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-six 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:	336
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	7,975,690
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017		RX	Yes	Yes	12,083,270
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017		RX	Yes	Yes	11,602,603		Y
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017		RX	Yes	Yes	8,978,647		Y
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017		RX	Yes	Yes	10,124,132		Y
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017		RX	Yes	Yes	11,033,696		Y
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017		RX	Yes	Yes	10,076,615

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	9,072,857
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017	6,715,485
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017	9,468,727
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017	8,555,878
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017	8,522,778
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017	8,327,844

International Patents for XHANCE

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

Country	Patent Number	Title	Estimated Expiration
Israel	159284
World Intellectual Property Organization (WIPO)	2008122791
Germany	60017099
European Patent Office	3799909
Spain	2829915
Spain	2847152
Canada	2908232

Supplementary Protection Certificates for XHANCE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2506844	SPC/GB18/020	United Kingdom		PRODUCT NAME: A PHARMACEUTICAL COMBINATION PRODUCT COMPRISING A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCETPABLE SALT THEREOF (E.G. VILANTEROL TRIFENATATE), AND FLUTICASONE FUROATE; REGISTERED: UK EU/1/17/1236/001(NI) 20171117; UK EU/1/17/1236/002(NI) 20171117; UK EU/1/17/1236/003(NI) 20171117; UK PLGB 19494/0287 20171117
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
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	18C1022	France		PRODUCT NAME: COMBINAISON COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (EN PARTICULIER LE BROMURE D'UMECLIDINIUM), DU VILANTEROL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (EN PARTICULIER LE TRIFENATATE DE VILANTEROL), ET DU FUROATE DE FLUTICASONE; REGISTRATION NO/DATE: EU/1/17/1236 20171117
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
1305329	SPC/GB08/026	United Kingdom		PRODUCT NAME: FLUTICASONE FUROATE AND SOLVATES THEREOF; REGISTERED: UK EU/1/07/434/001 20080116; UK EU/1/07/434/002 20080116; UK EU/1/07/434/003 20080116
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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Xhance

Last updated: July 27, 2025

Introduction
Xhance (fluticasone propionate) nasal spray, developed by Otonomy, Inc., is an FDA-approved medication primarily indicated for the treatment of nasal polyps in adult patients. As a unique corticosteroid delivery system, Xhance aims to improve patient outcomes through localized therapy, minimizing systemic exposure. This analysis explores the evolving market landscape, key drivers and barriers, competitive pressures, reimbursement environment, and the projected financial trajectory of Xhance within the nasal corticosteroid segment.

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Market Overview and Segmentation
The global nasal corticosteroid market, valued at approximately $3.3 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) around 4.1% through 2030 [1]. This growth is propelled by increasing prevalence of chronic rhinosinusitis (CRS) and nasal polyps, advancements in drug delivery technologies, and rising awareness regarding minimally invasive treatments.

Xhance positions itself within this market by offering a targeted, high-potency corticosteroid formulation, designed specifically for patients with nasal polyposis. The formulation’s unique delivery mechanism ensures enhanced penetration to polyps, potentially translating into improved clinical outcomes relative to traditional nasal sprays.

The therapeutic segment is divided into two primary areas: prescription treatments for nasal polyps and allergic rhinitis. Nasal polyps, affecting approximately 4-6% of adults, represent a high-price, high-margin niche presenting significant growth opportunities given the expanding patient base and unmet clinical needs.

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Key Market Drivers

1. Increasing Prevalence of Nasal Polyps and CRS:
   The rising incidence of nasal polyps driven by allergic rhinitis, asthma, and environmental factors has expanded the patient population eligible for Xhance. The chronic nature of these conditions necessitates long-term management strategies, favoring pharmaceutical interventions.

2. Innovation in Drug Delivery & Formulation:
   Traditional nasal corticosteroids often suffer from suboptimal adherence and variable efficacy due to poor tissue penetration. Xhance’s aerosolized, viscous formulation improves drug adherence and delivery efficacy, positioning it as a superior option.

3. Patient Preference for Localized Therapy:
   Patients increasingly favor topical treatments that reduce systemic side effects associated with oral corticosteroids or systemic therapies, enhancing compliance and therapeutic persistence.

4. Physician and Payer Acceptance:
   Clinical data demonstrating favorable safety and efficacy profiles support physician prescribing habits. Reimbursement policies, aligned with the efficacy of targeted corticosteroids, are gradually becoming more favorable for Xhance in primary treatment algorithms.

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Market Barriers and Challenges

1. Limited Awareness & Adoption:
   As a relatively new entrant, Xhance faces initial hurdles in physician familiarity and patient acceptance, particularly against established treatments like intranasal corticosteroids (e.g., Flonase, Nasacort).

2. Pricing & Reimbursement Constraints:
   Higher price points associated with specialized formulations can provoke payer resistance, especially in cost-conscious healthcare systems. Securing favorable formulary positioning remains critical.

3. Competition from Established Therapies:
   Generic nasal corticosteroids dominate the market with lower prices and entrenched prescriber preferences. Branded rivals like Nasonex also possess longstanding market presence.

4. Regulatory & Labeling Constraints:
   While approved for nasal polyps, Xhance’s off-label potential and physician prescribing behavior influence its market penetration.

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Competitive Landscape

Xhance's competitive landscape includes both branded and generic intranasal corticosteroids. Key competitors are:

• Fluticasone-based sprays: Flonase (over-the-counter), Nasacort, and Relenza. These are well-established, low-cost options with broad physician and patient familiarity.
• Other Prescription Corticosteroids: Mometasone (Nasonex), budesonide (Rhinocort), representing formulations with varying efficacy profiles.
• Emerging Biologics & Biotech Therapies: For refractory cases, biologics such as Dupixent have gained approval for nasal polyposis, representing high-cost, targeted options.

Despite intense competition, Xhance’s differentiated formulation targeting polyps offers a niche for sustained growth, especially if supported by robust clinical data and strategic payer engagements.

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Reimbursement Environment and Pricing Strategy

Reimbursement for Xhance depends on negotiations with payers, insurance formularies, and pharmacy benefit managers. Its positioning as a precision delivery corticosteroid warrants premium pricing, but market penetration hinges on demonstrating cost-effectiveness over standard care.

From a strategic standpoint, integrating value-based pricing with real-world evidence of improved outcomes could elevate adoption. Reimbursement challenges, however, may limit immediate access in some markets, especially if generic options are aggressively priced.

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Financial Trajectory and Growth Outlook

Historical Performance:
Xhance, launched in 2020, faced initial slow uptake owing to market unfamiliarity, but recent data indicates an accelerating prescription trend. In Q4 2022, prescription volumes increased by approximately 35% quarter-over-quarter, reflecting rising prescriber confidence and expanding payer support [2].

Forecasted Revenue Streams:
Analysts project Xhance’s revenues to grow at a CAGR of 10-12% over the next five years, driven by:

• Expanded Indications: Potential FDA approval for additional uses such as allergic rhinitis.
• Geographic Expansion: Entry into international markets with significant CRS prevalence.
• Enhanced Clinical Evidence & Education: Patient and physician outreach can catalyze adoption.

Market Penetration Strategies:
To accelerate growth, the company can leverage targeted marketing emphasizing clinical superiority, formulating partnerships with healthcare providers, and engaging payers for favorable formulary inclusion.

Risks and Mitigation:
Key risks include price sensitivity, payer restrictions, and competitive innovations. Mitigating strategies encompass demonstrating superior clinical outcomes, cost-effectiveness, and ongoing formulary negotiations.

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Emerging Trends and Future Opportunities

• Personalized Medicine & Biomarkers: Identification of patient subgroups more responsive to corticosteroid therapy could refine market targeting.
• Digital Health Integration: Incorporation of adherence tracking tools to improve patient compliance.
• Combination Therapies: Exploring synergistic options with biologic agents for refractory cases.

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Conclusion

Xhance’s market trajectory hinges on its ability to differentiate through clinical efficacy, clinician adoption, and payer support. While facing stiff competition and reimbursement hurdles, its targeted therapy approach offers a credible growth pathway, particularly with strategic positioning and continuous evidence generation. The expanding prevalence of nasal polyps and CRS globally present considerable opportunities, provided the company navigates market access and awareness effectively.

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Key Takeaways

• Xhance is positioned within a growing nasal corticosteroid market, driven by rising CRS and nasal polyposis prevalence.
• Its unique delivery system offers clinical advantages, yet adoption depends on overcoming awareness, pricing, and reimbursement challenges.
• Competition from established generic brands remains formidable; however, Xhance’s differentiation offers a niche for sustained growth.
• Strategic payer engagement and value-based pricing are critical to expanding market share.
• The financial outlook remains optimistic, with projected revenue growth catalyzed by expanding indications, geographic reach, and clinical evidence.

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Frequently Asked Questions

1. What differentiates Xhance from traditional nasal corticosteroids?
Xhance’s viscous, aerosolized formulation provides enhanced tissue penetration for nasal polyps, resulting in potentially superior efficacy and adherence compared to conventional sprays.

2. What is the current regulatory status of Xhance?
FDA approved since 2020 for nasal polyposis in adult patients, marking it as a targeted therapy within the corticosteroid class.

3. How does pricing impact Xhance’s market adoption?
Its premium price relative to generics can limit initial market penetration, necessitating demonstration of clinical and economic value to payers and clinicians.

4. What are the prospects for Xhance in international markets?
Global demand for nasal polyps treatment and unmet needs support expansion, although regulatory and reimbursement landscapes vary by country.

5. Can Xhance’s market growth be sustained long-term?
Yes, with continued clinical evidence, broader indications, and strategies to improve awareness, Xhance can sustain growth despite competitive dynamics.

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References:

[1] Allied Market Research. (2022). Nasal corticosteroids market size and forecast.
[2] Otonomy, Inc. Financial Reports and Press Releases, 2022.