BUDESONIDE - Generic Drug Details

What are the generic sources for budesonide and what is the scope of freedom to operate?

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-one patent family members in thirty-three countries.

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

Summary for BUDESONIDE

International Patents:	161
US Patents:	33
Tradenames:	15
Applicants:	30
NDAs:	36
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	43
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	470
Patent Applications:	8,067
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
University of Wisconsin, Madison	PHASE2
Meriter Foundation	PHASE2
AHS Cancer Control Alberta	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
Padagis Us	ENTOCORT EC	budesonide	CAPSULE, DELAYED RELEASE;ORAL	021324-001	Oct 2, 2001	AB	RX	Yes	Yes
Astrazeneca Ab	BREZTRI AEROSPHERE	budesonide; formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	212122-001	Jul 23, 2020		RX	Yes	Yes	9,415,009
Astrazeneca Ab	BREZTRI AEROSPHERE	budesonide; formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	212122-001	Jul 23, 2020		RX	Yes	Yes	10,716,753		Y
Takeda Pharms Usa	EOHILIA	budesonide	SUSPENSION;ORAL	213976-001	Feb 9, 2024		RX	Yes	Yes
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	7,143,764
Cheplapharm	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-002	Jul 12, 2006	6,142,145
Astrazeneca	PULMICORT	budesonide	POWDER, METERED;INHALATION	020441-003	Jun 24, 1997	4,524,769
Astrazeneca	PULMICORT RESPULES	budesonide	SUSPENSION;INHALATION	020929-001	Aug 8, 2000	6,598,603*PED
Salix	UCERIS	budesonide	TABLET, EXTENDED RELEASE;ORAL	203634-001	Jan 14, 2013	7,410,651

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
China	120053463	用于治疗IgA肾病的包含布地奈德的药物组合物 (Pharmaceutical composition comprising budesonide for treating IgA nephropathy)
Colombia	2024009565	Composición farmacéutica que comprende budesonida para tratamiento de la nefropatía iga
Hungary	E051538
Slovenia	3354276
World Intellectual Property Organization (WIPO)	2009064417

Supplementary Protection Certificates for BUDESONIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	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	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	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

Market Dynamics and Financial Trajectory for BUDESONIDE

Last updated: September 24, 2025

Introduction

Budesonide, a potent corticosteroid primarily used to treat inflammatory and allergic conditions, plays a significant role in respiratory, gastrointestinal, and ENT therapeutic areas. Since its emergence, the drug has evolved within a competitive landscape dominated by a combination of branded formulations and generics. Its market dynamics are shaped by patent expiries, regulatory pathways, clinical innovations, and global health trends, influencing its financial trajectory across therapeutic segments.

Pharmacological Profile and Therapeutic Applications

Budesonide is distinguished by its high topical potency and extensive first-pass metabolism, which minimizes systemic side effects. It is approved across various formulations, including oral, inhalational, nasal, and rectal preparations, each catering to specific indications:

• Inhalation (Pulmonary): Used for asthma and Chronic Obstructive Pulmonary Disease (COPD).
• Nasal: Approved for allergic rhinitis and nasal polyposis.
• Oral: Employed in Crohn’s disease and ulcerative colitis.
• Rectal: Utilized for ulcerative proctitis.

This versatility broadens its revenue streams, underpinning its sustainable market presence.

Market Dynamics

1. Patent and Regulatory Landscape

Budesonide’s initial formulations, such as Pulmicort (for asthma), benefited from patent protections that drove early market penetration. Typically, patent exclusivity spans 10-15 years, after which generics enter the marketplace.
The expiration of key patents—particularly in the U.S. and Europe—has catalyzed the proliferation of generic versions, intensifying price competition, reducing costs, and increasing accessibility. Regulatory agencies have also fast-tracked approvals of new formulations and delivery systems, further shaping market dynamics.

2. Competitive Environment

The market features a mixture of brand-name drugs like Pulmicort (AstraZeneca) and Rhinocort (AstraZeneca), alongside numerous generic manufacturers. The introduction of biosimilars and alternative corticosteroids exerts downward pressure on prices and margins.
Innovative delivery systems, such as hydrofluoroalkane (HFA) inhalers, have enhanced drug efficacy and patient adherence, asserting competitive differentiation.

3. Clinical and Technological Innovations

Recent advancements include biodegradable nasal sprays and dual-action inhalers that combine budesonide with long-acting bronchodilators. These innovations aim to improve efficacy, reduce dosing frequency, and foster patient compliance—potentially capturing new market segments and driving revenue.

4. Geographic and Demographic Factors

Growth in emerging markets like China, India, and Latin America presents significant opportunities due to rising respiratory and allergic disease prevalence amid increasing healthcare access. Developed markets, meanwhile, are characterized by a maturation phase with stable or declining growth, influenced by patent expiry and generic penetration.

5. Impact of COVID-19 and Pandemic-Driven Trends

While not directly aligned with COVID-19 treatments, budesonide’s role in managing respiratory symptoms and its use in off-label settings boosted awareness and demand during the pandemic. This temporarily stabilized sales dynamics and highlighted the importance of corticosteroids in respiratory care.

Financial Trajectory and Revenue Outlook

1. Revenue Drivers

• Brand loyalty and clinical efficacy: Sustains premium pricing in branded segments.
• Generic competition: Deters sustained price hikes, but volume increases often compensate, especially in emerging markets.
• Innovative delivery systems: Premium priced, functionally differentiated products bolster margins and revenue.

2. Market Size and Forecast

The global inhaled corticosteroids market was valued at approximately USD 5 billion in 2022 and is projected to grow at a CAGR of 4.5% through 2030, driven by expanding asthma and COPD patient populations [1]. The nasal corticosteroids segment, including budesonide-based products, is expected to similarly expand, reaching USD 3.2 billion by 2030.

In the gastrointestinal segment, increasing indications for budesonide suggest a compound annual growth rate (CAGR) of roughly 5%, driven by unmet needs and ongoing clinical research. The combination of stable developed markets and high-growth emerging economies sustains the overall positive financial trajectory.

3. Key Revenue Influencers

• Patent expiries: Anticipated expirations in North America and Europe within the next 3–5 years could lead to revenue declines unless offset by volume growth or incremental innovations.
• Regulatory approvals: New formulations and combination therapies may unlock premium pricing and extended market share.
• Market penetration: Entry into new markets and increased prescription adherence through improved formulations will be pivotal.

4. Investment and R&D Impact

Continued investment in inhaler technology, nasal spray devices, and oral formulations positions companies to maintain competitive advantages. R&D efforts also focus on indications like eosinophilic esophagitis and systemic inflammatory conditions, potentially expanding the addressable market.

Challenges and Opportunities

Challenges

• Generic erosion: Patent expiries significantly impact revenue streams.
• Pricing pressures: Healthcare reimbursement policies prioritize cost-efficiency, especially in developed markets.
• Competitive landscape: Emergence of new corticosteroids and biologics for inflammatory diseases threaten market share.

Opportunities

• Innovation pipeline: Novel delivery systems and combination therapies.
• Global health trends: Rising prevalence of asthma, COPD, and allergic diseases in developing countries.
• Regulatory strategies: Fast-track approvals and patent extensions through new indications and formulations.

Regulatory and Patent Outlook

Regulatory authorities are increasingly allowing flexible approval pathways for new formulations and delivery devices, which can extend product lifecycles. Meanwhile, companies seek to preserve market exclusivity via patent strategies, formulation patents, and data exclusivity periods.

Conclusion

Budesonide's market dynamics are characterized by a cyclical transition from patent-protected products to widespread generic availability, punctuated by continual innovation and geographic expansion. While patent expiries pose revenue risks, leveraging formulation innovation, expanding into emerging markets, and addressing unmet needs sustain its financial trajectory. The future of budesonide hinges on strategic R&D investments, regulatory agility, and market positioning within the competitive corticosteroid landscape.

Key Takeaways

• Patent expiries and generics dominate near-term market challenges but are offset by innovations and expanding markets.
• Emerging markets offer high-growth opportunities driven by increasing respiratory and allergic disease prevalence.
• Formulation and delivery system innovations are critical for maintaining premium pricing and patient adherence.
• Regulatory pathways and patent strategies play pivotal roles in extending product lifecycle and revenue stability.
• Continued investment in clinical research can unlock new indications and therapeutic combinations, diversifying revenue streams.

FAQs

1. How does patent expiration affect budesonide’s market share?
Patent expirations typically lead to increased generic competition, reducing prices and margins for branded formulations. However, introduced innovations and newer delivery mechanisms can offset revenue loss by attracting different patient segments and maintaining brand loyalty.

2. What are the key therapeutic segments for budesonide?
Budesonide is widely used in respiratory (asthma, COPD), nasal (allergic rhinitis, polyposis), and gastrointestinal (Crohn’s disease, ulcerative colitis) indications.

3. Which emerging markets present the greatest growth potential for budesonide?
China, India, and Latin America are expanding rapidly due to increasing disease prevalence, urbanization, and improving healthcare infrastructure.

4. Are there upcoming regulatory hurdles for budesonide?
Regulatory challenges include approval of new formulations, biosimilars, and navigating pricing and reimbursement policies, especially in heavily regulated markets like the U.S. and Europe.

5. How does innovation influence budesonide’s long-term market viability?
Innovations in inhaler technology, nasal spray formulations, and combination therapies are vital to differentiating products, extending patent life, and delivering sustained revenue streams.

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Sources

[1] Grand View Research. "Inhaled Corticosteroids Market Size & Trends Analysis." 2022.