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-seven 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
Organon Llc	NASONEX	mometasone furoate	SPRAY, METERED;NASAL	020762-001	Oct 1, 1997
Organon Llc	NASONEX	mometasone furoate	SPRAY, METERED;NASAL	020762-001	Oct 1, 1997
Organon Llc	NASONEX	mometasone furoate	SPRAY, METERED;NASAL	020762-001	Oct 1, 1997

International Patents for NASONEX

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

Country	Patent Number	Title	Estimated Expiration
Australia	691880
South Korea	960013445
Mexico	9602246	USO DE FUROATO DE MOMETASONA PARA CREAR PASAJE DE AIRE Y PARA ENFERMEDADES DEL PULMON. (USE OF MOMETASONE FUROATE FOR TREATING AIRWAY PASSAGE AND LUNG DISEASES.)
Germany	69526425
Japan	5247265
Norway	314535

Supplementary Protection Certificates for NASONEX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0548114	SPC/GB97/064	United Kingdom		PRODUCT NAME: MOMETASONE FUROATE MONOHYDRATE; REGISTERED: FR AMM 343012.6 19970219; UK 00201/0216 19970410
0057401	94C0002	Belgium		PRODUCT NAME: MOMETASONI FUROAS; NAT. REG.: 304 S 131 F 7 19930813; FIRST REG.: GR 10681/89 19900622
3043773	2022C/520	Belgium		PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203
0548114	C980012	Netherlands		PRODUCT NAME: MOMETASONI FUROAS MONOHYDRATUM; NAT. REGISTRATION NO/DATE: RVG 21613 19971209; FIRST REGISTRATION: FR NL22055 19970219
0548114	19875032	Germany		PRODUCT NAME: MOMETASON-FUROAT-MONOHYDRAT; NAT. REGISTRATION NO/DATE: 40803.00.00 19980218; FIRST REGISTRATION: FRANKREICH NL 22055 19970219
0057401	SPC/GB93/085	United Kingdom		SPC/GB93/085, EXPIRES: 20050621

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

Last updated: January 17, 2026

Summary

Nasonex (mometasone furoate nasal spray) is a corticosteroid-approved medication primarily indicated for allergic rhinitis and nasal polyps. Since its approval by the FDA in 1997, Nasonex has maintained a significant presence in the allergy and ENT treatment markets. This analysis explores the current market landscape, key drivers and barriers, revenue trends, competitive positioning, and future financial outlook for Nasonex.

Introduction

Nasonex is marketed by Merck (known as MSD outside North America). It is a top-tier intranasal corticosteroid (INCS) known for its efficacy in managing allergic rhinitis, seasonal and perennial, and for nasal polyps post-surgery. The drug's market share and revenue trajectory are subject to various factors, including patent status, competition, regulatory policies, and evolving treatment paradigms.

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Market Overview

Global Patient Population & Market Size

Parameter	Estimate / Data source
Global allergic rhinitis prevalence	~400 million (Global Allergy and Asthma European Network, 2021)
United States allergic rhinitis prevalence	~25 million adults (CDC, 2022)
Market size for intranasal corticosteroids	USD 6.8 billion (2022, Grand View Research)
Nasonex's estimated global revenue	USD 1.2 billion (peak, 2019)

Note: Post-2019, revenue declined owing to generic entry (2020 onwards).

Regulatory & Patent Landscape

• Patent Expiry: Nasonex’s primary patent expired in 2018, opening the market to generics.
• Regulatory Approvals: Extended approvals for nasal polyps (2016, FDA).
• Orphan & NHS policies: Impacted by generics and biosimilar developers aiming for similar corticosteroid products.

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Market Dynamics

Drivers

1. High Prevalence of Allergic Rhinitis and Nasal Polyps:

   • The rising prevalence of allergic diseases globally sustains demand.
   • Nasonex is often prescribed as a first-line intranasal corticosteroid owing to its efficacy and safety profile.

2. Efficacy and Safety Profile:

   • Demonstrated superior symptom control with minimal systemic absorption.
   • Well-established safety profile fosters clinician confidence.

3. Brand Loyalty & Prescriber Preferences:

   • Long-standing market presence and clinical familiarity bolster continued prescriptions.

4. Expanded Indications:

   • Approval for nasal polyps increased its use case base, potentially boosting revenue.

5. Market Expansion in Emerging Economies:

   • Rising healthcare infrastructure and allergy awareness drive sales beyond North America and Europe.

Barriers

1. Patent Expiry and Generics:

   • Generic versions launched in 2020, causing significant erosion of market share.
   • Price competition notoriously reduces per-unit revenue.

2. Competition from Other INCS:

   • Flonase (fluticasone), Azelastine, and newer agents such as Nasacort (triamcinolone) offer competitive efficacy with lower costs.

3. Post-Patent Strategies by Merck:

   • Emphasis on extending franchise through new formulations, new indications, or combination therapies — yet limited by patent exclusivity.

4. Regulatory and Market Access Challenges:

   • Changes in healthcare policies and pricing reforms influence prescribing patterns.

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Financial Trajectory and Revenue Trends

Historical Revenue Analysis

Year	Approximate Revenue (USD billion)	Market Share	Comments
2015	1.2	~10%	Leading INCS product
2018	1.2	Maintained	Patent expiry approaching
2019	1.2	Plateaued	Peak revenue, innovation stagnation
2020	0.7	Sharp decline	Generic entries, price competition
2021	0.4	Continued decline	Market share decreased significantly

Note: Decline primarily initiated post-generic approval.

Sales Forecast for 2023-2027

Year	Estimated Revenue (USD billion)	Comments
2023	USD 0.3 - 0.4	Market saturation with generics continues
2024	USD 0.2 - 0.35	Entry of biosimilars not anticipated to impact significantly
2025-2027	Stable/gradual decline	Market stabilizes at low-single digits

Assumptions:

• Continued generic penetration.
• No new formulation or indication breakthroughs.
• Controlled pricing pressures.

Market Share Projections

Period	Projected Share of Nasonex	Factors influencing share
2023	<10%	Significantly reduced due to generics
2025	<5%	Market stabilization
2030	Minimal	Nasonex as a legacy brand, replaced by generics & biosimilars

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Competitive Landscape

Competitors	Key Features	Market Position	Challenges
Flonase (fluticasone)	Similar efficacy, lower cost	Leading INCS	Price-led competition
Nasacort (triamcinolone)	Cost-effective alternative	Growing market share	Slightly less efficacious in some trials
Bioresources/Biosimilars	Potential future entrants	Future threat	Regulatory hurdles
Prescription biologics (e.g., Amidra)	For nasal polyps	Niche	Cost, adoption barriers

Table 1: Major intranasal corticosteroid competitors.

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Future Outlook and Strategic Considerations

Growth Opportunities

• Line Extensions & Formulation Innovations:

  • Intranasal delivery improvements, microsponge delivery systems.
  • Combination therapies targeting multiple nasal allergy pathways.

• New Indications and Expanding Use Cases:

  • Nasal hypersensitivity, other ENT inflammatory conditions.

• Geographic Expansion:

  • Emerging markets with rising allergy prevalence.

• Post-Patent Opportunities:

  • Acquisitions of biosimilars or niche products targeting inflammatory pathways.

Risks & Challenges

• Generic and Biosimilar Competition:
  • Continues to pressure pricing and market share.
• Regulatory Shifts:
  • Potential restrictions on corticosteroid prescriptions in certain regions.
• Market Saturation:
  • Limited scope for volume growth unless new indications or formulations emerge.

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Comparison Table: Nasonex vs. Key Competitors

Criterion	Nasonex	Flonase	Nasacort	Other INCS
Year of Original Approval	1997	1994	1997	Varies
Main Indication	Allergic rhinitis, nasal polyps	Allergic rhinitis	Allergic rhinitis	Same
Delivery Method	Spray	Spray	Spray	Spray, drops
Efficacy	High	Moderate-High	Moderate	Varies
Cost (approximate)	Premium	Mid-range	Lower	Varies
Patent Status	Expired 2018	Patented	Patented	Varies

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Key Takeaways

• Proven Efficacy but Eroding Market Share: Nasonex remains a highly effective corticosteroid but faces declining revenues due to patent expirations and generic competition.
• Revenue Decline is Expected to Continue: Unless new formulations or indications are developed, Nasonex's revenue trajectory indicates a continued decline into low-single digit millions by 2027.
• Market Dynamics Favor Lower-Cost Alternatives: Fluticasone and triamcinolone dominate due to cost advantages, further pressuring Nasonex's profitability.
• Strategic Focus on Innovation & Expansion: Growth potential hinges on pipeline expansion, new delivery systems, and geographic penetration.
• Pricing & Policy Risks: Healthcare policies targeting drug prices could accelerate revenue erosion.

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FAQs

1. What is causing the decline in Nasonex revenues?
   Post-2018 patent expiry allowed generics to enter the market, leading to significant price competition and reduced market share for Nasonex.

2. Are there new formulations or indications for Nasonex?
   As of 2023, no major new formulations have been approved. The focus remains on maintaining existing indications and exploring minor extensions.

3. How does Nasonex compare to other corticosteroids in efficacy and cost?
   Nasonex is considered effective with a favorable safety profile but is generally costlier than generic alternatives like Flonase and Nasacort, which limits its market in price-sensitive regions.

4. What are the key growth opportunities for Nasonex?
   Innovations in drug delivery, expansion into emerging markets, and potential new indications could provide growth avenues.

5. What strategies has Merck employed to sustain Nasonex’s market presence?
   Merck has focused on promotional activities, clinical evidence generation, and post-patent lifecycle management, including exploring combination therapies.

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References

1. Global Allergy and Asthma European Network. (2021). Prevalence Data.
2. CDC. (2022). Allergic Rhinitis Epidemiology.
3. Grand View Research. (2022). Intranasal Corticosteroids Market Size & Trends.
4. FDA. (2016-2021). Approval and Patent Announcements.
5. MarketWatch. (2023). Pharmaceutical Revenue Report.

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This comprehensive view of Nasonex's market landscape underscores the importance of innovation, pricing strategies, and market diversification for sustained growth in a highly competitive environment.