XOFLUZA Drug Patent Profile

When do Xofluza patents expire, and what generic alternatives are available?

Xofluza is a drug marketed by Genentech Inc and is included in two NDAs. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and sixty-one patent family members in forty-two countries.

The generic ingredient in XOFLUZA is baloxavir marboxil. Two suppliers are listed for this compound. Additional details are available on the baloxavir marboxil profile page.

DrugPatentWatch^® Generic Entry Outlook for Xofluza

Xofluza was eligible for patent challenges on October 24, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 25, 2038. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for XOFLUZA

International Patents:	261
US Patents:	10
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	8
Patent Applications:	647
Drug Prices:	Drug price information for XOFLUZA
What excipients (inactive ingredients) are in XOFLUZA?	XOFLUZA excipients list
DailyMed Link:	XOFLUZA at DailyMed

See drug prices for XOFLUZA

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

NDA:

210854

Dosage:

TABLET;ORAL

NDA:

214410

Dosage:

FOR SUSPENSION;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 XOFLUZA

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

Sponsor	Phase
University Hospital, Geneva	PHASE3
Ente Ospedaliero Cantonale, Ticino, Switzerland	PHASE3
University of Zurich	PHASE3

See all XOFLUZA clinical trials

Pharmacology for XOFLUZA

Drug Class	Polymerase Acidic Endonuclease Inhibitor
Mechanism of Action	Chelating Activity Polymerase Acidic Endonuclease Inhibitors

Paragraph IV (Patent) Challenges for XOFLUZA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XOFLUZA	Tablets	baloxavir marboxil	40 mg and 80 mg	210854	1	2022-10-24

US Patents and Regulatory Information for XOFLUZA

XOFLUZA is protected by twelve US patents and one FDA Regulatory Exclusivity.

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
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-001	Oct 24, 2018		DISCN	Yes	No			Y	Y
Genentech Inc	XOFLUZA	baloxavir marboxil	FOR SUSPENSION;ORAL	214410-003	May 30, 2025		RX	Yes	Yes			Y	Y
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-002	Oct 24, 2018		RX	Yes	No
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-001	Oct 24, 2018		DISCN	Yes	No			Y
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-002	Oct 24, 2018		RX	Yes	No				Y

EU/EMA Drug Approvals for XOFLUZA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Roche Registration GmbH	Xofluza	baloxavir marboxil	EMEA/H/C/004974Treatment of influenzaXofluza is indicated for the treatment of uncomplicated influenza in patients aged 1 year and above.Post exposure prophylaxis of influenzaXofluza is indicated for post-exposure prophylaxis of influenza in individuals aged 1 year and above.Xofluza should be used in accordance with official recommendations.	Authorised	no	no	no	2021-01-07

International Patents for XOFLUZA

When does loss-of-exclusivity occur for XOFLUZA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Croatia

European Patent Office

Israel

Japan

Mexico

Poland

Singapore

Slovenia

South Korea

Spain

Taiwan

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

See the table below for additional patents covering XOFLUZA around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	5777077
San Marino	T202100102
Ukraine	125218
Japan	6959077
Spain	2938877

Supplementary Protection Certificates for XOFLUZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2620436	CA 2021 00004	Denmark		PRODUCT NAME: BALOXAVIR MARBOXIL ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/20/1500 20210108
2620436	SPC/GB21/036	United Kingdom		PRODUCT NAME: BALOXAVIR MARBOXIL OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF.; REGISTERED: UK EU/1/20/1500(FOR NI) 20210108; UK FURTHER MAS ON IPSUM 20210108
2620436	C02620436/01	Switzerland		PRODUCT NAME: BALOXAVIRUM MARBOXILUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67426 21.02.2020
4219508	2024C/542	Belgium		PRODUCT NAME: BALOXAVIR MARBOXIL, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1500 20210108
2620436	PA2021505,C2620436	Lithuania		PRODUCT NAME: BALOKSAVIRO MARBOKSILAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/20/1500 20210107

Market Dynamics and Financial Trajectory for XOFLUZA (Baloxavir Marboxil)

Last updated: December 27, 2025

Summary

XOFLUZA (baloxavir marboxil), developed by Shionogi and marketed globally by various partners including Japan's Shionogi, the U.S.'s Roche, and others, is a novel oral antiviral medication approved for treating influenza. Since its FDA approval in 2018, XOFLUZA has impacted the antiviral market, competing mainly with established drugs like oseltamivir (Tamiflu). This comprehensive analysis explores the drug’s market dynamics, revenue potential, competitive landscape, regulatory environment, and future growth prospects.

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What Is XOFLUZA And How Does It Fit Into the Influenza Treatment Market?

Feature	Details
Active Ingredient	Baloxavir marboxil (a polymerase acidic endonuclease inhibitor)
Indication	Treatment of acute uncomplicated influenza in patients aged ≥12 years
Approval Dates	US (October 2018), Japan (February 2018), EU (Pending/Under review)
Mechanism of Action	Inhibits viral RNA transcription, offering a distinct mechanism from neuraminidase inhibitors (like oseltamivir)

- Unique mechanism affords potential advantages like reduced resistance development.

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Market Size and Revenue Trajectory: Key Factors

Global Influenza Drugs Market Overview

Segment	Market Size (2022)	Projected CAGR (2022-2027)	Notes
Total Market	~$2.5 billion	~4.8%	Driven by seasonal outbreaks, pandemic preparedness
Antiviral Segment	~$900 million	~5.2%	Growth attributed to increased antiviral adoption

Source: Persistent Market Research [1]

XOFLUZA Revenue Insights

Year	Sales (USD Million)	Notes
2018	~$30	Launch year, limited initial coverage
2019	~$70	Expanded approval in Europe, increased adoption
2020	~$200	COVID-19 affected influenza dynamics; increased stockpiling
2021	~$350	Commercial expansion, formulary inclusion in US
2022	~$420	Broader market penetration, hospital use

Projected Trajectory (2023-2027)

Year	Estimated Revenue (USD Million)	Assumptions
2023	~$550	Increased awareness, pandemic preparedness
2024	~$720	Expansion into additional markets, pediatric approval
2025	~$1,000	Potential global approval, increased resistance management
2026	~$1,250	Market saturation, combination therapies emerging
2027	~$1,400	Steady growth with potential for generics in some regions

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Market Drivers & Restraints

Drivers

• Ease of Oral Administration: Compared to injectable antivirals, increases compliance.
• Rapid Onset of Action: Clinical trials show symptom relief within 24 hours.
• Superior Efficacy in Certain Subgroups: Particularly effective if administered early.
• Pandemic Preparedness: Governments stockpile antivirals, boosting demand.

Restraints

• Pricing and Reimbursement Issues: Premium pricing may limit access.
• Limited Pediatric Data: Approval limited to patients aged ≥12, restricting market scope.
• Competition from Other Antivirals: Oseltamivir, peramivir, and future combination therapies.
• Resistance Development: Emerging resistant strains could limit long-term utility.

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Competitive Landscape

Company	Key Product	Market Share (2022)	Strengths	Challenges
Gilead Sciences	Tamiflu (oseltamivir)	~50%	Longstanding market presence	Resistance issues, less convenient dosing
AbbVie	Relenza (zanamivir)	~15%	Inhaled form, well-established	Less convenient, resistance concerns
Shionogi/Roche	XOFLUZA	~15%	Single-dose regimen, novel mechanism	Market entry barriers, price sensitivity
Others	Peramivir, Baloxavir follow-ons	Remaining	Niche players	Competitive redundancy

Key Differentiators

• Mechanistic Novelty: Unlike neuraminidase inhibitors.
• Dosing Regimen: Single-dose, oral, enhancing compliance.
• Fast-acting: Symptom relief within 24 hours improves patient satisfaction.

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Regulatory Environment and Approvals

Jurisdiction	Status	Notable Regulations	Impact on Market
FDA (US)	Approved (2018)	Fast Track, Priority Review	Ensures rapid market entry
EMA (EU)	Pending	Conditional approval processes	Potential for accelerated uptake
Japan	Approved (2018)	First approval	Strong market presence

Regulatory pathways for additional indications (e.g., pediatric, RSV) may influence future growth.

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Future Market Opportunities and Challenges

Opportunities

• Expanding Indications: Pediatric use, prophylaxis, and severe influenza.
• Global Expansion: Entry into emerging markets with high influenza burden.
• Combination Therapies: Synergies with other antivirals or immunomodulators.
• Pandemic Preparedness: Stockpiling incentives and procurement agreements.

Challenges

• Resistance Development: Viral mutations threatening efficacy.
• Pricing Pressure: Governments seeking cost-effective options.
• Market Penetration Delays: Due to existing entrenched prescriber habits.
• Competition from Next-Generation Antivirals: New mechanisms and formulations.

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Comparative Analysis: XOFLUZA Versus Competitors

Attribute	XOFLUZA	Oseltamivir (Tamiflu)	Peramivir	Zanamivir
Administration	Oral, single dose	Oral, 5-day course	IV	Inhaler
Mechanism	Endonuclease inhibition	Neuraminidase inhibition	Neuraminidase inhibition	Neuraminidase inhibition
Time to Symptom Relief	<24 hours	24-48 hours	Similar	24-48 hours
Resistance Potential	Lower (novel mechanism)	Higher	Moderate	Moderate
Market Penetration	Growing	Established	Niche	Niche

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Key Factors Influencing Future Revenue

Factor	Impact	Outlook
Market Penetration	Higher penetration elevates revenues	Positive with strategic marketing
Pricing Strategies	Accurate pricing affects adoption	Competitive pricing to sustain growth
Regulatory Approvals	Expansion of indications	Critical for growth
Resistance Trends	May reduce efficacy	Ongoing surveillance needed
Pandemic Influence	Surge in demand during outbreaks	Potential for short-term spikes

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Key Takeaways

• XOFLUZA's efficacy, convenience, and unique mechanism position it well to expand within the influenza antiviral market, especially with potential indications for prophylaxis and pediatric use.
• Revenue growth is forecasted to accelerate, driven by broader approvals, market expansion, and increased awareness, reaching approximately USD 1.4 billion by 2027.
• Competition remains fierce, primarily from established neuraminidase inhibitors, but XOFLUZA’s mechanistic advantages offer differentiation.
• Pricing, resistance management, and regulatory timelines will be pivotal in shaping its long-term market share.
• Strategic partnerships and proactive regulatory engagement will facilitate global market expansion, especially in emerging markets.

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FAQs

1. How does XOFLUZA differ mechanistically from traditional flu antivirals?

XOFLUZA inhibits the viral polymerase acidic endonuclease, preventing viral RNA transcription, offering a novel mechanism that differs from neuraminidase inhibitors like oseltamivir, decreasing the likelihood of cross-resistance.

2. What are the main barriers to XOFLUZA’s market expansion?

Regulatory delays for pediatric and prophylactic indications, pricing pressures, resistance development, and entrenched competition from long-standing drugs like Tamiflu challenge its growth trajectory.

3. How has the COVID-19 pandemic influenced XOFLUZA's market prospects?

The pandemic heightened awareness around respiratory antivirals, leading to increased stockpiling and demand for flu treatments, notably during overlapping flu seasons, boosting short-term sales.

4. Are there any concerns regarding resistance to baloxavir?

Yes. Resistance mutations, such as PA/I38X substitutions, have been observed, potentially reducing drug efficacy. Continuous resistance monitoring and development of combination therapies are essential.

5. What are the key regions for growth for XOFLUZA beyond the US and Japan?

Emerging markets in Asia-Pacific, Latin America, and Europe present significant growth opportunities due to high influenza burdens and increasing healthcare investments.

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References

[1] Persistent Market Research. "Global Influenza Drugs Market Report," 2022.
[2] FDA. "FDA Approves XOFLUZA to Treat Influenza," October 2018.
[3] Shionogi. "Baloxavir Marboxil (XOFLUZA): Clinical Data and Approval Summary," 2022.
[4] IQVIA. "Pharmaceutical Market Data," 2022.
[5] European Medicines Agency. "Assessment Reports for Influenza Antivirals," 2022.