Delafloxacin meglumine - Generic Drug Details

What are the generic sources for delafloxacin meglumine and what is the scope of freedom to operate?

Delafloxacin meglumine is the generic ingredient in one branded drug marketed by Melinta and is included in two NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Delafloxacin meglumine has one hundred and seventy-two patent family members in forty-two countries.

One supplier is listed for this compound.

Summary for delafloxacin meglumine

International Patents:	172
US Patents:	12
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	41
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for delafloxacin meglumine
What excipients (inactive ingredients) are in delafloxacin meglumine?	delafloxacin meglumine excipients list
DailyMed Link:	delafloxacin meglumine at DailyMed

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

Constraining patent/regulatory exclusivity:

7,728,143

Dosage:

POWDER;INTRAVENOUS

Constraining patent/regulatory exclusivity:

7,728,143

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 delafloxacin meglumine

Drug Class

Fluoroquinolone Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for delafloxacin meglumine

J01MA	Fluoroquinolones
J01M	QUINOLONE ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for delafloxacin meglumine

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	TABLET;ORAL	208610-001	Jun 19, 2017		RX	Yes	Yes
Melinta	BAXDELA	delafloxacin meglumine	TABLET;ORAL	208610-001	Jun 19, 2017		RX	Yes	Yes	8,273,892			Y
Melinta	BAXDELA	delafloxacin meglumine	POWDER;INTRAVENOUS	208611-001	Jun 19, 2017		RX	Yes	Yes	9,493,582		Y
Melinta	BAXDELA	delafloxacin meglumine	POWDER;INTRAVENOUS	208611-001	Jun 19, 2017		RX	Yes	Yes	8,252,813		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	8,871,938			Y

Expired US Patents for delafloxacin meglumine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Melinta	BAXDELA	delafloxacin meglumine	POWDER;INTRAVENOUS	208611-001	Jun 19, 2017	8,648,093
Melinta	BAXDELA	delafloxacin meglumine	TABLET;ORAL	208610-001	Jun 19, 2017	8,648,093
Melinta	BAXDELA	delafloxacin meglumine	TABLET;ORAL	208610-001	Jun 19, 2017	8,969,569
Melinta	BAXDELA	delafloxacin meglumine	POWDER;INTRAVENOUS	208611-001	Jun 19, 2017	9,539,250
Melinta	BAXDELA	delafloxacin meglumine	TABLET;ORAL	208610-001	Jun 19, 2017	9,539,250

International Patents for delafloxacin meglumine

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2010036329
Israel	212781
Poland	3214083
Russian Federation	2011116052	СПОСОБ ПОЛУЧЕНИЯ ХИНОЛОНОВЫХ СОЕДИНЕНИЙ ОБЛАСТЬ ТЕХНИКИ, К КОТОРОЙ ОТНОСИТСЯ НАСТОЯЩЕЕ ИЗОБРЕТЕНИЕ
World Intellectual Property Organization (WIPO)	2014152332
Mexico	375873	COMPOSICIONES DE ETER SULFOALQUILICO-CICLODEXTRINA. (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS)

Supplementary Protection Certificates for delafloxacin meglumine

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3214083	SPC/GB20/073	United Kingdom		PRODUCT NAME: DELAFLOXACIN OR A SALT OR ESTER THEREOF, INCLUDING DELAFLOXACIN MEGLUMINE; REGISTERED: UK EU/1/19/1393 20191219; UK PLGB 10649/0009(NI) 20191219; UK PLGB 10649/0010(NI) 20191219
3214083	5/2021	Austria		PRODUCT NAME: DELAFLOXACIN ODER EIN SALZ ODER ESTER DAVON, EINSCHLIESSLICH DELAFLOXACIN-MEGLUMIN; REGISTRATION NO/DATE: EU/1/19/1393 (MITTEILUNG) 20191219
3214083	301091	Netherlands		PRODUCT NAME: DELAFLOXACINE, OF EEN ZOUT OF ESTERS ERVAN, MET INBEGRIP VAN DELAFLOXACINE MEGLUMINE; REGISTRATION NO/DATE: 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	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	C03214083/01	Switzerland		PRODUCT NAME: DELAFLOXACIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67238 28.05.2020

Market Dynamics and Financial Trajectory for Delafloxacin Meglumine

Last updated: February 13, 2026

Market Overview

Delafloxacin meglumine is a broad-spectrum fluoroquinolone antibiotic approved for treating complicated skin and skin structure infections (cSSSI) and community-acquired pneumonia (CAP), including cases caused by methicillin-resistant Staphylococcus aureus (MRSA). Its specific mechanism confers activity against resistant bacteria, positioning it within a valuable niche for addressing unmet medical needs.

Regulatory Status and Approvals

• Approved by the U.S. Food and Drug Administration (FDA) in June 2017 for cSSSI and CAP.
• Approved in multiple countries with varying timelines, with the primary markets being the U.S. and European Union.
• Limited approval scope constrains rapid global adoption but aligns with a focused indication for drug reimbursement and utilization.

Market Demand Drivers

• Rising prevalence of antibiotic-resistant bacteria, notably MRSA, increases demand for agents like delafloxacin.
• Growing incidence of cSSSI and CAP, especially among aging populations and immunocompromised patients.
• Emergence of treatment guidelines favoring novel fluoroquinolones with improved safety profiles over older agents like ciprofloxacin and levofloxacin.

Competitive Landscape

• Competes with established antibiotics such as vancomycin, linezolid, and newer agents like omadacycline.
• Differentiates through its activity against resistant strains and once-daily dosing.
• Faces competition from generic fluoroquinolones, which sell at lower prices but lack specific activity against resistant bacteria.

Market Size and Revenue

• The global antibiotics market was valued at approximately $40 billion in 2022, with fluoroquinolones accounting for a significant share.
• Estimated that delafloxacin's addressable market in the U.S. for cSSSI and CAP could reach $1–2 billion annually, considering its target indications.
• Revenue generation depends heavily on market penetration, pricing strategies, and competing alternatives.

Financial Trajectory

• Sales Trends (2018–2022): Initial sales post-launch were modest due to limited indications and high pricing. Sales increased gradually as physician familiarity grew.
• Market Penetration: As the drug gains acceptance and formulary inclusion widens, sales are expected to accelerate.
• Pricing: Premium pricing compared to generics, with approximately $1,500–$2,000 per treatment course in the U.S.
• Reimbursement Policies: Reimbursement levels influence actual sales volume, with payers assessing cost-effectiveness relative to existing therapies.
• Forecasts: Analyst estimates project global sales reaching between $300 million and $600 million by 2025, contingent on approval expansion and formulary positioning.

Key Factors Impacting Financial Performance

• Market penetration speed: Faster adoption among infectious disease specialists and hospital formularies.
• Pricing strategy: Maintaining premium pricing without losing competitiveness.
• Regulatory legacies: Expanding approvals to other indications or geographies can significantly uplift revenue.
• Resistance Profile: Continued effectiveness against resistant bacteria sustains utility and demand.
• Competition and generics: Entry of generic fluoroquinolones limits pricing power over the long term.

Risks and Challenges

• Regulatory scrutiny stemming from the history of fluoroquinolone-associated adverse events.
• Market hesitations over safety profiles may slow adoption.
• Emergence of bacterial resistance to delafloxacin could diminish its utility.

Summary

Delafloxacin meglumine’s market sustainability relies on its differentiated activity profile, evolving clinical guidelines, and pricing strategies. Its revenue potential is poised for growth, especially if the approval scope widens and healthcare providers increasingly adopt it for resistant infections.

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Key Takeaways

• Delafloxacin is positioned within a niche targeting resistant bacterial infections, with a focus on cSSSI and CAP.
• Market penetration and sales growth are gradual, influenced by formulary inclusion, pricing, and competitive dynamics.
• Projected global sales between $300 million and $600 million by 2025 depend on regulatory expansion and market acceptance.
• Pricing remains premium due to its clinical advantages but faces pressure from generic competitors.
• Long-term success depends on maintaining efficacy against resistance and navigating safety concerns.

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FAQs

1. What are the main factors influencing delafloxacin’s market growth?
   Market growth depends on clinical acceptance, formulary inclusion, pricing strategies, resistance durability, and approval expansion.

2. How does delafloxacin compare to other fluoroquinolones?
   It offers activity against resistant bacteria like MRSA and is dosed once daily, distinguishing it from older fluoroquinolones lacking these features.

3. What are the regulatory outlooks for future indications?
   Further approvals for other bacterial infections and expanded geographic markets could significantly boost sales.

4. How does safety influence market acceptance?
   Concerns over fluoroquinolone-associated adverse events may slow adoption; positive safety profiles are critical.

5. What are the pricing pressures faced by delafloxacin?
   The presence of generic fluoroquinolones limits the ability to command premium prices long-term, especially as resistance patterns evolve.

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References

[1] IQVIA. "Global Antibiotics Market Insights," 2022.
[2] U.S. Food and Drug Administration. "Delafloxacin Approval Letter," 2017.
[3] Evaluate Pharma. "Fluoroquinolones Market Report," 2022.
[4] MarketWatch. "Delafloxacin Revenue Projections," 2023.