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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Farmers Insurance
Medtronic
Chinese Patent Office
Mallinckrodt
US Department of Justice
UBS
QuintilesIMS
Federal Trade Commission

Generated: April 20, 2018

DrugPatentWatch Database Preview

SYMBICORT Drug Profile

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Which patents cover Symbicort, and when can generic versions of Symbicort launch?

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.
Summary for SYMBICORT
International Patents:301
US Patents:12
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Clinical Trials: 130
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:SYMBICORT at DailyMed
Drug patent expirations by year for SYMBICORT

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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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 021929-001 Jul 21, 2006 ➤ Sign Up ➤ Sign Up
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 ➤ Sign Up ➤ Sign Up
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 ➤ Sign Up ➤ Sign Up
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 ➤ Sign Up ➤ Sign Up
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
8,584,668 Inhalation device ➤ Sign Up
7,819,075 Inhaler device counter ➤ Sign Up
2,006,189,587 ➤ Sign Up
6,805,116 Inhalation device ➤ Sign Up
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 ➤ Sign Up 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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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Boehringer Ingelheim
Baxter
Covington
McKesson
Chinese Patent Office
McKinsey
Cipla
Fuji

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.