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SYMBICORT Drug Profile

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Symbicort is a drug marketed by Astrazeneca and is included in one NDA. It is available from two suppliers. There are thirteen patents protecting this drug.

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

The generic ingredient in SYMBICORT is budesonide; formoterol fumarate dihydrate. There are nineteen drug master file entries for this compound. Two suppliers are 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 list2
Formulation / Manufacturing:see details
Drug Prices: :see details

Clinical Trials for: SYMBICORT

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, 2006RXYes7,759,328Jan 29, 2023Y
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-002Jul 21, 2006RXYes7,967,011Aug 11, 2021Y
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-002Jul 21, 2006RXYes8,875,699Nov 10, 2024Y
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Expired Patents for Tradename: SYMBICORT

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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, 20065,349,945<disabled>
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-002Jul 21, 20065,972,919<disabled>
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-002Jul 21, 20065,674,860<disabled>
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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
6,641,800 Pressurized aerosol compositions comprising powdered medicament dispersed in hydrofluoroalkane<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 Tradename: SYMBICORT

Country Document Number Estimated Expiration
Russian Federation2388052<disabled in preview>
Norway337006<disabled in preview>
Norway321864<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: SYMBICORT

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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