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, J And J Consumer Inc, 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-five 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 forty-seven patent family members in thirty-one countries.

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

Summary for budesonide

International Patents:	147
US Patents:	35
Tradenames:	15
Applicants:	30
NDAs:	36
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	43
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	433
Patent Applications:	6,862
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

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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

Sponsor	Phase
Assiut University	Phase 4
Ferring Pharmaceuticals	Phase 2
University of Calgary	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

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sciecure Pharma Inc	BUDESONIDE	budesonide	CAPSULE, DELAYED RELEASE;ORAL	209041-001	Sep 28, 2017		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-001	Jul 21, 2006	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Sun Pharm	BUDESONIDE	budesonide	SUSPENSION;INHALATION	211922-003	Apr 14, 2021	AN	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix	UCERIS	budesonide	TABLET, EXTENDED RELEASE;ORAL	203634-001	Jan 14, 2013	⤷ Sign Up	⤷ Sign Up
Cheplapharm	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-002	Jul 12, 2006	⤷ Sign Up	⤷ Sign Up
Cheplapharm	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-001	Jul 12, 2006	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for budesonide

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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

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Country	Patent Number	Title	Estimated Expiration
Canada	2704943	COMPOSITIONS POUR LE TRAITEMENT D'UNE INFLAMMATION GASTRO-INTESTINALE (COMPOSITIONS FOR THE TREATMENT OF GASTROINTESTINAL INFLAMMATION)	⤷ Sign Up
Poland	3354276		⤷ Sign Up
China	111741756	稳定的皮质类固醇组合物 (Stable corticosteroid compositions)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for budesonide

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	21C1020	France	⤷ Sign Up	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	SPC/GB21/029	United Kingdom	⤷ Sign Up	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	LUC00208	Luxembourg	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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