XHANCE Drug Patent Profile

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

Xhance is a drug marketed by Optinose Us Inc and is included in one NDA. There are fourteen patents protecting this drug.

This drug has three hundred and thirty-seven patent family members in twenty-nine countries.

The generic ingredient in XHANCE is fluticasone propionate. There are twenty-nine drug master file entries for this compound. Seventy-two suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Xhance

A generic version of XHANCE was approved as fluticasone propionate by ENCUBE on May 14^th, 2004.

Summary for XHANCE

International Patents:	337
US Patents:	14
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	1
Patent Applications:	2,807
Drug Prices:	Drug price information for XHANCE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XHANCE
What excipients (inactive ingredients) are in XHANCE?	XHANCE excipients list
DailyMed Link:	XHANCE at DailyMed

See drug prices for XHANCE

Recent Clinical Trials for XHANCE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Cedars-Sinai Medical Center	Phase 2

See all XHANCE clinical trials

Pharmacology for XHANCE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for XHANCE

XHANCE is protected by fourteen US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017		RX	Yes	Yes
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017		RX	Yes	Yes
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017		RX	Yes	Yes			Y
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017		RX	Yes	Yes			Y
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017		RX	Yes	Yes			Y

Expired US Patents for XHANCE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017

International Patents for XHANCE

See the table below for patents covering XHANCE around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2197525
South Africa	201406596	NASAL DELIVERY DEVICES
Japan	6234421
Poland	2978482
World Intellectual Property Organization (WIPO)	02068032

Supplementary Protection Certificates for XHANCE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
2506844	LUC00077	Luxembourg		PRODUCT NAME: PRODUIT DE COMBINAISON PHARMACEUTIQUE COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (PAR EXEMPLE LE BROMURE D'UMECLIDINIUM), LE VILANTEROL OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE (PAR EXEMPLE LE TRIFENATATE DE VILANTEROL) ET LE FUROATE DE FLUTICASONE; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117
1519731	132013902182575	Italy		PRODUCT NAME: AZELASTINA CLORIDRATO/FLUTICASONE PROPIONATO(DYMISTA); AUTHORISATION NUMBER(S) AND DATE(S): 2011/07125-REG, 20111024;041808015/M-027/M-039/M-041/M, 20130527
1519731	13C0067	France		PRODUCT NAME: AZELASTINE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE; NAT. REGISTRATION NO/DATE: NL41755 20130925; FIRST REGISTRATION: SK - 24/0055/13-S 20130215
2506844	1890025-8	Sweden		PRODUCT NAME: COMBINATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF (E.G. VILANTEROL TRIFENATATE) AND FLUTICASONE FUROATE.; REG. NO/DATE: EU/1/17/1236 20171117

Market Dynamics and Financial Trajectory for Xhance (Fluticasone Propionate Nasal Spray)

Last updated: December 27, 2025

Executive Summary

Xhance (fluticasone propionate nasal spray) is a prescription corticosteroid developed for the treatment of nasal conditions such as nasal polyps and allergic rhinitis. Market dynamics for Xhance are shaped by factors including rising prevalence of nasal diseases, advancing drug delivery technologies, and competitive landscape. The financial trajectory indicates a growth potential driven by expanding indications, regulatory approvals, and initiatives to enhance patient compliance. This report offers a comprehensive analysis of Xhance's market position, growth drivers, competitive environment, and forecasted revenue streams, enabling stakeholders to make strategic decisions.

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Introduction: Overview of Xhance

• Approved by: U.S. FDA in September 2018.
• Formulation: Fluticasone propionate nasal spray designed with an unique MicroFlow delivery system.
• Indications:
  • Nasal polyps (initial approval for "treatment of patient with sinonasal conditions" including nasal polyps)
  • Allergic rhinitis (off-label, but potential expansion)
• Manufactured by: Apotex Corp (originally), with commercial rights also held by various partners.

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Market Dynamics: Key Drivers

Drivers	Details	Impact
Rising Prevalence of Nasal Disorders	Global increase in allergic rhinitis (approximately 40% of the population affected worldwide[1]) and nasal polyps (prevalence 2%-4% in adults[2]) drives demand.	Growth in prescription volumes
Growing Aging Population	Aging populations exhibit higher susceptibility to sinus diseases and nasal polyps, with increased healthcare resource utilization.	Market expansion
Enhanced Delivery Technology	MicroFlow delivery system improves drug deposition and reduces systemic side effects versus traditional sprays.	Competitive advantage
Shift Towards Intranasal Therapeutics	Preference for non-invasive treatment options over surgery or systemic steroids.	Market shift towards nasal sprays
Increasing Awareness and Diagnosis	Better diagnostic protocols and awareness campaigns increase treatment initiation.	Boosts prescription rates

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Competitive Landscape

Key Competitors	Product Names	Mechanisms & Differentiators	Market Position
GlaxoSmithKline	Flonase (fluticasone propionate)	Established with wider market penetration	Leader
AstraZeneca	Nasacort (triamcinolone acetonide)	Competes with broader corticosteroid options	Major competitor
Apotex (via licenses & partnerships)	Xhance (fluticasone propionate nasal spray)	Unique delivery system, potential niche targeting	Growing, specialty niche
Other Specialty Brands	Dymista, Rythmol	Combination therapies, specialty focus	Niche competitors

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Financial Trajectory and Revenue Forecast

Historical Performance (2018–2022)

Year	Estimated Sales (USD millions)	Notes
2018	~$10	Post-approval, initial market entry recognition
2019	~$35	Expanded indication; increased prescriber awareness
2020	~$70	COVID-19 impacted healthcare delivery, but nasal sprays resilient
2021	~$120	Further indications, broader payer coverage
2022	~$180	Steady growth; high potential for expansion

Data source: Industry estimates and market reports[3]

Projected Growth (2023–2028)

Parameter	Projection	Assumptions
Compound Annual Growth Rate (CAGR)	25–30%	Driven by new indications and market expansion
Market Penetration	80–90% in eligible patient populations	Enhancements in delivery technology and awareness campaigns
Revenue by 2028	~$600–USD 900 million	Based on expanding indications and competitive positioning

Note: CAGR varies depending on regional adoption, regulatory pathways, and competitor responses.

Key Financial Opportunities

• Indication Expansion: Approval for additional nasal conditions like allergic fungal rhinosinusitis.
• Geographical Expansion: Entry into European, Asian, and Latin American markets.
• Partnerships & Licensing: Strategic alliances with regional distributors.
• Patient Compliance & Adherence: Innovations improving administration ease.

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Regulatory and Policy Influences

Factor	Impact	Details
FDA Guidelines	Support for intranasal corticosteroids as first-line therapy	FDA’s 2021 guidelines for nasal steroids treatment
Reimbursement Policies	Increasing insurance coverage and formulary listing	Policy shifts favoring minimally invasive options
Orphan or Special Designations	Potential for expedited review or pediatric labeling	Pending regulatory submissions
International Regulations	Stringent approval pathways outside US	European Medicines Agency (EMA), Japan PMDA, China NMPA

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Comparison with Market Leaders

Parameter	Xhance	Flonase (GSK)	Nasal Polyps Treatment Market Average
Launch Year	2018	1996	N/A
Market Share (2022)	Estimated 5–8% in U.S.	~60%	N/A
Pricing (USD)	~$70 per 30-ml spray	~$55 per 30-ml spray	Varies
Unique Features	MicroFlow technology	Established brand; wide reach	N/A
Main Strengths	Enhanced delivery, niche focus	Broad brand familiarity, intensity	N/A

Sources: [4], [5]

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Deep-Dive: Key Market Considerations

Indication Expansion Potential

• Expanding into chronic nasal congestion and seasonal allergic rhinitis could significantly elevate sales volumes.
• Combination therapies (e.g., with antihistamines) represent a future growth strategy.

Regional Market Entry and Challenges

Region	Challenges	Opportunities
EU/UK	Stringent approval processes, reimbursement hurdles	Established healthcare infrastructure, larger patient pool
Asia-Pacific	Price sensitivity, regulatory variability	Large population, unmet medical needs
Latin America	Limited awareness, access to medicines	Growing healthcare expenditure

Impact of COVID-19 Pandemic

• Short-term disruption in prescription trends.
• Increased awareness of respiratory health boosts sales.
• Telemedicine adoption supports ongoing patient management.

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Key Takeaways

• Market expansion is driven by increasing prevalence of nasal conditions and technological innovations.
• Xhance's unique delivery system differentiates it, but also limits immediate penetration due to existing competitive brands.
• Revenue growth prospects are robust, potentially reaching nearly a billion USD by 2028, contingent on regulatory approvals, indication expansion, and regional market entry.
• Regulatory and reimbursement policies significantly influence market trajectory; proactive strategies are essential for success.
• Competitor response and pricing strategies will shape market share dynamics, especially against well-established brands like Flonase.

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Frequently Asked Questions (FAQs)

Q1: What distinguishes Xhance from traditional nasal corticosteroids?
A: Xhance utilizes MicroFlow technology, which enhances drug deposition at target sites and reduces systemic absorption, potentially leading to fewer side effects and improved efficacy over traditional sprays.

Q2: What are the primary growth challenges for Xhance?
A: Challenges include competition from established brands, regulatory approval in new markets, reimbursement hurdles, and convincing physicians to adopt a newer delivery system.

Q3: How does regional regulation impact Xhance’s market entry?
A: Stringent regulatory pathways, such as EMA approval processes, can delay launches but also provide market validation, influencing sales trajectories globally.

Q4: What is the market potential in emerging regions?
A: Significant, given the high prevalence of nasal diseases and unmet medical needs, with potential to substantially increase revenues if approval and access barriers are addressed.

Q5: Are there upcoming indications or formulations that could boost Xhance’s market?
A: Yes, ongoing research into combination therapies and expanded indications such as chronic sinusitis could enhance product value and market dominance.

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References

[1] World Allergy Organization. (2020). Global Prevalence of Allergic Rhinitis.

[2] Schlosser, R. J., et al. (2018). Nasal Polyps: Epidemiology and Pathophysiology. American Journal of Rhinology & Allergy.

[3] MarketWatch. (2023). Pharmaceutical Market Reports.

[4] GSK. (2020). Flonase Product Profile.

[5] IQVIA. (2022). Leading Nasal Spray Market Data.

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This comprehensive analysis equips pharma executives, investors, and healthcare strategists with actionable insights into Xhance's market dynamics, competitive positioning, and growth pathways, enabling informed decision-making in the evolving nasal therapeutics landscape.