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 fifteen 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:	15
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

Dosage:

POWDER;INTRAVENOUS

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

Expired US Patents for delafloxacin meglumine

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

International Patents for delafloxacin meglumine

Country	Patent Number	Title	Estimated Expiration
Australia	2013226073	Alkylated cyclodextrin compositions and processes for preparing and using the same
Japan	2015110671	スルホアルキルエーテルシクロデキストリン組成物 (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS)
Eurasian Patent Organization	031355	КОМПОЗИЦИИ НА ОСНОВЕ СУЛЬФОАЛКИЛЬНЫХ ЭФИРОВ ЦИКЛОДЕКСТРИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARATION THEREOF)
South Korea	101767689

Supplementary Protection Certificates for delafloxacin meglumine

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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Delafloxacin Meglumine

Last updated: July 28, 2025

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Introduction

Delafloxacin meglumine is a novel fluoroquinolone antibiotic approved for treating acute bacterial skin and skin structure infections (ABSSSI) and community-acquired pneumonia (CAP). Developed by Melinta Therapeutics, its unique pharmacological profile and targeted clinical applications position it distinctly within the antibiotic market landscape. This analysis explores the market dynamics influencing delafloxacin meglumine's commercial trajectory, examining factors such as global demand, competitive landscape, regulatory environment, and potential revenue streams.

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Pharmaceutical Profile and Clinical Applications

Delafloxacin distinguishes itself by effective activity against both Gram-positive and Gram-negative bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa. Its unique chemical structure offers enhanced tissue penetration and activity across varied pH environments, addressing critical limitations of existing fluoroquinolones.

Approved by the U.S. Food and Drug Administration (FDA) in 2017, delafloxacin's primary indications—ABSSSI and CAP—are high-volume therapeutic areas with significant unmet needs, especially amid rising antimicrobial resistance. Its inclusion in the American Thoracic Society guidelines underscores its growing clinical relevance.

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Market Size and Demand Drivers

The global antibiotics market, valued at approximately USD 50 billion in 2022, is projected to reach USD 70 billion by 2030, driven by increasing bacterial infections, antimicrobial resistance, and expanding indications. Within this sector, the segment comprising fluoroquinolones is substantial, accounting for a notable share due to their broad-spectrum activity and oral affordability.

Delafloxacin's target markets—hospital and outpatient settings—are expanding amid rising bacterial infection rates, especially resistant strains. The increasing prevalence of MRSA-related infections (approximately 50-60% of skin infections) creates a sustained demand for potent antibiotics, elevating delafloxacin’s commercial appeal.

However, stringent prescribing guidelines and antimicrobial stewardship initiatives constrain the use of broad-spectrum fluoroquinolones, encouraging targeted and judicious use, which can influence revenue projections.

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Competitive Landscape

Delafloxacin enters a competitive field populated by established fluoroquinolones like levofloxacin, ciprofloxacin, and moxifloxacin, alongside newer agents targeting resistant strains. Its advantages over competitors include:

• Efficacy against MRSA: Unlike many fluoroquinolones, delafloxacin demonstrates potent activity against resistant Gram-positive pathogens.
• Bactericidal action in acidic environments: Offers clinical efficacy where other agents falter.
• Favorable safety profile: Lower incidence of some adverse events associated with fluoroquinolones (e.g., tendinopathy, QT prolongation).

Despite its benefits, prescriber familiarity with established agents and cost considerations influence uptake. Additionally, emerging resistance patterns may impact future sales.

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Regulatory and Reimbursement Environment

Regulatory approval has bolstered delafloxacin's market presence. However, reimbursement policies and formulary placements significantly influence utilization. The drug's pricing strategy—set at a premium relative to generic fluoroquinolones—necessitates demonstrating clear clinical benefit and cost-effectiveness to gain broader access.

In the U.S., successful inclusion in hospital formularies hinges on clinical guidelines, insurer negotiations, and stewardship policies. Global regulatory approvals remain limited, with potential opportunities in Europe, Asia, and emerging markets contingent upon ongoing evaluation of local unmet needs and antimicrobial resistance profiles.

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Market Penetration and Adoption Trends

Initially, delafloxacin's adoption experienced gradual growth, primarily among hospital-based infectious disease specialists. Its clinical advantages favor niche applications, especially in treating MRSA-associated infections resistant to other fluoroquinolones.

In 2021, Melinta reported modest revenues, reflecting the slow but steady market penetration. Growing awareness, clinical trial data, and emerging resistance patterns are expected to facilitate increased use.

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Financial Trajectory and Revenue Outlook

Forecasting delafloxacin’s financial trajectory involves assessing its market penetration rate, average selling price (ASP), and potential volume of prescriptions.

• Revenue potential: Given the sizable ABSSSI and CAP markets, combined with increasing resistance-driven demand, revenues could approach USD 200-300 million annually over the next five years, assuming wider adoption.

• Pricing considerations: Premium pricing may limit short-term volume but could be offset by higher margins. Reimbursement negotiations and generic competition for related agents will influence pricing dynamics.

• Pipeline prospects: Melinta is exploring new indications and formulations, which could diversify revenue streams. Ongoing clinical trials examining delafloxacin for other infections may unlock additional markets.

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Challenges to Market Growth

• Antimicrobial stewardship: Efforts to curb fluoroquinolone overuse may restrict prescribing.

• Resistance evolution: Emergent resistance could diminish efficacy over time, impacting sales.

• Market competition: Novel antibiotics and evolving standards of care will influence market share.

• Regulatory hurdles: Expansion into global markets requires navigating complex approval processes.

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Opportunities for Expansion

• New indications: Clinical trials in urinary tract infections, intra-abdominal infections, and osteomyelitis could extend delafloxacin’s application.

• Combination therapy protocols: Integration into multidrug regimens may enhance efficacy and market penetration.

• Global expansion: Tailoring strategies for Asian, European, and Latin American markets can diversify revenue streams.

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Conclusion

Delafloxacin meglumine’s market dynamics are shaped by its unique pharmacology, clinical utility in resistant bacterial infections, and the evolving landscape of antimicrobial stewardship. While initial growth remains cautious, the drug’s innovative features position it favorably to capitalize on unmet medical needs amid rising resistance. Strategic positioning, regulatory navigation, and demonstrating cost-effectiveness will underpin its financial trajectory.

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Key Takeaways

• Delafloxacin meglumine offers a targeted solution within the expanding antibiotics market, particularly for resistant infections.
• Its clinical advantages over traditional fluoroquinolones underpin its gradual market penetration.
• Revenue projections suggest potential growth to USD 200-300 million annually, contingent upon wider adoption and reimbursement strategies.
• Market challenges include antimicrobial stewardship policies, resistance emergence, and stiff competition.
• Opportunities lie in expanding indications, clinical trial insights, and global market entry, all critical for sustainable financial growth.

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FAQs

1. What distinguishes delafloxacin meglumine from other fluoroquinolones?
Delafloxacin exhibits enhanced activity against MRSA and Pseudomonas aeruginosa, maintains efficacy in acidic tissues, and has a favorable safety profile, setting it apart from traditional fluoroquinolones.

2. How does antimicrobial resistance impact delafloxacin’s market potential?
Emerging resistance could reduce its effectiveness, limiting long-term use. Conversely, increasing resistance boosts demand for potent agents like delafloxacin, especially in resistant infections.

3. What is the current global approval status of delafloxacin?
FDA approval was granted in 2017 for ABSSSI and CAP in the U.S. Other regulatory agencies, such as EMA or China’s NMPA, have yet to approve or publicly evaluate the drug extensively.

4. What are the main barriers to delafloxacin’s market growth?
Key barriers include antimicrobial stewardship guidelines restricting fluoroquinolone use, high costs, competition from existing antibiotics, and the risk of resistance development.

5. What strategies could enhance delafloxacin’s market penetration?
Clinical trial expansion for additional indications, cost-effective pricing, active engagement with formulary committees, and global regulatory submissions are vital strategies.

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References

[1] MarketWatch, “Global Antibiotics Market Size, Share & Trends,” 2022.
[2] U.S. FDA, “Delafloxacin Approved for Acute Bacterial Skin and Skin Structure Infections,” 2017.
[3] American Thoracic Society, “Guidelines on Infectious Disease Management,” 2021.
[4] Melinta Therapeutics Annual Report, 2022.
[5] ClinicalTrials.gov, “Studies on Delafloxacin,” 2022.