RHINOCORT ALLERGY Drug Patent Profile

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

Rhinocort Allergy is a drug marketed by Kenvue Brands and is included in one NDA.

The generic ingredient in RHINOCORT ALLERGY is budesonide. There are twenty-two drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the budesonide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Rhinocort Allergy

A generic version of RHINOCORT ALLERGY was approved as budesonide by TEVA PHARMS on November 18^th, 2008.

Summary for RHINOCORT ALLERGY

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	13
What excipients (inactive ingredients) are in RHINOCORT ALLERGY?	RHINOCORT ALLERGY excipients list
DailyMed Link:	RHINOCORT ALLERGY at DailyMed

Recent Clinical Trials for RHINOCORT ALLERGY

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

Sponsor	Phase
University of California, Los Angeles	Phase 4
Medstar Health Research Institute	Phase 4
University of Wisconsin, Madison	Phase 4

See all RHINOCORT ALLERGY clinical trials

Paragraph IV (Patent) Challenges for RHINOCORT ALLERGY

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RHINOCORT ALLERGY	Nasal Spray	budesonide	0.032 mg (32 mcg)/spray	020746	1	2007-05-14

US Patents and Regulatory Information for RHINOCORT ALLERGY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Kenvue Brands	RHINOCORT ALLERGY	budesonide	SPRAY, METERED;NASAL	020746-003	Mar 23, 2015		OTC	Yes	Yes

EU/EMA Drug Approvals for RHINOCORT ALLERGY

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Dr. Falk Pharma GmbH	Jorveza	budesonide	EMEA/H/C/004655Jorveza is indicated for the treatment of eosinophilic esophagitis (EoE) in adults (older than 18 years of age).	Authorised	no	no	yes	2018-01-08
Stada Arzneimittel AG	Kinpeygo	budesonide	EMEA/H/C/005653Kinpeygo is indicated for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram.	Authorised	no	no	yes	2022-07-15

International Patents for RHINOCORT ALLERGY

See the table below for patents covering RHINOCORT ALLERGY around the world.

Country	Patent Number	Title	Estimated Expiration
Sweden	9604486
Hungary	0000575
Japan	2000508675
Austria	239482
Portugal	1310243

Supplementary Protection Certificates for RHINOCORT ALLERGY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0613371	SPC/GB02/033	United Kingdom		PRODUCT NAME: FORMOTEROL (OPTIONALLY IN THE FORM OF THE FREE BASE OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE OF SUCH FREE BASE OR SALT ESPECIALLY AS FORMOTEROL FUMARATE DIHYDRATE) AND BUDESONIDE; REGISTERED: SE SE16047, 16048 20000825; UK PL17901/0091 20010515; UK PL17901/0092 20010515
2435024	2190014-7	Sweden		PRODUCT NAME: A COMBINATION OF FORMOTEROL INCLUDING ANY PHARMACEUUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, GLYCOPYRROLATE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, AND BUDESONIDE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALT, ESTERS ORSOLVATES THEREOF; REG. NO/DATE: EU/1/20/1498 20201210
2435024	2021C/518	Belgium		PRODUCT NAME: UNE COMBINAISON DE FORMOTEROL (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), GLYCOPYRROLATE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET BUDESONIDE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1498 20201210
2435024	SPC/GB21/029	United Kingdom		PRODUCT NAME: A COMBINATION OF FORMOTEROL, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, GLYCOPYRROLATE, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, AND BUDESONIDE INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ES; REGISTERED: UK EU/1/20/1498 (NI) 20201210; UK PLGB 17901/0352-001 20201210
2435024	LUC00208	Luxembourg		PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), DE GLYCOPYRRONIUM (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE BUDESONIDE (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1468 20201210

Market Dynamics and Financial Trajectory for Rhinocort Allergy

Last updated: July 30, 2025

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Introduction

Rhinocort Allergy, primarily marketed as Rhinocort Aqua or Rhinocort Turbuhaler depending on the formulation, is a nasal corticosteroid designed to treat allergic rhinitis and nasal congestion. Developed by AstraZeneca, it has established a significant presence in the global allergy treatment landscape. Its market dynamics and financial trajectory are influenced by factors such as regulatory approvals, competitive positioning, demographic trends, and evolving healthcare policies.

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Market Overview

The global allergy immunotherapy and symptomatic treatment market experienced substantial growth over the past decade, driven by rising prevalence of allergic rhinitis, urbanization, and increased health awareness. Rhinocort Allergy, recognized for its efficacy and safety profile, occupies a substantial segment within this sector. According to Grand View Research, the global allergic rhinitis market is projected to reach USD 11.8 billion by 2027, witnessing a CAGR of approximately 6.5% [1].

Rhinocort's primary competitors include medications such as Flonase (fluticasone), Nasacort (triamcinolone), and newer biologics. Its status as an over-the-counter (OTC) product in select markets adds to its accessibility and volume sales.

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Regulatory and Patent Landscape

Patent Expiry and Generic Competition: Rhinocort's patent protections, which historically shielded it from generic competition, began expiring in the early 2020s in key markets like the U.S. and Europe. The patent expiry has opened avenues for generic manufacturers to enter the market, exerting downward pressure on prices and impacting AstraZeneca's revenue from branded formulations.

Regulatory Approvals: Regulatory agencies such as the FDA and EMA have maintained stringent safety and efficacy standards for Rhinocort. Any new formulations or delivery devices require additional approvals, influencing the product’s lifecycle and market entry strategies.

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Market Dynamics Influencing Revenue

Demand Drivers:

• Increasing Prevalence of Allergic Rhinitis: Data indicates that up to 30% of adults and 40% of children globally suffer from allergic rhinitis [2]. This trend fuels the demand for effective nasal corticosteroids like Rhinocort.

• OTC Accessibility: In regions like the US, where Rhinocort is available OTC, consumer access leads to increased sales volume and wider adoption.

• Patient Compliance and Preference: Formulation convenience—such as spray delivery—enhances adherence, especially in pediatric and elderly populations.

Aspiration for Market Expansion:

• Emerging Markets: Growing urban populations and increasing health awareness in Asia-Pacific, Latin America, and Africa present expanding opportunities for Rhinocort. The affordability and availability of OTC options further bolster market penetration.

• Product Line Extensions: AstraZeneca’s potential development of combination therapies or novel delivery devices (e.g., metered-dose inhalers) could diversify revenue streams.

Competitive Pressures:

• Generic Entry: The expiration of patents introduces generic competitors offering similar corticosteroids at reduced prices. These generics capture market share, especially in price-sensitive regions.

• Alternative Therapies: Emergence of biologics and immunotherapies targeting allergic rhinitis could challenge traditional corticosteroid treatments. While biologics are typically reserved for severe cases, their rising usage impacts the market landscape.

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Financial Trajectory

Historical Revenue Trends:
AstraZeneca's revenues from Rhinocort have historically represented a stable segment, contributing approximately $300 million to $500 million annually pre-patent expiry. Post-patent expiry periods faced revenue declines due to generic competition, with estimates showing a 20-30% decrease in branded sales within two years of generic entry.

Pricing Strategies and Market Share:
Post-generic entry, AstraZeneca has reduced prices for branded Rhinocort to maintain market share. The company emphasizes formulation stability, inhalation device innovation, and consumer perception to differentiate its product.

Profitability and R&D Investment:
Although profitability from Rhinocort has faced pressure, AstraZeneca continues to invest in formulation improvements, delivery device technology, and research on allergy-related pathophysiology to sustain competitive advantages.

Forecasting:

• Short-term (1-3 years): Revenue is expected to decline modestly due to generic competition but stabilize with increased OTC access in emerging markets and potential new formulations or indications.

• Long-term (3-10 years): Innovation in delivery systems (e.g., smart inhalers) and expansion into biologics could offset declines, guiding a possible plateau or incremental growth phase. Strategic market penetration and licensing agreements could further influence the financial trajectory.

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Impact of COVID-19 Pandemic

The pandemic has temporarily disrupted supply chains and healthcare access, affecting sales. However, increased health awareness regarding respiratory health and telehealth adoption has partially offset adverse effects, encouraging increased self-management of allergy symptoms with OTC medications like Rhinocort.

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Future Opportunities and Challenges

Opportunities:

• Digital Health Integration: Incorporating digital adherence tools (e.g., mobile apps for nasal spray reminders) can improve patient outcomes and brand loyalty.

• New Indications: Research into Rhinocort’s efficacy for other respiratory conditions, such as chronic sinusitis, can expand its therapeutic potential.

• Expansion in Untapped Markets: Targeted strategies in Latin America, Southeast Asia, and Africa could significantly enhance sales.

Challenges:

• Price Competition and Cost Containment: Generic competition necessitates aggressive pricing and cost-management strategies.

• Regulatory Barriers: Varying approval standards across jurisdictions can delay new formulations or indications.

• Market Saturation: Mature markets show slowed growth, requiring innovation for future revenue sustenance.

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Key Takeaways

• The global allergic rhinitis market is poised for steady growth, driven by increasing prevalence and OTC availability of treatments like Rhinocort.

• Patent expirations have introduced generics, exerting downward pressure on prices and revenues; ongoing innovation and branding strategies remain vital.

• Expanding into emerging markets offers substantial growth opportunities, especially with localized marketing and affordable formulations.

• Digital health tools and product innovation are critical to differentiating Rhinocort amid fierce competitive pressures.

• Long-term financial success hinges on AstraZeneca’s ability to adapt through formulation enhancements, market expansion, and potential pipeline diversification.

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FAQs

Q1: How does patent expiry affect Rhinocort’s market share and revenue?
Patent expiry allows generic manufacturers to produce equivalent corticosteroid nasal sprays, typically leading to a decline in branded sales due to lower-priced alternatives. AstraZeneca may counter this through formulation innovations, brand loyalty efforts, and expanding OTC distribution.

Q2: What factors influence Rhinocort's growth in emerging markets?
Leverage of affordable pricing, increased health literacy, OTC availability, and strategic partnerships facilitate market penetration. Localized marketing and tailored formulations also contribute significantly.

Q3: Are there recent innovations or pipeline developments for Rhinocort?
Yes. AstraZeneca is exploring advanced delivery devices, combination therapies, and investigating potential new indications, aiming to enhance efficacy, adherence, and patient experience.

Q4: How does digital health impact Rhinocort’s market trajectory?
Integration of digital adherence and patient monitoring tools can improve treatment outcomes and differentiation, promoting sustained sales and customer engagement.

Q5: What is the outlook for Rhinocort amid increasing biologic therapies for allergies?
While biologics target severe allergic conditions, nasal corticosteroids like Rhinocort remain first-line for mild to moderate cases due to ease of use and cost-effectiveness. Nonetheless, a shift towards biologics could gradually influence overall market size.

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References

[1] Grand View Research. (2021). Allergic Rhinitis Market Size, Share & Trends Analysis Report.
[2] Bousquet J., et al. (2019). Allergic Rhinitis and its Impact on Asthma... Journal of Allergy and Clinical Immunology.