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Last Updated: August 9, 2020

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Which patents cover Budesonide, and what generic alternatives are available?

Budesonide is a drug marketed by Alvogen, Amneal Pharms, Appco, Barr Labs Div Teva, Mayne Pharma, Mylan, Sciecure Pharma Inc, Zydus Pharms, Apotex Inc, Cipla, Impax Labs Inc, Lupin Atlantis, Nephron, Sandoz Inc, Teva Pharms, Teva Pharms Usa, and Actavis Labs Fl Inc. and is included in seventeen NDAs.

The generic ingredient in BUDESONIDE is budesonide. There are twenty-two drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the budesonide profile page.

US ANDA Litigation and Generic Entry Outlook for Budesonide

A generic version of BUDESONIDE was approved as budesonide by TEVA PHARMS on November 18th, 2008.

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Drug patent expirations by year for BUDESONIDE
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

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
ENTOCORT EC CAPSULE;ORAL budesonide 021324 2008-02-01
RHINOCORT ALLERGY SPRAY, METERED;NASAL budesonide 020746 2007-05-14

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
Alvogen BUDESONIDE budesonide CAPSULE;ORAL 206724-001 Nov 23, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Sandoz Inc BUDESONIDE budesonide SUSPENSION;INHALATION 201966-003 Sep 27, 2013 AN RX No No   Start Trial   Start Trial   Start Trial
Actavis Labs Fl Inc BUDESONIDE budesonide TABLET, EXTENDED RELEASE;ORAL 205457-001 Jul 3, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Sciecure Pharma Inc BUDESONIDE budesonide CAPSULE;ORAL 209041-001 Sep 28, 2017 AB RX No No   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

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Express Scripts

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