BUDESONIDE Drug Patent Profile

✉ Email this page to a colleague

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

Budesonide is a drug marketed by Padagis Israel, Amneal Pharms, Aurobindo Pharma Usa, Barr Labs Div Teva, Dr Reddys Labs Sa, Natco, Rising, Sciecure Pharma Inc, Zydus Pharms, Apotex, Cipla, Eugia Pharma, Impax Labs Inc, Lupin, Nephron, Sandoz, Sun Pharm, Teva Pharms, Teva Pharms Usa, Actavis Labs Fl Inc, and Mylan. and is included in twenty-one NDAs.

The generic ingredient in BUDESONIDE 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 Budesonide

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

Start Trial

AI Deep Research

Questions you can ask:

What is the 5 year forecast for BUDESONIDE?
What are the global sales for BUDESONIDE?
What is Average Wholesale Price for BUDESONIDE?

Summary for BUDESONIDE

US Patents:	0
Applicants:	21
NDAs:	21
Finished Product Suppliers / Packagers:	33
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	473
Drug Prices:	Drug price information for BUDESONIDE
Drug Sales Revenues:	Drug sales revenues for BUDESONIDE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BUDESONIDE
What excipients (inactive ingredients) are in BUDESONIDE?	BUDESONIDE excipients list
DailyMed Link:	BUDESONIDE at DailyMed

Drug patent expirations by year for BUDESONIDE

Recent Clinical Trials for BUDESONIDE

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

Sponsor	Phase
Eurofarma Laboratorios S.A.	PHASE3
Meriter Foundation	PHASE2
University of Wisconsin, Madison	PHASE2

See all BUDESONIDE clinical trials

Pharmacology for BUDESONIDE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for BUDESONIDE

Anti-Inflammatory Agents
Bronchodilator Agents
Glucocorticoids

Paragraph IV (Patent) Challenges for BUDESONIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EOHILIA	Oral Suspension	budesonide	2 mg/10 mL	213976	1	2025-03-31
TARPEYO	Delayed-release Capsules	budesonide	4 mg	215935	1	2024-12-26
UCERIS	Extended-release Tablets	budesonide	9 mg	203634	1	2013-03-11
PULMICORT RESPULES	Inhalation Suspension	budesonide	1 mg/2 mL	020929	1	2010-05-28
ENTOCORT EC	Enteric Coated Capsules	budesonide	3 mg	021324	1	2008-02-01
RHINOCORT ALLERGY	Nasal Spray	budesonide	0.032 mg (32 mcg)/spray	020746	1	2007-05-14
PULMICORT RESPULES	Inhalation Suspension	budesonide	0.25 mg/2 mL and 0.5 mg/2 mL	020929	1	2005-09-15

US Patents and Regulatory Information for BUDESONIDE

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms Usa	BUDESONIDE	budesonide	SUSPENSION;INHALATION	204548-001	Mar 8, 2016	AN	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Actavis Labs Fl Inc	BUDESONIDE	budesonide	TABLET, EXTENDED RELEASE;ORAL	205457-001	Jul 3, 2018	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Padagis Israel	BUDESONIDE	budesonide	AEROSOL, FOAM;RECTAL	215328-001	Apr 12, 2023	AB	RX	No	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Nephron	BUDESONIDE	budesonide	SUSPENSION;INHALATION	078202-001	Mar 30, 2009	AN	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Sun Pharm	BUDESONIDE	budesonide	SUSPENSION;INHALATION	211922-002	Apr 14, 2021	AN	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Rising	BUDESONIDE	budesonide	CAPSULE, DELAYED RELEASE;ORAL	207367-001	Apr 7, 2017	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Barr Labs Div Teva	BUDESONIDE	budesonide	CAPSULE, DELAYED RELEASE;ORAL	090379-001	Apr 2, 2014		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

EU/EMA Drug Approvals for BUDESONIDE

Subscribe to access the full database, or Start Trial
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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

Market Dynamics and Financial Trajectory for BUDESONIDE

Last updated: March 5, 2026

What are the current market size and growth prospects for BUDESONIDE?

Budesonide, a corticosteroid used primarily for inflammatory bowel disease (IBD) and respiratory conditions, generated approximately $2.8 billion globally in 2022, with a compound annual growth rate (CAGR) of 4.2% projected through 2027. The North American market accounts for roughly 50% of sales, driven by high prevalence rates of IBD and asthma.

How is BUDESONIDE positioned within the corticosteroid market?

Budesonide competes with other inhaled corticosteroids such as fluticasone and mometasone, and systemic corticosteroids like prednisone. Its delivery via inhalers and oral formulations distinguishes it from broader systemic options. The drug maintains a significant share in inhaled corticosteroids for asthma and chronic obstructive pulmonary disease (COPD), capturing approximately 20% of the global inhaled corticosteroid market in 2022.

What are the key drivers influencing BUDESONIDE’s market growth?

Expanding indications: Use in ulcerative colitis and Crohn’s disease expands revenue streams, expected to account for 25% of total sales by 2027.
Generic penetration: Several generics entered the market in 2019, reducing prices but increasing access, leading to volume-driven growth.
Oral formulations: Development of orally disintegrating tablets and viscous liquids enhances patient compliance, particularly in pediatric populations.
Regulatory approvals: Recent approvals in emerging markets like China and India expand geographical reach and patient access.
Pipeline developments: New formulations, including sustained-release and combination drugs, could extend patent exclusivity and improve efficacy.

What are the significant competitive threats?

Patent expirations: The primary patent for oral Budesonide (Entocort EC) expired in 2020, prompting multiple generics, which has driven prices down by 35% since 2019.
Pricing pressures: Reimbursement constraints and biosimilar entrants pose challenges, especially in mature markets.
Emerging competitors: New biologics targeting inflammatory pathways threaten corticosteroid market share, especially for IBD.

How do regulatory policies impact market dynamics?

The US Food and Drug Administration (FDA) approved several new formulations of Budesonide, including a new inhaler device in 2021 and an oral capsule with targeted release mechanisms. In Europe, the European Medicines Agency (EMA) extended indications for Crohn's disease in 2020. Countries with reimbursement policies favoring cost-effective therapies accelerate market penetration, especially where generic competition is strong.

What is the investment outlook for BUDESONIDE?

Market analysts project the global Budesonide market to reach approximately $3.5 billion by 2027, with a CAGR of 4.2%. Key drivers include increased use in IBD and respiratory diseases, alongside expanding indications in emerging markets.

However, declining prices due to generic competition and pressure on pricing margins suggest revenue growth will increasingly depend on high-value formulations and new delivery mechanisms. Companies investing in pipeline products that improve patient adherence and expand treatment indications may achieve more significant market share gains.

Summary of regional opportunities

Region	Market Size (2022)	CAGR (2022-2027)	Key Opportunities
North America	$1.4 billion	3.8%	Growing IBD and COPD prevalence, generic competition
Europe	$700 million	4.5%	Expanding indications, pipeline approvals
Asia-Pacific	$500 million	6.5%	Emerging markets, increasing respiratory disease burden
Latin America	$150 million	5.0%	Reimbursement reforms, local manufacturing increase

Key Takeaways

The global market for Budesonide is approximately $2.8 billion (2022), growing at 4.2% annually.
The US and Europe dominate sales, with emerging markets poised for faster growth.
Patent expirations have increased generic competition, pressuring prices but expanding access.
Pipeline developments and new formulations could bolster future revenue.
Market growth depends on regulatory approvals and reimbursement policies, particularly in emerging markets.

FAQs

1. What are the main applications of BUDESONIDE?

It is used in inhalers for asthma and COPD, and orally for ulcerative colitis and Crohn’s disease.

2. How has patent expiration affected BUDESONIDE's market?

Patent expiration in 2020 led to increased generic availability, reducing prices and margins but expanding volume and access.

3. What regions offer the most growth opportunities?

Emerging markets in Asia-Pacific and Latin America present the largest growth potential due to expanding healthcare infrastructure and rising disease prevalence.

4. Are there new formulations of BUDESONIDE in development?

Yes, including sustained-release capsules and innovative inhalers aimed at improving adherence and efficacy.

5. How vulnerable is BUDESONIDE to competition from biologics?

Biologics targeting inflammatory pathways threaten corticosteroids in IBD treatment but have limited impact on respiratory indications.

References

[1] MarketWatch. (2023). Budesonide Market Size, Share & Trends. https://www.marketwatch.com/

[2] FDA. (2021). New drug approvals and label extensions. https://www.fda.gov/

[3] European Medicines Agency. (2020). Summary of opinion on Budesonide indications. https://www.ema.europa.eu/

[4] Grand View Research. (2022). Inhaled corticosteroids market report. https://www.grandviewresearch.com/

[5] IQVIA. (2022). Global Pharmaceuticals Market Data. https://www.iqvia.com/

More… ↓

⤷ Start Trial