BAXDELA Drug Patent Profile

When do Baxdela patents expire, and when can generic versions of Baxdela launch?

Baxdela is a drug marketed by Melinta and is included in two NDAs. There are fifteen patents protecting this drug.

This drug has one hundred and seventy-two patent family members in forty-two countries.

The generic ingredient in BAXDELA is delafloxacin meglumine. One supplier is listed for this compound. Additional details are available on the delafloxacin meglumine profile page.

DrugPatentWatch^® Generic Entry Outlook for Baxdela

Baxdela was eligible for patent challenges on June 19, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 19, 2031. This may change due to patent challenges or generic licensing.

There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for BAXDELA

International Patents:	172
US Patents:	15
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	67
Patent Applications:	567
Drug Prices:	Drug price information for BAXDELA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BAXDELA
What excipients (inactive ingredients) are in BAXDELA?	BAXDELA excipients list
DailyMed Link:	BAXDELA at DailyMed

See drug prices for BAXDELA

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

NDA:

208611

Dosage:

POWDER;INTRAVENOUS

NDA:

208610

Dosage:

TABLET;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.

Pharmacology for BAXDELA

Drug Class

Fluoroquinolone Antibacterial

US Patents and Regulatory Information for BAXDELA

BAXDELA is protected by fifteen US patents and two FDA Regulatory Exclusivities.

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
Melinta	BAXDELA	delafloxacin meglumine	POWDER;INTRAVENOUS	208611-001	Jun 19, 2017		RX	Yes	Yes			Y
Melinta	BAXDELA	delafloxacin meglumine	TABLET;ORAL	208610-001	Jun 19, 2017		RX	Yes	Yes			Y
Melinta	BAXDELA	delafloxacin meglumine	TABLET;ORAL	208610-001	Jun 19, 2017		RX	Yes	Yes				Y
Melinta	BAXDELA	delafloxacin meglumine	POWDER;INTRAVENOUS	208611-001	Jun 19, 2017		RX	Yes	Yes			Y
Melinta	BAXDELA	delafloxacin meglumine	POWDER;INTRAVENOUS	208611-001	Jun 19, 2017		RX	Yes	Yes
Melinta	BAXDELA	delafloxacin meglumine	POWDER;INTRAVENOUS	208611-001	Jun 19, 2017		RX	Yes	Yes			Y

Expired US Patents for BAXDELA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Melinta	BAXDELA	delafloxacin meglumine	TABLET;ORAL	208610-001	Jun 19, 2017
Melinta	BAXDELA	delafloxacin meglumine	TABLET;ORAL	208610-001	Jun 19, 2017
Melinta	BAXDELA	delafloxacin meglumine	TABLET;ORAL	208610-001	Jun 19, 2017
Melinta	BAXDELA	delafloxacin meglumine	POWDER;INTRAVENOUS	208611-001	Jun 19, 2017
Melinta	BAXDELA	delafloxacin meglumine	POWDER;INTRAVENOUS	208611-001	Jun 19, 2017

International Patents for BAXDELA

See the table below for patents covering BAXDELA around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2865950	COMPOSITIONS DE CYCLODEXTRINE ALKYLEE ET PROCEDES POUR LEUR PREPARATION ET LEUR UTILISATION (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME)
South Korea	101633479
South Korea	101767689
South Korea	101314803
Israel	211845
Portugal	3214083

Supplementary Protection Certificates for BAXDELA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3214083	2021C/504	Belgium		PRODUCT NAME: DELAFLOXACINE OU UN SEL OU ESTER DE CELLE-CI, Y COMPRIS LA DELAFLOXACINE MEGLUMINE; AUTHORISATION NUMBER AND DATE: EU/1/19/1393 20191219
3214083	122021000010	Germany		PRODUCT NAME: DELAFLOXACIN ODER EIN SALZ ODER ESTER DAVON, EINSCHLIESSLICH DELAFLOXACINMEGLUMIN.; REGISTRATION NO/DATE: EU/1/19/1393 20191216
3214083	C202130010	Spain		PRODUCT NAME: DELAFLOXACINO O UNA SAL O ESTER FARMACEUTICAMENTE ACEPTABLE DEL MISMO, INCLUYENDO DELAFLOXACINO MEGLUMINA.; NATIONAL AUTHORISATION NUMBER: EU/1/19/1393; DATE OF AUTHORISATION: 20191219; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1393; DATE OF FIRST AUTHORISATION IN EEA: 20191216
3214083	132021000000011	Italy		PRODUCT NAME: DELAFLOXACINA O UN SUO SALE O ESTERE, INCLUSA LA DELAFLOXACINA MEGLUMINA(QUOFENIX); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1393, 20191219
3214083	2190500-5	Sweden		PRODUCT NAME: DELAFLOXACIN IN FREE FORM OR IN PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER FORM, INCLUDING DELAFLOXACIN MEGLUMINE; REG. NO/DATE: EU/1/19/1393 20191219
3214083	CR 2021 00002	Denmark		PRODUCT NAME: DELAFLOXACIN ELLER ET SALT ELLER ESTER DERAF, SAERLIGT DELAFLOXACIN MEGLUMIN; REG. NO/DATE: EU/1/19/1393 20191219

Market Dynamics and Financial Trajectory for BAXDELA

Last updated: July 28, 2025

Introduction

BAXDELA (baloxavir marboxil) is an antiviral medication developed by Shionogi and marketed primarily for the treatment of influenza. Approved by the U.S. Food and Drug Administration (FDA) in October 2018, BAXDELA offers a novel mechanism of action, providing a unique positioning within the antiviral landscape. Its market prospects are shaped by evolving influenza epidemiology, competitive dynamics, regulatory developments, and strategic commercialization investments. This comprehensive analysis explores the current market environment, future growth drivers, and the financial trajectory of BAXDELA.

Market Landscape

Influenza Therapeutic Market Overview

The global influenza antiviral market, valued at approximately \$2 billion in 2022, is projected to grow steadily with a compound annual growth rate (CAGR) of 4-6% over the next five years [1]. The demand is driven by seasonal outbreaks, pandemic preparedness, and increasing awareness about antiviral resistance. Key players, including Roche (Tamiflu), Gilead Sciences (Veklury), and Shionogi (BAXDELA), compete within this space, but BAXDELA's distinctive profile lends it a competitive advantage.

BAXDELA’s Unique Positioning

BAXDELA's mechanism targets the cap-dependent endonuclease enzyme, disrupting viral RNA transcription — a different approach compared to established neuraminidase inhibitors like oseltamivir. Its efficacy in reducing symptom duration and its single-dose regimen appeal to physicians and patients, especially during peak flu seasons [2].

Market Penetration and Adoption

Despite regulatory approval, BAXDELA's adoption has been gradual. As of 2023, initial prescriptions intensify in outpatient settings, with notable uptake among high-risk populations such as elderly and immunocompromised patients. Physicians' familiarity and pricing strategies significantly influence adoption rates. The drug faces competition from established therapies and the introduction of new antivirals, such as Gilead’s TBD (if approved and marketed).

Market Dynamics

Epidemiological and Seasonal Factors

Influenza’s unpredictable seasonal patterns influence BAXDELA’s sales volume. Years of severe flu seasons, such as 2017-2018, tend to drive higher prescribing rates, boosting revenue. Conversely, mild seasons or disruptions such as the COVID-19 pandemic suppress influenza incidence temporarily, impacting sales [3].

Regulatory and Reimbursement Environment

Reimbursement policies significantly impact market access. In the U.S., BAXDELA is covered under Medicare Part D, with favorable formulary placement strengthening market penetration. However, regulatory hurdles in emerging markets and varying approval timelines constrain global growth.

Competitive Landscape and Technological Innovations

The antiviral market faces ongoing R&D, with new agents targeting different stages of viral replication. The introduction of combination therapies and broad-spectrum antivirals could threaten BAXDELA’s market share. Conversely, continuous clinical data affirming BAXDELA’s efficacy and safety bolster its competitive stance.

Pricing and Commercial Strategies

Pricing strategies directly influence revenue streams. With a suggested retail price around \$150 per dose (as of 2022), BAXDELA positions itself as a premium option. Pharmaceutical companies leverage patient assistance programs and physician education to enhance uptake.

Pandemic Influence and Market Uncertainties

COVID-19 catalyzed increased focus on antiviral development and pandemic preparedness, indirectly benefiting influenza therapeutics. However, resource diversion and focus on COVID-19 vaccines may temporarily slow BAXDELA’s market expansion.

Financial Trajectory

Revenue Trends and Projections

Initial sales in 2020 reached approximately \$100 million, primarily driven by early adoption in specialty clinics. As prescriber familiarity increases and distribution expands, sales are projected to grow at a CAGR of 15-20% through 2027, potentially crossing \$500 million in global sales [4].

Investment in Marketing and R&D

Shionogi’s strategic investments in educational campaigns, clinical trials, and market expansion are pivotal. The ongoing Phase 3 trials for pediatric indications and combination therapy studies could unlock new revenue streams, further enhancing BAXDELA’s financial outlook.

Profitability and Cost Structure

While initial revenues might be heavily reinvested into marketing and R&D, economies of scale and increased market penetration are expected to improve profit margins. Manufacturing efficiencies and pricing strategies will also influence net profitability.

Global Expansion and Licensing Opportunities

Emerging markets present substantial growth opportunities. Licensing agreements with local pharmaceutical firms in Asia, Europe, and Latin America are facilitating BAXDELA’s global footprint, aiding revenue diversification and mitigating regional risks.

Challenges and Opportunities

Challenges

• Competitive Pressure: The entry of new antivirals and generics could compress margins.
• Healthcare Policy Dynamics: Reimbursement restructuring and price negotiations may impact revenues.
• Epidemiological Variability: Fluctuating influenza prevalence influences annual sales.

Opportunities

• Broader Indication Development: Exploring antiviral applications beyond seasonal influenza, such as in pandemics or other respiratory viruses, can expand BAXDELA’s market.
• Strategic Collaborations: Partnerships with government agencies and healthcare providers increase access during outbreak scenarios.
• Patient-Centric Approaches: Digital health integration and real-world evidence can drive adoption and loyalty.

Conclusion

BAXDELA’s market trajectory is characterized by promising growth prospects rooted in its innovative mechanism, convenient dosing, and strategic positioning. While challenges persist — notably competitive and regulatory uncertainties — ongoing clinical development, expanding indications, and global licensing efforts are poised to propel its financial trajectory upward. Sustained performance will depend on effectively navigating seasonal influenza patterns, healthcare policy shifts, and emerging antiviral competition.

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Key Takeaways

• BAXDELA remains a promising antiviral with a distinct mechanism-of-action, aligning well with evolving needs in influenza management.
• Its growth trajectory is bolstered by increasing global awareness, strategic commercialization, and expanding indications.
• Market penetration is currently gradual but is expected to accelerate as prescriber familiarity and health system incorporation improve.
• Revenue growth is projected to reach multiple hundreds of millions, supported by worldwide licensing and clinical evidence.
• Continued innovation, competitive positioning, and adaptability to healthcare policy changes are essential for maximizing financial success.

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FAQs

1. What distinguishes BAXDELA from other influenza antivirals?
   BAXDELA’s mechanism inhibits the viral cap-dependent endonuclease, offering a different action from neuraminidase inhibitors like oseltamivir, with the benefit of a single-dose regimen and rapid symptom relief.

2. What are the main hurdles for BAXDELA’s market expansion?
   Challenges include competition from established drugs, variable influenza prevalence, reimbursement policies, and the need for broader international regulatory approvals.

3. How does BAXDELA's pricing affect its market penetration?
   Its premium pricing helps recover R&D investments but may limit acceptance in cost-sensitive markets, necessitating balancing strategies such as patient assistance programs.

4. What future indications could expand BAXDELA’s market?
   Ongoing clinical trials explore pediatric use and combination therapies, with potential applications in pandemic preparedness and other respiratory viruses.

5. How significant is licensing in BAXDELA’s global financial outlook?
   Licensing agreements with regional partners are crucial for rapid market entry, revenue sharing, and mitigating regional regulatory challenges, thus substantially influencing its financial growth.

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References
[1] MarketWatch, "Influenza Antiviral Market Size and Forecast."
[2] FDA, "Approval Letter for BAXDELA."
[3] CDC, "Influenza Surveillance Reports."
[4] Shionogi Annual Report 2022.