BALOXAVIR MARBOXIL - Generic Drug Details

What are the generic sources for baloxavir marboxil and what is the scope of freedom to operate?

Baloxavir marboxil is the generic ingredient in one branded drug marketed by Genentech Inc and is included in two NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Baloxavir marboxil has two hundred and fifty patent family members in forty-one countries.

One supplier is listed for this compound.

Summary for BALOXAVIR MARBOXIL

International Patents:	250
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	12
Patent Applications:	239
What excipients (inactive ingredients) are in BALOXAVIR MARBOXIL?	BALOXAVIR MARBOXIL excipients list
DailyMed Link:	BALOXAVIR MARBOXIL at DailyMed

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

Dosage:

TABLET;ORAL

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 BALOXAVIR MARBOXIL

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

Sponsor	Phase
Children's Hospital of Philadelphia	Phase 4
Weill Medical College of Cornell University	Phase 4
M.D. Anderson Cancer Center	Phase 2

See all BALOXAVIR MARBOXIL clinical trials

Pharmacology for BALOXAVIR MARBOXIL

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

Anatomical Therapeutic Chemical (ATC) Classes for BALOXAVIR MARBOXIL

J05AX	Other antivirals
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for BALOXAVIR MARBOXIL

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 BALOXAVIR MARBOXIL

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
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-003	Mar 18, 2021		RX	Yes	Yes			Y	Y
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-001	Oct 24, 2018		DISCN	Yes	No
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-003	Mar 18, 2021		RX	Yes	Yes			Y
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-002	Oct 24, 2018		RX	Yes	No				Y
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-002	Oct 24, 2018		RX	Yes	No			Y
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-003	Mar 18, 2021		RX	Yes	Yes			Y	Y

EU/EMA Drug Approvals for BALOXAVIR MARBOXIL

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 BALOXAVIR MARBOXIL

Country	Patent Number	Title	Estimated Expiration
Slovenia	3473629
Finland	3290424
Chile	2020002032
Japan	2019189635	安定性に優れた固形製剤 (SOLID FORMULATION HAVING EXCELLENT STABILITY)
Japan	5553393
Costa Rica	20190123
Israel	255295	נגזרות 11-מותמרות של 8,7-דיפלואורו-11,6-דיהידרובנזו[b,e]תיאפין (11-substituted-7,8-difluoro-6,11-dihydrodibenzo[b,e]thiepine derivatives)

Supplementary Protection Certificates for BALOXAVIR MARBOXIL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2620436	21C1012	France		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		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		PRODUCT NAME: BALOXAVIR MARBOXIL ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/20/1500 20210108
2620436	122021000017	Germany		PRODUCT NAME: BALOXAVIR MARBOXIL SOWIE SEINE PHARMAZEUTISCH ANNEHMBAREN SALZE UND SOLVATE; REGISTRATION NO/DATE: EU/1/20/1500 20210107
2620436	PA2021505,C2620436	Lithuania		PRODUCT NAME: BALOKSAVIRO MARBOKSILAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/20/1500 20210107
2620436	2021C/510	Belgium		PRODUCT NAME: BALOXAVIR MARBOXIL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN; AUTHORISATION NUMBER AND 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

BALOXAVIR MARBOXIL Market Analysis and Financial Projection Experimental

Baloxavir Marboxil: Market Dynamics and Financial Trajectory

Overview of Baloxavir Marboxil

Baloxavir marboxil, marketed under the brand name Xofluza, is an antiviral drug approved by the U.S. FDA in 2018 for the treatment of acute uncomplicated influenza. It has garnered significant attention due to its unique mechanism of action and efficacy against both influenza A and B viruses.

Market Growth and Projections

The global influenza treatment market, in which baloxavir marboxil plays a crucial role, is expected to experience steady growth over the next few years. Here are some key projections:

• The global influenza treatment market was estimated at around USD 5.91 billion in 2023 and is projected to grow at a CAGR of 1.18% from 2024 to 2030, reaching approximately USD 6.44 billion by 2030[1][4].
• Baloxavir marboxil is anticipated to exhibit the highest growth rate within this market during the forecast period. This is due to its increasing adoption for treating influenza through oral administration, which is a preferred route for many patients[1][3].

Mechanism of Action and Efficacy

Baloxavir marboxil inhibits the cap-dependent endonuclease, a distinct viral protein essential for the replication of influenza viruses. This mechanism of action is different from other antiviral drugs, making it an attractive option for combination therapies that integrate medications with diverse mechanisms of action[1][3].

Regulatory Approvals and Expansions

Recent regulatory approvals have significantly boosted the market presence of baloxavir marboxil. For instance:

• In August 2022, F. Hoffmann-La Roche Ltd announced the FDA approval of Xofluza for the treatment of acute uncomplicated influenza in children aged 5 to 12 years who have been symptomatic for 48 hours[1][4].
• This approval has expanded the drug's target population, increasing its market potential and contributing to its rapid growth.

Regional Market Performance

North America

North America dominates the influenza treatment market, with a significant revenue share attributed to the well-established healthcare infrastructure and high demand for effective therapeutics. Baloxavir marboxil is particularly popular in this region due to its efficacy and the preference for oral administration[1][3].

Asia Pacific

The Asia Pacific region is expected to show the fastest growth over the forecast period. This growth is driven by an increasing elderly population prone to respiratory conditions, enhanced influenza surveillance, and the development of healthcare infrastructure. Regional players are actively introducing novel treatment options, including baloxavir marboxil, to meet the rising demand for influenza drugs[1][3].

Distribution Channels

The distribution of baloxavir marboxil is primarily through hospital pharmacies and retail pharmacies. Hospital pharmacies captured the maximum market share in 2023, driven by the escalating rates of hospitalizations and the growing demand for prescribed medications. Retail pharmacies also play a significant role, especially with the expansion of product offerings through these channels[3].

Financial Performance

The financial trajectory of baloxavir marboxil is closely tied to the overall growth of the influenza treatment market. Here are some key financial indicators:

• Revenue Growth: The increasing demand for baloxavir marboxil is expected to fuel market growth, with the drug anticipated to grow at the fastest rate during the forecast period[1][3].
• Sales Expansion: Companies like Shionogi Inc., which develops and markets Xofluza, have reported steady progress in sales centered on infectious disease drugs, including baloxavir marboxil. This expansion is driven by the growing need for effective therapeutics against influenza[2].

Competitive Landscape

The competitive landscape in the influenza treatment market is dynamic, with several key players focusing on new product launches, FDA approvals, and strategic partnerships. For baloxavir marboxil, the competitive edge comes from its unique mechanism of action and the expanding approvals for different patient groups. Companies are also investing in R&D to develop novel combination therapies that include baloxavir marboxil, further enhancing its market position[1][4].

Impact of COVID-19

The COVID-19 pandemic has indirectly boosted the growth of the influenza treatment market, including the demand for baloxavir marboxil. The surge in demand for broad-spectrum antiviral drugs during the pandemic has accelerated research and development in antiviral therapeutics. Governments have also increased funding for the development of novel antiviral medicines, which has positively impacted the market for baloxavir marboxil[4].

Key Takeaways

• Market Growth: Baloxavir marboxil is expected to exhibit the highest growth rate in the influenza treatment market.
• Mechanism of Action: It inhibits the cap-dependent endonuclease, offering a unique mechanism of action.
• Regulatory Approvals: Recent FDA approvals have expanded its target population.
• Regional Performance: North America dominates, while Asia Pacific is expected to show the fastest growth.
• Distribution Channels: Primarily distributed through hospital and retail pharmacies.
• Financial Performance: Steady sales growth driven by increasing demand and expanding product offerings.

FAQs

What is baloxavir marboxil used for?

Baloxavir marboxil is used for the treatment of acute uncomplicated influenza in patients who have been symptomatic for no more than 48 hours.

Who approved baloxavir marboxil?

Baloxavir marboxil was approved by the U.S. FDA in 2018.

What is the mechanism of action of baloxavir marboxil?

It inhibits the cap-dependent endonuclease, a viral protein essential for the replication of influenza viruses.

Which region is expected to show the fastest growth for baloxavir marboxil?

The Asia Pacific region is expected to show the fastest growth due to an increasing elderly population and enhanced healthcare infrastructure.

How has the COVID-19 pandemic impacted the market for baloxavir marboxil?

The pandemic has accelerated research and development in antiviral therapeutics, indirectly boosting the demand for baloxavir marboxil.

Sources

1. Grand View Research: Influenza Treatment Market Size And Share Report, 2030.
2. Shionogi Inc.: 3rd Quarter of Fiscal 2023 Financial Results.
3. Vision Research Reports: Influenza Treatment Market Size, Growth, Trends, Report 2024-2033.
4. Research and Markets: Influenza Treatment Market Size, Share & Trends Analysis Report by ...