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-three 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	No
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	7,143,764
Cheplapharm	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-001	Jul 12, 2006	7,143,764
Cheplapharm	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-002	Jul 12, 2006	6,287,540
Cheplapharm	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-001	Jul 12, 2006	4,907,583
Cheplapharm	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-002	Jul 12, 2006	6,027,714
Cheplapharm	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-002	Jul 12, 2006	4,907,583

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
China	1222282
Brazil	9806892
Argentina	011080	COMPOSICION EN POLVO SECO, PROCESO PARA SU PREPARACION Y USO DE DICHA COMPOSICION PARA LA FABRICACION DEL MEDICAMENTO
Sweden	9700940
European Patent Office	0237507	DEVICE IN POWDER INHALATORS
Australia	5785798

Supplementary Protection Certificates for PULMICORT FLEXHALER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	301102	Netherlands		PRODUCT NAME: COMBINATIE VAN FORMOTEROL (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN), GLYCOPYRROLAAT (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN) EN BUDESONIDE (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN); REGISTRATION NO/DATE: EU/1/20/1498 20201210
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
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

Market Dynamics and Financial Trajectory for PULMICORT FLEXHALER

Last updated: July 27, 2025

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Introduction

PULMICORT FLEXHALER (budesonide inhalation powder) is an inhaled corticosteroid (ICS) indicated primarily for asthma management. As a flagship product of AstraZeneca, it commands a significant position within the respiratory therapeutics market. This analysis explores the current market dynamics influencing PULMICORT FLEXHALER’s commercial trajectory, factoring in industry trends, regulatory developments, competitive landscape, pricing strategies, and future growth prospects.

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Market Fundamentals and Product Profile

PULMICORT FLEXHALER was approved in 2013 by the U.S. Food and Drug Administration (FDA), filling a niche for a dry powder inhaler (DPI) within the corticosteroid segment. Its design allows for ease of use and improved drug delivery efficiency compared to metered-dose inhalers (MDIs). The drug’s efficacy in reducing airway inflammation makes it a mainstay for persistent asthma patients.

The global respiratory drug market is projected to grow at a CAGR of approximately 4.2% from 2022 to 2027[1], driven by increasing prevalence of asthma and COPD, especially in emerging economies, and heightened awareness around respiratory health.

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Market Drivers

1. Growing Asthma Prevalence
The WHO estimates over 300 million individuals worldwide have asthma, with rising incidences in both developed and developing nations. Urbanization, pollution, and smoking contribute to this trend, expanding the patient pool eligible for ICS therapy like PULMICORT FLEXHALER.

2. Advancements in Inhaler Technology
The shift from traditional MDIs to DPIs enhances patient compliance due to ease of use—a core feature of PULMICORT FLEXHALER. Ease of inhaler use reduces misadministration, thus improving outcomes and driving demand.

3. Evolving Treatment Guidelines
Guidelines such as GINA recommend ICS as first-line controller therapy for persistent asthma. The preference for inhaled corticosteroids supports steady demand for products like PULMICORT FLEXHALER.

4. Expanding Markets in Emerging Economies
In Latin America, Asia-Pacific, and Africa, increased healthcare investment and rising asthma awareness are expanding the market base, aligning with PULMICORT FLEXHALER’s profile.

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Market Challenges

1. Competitive Landscape

The respiratory market features diverse inhalation products, including generic equivalents, biologics, and combination therapies. Key competitors include Fluticasone (Flovent), Mometasone (Asmanex), and newer biologics like mepolizumab. Generics entering the market pressure margins, especially in mature regions.

2. Pricing and Reimbursement Dynamics
Pricing pressures from payers and regulatory frameworks aimed at cost containment impact revenue streams. Managed care organizations favor cost-effective therapies, potentially favoring generic alternatives over branded inhalers.

3. Patent Expiry and Loss of Exclusivity
Though PULMICORT FLEXHALER's patent protection ensures market exclusivity, upcoming patent cliffs on related drugs could influence the regulatory landscape, impact market share, and introduce generics.

4. Regulatory and Distribution Barriers
Regulatory hurdles in emerging markets can delay product launches or restrict access, influencing overall sales trajectories.

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Financial Trajectory Analysis

Revenue Trends:
AstraZeneca reported that respiratory products contributed approximately $5.5 billion in sales in 2021[2], with PULMICORT FLEXHALER representing a significant segment. Despite anticipated growth, price erosion and increased generic competition threaten margins.

Profitability Outlook:
Cost efficiencies and portfolio diversification are vital. PULMICORT FLEXHALER’s manufacturing economies of scale position it favorably unless impacted significantly by generics or biosimilars entering the landscape.

Market Penetration Strategies:
AstraZeneca focuses on expanding in emerging markets, leveraging strategic partnerships. Additionally, innovations such as digital inhalers aim to improve adherence, potentially translating to increased lifetime value.

Forecasting:
Industry analysts project a compound annual growth rate (CAGR) of roughly 3-4% for PULMICORT FLEXHALER over the next five years, contingent on regulatory developments, patent protections, and competitive responses[3]. While growth in mature markets may plateau, expanding adoption in developing regions and new formulations could offset these pressures.

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Emerging Trends and Future Directions

1. Personalized Medicine and Digital Health
Incorporation of digital inhalers enables remote monitoring; this enhances adherence and allows for data-driven therapy adjustments, potentially increasing PULMICORT FLEXHALER’s market share.

2. Biosimilars and Biologics Competition
The advent of biologics targeting severe asthma may redefine treatment paradigms but are unlikely to displace ICS for mild to moderate cases, where PULMICORT FLEXHALER is primarily positioned.

3. Regulatory Innovations
Regulatory pathways favoring biosimilars and generics might accelerate competitive entry, intensifying price competition.

4. Sustainability and Cost-Effectiveness Initiatives
Payer focus on cost containment may incentivize switch to generic options or combination inhalers that reduce overall treatment costs, thereby affecting PULMICORT FLEXHALER's market share.

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Regulatory and Patent Landscape

AstraZeneca’s patent protections for PULMICORT FLEXHALER extend until approximately 2025[4]. Patent expiries typically catalyze revenue decline; however, supplementary patents, formulations, or delivery device protections may prolong market exclusivity. The company actively explores line extensions and combination therapies to mitigate patent losses.

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Competitive and Strategic Outlook

The key competitive advantage for PULMICORT FLEXHALER remains its proven efficacy and patient-friendly design. Market penetration is dependent on awareness campaigns, clinician prescribing behavior, reimbursement policies, and innovation in delivery technology.

Strategic initiatives include:

• Expanding into low-income markets with tailored pricing
• Developing newer formulations with improved pharmacodynamics
• Integrating digital health tools to enhance patient engagement

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Conclusion

PULMICORT FLEXHALER's market trajectory is poised for moderate growth, supported by increasing asthma prevalence and advancements in inhaler technology. However, it faces headwinds from patent expiries, competitive pricing pressures, and evolving treatment guidelines favoring combination therapies and biologics.

Continued innovation, strategic geographic expansion, and leveraging digital health solutions will be critical for AstraZeneca to sustain and enhance the product's financial performance.

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Key Takeaways

• Market Expansion Opportunities: Emerging markets and digital adherence tools represent significant growth vectors.

• Competitive Dynamics: Patent expiration approaches; generic entrants will challenge pricing and market share.

• Treatment Paradigm Shifts: Preference for combination inhalers and biologics may limit PULMICORT FLEXHALER’s dominance but also open niche markets.

• Regulatory Environment: Patent protections and approval pathways in developing countries influence the product’s financial trajectory.

• Strategic Adaptation: Innovation in delivery devices, formulations, and digital health integration will be vital to sustain long-term profitability.

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FAQs

1. When is PULMICORT FLEXHALER’s patent expected to expire?
The primary patents are projected to expire around 2025, after which generic versions may enter the market, impacting pricing and revenue.

2. How does PULMICORT FLEXHALER compare with other inhaled corticosteroids?
It offers advantages in device design and ease of use, particular to DPI technology, with efficacy comparable to other ICS therapies like Flovent. However, market share hinges on clinician familiarity and formulary decisions.

3. What are the main barriers to expanding PULMICORT FLEXHALER’s market share?
Patent expiration, price competition from generics, evolving treatment guidelines favoring combination therapies, and reimbursement constraints are primary barriers.

4. How is digital technology affecting PULMICORT FLEXHALER's market position?
Digital inhalers improve adherence and enable data collection, potentially improving patient outcomes and loyalty, thus positively influencing market position.

5. What strategic measures can AstraZeneca implement to maintain PULMICORT FLEXHALER’s profitability?
Investing in formulation innovation, expanding access in emerging markets, leveraging digital health, and securing new patent protections or line extensions are key strategies.

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Sources
[1] Global Market Insights, “Respiratory Drugs Market Report,” 2022.
[2] AstraZeneca Annual Report, 2021.
[3] MarketWatch, “Forecast for Inhaled Corticosteroids,” 2022.
[4] U.S. Patent and Trademark Office, Patent Status Reports, 2022.