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Last Updated: September 25, 2022

PULMICORT FLEXHALER Drug Patent Profile


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When do Pulmicort Flexhaler patents expire, and what generic alternatives are available?

Pulmicort Flexhaler is a drug marketed by Astrazeneca and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Pulmicort Flexhaler

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

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US Patents and Regulatory Information for PULMICORT FLEXHALER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-001 Jul 12, 2006 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-002 Jul 12, 2006 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 PULMICORT FLEXHALER

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-001 Jul 12, 2006 See Plans and Pricing See Plans and Pricing
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-001 Jul 12, 2006 See Plans and Pricing See Plans and Pricing
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-001 Jul 12, 2006 See Plans and Pricing See Plans and Pricing
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-001 Jul 12, 2006 See Plans and Pricing See Plans and Pricing
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-002 Jul 12, 2006 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for PULMICORT FLEXHALER

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
Calliditas Therapeutics AB 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

International Patents for PULMICORT FLEXHALER

See the table below for patents covering PULMICORT FLEXHALER around the world.

Country Patent Number Title Estimated Expiration
China 1222282 See Plans and Pricing
Greece 1003290 ΝΕΑ ΣΥΝΘΕΣΗ ΓΙΑ ΕΙΣΠΝΟΗ (NEW FORMULATION FOR INHALATION) See Plans and Pricing
Russian Federation 2180563 PREPARATION FOR INHALATION WITH FILLED VOLUME DENSITY FROM 0,28 TO 0,38 G/ML CONTAINING BUDESONIDE See Plans and Pricing
Norway 327426 See Plans and Pricing
New Zealand 337551 Inhalation device including an indicating wheel with a viewable side surface See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PULMICORT FLEXHALER

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2435024 2021C/518 Belgium See Plans and Pricing 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
2435024 LUC00208 Luxembourg See Plans and Pricing 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 21C1020 France See Plans and Pricing PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI), GLYCOPYRROLATE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET BUDESONIDE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); REGISTRATION NO/DATE: EU/1/20/1498 20201210
2435024 132021000000095 Italy See Plans and Pricing PRODUCT NAME: UNA COMBINAZIONE DI FORMOTEROLO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI), GLICOPIRROLATO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI) E BUDESONIDE (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI)(TRIXEO AEROSPHERE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1498, 20201210
0613371 SPC/GB02/033 United Kingdom See Plans and Pricing 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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