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Serving leading biopharmaceutical companies globally:

Cerilliant
Johnson and Johnson
US Department of Justice
Dow
Colorcon
Farmers Insurance
Argus Health
Merck
Mallinckrodt
Fuji

Generated: January 20, 2018

DrugPatentWatch Database Preview

PULMICORT FLEXHALER Drug Profile

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Which patents cover Pulmicort Flexhaler, and what generic alternatives are available?

Pulmicort Flexhaler is a drug marketed by Astrazeneca and is included in one NDA. There are four patents protecting this drug.

This drug has one hundred and sixteen patent family members in thirty-eight countries.

The generic ingredient in PULMICORT FLEXHALER is budesonide. There are twenty-one drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the budesonide profile page.
Summary for PULMICORT FLEXHALER
Drug patent expirations by year for PULMICORT FLEXHALER
Pharmacology for PULMICORT FLEXHALER
Medical Subject Heading (MeSH) Categories 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 ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-002 Jul 12, 2006 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-001 Jul 12, 2006 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-002 Jul 12, 2006 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-001 Jul 12, 2006 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-001 Jul 12, 2006 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-002 Jul 12, 2006 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-002 Jul 12, 2006 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
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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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 ➤ Subscribe ➤ Subscribe
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-002 Jul 12, 2006 ➤ Subscribe ➤ Subscribe
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-002 Jul 12, 2006 ➤ Subscribe ➤ Subscribe
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-002 Jul 12, 2006 ➤ Subscribe ➤ Subscribe
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-001 Jul 12, 2006 ➤ Subscribe ➤ Subscribe
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-001 Jul 12, 2006 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for PULMICORT FLEXHALER

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,030,604 Formulation for inhalation ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for PULMICORT FLEXHALER

Supplementary Protection Certificates for PULMICORT FLEXHALER

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB02/033 United Kingdom ➤ Subscribe 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Chubb
Cipla
Dow
Healthtrust
Teva
Mallinckrodt
Daiichi Sankyo
Merck

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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