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Details for Generic Name: budesonide; formoterol fumarate dihydrate

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

This ingredient has three hundred and fifty-one patent family members in fifty countries.

There are nineteen drug master file entries for budesonide; formoterol fumarate dihydrate. One supplier is listed for this compound.

Summary for Generic Name: budesonide; formoterol fumarate dihydrate

Tradenames:1
Patents:14
Applicants:1
NDAs:1
Drug Master File Entries: see list19
Suppliers / Packaging: see list4

Pharmacology for Ingredient: budesonide; formoterol fumarate dihydrate

Clinical Trials for: budesonide; formoterol fumarate dihydrate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-002Jul 21, 2006RXYes8,575,137<disabled>Y <disabled>
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-002Jul 21, 2006RXYes7,759,328<disabled>Y <disabled>
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-001Jul 21, 2006RXYes7,967,011<disabled>Y <disabled>
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Expired Orange Book Patents for Generic Ingredient: budesonide; formoterol fumarate dihydrate

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-002Jul 21, 20065,972,919<disabled>
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-001Jul 21, 20065,349,945<disabled>
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-002Jul 21, 20065,674,860<disabled>
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Non-Orange Book Patents for Generic Ingredient: 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
5,972,919 Combination of a bronchodilator and a steroidal anti-inflammatory drug for the treatment of respiratory disorders, as well as its use and the preparation thereof<disabled in preview>
6,641,800 Pressurized aerosol compositions comprising powdered medicament dispersed in hydrofluoroalkane<disabled in preview>
6,805,116 Inhalation device<disabled in preview>
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International Patent Family for Ingredient: budesonide; formoterol fumarate dihydrate

Country Document Number Publication Date
Australia2006234785Jan 28, 2010
Iceland9028Apr 16, 2013
European Patent Office1768727Apr 04, 2007
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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 information. There is no warranty that the information contained herein is error free. 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.

Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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