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Serving 500+ biopharmaceutical companies globally:

AstraZeneca
Baxter
Accenture
Daiichi Sankyo
Queensland Health
US Army
Fish and Richardson
Fuji
Express Scripts
Johnson and Johnson

Generated: July 22, 2017

DrugPatentWatch Database Preview

SYMBICORT Drug Profile

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What is the patent landscape for Symbicort, and what generic Symbicort alternatives are available?

Symbicort is a drug marketed by Astrazeneca and is included in one NDA. There are thirteen patents protecting this drug.

This drug has three hundred and twenty-three patent family members in forty-eight countries.

The generic ingredient in SYMBICORT is budesonide; formoterol fumarate dihydrate. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the budesonide; formoterol fumarate dihydrate profile page.

Summary for Tradename: SYMBICORT

Patents:13
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Clinical Trials: see list129
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:SYMBICORT at DailyMed
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;INHALATION021929-001Jul 21, 2006RXYesYes6,123,924► SubscribeY ► Subscribe
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-002Jul 21, 2006RXYesYes7,897,646*PED► SubscribeY► Subscribe
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-002Jul 21, 2006RXYesYes8,875,699*PED► SubscribeY► Subscribe
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-001Jul 21, 2006RXYesYes8,387,615*PED► SubscribeY► Subscribe
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-001Jul 21, 2006RXYesYes7,759,328*PED► SubscribeY► Subscribe
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Expired Patents for Tradename: SYMBICORT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-002Jul 21, 20066,641,800► Subscribe
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-001Jul 21, 20065,349,945► Subscribe
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-002Jul 21, 20065,972,919► Subscribe
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-001Jul 21, 20065,972,919► Subscribe
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-002Jul 21, 20065,674,860► Subscribe
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Non-Orange Book Patents for Tradename: SYMBICORT

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
2,006,189,587► Subscribe
6,641,800 Pressurized aerosol compositions comprising powdered medicament dispersed in hydrofluoroalkane► Subscribe
7,743,765Inhalation device► Subscribe
8,584,668Inhalation 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 Tradename: SYMBICORT

Country Document Number Estimated Expiration
MexicoPA04007295► Subscribe
Turkey200001357► Subscribe
Norway20075848► Subscribe
Slovakia285330► Subscribe
Japan4869226► 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: SYMBICORT

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 500+ biopharmaceutical companies globally:

Baxter
Federal Trade Commission
US Department of Justice
Dow
Deloitte
Fuji
Merck
Chinese Patent Office
Julphar
Accenture

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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