PULMICORT Drug Patent Profile

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

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

The generic ingredient in PULMICORT is budesonide. Forty 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

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

International Patents for PULMICORT

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

Country	Patent Number	Title	Estimated Expiration
Austria	23272
Australia	559297
Australia	8560882
Canada	1178151	INHALATEUR (DOSAGE INHALATOR II)

Supplementary Protection Certificates for PULMICORT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	202140009	Slovenia		PRODUCT NAME: COMBINATION OF FORMOTEROL (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, SOLVATES OR ENANTIOMERS THEREOF), GLYCOPYRROLATE (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, SOLVATES OR ENANTIOMERS THEREOF) AND BUDESONIDE (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, SOLVATES OR ENANTIOMERS THEREOF); NATIONAL AUTHORISATION NUMBER: EU/1/20/1498; DATE OF NATIONAL AUTHORISATION: 20201209; AUTHORITY FOR NATIONAL AUTHORISATION: EU
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	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	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

Last updated: February 9, 2026

What is PULMICORT and its Market Position?

PULMICORT, generically known as budesonide, is an inhaled corticosteroid (ICS) used primarily for the management of asthma and allergic rhinitis. It is marketed by AstraZeneca and is available in various formulations, including inhalers and nasal sprays.

The drug addresses persistent asthma and seasonal allergic rhinitis, with a market that intersects respiratory and allergy sectors. Global inhaled corticosteroids had an estimated market value of approximately $10.8 billion in 2022, projected to grow at a compound annual growth rate (CAGR) of 4.9% through 2030. PULMICORT holds a notable share within this market due to established efficacy, regulatory approval, and brand recognition.

What Are the Key Market Dynamics for PULMICORT?

Market Size and Growth Trends

The respiratory inhaler market is driven by rising asthma prevalence and increasing awareness of allergy management. The global asthma and COPD therapeutic market reached $27 billion in 2022, with inhaled corticosteroids constituting over 40% of that segment.

North America accounts for approximately 45% of the inhaled corticosteroid market, with Europe capturing 30%, Asia-Pacific 20%, and the rest of the world (RoW) 5%. Brazil and China are expansion targets due to increased disease prevalence and healthcare investments.

Competitive Landscape

PULMICORT's primary competitors include Flovent (fluticasone), Qvar (beclomethasone), and Asmanex (mometasone). Flovent holds the largest market share due to aggressive marketing and longer market presence, followed closely by PULMICORT.

Patent and Regulatory Environment

The original patent for PULMICORT expired in 2018 in the U.S., allowing generic formulations. AstraZeneca retains some formulations under exclusivity agreements and line extensions. Regulatory approvals by FDA, EMA, and other agencies are current, with some formulations approved for pediatric use.

What Are the Investment Considerations?

Revenue Trends and Projections

AstraZeneca's respiratory portfolio, including PULMICORT, generated approximately $4.7 billion in 2022. Post-patent expiry, generic competition has led to revenue decline, but new formulations and expanded indications could stabilize sales.

Market share erosion from generics involves pricing pressures but may be offset by increased penetration in emerging markets.

R&D and Pipeline Potential

The development of improved inhaler devices and combination therapies featuring budesonide could create revenue streams. Fresh formulations, such as powder inhalers and nasal sprays with enhanced delivery, are under clinical development.

Regulatory and Pricing Risks

Regulatory challenges include recent restrictions on inhaled corticosteroids' use in certain markets due to safety concerns, although these are rare. Pricing pressures stem from healthcare cost containment policies worldwide.

Potential for Acquisition or Licensing

Larger pharmaceutical firms may seek licensing agreements or acquisitions to expand inhaler portfolios, particularly in regions with increasing disease burden.

What Are the Financial Metrics to Watch?

Metric	2022 Data	Notes
Global inhaled corticosteroid market size	$10.8 billion	Expected to grow at CAGR of 4.9% through 2030
AstraZeneca respiratory segment revenue	$4.7 billion	Declined from previous years due to patent expiry
PULMICORT sales	Not publicly broken out	Part of respiratory segment sales
Patent expiry in the U.S.	2018	Generic competition increased post-expiry

What Is the Outlook for PULMICORT?

The outlook remains cautiously optimistic. While patent expiration has introduced generic competition, opportunities exist in emerging markets and through pipeline enhancements. The shift toward personalized medicine and combined inhaler therapies may influence future revenue streams.

Investors should monitor regulatory changes, patent litigation, and market share shifts among competitors as critical factors affecting PULMICORT's valuation.

Key Takeaways

• PULMICORT is a well-established inhaled corticosteroid for asthma and allergy treatment with a significant market presence.
• Patent expiry in 2018 introduced generic competition, impacting sales but leaving room for growth through pipeline and regional expansion.
• The global market for inhaled respiratory drugs is projected to grow at nearly 5% annually, driven by increasing disease prevalence.
• R&D efforts focus on improved delivery devices and combination products, influencing long-term revenue prospects.
• Price sensitivity and regulatory policies can materially affect profitability and market access.

FAQs

1. How does PULMICORT's efficacy compare to its competitors?
PULMICORT has proven efficacy comparable to other ICS medications like Flovent, with some evidence suggesting better tolerability in certain populations. Clinical trial data support its use in pediatric and adult patients.

2. Are there emerging formulations of PULMICORT?
AstraZeneca has developed new delivery devices and formulations, including nasal sprays for allergic rhinitis, to extend its market presence.

3. What are the main risks associated with investing in PULMICORT?
Patent expiration leading to generic competition, regulatory restrictions, and price pressures constitute primary risks. Flat or declining sales post-generic entry are typical.

4. What are key geographic expansion opportunities?
Emerging markets like China, India, and Brazil offer increased demand due to rising asthma and allergy prevalence, with less intense generic competition compared to developed markets.

5. How does healthcare policy affect PULMICORT's market?
Cost containment policies and inhaler substitution initiatives can reduce prescriptions or favor cheaper generics, affecting branded sales.

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Sources

[1] MarketsandMarkets, "Inhaled Corticosteroids Market," 2022
[2] AstraZeneca Annual Report, 2022
[3] IQVIA, "Global Respiratory Drug Market Trends," 2022
[4] U.S. FDA Database, PULMICORT approvals and patent status, 2023
[5] GlobalData, "Respiratory Market Outlook," 2022