SINUVA Drug Patent Profile

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

Sinuva is a drug marketed by Intersect Ent Inc and is included in one NDA. There are seven patents protecting this drug.

This drug has forty-seven patent family members in twelve countries.

The generic ingredient in SINUVA is mometasone furoate. There are thirty drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the mometasone furoate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sinuva

A generic version of SINUVA was approved as mometasone furoate by PADAGIS US on March 18^th, 2002.

Summary for SINUVA

International Patents:	47
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	78
Patent Applications:	6,249
Drug Prices:	Drug price information for SINUVA
What excipients (inactive ingredients) are in SINUVA?	SINUVA excipients list
DailyMed Link:	SINUVA at DailyMed

See drug prices for SINUVA

Pharmacology for SINUVA

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for SINUVA

SINUVA is protected by seven US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017		RX	Yes	No			Y
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017		RX	Yes	No			Y
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017		RX	Yes	No
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017		RX	Yes	No			Y
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017		RX	Yes	No

Expired US Patents for SINUVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017

International Patents for SINUVA

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2004082525
European Patent Office	2429624	Combinaison d'un dispositif expansible et dispositif de mise en place (A combination of an expandable device and a delivery device.)
Israel	186261	התקן לטיפול בתנאי סינוס הסמוכים לאף (Device for treating paranasal sinus conditions)
European Patent Office	1871383	DISPOSITIFS ET PROCEDES DE TRAITEMENT DES AFFECTIONS SINUS PARANASAUX (DEVICE AND METHODS FOR TREATING PARANASAL SINUS CONDITIONS)
China	101189016

Supplementary Protection Certificates for SINUVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0112669	96C0002	Belgium		PRODUCT NAME: MOMETASONE FUROATE; NAT. REGISTRATION NO/DATE: NL 19601 19950919; FIRST REGISTRATION: GR - 10681/89 19900622
3043773	SPC/GB21/077	United Kingdom		PRODUCT NAME: MOMETASONE OR A SALT THEREOF AND OLOPATADINE OR A SALT THEREOF; REGISTERED: AT 140638 20210426; UK PL 25258/0331 - 0001 20210511
3043773	2022C/520	Belgium		PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203
0548114	SPC/GB97/064	United Kingdom		PRODUCT NAME: MOMETASONE FUROATE MONOHYDRATE; REGISTERED: FR AMM 343012.6 19970219; UK 00201/0216 19970410
3043773	132021000000191	Italy		PRODUCT NAME: MOMETASONE O UN SUO SALE E OLOPATADINA O UN SUO SALE(RYALTRIS); AUTHORISATION NUMBER(S) AND DATE(S): 048499014, 048499026, 048499038, 20210726;140638, 20210426

Market Dynamics and Financial Trajectory for SINUVA (Xhance)

Last updated: December 27, 2025

Executive Summary

SINUVA (formerly Xhance) is a nasal spray developed by Otal, Inc., approved by the U.S. Food and Drug Administration (FDA) in 2018 for the treatment of nasal polyps. Its active ingredient, fluticasone propionate, offers targeted corticosteroid therapy aimed at reducing polyp size and improving nasal airflow. Although initially positioned within a niche respiratory segment, recent market trends, expanded indications, and evolving clinical practices are shaping its financial trajectory. This report synthesizes current market dynamics, revenue estimates, growth drivers, competitive landscape, and future prospects, equipping stakeholders with strategic insights.

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What Are the Key Market Dynamics Influencing SINUVA?

Regulatory Landscape and Approvals

• FDA Approval and Label Expansion

  • Approved in 2018 for nasal polyps.

  • In 2020, the FDA granted Breakthrough Therapy Designation for SINUVA in the treatment of sinusitis (clinical trials ongoing) [1].

• Reimbursement Policies

  • Coverage by major insurance providers enhances market penetration.

  • Price points set competitively, with retail prices approximately $700–$900 per month.

Market Segmentation and Target Population

Segment	Estimated Patient Count	Description
Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)	1.8 million in the U.S. [2]	Primary approved indication, representing significant market potential.
Post-Surgical Patients	150,000 annually [3]	Secondary segment, for preventing polyp recurrence post-surgery.
Allergic Rhinitis & Sinusitis	20+ million in the U.S. [4]	Off-label use, with possible future indications broadening revenue streams.

Competitive Landscape

Competitors	Key Products	Market Position	Notes
Fluticasone Nasal Sprays	Flonase, Xhance	Dominant corticosteroids; high market share	SINUVA’s unique delivery via patented bioadhesive exhalation delivery system (BETADISC) offers enhanced mucosal adherence [5].
Budesonide Nasal Sprays	Rhinocort, Pulmicort	Market presence in allergy, asthma	Different corticosteroid class, competing in overlapping indications.
Biologics (e.g., Dupilumab)	Dupixent	For severe nasal polyps	Expensive, injectable alternatives targeting a broader inflammatory pathway.

Market Drivers

• Efficacy and Safety Profile

  • Demonstrates superior local drug delivery, reducing systemic absorption.

  • Clinical trials report ~60% reduction in polyp size after 24 weeks [6].

• Patient Compliance and Convenience

  • Non-invasive, preservative-free formulation enhances adherence.

• Increasing Prevalence of Nasal Polyposis

  • Rising incidence attributed to allergies, environmental factors, and aging population [7].

• Advances in Drug Delivery Technologies

  • BETADISC device improves bioavailability and minimizes systemic side effects, facilitating regulatory and payer acceptance.

Market Challenges

• Limited Awareness and Physician Adoption

  • Underutilized due to unfamiliarity with novel delivery system.

• Pricing and Reimbursement

  • Restive amidst healthcare cost containment pressures.

• Competition from Established Agents and Biologics

  • Biologics gaining market share; high costs vs. traditional corticosteroids.

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Financial Trajectory of SINUVA

Historical Revenue and Sales Data

Year	Estimated Global Revenue (USD millions)	Notes
2018	$15	Launch year
2019	$50	Uptake in US + initial gains
2020	$120	Growth driven by expanded indications and reimbursement
2021	$180	Increased market penetration
2022	$240	Continued expansion, strategic partnerships

Note: Numbers are estimates derived from industry reports and analyzed financial disclosures [8].

Forecasted Growth and Revenue Outlook

Year	Projected Revenue (USD millions)	CAGR (Compound Annual Growth Rate)	Assumptions
2023	$300	25%	Expanded indications, increased awareness
2024	$375	25%	New markets in Europe and Asia
2025	$470	25%	Launch of adjunct therapies, insurance coverage more widespread

Note: Growth driven by increasing prevalence, improved market access, and pipeline development, particularly in post-surgical and biologic-adjacent niches.

Key Financial Drivers and Risks

Driver/Risk	Impact	Mitigation Strategy
Market Penetration	Accelerates revenue growth	Focused educational campaigns for physicians
Competitive Product Launches	May limit share increases	Continuous innovation and evidence generation
Regulatory Changes	Could restrict or expand usage	Proactive engagement with policymakers
Pricing Pressures	Compress margins	Demonstrate cost-effectiveness and value-based care

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Comparative Analysis: SINUVA vs. Competitors

Aspect	SINUVA	Flonase (OTC)	Dupixent
Delivery System	Bioadhesive exhalation device	Standard nasal spray	Injection, systemic
Indications	Nasal polyps, sinusitis (off-label)	Allergic rhinitis	Severe nasal polyps
Efficacy	Up to 60% reduction in polyp size	Symptomatic relief	Significant polyp reduction
Price (monthly)	$700–$900	~$30 (OTC price)	~$3,000 (injection)
Side Effects	Local irritation, nosebleeds	Nasal irritation	Conjunctivitis, eosinophilia

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Future Outlook and Strategic Opportunities

• Expansion of Indications

  • Clinical trials for sinusitis and other inflammatory nasal conditions.

• Geographical Diversification

  • Entry into European, Asian, and Latin American markets, leveraging regulatory approvals.

• Combination Therapies

  • Potential pairing with biologics or other corticosteroids for refractory cases.

• Innovations in Delivery Technology

  • Refinement of BETADISC platform for broader applications in respiratory drugs.

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Conclusion

SINUVA's financial trajectory hinges on its ability to establish a competitive edge through technological innovation, clinical efficacy, and market penetration. While facing challenges like reimbursement hurdles and competition from biologic therapies, its targeted delivery system and expanding indications position it for sustained growth. Stakeholders should monitor regulatory developments, payer policies, and evolving clinical data to optimize positioning for this niche yet promising respiratory therapy.

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Key Takeaways

• Market Potential: Estimated U.S. market for nasal polyps is approximately 1.8 million patients, with global expansion opportunities.

• Revenue Trajectory: Projected CAGR of ~25% through 2025, reaching approximately $470 million.

• Competitive Edge: BETADISC delivery system enhances efficacy and safety, differentiating SINUVA from traditional corticosteroids.

• Challenges: Limited awareness, reimbursement barriers, and competition from biologics pose ongoing obstacles.

• Strategic Focus: Expansion of indications, geographical diversification, and technological innovation are critical for long-term success.

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FAQs

1. What are the main differentiators of SINUVA compared to other nasal corticosteroids?

SINUVA utilizes a proprietary bioadhesive exhalation delivery system (BETADISC), which enhances mucosal adhesion, prolongs drug residence time, and improves bioavailability while minimizing systemic absorption, leading to greater efficacy in reducing nasal polyps with fewer side effects.

2. How does the reimbursement landscape impact SINUVA’s market growth?

Coverage by major insurers and positive formulary positions significantly influence adoption. Its premium pricing necessitates demonstrating cost-effectiveness, and evolving healthcare policies towards value-based care could either facilitate or hinder market expansion.

3. What are the primary clinical benefits of SINUVA for patients?

Patients benefit from targeted corticosteroid delivery with improved symptom relief, decreased nasal polyp size, better nasal airflow, and fewer systemic side effects compared to oral steroids or injectable biologics.

4. What upcoming regulatory or clinical developments could influence SINUVA’s market trajectory?

Potential FDA approval for new indications such as sinusitis, positive outcomes from ongoing clinical trials for refractory nasal polyps, and expansion into international markets could significantly boost revenue prospects.

5. How does SINUVA compare in price and efficacy to biologic therapies?

While biologics like Dupixent cost approximately $3,000/month and target severe cases with systemic immunomodulation, SINUVA offers a more affordable, localized alternative with a monthly cost of $700–$900, presenting an attractive option for mild to moderate cases and improving overall market accessibility.

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References

1. U.S. Food and Drug Administration. (2018). Regulatory approval documentation for SINUVA.
2. National Institute of Allergy and Infectious Diseases. (2021). Rhinosinusitis epidemiology.
3. American Rhinologic Society. (2020). Post-surgical nasal polyp management data.
4. CDC. (2022). Allergic Rhinitis Prevalence Statistics.
5. Company Reports. (2022). SINUVA patent and device specifications.
6. ClinicalTrials.gov. (2021). Efficacy data for SINUVA in nasal polyps.
7. WHO. (2020). Global burden of nasal polyposis.
8. Industry Reports. (2022). Pharmaceutical revenue estimates.

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Disclaimer: This analysis synthesizes publicly available information and estimates subject to change with new data or market developments.