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Last Updated: August 15, 2022

BUDESONIDE - Generic Drug Details


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

Budesonide is the generic ingredient in thirteen branded drugs marketed by Salix, Astrazeneca, Amneal Pharms, Aurobindo Pharma Usa, Barr Labs Div Teva, Mayne Pharma, Natco, Rising, Sciecure Pharma Inc, Zydus Pharms, Padagis Us, Calliditas, Sun Pharm Inds Inc, Apotex Inc, J And J Consumer Inc, Cipla, Impax Labs Inc, Lupin, Nephron, Sandoz Inc, Sun Pharm, Teva Pharms, Teva Pharms Usa, Actavis Labs Fl Inc, Mylan, and Astrazeneca Ab, and is included in thirty-two NDAs. There are twenty-seven patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Budesonide has thirty-nine patent family members in nineteen countries.

There are twenty-two drug master file entries for budesonide. Thirty-eight 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

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SponsorPhase
University of UtahPhase 2
Assiut UniversityPhase 2/Phase 3
Cipla Ltd.Phase 3

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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
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Astrazeneca Ab BREZTRI AEROSPHERE budesonide; formoterol fumarate; glycopyrrolate AEROSOL, METERED;INHALATION 212122-001 Jul 23, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Astrazeneca Ab BREZTRI AEROSPHERE budesonide; formoterol fumarate; glycopyrrolate AEROSOL, METERED;INHALATION 212122-001 Jul 23, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 RESPULES budesonide SUSPENSION;INHALATION 020929-002 Aug 8, 2000 See Plans and Pricing See Plans and Pricing
Astrazeneca PULMICORT budesonide POWDER, METERED;INHALATION 020441-002 Jun 24, 1997 See Plans and Pricing See Plans and Pricing
Salix UCERIS budesonide TABLET, EXTENDED RELEASE;ORAL 203634-001 Jan 14, 2013 See Plans and Pricing See Plans and Pricing
>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
Calliditas Therapeutics AB 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

Supplementary Protection Certificates for BUDESONIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2435024 132021000000095 Italy See Plans and Pricing 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 LUC00208 Luxembourg See Plans and Pricing 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 301102 Netherlands See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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