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Last Updated: May 20, 2022

PULMICORT RESPULES Drug Patent Profile


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Which patents cover Pulmicort Respules, and when can generic versions of Pulmicort Respules launch?

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

The generic ingredient in PULMICORT RESPULES 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 Respules

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

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Drug patent expirations by year for PULMICORT RESPULES
Drug Prices for PULMICORT RESPULES

See drug prices for PULMICORT RESPULES

Paragraph IV (Patent) Challenges for PULMICORT RESPULES
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PULMICORT RESPULES Inhalation Suspension budesonide 1 mg/2 mL 020929 1 2010-05-28
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 PULMICORT RESPULES

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929-001 Aug 8, 2000 AN RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929-002 Aug 8, 2000 AN RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929-003 Aug 8, 2000 AN 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 RESPULES

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929-003 Aug 8, 2000 See Plans and Pricing See Plans and Pricing
Astrazeneca PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929-001 Aug 8, 2000 See Plans and Pricing See Plans and Pricing
Astrazeneca PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929-002 Aug 8, 2000 See Plans and Pricing See Plans and Pricing
Astrazeneca PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929-001 Aug 8, 2000 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for PULMICORT RESPULES

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

Country Patent Number Title Estimated Expiration
Germany 3675564 See Plans and Pricing
Argentina 013765 PROCESO PARA LA ESTERILIZACION DE UN GLUCOCORTICOESTEROIDE See Plans and Pricing
Denmark 1032396 See Plans and Pricing
Australia 1266699 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PULMICORT RESPULES

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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