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Last Updated: August 8, 2020

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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 ten branded drugs marketed by Salix, Astrazeneca, Sun Pharma Global, Alvogen, Amneal Pharms, Appco, Barr Labs Div Teva, Mayne Pharma, Mylan, Sciecure Pharma Inc, Zydus Pharms, Perrigo Pharma Intl, Apotex Inc, Astrazeneca Pharms, Cipla, Impax Labs Inc, Lupin Atlantis, Nephron, Sandoz Inc, Teva Pharms, Teva Pharms Usa, and Actavis Labs Fl Inc, and is included in twenty-seven NDAs. There are twenty-six patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Budesonide has twenty-nine patent family members in seventeen countries.

There are twenty-two drug master file entries for budesonide. Thirty-five 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
Washington University School of MedicinePhase 2
Lawson Health Research InstitutePhase 4
St. Justine's HospitalN/A

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Pharmacology for budesonide
Medical Subject Heading (MeSH) Categories for budesonide
Paragraph IV (Patent) Challenges for BUDESONIDE
Tradename Dosage Ingredient NDA Submissiondate
UCERIS TABLET, EXTENDED RELEASE;ORAL budesonide 203634 2013-03-11
PULMICORT RESPULES SUSPENSION;INHALATION budesonide 020929 2010-05-28
ENTOCORT EC CAPSULE;ORAL budesonide 021324 2008-02-01
RHINOCORT ALLERGY SPRAY, METERED;NASAL budesonide 020746 2007-05-14
PULMICORT RESPULES SUSPENSION;INHALATION budesonide 020929 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
Mylan BUDESONIDE budesonide CAPSULE;ORAL 090410-001 May 16, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Perrigo Pharma Intl ENTOCORT EC budesonide CAPSULE;ORAL 021324-001 Oct 2, 2001 AB RX Yes Yes   Start Trial   Start Trial   Start 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 021949-001 Jul 12, 2006   Start Trial   Start Trial
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-001 Jul 12, 2006   Start Trial   Start Trial
Salix UCERIS budesonide TABLET, EXTENDED RELEASE;ORAL 203634-001 Jan 14, 2013   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for budesonide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0613371 SPC/GB02/033 United Kingdom   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Baxter
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Harvard Business School

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