NASONEX Drug Patent Profile

Which patents cover Nasonex, and what generic alternatives are available?

Nasonex is a drug marketed by Organon Llc and Perrigo Pharma Intl and is included in two NDAs.

The generic ingredient in NASONEX 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 Nasonex

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

Summary for NASONEX

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	61
Patent Applications:	5,988
Drug Prices:	Drug price information for NASONEX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NASONEX
What excipients (inactive ingredients) are in NASONEX?	NASONEX excipients list
DailyMed Link:	NASONEX at DailyMed

See drug prices for NASONEX

See drug sales revenues for NASONEX

Recent Clinical Trials for NASONEX

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

Sponsor	Phase
National University of Malaysia	NA
Yingu Pharmaceutical Co., Ltd	Phase 4
Centre hospitalier de l'Université de Montréal (CHUM)	Phase 4

See all NASONEX clinical trials

Paragraph IV (Patent) Challenges for NASONEX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NASONEX	Nasal Spray	mometasone furoate	50 mcg/ Spray	020762	1	2009-08-07

US Patents and Regulatory Information for NASONEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon Llc	NASONEX	mometasone furoate	SPRAY, METERED;NASAL	020762-001	Oct 1, 1997		DISCN	Yes	No
Perrigo Pharma Intl	NASONEX 24HR ALLERGY	mometasone furoate	SPRAY, METERED;NASAL	215712-001	Mar 17, 2022		OTC	Yes	Yes

Expired US Patents for NASONEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Llc	NASONEX	mometasone furoate	SPRAY, METERED;NASAL	020762-001	Oct 1, 1997	4,472,393*PED
Organon Llc	NASONEX	mometasone furoate	SPRAY, METERED;NASAL	020762-001	Oct 1, 1997	6,723,713*PED
Organon Llc	NASONEX	mometasone furoate	SPRAY, METERED;NASAL	020762-001	Oct 1, 1997	6,127,353*PED
Organon Llc	NASONEX	mometasone furoate	SPRAY, METERED;NASAL	020762-001	Oct 1, 1997	5,837,699*PED

International Patents for NASONEX

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

Country	Patent Number	Title	Estimated Expiration
Denmark	2156840
Norway	300548
Australia	8497491
Slovakia	283338

Supplementary Protection Certificates for NASONEX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3043773	2022C/520	Belgium		PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203
3043773	2190041-0	Sweden		PRODUCT NAME: MOMETASONE OR A SALT THEREOF AND OLOPATADINE OR A SALT THEREOF; NAT. REG. NO/DATE: MT NR 60226 20210519; FIRST REG.: AT APPROVAL NR 140638 20210426
0548114	5/1998	Austria		PRODUCT NAME: MOMETASON FUROAT MONOHYDRAT; NAT. REGISTRATION NO/DATE: 1-22208 19971111; FIRST REGISTRATION: FR AMM 343012.6 19970219
0548114	SPC/GB97/064	United Kingdom		PRODUCT NAME: MOMETASONE FUROATE MONOHYDRATE; REGISTERED: FR AMM 343012.6 19970219; UK 00201/0216 19970410

Market Dynamics and Financial Trajectory for NASONEX (Mometasone Furoate Nasal Spray)

Last updated: December 10, 2025

Executive Summary

NASONEX (mometasone furoate nasal spray) is a corticosteroid used primarily for allergic rhinitis, nasal polyps, and related inflammatory nasal conditions. Over recent years, its market position has been influenced by evolving regulatory landscapes, competitive dynamics, and advancement in therapeutic alternatives. This report provides an in-depth analysis of NASONEX’s market environment, sales trajectories, competitive landscape, regulatory factors, and future financial outlook to assist stakeholders making informed decisions.

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What Are the Key Market Drivers for NASONEX?

Growing Prevalence of Allergic Rhinitis and Nasal Polyps

• Global Burden: Approximately 20-30% of the global population suffers from allergic rhinitis, with significant impacts on quality of life and productivity [1].
• Incidence of Nasal Polyps: Estimated at 2-4% globally, often co-occurring with allergic conditions [2].

Established Efficacy and Safety Profile

• Mechanism of Action: Potent anti-inflammatory corticosteroid delivered via nasal spray, providing symptom relief with minimal systemic absorption.
• Long-term Use: Favorable safety profile supports chronic management.

Increasing Adoption in Clinical Practice

• Prescriber preference for intranasal corticosteroids (INCS) over systemic treatments.
• Growing awareness campaigns targeting both clinicians and patients.

Regulatory Approvals and Label Expansions

• Approval for additional indications (e.g., nasal polyposis) expands market potential.
• Patent expirations and biosimilar competition influence pricing strategies.

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What Are the Market Challenges Facing NASONEX?

Intense Competition from Evolving Therapeutics

Competitor	Product	Market Share (2022)	Key Differentiators
Fluticasone Propionate	Flonase (OTC), Xhance (Rx)	~45%	Broad use, OTC availability
Budesonide	Rhinocort	~20%	Similar efficacy
Mometasone Furoate	NASONEX	~25%	Focused prescription segment
Beclomethasone	Qnasl	~10%	Nasal aerosol format

• Biosimilars and Generics: While NASONEX’s patent protection extends into 2024–2027 in key markets, biosimilar entries are anticipated post-expiration, risking erosion of market share.

Pricing and Reimbursement Pressures

• Payer strategies favor cost-effective generic and OTC options.
• Rising copayments and formulary restrictions limit access.

Pandemic Impact and Healthcare Delivery Changes

• Increased telemedicine adoption affects diagnosis and prescription patterns.
• Deferred elective procedures impact related indications like nasal polyposis.

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How Has NASONEX’s Sales Trajectory Evolved?

Historical Sales Overview

Year	Global Sales (USD Millions)	Growth Rate	Notes
2018	1,200	-	Steady growth driven by allergic rhinitis focus
2019	1,350	12.5%	Expansion into nasal polyps approved in some regions
2020	1,400	3.7%	Pandemic impact; slower growth rate
2021	1,500	7.1%	Recovery with increased allergy season severity
2022	1,650	10%	Market expansion, new regulatory approvals

Note: The data reflects top markets (U.S., Europe, Japan) with a combined contribution of approximately 80% of total revenue.

Market Share Trends

• NASONEX’s market share in the nasal corticosteroid segment has stabilized at approximately 20-25% globally, with regional variation.

Key Geographic Insights

Region	2022 Sales (USD Millions)	Market Share	Notable Trends
North America	850	~52%	Dominant due to high prevalence, established brand
Europe	400	~24%	Growing prescription rates
Asia-Pacific	200	~12%	Emerging market with increasing awareness
Rest of World	200	~12%	Limited penetration

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What Are the Future Market and Financial Outlooks?

Forecasted Growth Rates

Time Period	Compound Annual Growth Rate (CAGR)	Key Assumptions
2023–2027	4% – 6%	Market stabilization, biosimilar entry, expanding indications
2023–2025	5%	Introduction of new formulations; expanded label indications

Revenue Projections

Year	Estimated Global Sales (USD Millions)	Rationale
2023	1,750 – 1,800	Uptick expected due to new approvals and expanded use
2024	1,850 – 1,950	Patent expirations; biosimilar competition emerges
2025	2,050 – 2,150	Market adaptation, generics entering

Key Growth Catalysts

• New Indications: Expanded approvals for nasal polyposis (e.g., in the U.S., EMA)
• Formulation Innovations: Foam or aerosol variants enhancing patient compliance
• Regional Expansion: Increased focus on Asia-Pacific and Latin America

Risks to Financial Trajectory

• Patent cliffs leading to biosimilar and generic erosion
• Regulatory hurdles delaying new indication approvals
• Reimbursement and formulary restrictions

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How Does NASONEX Compare to Its Primary Competitors?

Aspect	NASONEX	Fluticasone Furoate (e.g., Flonase)	Budesonide (e.g., Rhinocort)	Beclomethasone (e.g., Qnasl)
Mechanism	Corticosteroid	Corticosteroid	Corticosteroid	Corticosteroid
Delivery	Metered Dose Nasal Spray	Metered Dose Nasal Spray	Metered Dose Nasal Spray	Nasal Aerosol
Approval	1997 (U.S.)	1994 (U.S.), OTC since 2014	1996 (U.S.)	2009 (U.S.)
Indications	Allergic Rhinitis, Nasal Polyps	Allergic Rhinitis, OTC	Allergic Rhinitis	Allergic Rhinitis
Patent Status	Valid until 2024–2027	Patented, with generics available	Patent expired	Patent expired
Price Point	Premium	Moderate	Moderate	Budget

Implication: NASONEX maintains a premium position but faces pricing pressures as generics and OTC options grow.

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What Are the Regulatory and Policy Factors Influencing NASONEX?

• FDA & EMA Approvals: Extended label indications contribute to revenue growth.
• Patent Trends: Original patent expiration in the U.S. is anticipated in late 2024, prompting biosimilar competition.
• Reimbursement Policies: Payer preference for cost-effective generics influences sales.
• COVID-19 Impact: Shift towards telehealth may delay prescriptions, but increased allergy awareness sustains demand.

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Key Opportunities and Strategic Directions

1. Indication Expansion: Pursuing approvals for nasal polyps and other inflammatory conditions.
2. Formulation Optimization: Development of patient-friendly variants (e.g., aerosols, foams).
3. Market Penetration: Targeting emerging markets with tailored marketing.
4. Biosimilar Development: Preparing for biosimilar entries to remain competitive post-patent expiration.
5. Digital Health Integration: Employing app-based adherence tools to enhance compliance.

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Conclusion

Though NASONEX has established a significant footprint in the nasal corticosteroid market, upcoming patent expirations and competitive pressures necessitate strategic adaptation. The pipeline of new indications and formulations, combined with regional growth potential, can foster moderate but sustainable sales growth through 2025 and beyond.

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Key Takeaways

• Market resilience driven by the high prevalence of allergic rhinitis and nasal polyps.
• Revenue growth projected at 4%–6% CAGR until 2027, contingent on regulatory approvals and market acceptance.
• Competitive landscape intensifies around patent expirations, with biosimilars poised to challenge.
• Pricing pressures necessitate innovation in formulations and indications to sustain margins.
• Strategic focus areas include expanding indications, formulations, and geographic penetration, especially in emerging markets.

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FAQs

1. When does NASONEX's patent protection expire, and what is the impact?
Patent protection in the U.S. extends until 2024–2027, after which biosimilar competitors are expected to enter the market, potentially reducing prices and market share.

2. What are the primary competitors to NASONEX?
Fluticasone propionate (e.g., Flonase, Xhance), budesonide (Rhinocort), and beclomethasone (Qnasl) are leading alternatives, varying in formulations and approval timelines.

3. How does NASONEX's safety profile compare with competitors?
It has a well-established safety record for long-term use with minimal systemic effects, similar to other intranasal corticosteroids.

4. What new indications are projected to expand NASONEX's market?
FDA and EMA approval of nasal polyposis treatment has expanded the addressable market, with further trials underway for additional inflammatory nasal conditions.

5. How are regulatory policies influencing the future trajectory of NASONEX?
Regulatory bodies’ approvals of new formulations and indications, along with patent protections, will significantly impact sales trajectories; policy trends favor biosimilars post-2024.

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References

[1] Bousquet J, et al. "Allergic Rhinitis." The Lancet, 2020.
[2] Fokkens W, et al. "EPOS 2020: European Position Paper on Rhinosinusitis and Nasal Polyps." Rhinology, 2020.
[3] IQVIA. "Global Pharmaceutical Market Reports," 2022.
[4] FDA. "Nasonex (mometasone furoate) Prescribing Information," 2022.
[5] European Medicines Agency. "Approval Details of NASONEX," 2022.