Budesonide - Generic Drug Details

What are the generic sources for budesonide and what is the scope of patent protection?

Budesonide is the generic ingredient in fifteen branded drugs marketed by Padagis Israel, Salix, Astrazeneca, Amneal Pharms, Aurobindo Pharma Usa, Barr Labs Div Teva, Dr Reddys Labs Sa, Natco, Rising, Sciecure Pharma Inc, Zydus Pharms, Padagis Us, Sun Pharm Inds Inc, Calliditas, Cheplapharm, Apotex, Kenvue Brands, Cipla, Eugia Pharma, Impax Labs Inc, Lupin, Nephron, Sandoz, Sun Pharm, Teva Pharms, Teva Pharms Usa, Takeda Pharms Usa, Actavis Labs Fl Inc, Mylan, and Astrazeneca Ab, and is included in thirty-six NDAs. There are thirty-three patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Budesonide has one hundred and sixty-six patent family members in thirty-four countries.

There are twenty-two drug master file entries for budesonide. Forty-two suppliers are listed for this compound.

Summary for budesonide

International Patents:	166
US Patents:	33
Tradenames:	15
Applicants:	30
NDAs:	36
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	42
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	473
Drug Prices:	Drug price trends 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

See drug prices for budesonide

See drug sales revenues for budesonide

Recent Clinical Trials for budesonide

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

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

Anatomical Therapeutic Chemical (ATC) Classes for budesonide

A07EA	Corticosteroids acting locally
A07E	INTESTINAL ANTIINFLAMMATORY AGENTS
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

D07AC	Corticosteroids, potent (group III)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

R01AD	Corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03BA	Glucocorticoids
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	BUDESONIDE	budesonide	SUSPENSION;INHALATION	201966-001	Sep 27, 2013		DISCN	No	No
Takeda Pharms Usa	EOHILIA	budesonide	SUSPENSION;ORAL	213976-001	Feb 9, 2024		RX	Yes	Yes	8,324,192
Sun Pharm	BUDESONIDE	budesonide	SUSPENSION;INHALATION	211922-003	Apr 14, 2021	AN	RX	No	No
Calliditas	TARPEYO	budesonide	CAPSULE, DELAYED RELEASE;ORAL	215935-001	Dec 15, 2021		RX	Yes	Yes	11,896,719

Expired US Patents for budesonide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cheplapharm	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-002	Jul 12, 2006	6,027,714
Astrazeneca	PULMICORT RESPULES	budesonide	SUSPENSION;INHALATION	020929-001	Aug 8, 2000	7,524,834*PED
Salix	UCERIS	budesonide	TABLET, EXTENDED RELEASE;ORAL	203634-001	Jan 14, 2013	10,143,698
Cheplapharm	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-001	Jul 12, 2006	6,142,145

EU/EMA Drug Approvals for budesonide

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 budesonide

Country	Patent Number	Title	Estimated Expiration
Spain	2781949
Cyprus	1120048
Japan	2011503074
United Kingdom	202210430

Supplementary Protection Certificates for budesonide

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	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
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

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/