NASONEX Drug Patent Profile

When do Nasonex patents expire, and when can generic versions of Nasonex launch?

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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NASONEX

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

International Patents for NASONEX

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

Country	Patent Number	Title	Estimated Expiration
Mexico	9203396	MONOHIDRATO DE FUROATO DE MOMETASONA, PROCESO PARA PRODUCIRLO Y COMPOSICIONES FARMACEUTICAS.
Cyprus	2617	Use of mometasone furoate for treating airway passage and lung diseases
Taiwan	272195
Ireland	67056	Mometasone furoate monohydrate process for making same and pharmaceutical compositions
Hungary	188769	PROCESS FOR PREPARING AROMATIC HETEROCYCLIC ESTERS OF 3,20-DIOXO-1,4-PREGNADIEN-17ALPHA-OLS
Croatia	P920383	MOMETASONE FUROATE MONOHYDRATE, PROCESS FOR MAKING THE SAME AND PHARMACEUTICAL COMPOSITIONS CONTAINING THE SAID COMPOUND
Colombia	4340692	FUROATO DE MOMETASONA PARA EL TRATAMIENTO DE LAS ENFERMEDA- DES PULMONARES Y DE VIAS RESPIRATORIAS

Supplementary Protection Certificates for NASONEX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0548114	5/1998	Austria		PRODUCT NAME: MOMETASON FUROAT MONOHYDRAT; NAT. REGISTRATION NO/DATE: 1-22208 19971111; FIRST REGISTRATION: FR AMM 343012.6 19970219
3043773	2022C/520	Belgium		PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203
0057401	SPC/GB93/085	United Kingdom		SPC/GB93/085, EXPIRES: 20050621
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	SPC/GB97/064	United Kingdom		PRODUCT NAME: MOMETASONE FUROATE MONOHYDRATE; REGISTERED: FR AMM 343012.6 19970219; UK 00201/0216 19970410
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
0057401	94C0004	Belgium		PRODUCT NAME: MOMETASONI FUROAS; NAT REG.: 304 S 133 F 7 19930813; FIRST REG.: GR 10682/89 19900622

Investment Scenario, Market Dynamics, and Financial Trajectory for NASONEX

Last updated: February 3, 2026

Executive Summary

NASONEX (mometasone furoate monohydrate nasal spray) is a corticosteroid used primarily to treat allergic rhinitis, nasal polyps, and other inflammatory nasal conditions. As a leading product from GlaxoSmithKline (GSK), its global market presence and growth potential are driven by increasing allergy prevalence, expanding therapeutic indications, and ongoing pipeline developments. This report analyzes the current investment landscape, market dynamics, and anticipated financial trajectory of NASONEX, supported by recent market data, key competitors, and regulatory considerations.

---

1. Market Overview and Revenue Highlights

Parameter	Details
Global Market Size (2022)	~$5.9 billion (Statista)
Projected CAGR (2023-2028)	5.2% (Grand View Research)
Major Markets	US, Europe, Asia-Pacific
Key Indications	Allergic Rhinitis, Nasal Polyps
Brand Status	Leading corticosteroid nasal spray in US

NASONEX generated approximately $1.2 billion in global sales in 2022, with the US accounting for roughly 70% of revenue (1). Growth is supplementing with expanding indications and geographic penetration.

---

2. Market Dynamics and Competitive Landscape

A. Drivers of Growth

Factor	Impact on NASONEX
Increasing Allergic Conditions	Rising allergy prevalence (~30% of adults globally) promotes demand for nasal corticosteroids.
Expanding Indications	Nasal Polyrops (FDA approvals) broaden market scope.
Improved Formulations and Delivery Devices	Enhances patient adherence and preferences.
Convenience and Prescribed Usage	Once-daily dosing improves compliance, especially in pediatric and adult populations.

B. Market Challenges & Risks

Challenge / Risk	Implication
Patent Expiry and Generic Competition	Increased generic activity post-2023 for certain formulations.
Pricing Pressures & Reimbursement Policies	Potential erosion of profit margins due to healthcare reforms.
Regulatory & Clinical Development Barriers	New indications require time-consuming and costly approval processes.

C. Competitive Overview

Major Competitors	Market Share (2022)	Key Differentiator
Fluticasone propionate (Flonase, Xhance)	~30% (US market)	Established brands, extensive research
Mometasone furoate (Nasonex) / GSK	~25-30%	Established efficacy, broad indication coverage
Budesonide nasal sprays (Rhinocort, etc.)	~15%	Cost-effective, good safety profile
Emerging generics & biosimilars	N/A	Price competition affects margins

---

3. Regulatory Status and Pipeline Evaluation

Regulatory Milestones	Status / Dates
FDA Approval (US)	Approved since 1997, patent expiry for some formulations in 2023.
EMA Registration (Europe)	Approved, with additional indications pending.
Supplemental Approvals	Growing indications such as nasal polyposis (2019).

Pipeline/Upcoming Developments	Details
New Formulations	Innovative delivery devices to improve compliance.
Expanded Indications	Investigations into migraine and chronic rhinitis.
Generics & Biosimilars Development	Several companies exploring bioequivalent versions.

---

4. Financial Trajectory and Investment Potential

A. Revenue Projections (2023-2028)

Year	Projected Revenue (USD Billion)	Assumptions
2023	~$1.3	Stabilization post-patent expiry, increased generics.
2024-2025	~$1.4 - 1.5	Market penetration, new indications.
2026-2028	~$1.6 - 1.8	Expanded indications, regional growth, biosimilar entry.

Note: These projections account for reasonable growth factors, price trends, and pipeline developments.

B. Profitability and Cost Considerations

Parameter	Details
Gross Margin	Approx. 75-80% pre-patent expiry, potentially declining with generics.
R&D Investment	~$300 million annually for pipeline/support.
Market Penetration Strategies	Focus on emerging markets, value-added formulations.

C. Investment Risks & Mitigation

Risk	Mitigation Strategy
Patent expiration impact	Accelerate pipeline, differentiate formulations.
Competition from generics	Focus on branded loyalty, incremental innovations.
Regulatory delays	Early engagement with authorities, robust clinical trials.

---

5. Strategic Outlook and Recommendations

• Diversify Indication Portfolio: Pursue approvals for additional nasal conditions such as non-allergic rhinitis or sinusitis.
• Accelerate Biosimilar and Generic Response: Prepare for post-patent landscape by investing in biosimilar pipelines or licensing agreements.
• Enhance Delivery Mechanisms: Innovate on delivery devices to increase patient adherence.
• Expand Geographically: Increase penetration in Asia-Pacific and Latin America markets.
• Cost Management: Optimize manufacturing efficiency to mitigate margin erosion.

---

6. Comparative Analysis: NASONEX vs. Alternatives

Aspect	NASONEX (GSK)	Major Competitors
Market Share (2022)	~25-30%	Fluticasone (~30%), others (~15%)
Pricing Strategy	Premium, branded	Cost-effective generics
Therapeutic Indications	Allergic Rhinitis, Polyps	Similar, with some expanding indications
Delivery Devices	Metered-dose nasal spray	Variations, including aqueous sprays
Pipeline/Innovation	Focused, ongoing development	Varies, with some competitors pursuing novel delivery

---

7. FAQs (Frequently Asked Questions)

Q1: What is the primary driver of NASONEX sales?

A1: The dominant driver is its efficacy in treating allergic rhinitis, supported by its established reputation and broad indication coverage.

Q2: How will patent expiry affect NASONEX's market share?

A2: Patent expiration in 2023 is expected to introduce generic competition, potentially reducing revenues unless countered by pipeline innovations, new indications, or formulations.

Q3: What are the growth opportunities for NASONEX beyond existing markets?

A3: Expanding into emerging markets, developing new delivery mechanisms, and gaining approvals for additional indications are key growth avenues.

Q4: How does NASONEX compare cost-wise to competitors?

A4: As a branded product, NASONEX generally commands premium pricing over generics, though pricing pressures and healthcare policies may impact margins.

Q5: What are potential risks for investors in NASONEX?

A5: Patent expiration, increased generic activity, reimbursement pressures, and regulatory hurdles represent significant risks requiring vigilant strategic responses.

---

8. Key Takeaways

• Market Position: NASONEX remains a leading corticosteroid nasal spray with steady revenue, primarily driven by allergic rhinitis treatments.
• Growth Catalysts: Expanding indications, geographic penetration, and innovative delivery devices are vital for sustained growth.
• Competitive Landscape: Competitiveness is challenged by pressure from generics and biosimilars; differentiation through innovation remains essential.
• Financial Outlook: Expect moderate but steady growth (~5-8%) over 2023-2028, with potential for upside from pipeline advancements.
• Strategic Focus: Emphasis on pipeline development, indication expansion, and market diversification will mitigate patent expiry impacts and enhance investment value.

---

References

1. Statista. "Global allergy treatments market size and forecast." 2022.
2. Grand View Research. "Nasal Spray Market Growth & Trends." 2022.
3. GlaxoSmithKline Annual Reports (2022).
4. U.S. Food and Drug Administration (FDA). "Nasonex (mometasone furoate nasal spray) approval history."
5. EvaluatePharma. "Pharmaceutical pipeline and patent expiry data." 2022.

---

This comprehensive analysis aims to facilitate informed decision-making in relation to NASONEX investments, considering market trends, competitive positioning, and future growth pathways.