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Generated: October 20, 2017

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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 freedom to operate?

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

Budesonide; formoterol fumarate dihydrate has three hundred and forty-six patent family members in forty-eight countries and one supplementary protection certificate in one country.

There are twenty drug master file entries for budesonide; formoterol fumarate dihydrate. Two suppliers are listed for this compound.

Summary for Generic Name: BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE

US Patents:13
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: see list20
Suppliers / Packagers: see list2
Clinical Trials: see list928
Drug Prices:see low prices
DailyMed Link:BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE at DailyMed

Pharmacology for Ingredient: 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;INHALATION021929-002Jul 21, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-001Jul 21, 2006RXYesYes► Subscribe► Subscribe► Subscribe
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-001Jul 21, 2006RXYesYes► Subscribe► SubscribeY► Subscribe
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-001Jul 21, 2006RXYesYes► Subscribe► SubscribeY► Subscribe
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-001Jul 21, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-001Jul 21, 2006RXYesYes► Subscribe► SubscribeY► Subscribe
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-001Jul 21, 2006RXYesYes► Subscribe► SubscribeY► Subscribe
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-002Jul 21, 2006RXYesYes► Subscribe► SubscribeY► Subscribe
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-002Jul 21, 2006RXYesYes► Subscribe► SubscribeY► Subscribe
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-002Jul 21, 2006RXYesYes► Subscribe► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: budesonide; formoterol fumarate dihydrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-002Jul 21, 2006► Subscribe► Subscribe
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-002Jul 21, 2006► Subscribe► Subscribe
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-001Jul 21, 2006► Subscribe► Subscribe
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-002Jul 21, 2006► Subscribe► Subscribe
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-001Jul 21, 2006► Subscribe► Subscribe
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-002Jul 21, 2006► Subscribe► Subscribe
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-001Jul 21, 2006► Subscribe► Subscribe
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-001Jul 21, 2006► Subscribe► Subscribe
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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
7,819,075Inhaler device counter► Subscribe
6,641,800 Pressurized aerosol compositions comprising powdered medicament dispersed in hydrofluoroalkane► Subscribe
2,006,189,587► Subscribe
7,743,765Inhalation device► Subscribe
8,584,668Inhalation device► Subscribe
6,805,116 Inhalation device► 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 Ingredient: budesonide; formoterol fumarate dihydrate

Country Document Number Estimated Expiration
Taiwan200616684► Subscribe
Bulgaria1354► Subscribe
Slovakia286209► Subscribe
Malaysia127812► Subscribe
Portugal2036549► Subscribe
European Patent Office1474117► Subscribe
Russian Federation2301673► Subscribe
Spain2359251► Subscribe
Austria10426► Subscribe
South Africa200603934► 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: BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE

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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Johnson and Johnson
Citi
Cipla
Chinese Patent Office
Cantor Fitzgerald
Boehringer Ingelheim
Teva
Novartis
US Army

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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