XOFLUZA Drug Patent Profile

Which patents cover Xofluza, 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-three 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:	263
US Patents:	10
Applicants:	1
NDAs:	2

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

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
Croatia	P20180885
South Africa	201707111	SUBSTITUTED POLYCYCLIC PYRIDONE DERIVATIVE AND PRODRUG THEREOF
South Korea	20170131651
South Korea	20110132462	PROCESS FOR PRODUCING PYRONE AND PYRIDONE DERIVATIVES
Croatia	P20181250

Supplementary Protection Certificates for XOFLUZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
4219508	122024000036	Germany		PRODUCT NAME: BALOXAVIR MARBOXIL ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/20/1500 20210107
2620436	7/2021	Austria		PRODUCT NAME: BALOXAVIR MARBOXIL ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/20/1500 (MITTEILUNG) 20210108
3428170	C20210003 00390	Estonia		PRODUCT NAME: BALOKSAVIIRMARBOKSIIL;REG NO/DATE: EU/1/20/1500 08.01.2021
2620436	PA2021505	Lithuania		PRODUCT NAME: BALOKSAVIRO MARBOKSILAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/20/1500 20210107
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 MORE ON HISTORY TAB 20210108

Investment Scenario and Fundamentals Analysis for XOFLUZA (Baloxavir Marboxil)

Last updated: February 20, 2026

What is XOFLUZA?

XOFLUZA (baloxavir marboxil) is an antiviral medication approved for the treatment of influenza. It was developed by Shionogi & Co. and licensed to Roche in the U.S. and certain other markets. The drug is a selective cap-dependent endonuclease inhibitor that interferes with viral replication. Approved by the FDA in 2018, XOFLUZA targets acute uncomplicated influenza in patients aged 12 and older.

Market Overview and Revenue Potential

Current Market Position

• Global influenza treatment market was valued at approximately USD 2.8 billion in 2021.
• XOFLUZA is positioned as a faster-acting alternative to oseltamivir (Tamiflu), with a reduced treatment duration of one dose versus five.
• Competitive landscape includes oseltamivir, zanamivir, baloxavir (other formulations), and emerging generics.

Sales Milestones

• Full-year 2021 sales in the U.S. reached approximately USD 200 million.
• In 2022, Roche projected sales exceeding USD 300 million, driven by increased flu seasons and expanded prescriptions.

Growth Drivers

• Elevated demand during seasonal flu peaks.
• Potential expansion into pediatric market (currently approved for ages 12+).
• Post-pandemic increased awareness and investment in antiviral stockpiling.

Market Expansion and Regulatory Outlook

Pending Approvals

• Regulatory submissions for pediatric populations (ages 5-11) are under review; approval could broaden addressable market.
• Label updates for prophylactic use and use in high-risk populations are under consideration by the FDA and EMA.

Geographic Expansion

• Market entry in Europe, Japan, and emerging markets is ongoing, contingent upon regulatory approval.
• Development partnerships with local pharma firms facilitate market access.

Competitor Dynamics

Product	Market Share (2022)	Key Advantages	Limitations
Oseltamivir (Tamiflu)	60%	Established, OTC options	Five-day dosing, resistance emerging
Zanamivir	15%	Inhalation delivery	Less convenient, contraindications
XOFLUZA	25%	Single dose, rapid action	Cost, limited pediatric approval (current)

Patent and IP Landscape

• Patent Portfolio: Patents granted for baloxavir's composition, synthesis, and methods of use extend into 2030s.
• Generic Entry Risks: Patent expiry in key markets expected by late 2020s, potentially reducing exclusivity.

Investment Risks and Challenges

Market Volatility

• Flu season variability influences sales.
• Competitive pressure intensified by potential generics.

Clinical and Regulatory Uncertainties

• Pending label expansions are not guaranteed.
• Post-marketing surveillance could reveal safety issues, impacting revenue.

Pricing and Reimbursement

• Q4 2022 pricing in the U.S. averaged USD 150 per dose.
• Payer negotiation impacts margins and market access.

Financial Outlook

• Projected global sales for XOFLUZA could reach USD 500-700 million annually by 2025 with market expansion.
• Peak market penetration depends on approval in pediatric cohorts and prophylactic indications.

Strategic Considerations

• Diversify geographic presence.
• Invest in life cycle management to delay patent cliffs.
• Foster collaborations for new indications or combination therapies.

Key Takeaways

• XOFLUZA is a leading antiviral with a growing market share due to its single-dose regimen and efficacy.
• The drug faces impending patent expiries, demanding strategic innovation.
• Expansion into pediatric and prophylactic uses presents growth opportunities.
• Competitive landscape remains intense, with oseltamivir's established position and risk of generics.
• Market growth hinges on regulatory approvals and flu season variability.

Frequently Asked Questions

1. When is XOFLUZA expected to face generic competition?
   Patent expiry in major markets like the U.S. is projected around late 2020s, with some patents extending into the early 2030s.

2. What are the primary development plans for XOFLUZA?
   Focus areas include approval for pediatric populations, prophylaxis, and combination treatments.

3. How does XOFLUZA compare to existing influenza treatments?
   It offers faster symptom relief with a single dose, though its market share remains below oseltamivir.

4. Are there safety concerns that could impact sales?
   No significant safety issues have been reported; ongoing surveillance is standard.

5. What are the key regulatory hurdles?
   Regulatory bodies may require additional data for pediatric approval and prophylactic indications, which could delay expansion.

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Citations

1. Statista. (2022). Influenza treatment market size worldwide.
2. Shionogi & Co. Ltd. (2022). Annual Report.
3. U.S. Food & Drug Administration. (2018). FDA approves new flu treatment.
4. Roche. (2022). Financial Report.
5. Frost & Sullivan. (2022). Influenza antiviral therapeutics market overview.