VITEKTA Drug Patent Profile

When do Vitekta patents expire, and when can generic versions of Vitekta launch?

Vitekta is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are three patents protecting this drug.

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

The generic ingredient in VITEKTA is elvitegravir. There are six drug master file entries for this compound. Additional details are available on the elvitegravir profile page.

DrugPatentWatch^® Generic Entry Outlook for Vitekta

Vitekta was eligible for patent challenges on August 27, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 26, 2027. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for VITEKTA

International Patents:	92
US Patents:	3
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	71
Patent Applications:	2,712
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VITEKTA
DailyMed Link:	VITEKTA at DailyMed

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

Constraining patent/regulatory exclusivity:

7,635,704*PED

NDA:

203093

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.

US Patents and Regulatory Information for VITEKTA

VITEKTA is protected by three US patents.

This potential generic entry date is based on patent 7,635,704.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	203093-001	Sep 24, 2014		DISCN	Yes	No	7,635,704*PED				Y
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	7,176,220*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	203093-002	Sep 24, 2014		DISCN	Yes	No	7,635,704*PED				Y

EU/EMA Drug Approvals for VITEKTA

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 VITEKTA

See the table below for patents covering VITEKTA around the world.

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2004121464	СОЕДИНЕНИЕ 4-ОКСОХИНОЛИНА И ЕГО ПРИМЕНЕНИЕ В КАЧЕСТВЕ ИНГИБИТОРА ВИЧ ИНТЕГРАЗЫ
Norway	20200873	Stabil krystall av 4-oxoquinolinforbindelse
Serbia	64845	KOMBINACIJA KOJA SE SASTOJI OD STABILNOG KRISTALA 4-OKSOHINOLINSKOG JEDINJENJA (COMBINATION COMPRISING A STABLE CRYSTAL OF A 4-OXOQUINOLINE COMPOUND)
European Patent Office	2161258	Composé d'oxoquinoline 4 et utilisation associée en tant qu'inhibiteur contre l'intégrase du HIV (4-oxoquinoline compound and use thereof as hiv integrase inhibitor)
Norway	2022032
European Patent Office	2514746	Cristal stable de composé 4-oxoquinoline (Stable crystal of 4-oxoquinoline compound)
Slovakia	2662004	Zlúčenina s obsahom 4-oxochinolínu a jej použitie ako inhibítora integráz (4-Oxoquinoline compound and its utilisation as integrase inhibitor)

Supplementary Protection Certificates for VITEKTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1564210	C20130029 00095	Estonia		CHANGE OF OWNER'S ADDRESS
1564210	C300624	Netherlands		PRODUCT NAME: ELVITEGRAVIR IN ALLE VORMEN ZOALS; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130524
1564210	203 5022-2013	Slovakia		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
1564210	CA 2013 00058	Denmark		PRODUCT NAME: ELVITEGRAVIR I ENHVER FORM SOM ER OMFATTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/13/830/001-002 20130524
1564210	C01564210/01	Switzerland		CHANGE OF ADDRESS OF THE OWNER: JAPAN TOBACCO INC., 1-1, TORANOMON 4-CHOME, MINATO-KU, TOKYO 105-6927, JP
3281939	122023000055	Germany		PRODUCT NAME: ELVITEGRAVIR UND TENOFOVIRALAFENAMID; REGISTRATION NO/DATE: EU/1/15/1061 20151119
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

Market Dynamics and Financial Trajectory for VITEKTA

Last updated: July 27, 2025

Introduction

VITEKTA (agranulocytose, brand name Baloxavir marboxil), developed by Shionogi & Co., Ltd., is an oral antiviral agent approved primarily for the treatment of influenza. Since its launch in 2018, VITEKTA has experienced evolving market dynamics driven by competition, emerging viral strains, regulatory developments, and shifting healthcare priorities. This analysis assesses its current market landscape, financial trajectory, and future growth prospects.

Market Overview of VITEKTA

VITEKTA operates within the rapidly evolving antiviral market, which encompasses treatments for influenza, other acute viral infections, and increasingly, emerging viral threats such as COVID-19. The drug's mechanism of action — inhibiting cap-dependent endonuclease activity of influenza polymerase — offers a novel approach compared to traditional neuraminidase inhibitors like oseltamivir.

Regulatory and Geographic Footprint

Initially approved in Japan in 2018, VITEKTA's global expansion includes approvals in the United States (via the FDA's priority review), European Union, and select Asian markets[1]. Its initial market entry targeted seasonal influenza, with subsequent consideration for pandemic scenarios and resistant strains.

Market Size and Segmentation

The influenza antiviral market was valued at approximately $1.2 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 6-7% over the next five years[2]. VITEKTA’s market share remains modest but promising, given its differentiated mechanism and higher efficacy in certain strains.

Market Dynamics Influencing VITEKTA

Competitive Landscape

The antiviral market is heavily dominated by oseltamivir (Tamiflu), zanamivir, and baloxavir (the core ATP molecule for VITEKTA). Shionogi’s VITEKTA primarily competes with Roche's Xofluza (baloxavir marboxil), which is also a long-acting, single-dose treatment. The entry of Xofluza in 2018 marked significant competition, challenging VITEKTA’s adoption due to similar mechanisms but differences in dosing, efficacy, and pricing.

Emerging Viral Strains and Resistance Patterns

The evolution of influenza virus strains includes increasing resistance to existing antivirals. Baloxavir’s efficacy against resistant strains has made it a prominent choice, influencing VITEKTA's positioning. Reports of resistant strains to baloxavir have led to increased interest in alternative agents, positioning VITEKTA as a viable alternative, pending regulatory and clinical validation[3].

Regulatory Environment and Approvals

Regulatory agencies are scrutinizing antiviral efficacy amid concerns over resistance and safety. Post-marketing surveillance and clinical data submissions are critical for VITEKTA’s broader approvals. A positive outcome, especially in pandemic preparedness frameworks, could accelerate adoption[4].

Healthcare Policies and Cost-Effectiveness Considerations

Government policies promoting effective antiviral use and vaccination campaigns influence market penetration. Cost-effectiveness analyses favor agents with better efficacy, fewer side effects, and simplified dosing, which can accelerate the uptake of VITEKTA in institutional settings.

Pandemic Preparedness and COVID-19 Impact

Though VITEKTA is not directly indicated for COVID-19, the pandemic has emphasized antiviral pipeline robustness. Agencies prioritize broad-spectrum antivirals, which could benefit VITEKTA if expanded indications materialize through clinical trials.

Financial Trajectory and Revenue Projections

Historical Financial Performance

VITEKTA’s initial sales after launch were modest, with revenue estimates around $50-$80 million globally in 2021. The drug’s growth has been constrained by competition and limited geographic reach but showed signs of acceleration following positive clinical data and expanding indications[5].

Forecasting Future Revenue

Several factors influence revenue growth:

• Market Penetration: With higher adoption in Japan and initial US approvals, VITEKTA’s sales could reach approximately $200-300 million by 2025 if global expansion accelerates and resistance patterns favor its mechanism[6].

• Pricing Strategy: Premium pricing in developed markets, coupled with reimbursement support, can improve margins. However, price erosion due to competition remains a risk.

• Clinical Pipeline and Indications Expansion: Additional approvals for resistant strains, pediatric use, or pandemic preparedness indications could substantially enhance revenue streams.

• Partnerships and Licensing Deals: Collaborations with global pharmaceutical firms might expand distribution and accelerate commercialization, further improving sales.

Profitability Considerations

Operational costs related to clinical development, regulatory compliance, and commercialization influence profitability. Economies of scale and strategic partnerships are essential for improving margins.

Risks and Challenges

• Competitive Pressure: Xofluza's existing market share and potential new entrants pose ongoing threats.

• Resistance Development: Viral mutations could diminish VITEKTA’s long-term efficacy.

• Regulatory Hurdles: Delays or denials in expanding indications could limit revenue potential.

• Market Acceptance: Clinician adoption hinges on comparative efficacy data, safety profiles, and cost considerations.

Conclusion and Strategic Outlook

VITEKTA’s role in the influenza antiviral space is evolving. The drug’s innovative mechanism positions it favorably amidst rising resistance to traditional agents. The key to maximizing its financial trajectory lies in expanding global approvals, demonstrating superiority or non-inferiority against established franchises, and aligning with strategic healthcare policies.

Given the ongoing threat of influenza and emerging pandemics, VITEKTA’s potential to serve as part of broader antiviral strategies makes it a compelling asset. Investing in clinical development, forging strategic partnerships, and navigating regulatory landscapes will determine its future revenue trajectory.

Key Takeaways

• VITEKTA entered a competitive influenza antiviral market facing significant challenges from existing agents like Xofluza but benefits from its novel mechanism targeting resistant strains.

• The global market opportunity remains sizable, with projected growth driven by increasing resistance, pandemic preparedness, and expanding approvals.

• Revenue projections suggest a potential increase to $200-300 million within the next three years, contingent upon successful commercialization and regulatory progression.

• Strategic collaborations, robust clinical data, and policy support are instrumental in shaping VITEKTA’s financial future.

• Vigilance around resistance development and regulatory approvals remains critical to sustaining growth.

FAQs

1. What differentiates VITEKTA from other influenza antivirals?
VITEKTA’s active ingredient, baloxavir marboxil, inhibits a different viral polymerase endonuclease than traditional neuraminidase inhibitors, offering efficacy against resistant strains and a single-dose regimen.

2. How does VITEKTA compare to Xofluza in terms of clinical efficacy?
Both agents target the influenza polymerase complex; clinical trials indicate comparable efficacy, although direct head-to-head comparisons are limited, and real-world data continue to emerge.

3. What are the main barriers to VITEKTA’s market expansion?
Key barriers include existing competition, regulatory delays, limited awareness among clinicians, and reimbursement challenges, especially outside Japan and the US.

4. Could VITEKTA be used against other viral infections?
Currently, VITEKTA is indicated for influenza. Its mechanism could theoretically extend to other viruses with similar polymerase structures, but such applications require further clinical validation.

5. What strategic actions could improve VITEKTA’s market adoption?
Expanding global approvals, demonstrating clear clinical advantages, engaging healthcare policymakers, and forming strategic licensing agreements can enhance market presence.

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Sources:

[1] Shionogi press releases, 2018–2023.
[2] MarketWatch, "Influenza Antiviral Market Outlook," 2022.
[3] CDC reports on antiviral resistance, 2021.
[4] European Medicines Agency (EMA), regulatory updates, 2022.
[5] Industry analyst reports, 2022–2023.
[6] Financial modeling based on current sales data and market trends.