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-eight patent family members in thirty-four countries.

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

Summary for BUDESONIDE

International Patents:	168
US Patents:	33
Tradenames:	15
Applicants:	30
NDAs:	36
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	41
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	201966-002	Sep 27, 2013		DISCN	No	No
Takeda Pharms Usa	EOHILIA	budesonide	SUSPENSION;ORAL	213976-001	Feb 9, 2024		RX	Yes	Yes			Y
Padagis Us	ENTOCORT EC	budesonide	CAPSULE, DELAYED RELEASE;ORAL	021324-001	Oct 2, 2001	AB	RX	Yes	Yes
Calliditas	TARPEYO	budesonide	CAPSULE, DELAYED RELEASE;ORAL	215935-001	Dec 15, 2021		RX	Yes	Yes			Y

Expired US Patents for BUDESONIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cheplapharm	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-001	Jul 12, 2006
Astrazeneca	PULMICORT	budesonide	POWDER, METERED;INHALATION	020441-003	Jun 24, 1997
Salix	UCERIS	budesonide	TABLET, EXTENDED RELEASE;ORAL	203634-001	Jan 14, 2013
Salix	UCERIS	budesonide	AEROSOL, FOAM;RECTAL	205613-001	Oct 7, 2014

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
South Korea	20240141771
Spain	2729925
World Intellectual Property Organization (WIPO)	2010021636
Japan	6744891

Supplementary Protection Certificates for BUDESONIDE

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	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	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

BUDESONIDE: Market Dynamics and Financial Trajectory

Last updated: April 24, 2026

What drives budesonide’s market dynamics?

Budesonide is a corticosteroid used for inflammatory control across respiratory, gastrointestinal, and off-label indications. Its market behavior is shaped by (1) dose-form substitution within inhaled and intranasal segments, (2) patent and lifecycle management for key brands, and (3) reimbursement and payer pressure toward lower-cost generics and authorized biosimilars/therapeutic equivalents where applicable.

Demand profile by therapeutic area

Budesonide’s demand concentrates in three channels:

• Respiratory anti-inflammatory (notably asthma and COPD-adjacent inflammatory management via inhaled forms; and allergic rhinitis via intranasal forms).
• Otolaryngology and allergy (intranasal corticosteroid use).
• Gastroenterology (oral/enteric or rectal formulations used in inflammatory bowel disease contexts, depending on product and jurisdiction).

Competitive structure

The competitive set typically follows a “brand-to-generic ladder”:

• Established originator brands remain present where switching friction exists (formulation-specific devices, dosing equivalence perceptions, patient history, and physician preference).
• Generic entry compresses price and shifts volume to lower wholesale acquisition costs where formularies permit.
• Device competition matters for inhaled products: delivery device and formulation attributes affect payer coverage and prescriber behavior.

How has pricing and volume evolved since generic penetration?

Budesonide’s financial trajectory is structurally tied to generic penetration in multiple jurisdictions. Price compression tends to show up first in high-volume formulations with mature patent estates, then later in lower-volume formulations with steeper switching barriers (device and patient-specific management).

Typical market pattern for budesonide

• Early cycle: Brand pricing holds while originator exclusivity persists.
• Mid cycle: Generic launch shifts the mix toward lower-cost SKUs. Net revenue decelerates even when unit volume rises.
• Late cycle: Consolidation across wholesalers and aggressive formulary controls accelerate margin erosion.

What this means for financial trajectory

For the portfolio as a whole, budesonide’s financial curve generally shows:

• Revenue stability driven by entrenched indications and continued guideline use.
• Profit margin pressure after generic entry and tendering.
• Volume resilience relative to higher-risk specialty launches because the clinical positioning is maintenance and anti-inflammatory rather than curative.

Which formulations and product types matter most to revenue?

Market value is distributed across budesonide product formats. The revenue ranking changes by country and channel, but the general global pattern is:

1. Inhaled budesonide (asthma control backbone; often the largest chronic-use segment).
2. Intranasal budesonide (allergic rhinitis).
3. Oral GI formulations (IBD-related use, where marketed).
4. Other routes (rectal/oral liquid in some markets; typically smaller revenue share but can be important where specific indications dominate).

Route-to-cash linkage

• Inhaled and intranasal products are high-frequency repeat prescriptions. They monetize through durable demand and wide guideline acceptance, offset by fast generic substitution after entry.
• GI products often face more payer nuance and prescriber specificity, which can slow erosion in select markets versus inhaled products.

What does the financial trajectory look like for manufacturers?

Budesonide is usually owned and marketed through originator and generic competition rather than high-cost manufacturing economics. As a result, manufacturer financial performance often breaks into two regimes:

• Originator period: higher pricing and margin; moderate volume growth; strong brand share.
• Generic-led period: revenue shifts to volume and contract wins; margins shrink; some manufacturers exit low-margin SKUs.

Market-relevant financial mechanisms

• Tendering and formulary placement drive revenue more than pure demand.
• Channel inventory cycles can temporarily boost sales after launches and stocking agreements.
• Regulatory approval timing (especially for device-combination products) creates discrete commercial steps.

How do ex-U.S. and U.S. dynamics differ?

Budesonide’s global trade patterns reflect differences in:

• Patent and exclusivity timing by jurisdiction.
• Formulary access (especially for inhaled products).
• Competitive intensity and authorized generic strategies.

Practical impact on trajectory

• In markets with earlier generic authorization, budesonide tends to experience faster gross margin decline.
• In markets with more constrained switching or where branded devices persist longer, unit share may transfer more slowly, flattening revenue decline.

What patent and lifecycle factors shape the outlook?

Budesonide’s long-standing clinical use means the main drivers are lifecycle events, not breakthrough exclusivity:

• Generic expiration and entry for existing budesonide SKUs.
• Product-by-product formulation patents (salt form, device, delivery mechanism, or manufacturing process claims).
• Brand-specific device ecosystems that delay full therapeutic interchange.

Why lifecycle matters for cash flow

Even after active ingredient patents expire, line-extension strategy can preserve:

• Device-specific share.
• Higher-cost reimbursement positioning for branded formulations.
• Patient adherence through consistent delivery performance.

What are the key market metrics that determine future sales?

For budesonide specifically, the most predictive metrics are not clinical endpoints but commercial execution variables:

• Formulary inclusion and step-therapy rules for respiratory and GI indications.
• Generic penetration rates and number of competing SKUs in each country.
• Device adoption for inhaled products and patient retention effects.
• Price erosion curves driven by tender cycles and wholesaler rebate structures.

Where does growth come from in a mature molecule?

Growth does not typically come from new clinical paradigms. It comes from:

• Geographic expansion into markets with later generic entry.
• Increased utilization within guideline-defined care pathways.
• Demand stability from chronic conditions and ongoing maintenance treatment.

How do regulatory and safety issues influence commercial trajectory?

Budesonide is well-established, with regulatory focus mainly on:

• Formulation/device quality and bioequivalence for generic entries.
• Label updates and indication-specific language affecting payer policies.
• Risk communications that can influence prescriber behavior and device selection.

For mature corticosteroids, these effects are usually incremental rather than structural, but they can affect switching behavior at launch windows.

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Financial trajectory summary (investment framing by phase)

The most business-relevant view is the phase-based trajectory that maps to market structure:

Phase	Market condition	Revenue behavior	Margin behavior	Main driver
Brand-dominant	Limited competition; active originator position	Higher, steadier topline growth	Stronger gross margin	Brand pricing and formulary positioning
Generic-transition	Generic SKUs enter; contracting intensifies	Units may hold or rise; net sales compress	Sharp margin compression	Price competition and payer rebates
Mature-generic	Broad generic availability	Low growth; sensitivity to tenders	Persistently low margins	Contract wins, distribution leverage

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Key Takeaways

• Budesonide’s market dynamics are dominated by formulation-specific competition, generic penetration, and payer-driven contracting, not by innovation cycles.
• Its financial trajectory typically shows stable demand with margin erosion after generic entry across major respiratory and intranasal channels.
• Growth in a mature molecule is usually geographic and utilization-based, with device and formulary placement determining whether brands and select manufacturers retain share.
• Portfolio-level cash flow depends on SKU mix (inhaled vs GI), device ecosystems, and tender timing that resets pricing on a recurring basis.

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FAQs

1) Why does budesonide revenue often decline after generic entry?

Generic substitution shifts purchasing to lower-priced equivalents. Even if unit volume stabilizes, net price and gross margin compress through rebate and tender structures.

2) Which budesonide formulations are most commercially durable?

Inhaled and intranasal products generally remain most durable because they align with chronic and recurring maintenance therapy, creating steady prescribing and repeat demand.

3) What most affects tender and contracting outcomes?

Therapeutic equivalence, bioequivalence outcomes, device performance considerations, and formulary mechanics such as step therapy rules and substitution policies.

4) Does lifecycle management still matter for a mature corticosteroid?

Yes. Originators can extend commercial relevance through device-specific ecosystems, formulation-level IP, and manufacturing or delivery improvements that reduce switching friction.

5) Where can manufacturers still find growth in budesonide?

Growth typically comes from markets with later generic entry, incremental increases in utilization in guideline care pathways, and winning share in contracted formularies through reliable supply and pricing discipline.

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References

[1] FDA. (n.d.). Drug approvals and related information for budesonide products. U.S. Food and Drug Administration. https://www.fda.gov/drugs
[2] EMA. (n.d.). Medicines: budesonide. European Medicines Agency. https://www.ema.europa.eu/
[3] National Library of Medicine. (n.d.). Budesonide: PubChem compound summary. PubChem. https://pubchem.ncbi.nlm.nih.gov/