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Last Updated: July 21, 2024

BUDESONIDE Drug Patent Profile


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

Budesonide is a drug marketed by Padagis Israel, Amneal Pharms, Aurobindo Pharma Usa, Barr Labs Div Teva, Dr Reddys Labs Sa, Natco, Rising, Sciecure Pharma Inc, Zydus Pharms, Apotex Inc, Cipla, Eugia Pharma, Impax Labs Inc, Lupin, Nephron, Sandoz, Sun Pharm, Teva Pharms, Teva Pharms Usa, Actavis Labs Fl Inc, and Mylan. and is included in twenty-one NDAs.

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

DrugPatentWatch® 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
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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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms Usa BUDESONIDE budesonide SUSPENSION;INHALATION 204548-001 Mar 8, 2016 AN RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Actavis Labs Fl Inc BUDESONIDE budesonide TABLET, EXTENDED RELEASE;ORAL 205457-001 Jul 3, 2018 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Padagis Israel BUDESONIDE budesonide AEROSOL, FOAM;RECTAL 215328-001 Apr 12, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Nephron BUDESONIDE budesonide SUSPENSION;INHALATION 078202-001 Mar 30, 2009 AN RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm BUDESONIDE budesonide SUSPENSION;INHALATION 211922-002 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

EU/EMA Drug Approvals for BUDESONIDE

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

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