NASACORT ALLERGY 24 HOUR Drug Patent Profile

When do Nasacort Allergy 24 Hour patents expire, and when can generic versions of Nasacort Allergy 24 Hour launch?

Nasacort Allergy 24 Hour is a drug marketed by Chattem Sanofi and is included in one NDA.

The generic ingredient in NASACORT ALLERGY 24 HOUR is triamcinolone acetonide. There are fifty-one drug master file entries for this compound. Seventy-eight suppliers are listed for this compound. Additional details are available on the triamcinolone acetonide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nasacort Allergy 24 Hour

A generic version of NASACORT ALLERGY 24 HOUR was approved as triamcinolone acetonide by SUN PHARMA CANADA on October 1^st, 1986.

Summary for NASACORT ALLERGY 24 HOUR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	8
Patent Applications:	4,539
DailyMed Link:	NASACORT ALLERGY 24 HOUR at DailyMed

Recent Clinical Trials for NASACORT ALLERGY 24 HOUR

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

Sponsor	Phase
Gail Gauvreau	N/A
Stanford University	Phase 4
Sanofi	Phase 4

See all NASACORT ALLERGY 24 HOUR clinical trials

Pharmacology for NASACORT ALLERGY 24 HOUR

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for NASACORT ALLERGY 24 HOUR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chattem Sanofi	NASACORT ALLERGY 24 HOUR	triamcinolone acetonide	SPRAY, METERED;NASAL	020468-002	Oct 11, 2013		OTC	Yes	Yes

Expired US Patents for NASACORT ALLERGY 24 HOUR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chattem Sanofi	NASACORT ALLERGY 24 HOUR	triamcinolone acetonide	SPRAY, METERED;NASAL	020468-002	Oct 11, 2013	5,976,573
Chattem Sanofi	NASACORT ALLERGY 24 HOUR	triamcinolone acetonide	SPRAY, METERED;NASAL	020468-002	Oct 11, 2013	7,977,045
Chattem Sanofi	NASACORT ALLERGY 24 HOUR	triamcinolone acetonide	SPRAY, METERED;NASAL	020468-002	Oct 11, 2013	6,143,329

International Patents for NASACORT ALLERGY 24 HOUR

See the table below for patents covering NASACORT ALLERGY 24 HOUR around the world.

Country	Patent Number	Title	Estimated Expiration
China	1228712
Czech Republic	299689	Farmaceutický prostredek na vodné bázi (Water-based pharmaceutical composition)
European Patent Office	1382330
Canada	2268927	COMPOSITION PHARMACEUTIQUE A BASE AQUEUSE (AQUEOUS-BASED PHARMACEUTICAL COMPOSITION)

Market Dynamics and Financial Trajectory for NASACORT ALLERGY 24 HOUR

Last updated: August 5, 2025

Introduction

NASACORT ALLERGY 24 HOUR (triamcinolone acetonide) is a prescription and over-the-counter (OTC) intranasal corticosteroid (ICS) predominantly used for allergic rhinitis management. Its market performance is influenced by a complex interplay of regulatory changes, competitive landscape, consumer preferences, and broader healthcare trends. This analysis dissects the current market dynamics and forecasts the financial trajectory of NASACORT ALLERGY 24 HOUR, offering insights valuable to stakeholders in the pharmaceutical sector.

Regulatory and Market Entry Landscape

Historically, NASACORT was marketed exclusively by AstraZeneca as a prescription drug. However, regulatory shifts in several markets, notably the U.S., have transitioned NASACORT into OTC status, broadening consumer access. In the U.S., the Food and Drug Administration (FDA) approved OTC sales of NASACORT in 2014, reflecting a strategic pivot to expand market penetration amid a rising prevalence of allergic rhinitis [1].

This shift lowers barriers for consumer purchase, potentially enlarging the addressable market size. Nevertheless, OTC status also increases competitive pressures from generic and branded rivals, influencing pricing strategies and profit margins.

Market Size and Growth Drivers

The global allergic rhinitis treatment market is projected to grow at a Compound Annual Growth Rate (CAGR) of approximately 4.5% from 2022 to 2027, driven primarily by increasing prevalence, urbanization, and heightened awareness of allergy management [2].

In the U.S., the prevalence of allergic rhinitis affects approximately 20-30% of adults and children, equating to an estimated 60 million Americans, underscoring the sizable potential consumer base for NASACORT [3]. The OTC availability further amplifies accessibility, especially among individuals seeking quick symptom relief.

Key growth drivers include:

• Rising prevalence: Urban lifestyles, pollution, and climate change contribute to increasing allergy incidences.
• Consumer preference: Shift towards OTC medications for convenience and autonomy.
• Healthcare cost containment: Patients favor self-medication over physician consultation, reducing healthcare system burdens.
• Product innovation: Formulation improvements and combination therapies enhance treatment efficacy and patient adherence.

Competitive Landscape

NASACORT faces competition from other intranasal corticosteroids such as Flonase (fluticasalone propionate), Rhinocort (budesonide), and Nasacort’s own generic equivalents. These competitors also transitioned to OTC markets, intensifying price competition.

Generics account for approximately 85% of the nasal corticosteroid market in the U.S., exerting downward pressure on prices. However, brand recognition and consumer loyalty sustain NASACORT's market share, especially among patients with established brand preferences.

Furthermore, new entrants occasionally introduce innovative formulations, such as fixed-dose combinations or улучшенной delivery systems, potentially capturing market share.

Pricing and Revenue Trajectory

Post-OTC approval, NASACORT experienced an initial surge in sales, primarily driven by increased accessibility. However, price elasticity and competitive pricing have tempered aggressive growth. Typically, OTC sales margins are lower than prescription counterparts, but volume increases compensate.

Revenue projections exhibit a moderate CAGR of approximately 2-4% over the next five years, contingent on:

• Market penetration: Continued consumer adoption and retention.
• Pricing strategies: Competitive pricing to sustain margins amidst generic competition.
• Regulatory environment: Potential OTC switches or new indications.
• Consumer health trends: Rising allergic rhinitis prevalence sustains demand.

Impact of Biosimilars and Generics

The proliferation of generics diminishes revenue potential for branded NASACORT. According to industry reports, generics hold dominant market share, with the branded product accounting for less than 20% in key markets.

However, brand loyalty and physician recommendations still play pivotal roles in maintaining premium pricing among certain consumer segments. Strategies incorporating product differentiation, such as improved delivery mechanisms, could mitigate erosion.

Emerging Trends and Opportunities

Innovations such as digital health integrations (e.g., allergy symptom tracking apps), personalized medicine approaches, and combination therapies offer avenues for revenue enhancement. Additionally, expanding into emerging markets where OTC regulatory frameworks are evolving could unlock new growth opportunities.

Financial Projections Summary

Parameter	Outlook (Next 5 Years)	Key Factors Impacting Trajectory
Revenue Growth	2-4% CAGR	Price competition, OTC market saturation, new formulations
Market Share	Stabilization or slight decline for branded NASACORT	Generic market dominance, regulatory changes
Profit Margins	Slight compression	Competitive pricing, manufacturing overheads
Investment Opportunities	Expansion into emerging markets, product innovation	Regulatory facilitation, market-specific adaptations

Risks and Challenges

Major risks include aggressive price undercutting by generics, regulatory reversals restricting OTC sales, or shifts in consumer preferences toward alternative therapies or natural remedies. Additionally, supply chain disruptions and manufacturing delays could impact availability and revenue.

Conclusion

NASACORT ALLERGY 24 HOUR operates within a mature yet evolving pharmaceutical segment characterized by intense competition, regulatory shifts, and innovative consumer engagement strategies. Its financial trajectory hinges on maintaining brand relevance amidst generic erosion, leveraging OTC accessibility, and capitalizing on the expanding allergic rhinitis prevalence worldwide. Strategic emphasis on product differentiation, market expansion, and consumer loyalty retention will shape its future financial performance.

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Key Takeaways

• Market Expansion: OTC approval has expanded reach but increased competitive pressures, necessitating strategic pricing and marketing.
• Competitive Dynamics: Dominated by generics, requiring brand differentiation and innovation for continued profitability.
• Growth Opportunities: Emerging markets and product innovation present avenues to offset mature market challenges.
• Revenue Outlook: Moderate growth projected, heavily influenced by regulatory, competitive, and consumer trend factors.
• Risk Management: Vigilance over regulatory changes, competitive actions, and market preferences is vital for sustaining financial health.

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FAQs

1. How has OTC availability affected NASACORT's market share?
OTC availability has significantly expanded NASACORT's consumer base, increasing sales volume. However, it has intensified competition from generics and other OTC nasal corticosteroids, leading to a more commoditized market and constraining profit margins.

2. What are the main drivers of allergic rhinitis treatment market growth?
Key drivers include rising allergy prevalence due to urbanization and pollution, increased awareness, consumer preference for OTC medications, and healthcare cost containment measures promoting self-medication.

3. How does generic competition influence NASACORT's financial outlook?
Generics capture the majority of the market share, exerting downward pressure on prices. While brand loyalty provides some buffer, sustained profitability requires differentiation through formulation improvements and marketing.

4. What strategic initiatives could enhance NASACORT's market position?
Product innovation (e.g., enhanced delivery systems), entering emerging markets, digital health integrations, and targeted marketing campaigns can bolster consumer loyalty and market share.

5. What future regulatory changes could impact NASACORT?
Potential reclassification of OTC status, approvals for new indications, or generic patent challenges could affect sales volume and pricing strategies.

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Sources:

[1] FDA. (2014). NASACORT Allergy 24 Hour switches to OTC.
[2] MarketsandMarkets. (2022). Allergic Rhinitis Therapeutics Market.
[3] American College of Allergy, Asthma & Immunology. (2021). Allergy prevalence data.