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Generated: August 21, 2018

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SYMBICORT Drug Profile

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When do Symbicort patents expire, and what generic alternatives are available?

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

This drug has three hundred and one patent family members in forty-four countries.

The generic ingredient in SYMBICORT is budesonide; formoterol fumarate dihydrate. There are twenty-one 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.

Drug patent expirations by year for SYMBICORT
Generic Entry Opportunity Date for SYMBICORT
Generic Entry Date for SYMBICORT*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
AEROSOL, METERED;INHALATION

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for SYMBICORT

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;INHALATION 021929-002 Jul 21, 2006 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for SYMBICORT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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
6,805,116 Inhalation device ➤ Try a Free Trial
2,006,189,587 ➤ Try a Free Trial
8,584,668 Inhalation device ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for SYMBICORT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB02/033 United Kingdom ➤ Try a Free Trial 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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