XTORO Drug Patent Profile

When do Xtoro patents expire, and what generic alternatives are available?

Xtoro is a drug marketed by Fonseca Biosciences and is included in one NDA. There are four patents protecting this drug.

This drug has forty-two patent family members in eighteen countries.

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

DrugPatentWatch^® Generic Entry Outlook for Xtoro

Xtoro was eligible for patent challenges on December 17, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 2, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for XTORO

International Patents:	42
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	44
Patent Applications:	143
What excipients (inactive ingredients) are in XTORO?	XTORO excipients list
DailyMed Link:	XTORO at DailyMed

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

NDA:

206307

Dosage:

SUSPENSION/DROPS;OTIC

^*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 XTORO

Drug Class

Quinolone Antimicrobial

US Patents and Regulatory Information for XTORO

XTORO is protected by four US patents.

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
Fonseca Biosciences	XTORO	finafloxacin	SUSPENSION/DROPS;OTIC	206307-001	Dec 17, 2014		RX	Yes	Yes
Fonseca Biosciences	XTORO	finafloxacin	SUSPENSION/DROPS;OTIC	206307-001	Dec 17, 2014		RX	Yes	Yes			Y
Fonseca Biosciences	XTORO	finafloxacin	SUSPENSION/DROPS;OTIC	206307-001	Dec 17, 2014		RX	Yes	Yes			Y
Fonseca Biosciences	XTORO	finafloxacin	SUSPENSION/DROPS;OTIC	206307-001	Dec 17, 2014		RX	Yes	Yes

Expired US Patents for XTORO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fonseca Biosciences	XTORO	finafloxacin	SUSPENSION/DROPS;OTIC	206307-001	Dec 17, 2014
Fonseca Biosciences	XTORO	finafloxacin	SUSPENSION/DROPS;OTIC	206307-001	Dec 17, 2014

International Patents for XTORO

When does loss-of-exclusivity occur for XTORO?

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

Argentina

Australia

Brazil

Canada

Chile

China

European Patent Office

Japan

Mexico

Russian Federation

South Africa

South Korea

Spain

Taiwan

Uruguay

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 XTORO around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	214929
Australia	5854198
Australia	717751
Bulgaria	103474
Bulgaria	64615

Last updated: May 29, 2026

XTORO market dynamics and financial trajectory (revenue drivers, exclusivity, and competitive pressure)

XTORO’s market trajectory is defined by three levers: (1) exclusivity and Orange Book runway for payer coverage and channel formation, (2) competitive entry risk from generics and, if applicable, follow-on products, and (3) reimbursement dynamics that determine net price stability versus volume dependence. A complete, data-grade assessment requires XTORO’s active ingredient, dosage form(s), FDA approval date, Orange Book listings, and current commercial performance metrics; these are not provided in the input, so no complete and accurate market-financial trajectory can be produced.

What is XTORO’s active ingredient, FDA approval status, and route of administration that drive market adoption?

Featured snippet answer: Market dynamics for XTORO depend on its FDA status, approval pathway, and label scope, which determine pharmacy uptake, payer formularies, and prescriber confidence.

XTORO label scope, patient population, and treatment line

• Indication and treatment setting govern target prescriber networks (hospital vs outpatient), specialty pharmacy vs retail flow, and prior authorization incidence.
• Broad label coverage generally reduces restriction, raising addressable patient volume and lowering abandonment risk.

FDA pathway implications for exclusivity

• NDA/BLA pathway and reference-product linkages determine statutory exclusivity and expected generic or biosimilar timing.

When does XTORO lose exclusivity, and what is the Orange Book status that sets generic launch timing?

Featured snippet answer: Exclusivity loss timing controls Paragraph IV incentives, settlement probability, and the window for revenue ramp or decline.

Orange Book listings that matter for launch calendars

• Active ingredient and dosage form are the unit of analysis for patent listings.
• Key entries to confirm in the Orange Book include:
  • Drug substance patents (composition of matter)
  • Drug product patents (formulation, crystallinity, polymorphs, salts, particle engineering)
  • Method-of-use patents (clinical endpoints, dosing regimens)
  • Exclusivity codes tied to regulatory exclusivity

Generic launch scenarios

• Approval pathway for any generic depends on whether required patents are listed and whether exclusivity bars ANDA approval timelines.
• If Orange Book lists method-of-use patents, carve-out labeling can still face litigation friction.

Which patents protect XTORO, and how strong is the patent estate versus generic entry risk?

Featured snippet answer: Patent strength drives entry costs, launch deferral risk, and the probability that payers and patients shift to competitors.

Patent categories that typically block generics

• Composition-of-matter patents are usually the hardest to design around.
• Formulation patents can block “bioequivalent only” competition if they claim specific processing or physical attributes.
• Method-of-use patents can force labeling workarounds, lowering substitution velocity.

Litigation indicators that affect market expectations

• Active district court litigation or ITC threats change the probability of near-term generic launch and can affect acquisition or licensing strategy.

How does XTORO’s pricing and payer reimbursement shape net revenue and profitability?

Featured snippet answer: Net revenue is determined by unit net price after rebates and discounts, and by patient access controls like prior authorization.

Typical reimbursement levers

• Formulary placement (preferred vs non-preferred) affects volume.
• Prior authorization and step therapy impact conversion from intent to filled prescriptions.
• Biosimilar/generic reference pricing can compress net price even when gross list pricing holds.

Channel mix effects

• Specialty pharmacy distribution often produces higher gross-to-net discounts than retail, but can improve adherence and persistency.
• Hospital systems can negotiate bundled pricing, changing quarterly volatility.

What revenue drivers explain XTORO’s financial trajectory (volume, price, and mix)?

Featured snippet answer: The financial trajectory for XTORO is generally decomposed into (a) scripts/patient starts, (b) average net price per unit, and (c) mix across doses and channels.

Volume build vs churn

• Early-stage ramp typically depends on prescriber adoption and access friction.
• Mid-to-late-stage sustainability depends on refill/persistency and whether competitors create substitution.

Price/mix shift mechanisms

• Dose migrations, pack-size changes, and channel shifts can increase revenue per treated patient even with stable net price per unit.
• Conversely, payer re-tiering can reduce net price rapidly without immediate script loss.

Which companies challenge XTORO with Paragraph IV ANDAs or biosimilar applications, and what does that mean for sales?

Featured snippet answer: Paragraph IV or biosimilar filings forecast entry timing and can trigger payer de-listing plans and prescriber contingency switching.

ANDA challenge dynamics

• Challengers with early filing dates and strong Paragraph IV positions increase the probability of an earlier settlement or court timeline acceleration.
• If XTORO has method-of-use patents, labeling carve-outs can still allow partial competition with slower uptake.

Biosimilar risk framework (if biologic)

• For biologics, interchangeability and reference product exclusivity timing govern market compression more than formulation-only patents.

What is the competitive landscape for XTORO, and how does it compare with key alternatives by efficacy and access?

Featured snippet answer: Competition is determined by therapeutic equivalence, formulary tier placement, and managed-care controls.

Direct competitor types

• Same-mechanism competitors tend to win when payer policies hinge on class outcomes or clinical guidelines.
• “Different mechanism, similar endpoint” competitors can substitute when access barriers favor cheaper options.

Comparative access

• If XTORO requires extensive prior authorization, competitors with easier criteria often capture share even at similar net prices.

How do patent settlements and licensing deals around XTORO affect expected launches and revenue downside?

Featured snippet answer: Settlement agreements compress uncertainty by defining launch timing, design-around boundaries, and sometimes market allocation mechanisms.

Common settlement terms that change economics

• Carve-out dates for specific strengths/dosage forms
• Forbearance on certain patent claims
• Royalty or profit-share structures if licensed competition proceeds
• “No-at-risk” commitments that stabilize early net revenue

What manufacturing and formulation/IP barriers could delay generic versions of XTORO?

Featured snippet answer: If formulation patents tie to physical attributes or processing, manufacturing replication increases regulatory risk and launch timing volatility.

Manufacturing-scale constraints

• Specialized processes or analytical controls can slow tech transfer.
• If XTORO has tight specs for particle size, polymorph, or stability, generics may need more development time.

What is the FDA regulatory and lifecycle roadmap for XTORO (supplements, label changes, and REMS)?

Featured snippet answer: Lifecycle events can extend market presence via label expansion, new dosages, or safety program changes, altering payer utilization.

Lifecycle events that change unit demand

• New indication adds addressable population.
• Dose form changes can improve adherence but also create new exclusivity and patent listings.

Safety program impacts

• REMS or monitoring requirements can reduce prescriber throughput and slow adoption, while improving persistence in controlled populations.

Key Takeaways

• XTORO’s market dynamics hinge on exclusivity and Orange Book-driven generic and, if applicable, biosimilar entry calendars.
• Net revenue trajectory is driven by access (formulary placement and prior authorization), price concessions (rebates/discounts), and mix across dosage strengths and channels.
• Competitive pressure likelihood depends on Paragraph IV or biosimilar filings, patent estate breadth, and settlement/licensing outcomes.
• Manufacturing and formulation/IP barriers can delay entry and smooth revenue decline, even when patent expiration approaches.

FAQs

1. How do Orange Book exclusivity codes for XTORO change ANDA filing timelines?
2. What factors most influence XTORO net price versus list price under US payer contracting?
3. How do method-of-use patents for XTORO limit label substitution even after composition-of-matter expiry?
4. What indicators predict whether challengers will litigate versus settle XTORO patent disputes?
5. How do dosage form or strength-specific XTORO exclusivities affect the timing of generic switching by payers?

References

1. No sources were cited because no XTORO identifiers (active ingredient, FDA application, Orange Book listings, or financial disclosures) were provided in the input.