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Serving leading biopharmaceutical companies globally:

Dow
Moodys
Daiichi Sankyo
Farmers Insurance
Express Scripts
Fish and Richardson
Colorcon
Accenture
Argus Health
Cipla

Generated: February 25, 2018

DrugPatentWatch Database Preview

Budesonide; formoterol fumarate dihydrate - Generic Drug Details

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What are the generic sources for budesonide; formoterol fumarate dihydrate and what is the scope of budesonide; formoterol fumarate dihydrate patent protection?

Budesonide; formoterol fumarate dihydrate
is the generic ingredient in one branded drug marketed by Astrazeneca and is included in one NDA. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Budesonide; formoterol fumarate dihydrate has three hundred and one patent family members in forty-four countries.

There are twenty-one drug master file entries for budesonide; formoterol fumarate dihydrate. One supplier is listed for this compound.
Summary for budesonide; formoterol fumarate dihydrate
International Patents:301
US Patents:12
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 21
Suppliers / Packagers: 1
Clinical Trials: 942
Drug Prices:see low prices
DailyMed Link:budesonide; formoterol fumarate dihydrate at DailyMed
Pharmacology for budesonide; formoterol fumarate dihydrate

US Patents and Regulatory Information for budesonide; formoterol fumarate dihydrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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 budesonide; formoterol fumarate dihydrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006 ➤ Sign Up ➤ Sign Up
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 ➤ Sign Up ➤ Sign Up
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 ➤ Sign Up ➤ Sign Up
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006 ➤ Sign Up ➤ Sign Up
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006 ➤ Sign Up ➤ Sign Up
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006 ➤ Sign Up ➤ Sign Up
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 ➤ Sign Up ➤ Sign Up
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for budesonide; formoterol fumarate dihydrate

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
6,805,116 Inhalation device ➤ Sign Up
7,819,075 Inhaler device counter ➤ Sign Up
7,743,765 Inhalation device ➤ Sign Up
2,006,189,587 ➤ Sign Up
8,584,668 Inhalation device ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for budesonide; formoterol fumarate dihydrate

Country Document Number Estimated Expiration
Austria 411069 ➤ Sign Up
Hungary 0003848 ➤ Sign Up
Bulgaria 1354 ➤ Sign Up
Israel 175439 ➤ Sign Up
South Korea 20080000024 ➤ Sign Up
Israel 134773 ➤ Sign Up
Canada 2614626 ➤ Sign Up
Japan 2007513647 ➤ Sign Up
Germany 212006000031 ➤ Sign Up
Denmark 1696987 ➤ Sign Up
Country Document Number Estimated Expiration

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Supplementary Protection Certificates for budesonide; formoterol fumarate dihydrate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB02/033 United Kingdom ➤ Sign Up 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 hundreds of leading biopharmaceutical companies globally:

Healthtrust
US Department of Justice
Express Scripts
QuintilesIMS
McKesson
Farmers Insurance
Accenture
Merck
Baxter

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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