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Last Updated: August 3, 2021

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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 eleven branded drugs marketed by Salix, Astrazeneca, Alvogen, Amneal Pharms, Barr Labs Div Teva, Mayne Pharma, Mylan, Rising, Sciecure Pharma Inc, Zydus Pharms, Perrigo Pharma Intl, Sun Pharma Global, 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, and Astrazeneca Ab, and is included in thirty NDAs. There are twenty-four 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-nine suppliers are listed for this compound. There is one tentative approval 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
Washington University School of MedicinePhase 2
Hospital Clinic of BarcelonaPhase 4
Bond Avillion 2 Development LPPhase 1

See all budesonide clinical trials

Generic filers with tentative approvals for BUDESONIDE
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free0.08MG/INH; 0.0045MG/INHAEROSOL, METERED;INHALATION
⤷  Try it Free⤷  Try it Free0.16MG/INH; 0.0045MG/INHAEROSOL, METERED;INHALATION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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, DELAYED RELEASE;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
Sandoz Inc BUDESONIDE budesonide SUSPENSION;INHALATION 201966-002 Sep 27, 2013 AN RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Impax Labs Inc BUDESONIDE budesonide SUSPENSION;INHALATION 078404-002 Jul 31, 2012 AN RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Cipla BUDESONIDE budesonide SUSPENSION;INHALATION 205710-001 Nov 16, 2017 AN RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-001 Jul 12, 2006 RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 it Free ⤷  Try it Free
Salix UCERIS budesonide TABLET, EXTENDED RELEASE;ORAL 203634-001 Jan 14, 2013 ⤷  Try it Free ⤷  Try it Free
Astrazeneca PULMICORT budesonide POWDER, METERED;INHALATION 020441-002 Jun 24, 1997 ⤷  Try it Free ⤷  Try it Free
Astrazeneca PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929-002 Aug 8, 2000 ⤷  Try it Free ⤷  Try it Free
Astrazeneca PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929-003 Aug 8, 2000 ⤷  Try it Free ⤷  Try it Free
>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
2435024 LUC00208 Luxembourg ⤷  Try it 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 301102 Netherlands ⤷  Try it 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 2021C/518 Belgium ⤷  Try it 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
0613371 SPC/GB02/033 United Kingdom ⤷  Try it Free 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:

Johnson and Johnson
Baxter
Medtronic
Dow
Express Scripts
Harvard Business School

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