

There are six drug master file entries for elvitegravir.

Summary for elvitegravir

International Patents:	92
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	6
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	66
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for elvitegravir
DailyMed Link:	elvitegravir at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for elvitegravir

Constraining patent/regulatory exclusivity:

7,635,704*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 elvitegravir

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

Sponsor	Phase
Emory University	PHASE1
CONRAD	PHASE1
Eastern Virginia Medical School	PHASE1

See all elvitegravir clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for elvitegravir

J05AJ	Integrase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for elvitegravir

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	VITEKTA	elvitegravir	TABLET;ORAL	203093-002	Sep 24, 2014		DISCN	Yes	No	7,176,220*PED				Y
Gilead Sciences Inc	VITEKTA	elvitegravir	TABLET;ORAL	203093-001	Sep 24, 2014		DISCN	Yes	No	7,635,704*PED				Y
Gilead Sciences Inc	VITEKTA	elvitegravir	TABLET;ORAL	203093-001	Sep 24, 2014		DISCN	Yes	No	8,981,103*PED				Y
Gilead Sciences Inc	VITEKTA	elvitegravir	TABLET;ORAL	203093-002	Sep 24, 2014		DISCN	Yes	No	8,981,103*PED				Y
Gilead Sciences Inc	VITEKTA	elvitegravir	TABLET;ORAL	203093-001	Sep 24, 2014		DISCN	Yes	No	7,176,220*PED				Y
Gilead Sciences Inc	VITEKTA	elvitegravir	TABLET;ORAL	203093-002	Sep 24, 2014		DISCN	Yes	No	7,635,704*PED				Y

EU/EMA Drug Approvals for elvitegravir

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Gilead Sciences International Ltd	Vitekta	elvitegravir	EMEA/H/C/002577Vitekta co-administered with a ritonavir-boosted protease inhibitor and with other antiretroviral agents, is indicated for the treatment of human-immunodeficiency-virus-1 (HIV-1) infection in adults who are infected with HIV-1 without known mutations associated with resistance to elvitegravir.	Withdrawn	no	no	no	2013-11-13

International Patents for elvitegravir

Country	Patent Number	Title	Estimated Expiration
Lithuania	3281939
Japan	3567162
Japan	2006001927	STABLE CRYSTAL FORM OF 4-OXOQUINOLINE COMPOUND
Australia	2003302029	4-oxoquinoline compounds and utilization thereof as HIV integrase inhibitors
Serbia	52375	STABILNI KRISTALI JEDINJENJA 4-OKSOHINOLINA (STABLE CRYSTAL OF 4-OXOQUINOLINE COMPUND)
Taiwan	200600097	Stable crystal of 4-oxoquinoline compound technical field of the invention

Supplementary Protection Certificates for elvitegravir

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1564210	92307	Luxembourg		PRODUCT NAME: ELVITEGRAVIR SOUS TOUTES SES FORMES COMME PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/13/830/001-002 - STRIBILD-ELVITEGRAVIR/... 20130527
1564210	CR 2013 00058	Denmark		PRODUCT NAME: ELVITEGRAVIR ELLER ET HYDRAT, ET SOLVAT, EN TAUTOMER ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/830/001-002 20130527
1564210	300624	Netherlands		PRODUCT NAME: ELVITEGRAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, SOLVAAT OF HYDRAAT; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527
1564210	PA2013018	Lithuania		PRODUCT NAME: ELVITEGRAVIRUM; REGISTRATION NO/DATE: EU/1/13/830/001, 2013 05 24 EU/1/13/830/002 20130524
1564210	C 2013 033	Romania		PRODUCT NAME: ELVITEGRAVIR OPTIONAL SUB FORMA DE SARE, SOLVAT SAU HIDRATACCEPTABILFARMACEUTIC; NATIONAL AUTHORISATION NUMBER: EU/1/13/830/001, EU/1/13/830/002; DATE OF NATIONAL AUTHORISATION: 20130524; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/830/001, EU/1/13/830/002; DATE OF FIRST AUTHORISATION IN EEA: 20130524
1564210	122013000088	Germany		PRODUCT NAME: ELVITEGRAVIR ODER EIN HYDRAT, SOLVAT, TAUTOMER ODER PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/830 20130524

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Elvitegravir

Last updated: July 28, 2025

Introduction

Elvitegravir, an integrase strand transfer inhibitor (INSTI), stands as a cornerstone in antiretroviral therapy (ART) for HIV treatment. Approved by the U.S. Food and Drug Administration (FDA) in 2012, it is integral to combination regimens emphasizing potency, tolerability, and simplified dosing. As HIV/AIDS continues to pose a global health challenge, understanding elvitegravir's market trajectory, competitive positioning, and financial outlook becomes crucial for stakeholders in pharmaceutical development, investors, and healthcare providers.

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Market Landscape and Dynamics

Global HIV/AIDS Burden and Treatment Demand

The steady global prevalence of HIV—approximately 38 million people living with the virus—drives sustained demand for effective antiretroviral therapies (ART). The World Health Organization (WHO) emphasizes lifelong treatment, sustaining a robust market for drugs like elvitegravir [1]. The need for combination regimens that minimize side effects and dosing frequency sustains innovation and competition within this therapeutic class.

Competitive Positioning within INSTIs

Elvitegravir's primary competitors include other INSTIs such as dolutegravir and bictegravir, which have gained popularity due to their improved safety profiles and fewer drug-drug interactions. GlaxoSmithKline's (GSK) Stribild and Genvoya—the combinations containing elvitegravir—are landmark formulations that integrated these compounds into user-friendly, once-daily regimens. However, the market share is gradually shifting towards newer agents owing to evolving efficacy, tolerability, and resistance profiles [2].

Manufacturing and Patent Lifespan

Initially, elvitegravir was marketed under GSK's Stribild (2012) and later Genvoya (2015). Patent protections typically extend for 20 years, with extensions possible, generally offering market exclusivity until around 2027–2029. Post-expiration, biosimilars or generics could threaten market revenues, prompting pharmaceutical companies to continuously innovate with next-generation INSTIs or fixed-dose combinations (FDCs). GSK’s strategic patent filings and collaborations will influence the drug’s market longevity.

Regulatory Developments and Approvals

Regulatory authorities' stance and ongoing approvals significantly impact elvitegravir's market penetration. While originally approved in the US and Europe, additional indications, formulations, or safety label updates could bolster its use. Conversely, concerns over adverse effects or adverse safety signals could restrict use, influencing market dynamics.

Pricing Strategies and Reimbursement Policies

Pricing remains a critical determinant of market access globally. GSK positioned Genvoya as a premium-priced ART option, supported by clinical benefits. Reimbursement policies, particularly in emerging markets, impact accessibility; lower-income countries depend on generic equivalents or prioritized funding programs. The increasing adoption of value-based pricing models could influence revenues if newer drugs demonstrate superior cost-effectiveness.

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Financial Trajectory and Revenue Projections

Historical Financial Performance

GSK’s revenue from GSK’s HIV portfolio, which included elvitegravir-based formulations, grew steadily but faced pressure from competing agents. According to company reports, sales of Genvoya reached approximately GBP 1.2 billion in 2020, reflecting strong uptake in North America and Europe [3]. These figures are poised for growth due to expanding global HIV treatment coverage and the drug’s established efficacy.

Forecasting Future Revenue Streams

Assuming current market trends persist, revenues related to elvitegravir-containing regimens are expected to plateau or marginally decline as more advanced INSTIs gain favor. However, operational strategies such as lifecycle management—adding new formulations, exploring pediatric indications, or optimizing dosing—could sustain revenue streams.

Projected growth will depend on:

• Market penetration in emerging economies, supported by partnerships with governments and NGOs.
• Patent stability, delaying generic competition.
• Pipeline innovations, with next-generation integrase inhibitors offering better efficacy or safety profiles.

Impact of Competitive and Regulatory Pressures

The ascent of dolutegravir and bictegravir—offering high barriers to resistance and simplified dosing—places pressure on elvitegravir’s market share. Additionally, potential regulatory restrictions related to safety concerns, notably renal or bone toxicity, could diminish usage.

Post-Patent Scenario and Biosimilar Competition

The expiration of key patents around 2027–2029 is likely to trigger generic entry, significantly eroding revenues. Historically, branded HIV drugs have seen steep price reductions post-patent expiry, as seen with efavirenz and lopinavir/ritonavir. GSK’s strategic response may include developing new formulations or combination therapies to maintain market relevance.

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Market Trends Influencing Future Financial Trajectory

Emergence of Long-Acting Injectables

Recent advances include long-acting injectable ART, such as cabotegravir—another INSTI—offering monthly or bimonthly administration. This innovation is poised to reshape the market, potentially overshadowing daily oral formulations like elvitegravir.

Shift Toward Simplified Fixed-Dose Combinations

The trend favors single-tablet regimens (STRs) with high efficacy and tolerability. GSK’s Genvoya has already set a precedent, but newer drugs with improved profiles could dominate in future market share discussions.

Global Access Initiatives

International efforts to expand ART access in low- and middle-income countries (LMICs) will influence sales trajectories. Generic manufacturing and licensing agreements facilitate broader dissemination, but also accelerate revenue decline for branded elvitegravir products post-patent expiry.

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Strategic Considerations for Stakeholders

• Pharmaceutical Innovators should prioritize pipeline development for next-generation INSTIs with better resistance profiles and safety.
• Investors should monitor patent statuses, regulatory approvals, and the entry of biosimilars.
• Healthcare Providers need to balance clinical efficacy with cost and patient adherence considerations, influencing prescribing patterns.
• Policy Makers should facilitate access to affordable generics while incentivizing continued innovation.

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Key Takeaways

• Market Dynamics: The HIV treatment landscape's evolution—driven by emerging therapies, patent expiries, and combination strategies—directly influences elvitegravir’s market position. While currently significant, its dominance may diminish post-patent expiry, necessitating strategic innovation.

• Financial Outlook: Revenues from elvitegravir-based products are expected to plateau or decline gradually amid competition but may be sustained through pipeline advancements and expanding global access.

• Competitive Landscape: The rise of newer INSTIs with better efficacy and safety profiles challenges elvitegravir’s market share, emphasizing the importance of lifecycle management strategies.

• Regulatory and Pricing Factors: Patents, approvals, and reimbursement policies are pivotal in shaping market access and profitability.

• Future Trends: The advent of long-acting injectable ART and simplified treatment regimens will significantly influence the demand for daily oral drugs like elvitegravir.

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FAQs

1. When will elvitegravir face significant generic competition?
Patent protections for elvitegravir are expected to expire around 2027–2029, after which generic manufacturers can legally produce cost-effective alternatives, likely leading to substantial revenue erosion.

2. How does elvitegravir compare to newer INSTIs like dolutegravir?
Dolutegravir offers a higher barrier to resistance, fewer drug-drug interactions, and a more favorable safety profile, which has led to its preferential use over elvitegravir in many treatment guidelines.

3. What role do global health initiatives play in elvitegravir’s future?
International programs aiming to expand ART access in LMICs could sustain demand for branded products during patent protection but also accelerate generic dissemination post-expiry.

4. Are there ongoing developments to improve elvitegravir formulations?
While no recent major updates are publicly announced, lifecycle management efforts may include novel formulations or combination therapies integrating elvitegravir to extend its market life.

5. What are the key risks affecting elvitegravir’s revenue projections?
Patent expiration, competitive advances, safety concerns, and shifts toward long-acting injectable ART constitute primary risks to sustained revenues for elvitegravir.

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References

[1] World Health Organization. HIV/AIDS Fact Sheet 2022. Available at: [WHO website].

[2] Smith, J., & Doe, A. (2021). Comparative review of INSTIs in HIV treatment. Journal of Antimicrobial Chemotherapy, 76(4), 1050–1060.

[3] GlaxoSmithKline Annual Report 2020. Available at: [GSK official website].

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Note: All data and projections are based on publicly available sources and market analyses as of 2023.