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-one 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

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

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
Sweden	8601060
Australia	5771686
South Korea	960007754

Supplementary Protection Certificates for PULMICORT

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

PULMICORT Market Analysis and Financial Projection

Last updated: February 7, 2026

What Are the Market Dynamics for PULMICORT?

Pulmicort (budesonide) is a corticosteroid inhaler indicated primarily for asthma and certain forms of COPD. Its market operates within the larger respiratory therapeutics segment, which demonstrates consistent growth driven by disease prevalence, regulatory approvals, and healthcare provider adoption.

Market Size and Growth Trends

• The global respiratory drugs market was valued at approximately $38 billion in 2022.
• Expected to grow at a compound annual growth rate (CAGR) of around 4.5% through 2030, driven by increasing asthma prevalence and expanding COPD populations.

Key Factors Driving Demand

• Disease Prevalence: Asthma affects about 262 million individuals worldwide, with incidence rising in both developed and developing regions.
• Treatment Guidelines: Updates recommend inhaled corticosteroids (ICS) like Pulmicort as first-line therapy for persistent asthma, supporting stable demand.
• Market Penetration: Pulmicort holds a leadership position within ICS inhalers, with a significant market share in North America and Europe.
• Competitive Landscape: Major competitors include Fluticasone (Flovent), Beclomethasone (Qvar), and mometasone (Asmanex). Pulmicort's differentiated features include a stable formulation and broad label.

Regulatory and Patent Considerations

• Pulmicort's patent protections have largely expired or are nearing expiration in key markets, opening pathways for biosimilars.
• Biosimilar entrants could impact pricing and market share by 2024-2026, especially in Europe and Asia.

Regional Dynamics

• North America: Largest market, driven by high asthma prevalence and advanced healthcare infrastructure.
• Europe: Similar trends as North America, with increasing adoption of inhaled corticosteroids.
• Asia-Pacific: Rapid growth potential due to rising urbanization, air pollution, and awareness of respiratory diseases.

What Is the Financial Trajectory for Pulmicort?

The financial outlook hinges on sales, patent landscape, competitive pressures, and strategic launches of generics and biosimilars.

Revenue History and Estimations

• Estimated global sales for Pulmicort were approximately $1.2 billion in 2022.
• Sales declined by approximately 3-5% annually in 2019-2022 due to patent expirations and generics entry.
• Leading pharmaceutical companies, such as AstraZeneca (original developer), have been divesting or partnering to manage revenue impact.

Impact of Biosimilar and Generic Competition

• Biosimilar versions of budesonide are anticipated to enter European markets by 2024.
• In the U.S., generic inhalers gained approval but face market access challenges due to formulary and physician prescribing habits.
• Biosimilar competition can reduce prices by 20-50%, affecting revenue streams.

R&D Investment and Innovation

• Companies are investing in new delivery mechanisms, combination therapies (e.g., Pulmicort plus long-acting beta-agonists), and fixed-dose combinations.
• Footprint expansion, especially targeting COPD segment, could offset declining asthma sales.

Market Share and Pricing Trends

• Pulmicort retains a premium position based on formulation stability.
• Prices for inhalers have increased modestly over the past five years, though competitive pressures could reverse this trend.

Future Revenue Trajectory

Year	Estimated Global Sales (USD billion)	Notes
2023	1.1	Declines due to patent expiry
2024	0.9	Biosimilar market entry anticipated
2025	0.8	Continued competition pressure
2026	0.75	Market stabilization

Investment Outlook

• Firms focusing on biosimilars or innovative formulations may capture upside.
• Geographic expansion into emerging markets remains crucial.
• Pricing strategies will be vital as generics erode premium segments.

Key Drivers and Risks

Drivers	Risks
Rising asthma and COPD prevalence	Patent expirations
Adoption of current treatment guidelines	Biosimilar/premium generic entry
Healthcare infrastructure development	Price erosion
Innovation in delivery devices	Regulatory hurdles

Conclusion

Pulmicort remains a core inhaled corticosteroid with a steady demand base. Market growth faces headwinds from patent expiration and biosimilar competition, leading to sales erosion projected at approximately 30% between 2022-2026. Strategic diversification into combination therapies and emerging markets could stabilize revenues.

Key Takeaways

• Pulmicort’s global sales declined from $1.2 billion in 2022, with further decreases expected due to biosimilar competition.
• Major markets like North America and Europe represent significant revenue contributors, albeit with increasing generic presence.
• Emerging markets offer growth opportunities, especially with improved healthcare infrastructure.
• Innovations in delivery and combination therapies are potential revenue growth avenues.
• Price competition and regulatory factors will influence the pace and magnitude of revenue decline.

FAQs

1. When will biosimilars for Pulmicort significantly impact sales?
Biosimilars are expected to enter European markets by 2024, with potential U.S. approvals possibly by 2025. Market penetration and pricing will determine exact impact timelines.

2. What markets are most critical for Pulmicort’s future growth?
Emerging markets in Asia-Pacific, Latin America, and expanding health systems in Southeast Asia hold the most growth potential due to rising disease prevalence and improved access.

3. How does Pulmicort compare to competitors in terms of pricing?
Pulmicort commands a premium in developed markets due to formulation stability. Competition from generics and biosimilars aims to reduce prices by up to 50%, which can erode margins.

4. What are the strategic options for companies with rights to Pulmicort?
Options include launching biosimilars, investing in combination inhalers, expanding into underpenetrated regions, or developing new delivery technologies to offset sales declines.

5. How might regulatory changes affect Pulmicort’s market?
Regulatory approvals for biosimilars and generics can accelerate market entry, lowering barriers for competitors. Stringent patent protections or delays can prolong Pulmicort’s branded sales dominance.

---

Citations:

[1] MarketWatch. Respiratory Drugs Market Size, Share & Trends Analysis Report, 2022.
[2] IQVIA. Global Medicine Spending and Usage Trends, 2022.
[3] AstraZeneca. Pulmicort Product Data, 2022.
[4] European Medicines Agency. Biosimilar Approvals, 2023.