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Last Updated: March 28, 2024

Budesonide - Generic Drug Details


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

Budesonide is the generic ingredient in fourteen 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, Apotex Inc, J And J Consumer Inc, Cipla, Eugia Pharma, Impax Labs Inc, Lupin, Nephron, Sandoz, Sun Pharm, Teva Pharms, Teva Pharms Usa, Actavis Labs Fl Inc, Mylan, and Astrazeneca Ab, and is included in thirty-five NDAs. There are twenty-two patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Budesonide has forty patent family members in nineteen countries.

There are twenty-two drug master file entries for budesonide. Forty-two 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
SanofiPhase 3
Mansoura UniversityN/A
Wolfson Medical CenterN/A

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Pharmacology for budesonide
Medical Subject Heading (MeSH) Categories for budesonide
Paragraph IV (Patent) Challenges for BUDESONIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
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
Eugia Pharma BUDESONIDE budesonide SUSPENSION;INHALATION 216667-001 Nov 29, 2023 AN RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
J And J Consumer Inc RHINOCORT ALLERGY budesonide SPRAY, METERED;NASAL 020746-003 Mar 23, 2015 OTC Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Salix UCERIS budesonide TABLET, EXTENDED RELEASE;ORAL 203634-001 Jan 14, 2013 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Cipla BUDESONIDE budesonide SUSPENSION;INHALATION 205710-002 Nov 16, 2017 AN RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Calliditas TARPEYO budesonide CAPSULE, DELAYED RELEASE;ORAL 215935-001 Dec 15, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab BREZTRI AEROSPHERE budesonide; formoterol fumarate; glycopyrrolate AEROSOL, METERED;INHALATION 212122-001 Jul 23, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for budesonide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-002 Jul 12, 2006 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929-001 Aug 8, 2000 ⤷  Try a Trial ⤷  Try a Trial
Salix UCERIS budesonide TABLET, EXTENDED RELEASE;ORAL 203634-001 Jan 14, 2013 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-001 Jul 12, 2006 ⤷  Try a Trial ⤷  Try a Trial
Salix UCERIS budesonide AEROSOL, FOAM;RECTAL 205613-001 Oct 7, 2014 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-001 Jul 12, 2006 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for budesonide

Country Patent Number Title Estimated Expiration
Japan 5279850 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2009138716 ⤷  Try a Trial
Mexico PA01012889 COMPOSICIONES FARMACEUTICAS ORALES DE LIBERACION CONTROLADA Y SABOR DISFRAZADO. (CONTROLLED RELEASE AND TASTE MASKING ORAL PHARMACEUTICAL COMPOSITIONS.) ⤷  Try a Trial
Italy MI20000422 SISTEMI TERAPEUTICI PER FORME FARMACEUTICHE ORALI DI PRINCIPI ATTIVI AVENTI SFAVOREVOLI CARATTERISTICHE ORGANOLETTICHE ⤷  Try a Trial
European Patent Office 2278958 COMPOSITIONS POUR L'ADMINISTRATION DE CORTICOSTÉROÏDES PAR VOIE ORALE (COMPOSITIONS FOR THE ORAL DELIVERY OF CORTICOSTEROIDS) ⤷  Try a Trial
Japan 2011102310 CONTROLLED RELEASE AND TASTE MASKING ORAL PHARMACEUTICAL COMPOSITIONS ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for budesonide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2435024 21C1020 France ⤷  Try a Trial 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 a Trial 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 a Trial 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 132021000000095 Italy ⤷  Try a Trial 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 SPC/GB21/029 United Kingdom ⤷  Try a Trial 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 ⤷  Try a Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.