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Serving leading biopharmaceutical companies globally:

Citi
Daiichi Sankyo
Federal Trade Commission
Express Scripts
Healthtrust
AstraZeneca
Novartis
Colorcon
Medtronic
Fuji

Generated: December 16, 2017

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 and one supplementary protection certificate in one country.

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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
AstrazenecaPULMICORT FLEXHALERbudesonidePOWDER, METERED;INHALATION021949-001Jul 12, 2006RXYesNo► Subscribe► SubscribeY► Subscribe
AstrazenecaPULMICORT FLEXHALERbudesonidePOWDER, METERED;INHALATION021949-002Jul 12, 2006RXYesYes► Subscribe► SubscribeY► Subscribe
AstrazenecaPULMICORT FLEXHALERbudesonidePOWDER, METERED;INHALATION021949-001Jul 12, 2006RXYesNo► Subscribe► SubscribeY► Subscribe
AstrazenecaPULMICORT FLEXHALERbudesonidePOWDER, METERED;INHALATION021949-002Jul 12, 2006RXYesYes► Subscribe► SubscribeY► Subscribe
AstrazenecaPULMICORT FLEXHALERbudesonidePOWDER, METERED;INHALATION021949-001Jul 12, 2006RXYesNo► Subscribe► SubscribeY► Subscribe
AstrazenecaPULMICORT FLEXHALERbudesonidePOWDER, METERED;INHALATION021949-001Jul 12, 2006RXYesNo► Subscribe► SubscribeY► Subscribe
AstrazenecaPULMICORT FLEXHALERbudesonidePOWDER, METERED;INHALATION021949-002Jul 12, 2006RXYesYes► Subscribe► SubscribeY► Subscribe
AstrazenecaPULMICORT FLEXHALERbudesonidePOWDER, METERED;INHALATION021949-002Jul 12, 2006RXYesYes► Subscribe► SubscribeY► Subscribe
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Expired Patents for Tradename: PULMICORT FLEXHALER

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
AstrazenecaPULMICORT FLEXHALERbudesonidePOWDER, METERED;INHALATION021949-001Jul 12, 2006► Subscribe► Subscribe
AstrazenecaPULMICORT FLEXHALERbudesonidePOWDER, METERED;INHALATION021949-002Jul 12, 2006► Subscribe► Subscribe
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Non-Orange Book Patents for Tradename: 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
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: PULMICORT FLEXHALER

Country Document Number Estimated Expiration
Canada2283191► Subscribe
Denmark1019033► Subscribe
Germany69839275► Subscribe
Slovakia95799► Subscribe
Czech Republic295083► Subscribe
Norway993537► Subscribe
Estonia9900320► Subscribe
Czech Republic9902555► Subscribe
Poland334527► Subscribe
Spain2235311► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: PULMICORT FLEXHALER

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB02/033United Kingdom► SubscribePRODUCT 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
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Serving leading biopharmaceutical companies globally:

Deloitte
Merck
Citi
Farmers Insurance
QuintilesIMS
Novartis
Harvard Business School
UBS
Baxter
Fuji

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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