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 Inc, 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-seven 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 fifty-five patent family members in thirty-two countries.

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

Summary for budesonide

International Patents:	155
US Patents:	37
Tradenames:	15
Applicants:	30
NDAs:	36
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	44
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	433
Patent Applications:	6,354
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
Assiut University	Phase 4
University of Calgary	Phase 2
Ferring Pharmaceuticals	Phase 2

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
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
Astrazeneca	PULMICORT RESPULES	budesonide	SUSPENSION;INHALATION	020929-003	Aug 8, 2000	AN	RX	Yes	Yes
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-002	Jul 21, 2006	AB	RX	Yes	Yes					Y
Cipla	BUDESONIDE	budesonide	SUSPENSION;INHALATION	205710-001	Nov 16, 2017	AN	RX	No	No
Astrazeneca	PULMICORT	budesonide	POWDER, METERED;INHALATION	020441-003	Jun 24, 1997		DISCN	No	No
Sun Pharm Inds Inc	ORTIKOS	budesonide	CAPSULE, DELAYED RELEASE;ORAL	211929-001	Jun 13, 2019		DISCN	Yes	No			Y
Dr Reddys Labs Sa	BUDESONIDE	budesonide	CAPSULE, DELAYED RELEASE;ORAL	206623-001	Apr 8, 2016	AB	RX	No	No

Expired US Patents for budesonide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix	UCERIS	budesonide	TABLET, EXTENDED RELEASE;ORAL	203634-001	Jan 14, 2013
Astrazeneca	PULMICORT RESPULES	budesonide	SUSPENSION;INHALATION	020929-002	Aug 8, 2000
Astrazeneca	PULMICORT RESPULES	budesonide	SUSPENSION;INHALATION	020929-001	Aug 8, 2000
Astrazeneca	PULMICORT	budesonide	POWDER, METERED;INHALATION	020441-003	Jun 24, 1997
Astrazeneca	PULMICORT	budesonide	POWDER, METERED;INHALATION	020441-003	Jun 24, 1997
Padagis Us	ENTOCORT EC	budesonide	CAPSULE, DELAYED RELEASE;ORAL	021324-001	Oct 2, 2001

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/004655 Jorveza 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/005653 Kinpeygo 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
Croatia	P20180408
European Patent Office	1183014	COMPOSITIONS PHARMACEUTIQUES ADMINISTRABLES PAR VOIE ORALE A LIBERATION CONTROLEE ET GOUT MASQUE (CONTROLLED RELEASE AND TASTE MASKING ORAL PHARMACEUTICAL COMPOSITIONS)
Slovenia	2211896
Denmark	2328553
Portugal	1183014
European Patent Office	2214677	COMPOSITIONS POUR LE TRAITEMENT DE L'INFLAMMATION DES VOIES GASTRO-INTESTINALES (COMPOSITIONS FOR THE TREATMENT OF INFLAMMATION OF THE GASTROINTESTINAL TRACT)

Supplementary Protection Certificates for budesonide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	LUC00208	Luxembourg		PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), DE GLYCOPYRRONIUM (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE BUDESONIDE (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1468 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
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	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
2435024	21C1020	France		PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI), GLYCOPYRROLATE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET BUDESONIDE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); REGISTRATION NO/DATE: EU/1/20/1498 20201210

Budesonide Market Dynamics and Financial Trajectory

Introduction

Budesonide, a corticosteroid used primarily to treat respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD), has been a significant player in the pharmaceutical market. Here, we delve into the market dynamics and financial trajectory of budesonide, highlighting key factors driving its growth and the challenges it faces.

Market Size and Growth

The global budesonide market has been experiencing steady growth. As of 2024, the market size was valued at USD 8.98 billion, and it is projected to reach USD 11.5 billion by 2032, exhibiting a Compound Annual Growth Rate (CAGR) of 3.1% over this period[3].

Key Drivers of Growth

Several factors are driving the growth of the budesonide market:

Increasing Prevalence of Asthma and COPD

The rising prevalence of asthma and COPD globally is a significant driver. For instance, in the U.S., 8.4% of adults and 5.8% of children under 18 have been diagnosed with asthma, contributing to the demand for budesonide[4].

Strong Healthcare Infrastructure

The growth in healthcare infrastructure, particularly in regions like the Asia Pacific, has enhanced the diagnosis and treatment rates of respiratory diseases, further boosting the demand for budesonide[1].

Favourable Reimbursement Policies

Favourable reimbursement policies in many countries have made budesonide more accessible, thereby increasing its adoption[1].

Generic Versions and Patent Expiry

The emergence of generic versions of budesonide, following the expiry of patented drugs, has expanded the market. Companies like Cipla have received approvals for generic versions, which are expected to drive market growth[4].

Regional Market Dynamics

Asia Pacific Dominance

The Asia Pacific region, particularly China, has been the largest market for budesonide and is expected to continue growing at a substantial CAGR. China's large population and increasing healthcare spending are key factors contributing to this growth[1].

U.S. Market

In the U.S., the increasing prevalence of chronic obstructive pulmonary disease and asthma is expected to boost the growth of the budesonide market. According to the CDC, 5.0% of the U.S. population has been diagnosed with COPD, and 8.4% of adults have asthma, which are significant market drivers[4].

Application Segments

The budesonide market is segmented into several application areas:

Respiratory Disease Treatment

This segment is expected to grow at the highest CAGR during the forecast period due to the increasing prevalence of asthma and COPD. Budesonide is primarily used to prevent and control symptoms such as shortness of breath and wheezing caused by asthma[1].

Nose Disease Treatment

Budesonide is also used in the treatment of nasal polyps and allergic rhinitis, though this segment is smaller compared to respiratory disease treatment.

Inflammatory Bowel Disease Treatment

Budesonide is used in the treatment of inflammatory bowel diseases like Crohn's disease and ulcerative colitis, though this is a smaller market segment compared to respiratory diseases[1].

Key Players

Several pharmaceutical companies are key players in the budesonide market:

AstraZeneca

Known for its brand name Pulmicort, AstraZeneca is a major player in the budesonide market.

Teva, Mylan, and Sandoz

These companies are also significant players, offering both branded and generic versions of budesonide.

Cosmo Pharmaceuticals, Chiesi Farmaceutici, and Orion Corporation

Other notable players include Cosmo Pharmaceuticals, Chiesi Farmaceutici, and Orion Corporation, which contribute to the market's competitive landscape[1][3].

Cost-Effectiveness and Economic Evaluation

Studies have shown that budesonide/formoterol combinations are cost-effective compared to other treatments:

Cost-Consequence Analysis

A study in China found that budesonide/formoterol led to a slightly higher total cost but significantly reduced hospitalization and outpatient events, making it a cost-effective option for pediatric asthma patients[2].

Healthcare Costs

Another study using German and Dutch unit costs found that budesonide/formoterol was associated with lower total healthcare costs per patient compared to fluticasone propionate over a 12-week period[5].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the budesonide market:

Increased Demand

The pandemic has led to an increased demand for budesonide due to its use in treating respiratory illnesses. A study by the University of Oxford found that early treatment with inhaled budesonide shortens recovery time in non-hospitalized COVID-19 patients[4].

Production and Supply Chain Disruptions

However, the pandemic has also caused production and supply chain disruptions, affecting the availability of raw materials and limiting workforce operations, which has moderately affected the industry's growth[1].

Future Outlook

The budesonide market is poised for continued growth driven by increasing prevalence of respiratory diseases, strong healthcare infrastructure, and favourable reimbursement policies. The emergence of generic versions and technological advancements in the medical industry are expected to offer further growth opportunities.

Key Takeaways

• The global budesonide market is projected to reach USD 11.5 billion by 2032.
• The Asia Pacific region, particularly China, is the largest market and is expected to grow substantially.
• Respiratory disease treatment is the fastest-growing application segment.
• Budesonide/formoterol combinations are cost-effective and reduce healthcare costs.
• The COVID-19 pandemic has driven demand but also caused production disruptions.

FAQs

What is the projected market size of the budesonide market by 2032?

The budesonide market is expected to touch USD 11.5 billion by 2032[3].

What is the CAGR of the budesonide market over the forecast period?

The budesonide market is expected to exhibit a CAGR of 3.1% over the forecast period[3].

Which region dominates the budesonide market?

The Asia Pacific region, particularly China, dominates the budesonide market and is expected to grow at a substantial CAGR[1].

What are the key drivers of the budesonide market?

Key drivers include the increasing prevalence of asthma and COPD, strong healthcare infrastructure, favourable reimbursement policies, and the emergence of generic versions[1][3].

How has the COVID-19 pandemic affected the budesonide market?

The pandemic has increased demand for budesonide due to its use in treating respiratory illnesses but has also caused production and supply chain disruptions[1][4].

Sources

1. Stratview Research - Budesonide Market Report
2. ISPOR - The Cost-Consequence of Budesonide/Formoterol Plus As-Needed Saba As Treatment for 6-12 Years Old Pediatric Asthma Patients in China
3. Business Research Insights - Budesonide (BUD) Market Size, Share, Trends, Growth
4. Coherent Market Insights - Budesonide Inhaler Market Size and Trends
5. PubMed - Cost-effectiveness analysis of budesonide/formoterol compared with fluticasone propionate in patients with moderate-persistent asthma.