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Last Updated: July 23, 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 freedom to operate?

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. Eighteen 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

See drug sales revenues for BUDESONIDE

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 FreeUNKNOWNUNKNOWN

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
Sun Pharm BUDESONIDE budesonide SUSPENSION;INHALATION 211922-002 Apr 14, 2021 AN RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Sun Pharma Global ORTIKOS budesonide CAPSULE, EXTENDED RELEASE;ORAL 211929-001 Jun 13, 2019 RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Actavis Labs Fl Inc BUDESONIDE budesonide TABLET, EXTENDED RELEASE;ORAL 205457-001 Jul 3, 2018 AB RX No 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 021949-001 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 RESPULES budesonide SUSPENSION;INHALATION 020929-001 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
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:

Mallinckrodt
AstraZeneca
Medtronic
Express Scripts
McKesson
Harvard Business School

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