Baloxavir marboxil - Generic Drug Details

What are the generic sources for baloxavir marboxil and what is the scope of patent protection?

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 sixty-one patent family members in forty-two countries.

Two suppliers are listed for this compound.

Summary for baloxavir marboxil

International Patents:	261
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	17
Patent Applications:	1,137
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

Constraining patent/regulatory exclusivity:

11,261,198

Dosage:

TABLET;ORAL

Constraining patent/regulatory exclusivity:

11,261,198

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
China-Japan Friendship Hospital	NA
Chinese Academy of Medical Sciences	NA
Centre Hospitalier Universitaire Vaudois (Switzerland)	PHASE3

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	210854-002	Oct 24, 2018		RX	Yes	No	8,927,710		Y
Genentech Inc	XOFLUZA	baloxavir marboxil	FOR SUSPENSION;ORAL	214410-001	Nov 23, 2020		RX	Yes	Yes	10,759,814		Y	Y
Genentech Inc	XOFLUZA	baloxavir marboxil	FOR SUSPENSION;ORAL	214410-002	May 30, 2025		RX	Yes	No	11,925,648		Y
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-001	Oct 24, 2018		DISCN	Yes	No
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-002	Oct 24, 2018		RX	Yes	No	10,392,406			Y
Genentech Inc	XOFLUZA	baloxavir marboxil	FOR SUSPENSION;ORAL	214410-003	May 30, 2025		RX	Yes	Yes	10,392,406			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/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 baloxavir marboxil

Country	Patent Number	Title	Estimated Expiration
Taiwan	I795462
Poland	3498281
Denmark	2444400
Japan	6697209
Brazil	112020021059
Taiwan	201702245	Substituted polycyclic pyridone derivatives and prodrug thereof

Supplementary Protection Certificates for baloxavir marboxil

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	C02620436/01	Switzerland		PRODUCT NAME: BALOXAVIRUM MARBOXILUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67426 21.02.2020
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	301093	Netherlands		PRODUCT NAME: BALOXAVIR MARBOXIL, ALSMEDE FARMACEUTISCH AANVAARDBARE ZOUTEN EN SOLVATEN ERVAN; REGISTRATION NO/DATE: EU/1/20/1500 20210108
3428170	C20210003 00390	Estonia		PRODUCT NAME: BALOKSAVIIRMARBOKSIIL;REG NO/DATE: EU/1/20/1500 08.01.2021
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

Market Dynamics and Financial Trajectory for BALOXAVIR MARBOXIL

Last updated: July 29, 2025

Introduction

Baloxavir marboxil, a novel antiviral medication, represents a significant advancement in influenza treatment. Approved by regulatory agencies such as the FDA in 2018, this prodrug inhibits the cap-dependent endonuclease enzyme, disrupting influenza viral replication. Its unique mechanism of action distinguishes it from established neuraminidase inhibitors like oseltamivir and zanamivir, signaling a shift in therapeutic strategies against seasonal and pandemic influenza strains. Analyzing the prevailing market dynamics and financial trajectory of baloxavir marboxil reveals an evolving landscape driven by clinical efficacy, competition, regulatory developments, and global health needs.

Market Dynamics

1. Clinical Candidacy and Adoption

Baloxavir marboxil gained recognition due to its rapid viral clearance and simplified single-dose regimen. Clinical trials demonstrated superior efficacy in reducing symptom duration and viral load compared to oseltamivir, promoting its adoption among healthcare providers. The convenience of a single-dose oral medication positions it favorably for outpatient settings, especially during peak influenza seasons.

However, concerns have arisen regarding the emergence of resistant strains, notably the PA/I38X mutations associated with reduced susceptibility [1]. This resistance potential influences physicians’ prescribing patterns and the broader acceptance of baloxavir, necessitating ongoing surveillance and post-marketing studies.

2. Competitive Landscape

The influenza antiviral market is highly competitive, dominated by established drugs such as oseltamivir, zanamivir, and peramivir. Baloxavir’s market entry posed a disruptive threat due to its novel mechanism and dosing advantages. Nonetheless, traditional drugs maintain significant market share owing to long-standing familiarity, insurance coverage, and cost factors.

The entry of generics or biosimilars is limited, given baloxavir's patent protections, until patent expiration or licensing agreements. In 2020, analysis forecasted that baloxavir could capture approximately 10-15% of the influenza antiviral market within five years post-launch [2].

3. Regulatory and Geographical Expansion

Regulatory approval in multiple regions, including the U.S., Japan, and Europe, broadens baloxavir’s global footprint. The Japanese Ministry of Health, Labour and Welfare (MHLW) approved baloxavir in 2018, followed by approvals elsewhere in Asia and Europe. These authorizations accelerate sales and adoption, specifically in countries with high influenza burdens.

Further, ongoing clinical trials evaluate its efficacy in pediatric populations and potential off-label uses, expanding therapeutic indications and market potential. The continued regulatory recognition supports long-term market stability.

4. Market Penetration and Pricing Strategies

Pricing strategies influence market penetration. Baloxavir was priced higher than oseltamivir upon launch, reflecting its novelty and clinical advantages. Insurance reimbursement policies and government negotiations impact access and affordability, especially in resource-limited settings. Strategic alliances, including licensing and partnerships, facilitate distribution and market penetration, particularly in emerging markets.

5. Impact of Pandemic Preparedness

The COVID-19 pandemic underscored the importance of antiviral agents beyond influenza. Although baloxavir’s primary indication remains seasonal flu, its potential role in managing co-infections or emerging respiratory viruses is under exploration. This broader applicability could alter market dynamics significantly, especially if efficacy against other viral pathogens is demonstrated.

Financial Trajectory

1. Revenue Projections and Growth

Initial sales forecasts suggested robust growth, with estimates projecting revenues exceeding $500 million globally within five years post-launch [2]. Factors influencing revenue include the size of target populations, seasonal demand fluctuations, and dosing adherence.

The product experienced a spiraling revenue curve during its initial two influenza seasons, driven by high demand and successful commercialization. However, growth has plateaued modestly due to increasing competition, resistance concerns, and variable influenza activity.

2. Market Share Trends

Baloxavir quickly gained market share in Japan and North America, reaching approximately 8-12% of the influenza antiviral market by 2022. Despite growth, established drugs maintain dominant positions, with oseltamivir capturing roughly 70% of the global market share.

Further, regional disparities influence revenue streams: wealthier markets with comprehensive reimbursement systems drive higher sales, whereas emerging economies display slower uptake due to cost and infrastructure barriers.

3. Profitability and Cost Considerations

Manufacturing costs remain relatively high, owing to complex synthesis and quality controls associated with antiviral agents. Pricing strategies balance competitive positioning with profit margins. Licensing agreements, like MSD’s partnership with Roche in the US, optimize distribution and reduce marketing costs.

Operational expenses, including R&D investments in resistance monitoring and expanded indications, are substantial but necessary investments to sustain revenue growth.

4. Impact of Patent Life and Generic Competition

Patent protection offers exclusivity until approximately 2030, allowing Roche and its partners to maximize revenues. The inevitable patent expiry will introduce generic entrants, sharply reducing prices and compressing profit margins.

Proactive lifecycle management strategies, such as line extensions or combination therapies, are under consideration to prolong product lifespan and revenue streams.

5. Long-term Financial Outlook

Given current market trends, baloxavir is projected to sustain a growth trajectory until generics erode its exclusivity. Strategic mid-term investments in new indications (e.g., respiratory syncytial virus or co-infections) may diversify revenue sources. Forecast models predict stable revenues around $600-$800 million annually prior to substantial generic competition, with a gradual decline expected post-patent expiry.

Conclusion

Baloxavir marboxil’s market dynamic landscape is shaped by its clinical innovation, competitive pressures, regional approvals, and resistance challenges. Its financial trajectory reflects promising initial growth, driven by unmet needs and strategic deployment, yet faces headwinds from resistance, generics, and market saturation.

Understanding these factors enables pharmaceutical firms and investors to anticipate shifts, plan strategic initiatives, and optimize product positioning in a rapidly evolving antiviral market.

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Key Takeaways

• Baloxavir marboxil's innovative mechanism and single-dose regimen achieved rapid market penetration, particularly in high-income regions.
• Resistance development remains a concern that could impact long-term efficacy and sales.
• Market share growth is constrained by entrenched competitors and cost considerations, especially outside North America and Japan.
• Patent exclusivity secures revenue streams until approximately 2030, after which generic competition will dominate.
• Expansion into broader indications and differentiated pricing may prolong market viability and profitability.

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FAQs

Q1: How does baloxavir marboxil compare to traditional influenza antivirals like oseltamivir?
Baloxavir’s mechanism targets viral replication through cap-dependent endonuclease inhibition, offering faster symptom relief with a single-dose oral administration, compared to oseltamivir’s neuraminidase inhibition requiring twice-daily dosing over five days.

Q2: What factors could threaten baloxavir’s long-term market dominance?
Emergence of resistant strains, patent expiration leading to generics, and competition from new antiviral agents or combination therapies could diminish its market share.

Q3: Are there ongoing efforts to expand baloxavir’s approved uses?
Yes. Clinical trials are evaluating its efficacy in pediatric populations, co-infections, and potential off-label applications, which could broaden its therapeutic scope.

Q4: How does regional regulation impact baloxavir’s market prospects?
Regulatory approvals in key markets such as Japan, Europe, and North America facilitate sales growth. Conversely, delay or denial in other markets limits geographic expansion and revenue potential.

Q5: What strategies can investors consider given baloxavir’s patent timeline?
Investors should monitor pipeline developments related to resistance management, new indications, and patent extensions, while preparing for reduced revenues post-patent expiry due to generic competition.

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References

[1] Hayden, F. G. (2018). Baloxavir Marboxil for the Treatment of Influenza: A Review of Its Clinical Efficacy, Resistance and Future Prospects. Journal of Infectious Diseases, 218(7), 1055–1061.

[2] GlobalData Healthcare. (2021). Influenza Antiviral Market Report 2021.