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 thirteen 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:	13
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	67
Patent Applications:	476
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 thirteen 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	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
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

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	POWDER;INTRAVENOUS	208611-001	Jun 19, 2017
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	POWDER;INTRAVENOUS	208611-001	Jun 19, 2017

International Patents for BAXDELA

When does loss-of-exclusivity occur for BAXDELA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

China

European Patent Office

Hong Kong

Japan

Mexico

Russian Federation

South Korea

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Country	Patent Number	Title	Estimated Expiration
Canada	2582954	SEL ET SES FORMES CRISTALLINES D'UN MEDICAMENT (SALT AND CRYSTALLINE FORMS THEREOF OF A DRUG)
Cyprus	1125048
Denmark	3056492
European Patent Office	1802607	SEL ET SES FORMES CRISTALLINES D'UN MEDICAMENT (SALT AND CRYSTALLINE FORMS THEREOF OF A DRUG)
European Patent Office	3056492	SEL DE MEGLUMINE ET FORMES CRISTALLINES CORRESPONDANTES D'UN MÉDICAMENT (DELAFLOXACIN) (MEGUMINE SALT AND CRYSTALLINE FORMS THEREOF OF A DRUG (DELAFLOXACIN))
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))

Supplementary Protection Certificates for BAXDELA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	122021000010	Germany		PRODUCT NAME: DELAFLOXACIN ODER EIN SALZ ODER ESTER DAVON, EINSCHLIESSLICH DELAFLOXACINMEGLUMIN.; REGISTRATION NO/DATE: EU/1/19/1393 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	LUC00196	Luxembourg		PRODUCT NAME: DELAFLOXACINE OU UN DE SES SELS OU ESTERS, Y COMPRIS LA MEGLUMINE DE DELAFLOXACINE; AUTHORISATION NUMBER AND DATE: EU/1/19/1393 20191219
3214083	PA2021002	Lithuania		PRODUCT NAME: DELAFLOKSACINAS ARBA JO DRUSKA AR ESTERIS, ISKAITANT DELAFLOKSACINO MEGLUMINA; REGISTRATION NO/DATE: EU/1/19/1393 20191216
3214083	2021C/504	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), OTHER

BAXDELA (delafloxacin): Market dynamics and financial trajectory for the branded antibacterial

Last updated: July 30, 2026

Executive summary

• BAXDELA (delafloxacin) remains a hospital- and clinic-centric branded fluoroquinolone positioned for acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). Uptake has been constrained by class competition (ciprofloxacin/levofloxacin and other fluoroquinolones), antimicrobial stewardship pressure, and generic pressure dynamics across older fluoroquinolone backbones.
• The financial trajectory has been shaped by (1) label breadth vs. payer and hospital formulary acceptance, (2) seasonality and case mix for CABP and ABSSSI, and (3) portfolio competition within the same stewardship targets (shorter courses and newer alternatives).
• A rigorous view of revenue depends on public company segment reporting by the commercial rights holder and invoice-level trends not fully standardized in public disclosures; therefore, this analysis focuses on market structure, competitive drivers, and the most important near-term financial catalysts for BAXDELA.

Where does BAXDELA fit in the ABSSSI and CABP antibiotic market?

Featured snippet answer: BAXDELA is used in ABSSSI and CABP as a systemic fluoroquinolone option, typically competing against other fluoroquinolones and broad-spectrum antibacterials chosen through hospital antibiograms and stewardship rules.

What are the main demand drivers for ABSSSI?

ABSSSI utilization follows a pattern tied to:

• Hospital inpatient and emergency department volumes for cellulitis, wound infections, and postoperative or trauma-linked infections.
• Shift toward shorter-duration regimens and protocols favoring agents with lower risk profiles for Clostridioides difficile and tendon or QT concerns.
• Escalation/de-escalation pathways. Clinicians start empiric therapy and narrow once cultures or biomarkers return.

BAXDELA’s sales mix has tended to track with penetration into institutions that support fluoroquinolones as part of their ABSSSI algorithm and where dosing simplicity supports formulary adoption.

What are the main demand drivers for CABP?

CABP demand is influenced by:

• Seasonality (winter respiratory spikes).
• Pulmonary service pathways and use of inpatient vs outpatient settings.
• Guideline alignment and local antimicrobial resistance patterns.

For fluoroquinolones used in CABP, prescribing is sensitive to:

• macrolide resistance,
• atypical coverage needs,
• beta-lactam limitations,
• and stewardship restrictions on broad-spectrum fluoroquinolones.

How has BAXDELA competed against generic fluoroquinolones and other ABSSSI/CABP options?

Featured snippet answer: In ABSSSI and CABP, BAXDELA competes mainly against older, often cheaper antibacterials and institutional formulary tiers; the branded pricing case depends on outcomes, stewardship fit, and route convenience.

Core competitive set (therapeutic interchange)

For an institutional payer or ID service, fluoroquinolones and adjacent agents are often substituted based on:

• spectrum coverage,
• dosing schedule,
• route (IV-to-oral transitions),
• adverse-event profile,
• and formulary tiering.

BAXDELA competes with:

• Generic fluoroquinolones used for ABSSSI and CABP indications (class competitors),
• non-fluoroquinolone broad-spectrum antibiotics (selected by resistance patterns and toxicity constraints),
• and newer ABSSSI or CABP regimens when institutions have pathway-driven preferences.

Market access reality: formulary tiering and prior authorization

Financial outcomes in this category depend more on:

• formulary status (preferred vs non-preferred),
• utilization management (prior authorization, step edits),
• hospital contracting (rebates, GPO dynamics), than on headline label approvals.

Branded fluoroquinolones often underperform when:

• substitution to generics is easy,
• stewardship limits fluoroquinolone use to specific scenarios,
• and the net price collapses after rebates.

What is the financial trajectory of BAXDELA based on public disclosures and typical branded antibacterial dynamics?

Featured snippet answer: BAXDELA’s revenue performance has followed a typical branded antibacterial pattern: initial uptake after launch, then slower growth or plateauing driven by competitive substitution and contracting-driven net price compression. The trajectory is tied to institutional conversion and sustained formulary retention rather than broad outpatient scaling.

Typical post-launch curve in hospitals

In hospital-centric antibacterial brands, revenue typically reflects:

• Year 1-2: targeted wins across ID departments and pharmacy contracts
• Year 2-4: incremental expansion or stalling based on stewardship feedback and formulary renewals
• Year 4+: normalization to acquisition costs, competitive pressure, and generic-era economics

For BAXDELA, the presence of generic class competitors means the net revenue ceiling is usually bounded by:

• formulary discipline,
• payer pressure,
• and contracting outcomes.

What tends to move BAXDELA revenue quarter-to-quarter?

Quarterly movement often correlates with:

• hospital case volumes for ABSSSI and CABP,
• seasonal CABP incidence,
• ID committee updates to antibiograms,
• and channel shifts (ID vs pulmonary vs emergency medicine ordering patterns).

Financial trajectory can also be impacted by manufacturing supply and gross-to-net mechanics, but those details are generally not consistently transparent in public filings at a product level.

How strong is BAXDELA’s exclusivity and patent protection versus generic entry risk?

Featured snippet answer: Generic fluoroquinolone class pressure is persistent; brand-specific protection determines whether BAXDELA faces true substitution risk or only competitive pressure from within-class alternatives. The key question for financial trajectory is whether any BAXDELA-specific exclusivity/patent cliffs coincide with stewardship-driven prescribing shifts.

How exclusivity affects near-term earnings

Financial outcomes depend on:

• whether there are route/formulation-specific protections that sustain differentiation,
• whether method-of-use protections constrain label-based substitution,
• and whether Paragraph IV pathways are active or expected.

Because the generic threat differs from class substitution, BAXDELA’s revenue can fall even without direct patent challenge if hospitals switch to cheaper equivalents under stewardship pressure.

What lawsuits, Paragraph IV filings, and settlements affect BAXDELA’s market timing?

Featured snippet answer: The most material financial impacts come when exclusivity/patent challenges create credible timelines for generic entry. BAXDELA’s market dynamics therefore depend on whether there are active or threatened challenges tied to its specific label-protecting IP.

A proper market-timing analysis requires:

• listing each Orange Book patent family for BAXDELA,
• tracking Hatch-Waxman litigation and settlements,
• and mapping the “earliest possible generic launch” scenario.

No complete, product-specific, publicly indexed patent-entry timeline is provided in the available input, so a definitive litigation-driven launch clock cannot be stated here.

What is BAXDELA’s Orange Book status and how does it influence pricing power?

Featured snippet answer: Orange Book-listed patents drive the legal floor on substitution. Pricing power in branded antibacterials is typically sustained only when the brand can preserve contracting differentiation alongside legal exclusivity.

How Orange Book status translates to net price

Even with patent protection, branded antibiotics often see net price compression when:

• hospitals build tender-based contracts,
• ID committees allow fallback agents,
• and rebating reduces the effective price differential to generics.

If BAXDELA has strong, broadly applicable IP protection, it can support:

• higher net price retention,
• longer formulary shelf life,
• and leverage in hospital contracting.

If protections are narrow, the commercial ceiling becomes the expected “within-class substitution” ceiling even before a legal expiration.

How does BAXDELA differ commercially from competing fluoroquinolones?

Featured snippet answer: BAXDELA differentiates on its clinical and dosing positioning within ABSSSI and CABP workflows rather than on a wholly separate antibiotic class.

Brand differentiation levers that matter financially

• IV-to-oral transition practicality for hospital-to-outpatient continuity
• protocol compatibility with empiric and de-escalation pathways
• adverse-event and monitoring burden relative to competitors
• ID committee acceptance in antibiogram-driven decisions

Where the brand fits best financially is usually in institutions whose stewardship protocols allow fluoroquinolone use for ABSSSI/CABP without excessive restrictions.

What is the biosimilar or biologics angle for BAXDELA?

Featured snippet answer: None. BAXDELA is a small-molecule antibacterial; biosimilar dynamics do not apply.

What commercial risks could accelerate BAXDELA revenue decline?

Featured snippet answer: The largest risks are typically competitive substitution, stewardship restriction tightening, and net price erosion through contract renegotiations.

Key risk channels:

• Stewardship de-prioritization of fluoroquinolones outside specific indications.
• Hospital formulary switches at renewal cycles.
• Generic substitution driven by class economics if no meaningful differentiation persists.
• Resistance-pattern shifts that reduce recommended fluoroquinolone use.

Key Takeaways

• BAXDELA’s market performance is governed by hospital formulary dynamics and antimicrobial stewardship more than by outpatient scale.
• The branded financial ceiling is bounded by within-class competition and net price compression through contracting.
• The biggest earnings inflection points come from (1) formulary retention/expansion, (2) seasonal CABP case volumes, and (3) any BAXDELA-specific IP or exclusivity events that change generic entry expectations.

FAQs

1. How do hospital antibiograms affect BAXDELA prescribing in ABSSSI?
2. What net price dynamics typically determine branded fluoroquinolone earnings in hospital contracting?
3. How do ABSSSI length-of-therapy protocols shift fluoroquinolone utilization versus alternatives?
4. What role do prior authorization and step edits play in limiting BAXDELA uptake?
5. What revenue model best forecasts BAXDELA growth: hospital acquisition, formulary retention, or outpatient spillover?

References

1. (No sources were provided in the input to support a product-specific market/financial trajectory with citations.)

DrugChatter Q&A for BAXDELA

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