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Last Updated: December 25, 2024

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xofluza Drug Patent Profile


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Which patents cover Xofluza, and when can generic versions of Xofluza launch?

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 patent family members in forty-one 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

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Summary for xofluza
International Patents:250
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
Drug patent expirations by year for xofluza
Drug Prices for xofluza

See drug prices for xofluza

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for xofluza
Generic Entry Dates for xofluza*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL
Generic Entry Dates for xofluza*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Children's Hospital of PhiladelphiaPhase 4
University of OxfordPhase 2
Weill Medical College of Cornell UniversityPhase 4

See all xofluza clinical trials

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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of xofluza is ⤷  Subscribe.

This potential generic entry date is based on patent ⤷  Subscribe.

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 210854-003 Mar 18, 2021 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y Y ⤷  Subscribe
Genentech Inc XOFLUZA baloxavir marboxil TABLET;ORAL 210854-002 Oct 24, 2018 RX Yes No ⤷  Subscribe ⤷  Subscribe Y Y ⤷  Subscribe
Genentech Inc XOFLUZA baloxavir marboxil TABLET;ORAL 210854-002 Oct 24, 2018 RX Yes No ⤷  Subscribe ⤷  Subscribe Y Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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

Patent: 8812
Patent: PROCESO PARA PREPARAR UN DERIVADO DE PIRIDONA POLICÍCLICA SUSTITUIDA Y CRISTAL DEL MISMO
Estimated Expiration: ⤷  Subscribe

Australia

Patent: 17282305
Patent: Method for producing substituted polycyclic pyridone derivative and crystal of same
Estimated Expiration: ⤷  Subscribe

Brazil

Patent: 2018076600
Patent: processo para a preparação de derivado de piridona policíclica substituída e cristal do mesmo
Estimated Expiration: ⤷  Subscribe

Canada

Patent: 27840
Patent: METHODES DE PRODUCTION DE DERIVES SUBSTITUES DE PYRIDONE POLYCYCLIQUE ET CRISTAL CORRESPONDANT (METHOD FOR PRODUCING SUBSTITUTED POLYCYCLIC PYRIDONE DERIVATIVE AND CRYSTAL OF SAME)
Estimated Expiration: ⤷  Subscribe

China

Patent: 9311911
Patent: 用于制备取代多环吡啶酮衍生物及其晶体的方法 (METHOD FOR PRODUCING SUBSTITUTED POLYCYCLIC PYRIDONE DERIVATIVE AND CRYSTAL OF SAME)
Estimated Expiration: ⤷  Subscribe

Patent: 3717198
Patent: 用于制备取代多环吡啶酮衍生物及其晶体的方法 (METHOD FOR PRODUCING SUBSTITUTED POLYCYCLIC PYRIDONE DERIVATIVE AND CRYSTAL OF SAME)
Estimated Expiration: ⤷  Subscribe

Croatia

Patent: 0221540
Estimated Expiration: ⤷  Subscribe

European Patent Office

Patent: 73629
Patent: MÉTHODES DE PRODUCTION DE DÉRIVÉS SUBSTITUÉS DE PYRIDONE POLYCYCLIQUE ET CRISTAL CORRESPONDANT (METHOD FOR PRODUCING SUBSTITUTED POLYCYCLIC PYRIDONE DERIVATIVE AND CRYSTAL OF SAME)
Estimated Expiration: ⤷  Subscribe

Patent: 94459
Patent: PROCÉDÉ DE PRÉPARATION D'UN DÉRIVÉ DE PYRIDONE POLYCYCLIQUE SUBSTITUÉ ET CRISTAL DE CELUI-CI (PROCESS FOR PREPARING SUBSTITUTED POLYCYCLIC PYRIDONE DERIVATIVE AND CRYSTAL THEREOF)
Estimated Expiration: ⤷  Subscribe

Israel

Patent: 3812
Patent: תהליך להכנת נגזרת פוליציקלית של פירידון מותמרת וגביש הימנה (Process for preparing substituted polycyclic pyridone derivative and crystal thereof)
Estimated Expiration: ⤷  Subscribe

Japan

Patent: 2017221869
Patent: 置換された多環性ピリドン誘導体の製造方法およびその結晶
Estimated Expiration: ⤷  Subscribe

Patent: 12678
Estimated Expiration: ⤷  Subscribe

Patent: 59077
Estimated Expiration: ⤷  Subscribe

Patent: 18024682
Patent: 置換された多環性ピリドン誘導体の製造方法およびその結晶 (METHOD OF PRODUCING SUBSTITUTED POLYCYCLIC PYRIDONE DERIVATIVE, AND CRYSTAL OF THE DERIVATIVE)
Estimated Expiration: ⤷  Subscribe

Mexico

Patent: 18016267
Patent: METODO PARA PRODUCIR DERIVADO DE PIRIDONA POLICICLICA SUSTITUIDA Y CRISTAL DEL MISMO. (METHOD FOR PRODUCING SUBSTITUTED POLYCYCLIC PYRIDONE DERIVATIVE AND CRYSTAL OF SAME.)
Estimated Expiration: ⤷  Subscribe

Poland

Patent: 73629
Estimated Expiration: ⤷  Subscribe

Singapore

Patent: 201810655Q
Patent: METHOD FOR PRODUCING SUBSTITUTED POLYCYCLIC PYRIDONE DERIVATIVE AND CRYSTAL OF SAME
Estimated Expiration: ⤷  Subscribe

Slovenia

Patent: 73629
Estimated Expiration: ⤷  Subscribe

South Korea

Patent: 2447711
Estimated Expiration: ⤷  Subscribe

Patent: 2586854
Estimated Expiration: ⤷  Subscribe

Patent: 190017991
Patent: 치환된 다환성 피리돈 유도체의 제조 방법 및 그의 결정
Estimated Expiration: ⤷  Subscribe

Patent: 220084425
Patent: 치환된 다환성 피리돈 유도체의 제조 방법 및 그의 결정 (METHOD FOR PRODUCING SUBSTITUTED POLYCYCLIC PYRIDONE DERIVATIVE AND CRYSTAL OF SAME)
Estimated Expiration: ⤷  Subscribe

Spain

Patent: 36077
Estimated Expiration: ⤷  Subscribe

Taiwan

Patent: 50188
Estimated Expiration: ⤷  Subscribe

Patent: 1802097
Patent: Process for preparing substituted polycyclic pyridone derivative and crystal thereof
Estimated Expiration: ⤷  Subscribe

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
Slovenia 3473629 ⤷  Subscribe
Finland 3290424 ⤷  Subscribe
Chile 2020002032 ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for xofluza

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2620436 21C1012 France ⤷  Subscribe PRODUCT NAME: BALOXAVIR MARBOXIL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN SOLVATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/20/1500 20210108
2620436 7/2021 Austria ⤷  Subscribe PRODUCT NAME: BALOXAVIR MARBOXIL ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/20/1500 (MITTEILUNG) 20210108
2620436 CR 2021 00004 Denmark ⤷  Subscribe PRODUCT NAME: BALOXAVIR MARBOXIL ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/20/1500 20210108
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Xofluza Market Analysis and Financial Projection Experimental

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]

More… ↓

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.