PULMICORT Drug Patent Profile

Which patents cover Pulmicort, and what generic alternatives are available?

Pulmicort is a drug marketed by Astrazeneca and Cheplapharm and is included in three NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pulmicort

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

Summary for PULMICORT

US Patents:	0
Applicants:	2
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	80
Drug Prices:	Drug price information for PULMICORT
Drug Sales Revenues:	Drug sales revenues for PULMICORT
What excipients (inactive ingredients) are in PULMICORT?	PULMICORT excipients list
DailyMed Link:	PULMICORT at DailyMed

See drug prices for PULMICORT

See drug sales revenues for PULMICORT

Recent Clinical Trials for PULMICORT

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

Sponsor	Phase
Unither Pharmaceuticals, France	PHASE1
Analytical Clinical Concepts (ACC GmbH)	PHASE1
Kafrelsheikh University	Phase 4

See all PULMICORT clinical trials

US Patents and Regulatory Information for PULMICORT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	PULMICORT	budesonide	POWDER, METERED;INHALATION	020441-002	Jun 24, 1997		DISCN	No	No
Astrazeneca	PULMICORT RESPULES	budesonide	SUSPENSION;INHALATION	020929-003	Aug 8, 2000	AN	RX	Yes	Yes
Cheplapharm	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-002	Jul 12, 2006		RX	Yes	Yes
Astrazeneca	PULMICORT	budesonide	POWDER, METERED;INHALATION	020441-003	Jun 24, 1997		DISCN	No	No
Cheplapharm	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-001	Jul 12, 2006		RX	Yes	No
Astrazeneca	PULMICORT RESPULES	budesonide	SUSPENSION;INHALATION	020929-002	Aug 8, 2000	AN	RX	Yes	No
Astrazeneca	PULMICORT RESPULES	budesonide	SUSPENSION;INHALATION	020929-001	Aug 8, 2000	AN	RX	Yes	No

Expired US Patents for PULMICORT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	PULMICORT	budesonide	POWDER, METERED;INHALATION	020441-002	Jun 24, 1997
Astrazeneca	PULMICORT	budesonide	POWDER, METERED;INHALATION	020441-003	Jun 24, 1997
Astrazeneca	PULMICORT	budesonide	POWDER, METERED;INHALATION	020441-003	Jun 24, 1997
Astrazeneca	PULMICORT	budesonide	POWDER, METERED;INHALATION	020441-002	Jun 24, 1997
Astrazeneca	PULMICORT	budesonide	POWDER, METERED;INHALATION	020441-002	Jun 24, 1997
Astrazeneca	PULMICORT	budesonide	POWDER, METERED;INHALATION	020441-003	Jun 24, 1997

EU/EMA Drug Approvals for PULMICORT

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

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

Country	Patent Number	Title	Estimated Expiration
Greece	76522
Finland	882983
Poland	132252
Australia	601400
Finland	822423
South Korea	960007754
Norway	864838

Supplementary Protection Certificates for PULMICORT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	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	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	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	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

Market Dynamics and Financial Trajectory for PULMICORT

Last updated: August 1, 2025

Introduction

Pulmicort (budesonide) is an inhaled corticosteroid primarily prescribed for asthma and chronic obstructive pulmonary disease (COPD). Since its debut, Pulmicort has become a significant player in the respiratory therapeutics market due to its proven efficacy, favorable safety profile, and pediatric applicability. Analyzing its market dynamics and financial trajectory provides valuable insights into its growth potential, competitive positioning, and future outlook within the evolving pharmaceutical landscape.

Market Overview of Pulmicort

Pulmicort’s patent history and market presence have shaped its commercial trajectory. Originally launched by AstraZeneca (now part of AstraZeneca PLC), Pulmicort was approved by the FDA in 1993 and has maintained a stronghold in asthma management.

The respiratory drug market has expanded significantly owing to increasing incidence of respiratory disorders, aging populations, and heightened awareness of chronic disease management. Expected annual growth rates of the respiratory drugs segment are around 4-6% globally, with inhaled corticosteroids like Pulmicort representing a substantial share[1].

Market Segmentation and Geographies

Pulmicort’s sales distribution is geographically diversified, with the primary markets being North America, Europe, and Asia-Pacific. North America historically leads due to high prevalence rates, advanced healthcare infrastructure, and high medication adherence. Europe maintains a robust market owing to comprehensive healthcare systems, while Asia-Pacific presents high growth potential driven by rising urban pollution, growing awareness, and expanding healthcare access.

Competitive Landscape

Key competitors include Fluticasone (Flovent), Beclomethasone (Qvar), and other inhaled corticosteroids. The competitive pressure is intensified by the availability of generics following patent expirations and the advent of biologic therapies for severe asthma.

Market Dynamics Influencing Pulmicort

1. Patent Expirations and Generic Competition

Pulmicort's patent expired in developed markets around 2011 in the US and EU, leading to increased generic competition. Generics typically erode market share and reduce pricing power, resulting in revenue compression. However, AstraZeneca and other manufacturers have leveraged formulation patents and device patents to extend market exclusivity through authorized generics, device patents, and formulation-specific protections[2].

2. Regulatory and Patent Landscape

Ongoing patent litigation and regulatory pathways influence Pulmicort’s market trajectory. The shift to high-cost biosimilars and generic inhaled corticosteroids exerts downward pressure on prices. Conversely, regulatory approvals of new formulations (e.g., dry powder inhalers) and combination therapies extend market opportunities.

3. Price Dynamics and Reimbursement Policies

Price sensitivity is pronounced in many markets, especially where government or insurance reimbursement dictates access. In regions with stringent price controls (e.g., Europe), revenue growth is constrained, whereas in the US, managed care payers influence formulary placement. Pharmaceutical companies continuously navigate these dynamics to optimize profit margins.

4. Healthcare Trends and Disease Prevalence

The global increase in asthma and COPD prevalence — driven by environmental factors, urbanization, and aging populations — sustains demand for inhaled corticosteroids like Pulmicort. According to the Global Initiative for Asthma (GINA), asthma affects approximately 262 million people worldwide, with prevalence rising annually[3].

5. Innovation and Formulation Developments

Introduction of novel inhalation devices and combination therapies (e.g., budesonide/formoterol) enhance therapeutic efficacy and patient adherence. Such innovations influence market share and offer new revenue streams.

Financial Trajectory

Historical Financial Performance

AstraZeneca reported Pulmicort contributing significantly to its respiratory segment revenues before patent expiry. Post-2011, sales declined due to generic entry, but strategic reforms and pipeline development mitigated losses.

Post-Patent Market Reactions

Post-patent expiration, revenues from Pulmicort in developed nations decreased by approximately 30-50% over several years due to generic competition. However, emerging markets and the launch of authorized generics partially offset these declines.

Current and Projected Revenue Streams

Despite patent expirations, Pulmicort retains a steady revenue flow owing to:

• Brand loyalty in certain markets.
• Formulation and device patents protecting newer inhaler delivery systems.
• Expansion in emerging markets, where access and affordability constraints delay generic substitution.
• Combination therapies involving budesonide, which preserve higher margins.

Forecasts indicate a continued decline in Pulmicort sales in traditional markets, with compound annual decline rates of approximately 3-5%. However, ancillary revenues from newer formulations and combination products could sustain or grow certain segments.

R&D and Pipeline Influence

Research and development investing in improved inhaled corticosteroids and delivery systems could bolster future revenues, especially if regulatory approvals for novel formulations occur. Additionally, biosimilars and competitors' innovations might intensify price competition.

Strategic Implications

• Diversification: Companies are increasingly focusing on multi-indication inhaled therapies, including combination drugs and biologics, to diversify revenue streams.
• Market Penetration Strategy: Leveraging collaborations and emerging market entry strategies offers growth prospects.
• Pricing and Reimbursement Navigation: Proactive engagement with regulators and payers is vital to maintain market share.

Conclusion

The financial trajectory of Pulmicort reflects a typical lifecycle pattern for inhaled corticosteroids — initial rapid growth, plateau following patent expiry, and subsequent decline due to generic competition. Strategic innovation in formulations and expanding into emerging markets present opportunities for revenue stabilization and growth.

Key Takeaways

• Pulmicort holds a dominant position in asthma management, but patent expirations have eroded its revenue in developed markets.
• The global rise in respiratory diseases sustains demand, especially in emerging markets, offsetting declines elsewhere.
• Regulatory hurdles, patent strategies, and reimbursement policies are critical to the drug’s financial outlook.
• Innovation through new inhalation devices and combination therapies offers potential for revenue recovery.
• Strategic diversification and targeted market expansion are essential for maintaining profitability amid an evolving competitive landscape.

FAQs

1. How has patent expiry affected Pulmicort’s sales?
Patent expiry led to significant revenue declines in major markets due to generic competition. While brand loyalty persists in certain regions, overall sales declined approximately 30-50% post-patent expiration.

2. What are the main competitors to Pulmicort?
Primary competitors include fluticasone-based inhalers (e.g., Flovent), beclomethasone formulations (Qvar), and newer combination inhalers integrating long-acting beta-agonists.

3. Are there new formulations or technologies that could boost Pulmicort’s market share?
Yes. Inhaler device innovations, such as smart inhalers and combination therapies (budesonide/formoterol), improve adherence and efficacy, potentially reinvigorating market position.

4. How do regulatory and reimbursement policies impact Pulmicort’s financial trajectory?
Regulatory hurdles, patent protections, and reimbursement controls significantly influence pricing, market access, and ultimately revenue growth or decline.

5. What future prospects exist for Pulmicort in the global respiratory market?
While mature markets face declining revenues, emerging markets and new inhalation formulations offer growth opportunities, especially as respiratory disease awareness and healthcare infrastructure improve.

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Sources

1. Global Data. (2022). Respiratory Drugs Market Report.
2. AstraZeneca Annual Reports. (2011-2022).
3. GINA Report, 2022. Global Initiative for Asthma.