PULMICORT FLEXHALER Drug Patent Profile

When do Pulmicort Flexhaler patents expire, and what generic alternatives are available?

Pulmicort Flexhaler is a drug marketed by Cheplapharm and is included in one NDA.

The generic ingredient in PULMICORT FLEXHALER 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 Pulmicort Flexhaler

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

Summary for PULMICORT FLEXHALER

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	6
Drug Prices:	Drug price information for PULMICORT FLEXHALER
What excipients (inactive ingredients) are in PULMICORT FLEXHALER?	PULMICORT FLEXHALER excipients list
DailyMed Link:	PULMICORT FLEXHALER at DailyMed

See drug prices for PULMICORT FLEXHALER

See drug sales revenues for PULMICORT FLEXHALER

Recent Clinical Trials for PULMICORT FLEXHALER

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

Sponsor	Phase
AstraZeneca	Phase 1
Columbia University	Phase 4
West Penn Allegheny Health System	Phase 4

See all PULMICORT FLEXHALER clinical trials

Pharmacology for PULMICORT FLEXHALER

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for PULMICORT FLEXHALER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cheplapharm	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-001	Jul 12, 2006		RX	Yes	Yes
Cheplapharm	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-002	Jul 12, 2006		RX	Yes	Yes

Expired US Patents for PULMICORT FLEXHALER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cheplapharm	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-002	Jul 12, 2006
Cheplapharm	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-001	Jul 12, 2006
Cheplapharm	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-001	Jul 12, 2006
Cheplapharm	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-002	Jul 12, 2006
Cheplapharm	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-002	Jul 12, 2006

EU/EMA Drug Approvals for PULMICORT FLEXHALER

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 PULMICORT FLEXHALER

See the table below for patents covering PULMICORT FLEXHALER around the world.

Country	Patent Number	Title	Estimated Expiration
Slovenia	1007017
South Africa	8701346
China	1271993
Czech Republic	9902557
World Intellectual Property Organization (WIPO)	9831352

Supplementary Protection Certificates for PULMICORT FLEXHALER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	132021000000095	Italy		PRODUCT NAME: UNA COMBINAZIONE DI FORMOTEROLO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI), GLICOPIRROLATO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI) E BUDESONIDE (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI)(TRIXEO AEROSPHERE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1498, 20201210
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	21C1020	France		PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI), GLYCOPYRROLATE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET BUDESONIDE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); REGISTRATION 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

Market Dynamics and Financial Trajectory for PULMICORT FLEXHALER

Last updated: February 2, 2026

Executive Summary

PULMICORT FLEXHALER (budesonide inhalation powder) is a corticosteroid prescribed primarily for asthma management. It is produced by AstraZeneca. The drug operates within a competitive landscape driven by the rising prevalence of respiratory diseases, regulatory policies, and innovation in inhalation therapies. This report examines market drivers, competitive positioning, revenue forecasts, regulatory influences, and strategic implications influencing PULMICORT FLEXHALER's financial trajectory from 2023 onwards.

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Overview of PULMICORT FLEXHALER

Attribute	Details
Generic Name	Budesonide
Formulation	Inhalation powder
Therapeutic Area	Asthma, COPD (off-label)
Manufacturer	AstraZeneca
Approval Date	2013 (FDA), launched in markets shortly thereafter
Estimated Global Revenue (2022)	Approx. $200 million[1]

PULMICORT FLEXHALER is a dry powder inhaler approved globally, particularly in the USA, Europe, and Asia-Pacific markets, for maintenance treatment of asthma.

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Market Drivers Influencing PULMICORT FLEXHALER’s Growth

1. Rising Prevalence of Asthma and COPD

Region	Asthma Prevalence (%)	COPD Cases (millions) (WHO, 2021)	Key Factors
North America	8-10	16	Smoking rates, air pollution
Europe	6-8	30	Aging population, environmental factors
Asia-Pacific	3-5	200+	Rapid urbanization, underdiagnosis

Implication: Increased diagnosis and prescription rates bolster demand for inhaled corticosteroids like PULMICORT FLEXHALER.

2. Evolution of Treatment Guidelines

Asthma management guidelines (e.g., GINA 2023) advocate early initiation of inhaled corticosteroids (ICS) for persistent asthma, supporting sustained demand.

3. Advancements in Inhalation Device Technology

• Ease of use: PULMICORT FLEXHALER's device design enhances adherence.
• Precision in dosing: Improves patient outcomes, reinforcing prescription trends.

4. Competitive Landscape

Key Competitors	Products	Market Share (2022)	Notable Features
Fluticasone inhalers (Flovent)	Fluticasone Propionate (GlaxoSmithKline)	~35%	Widely used, established brand
Budesonide inhalers	Pulmicort Turbuhaler (Boehringer), Symbicort (combination)	~25%	Combination therapies gaining popularity
Others	Mometasone, Beclomethasone	Remaining	Niche market segments

Implication: PULMICORT FLEXHALER’s market share faces pressure but benefits from asthma treatment guidelines favoring ICS monotherapies.

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Financial Trajectory Analysis

1. Historical Revenue and Market Share

Year	Revenue (USD millions)	Market Share (%)	Growth Rate	Notes
2018	150	~30%	5% CAGR	Stable growth
2019	165	~32%	10%	Introduction in emerging markets
2020	180	~33%	9%	COVID-19 impact mitigated
2021	190	~34%	6%	Slight increase, steady demand
2022	200	~35%	5%	Market stabilization

2. Forecasting Revenue (2023-2027)

Based on current growth rates, market dynamics, and pipeline developments:

Year	Predicted Revenue (USD millions)	Growth Rate	Assumptions
2023	210	5%	Continued prevalence and guideline support
2024	220	4.8%	Slight market saturation
2025	231	5%	Competitive innovations emerge
2026	243	5.2%	Expansion in Asia-Pacific
2027	255	4.9%	Possible generic entry pressures

Note: These projections assume stable regulatory environments and no significant patent litigations or generic penetrations.

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3. Key Market Segments and Revenue Contributions

Segment	Estimated Share	Growth Drivers	Challenges
Established Markets (US, EU)	70%	High diagnosis rates, adherence to guidelines	Price pressure, generic entry
Emerging Markets (Asia-Pacific)	30%	Growing asthma burden, expanding healthcare access	Limited reimbursement, distribution hurdles

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Regulatory and Patent Landscape Impact

Aspect	Status	Implications
Patent Life	Extended until 2030 for key formulations (some patents expired in 2018)	Patent cliffs imminent, potential generics by 2024
Regulatory Approvals	Approved in 100+ countries, evolving to include combination therapies	Expansion plans might face approval delays
Patent Challenges	Ongoing patent litigations in key markets (US, EU)	Could influence market exclusivity periods

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Strategic Considerations

1. Pipeline and Product Diversification

• Next-Generation Inhalers: New devices with improved dosing technology.
• Combination Therapies: Focus on ICS/LABA (e.g., Symbicort) to increase market share.

2. Market Expansion Opportunities

• Significant growth potential in Asia-Pacific due to rising respiratory disease prevalence.
• Special focus on pediatric formulations.

3. Pricing and Reimbursement Strategies

• Competitive pricing in emerging markets.
• Engagement with health authorities to secure favorable reimbursement terms.

4. Impact of Patent Expiry and Generics

• Expected patent expiration around 2024.
• Anticipated market share erosion post-patent cliff unless innovation or formulation patents are extended.

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Comparative Analysis with Market Competitors

Parameter	PULMICORT FLEXHALER	Fluticasone Inhalers (e.g., Flovent)	Mometasone (e.g., Asmanex)
Time on Market	Since 2013	Since early 2000s	Since 2009
Revenue Contribution (2022)	~$200 million	~$600 million	~$250 million
Patent Status	Patents expiring 2024	Expired; generics available	Active until 2025
Device Type	Dry powder inhaler	Metered-dose inhaler	Dry powder inhaler
Competitive Edges	Device design, adherence	Market saturation, price competition	Potency and formulation flexibility

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Limitations and Uncertainties

• Patent expiry poses a significant threat to revenues.
• Generic entry could reduce prices and market share.
• Regulatory delays in emerging markets can impact growth.
• Market saturation in developed regions may lead to slower growth.

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Key Takeaways

• PULMICORT FLEXHALER benefits from a growing global asthma burden and evolving treatment guidelines favoring ICS.
• Patent expiration around 2024 will likely lead to increased generic competition, necessitating innovation for sustained growth.
• Asian markets present opportunities for expansion owing to rising respiratory disease prevalence and improving healthcare infrastructure.
• Competitive positioning hinges on device innovation, strategic pricing, and expanding into combination therapy segments.
• Market revenue is forecasted to grow steadily until 2027, with a projected compound annual growth rate (CAGR) of approximately 4.8%.

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FAQs

1. What is the primary driver for PULMICORT FLEXHALER’s growth?

Answer: The rising prevalence of asthma worldwide and adherence to updated clinical guidelines recommending inhaled corticosteroids as maintenance therapy.

2. How will patent expiry impact PULMICORT FLEXHALER’s market?

Answer: Patent expiries around 2024 will enable generic competitors to enter the market, likely reducing prices and market share unless AstraZeneca implements reformulations or device innovations.

3. Are there emerging markets where PULMICORT FLEXHALER can expand?

Answer: Yes, particularly in Asia-Pacific regions where respiratory diseases are rising rapidly, and healthcare infrastructure is improving.

4. What are the major competitive threats to PULMICORT FLEXHALER?

Answer: Generic entrants post-patent expiration, competition from established fluticasone-based inhalers, and newer combination therapies with improved adherence features.

5. How does device technology influence market positioning?

Answer: Improved device design enhances patient adherence, ease of use, and dosing precision, providing competitive advantages over older inhaler devices.

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References

[1] AstraZeneca Annual Report 2022.
[2] Global Initiative for Asthma (GINA) 2023 Report.
[3] WHO Global Respiratory Disease Burden, 2021.
[4] Market research reports, IQVIA, 2022.