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Budesonide; formoterol fumarate dihydrate - Generic Drug Details

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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 thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has three hundred and fifteen patent family members in forty-seven countries.

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

Summary for Generic Name: budesonide; formoterol fumarate dihydrate

Tradenames:1
Patents:13
Applicants:1
NDAs:1
Drug Master File Entries: see list19
Suppliers / Packaging: see list2
Formulation / Manufacturing:see details

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;INHALATION021929-001Jul 21, 2006RXYes8,875,699<disabled>Y <disabled>
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-002Jul 21, 2006RXYes6,123,924<disabled>Y <disabled>
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-002Jul 21, 2006RXYes8,528,545<disabled>Y <disabled>
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Expired Orange Book Patents for Generic Ingredient: budesonide; formoterol fumarate dihydrate

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-001Jul 21, 20066,641,800<disabled>
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, 20065,674,860<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
6,805,116 Inhalation device<disabled in preview>
8,584,668Inhalation device<disabled in preview>
7,743,765Inhalation device<disabled in preview>
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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
Japan2008504923<disabled in preview>
Estonia00721<disabled in preview>
Denmark0605578<disabled in preview>
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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<disabled>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
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