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Last Updated: July 12, 2020

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PULMICORT FLEXHALER Drug 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-six suppliers are listed for this compound. Additional details are available on the budesonide profile page.

US ANDA 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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Drug patent expirations by year for PULMICORT FLEXHALER
Drug Prices for PULMICORT FLEXHALER

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Drug Sales Revenue Trends for PULMICORT FLEXHALER

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Recent Clinical Trials for PULMICORT FLEXHALER

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SponsorPhase
AstraZenecaPhase 1
Columbia UniversityPhase 4
West Penn Allegheny Health SystemPhase 4

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Pharmacology for PULMICORT FLEXHALER

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   Start Trial   Start Trial   Start Trial
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-002 Jul 12, 2006 RX Yes Yes   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

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

Supplementary Protection Certificates for PULMICORT FLEXHALER

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0613371 SPC/GB02/033 United Kingdom   Start Trial 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
Harvard Business School
Dow
Boehringer Ingelheim
AstraZeneca
Colorcon

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