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Last Updated: March 17, 2025

Budesonide - Generic Drug Details


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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-three suppliers are listed for this compound.

Drug Prices for budesonide

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Drug Sales Revenue Trends for budesonide

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Recent Clinical Trials for budesonide

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

SponsorPhase
Assiut UniversityPhase 4
Ferring PharmaceuticalsPhase 2
University of CalgaryPhase 2

See all budesonide clinical trials

Pharmacology for budesonide
Medical Subject Heading (MeSH) Categories for budesonide
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

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Astrazeneca PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929-002 Aug 8, 2000 AN RX Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006 AB RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Salix UCERIS budesonide TABLET, EXTENDED RELEASE;ORAL 203634-001 Jan 14, 2013 AB RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Salix UCERIS budesonide TABLET, EXTENDED RELEASE;ORAL 203634-001 Jan 14, 2013 AB RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Salix UCERIS budesonide TABLET, EXTENDED RELEASE;ORAL 203634-001 Jan 14, 2013 AB RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Mylan BUDESONIDE budesonide TABLET, EXTENDED RELEASE;ORAL 208851-001 Sep 17, 2020 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 6 of 6 entries

Expired US Patents for budesonide

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Astrazeneca PULMICORT budesonide POWDER, METERED;INHALATION 020441-003 Jun 24, 1997 ⤷  Try for Free ⤷  Try for Free
Astrazeneca PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929-002 Aug 8, 2000 ⤷  Try for Free ⤷  Try for Free
Astrazeneca PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929-003 Aug 8, 2000 ⤷  Try for Free ⤷  Try for Free
Salix UCERIS budesonide TABLET, EXTENDED RELEASE;ORAL 203634-001 Jan 14, 2013 ⤷  Try for Free ⤷  Try for Free
Salix UCERIS budesonide TABLET, EXTENDED RELEASE;ORAL 203634-001 Jan 14, 2013 ⤷  Try for Free ⤷  Try for Free
Salix UCERIS budesonide AEROSOL, FOAM;RECTAL 205613-001 Oct 7, 2014 ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 6 of 6 entries

EU/EMA Drug Approvals for budesonide

CompanyDrugnameInnProduct Number / IndicationStatusGenericBiosimilarOrphanMarketing AuthorisationMarketing 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
>Company>Drugname>Inn>Product Number / Indication>Status>Generic>Biosimilar>Orphan>Marketing Authorisation>Marketing Refusal
Showing 1 to 2 of 2 entries

International Patents for budesonide

CountryPatent NumberTitleEstimated Expiration
Denmark 1183014 ⤷  Try for Free
Israel 314067 תכשיר רוקחי הכולל בודזונייד לטיפול בנפרופתיה מסוג iga (Pharmaceutical composition comprising budesonide for treating iga nephropathy) ⤷  Try for Free
Lithuania 2211896 ⤷  Try for Free
Lithuania 3354276 ⤷  Try for Free
Russian Federation 2010119165 ⤷  Try for Free
South Korea 20100087007 ⤷  Try for Free
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 6 of 6 entries

Supplementary Protection Certificates for budesonide

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
2435024 132021000000095 Italy ⤷  Try for Free 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 2021C/518 Belgium ⤷  Try for Free 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 21C1020 France ⤷  Try for Free 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
2435024 301102 Netherlands ⤷  Try for Free 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 LUC00208 Luxembourg ⤷  Try for Free 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 SPC/GB21/029 United Kingdom ⤷  Try for Free 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
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 6 of 6 entries

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.

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