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Serving 500+ biopharmaceutical companies globally:

Teva
Farmers Insurance
Harvard Business School
Mallinckrodt
Federal Trade Commission
Cantor Fitzgerald
Boehringer Ingelheim
UBS
US Department of Justice
AstraZeneca

Generated: June 29, 2017

DrugPatentWatch Database Preview

BYDUREON Drug Profile

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

Bydureon is a drug marketed by Astrazeneca Ab and is included in one NDA. There are twenty patents protecting this drug.

This drug has two hundred and eighty-four patent family members in thirty-two countries.

The generic ingredient in BYDUREON is exenatide synthetic. There are seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the exenatide synthetic profile page.

Summary for Tradename: BYDUREON

Patents:18
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Bulk Api Vendors: see list11
Clinical Trials: see list26
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:BYDUREON at DailyMed

Pharmacology for Tradename: BYDUREON

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Ab
BYDUREON PEN
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes7,741,269► Subscribe ► Subscribe
Astrazeneca Ab
BYDUREON PEN
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes5,424,286► Subscribe ► Subscribe
Astrazeneca Ab
BYDUREON PEN
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes8,329,648► Subscribe ► Subscribe
Astrazeneca Ab
BYDUREON PEN
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes6,872,700► Subscribe ► Subscribe
Astrazeneca Ab
BYDUREON
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-001Jan 27, 2012RXYesYes6,479,065► SubscribeY ► Subscribe
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Expired Patents for Tradename: BYDUREON

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab
BYDUREON
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-001Jan 27, 20125,424,286► Subscribe
Astrazeneca Ab
BYDUREON
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-001Jan 27, 20126,858,576► Subscribe
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Non-Orange Book Patents for Tradename: BYDUREON

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
7,223,725Exendin agonist compounds► Subscribe
7,297,761Pharmaceutical compositions containing exendins► Subscribe
6,902,744 Exendin agonist formulations and methods of administration thereof► Subscribe
7,138,375Use of exendins and agonists thereof for lowering plasma lipid► Subscribe
7,524,530Residual solvent extraction method and microparticles produced thereby► 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: BYDUREON

Country Document Number Estimated Expiration
Japan2001523688► Subscribe
Slovenia1971362► Subscribe
Norway2010012► Subscribe
Japan4426727► Subscribe
Canada2299425► 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: BYDUREON

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1734971/01Switzerland► SubscribePRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: SWISSMEDIC 61629 17.02.2012
989Luxembourg► Subscribe91989, EXPIRES: 20260617
342Luxembourg► Subscribe91342, EXPIRES: 20211120
2012000028Germany► SubscribePRODUCT NAME: BYDUREON-EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
8 5006-2012Slovakia► SubscribePRODUCT NAME: EXENATID; REGISTRATION NO/DATE: EU/1/11/696/001 - EU/1/11/696/002 20110623
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Accenture
AstraZeneca
McKinsey
McKesson
Chubb
Citi
QuintilesIMS
Harvard Business School
Healthtrust
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.

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