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 fifty-six patent family members in forty-two countries.

The generic ingredient in XOFLUZA is baloxavir marboxil. One supplier is 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:	256
US Patents:	10
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	7
Patent Applications:	73
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

Constraining patent/regulatory exclusivity:

11,261,198

NDA:

210854

Dosage:

TABLET;ORAL

Constraining patent/regulatory exclusivity:

11,261,198

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
Children's Hospital of Philadelphia	Phase 4
University of Oxford	Phase 2
Weill Medical College of Cornell University	Phase 4

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.

This potential generic entry date is based on patent 11,261,198.

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	210854-002	Oct 24, 2018		RX	Yes	No	10,759,814		Y	Y
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-002	Oct 24, 2018		RX	Yes	No	8,987,441		Y	Y
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-002	Oct 24, 2018		RX	Yes	No	11,261,198		Y
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-003	Mar 18, 2021		RX	Yes	Yes	10,759,814		Y	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/004974 Treatment 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	6249434
Japan	WO2018030463	置換された多環性ピリドン誘導体およびそのプロドラッグを含有する医薬組成物
Portugal	2620436
Turkey	201810736

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
4219508	2024C/542	Belgium		PRODUCT NAME: BALOXAVIR MARBOXIL, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1500 20210108
2620436	C202130015	Spain		PRODUCT NAME: BALOXAVIR MARBOXIL; NATIONAL AUTHORISATION NUMBER: EU/1/20/1500; DATE OF AUTHORISATION: 20210107; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1500; DATE OF FIRST AUTHORISATION IN EEA: 20210107
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

Market Dynamics and Financial Trajectory for Xofluza

Introduction to Xofluza

Xofluza, also known as baloxavir marboxil, is a revolutionary antiviral drug developed for the treatment of acute influenza. It was first launched by F. Hoffmann-La Roche AG in 2018 and has since been a significant player in the influenza treatment market.

Market Growth Drivers

Increasing Incidences of Influenza

The global influenza treatment market is driven by the rising incidence of influenza cases worldwide. This increase in cases necessitates the development and use of effective antiviral medications like Xofluza[4].

Approval and Commercialization

The FDA approval of Xofluza for the treatment of acute influenza in children aged 5 to 12 years in August 2022 has been a crucial factor in its market growth. This approval expanded the drug's target demographic, contributing to its increased sales and market share[3].

R&D Investments and Innovative Medications

Significant investments in research and development (R&D) for anti-viral drugs have boosted the market growth. Xofluza, being the first new flu medicine with a novel proposed mechanism of action, offers better treatment options for patients, thereby driving market demand[4].

Financial Performance of Xofluza

Revenue Growth

Xofluza has been a key contributor to the revenue growth of its parent companies. For Shionogi Inc., which has rights to the drug in certain regions, the sales of Xofluza have been instrumental in achieving record-high revenues. In the first half of fiscal 2023, Shionogi reported significant increases in sales revenue, partly due to the strong performance of Xofluza and another influenza drug, Xocova[2].

Segmental Contribution

Xofluza falls under the prescription drugs segment, which has shown substantial growth. For Shionogi, the sales of Xofluza, along with other infectious disease drugs like Xocova and cefiderocol, have driven the company's revenue and profit margins. The segment excluding temporary income saw a significant increase, with Xofluza being a major contributor[1].

Market Size and Projections

Global Influenza Treatment Market

The global influenza treatment market is expected to grow, with Xofluza playing a pivotal role. The market is projected to reach USD 6.44 billion by 2030, growing at a CAGR of 1.18% from 2024 to 2030. Another estimate suggests the market could reach $1.225 billion by 2026, growing at a CAGR of 4.5%[3][4].

Challenges and Opportunities

Adoption of Influenza Vaccines

One of the challenges facing the growth of the influenza treatment market, including Xofluza, is the adoption of influenza vaccines. Vaccines can reduce the incidence of influenza, thereby decreasing the demand for antiviral treatments. However, the high growth potential in developing economies like India and China, where there is a large population base and notable epidemiology of influenza infection, offers lucrative opportunities for Xofluza and other antiviral drugs[4].

Geographical Expansion

Global Sales Expansion

Shionogi Inc. is actively investing in the global expansion of Xofluza. The company aims to achieve growth in the global market, particularly through the expansion of its in-house sales centered on infectious disease drugs. This includes accelerating investments for the overseas growth of vaccines and Xofluza[1].

R&D and Pipeline Activities

Continuous Innovation

The success of Xofluza has prompted continuous R&D activities to develop new and innovative medications. Shionogi is focusing on building external networks to acquire new capabilities and advancing its focused pipelines. This strategic approach ensures sustainable growth beyond 2026 by rolling out new products and expanding existing product lines[1].

Financial Metrics and Forecasts

Revenue and Profit Forecasts

For Shionogi Inc., the revenue and all profit items are on track to achieve full-year forecasts, driven significantly by the sales of Xofluza and other infectious disease drugs. The company has maintained its initial forecasts for revenue and various profit items, indicating steady progress and growth[2].

Key Takeaways

• Market Growth: The global influenza treatment market is driven by increasing incidences of influenza and R&D investments, with Xofluza being a key player.
• Financial Performance: Xofluza has contributed significantly to the revenue growth of its parent companies, particularly Shionogi Inc.
• Geographical Expansion: Shionogi is investing in global sales expansion, focusing on infectious disease drugs like Xofluza.
• Challenges and Opportunities: While vaccine adoption poses a challenge, developing economies offer significant growth opportunities.
• R&D and Innovation: Continuous R&D activities are crucial for sustaining market growth and expanding product lines.

FAQs

Q: What is Xofluza used for? A: Xofluza (baloxavir marboxil) is used for the treatment of acute influenza in patients who have been symptomatic for no more than 48 hours.

Q: Who developed Xofluza? A: Xofluza was developed by F. Hoffmann-La Roche AG and is also marketed by Shionogi Inc. in certain regions.

Q: What is the projected market size for the global influenza treatment market by 2030? A: The global influenza treatment market is expected to reach USD 6.44 billion by 2030, growing at a CAGR of 1.18% from 2024 to 2030[3].

Q: How has the FDA approval impacted Xofluza's market? A: The FDA approval of Xofluza for children aged 5 to 12 years has expanded its target demographic, contributing to increased sales and market share[3].

Q: What are the key challenges facing the growth of Xofluza in the market? A: One of the main challenges is the adoption of influenza vaccines, which can reduce the demand for antiviral treatments like Xofluza[4].

Cited Sources

1. Shionogi Inc. - 3rd Quarter of Fiscal 2023 Financial Results[1]
2. Shionogi Inc. - 1st Half of Fiscal 2023 Financial Results[2]
3. ResearchAndMarkets.com - Influenza Treatment Market Size, Share & Trends Analysis Report[3]
4. Allied Market Research - Influenza Treatment Market Size, Share | Industry Growth, 2026[4]