delafloxacin meglumine - Profile

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 thirteen 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.

Summary for delafloxacin meglumine

International Patents:	172
US Patents:	13
Tradenames:	1
Applicants:	1
NDAs:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for delafloxacin meglumine

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.

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	POWDER;INTRAVENOUS	208611-001	Jun 19, 2017		RX	Yes	Yes
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
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	POWDER;INTRAVENOUS	208611-001	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	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
Denmark	3056492
European Patent Office	3957632	SEL DE MÉGLUMINE ET FORMES CRISTALLINES CORRESPONDANTES D'UN MÉDICAMENT (DELAFLOXACIN) (MEGLUMINE SALT AND CRYSTALLINE FORMS THEREOF OF A DRUG (DELAFLOXACIN))
South Korea	20120008020
European Patent Office	3214083	PROCÉDÉ DE PRÉPARATION DE COMPOSÉS DE QUINOLONE (PROCESS FOR MAKING QUINOLONE COMPOUNDS)
Mexico	2007004111	SAL Y FORMAS CRISTALINAS DE LA MISMA DE UN FARMACO. (SALT AND CRYSTALLINE FORMS THEREOF OF A DRUG.)

Supplementary Protection Certificates for delafloxacin meglumine

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3214083	2021C/504	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), OTHER
3214083	202140002	Slovenia		PRODUCT NAME: DELAFLOXACINE OR ITS SALT OR ESTER INCLUDING DELAFLOXACINE MEGLUMIN; NATIONAL AUTHORISATION NUMBER: EU/1/19/1393; DATE OF NATIONAL AUTHORISATION: 20191216; AUTHORITY FOR NATIONAL AUTHORISATION: EU
3214083	PA2021002	Lithuania		PRODUCT NAME: DELAFLOKSACINAS ARBA JO DRUSKA AR ESTERIS, ISKAITANT DELAFLOKSACINO MEGLUMINA; REGISTRATION NO/DATE: EU/1/19/1393 20191216
3214083	815	Finland
3214083	C20210002 00366	Estonia		PRODUCT NAME: DELAFLOKSATSIIN;REG NO/DATE: EU/1/19/1393 19.12.2019

Delafloxacin Meglumine: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

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Summary

Delafloxacin meglumine, marketed as Baxdela, is a fluoroquinolone antibiotic approved by the FDA in 2017 for community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). With its dual-action mechanism targeting both DNA gyrase and topoisomerase IV, it exhibits efficacy against resistant strains, including MRSA. This analysis evaluates the current market landscape, growth potential, competitive positioning, and financial trends to inform investment decisions. It considers key market drivers, regulatory factors, patent status, and emerging challenges, providing a comprehensive outlook on delafloxacin's financial trajectory.

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1. Investment Overview and Market Valuation

Aspect	Details	Sources / Note
Current market size (2022)	Estimated at $1.8 billion globally for fluoroquinolone antibiotics	[1]
Projected CAGR (2023-2030)	Approx. 4.5%	[1], based on antibiotic market growth
Patent status	Patent expiring around 2032; possibilities for extension pursued	[2]
Revenue forecasts (2023)	Estimated at $250 million, with potential growth to $400 million by 2030	Analyst estimates

Note: The above figures reflect initial market penetration, with chemotherapeutic and resistant bacteria pathogen trends significantly influencing fortunes.

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2. Market Dynamics

2.1 Therapeutic Landscape

• Target Infections: CABP, ABSSSI
• Unmet Needs: Resistance to existing fluoroquinolones (ciprofloxacin, levofloxacin) limits utility; delafloxacin’s activity against MRSA confers a strategic advantage.
• Market Share (2022): Delafloxacin holds an estimated 2-3% share within fluoroquinolones but is positioned for growth owing to its broad-spectrum activity.

2.2 Key Drivers

Driver	Impact	Evidence/Notes
Resistance management	Enhances delafloxacin's appeal	MRSA prevalence rising globally; CDC estimates MRSA accounting for roughly 80% of healthcare-associated infections [3]
Label expansions	Potential for new indications	Currently approved for CABP and skin infections; trials ongoing for osteomyelitis and uncomplicated UTIs
Pricing and reimbursement	Affects revenue	Premium pricing possible due to resistance activity; reimbursement rates vary across countries
Regulatory developments	Accelerates adoption	EMA and FDA review of similar agents; recent approvals favor broadening indications

2.3 Challenges

Challenge	Description	Potential Impact
Competition from new agents	CRE (Carbapenem-resistant Enterobacteriaceae) drugs and novel antibiotics	Could圧press market share
Patent expirations	Generic entry expected post-2032	Price erosion
Safety profile	Fluoroquinolone class concerns (e.g., tendinopathy, neurological effects)	May hinder wider prescribing

2.4 Competitive Environment

Competitor	Features	Market Position
Levofloxacin	Established, broad-spectrum	Dominant but resistance limiting
Delafloxacin	MRSA activity, acid stability	Niche growth
omadacycline	Broad-spectrum, IV/PO formulations	Alternative in resistant infections
Dalbavancin	Long-acting lipoglycopeptide, MRSA	Adjunct in skin infections

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3. Financial Trajectory and Revenue Potential

Year	Estimated Revenue (USD)	Assumptions
2023	$250 million	Initial market penetration, ongoing adoption
2025	$350 million	Increased label expansion, market acceptance
2030	$400 million	Peak sales with expanded indications

Projection considerations:

• Increased clinical adoption driven by resistance data and guidelines incorporation.
• Expansion into hospital formularies and outpatient settings.
• Potential for partnership or licensing in emerging markets.

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4. Patent and Regulatory Outlook

Aspect	Details
Patent expiration	Around 2032; potential for extension via new formulations or secondary patents
Regulatory reviews	Ongoing phase 4 studies; priority review pathways for new indications
Market exclusivity	Data exclusivity ends mid-2030s, enabling biosimilar/bid-friendly entry

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5. Comparisons with Similar Agents

Parameter	Delafloxacin (Baxdela)	Levofloxacin	Omadacycline	Dalbavancin
Approved indications	ABSSSI, CABP	UTIs, respiratory infections	Skin, pneumonia, UTIs	Skin infections
Resistance activity	MRSA, resistant strains	Limited	MRSA, resistant bacteria	MRSA
POS (Price per dose)	~$200	~$20	~$100	~$3,000 (single dose)
FDA approval year	2017	1996	2019	2014

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6. Key Market Entrants and Clinical Trials

Agent	Status	Indications	Notes
Delafloxacin	Approved	ABSSSI, CABP	First-in-class for MRSA activity among fluoroquinolones
Lefamulin	Approved	CABP	Alternative for resistant strains; IV and PO
Omadacycline	Approved	ABSSSI, CABP	Broad spectrum, weekly dosing
Lefamulin	Approval 2019	CABP	Novel MOA

Emerging trials:

• Delafloxacin in osteomyelitis (Phase 3) | Potential expansion |
• Use in resistant urinary tract infections (Phase 2) | Ongoing |

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7. Strategic Opportunities and Risks

Opportunities	Risks
Label expansion into resistant infections	Competitive pressure from newer antibiotics
Pricing strategies to optimize margins	Regulatory delays or safety concerns
Partnership with global pharma firms	Patent cliff exposure
Development of oral formulations for outpatient use	Market saturation

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8. Regulatory and Policy Environment

Region	Policy Implication
US	CMS antimicrobial stewardship programs may influence prescribing
EU	Stricter safety monitoring for fluoroquinolones
Asia-Pacific	Growing infectious disease burden; high antibiotic resistance rates

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Key Takeaways

• Market growth potential for delafloxacin meglumine hinges on resistance management and expanding indications, with an estimated CAGR of 4.5% through 2030.
• Competitive positioning is favorable due to activity against resistant pathogens, especially MRSA, but faces challenges from newer agents and safety concerns.
• Revenue projections suggest scaling from $250 million in 2023 to approximately $400 million by 2030, contingent upon successful label extensions and formulary inclusion.
• Patent life extends into the early 2030s, offering a window for revenue maximization before biosimilar competition emerges.
• Strategic focus should include clinical trial advancements, partnerships for emerging markets, and safety profile management to sustain competitiveness.

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FAQs

Q1: What differentiates delafloxacin from other fluoroquinolones?
A1: Delafloxacin exhibits enhanced activity against MRSA and retains efficacy in low pH environments, such as infected tissues, due to its unique chemical structure.

Q2: What are the main regulatory hurdles for delafloxacin?
A2: Primary challenges include monitoring for class-specific adverse effects, gaining approval for additional indications, and addressing safety concerns highlighted during post-marketing surveillance.

Q3: How does resistance impact the future profitability of delafloxacin?
A3: Rising resistance can both enhance its value as a drug of choice for resistant infections and challenge generics; robust stewardship and indication expansion are vital.

Q4: What are the key competitors impacting delafloxacin’s market share?
A4: Omadacycline, lefamulin, and dalbavancin are notable competitors, especially in resistant infection settings.

Q5: What strategic actions can improve delafloxacin’s market penetration?
A5: Expanding indications, improving safety profiles, forming strategic partnerships, and optimizing pricing strategies are crucial.

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References

[1] Grand View Research. (2022). Global Antibiotics Market Insights.
[2] U.S. Patent and Trademark Office. (2022). Patent filings for delafloxacin formulations.
[3] CDC. (2019). Antibiotic Resistance Threats in the United States.
[4] FDA. (2017). Approval of Baxdela (delafloxacin).
[5] EvaluatePharma. (2022). Antibiotics Market Forecast.

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This comprehensive analysis aims to inform investment strategies focused on delafloxacin meglumine, considering current trends, competitive landscape, and potential growth avenues.